Kryochirurgie-System

Abstract

Cryosurgery system comprising a display device (1), an input device (2), a host computer (3), a power supply (4), a control board (5), a relay board (6), a control gas route (7), an ablation needle (8), an argon source (9) and a helium source (10), wherein the control gas route (7) comprises a first dynamic pressure control module (71), a pressure relief valve combination (72), a second dynamic pressure control module (73) and a booster pump together with its valve combination (74), wherein the display device (1) and the input device (2) are each electrically connected to the host computer (3), wherein the control board (5) is electrically connected to the host computer (3), wherein an input end of the control board (5) is electrically connected to the first dynamic pressure setting module (71), the pressure relief valve combination (72), the second dynamic pressure setting module (73), the booster pump together with its valve combination (74) and the ablation needle (8), wherein an output end of the control board (5) is electrically connected to an input end of the relay board (6), wherein an output end of the relay board (6) is electrically connected to the first dynamic pressure setting module (71), the pressure relief valve combination (72), the second dynamic pressure setting module (73), solenoid valves in the booster pump together with their valve combination (74) and the ablation needle (8), wherein the power supply (4) is electrically connected to the host computer (3), the control board (5) and the relay board (6), and the argon source (9) is connected to gas inlets of the first dynamic pressure setting module (71) and the pressure relief valve combination (72), wherein the helium source (10) is connected to a gas inlet of the second dynamic pressure control module (73), and wherein gas outlets of the first dynamic pressure setting module (71), the pressure relief valve combination (72), the second dynamic pressure setting module (73) and the booster pump together with their valve combination (74) are each connected to a gas inlet of the ablation needle (8).

Description

TECHNICAL AREA OF INVENTION

[0001] The present invention relates to the technical field of medical devices and in particular a cryosurgery system. BACKGROUND OF THE INVENTION

[0002] Cancer can currently be treated with many methods, such as excision, interventional therapy, drug therapy, or local ablation therapy, etc. Local ablation therapy has seen massive advancements in the last decade following the development of medical ablation devices. Cryonic ablation for local ablation therapy offers many advantages, including a larger ablation area, the ability to use multiple blades, a wider range of indications, and immunological effects, among others, and is widely accepted among experts.

[0003] The basic principle of cryonic ablation is that tumor cells are frozen to form ice crystals within them, thus destroying the cancer cells. Currently, two main cryosurgery systems are available on the market. One cryosurgery system uses liquid nitrogen, which is vaporized to absorb a large amount of heat and thus reach the cryogenic temperature. However, liquid nitrogen has several disadvantages, such as: Liquid nitrogen is difficult to store and transport, and leaks easily. - The temperature and power in the liquid nitrogen system cannot be controlled and adjusted, so the normal tissue in the vicinity of the tumor is easily and unnecessarily damaged. The liquid nitrogen system is not suitable for rapid cryotherapy due to its slower temperature reduction rate. The other cryosurgery system is based on the Joule-Thomson principle. The temperature is lowered by the throttling effect of argon and raised by the heating effect of helium, also throttling. In the cryogenic system using argon and helium, the temperature and power can be rapidly lowered and adjusted, with American Endocare being a typical user (FDA approval 1997). Following the advent of this technology, the liquid nitrogen system was discontinued.

[0004] However, the well-known cryogenic system using argon and helium has several disadvantages, such as: - The normal operating pressure of argon in the cryogenic system with argon and helium is approximately 3,000 psi, and the argon is therefore a high-pressure gas source; however, no function for monitoring the pressure in the cryogenic system with argon and helium is designed, and the potential safety risk of surgical procedures is greatly increased. - the cryogenic temperature cannot be precisely controlled in the cryogenic system with argon and helium, and the function of presetting the cryogenic temperature is not further developed in the cryogenic system with argon and helium, - if the cryogenic temperature needs to be controlled to maintain cell activity (such as that of a nerve cell which could be destroyed below a certain temperature, while the cells can otherwise survive), the power can only be adjusted by the physician in real time based on the temperature of the ablation needle in the cryogenic system with argon and helium. - The setting procedure is very cumbersome to perform, and the temperature of the ablation needle cannot be precisely controlled, which can cause greater fluctuations in the cryogenic temperature and easily lead to additional injuries. - when the temperature in the cryogenic system is increased with argon and helium, the highest temperature can only be reached at about 40 °C, while the coagulation temperature of proteins is greater than or equal to 57 °C, - The cryogenic system with argon and helium does not enhance protein coagulation and hemostasis, and the risk of postoperative bleeding is greatly increased. - the pressure cannot be dynamically adjusted in the cryogenic system currently available on the market using argon and helium, - During the cryogenic process, the pressure in the cryogenic system with argon and helium is in the high-pressure range, so that the gas is wasted, - In the cryogenic system with argon and helium, two gas sources are essential and must be adequately prepared; however, helium is rare and therefore more expensive, and its use is also very impractical. - because the purity of the gas source in China is not high, impurities such as particles, oil mist, moisture, etc. are mixed into the gas. - the impurities mixed with the gas cannot be completely filtered out and enter the ablation needle, - The diameter of the constriction opening in the ablation needle is less than 1 mm, approximately only 0.4 mm, and thus the constriction opening is easily blocked by impurities, so that the surgical procedure has to be interrupted. - The ablation capability of the different ablation needles depends on their intrinsic temperature, - The temperature of the ablation needle cannot be preset in the cryogenic system with argon and helium currently on the market, and the surgical procedure cannot be preset by the doctor based on the patient's tumor situation; the area covered by the ice sphere can only be monitored in real time using CT (computed tomography) or color Doppler ultrasound, which not only wastes time but also increases the amount of radiation absorbed by the patient. - the high-pressure gas continues to be supplied using the conventional cryogenic control method, - Relevant studies have shown that the gas transfer pipeline and the outer surface of the ablation needle handle ice up heavily in the conventional cryogenic control method, indicating that a large amount of cryogenic capacity is wasted with the supply gas, and the maximum amount of supply gas cannot reach the low temperature of the ablation needle, thus making it a suboptimal cryogenic control method.

[0005] CN 107485443 A shows a cryosurgery-microwave combination system that enables both cryoablation and microwave ablation. The system includes a control board with a PID controller for precise temperature control of the ablation needle. The path taken by the cryogenic gas contains filters, safety valves, and solenoid valves for controlling argon and helium gas. The system can switch between different operating modes, including pure cryoablation, pure microwave ablation, or a combination of both. The ablation needle has both gas delivery lines for the cryo-function and a radiation head for the microwave function.

