A drug infusion device for tumor interventional treatment

Abstract

The present invention provides a drug perfusion device for tumor interventional treatment, which belongs to the technical field of drug perfusion devices. The drug perfusion device for tumor interventional treatment comprises a main body, a seal, a support and fixation, a drug delivery, a pressure control, a temperature regulation, a rotation drive, a liquid filtration and a safety protection component; the main body is cylindrical, the inner wall is made of medical-grade polytetrafluoroethylene, and the bottom has a stepped base; the sealing component comprises a sealing cover plate and a leak-proof pad, which are fixed by bolts; the supporting component consists of a U-shaped base and a hexagonal column; the drug delivery component has a precision flow control valve; the pressure control component comprises a sensor and a regulating valve; the temperature regulation component can be adjusted from 2°C to 42°C; the rotation drive component consists of a shaft and a motor; the safety protection component comprises a protective cover and an emergency drain valve; the present invention can solve the defects of traditional tumor interventional treatment perfusion equipment in structure, drug delivery and cleanliness, facilitates operation and use by medical staff, and improves safety performance.

Description

Technical Field

[0001] The present invention belongs to the technical field of drug perfusion equipment, and in particular, relates to a drug perfusion equipment for tumor interventional treatment. Background Art

[0002] Tumor interventional therapy is an emerging treatment method that has been widely used in the medical field in recent years. This method can increase the concentration of drugs in tumor tissues by local drug perfusion at the tumor site, thereby significantly improving the treatment effect and reducing the toxic side effects caused by systemic medication. However, the existing drug perfusion equipment for tumor interventional therapy still has some key problems that need to be solved in practical applications.

[0003] First, the overall structural design of existing equipment is often not targeted. Most devices use a simple columnar or box structure, which is difficult to meet the needs of different treatment parts and operating postures. In addition, existing equipment also generally has the problem of structural instability, prone to tilt or vibration, affecting the accuracy and safety of treatment.

[0004] Secondly, existing devices have defects in drug delivery control. Most devices rely only on simple flow control valves to adjust drug flow, making it difficult to achieve precise closed-loop control of key parameters such as pressure and temperature. This is not conducive to maintaining the optimal perfusion state of drugs in tumor tissue, thus affecting the consistency and repeatability of treatment effects.

[0005] Furthermore, the existing equipment has a relatively rough control over the cleanliness of drugs. Most equipment only has simple filters at the inlet and outlet, which makes it difficult to ensure the high purity of drugs during the entire perfusion process. This may cause the deposition of drugs in tumor tissues, affect the treatment effect, and even cause serious complications.

[0006] Finally, the safety protection measures of existing equipment are also insufficient. Most equipment lacks an effective pressure release mechanism. Once a failure occurs and the internal pressure is too high, it may cause the equipment to burst, posing a huge danger to operators and patients. In addition, for the use of radioactive drugs, the radiation protection of existing equipment is generally relatively simple. Summary of the invention

[0007] In view of this, the present invention provides a drug perfusion device for tumor interventional treatment, which can solve the defects of traditional tumor interventional treatment perfusion equipment in structure, drug delivery and cleanliness, facilitate operation and use by medical staff, and improve safety performance.

[0008] The present invention is achieved in that:

[0009] The present invention provides a drug perfusion device for tumor interventional treatment, which includes: a drug perfusion body, a sealing component, a supporting and fixing component, a drug delivery component, a pressure control component, a temperature adjustment component, a rotation drive component, a liquid filtering component and a safety protection component;

[0010] The drug infusion body is a cylindrical structure, the outer wall is made of stainless steel, the inner wall is made of medical grade polytetrafluoroethylene material, the main body length is 350mm, and the diameter is 120mm; the bottom of the drug infusion body has a circular base, and the outer edge of the base is a stepped structure for connection with the supporting fixing component;

[0011] The sealing assembly is arranged on the top of the drug infusion body, and includes a sealing cover plate and a leakproof sealing pad; the sealing cover plate is circular, and the edge has a groove structure, the leakproof sealing pad is embedded in the groove, and the sealing cover plate is fixed to the top of the drug infusion body by bolts to ensure the sealing performance;

[0012] The support and fixing assembly includes a base bracket and a support column. The base bracket is a steel U-shaped structure with an anti-slip texture on the surface. The support column is vertically fixed at the center of the base bracket. The cross-section of the support column is a hexagon and the surface is coated with an anti-corrosion coating.

[0013] The drug delivery assembly includes a drug inlet and a drug outlet. The drug inlet is arranged on the side of the sealing cover plate, and the drug outlet is located at the bottom center of the drug infusion body. Both drug outlets are equipped with precision flow control valves, and the valve opening diameter is 3mm.