[0006] CN 105411665 A describes a low-temperature surgical system with a gas recovery function to reduce gas consumption. The system includes a gas amplification device that collects the low-pressure gas exiting after throttling and recompresses it to operating pressure. The gas amplification device contains separate amplification units for argon and helium with corresponding low-pressure vessels, amplification pumps, and high-pressure vessels. The system enables closed gas circulation, which significantly reduces gas consumption and environmental impact. Additionally, the amplification pumps can create a vacuum in the return channel, increasing the pressure differential at the cryogenic instrument and providing improved cooling. REVELATION OF THE INVENTION

[0007] To solve problems such as the lack of presettable cryogenic temperature and precise controllability, impractical usability, easy clogging of the ablation needle's throttle opening, and higher gas consumption, etc., the present invention provides a safe and efficient cryosurgery system comprising a display device, an input device, a host computer, a power supply, a control board, a relay board, a control gas route, an ablation needle, an argon source, and a helium source. The control gas route includes a first dynamic pressure setting module, a pressure relief valve combination, a second dynamic pressure setting module, and a booster pump together with its valve combination. The display device and the input device are each electrically connected to the host computer, and the control board is electrically connected to the host computer.One input end of the control board is electrically connected to the first dynamic pressure setting module, the pressure relief valve combination, the second dynamic pressure setting module, the booster pump together with its valve combination, and the ablation needle.

[0008] One output end of the control board is electrically connected to an input end of the relay board; one output end of the relay board is electrically connected to the first dynamic pressure setting module, the pressure relief valve combination, the second dynamic pressure setting module, the solenoid valves in the booster pump along with their valve combination, and the ablation needle; the power supply is electrically connected to the host computer, the control board, and the relay board, respectively; the argon source is connected to the gas inlets of the first dynamic pressure setting module and the pressure relief valve combination, respectively; the helium source is connected to a gas inlet of the second dynamic pressure setting module, and to the gas outlets of the first dynamic pressure setting module and the pressure relief valve combination.The second dynamic pressure setting module and the booster pump, together with their valve combination, are each connected to a gas inlet of the ablation needle.

[0009] The first dynamic pressure control module comprises a particulate filter, an oil vapor filter, a safety valve, a primary pressure transmitter, a primary solenoid valve, a gas cylinder, a secondary pressure transmitter, a blow-off solenoid valve, a secondary solenoid valve, and a first gas distribution branch line. The argon source is connected to an inlet of the particulate filter, an outlet of the particulate filter is connected to an inlet of the oil vapor filter, an outlet of the oil vapor filter is connected to an inlet of the safety valve, an outlet of the safety valve is connected to the primary pressure transmitter and an inlet of the primary solenoid valve, an outlet of the primary solenoid valve is connected to an inlet of the gas cylinder, and an outlet of the gas cylinder is connected to the secondary pressure transmitter and an inlet of the secondary solenoid valve.An outlet of the secondary solenoid valve is connected to an inlet of the first gas distribution branch line, and an outlet of the first gas distribution branch line is connected to a gas inlet of the ablation needle; outlets of the primary pressure transmitter and the secondary pressure transmitter are each electrically connected to the input end of the control board; an outlet of the safety valve is connected to an inlet of the blow-off solenoid valve, and an outlet of the blow-off solenoid valve is connected to a gas outlet; the output end of the relay board is electrically connected to the primary solenoid valve, the blow-off solenoid valve, the secondary solenoid valve, and solenoid valves in the first gas distribution branch line; the gas flow meter in the first gas distribution branch line is electrically connected to the control board.

[0010] The first gas distribution branch line consists of several gas distribution units connected in parallel to each other. Each gas distribution unit includes a gas distribution solenoid valve, a water vapor filter, and a gas flow meter. An inlet of the gas distribution solenoid valve is connected to the outlet of the secondary solenoid valve. An outlet of the gas distribution solenoid valve is connected to an inlet of the water vapor filter. An outlet of the water vapor filter is connected to an inlet of the gas flow meter. An outlet of the gas flow meter is connected to a gas inlet of the ablation needle. The gas flow meter is electrically connected to the input end of the control board. The gas distribution solenoid valve is electrically connected to the output end of the relay board.

[0011] The pressure relief valve combination comprises a primary solenoid valve, a check valve, a pressure relief valve, a pressure transmitter, a secondary solenoid valve, and a second gas distribution branch line. The argon source is connected to an inlet of the primary solenoid valve, an outlet of the primary solenoid valve is connected to an inlet of the check valve, an outlet of the check valve is connected to an inlet of the pressure relief valve, an outlet of the pressure relief valve is connected to the pressure transmitter and an inlet of the secondary solenoid valve, an outlet of the secondary solenoid valve is connected to an inlet of the second gas distribution branch line, and an outlet of the second gas distribution branch line is connected to a gas inlet of the ablation needle. An outlet of the pressure transmitter is electrically connected to the input end of the control board.The output end of the relay board is electrically connected to the primary solenoid valve, the secondary solenoid valve, and solenoid valves in the second gas distribution branch line.

[0012] The second dynamic pressure control module comprises a particulate filter, an oil vapor filter, a safety valve, a pressure transmitter, a primary solenoid valve, a blow-off solenoid valve, and a third gas distribution branch line. The helium source is connected to an inlet of the particulate filter, an outlet of the particulate filter is connected to an inlet of the oil vapor filter, an outlet of the oil vapor filter is connected to an inlet of the safety valve, an outlet of the safety valve is connected to the pressure transmitter and an inlet of the primary solenoid valve, an outlet of the primary solenoid valve is connected to an inlet of the third gas distribution branch line, and an outlet of the third gas distribution branch line is connected to a gas inlet of the ablation needle. An outlet of the pressure transmitter is electrically connected to the input end of the control board.One outlet of the safety valve is connected to one inlet of the blow-off solenoid valve, and one outlet of the blow-off solenoid valve is connected to a gas outlet; the output end of the relay board is electrically connected to the primary solenoid valve, the blow-off solenoid valve, and solenoid valves in the third gas distribution branch line.

[0013] The booster pump, together with its valve assembly, comprises a particulate filter, a booster pump, an oil vapor filter, a safety valve, a pressure transmitter, a primary solenoid valve, a blow-off solenoid valve, and a fourth gas distribution branch line. An inlet of the particulate filter is connected to an air source, an outlet of the particulate filter is connected to an inlet of the booster pump, an outlet of the booster pump is connected to an inlet of the oil vapor filter, an outlet of the oil vapor filter is connected to an inlet of the safety valve, an outlet of the safety valve is connected to the pressure transmitter and an inlet of the primary solenoid valve, an outlet of the primary solenoid valve is connected to an inlet of the fourth gas distribution branch line, and an outlet of the fourth gas distribution branch line is connected to a gas inlet of the ablation needle.One outlet of the pressure transmitter is electrically connected to the input end of the control board, one outlet of the safety valve is connected to an inlet of the blow-off solenoid valve, and one outlet of the blow-off solenoid valve is connected to a gas outlet; the output end of the relay board is electrically connected to the booster pump, the primary solenoid valve, the blow-off solenoid valve, and solenoid valves in the fourth gas distribution branch line.

[0014] The second gas distribution branch line consists of several gas distribution units that are parallel to each other and interconnected. Each gas distribution unit includes a gas distribution solenoid valve and a check valve. An inlet of the gas distribution solenoid valve is connected to a gas transfer pipeline, an outlet of the gas distribution solenoid valve is connected to an inlet of the check valve, and an outlet of the check valve is connected to a gas inlet of the ablation needle. The gas distribution solenoid valve is electrically connected to the output end of the relay board.

[0015] The third gas distribution branch line consists of several gas distribution units that are parallel to each other and interconnected. Each gas distribution unit includes a gas distribution solenoid valve and a check valve. An inlet of the gas distribution solenoid valve is connected to a gas transfer pipeline, an outlet of the gas distribution solenoid valve is connected to an inlet of the check valve, and an outlet of the check valve is connected to a gas inlet of the ablation needle. The gas distribution solenoid valve is electrically connected to the output end of the relay board.

[0016] The fourth gas distribution branch line consists of several gas distribution units that are parallel to each other and interconnected. Each gas distribution unit includes a gas distribution solenoid valve and a check valve. An inlet of the gas distribution solenoid valve is connected to a gas transfer pipeline, an outlet of the gas distribution solenoid valve is connected to an inlet of the check valve, and an outlet of the check valve is connected to a gas inlet of the ablation needle. The gas distribution solenoid valve is electrically connected to the output end of the relay board.

[0017] The ablation needle comprises an ablation needle tip, a temperature thermocouple, a gas transfer tube, a vacuum insulation layer, a heat exchanger, an electrical heating component, a temperature sensor, and an ablation needle handle. The ablation needle tip is connected to the ablation needle handle. A throttle orifice is fixed in the front end of the gas transfer tube. The vacuum insulation layer is fixed to the inner wall of the ablation needle handle. The gas transfer tube is connected to the heat exchanger. The temperature thermocouple is fixed in the ablation needle handle. The electrical heating component is mounted on the heat exchanger and electrically connected to the relay board via a heating interface. The temperature sensor is fixed to the electrical heating component. The temperature thermocouple and the temperature sensor are each electrically connected to the input end of the control board.

[0018] The electrical heating component is a silica gel heating element or a foil heating element; the temperature sensor is a thermocouple or a thermistor.

[0019] The input device includes a keyboard or a mouse, the display device includes an LCD screen or a touch-controlled LCD screen, the control board includes a PID controller, a parallel communication interface, a serial communication interface, a CPU, a memory device, a DC-DC conversion module and an optocoupler, the CPU is electrically connected to the parallel communication interface, the serial communication interface, the memory device and the optocoupler, the PID controller is electrically connected to the optocoupler, the DC-DC conversion module is electrically connected to the PID controller, the parallel communication interface, the serial communication interface, the CPU, the memory device and the optocoupler.

[0020] The cryosurgery system of the present invention is capable of precisely controlling and presetting the cryogenic temperature of the ablation needle, monitoring gas consumption in the gas transfer channel in real time via the first dynamic pressure control module, and dynamically adjusting the gas supply pressure to achieve the optimal gas supply pressure. The cryosurgery system of the present invention is capable of ensuring the cryogenic effect and reducing gas reflux resistance so that the ablation needle operates at a deep cryogenic temperature, thereby increasing the cryogenic range and cryogenic efficiency and reducing gas consumption. When the helium temperature is increased by the second dynamic pressure control module, the temperature of the ablation needle can be raised above 100 °C, thereby coagulating proteins and controlling bleeding in the needle path.The multi-stage high-pressure protection system effectively ensures the safety of patients and operators. The multi-stage filtration system completely filters out particles, oil mist, moisture, and other contaminants from the gas, effectively preventing ablation needle clogging. BRIEF DESCRIPTION OF THE DRAWING Fig. Figure 1 is a schematic diagram of the circuit diagram of the cryosurgery system in the preferred embodiment of the present invention. Fig. Figure 2 is a schematic structural view of the control gas route in the preferred embodiment of the present invention. Fig. Figure 3 is a schematic structural view of the first dynamic pressure setting module in the preferred embodiment of the present invention. Fig. Figure 4 is a schematic structural view of the pressure relief valve combination in the preferred embodiment of the present invention. Fig. Figure 5 is a schematic structural view of the second dynamic pressure setting module in the preferred embodiment of the present invention. Fig. Figure 6 is a schematic structural view of the booster pump together with its valve combination in the preferred embodiment of the present invention. Fig. Figure 7 is a schematic diagram of the setup of the precise control of the cryogenic temperature of the ablation needle in the preferred embodiment of the present invention. Fig. Figure 8 is a schematic view of the internal structure of the ablation needle in the preferred embodiment of the present invention. Fig. Figure 9 is a schematic view of the cryogenic process of the ablation needle in the preferred embodiment of the present invention. Fig. Figure 10 is a curve representation of the temperature fluctuation of the operating pressure and the ablation needle during the cryogenic process according to the state of the art. Fig. Figure 11 is a curve representation of the temperature fluctuation of the operating pressure and the ablation needle during the cryogenic process in the preferred embodiment of the present invention. Fig. 12 is a multi-stage high-pressure protection structure in the preferred embodiment of the present invention. Fig. Figure 13 is a schematic diagram of the circuit diagram of the control board in the preferred embodiment of the present invention. DESCRIPTION OF PREFERRED EXECUTION FORMS

[0021] The technical scheme of the present invention is further described below with reference to the accompanying drawings and the preferred embodiment. With reference to Fig. 1 and Fig. 2 The preferred embodiment of the present invention provides a cryosurgery system comprising a display device 1, an input device 2, a host computer 3, a power supply 4, a control board 5, a relay board 6, a control gas route 7, an ablation needle 8, an argon source 9 and a helium source 10, wherein the control gas route 7 comprises a first dynamic pressure setting module 71, a pressure relief valve combination 72, a second dynamic pressure setting module 73 and a booster pump 74 together with their corresponding valve combination.

[0022] The display device 1 and the input device 2 are each electrically connected to the host computer 3, the control board 5 is electrically connected to the host computer 3, an input end of the control board 5 is electrically connected to the first dynamic pressure setting module 71, the pressure relief valve combination 72, the second dynamic pressure setting module 73, the booster pump together with its valve combination 74 and the ablation needle 8.

[0023] One output end of the control board 5 is electrically connected to one input end of the relay board 6. Each output end of the relay board 6 is electrically connected to the first dynamic pressure setting module 71, the pressure relief valve combination 72, the second dynamic pressure setting module 73, the solenoid valves in the booster pump together with their valve combination 74, and the ablation needle 8.The power supply 4 is connected to the host computer 3, the control board 5, and the relay board 6, respectively. The argon source 9 is connected to inlets of the first dynamic pressure setting module 71 and the pressure relief valve 72, respectively. The helium source 10 is connected to a gas inlet of the second dynamic pressure setting module 73. Gas outlets of the first dynamic pressure setting module 71, the pressure relief valve 72, the second dynamic pressure setting module 73, and the booster pump, together with its valve assembly 74, are each connected to a gas inlet of the ablation needle 8. The booster pump is supplied with air from an air source 75.