[0014] The pressure control assembly includes a pressure sensor and a pressure regulating valve. The pressure sensor is installed on the side wall of the drug infusion body, and the sensing end directly contacts the inner wall of the drug infusion body. The pressure regulating valve is located on the pipeline between the drug inlet and the drug outlet, and the valve opening pressure range is 0.1MPa to 0.5MPa.

[0015] The temperature adjustment component includes an external cooling sleeve and an internal heating wire, wherein the external cooling sleeve is spirally wound on the surface of the drug infusion body, and the internal heating wire is evenly distributed on the inner wall of the drug infusion body; the temperature adjustment range is 2°C to 42°C;

[0016] The rotary drive assembly includes a rotary shaft and a rotary motor. The rotary shaft passes through the bottom of the drug infusion body and is connected to the output shaft of the rotary motor. The rotary motor is fixedly mounted at the bottom of the supporting column and drives the rotary shaft to rotate at a speed of 10 rpm to 50 rpm.

[0017] The liquid filter assembly comprises an inlet filter and an outlet filter, wherein the inlet filter is arranged inside the drug inlet and the outlet filter is arranged at the front end of the drug outlet, and the mesh size of the two filters is 20 μm;

[0018] The safety protection component includes a protective cover and an emergency drain valve. The protective cover covers the entire exterior of the drug infusion body and is made of stainless steel. The emergency drain valve is located at the bottom of the drug infusion body and automatically opens when the internal pressure exceeds 0.6MPa.

[0019] On the basis of the above technical solution, the drug infusion device for tumor interventional treatment of the present invention can also be improved as follows:

[0020] The base bracket has a length of 500 mm, a width of 300 mm and a height of 200 mm; the base bracket contacts the ground through four adjusting feet, and the height of each adjusting foot can be adjusted from 20 mm to 50 mm.

[0021] Furthermore, the sealing cover plate has two drug inlets and one exhaust port, the internal thread diameter of the drug inlet is 6 mm, and the internal thread diameter of the exhaust port is 4 mm; the thickness of the sealing cover plate is 15 mm, and the material is medical grade stainless steel.

[0022] Furthermore, the pressure sensor is a piezoresistive pressure sensor with a measurement accuracy of ±0.1% and a response time of less than 50ms; the shell material of the pressure sensor is titanium alloy, which has good corrosion resistance.

[0023] Furthermore, the external cooling jacket is made of a stainless steel tube with a tube diameter of 8 mm and a tube wall thickness of 1.5 mm; high thermal conductivity silicone grease is used to fill the space between the cooling jacket and the drug infusion body to ensure heat exchange efficiency.

[0024] Furthermore, the inlet filter screen and the outlet filter screen are both woven from 316 stainless steel wire mesh, the wire diameter is 0.05 mm, and the mesh is a square grid structure.

[0025] Furthermore, a gap of 10 mm is left between the protective cover and the drug infusion body, and the surface of the protective cover is coated with a radiation protection coating with a thickness of 2 mm.

[0026] Furthermore, the emergency drain valve is a spring-reset solenoid valve, the valve body is made of titanium alloy, and the valve opening time is less than 100ms.

[0027] Furthermore, an angle adjustment mechanism is provided on the top of the support column, and the angle adjustment range is 0° to 45°, and precise positioning is achieved by manually rotating the adjustment bolt.

[0028] Furthermore, the drug perfusion device for tumor interventional treatment performs constrained optimization on corresponding component parameters through a parameter optimization equation group, and the parameter optimization equation group includes a component structure coupling constraint equation, a sealing performance constraint equation, a temperature uniformity constraint equation and a pressure dynamic response equation.

[0029] The drug infusion therapy device of the present invention complies with the following equation:

[0030] 1. Component structure coupling constraint equation:

[0031]

[0032] Among them, this equation comprehensively considers the length of the drug perfusion body (L m ), diameter (D m ), support column height (h s ) and the tilt angle (θ s ); the overall structural stability of the equipment is limited by geometric proportionality; sin(θ s ) The influence of the introduction angle on the structure; k1 is the structural stability threshold; the purpose is to ensure the structural integrity and force balance of the equipment under different working conditions;

[0033] 2. Sealing performance constraint equation:

[0034]

[0035] Here, this equation relates the internal pressure (P i ), gasket thickness (δ s ) and material compressive strength (σ m );Evaluate the sealing reliability of sealing components under pressure; It represents the inverse of material strength and introduces the intrinsic characteristics of the material; ζ0 is the lower limit of sealing performance; the sealing performance is tested through the composite relationship between pressure and material strength;

[0036] 3. Temperature uniformity constraint equation:

[0037]