[0024] With reference to Fig. 1, Fig. 2 and Fig. 3 The first dynamic pressure setting module 71 comprises a particulate filter 7101, an oil vapor filter 7102, a safety valve 7103, a primary pressure transmitter 7104, a primary solenoid valve 7105, a gas cylinder (a gas buffer pool) 7106, a secondary pressure transmitter 7107, a blow-off solenoid valve 7108, a secondary solenoid valve 7109, and a first gas distribution branch line 21, which is schematically indicated by the dashed line, wherein the helium source 9 is connected to an inlet of the particulate filter 7101, an outlet of the particulate filter 7101 is connected to an inlet of the oil vapor filter 7102, an outlet of the oil vapor filter 7102 is connected to an inlet of the safety valve 7103, and an outlet of the safety valve 7102 is connected to the inlet of the safety valve 7103. connected to the primary pressure transmitter 7104 and an inlet of the primary solenoid valve 7105, an outlet of the primary solenoid valve 7105 is connected to an inlet of the gas cylinder 7106,An outlet of the gas cylinder 7106 is connected to the secondary pressure transmitter 7107 and an inlet of the secondary solenoid valve 7109, an outlet of the secondary solenoid valve 7109 is connected to an inlet of the first gas distribution branch line 21, and an outlet of the first gas distribution branch line 21 is connected to an inlet of the ablation needle 8. As indicated by the dots, the in , Fig. 3 In the embodiment shown, several ablation needles 8, of which only three are shown, are connected to a respective outlet of the first gas distribution branch line 21.

[0025] An output of the primary pressure transmitter 7104 and the secondary pressure transmitter 7017 are each electrically connected to the input end of the control board 5, an outlet of the safety valve 7103 is connected to an inlet of the blow-off solenoid valve 7108, and an outlet of the blow-off solenoid valve 7108 is connected to a gas outlet 76, the output end of the relay board 6 is electrically connected to the primary solenoid valve 7105, the blow-off solenoid valve 7108, the secondary solenoid valve 7109 and solenoid valves in the first gas distribution branch line, the gas flow meter in the first gas distribution branch line is connected to the control board 5.

[0026] In practical application, the first gas distribution branch line consists – as schematically shown by the points in Fig. 3 indicated - from several gas distribution units that are parallel to each other and interconnected, of which in Fig. Figure 3 shows each gas distribution unit. Each gas distribution unit comprises a gas distribution solenoid valve 7110, 7111, 7112, a water vapor filter 7113, 7114, 7115 and a gas flow meter 7116, 7117, 7118. An inlet of each gas distribution solenoid valve 7110, 7111, 7112 is connected to an outlet of the secondary solenoid valve 7109.

[0027] In the Fig. In the embodiment shown in Figure 3, an outlet of each gas distribution solenoid valve 7110, 7111, 7112 is connected to an inlet of the respective water vapor filter 7113, 7114, 7115, an outlet of each water vapor filter is connected to an inlet of the respective gas flow meter 7116, 7117, 7118, an outlet of each gas flow meter is connected to a gas inlet of the respective ablation needle 8, and each gas flow meter is electrically connected to the input end of the control board 5.

[0028] Each gas distribution solenoid valve 7110, 7111, 7112 is electrically connected to the output end of relay board 6. In the Fig. In the preferred embodiment shown in Figure 3, a three-stage solenoid valve 7110, a steam filter 7113, and a gas flow meter 7116 form a gas distribution unit in the first gas distribution branch line 21; a three-stage solenoid valve 7111, a steam filter 7114, and a gas flow meter 7117 form another gas distribution unit in the first gas distribution branch line 21; and a three-stage solenoid valve 7112, a steam filter 7115, and a gas flow meter 7118 form another gas distribution unit in the first gas distribution branch line 21. To meet the cryogenic requirements of a clinician for tumors of varying sizes, the first gas distribution branch line can be a multi-channel gas transmission channel with 8, 10, or 12 channels, etc.The solenoid valves in the multi-channel gas transfer channels can be alternately controlled by the control board 5 to adjust the cryogenic power and precisely control the temperature of the ablation needle 8.

[0029] With reference to Fig. 1, Fig. 2 and Fig. In the preferred embodiment of the present invention, the multi-stage filter devices are provided in the first dynamic pressure adjustment module 71, which includes the particle filter 7101, the oil mist filter 7102 and the water vapor filters 7113, 7114 and 7115 etc. for the complete filtering out of the particles, oil mist, moisture and other impurities in the gas in order to effectively solve the problem of clogging the ablation needle.

[0030] In the preferred embodiment of the present invention, the multi-stage pressure safety devices are provided in the first dynamic pressure setting module 71, wherein the primary pressure transmitter 7104 is used to monitor the pressure in the control gas route in real time, and the safety valve is automatically relieved when the pressure is too high; when the pressure is slowly relieved, the blow-off solenoid valve 7108 can be opened through the control gas route to relieve the pressure.

[0031] The first dynamic pressure adjustment module 71, provided in the preferred embodiment of the present invention, is used to dynamically adjust the pressure. The amount of argon entering the gas cylinder 7106 can be controlled by the primary solenoid valve 7105, and the gas cylinder 7106 is used to stabilize the pressure and prevent temperature fluctuations of the ablation needle caused by excessive pressure fluctuations. The secondary pressure transmitter 7107 is used to monitor the pressure of the gas cylinder 7106. The pressure of the gas cylinder 7106 is taken by the control board 5, and the opening / closing load cycle of the solenoid valve 7105 is controlled by the control board 5 according to the pressure value to control the gas pressure.

[0032] In the preferred embodiment of the present invention, several solenoid valves with different stages are provided in the first dynamic pressure control module 71. The amount of gas inlet is controlled by the primary solenoid valve 7105 to control the gas pressure. When the gas pressure is suitable, the secondary solenoid valve 7109 is opened to control the gas outlet. The three-stage solenoid valve is provided in each gas transmission channel in the first gas distribution branch line, for example, the three-stage solenoid valves 7110, 7111, and 7112, and is used to control the gas flow to the different gas transmission channels. The gas outlet of each gas transmission channel is connected to the gas flow meter, for example, the gas flow meters 7116, 7117, and 7118, which is used to measure the gas consumption in the gas transmission channel in real time. The output value of the gas flow meter is taken from the control board 5.to calculate the available time of the residual gas in the gas cylinder (the argon cylinder) and to monitor whether the ablation needle is blocked or not.

[0033] With reference to Fig. 1, Fig. 2 and Fig. 4 The pressure relief valve combination 72 comprises a primary solenoid valve 7201, a check valve 7202, a pressure relief valve 7203, a pressure transmitter 7204, a secondary solenoid valve 7205, and a second gas distribution branch line 22, which is schematically indicated by the dashed line, wherein the argon source 9 is connected to an inlet of the primary solenoid valve 7201, an outlet of the primary solenoid valve 7201 is connected to an inlet of the check valve 7202, an outlet of the check valve 7202 is connected to an inlet of the pressure relief valve 7203, an outlet of the pressure relief valve 7203 is each connected to the pressure transmitter 7204 and an inlet of the secondary solenoid valve 7205, wherein an outlet of the secondary solenoid valve 7205 is connected to is connected to an inlet of the second gas distribution branch line 22,and an outlet of the second gas distribution branch line is connected to a gas inlet of the ablation needle 8, an outlet of the pressure transmitter 7204 is electrically connected to the input end of the control board 5.

[0034] The output end of the relay board 6 is electrically connected to the primary solenoid valve 7201, the secondary solenoid valve 7205, and solenoid valves in the second gas distribution branch line 22. In practical application, the second gas distribution branch line 22 consists of several gas distribution units connected in parallel to each other, as schematically indicated by the dots in Fig. 4 indicated. Each gas distribution unit comprises a gas distribution solenoid valve and a check valve. An inlet of the gas distribution solenoid valve is connected to an outlet of the gas distribution solenoid valve 7205, an outlet of the gas distribution solenoid valve is connected to an inlet of the check valve, and an outlet of the check valve is connected to a gas inlet of the ablation needle 8. The gas distribution solenoid valve is electrically connected to the output end of the relay board 6. In a preferred embodiment of the present invention, which is described in Fig. As shown in Figure 4, the three-stage solenoid valve 7206 and the check valve 7214 form a gas distribution unit in the second gas distribution branch line 22, the three-stage solenoid valve 7207 and the check valve 7215 form another gas distribution unit in the second gas distribution branch line 22, and the three-stage solenoid valve 7208 and the check valve 7216 form yet another gas distribution unit in the second gas distribution branch line 22.

[0035] With reference to Fig. 1, Fig. 2 and Fig. 4 In the preferred embodiment of the present invention, the pressure relief valve combination is implemented such that the argon source 9 passes through the pressure relief valve 7203 under the control of the primary solenoid valve 7201, so that the argon pressure is reduced to a lower pressure. A check valve 7202 is mounted between the primary solenoid valve 7201 and the pressure relief valve 7203 and is used to prevent gas backflow. The pressure transmitter 7204 is used to detect the outlet pressure of the pressure relief valve 7203. The decompressed gas passes through the secondary solenoid valve 7205 to control the gas outlet and then through the three-stage solenoid valve (such as the three-stage solenoid valves 7206, 7207, or 7208, etc.).) and is transferred to the different gas transfer channels for use as the gas for temperature increase. Each gas transfer channel is equipped with a check valve (such as check valves 7214, 7215 or 7216 etc.) to prevent gas backflow.

[0036] The operating state of an electrical heating component 811 in the ablation needle 8 is controlled by the control board 5 via the relay board 6 to heat the low-pressure argon, and the low-pressure argon enters the ablation needle tip with slight throttling and cryogenic effect.

[0037] The ablation needle is heated by the high-temperature, low-pressure argon, and the needle transfers the heat to the surrounding tissues to raise the temperature. The electric heating component 811 is mounted on a heat exchanger 810 inside the ablation needle 8 to ensure that the low-pressure argon is thoroughly heated. It is located very close to the tip of the ablation needle handle 814, which needs to be heated, and there is almost no temperature loss in the tubing.The temperature sensor 813 is mounted on the electric heating component 811 and is used to measure the heating temperature of the electric heating component 811. The temperature of the temperature sensor 813 is measured by the control board 5, and when the heating temperature equals the preset value, the electric heating component 811 is no longer heated by the control board 5 via the relay board 6. The electric heating component 811 is a quartz heating element or a foil heating element. The temperature sensor 813 is a thermocouple or a thermistor.

[0038] With reference to Fig. 1, Fig. 2 and Fig. 5 the second dynamic pressure setting module 73 comprises a particulate filter 7301, an oil vapor filter 7302, a safety valve 7303, a pressure transmitter 7304, a primary solenoid valve 7305, a blow-off solenoid valve 7310 and a third gas distribution branch line, wherein the helium source 10 is connected to an inlet of the particulate filter 7301, an outlet of the particulate filter 7301 is connected to an inlet of the oil vapor filter 7302, an outlet of the oil vapor filter 7302 is connected to an inlet of the safety valve 7303, an outlet of the safety valve 7303 is each connected to the pressure transmitter 7304 and an inlet of the primary solenoid valve 7305, an outlet of the primary solenoid valve 7305 is connected to an inlet of the third gas distribution branch line, and an outlet of the third gas distribution branch line is connected to a gas inlet of the ablation needle 8,An outlet of the pressure transmitter 7304 is electrically connected to the input end of the control board 5, an outlet of the safety valve 7303 is connected to an inlet of the blow-off solenoid valve 7310, and an outlet of the blow-off solenoid valve 7310 is connected to a gas outlet 76, the output end of the relay board 6 is electrically connected to the primary solenoid valve 7305.

[0039] The blow-off solenoid valve 7310 and the solenoid valves are each part of a third gas distribution branch line. In practical application, the third gas distribution branch line consists of several gas distribution units connected in parallel to each other. Each gas distribution unit includes a gas distribution solenoid valve and a check valve. An inlet of the gas distribution solenoid valve is connected to an outlet of the gas distribution solenoid valve 7305, an outlet of the gas distribution solenoid valve is connected to an inlet of the check valve, and an outlet of the check valve is connected to a gas inlet of the ablation needle 8. The gas distribution solenoid valve is electrically connected to the output end of the relay board 6.In the preferred embodiment of the present invention, the secondary solenoid valve 7306 and the check valve 7308 form a gas distribution unit in the third gas distribution branch line, and the secondary solenoid valve 7307 and the check valve 7309 form a further gas distribution unit in the third gas distribution branch line.

[0040] With reference to Fig. 1, Fig. 2 and Fig. 5. In the preferred embodiment of the present invention, if the temperature of the helium is increased by the second dynamic pressure adjustment module 73, the temperature of the ablation needle 8 can be increased by more than 100 °C to coagulate protein and stop bleeding in the needle path. However, this method can also be applied for thermal ablation. The method is implemented by mounting the electrical heating component 811 on the heat exchanger 810 in the ablation needle. The electrical heating component 811 is a quartz heating element or a foil heating element, etc. If the electrical heating component can be heated to a higher temperature, the ablation needle 8 can also be heated to a higher temperature. Since the helium has a throttling heating effect on the tip of the ablation needle 8, the temperature can be increased further.

[0041] The temperature sensor 813 is mounted on the electric heating component 811 and is used to measure the heating temperature of the electric heating component 811. The control board 5 takes the temperature from the temperature sensor 813, and when the heating temperature equals the preset value, the control board 5 stops the heating of the electric heating component 811 via the relay board 6. The temperature sensor 813 is a thermocouple or a thermistor.

[0042] With reference to Fig. 1, Fig. 2 and Fig. 6 comprises the booster pump together with its valve assembly 74, a particulate filter 7401, a booster pump 7402, an oil vapor filter 7403, a safety valve 7404, a pressure transmitter 7405, a primary solenoid valve 7406, a blow-off solenoid valve 7411 and the fourth gas distribution branch line 24, wherein an inlet of the particulate filter 7401 is connected to the air source 75, an outlet of the particulate filter 7401 is connected to an inlet of the booster pump 7402, an outlet of the booster pump 7402 is connected to an inlet of the oil vapor filter 7403, an outlet of the oil vapor filter 7403 is connected to an inlet of the safety valve 7404, an outlet of the safety valve 7404 is connected to the pressure transmitter 7405 and an inlet of the is connected to the primary solenoid valve 7406.