[0038] Here, this equation describes the external temperature (T e ) and internal temperature (T i ) temperature difference; introduce the cooling tube radius (r c ) and length (l c ) as the geometric parameter for temperature transfer; ∈ T is the permissible threshold value for temperature non-uniformity; the temperature distribution is controlled by the ratio of the temperature difference to the cooling tube size; the purpose is to achieve temperature uniformity in the drug perfusion body;

[0039] 4. Pressure dynamic response equation:

[0040]

[0041] The equation describes the dynamic response characteristics of the pressure sensor; P t is the pressure sensor output; τ ris the response time; K p is the pressure gain coefficient; ω(t) is the external disturbance or signal; the dynamic characteristics of the pressure sensor are simulated using a first-order linear differential equation; it reflects the rate of pressure change and the response mechanism of the sensor to pressure changes.

[0042] In the present invention, the formula variable acquisition method is shown in Table 1:

[0043] Table 1 Formula variables and their explanations

[0044]

[0045] Compared with the prior art, the drug perfusion device for tumor interventional treatment proposed by the present invention has the following significant technical advantages:

[0046] Optimized structural design: The device of the present invention adopts a cylindrical structure, with a stainless steel shell and a medical polytetrafluoroethylene lining. This structure not only improves the overall stability of the device, but also ensures that the internal surface in contact with the drug has excellent corrosion resistance and biocompatibility. At the same time, the device is also equipped with an adjustable angle support column, which can adapt to the needs of different treatment sites and operating postures, greatly improving the flexibility of clinical applications;

[0047] Precise parameter control: The device of the present invention integrates key components such as pressure sensors, temperature sensors and precision flow control valves, which can monitor and adjust parameters such as pressure, temperature and flow rate in real time during the drug infusion process. This closed-loop feedback control mechanism ensures the stability and uniformity of these key parameters throughout the treatment process, thereby improving the repeatability and consistency of the treatment;

[0048] Enhanced cleanliness guarantee: The device of the present invention is equipped with a filter with a mesh size of 20 μm at the inlet and outlet, which can effectively remove particle impurities larger than 20 μm, ensuring the high purity of the drug during the entire infusion process. This is not only conducive to improving the treatment effect, but also effectively reduces the risk of complications;

[0049] Perfect safety protection: The equipment of the present invention is equipped with a pressure release mechanism such as an emergency discharge valve. Once the internal pressure exceeds the preset threshold, it can quickly discharge the excess pressure to avoid equipment explosion accidents, greatly improving the safety of operation. In addition, the equipment also uses a protective cover made of stainless steel, with an anti-radiation coating on the inside, which can effectively block the radiation of radioactive drugs and effectively protect the safety of operators.

[0050] In summary, the drug perfusion equipment for tumor interventional treatment proposed in the present invention has significant innovations and improvements in key technical aspects such as structural design, parameter control, cleanliness assurance and safety protection, which can better meet the needs of clinical treatment and provide more reliable and efficient equipment support for tumor interventional treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings required for use in the description of the embodiments of the present invention will be briefly introduced below. Obviously, the accompanying drawings in the following description are only some embodiments of the present invention. For ordinary technicians in this field, other accompanying drawings can be obtained based on these accompanying drawings without paying creative labor.

[0052] Figure 1 This is a schematic diagram of a drug infusion device for tumor interventional treatment;

[0053] Figure 2 It is a cross-sectional view of a drug perfusion device for tumor interventional treatment;

[0054] In the accompanying drawings, the components represented by the reference numerals are listed as follows:

[0055] 1. Drug infusion body; 2. Sealing assembly; 3. Support and fixing assembly; 4. Drug delivery assembly; 5. Pressure control assembly; 6. Temperature adjustment assembly; 7. Rotary drive assembly; 8. Liquid filtration assembly. DETAILED DESCRIPTION

[0056] In order to make the purpose, technical solution and advantages of the embodiments of the present invention more clear, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention.

[0057] like Figure 1 , Figure 2 FIG. 1 is a first embodiment of a drug infusion device for tumor interventional treatment provided by the present invention. In this embodiment, the device comprises:

[0058] The drug infusion body 1 is a cylindrical stainless steel shell lined with medical grade polytetrafluoroethylene material. This structural design not only improves the corrosion resistance and high temperature resistance of the drug infusion body 1, but also ensures the biocompatibility of the internal surface in contact with the drug.

[0059] The sealing assembly 2 is arranged on the top of the drug infusion body 1, and includes a sealing cover plate and a leakproof sealing pad. The sealing cover plate is made of stainless steel, and a groove is provided on the edge for embedding the leakproof sealing pad. This sealing structure can effectively prevent the drug from leaking during the infusion process, ensuring the airtightness and safety of the operation.