[0043] An outlet of the primary solenoid valve 7406 is connected to an inlet of the fourth gas distribution branch line, and an outlet of the fourth gas distribution branch line is connected to a gas inlet of the ablation needle 8, an outlet of the pressure transmitter 7405 is electrically connected to the input end of the control board 5, an outlet of the safety valve 7404 is connected to an inlet of the blow-off solenoid valve 7411, and an outlet of the blow-off solenoid valve 7411 is connected to a gas outlet 76, the output end of the relay board 6 is electrically connected to the booster pump 7403, the primary solenoid valve 7406, the blow-off valve 7411 and solenoid valves in the fourth gas distribution branch line 24.

[0044] In practical application, the fourth gas distribution branch line consists of several gas distribution units that are parallel to each other and interconnected; each gas distribution unit includes a gas distribution solenoid valve and a check valve; an inlet of the gas distribution solenoid valve is connected to an outlet of the gas distribution solenoid valve 7406; an outlet of the gas distribution solenoid valve is connected to an inlet of the check valve; and an outlet of the check valve is connected to a gas inlet of the ablation needle 8; the gas distribution solenoid valve is electrically connected to the output end of the relay board 6.In the preferred embodiment of the present invention, the secondary solenoid valve 7407 and the check valve 7409 form a gas distribution unit in the fourth gas distribution branch line, and the secondary solenoid valve 7408 and the check valve 7410 form a further gas distribution unit in the fourth gas distribution branch line.

[0045] With reference to Fig. 1, Fig. 2 and Fig. In the preferred embodiment of the present invention, the booster pump 7402 is a pneumatic or electric pump. When the booster pump is operating, the vacuum created between the booster pump 7402 and the particle filter 7401 draws air through the particle filter 7401 into the pump head. An outlet of the booster pump 7402 is connected to the safety valve 7404, which is connected to the blow-off solenoid valve 7411. Pressure relief and blow-off are automatically implemented in the event of excessive pressure. The pressure transmitter 7405 is used to monitor the outlet pressure of the booster pump 7402. Meanwhile, the relay board is controlled by the control board, and the operating time and power of the electric heating component are controlled by the heating interface 30 of the ablation needle 8.The temperature sensor 813 is mounted on the electric heating component 811 and is used to measure the heating temperature of the electric heating component 811. The temperature of the temperature sensor 813 is measured by the control board 5, and when the heating temperature equals the preset temperature, the control board 5 stops the heating of the electric heating component 811 via the relay board 6. The temperature sensor 813 is a thermocouple or a thermistor.

[0046] With reference to Fig. 1 to 6 and Fig. The ablation needle 8 comprises an ablation needle tip 801, a temperature thermocouple 802, a gas transfer pipe 803, a vacuum insulating layer 804, a heat exchanger 810, an electrical heating component 811, a temperature sensor 813, and an ablation needle handle 814, wherein the ablation needle tip 801 is connected to the ablation needle handle 814, a throttle opening is fixed in the front end of the gas transfer pipe 803, the vacuum insulating layer 804 is fixed to the inner wall of the ablation needle handle 814, the gas transfer pipe 803 is connected to the heat exchanger 810, the temperature thermocouple 802 is fixed in the ablation needle handle 814, and the electrical heating component 811 is attached to the heat exchanger 810 mounted and electrically connected to the relay board 6 via a heating interface 30 to proceed to heating control via the relay board 6,The temperature sensor 813 is fixed to the electrical heating component 811. The temperature thermocouple 802 and the temperature sensor 813 are each electrically connected to the input end of the control board 5. The temperature of the electrical heating component 811 is measured by the control board 5 via the temperature sensor 813 to precisely control the electrical heating temperature and prevent overheating. The temperature of the ablation needle 8 is measured by the control board 5 via the temperature thermocouple 802. In practical applications, the electrical heating component 811 is a quartz heating element or a foil heating element, and the temperature sensor 813 is a thermocouple or a thermistor.

[0047] With reference to Fig. Argon enters the heat exchanger 810 under high pressure for heat exchange during the cryogenic operation of the ablation needle and then passes through the gas transfer pipe 803 into the ablation needle tip 801. The throttling effect of the high-pressure gas occurs at the front end of the gas transfer pipe 803 to reduce the temperature, and the gas enters the outer fins of the heat exchanger 810 at a lower temperature to pre-cool the newly entered gas before finally being released into the ambient air. The temperature thermocouple 802 is used to detect the temperature of the ablation needle tip, and the vacuum insulation layer 804 is used to prevent the cryogenic temperature of the ablation needle handle from causing frost damage to normal tissue.Since the throttled gas must pass through the heat exchanger 810 and encounters a certain resistance, the gas pressure at the ablation needle tip 801 is higher than normal atmospheric pressure (greater than 0.1 MPa). Based on the physical properties of argon (as shown in Table 1 below), the boiling point of argon increases as a result of the pressure increase. The lowest temperature of the ablation needle is equal to the boiling point of argon, and the lower cryogenic temperature of the ablation needle can be achieved by reducing the gas reflux resistance. The gas reflux resistance can be effectively reduced by decreasing the gas supply pressure and the gas flow rate, thereby lowering the pressure at the ablation needle tip 801.The gas supply pressure can be reduced appropriately, and if the gas pressure is reduced too much, the throttling effect and cryogenic efficiency are diminished, thus increasing the temperature. In the preferred embodiment of the present invention, the temperature of the ablation needle is used as the feedback signal, and the gas supply pressure is dynamically adjusted to achieve the optimal pressure, ensuring the throttling effect and reducing gas backflow resistance. In this way, the temperature of the ablation needle can be maintained at the lower cryogenic temperature, thereby extending the cryogenic range and increasing cryogenic efficiency. Table 1 Argondruck (MPa) Siedepunkt Argon (°C) 0,1 -185,981 0,4 -170,42 0,8 -160,27 1 -156,56 2 -143,43 4 -127,47

[0048] With reference to Fig. 1 and Fig. The control board 5 comprises a PID controller 1301, a parallel communication interface 1302, a serial communication interface 1303, a CPU 1304, a memory device 1305, a DC-DC conversion module 1306, and an optocoupler 1307. The CPU 1304 is electrically connected to the parallel communication interface 1302, the serial communication interface 1303, the memory device 1305, and the optocoupler 1307. The PID controller 1301 is electrically connected to the optocoupler 1307. The DC-DC conversion module 1306 is electrically connected to the PID controller 1301, the parallel communication interface 1302, the serial communication interface 1303, the CPU 1304, the memory device 1305, and the optocoupler 1307. connected. In practical application, the control board 5 is electrically connected to the host computer 3 via the parallel communication interface 1302 and / or the serial communication interface 1303.The DC-DC converter module 1306 is used as the power supply to convert 24 VDC to 5 VDC. The memory device 1305 is used to store data, the optocoupler 1307 is used to provide electrical isolation between the PID controller 1301 and the CPU 1304, and the CPU 1304 is used to calculate and manipulate data.