[0060] The support and fixing assembly 3 is composed of a steel U-shaped base bracket and a hexagonal cross-section support column, which is used to support and fix the drug infusion body 1. The surface of the base bracket has an anti-slip texture, and the surface of the column is coated with an anti-corrosion coating. An angle adjustment mechanism is also provided on the top of the support column, so that the drug infusion body 1 can be adjusted in the range of 0° to 45° to meet different clinical operation requirements.

[0061] The drug delivery component 4 is equipped with the drug infusion body 1 and has a precise drug delivery capability. The drug inlet is arranged on the side of the sealing cover plate, and the drug outlet is located at the bottom center of the drug infusion body 1. Both drug outlets are equipped with precise flow control valves. This design can not only accurately control the drug delivery flow, but also ensure the stability and uniformity of the drug during the infusion process.

[0062] The pressure control assembly 5 includes a pressure sensor and a pressure regulating valve. The pressure sensor is installed on the side wall of the drug infusion body 1 and can monitor the pressure change of the drug in the drug infusion body 1 in real time. The pressure regulating valve has a pressure range of 0.1MPa to 0.5MPa and can automatically adjust the drug delivery pressure according to the feedback signal of the pressure sensor to ensure the pressure stability during the entire infusion process.

[0063] The temperature adjustment component 6 is composed of an external cooling sleeve and an internal heating wire, and is used to adjust the temperature inside the drug infusion body 1. The external cooling sleeve is spirally wound on the surface of the drug infusion body 1, and efficiently transfers heat with the drug infusion body 1 through high thermal conductivity silicone grease. The internal heating wire is evenly distributed on the inner wall of the drug infusion body 1, and can accurately adjust the temperature inside the drug infusion body 1 according to the feedback temperature signal. The entire temperature adjustment range is 2°C to 42°C, which meets the temperature requirements of different drugs.

[0064] The rotary drive assembly 7 is composed of a rotating shaft and a rotary motor, and is disposed on the drug infusion body 1, and can drive the drug infusion body 1 to rotate at a speed of 10 rpm to 50 rpm. This rotary design is conducive to improving the diffusion and penetration effect of the drug in the tumor tissue and enhancing the therapeutic effect.

[0065] The liquid filter assembly 8 is arranged in the drug inlet and outlet paths of the drug infusion body 1. The mesh sizes of the inlet filter and the outlet filter are both 20 μm, which can effectively intercept impurity particles larger than 20 μm and ensure the high purity of the drug.

[0066] In addition, the drug infusion body 1 is also equipped with a safety protection component, including a protective cover made of stainless steel, which can cover the entire drug infusion body 1 and is coated with a radiation protection coating on the inside to ensure radiation protection for operators. When the internal pressure exceeds 0.6MPa, the emergency drain valve will automatically open to quickly discharge the excess pressure and avoid equipment explosion accidents.

[0067] The drug infusion device for tumor interventional treatment of the present invention is suitable for accurate drug infusion in clinical tumor interventional treatment. The specific use process is as follows:

[0068] 1. Place the device on the treatment table and adjust the height of the base bracket to ensure that the device is at a suitable working height.

[0069] 2. Inject the medicine into the medicine inlet, and the pressure sensor and temperature sensor inside the device will monitor the pressure and temperature data in real time.

[0070] 3. Start the rotating motor to drive the entire drug infusion body to rotate slowly to enhance the diffusion and penetration of the drug in the tumor tissue.

[0071] 4. According to the pressure and temperature feedback signals, the pressure regulating valve and temperature regulating components are automatically adjusted to ensure the stability of pressure and temperature parameters during the drug infusion process.

[0072] 5. When an abnormal pressure rise is detected, the emergency drain valve will automatically open to release excess pressure to ensure the safety of the equipment.

[0073] 6. After the filling is completed, turn off the rotating motor and wait until the equipment is completely still before carefully removing it.

[0074] The maintenance of the equipment mainly includes the following aspects:

[0075] 1. Regularly clean the various components of the equipment, especially the sealing components, filters and other easily contaminated parts, to ensure the hygiene and disinfection of the equipment.

[0076] 2. Check the stability of the supporting and fixing components, and adjust the height of the base bracket if necessary to ensure the stability of the equipment during use.

[0077] 3. Calibrate the measurement accuracy of pressure sensors and temperature sensors to ensure the accuracy of monitoring data.

[0078] 4. Maintain rotating motors to ensure their long-term operating reliability.

[0079] 5. Regularly check the integrity of the protective cover and the status of the anti-radiation coating to ensure the safety protection of the operator.