[0049] With reference to Fig. 3 to Fig. The control board 5 is used not only to control the operation of the relay board 6, but also to receive the temperature signals of the ablation needle 8 and the electric heating component 811, the pressure signals and flow signals of the first dynamic pressure setting module 71, and the pressure signals of the pressure relief valve 72, the second dynamic pressure setting module 73 and the booster pump together with its valve combination 74. The relay board 6 is used to control the operation of the solenoid valves in the first dynamic pressure setting module 71, the pressure relief valve 72, the second dynamic pressure setting module 73, the booster pump together with its valve combination 74 and the heating of the electric heating component 811.

[0050] In a preferred embodiment of the present invention, the cryogenic temperature and time can also be preset in the system along with the heating temperature and time, and the temperature can be precisely controlled in the system. The internal timer in the system is used to control the duration. The schematic diagram of the temperature control is shown in Fig. Figure 7 shows that the PID controller 94, integrated into the system's control board, is used to stabilize the temperature at the preset temperature within the shortest possible time period. After the gas enters the system via the gas inlet 99, the incoming gas quantity is controlled by the primary solenoid valve 91, and a large-volume gas cylinder 97 downstream of the primary solenoid valve 91 is used to stabilize the gas pressure.The temperature sensor 93 is used to detect the temperature of the ablation needle 8 in real time, the A / D converter 96 in the PID controller is used to take the temperature, the pulse width modulator 95 in the PID controller is used to preset the pulse width, the relay 98 is used to set the opening / closing load cycle of the primary solenoid valve 91 for setting the gas pressure (monitored by the pressure transmitter), and thus the preset temperature can be set within the optimal time and with the shortest possible temperature overshoot and maintained at the preset temperature until the end of the surgical operation.

[0051] The ablation needle operates on the Joule-Thomson principle; therefore, the gas supply pressure to the ablation needle must be precisely controlled to achieve precise temperature control. While an electric pressure regulator can be used to control the gas pressure, its greater pressure inertia and slower response result in greater fluctuations in the pressurized gas, leading to larger temperature fluctuations. In a preferred embodiment of the present invention, a PID controller is used to control the opening / closing load cycle of the gas supply solenoid valve, and a large-volume gas cylinder is mounted downstream of the PID controller to stabilize the gas pressure. The PID controller consists of a proportional element P, an integrating element I, and a differential element D.The proportional element P is used to accelerate the response speed and improve the set precision of the system, the integration element I is used to set the steady-state error of the system, and the differential element D is used to improve the dynamic properties of the system. These three parameters complement each other to achieve optimal control for precise and rapid temperature regulation.

[0052] The parameters of the PID controller are preset based on a large number of prior experiments. For example, the temperature of the ablation needle is preset by the surgeon to T before the start of the operation. After the operation begins, the temperature of the ablation needle is measured in the system once per second based on the preset control period (if the control period is preset too long, greater pressure and temperature fluctuations will occur, and if the control period is preset too short, the solenoid valve will respond more slowly). The preset control period is set by the PID controller integrated into the control board; for example, the control period is 5 seconds. An average temperature reading within a control period is fed back to the PID controller.The opening / closing load cycle of the solenoid valve is set by the PID controller according to the change in temperature, and this adjusts the gas supply pressure to ultimately reach the target temperature T.

[0053] When the cryosurgery system is implemented for surgical procedures in the preferred embodiment of the present invention, the temperature and operating time of the ablation needle are preset by the physician based on the size and location of the tumor. The cryotherapy processes and temperature increase can be implemented automatically in the system based on the preset temperature and operating time. For example, the cryogenic time and temperature are set to 15 minutes and -120 °C, or the heating time and temperature are preset by the physician via the input device to 2 minutes and 10 °C. After confirmation by the physician, the preset operating curves corresponding to the preset values ​​are displayed on the display device in the system, and the surgical process begins to be implemented automatically in the system.The real-time operating curves are also displayed on the display device during the operation process and are obviously in contrast to the preset operating curves, and the operating status of the system can also be intuitively observed by the doctor.

[0054] The precise temperature control functions of the cryosurgery system are described below in the preferred embodiment of the present invention: after the start of the cryogenic operation, the argon enters the particle filter through the gas inlet of the system, and the particulate impurities in the argon are filtered out to prevent damage to the downstream solenoid valves; the argon enters the oil vapor filter through the particle filter, and the oil vapor impurities in the gas are also filtered out; and subsequently, the gas enters the safety valve, which is used for high-pressure protection.The system's gas inlet pressure is measured by the control board via the primary pressure transmitter. When the gas inlet pressure is within the safe pressure range, the primary solenoid valve opens, and the gas enters the gas cylinder. The pressure of the gas cylinder is measured by the control board via the secondary pressure transmitter. When the pressure of the gas cylinder equals the operating pressure, the secondary solenoid valve opens, and the respective three-stage solenoid valve opens based on the inserted channel of the ablation needle. After moisture is filtered out of the argon by the water vapor filter, the argon flows through the gas flow meter and enters the ablation needle. The throttling effect is created by the high-pressure argon at the tip of the ablation needle, generating the cryogenic temperature necessary for cryotherapy.

[0055] The ablation needle temperature is monitored in real time by the control board. Once the needle temperature reaches the preset value of -120°C, the control board adjusts the operating frequency of the primary solenoid valve to control the gas inlet volume to the gas cylinder and reduce the gas pressure. The gas cylinder contains a specific volume of gas, which buffers the gas and stabilizes the pressure. As the cryogenic period increases, the temperature of the system piping and the gas transfer piping of the ablation needle decreases. Simultaneously, the load on the ablation needle is also reduced, and the operating pressure required to maintain the cryogenic temperature of -120°C is significantly lower. The operating frequency of the primary solenoid valve is further reduced based on the system's cryogenic period, thus decreasing the system's gas consumption.