[0080] In the present invention, the meanings of the formula symbols are shown in Table 2:

[0081] Table 2 Formula symbols and their meanings

[0082]

[0083]

[0084] The second embodiment of a drug perfusion device for tumor interventional treatment provided by the present invention provides a comparison of the effects of a device that does not use a parameter optimization equation group and a device that uses a parameter optimization equation group. The following is an example of a device that does not use a parameter optimization equation group:

[0085] The Tumor Intervention Diagnosis and Treatment Center of a hospital plans to purchase a drug perfusion device for tumor interventional treatment. The center mainly conducts interventional treatments for liver tumors, lung tumors and other parts, and has high requirements for the angle adjustment and structural stability of the equipment. At the same time, since some radioactive drugs need to be used, the radiation protection performance of the equipment is also very important.

[0086] Based on the above requirements, the hospital selected a traditional drug infusion device for tumor interventional treatment that was not designed with parameter optimization equations. The specific parameters of the device are as follows:

[0087] Drug infusion body: 350mm in length, 120mm in diameter, the outer shell is made of stainless steel and lined with polytetrafluoroethylene. The bottom is equipped with a circular base with a diameter of 150mm, and the outer edge of the base is a stepped structure.

[0088] Support and fixing components: The base bracket adopts a steel U-shaped structure with a length of 500mm, a width of 300mm and a height of 150mm. The support column is fixedly installed in the center of the base bracket, with a circular cross-section, an anti-corrosion coating on the surface, and a height of 200mm.

[0089] Sealing assembly: The sealing cover is made of stainless steel, 10 mm thick, with a 5 mm diameter groove on the edge for embedding the rubber seal. The sealing cover is fixed to the top of the drug infusion body by 4 M8 bolts.

[0090] Drug delivery component: The drug inlet is set on the side of the sealing cover, with an internal thread diameter of 6mm; the drug outlet is located in the center of the bottom of the drug infusion body, with a diameter of 3mm, and is equipped with a precision flow control valve.

[0091] Pressure control component: The pressure sensor is piezoresistive, installed on the side wall of the drug infusion body, with a range of 0-1MPa and an accuracy of ±1%. The pressure regulating valve is installed between the drug inlet and outlet, with an adjustment range of 0.1-0.5MPa.

[0092] Temperature regulation component: The outer part is made of a spiral cooling jacket made of 8mm diameter stainless steel tube, and the inner part is equipped with a 1kW electric heating tube. The temperature regulation range is 2-42 degrees Celsius.

[0093] Rotation drive assembly: The rotating shaft passes through the bottom of the drug infusion body and is connected to a 0.25kW motor installed under the base bracket, which can achieve a rotation speed of 10-50rpm.

[0094] Liquid filter assembly: The inlet filter and outlet filter are made of 316 stainless steel mesh with a mesh size of 20μm.

[0095] Safety protection components: The protective cover made of stainless steel covers the entire device, and the inside is coated with a 2mm thick lead-based radiation protection coating. The emergency drain valve adopts a spring return type solenoid valve, the valve body is made of stainless steel, and the pressure setting value is 0.6MPa.

[0096] During clinical application, the device mainly follows the following usage process:

[0097] 1. Place the device on the treatment table and adjust the height of the base bracket to a suitable working height.

[0098] 2. Inject the required tumor interventional treatment drugs into the drug inlet, start the temperature regulation component, and preheat the drugs to the target temperature.

[0099] 3. Start the rotating motor to drive the entire drug infusion body to rotate slowly to improve the drug's penetration and diffusion effect in the tumor tissue. At the same time, monitor the output of the pressure sensor and adjust the pressure regulating valve appropriately to maintain the drug delivery pressure within the range of 0.1-0.5MPa.

[0100] 4. During treatment, if the pressure sensor detects that the internal pressure exceeds 0.6MPa, the emergency drain valve will automatically open to release excess pressure to ensure the safety of the equipment.

[0101] 5. After the treatment, turn off the rotating motor and temperature adjustment components, and carefully remove the equipment after it has come to a complete stop.

[0102] This traditional device, which was not designed with a set of parameter optimization equations, has some problems in terms of structural stability, parameter control accuracy, and safety protection performance. First, the proportional relationship between the height and inclination angle of the support column and the drug infusion body has not been deeply optimized, which can easily cause overall structural instability and affect the accuracy of treatment. Secondly, the dynamic response characteristics of the pressure sensor and temperature sensor have not been modeled and analyzed, making it difficult to achieve precise closed-loop control of key parameters, and the consistency and repeatability of the treatment effect are poor. Finally, although the equipment is equipped with safety protection measures such as an emergency drain valve and a protective cover, there is still room for improvement in pressure threshold setting and radiation protection performance, and safety needs to be improved.

[0103] In general, this traditional drug perfusion device for tumor interventional therapy, which is not designed with parameter optimization equations, still has some key problems to be solved while meeting the basic clinical needs. In order to further improve the performance of the device, a more scientific and reasonable parameter optimization method is needed for design optimization.

[0104] The following are the optimized devices designed using the parameter optimization equation set:

[0105] Based on the problems of the traditional equipment in Example 1, the hospital decided to purchase an optimized version of drug perfusion equipment for tumor interventional treatment designed with parameter optimization equations. The equipment has been deeply optimized in terms of structural design, parameter control and safety protection. The specific parameters are as follows:

[0106] Drug infusion body: 350mm in length, 120mm in diameter, the outer shell is made of stainless steel and lined with medical grade polytetrafluoroethylene. The bottom is equipped with a circular base with a diameter of 150mm, and the outer edge of the base is a stepped structure.

[0107] Support and fixing components: The base bracket adopts a steel U-shaped structure with a length of 500mm, a width of 300mm and a height of 200mm. The support column has a hexagonal cross-section and a height of 250mm. The surface is coated with an anti-corrosion coating and an angle adjustment mechanism is provided on the top with an adjustment range of 0-45 degrees.

[0108] Sealing assembly: The sealing cover is made of stainless steel, 15mm thick, with a 6mm diameter groove on the edge for embedding a 6mm thick rubber seal. The sealing cover is fixed to the top of the drug infusion body by 4 M10 bolts.

[0109] Drug delivery assembly: The drug inlet (2) and the exhaust port (1) are both set on the sealing cover plate, the internal thread diameter of the drug inlet is 6mm, and the internal thread diameter of the exhaust port is 4mm. The drug outlet is located at the center of the bottom of the drug infusion body, with a diameter of 3mm and equipped with a precision flow control valve.

[0110] Pressure control component: The pressure sensor is piezoresistive, installed on the side wall of the drug infusion body, with a range of 0-1MPa, an accuracy of ±0.1%, and a response time of less than 50ms. The pressure regulating valve is installed between the drug inlet and the drug outlet, with an adjustment range of 0.1-0.5MPa.

[0111] Temperature adjustment component: The outer part is made of a spiral cooling jacket made of a stainless steel tube with a diameter of 8mm and a wall thickness of 1.5mm. The space between the cooling jacket and the drug infusion body is filled with thermal conductive silicone grease. A 2kW heating wire is installed inside. The temperature adjustment range is 2-42 degrees Celsius.

[0112] Rotation drive assembly: The rotating shaft passes through the bottom of the drug infusion body and is connected to a 0.5kW motor installed under the base bracket, which can achieve a rotation speed of 10-50rpm.

[0113] Liquid filter assembly: The inlet filter and the outlet filter are woven with 316 stainless steel wire mesh, the wire diameter is 0.05mm, and the mesh is square 20μm.

[0114] Safety protection components: The protective cover made of stainless steel covers the entire device, leaving a 10mm gap between it and the drug infusion body, and a 2mm thick lead-based radiation protection coating is applied on the inside. The emergency drain valve adopts a spring-reset titanium alloy solenoid valve, with a pressure setting value of 0.6MPa and an opening time of less than 100ms.

[0115] The key parameter designs of the optimization equipment are deeply analyzed and optimized based on the aforementioned parameter optimization equations, as follows:

[0116] 1. Component structure coupling constraint equation

[0117] By adjusting the size of the drug infusion body (L m =350mm,D m =120mm), height of supporting column (h s =250mm) and the tilt angle (θ s =0-45°), meeting the stability requirements of the overall structure (k1=12).

[0118] 2. Sealing performance constraint equation

[0119] Use 6mm thick rubber seal (δ s =6mm), stainless steel (σ m =200MPa), at an internal pressure of 0.1-0.5MPa (P i ) can meet the minimum requirement of sealing performance (ζ0=2.0).

[0120] 3. Temperature uniformity constraint equation

[0121] Use spiral 8mm diameter stainless steel cooling tube (r c =4mm,l c = 800mm), and through the thermal conductive silicone grease and the drug infusion body for efficient heat dissipation, within the temperature adjustment range of 2-42 degrees Celsius, it can meet the uniformity requirements of temperature distribution (∈ T =0.1°C / mm).

[0122] 4. Pressure dynamic response equation

[0123] The response time of the pressure sensor (τ r <50ms)) and gain factor (K p =0.02MPa -1 )) Parameter design can meet the requirements of rapid response and precise control of pressure changes.

[0124] Through the above parameter optimization design, the drug perfusion device for tumor interventional treatment has been significantly improved in terms of structural stability, parameter control accuracy and safety. The specific comparison is shown in Table 3:

[0125] Table 3 Comparison of equipment performance indicators with and without parameter optimization equations

[0126] Performance Indicators Devices without parameter optimization equations Optimization equipment designed using parameter optimization equations Structural stability Generally, prone to tilt and vibration Excellent, adjustable mechanism ensures stability Parameter control accuracy Generally, it is difficult to achieve closed-loop control Excellent, precise sensors and control algorithms Security Better, but the pressure threshold is set lower Excellent, high pressure threshold and fast response Temperature uniformity Generally, the temperature difference is large Excellent, temperature difference less than 0.1℃ / mm Cleanliness guarantee Better, use 20μm filter Excellent, using 20μm high efficiency filter Radiation protection Better, 2mm lead-based coating Excellent, 2mm lead-based coating + 10mm gap

[0127] From the above comparison, it can be seen that the optimized drug perfusion equipment for tumor interventional treatment designed with parameter optimization equation group is significantly superior to the unoptimized traditional equipment in all key performance indicators.

[0128] This is mainly reflected in:

[0129] 1. Through the optimization of the structural coupling constraint equation, the overall structure of the device is more stable, less prone to tilt and vibration, and greatly improves the accuracy of treatment.

[0130] 2. The optimization of the sealing performance and temperature uniformity constraint equations ensures that the pressure and temperature parameters during the drug infusion process can be precisely controlled, which is beneficial to improving the consistency and repeatability of the treatment effect.

[0131] 3. The optimization of the pressure dynamic response equation enables the pressure sensor to quickly and accurately feedback internal pressure changes, and cooperates with the precise pressure regulating valve to effectively ensure the safety of the entire process.

[0132] 4. The optimized design in terms of cleanliness assurance and radiation protection effectively reduces the risk of complications and provides patients with a safer and more reliable treatment environment.

[0133] The core technical principles of the drug infusion device for tumor interventional treatment proposed by the present invention are mainly reflected in the following aspects:

[0134] Optimization of structural design: The device of the present invention adopts a cylindrical structure, which can not only effectively improve the overall stability, but also minimize the internal dead angle, which is conducive to the uniform distribution of drugs in tumor tissue. At the same time, the device is also equipped with an adjustable angle support column, which can adapt to the needs of different treatment sites and operating postures, greatly improving the adaptability of clinical applications. These innovative designs are based on in-depth analysis and optimization of the structural problems of existing equipment;

[0135] Implementation of precise parameter control: The device of the present invention integrates key components such as pressure sensors, temperature sensors and precision flow control valves, which can monitor and adjust parameters such as pressure, temperature and flow in real time during drug infusion. This closed-loop feedback control mechanism can automatically compensate for disturbance factors in the external environment or during operation, ensuring the stability and uniformity of key parameters. This innovative design is conducive to improving the repeatability and reliability of treatment, and also makes the enrichment of drugs in tumor tissue more uniform, thereby improving the treatment effect;

[0136] Improved cleanliness assurance: The equipment of the present invention is equipped with a filter with a mesh size of 20 μm at the inlet and outlet, which can effectively remove impurities with particles larger than 20 μm. This design can not only ensure the high purity of the drug during the entire infusion process, but also avoid the decline in treatment effect or complications caused by drug deposition. Compared with the existing equipment that only relies on a simple filter, the cleanliness assurance measures of the present invention are more comprehensive and reliable;

[0137] Sound safety protection mechanism: The equipment of the present invention is equipped with a pressure release mechanism such as an emergency drain valve, which can quickly discharge the internal excess pressure and avoid the occurrence of equipment explosion accidents. In addition, a protective cover made of stainless steel is used, and the inside is coated with a radiation-proof coating, which can effectively block the radiation of radioactive drugs. These innovative safety protection measures can not only protect the safety of operators, but also minimize the risks faced by patients during treatment.

Claims

1. A drug infusion device for tumor interventional treatment, characterized in that: include: Drug perfusion body, sealing assembly, supporting and fixing assembly, drug delivery assembly, pressure control assembly, temperature regulating assembly, rotary drive assembly, liquid filtering assembly and safety protection assembly; The drug infusion body is a cylindrical structure, the outer wall is made of stainless steel, the inner wall is made of medical grade polytetrafluoroethylene material, the main body length is 350mm, and the diameter is 120mm; the bottom of the drug infusion body has a circular base, and the outer edge of the base is a stepped structure for connection with the supporting fixing component; The sealing assembly is arranged on the top of the medicine infusion body, and comprises a sealing cover plate and a leakproof sealing pad; The sealing cover plate is circular, and the edge has a groove structure, the leakproof sealing gasket is embedded in the groove, and the sealing cover plate is fixed to the top of the drug infusion body by bolts to ensure the sealing performance; The support and fixing assembly includes a base bracket and a support column. The base bracket is a steel U-shaped structure with an anti-slip texture on the surface. The support column is vertically fixed at the center of the base bracket. The cross-section of the support column is a hexagon and the surface is coated with an anti-corrosion coating. The drug delivery assembly includes a drug inlet and a drug outlet. The drug inlet is arranged on the side of the sealing cover plate, and the drug outlet is located at the bottom center of the drug infusion body. Both drug outlets are equipped with precision flow control valves, and the valve opening diameter is 3mm. The pressure control assembly includes a pressure sensor and a pressure regulating valve. The pressure sensor is installed on the side wall of the drug infusion body, and the sensing end directly contacts the inner wall of the drug infusion body. The pressure regulating valve is located on the pipeline between the drug inlet and the drug outlet, and the valve opening pressure range is 0.1MPa to 0.5MPa. The temperature adjustment component includes an external cooling sleeve and an internal heating wire, wherein the external cooling sleeve is spirally wound on the surface of the drug infusion body, and the internal heating wire is evenly distributed on the inner wall of the drug infusion body; the temperature adjustment range is 2°C to 42°C; The rotary drive assembly includes a rotary shaft and a rotary motor. The rotary shaft passes through the bottom of the drug infusion body and is connected to the output shaft of the rotary motor. The rotary motor is fixedly mounted at the bottom of the supporting column and drives the rotary shaft to rotate at a speed of 10 rpm to 50 rpm. The liquid filter assembly comprises an inlet filter and an outlet filter, wherein the inlet filter is arranged inside the drug inlet and the outlet filter is arranged at the front end of the drug outlet, and the mesh size of the two filters is 20 μm; The safety protection component includes a protective cover and an emergency drain valve. The protective cover covers the entire exterior of the drug infusion body and is made of stainless steel. The emergency drain valve is located at the bottom of the drug infusion body and automatically opens when the internal pressure exceeds 0.6MPa.

2. The drug infusion device for tumor interventional treatment according to claim 1, characterized in that: The base bracket has a length of 500 mm, a width of 300 mm and a height of 200 mm; the base bracket contacts the ground through four adjusting feet, and the height of each adjusting foot can be adjusted in the range of 20 mm to 50 mm.

3. The drug infusion device for tumor interventional treatment according to claim 2, characterized in that: The sealing cover plate is provided with two drug inlets and one exhaust port, the internal thread diameter of the drug inlet is 6 mm, and the internal thread diameter of the exhaust port is 4 mm; the thickness of the sealing cover plate is 15 mm, and the material is medical grade stainless steel.

4. The drug infusion device for tumor interventional treatment according to claim 3, characterized in that: The pressure sensor is a piezoresistive pressure sensor with a measurement accuracy of ±0.1% and a response time of less than 50ms. The shell of the pressure sensor is made of titanium alloy and has good corrosion resistance.

5. The drug infusion device for tumor interventional treatment according to claim 4, characterized in that: The external cooling jacket is made of a stainless steel tube with a tube diameter of 8 mm and a tube wall thickness of 1.5 mm; high thermal conductivity silicone grease is used to fill the space between the cooling jacket and the drug infusion body to ensure heat exchange efficiency.

6. The drug infusion device for tumor interventional treatment according to claim 5, characterized in that: The inlet filter screen and the outlet filter screen are both woven from 316 stainless steel wire mesh, the wire diameter is 0.05 mm, and the mesh is a square grid structure.

7. The drug infusion device for tumor interventional treatment according to claim 6, characterized in that: A 10mm gap is left between the protective cover and the drug infusion body, and the surface of the protective cover is coated with a radiation protection coating with a thickness of 2mm.

8. The drug infusion device for tumor interventional treatment according to claim 7, characterized in that: The emergency drain valve is a spring-reset solenoid valve, the valve body is made of titanium alloy, and the valve opening time is less than 100ms.

9. The drug infusion device for tumor interventional treatment according to claim 8, characterized in that: An angle adjustment mechanism is provided on the top of the support column, and the angle adjustment range is 0° to 45°. Precise positioning is achieved by manually rotating the adjustment bolt.

10. The drug infusion device for tumor interventional treatment according to claim 9, characterized in that: The drug perfusion device for tumor interventional treatment performs constrained optimization on corresponding component parameters through a parameter optimization equation group, wherein the parameter optimization equation group includes a component structure coupling constraint equation, a sealing performance constraint equation, a temperature uniformity constraint equation and a pressure dynamic response equation.

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