[0056] During the temperature increases, the following three different methods for increasing the temperature in the cryosurgery system are provided in the preferred embodiment of the present invention: 1) Temperature increase by helium. The helium flows through the particulate filter and the oil vapor filter, and the impurities in the helium are filtered out. The supply pressure of the helium is taken from the control board via the pressure transmitter after the system pressure has been detected as normal. The relay board is controlled by the control board to operate the electrical heating component in the ablation needle via the heating interface, and the heat exchanger in the ablation needle is heated. Meanwhile, the primary solenoid valve is controlled by the control board via the relay board so that it opens together with the secondary solenoid valve of the corresponding channel. After the helium has flowed through the check valve, it enters the ablation needle to be used as the temperature-increasing gas.The helium flows through the gas transfer line and enters the heat exchanger. After being heated by the electric heating component, the heated helium enters the ablation needle tip to create the throttling effect. The temperature of the helium is further increased to up to 100 °C or similar, and protein is coagulated at this temperature to stop bleeding. 2) Temperature increase via argon (the gas route consisting of the pressure relief valves). If the helium source cannot be used due to a lack of helium, or for other reasons that would lead to damage and helium leakage during surgery, the temperature increase is achieved using argon. The primary solenoid valve is opened by the control board via the relay board, and the argon enters the check valve to prevent backflow. The argon pressure is reduced after the argon has passed through the pressure relief valve, and the outlet pressure of the pressure relief valve is detected by the pressure transmitter.Once the control board detects that the pressure relief valve's outlet pressure is the appropriate gas pressure, the secondary solenoid valve and the three-stage solenoid valve open under the relay board's control, and low-pressure argon enters the temperature-increasing gas inlet of the channel connected to the ablation needle. Meanwhile, the electrical heating element in the ablation needle is heated by the relay board via the heating interface connected to the needle. The low-pressure argon heats up and enters the tip of the ablation needle, and the throttling or cooling effect is not generated by the low argon pressure. Heat is exchanged between the high-temperature, low-pressure argon and the ablation area at the needle tip, thus increasing the ambient temperature. 3) Temperature increase via air (the gas route consisting of the booster pump and its valve assembly). The temperature increase and needle extraction occur during the surgical procedure. If both the argon and helium in the system are depleted, or the gas source cannot be used for other reasons, the ablation needle cannot be extracted from the patient's body. It takes a long time for the temperature to slowly increase due to the body's own heat, thus increasing the operating time and risks. In the preferred embodiment of the present invention, the temperature increase is achieved via air. After the physician initiates the temperature increase procedure, the booster pump begins operating under the control of the relay board.A vacuum is created at the gas inlet of the booster pump, and air is drawn in. The drawn-in air flows through the particulate filter and the oil vapor filter, and after the contaminants are filtered out, the air is transferred to the safety valve. Once the control board detects via the pressure transmitter that the air pressure matches the operating pressure, the secondary solenoid valve and the three-stage solenoid valve open. The air flows through the check valve downstream of the three-stage solenoid valve to prevent backflow and then enters the ablation needle through the temperature boost inlet. Meanwhile, the electrical heating element in the ablation needle is heated by the relay board via the heating interface connected to the needle. The air is heated by the electrical heating element and enters the tip of the ablation needle.Heat is exchanged between the high-temperature air and the surrounding area of ​​the ablation needle tip, and the ambient temperature is increased to achieve the temperature rise.

[0057] The conventional cryogenic control method involves maintaining a constant pressure of gas throughout the cryogenic process. During the initial cryogenic period, the temperature of the system's piping and the gas delivery piping of the ablation needle are higher. Since the tumor temperature is equal to the temperature of the human body, this results in a higher load on the ablation needle during the initial cryogenic period. Therefore, the surgical procedure is performed in a high-performance operating mode during this initial period. However, as the cryogenic duration increases, the temperature of the system's piping and the gas delivery piping of the ablation needle decrease, along with the load on the ablation needle, and the high-performance operating mode is no longer maintained.In the preferred embodiment of the present invention, the gas is then no longer supplied at constant pressure during the entire cryogenic process, and the gas supply pressure is reduced in a suitable manner based on the load situations in order to achieve the purpose of saving the amount of gas, resulting in a highly efficient and energy-saving cryogenic control method.

[0058] The cryogenic ablation surgery procedure performed is in Fig. Figure 9 illustrates the cryosurgery system of the preferred embodiment of the present invention. After the cryogenic operation has started at step 100, the cryogenic operation is first performed by the constant high-pressure gas (the argon) in the system (step 101), and the temperature of the ablation needle is taken by the temperature sensor at the front end of the ablation needle to detect (step 102) whether the temperature of the ablation needle has reached its lowest temperature (e.g., no further decrease within 30 seconds). If not, the cryogenic operation is continued with the constant high-pressure gas source. If so, the opening time of the primary solenoid valve is controlled by the first dynamic pressure adjustment module (step 103) to control the amount of argon entering the gas cylinder and to reduce the pressure (step 104).For example, each dynamic adjustment time is set to 30 seconds, along with a reduction in the system gas pressure of 100 psi. Each time the gas pressure is reduced, changes in the internal temperature of the ablation needle are recorded. If the ablation needle temperature decreases, the gas pressure is further reduced by 100 psi, and the changes in the internal temperature of the ablation needle are recorded. If the ablation needle temperature increases (step 105), the gas pressure is increased by 200 psi (step 106). The purpose of this relatively high pressure increase is to rapidly lower the temperature. The temperature increase indicates that the load is higher than the current power of the ablation needle, and the temperature must be rapidly reduced with the higher power. Subsequently, the gas pressure is reduced by 100 psi.

[0059] If the temperature remains constant, the pressure corresponds to the optimal gas supply pressure. If the volume of the ice sphere increases due to the lengthening of the cryogenic period, and the load continues to increase to the point where the temperature can no longer be maintained constant, the gas pressure is again increased by 200 psi, as described in the procedure above. After another dynamic adjustment cycle, the gas pressure is reduced by 100 psi until the temperature can be maintained constant. The dynamic adjustment process in the control procedure described above is repeated during a cryogenic cycle until the temperature of the ablation needle can be kept stable at the lowest cryogenic temperature (step 107), until the end of the cryosurgical procedure (step 108).The aforementioned cryogenic control method is used not only to significantly reduce gas consumption, but also to maintain a lower temperature of the ablation needle and to expand the cryogenic range. Fig. 10 and Fig. Figure 11 shows schematic diagrams comparing the cryogenic process according to the prior art and the cryogenic process in the preferred embodiment of the present invention. The high-pressure argon source in China is currently a steel gas cylinder with a capacity of 40 liters and a maximum pressure of 35 MPa (approximately 5,000 psi). The gas pressure regulator is typically used to connect to the interface of the gas cylinder and to reduce the pressure to 3,000 psi to supply the system. Therefore, the high-pressure protection must be designed to ensure the safety of patients and operators. In the preferred embodiment of the present invention, as shown in Figure 11, the pressure regulator is used to reduce the pressure to 3,000 psi to 3,000 psi. Fig. Figure 12 illustrates a multi-stage high-pressure protection system. If the system pressure becomes too high (step 120), for example, due to damage to the gas pressure regulator connected to the gas cylinder, resulting in a failure of the pressure reduction mechanism and the direct ingress of high-pressure gas from the gas cylinder into the system, a high-pressure message is displayed at the system interface (step 121). The first protection stage in the system (step 122) is then activated. This stage controls the opening time of the primary solenoid valve via the first dynamic pressure adjustment module (step 123), thus controlling the amount of argon entering the gas cylinder to reduce the pressure and ensure the successful completion of the surgical procedure.

[0060] Once the surgical operation is complete, the gas pressure regulator can be repaired. If the system pressure is still too high after adjustment, the second protection stage (step 124) is implemented to close the primary solenoid valve (step 125) and prevent gas from entering. Simultaneously, the vent solenoid valve opens (step 126) to reduce the pressure by venting, and the surgical operation is stopped. If the entire control system malfunctions, the third protection stage (step 127), independent of the system control, is a mechanical proportional relief valve (i.e., a safety valve). If the pressure exceeds a certain value, the safety valve opens automatically (step 128) to relieve the pressure without electrical control, and the surgical operation is stopped.

[0061] The cryosurgery system in the preferred embodiment of the present invention is capable of precisely controlling and presetting the cryogenic temperature of the ablation needle, monitoring the gas consumption in the gas transfer channel in real time via the first dynamic pressure adjustment module, and dynamically adjusting the gas supply pressure to achieve the optimal gas supply pressure. The cryosurgery system in the preferred embodiment of the present invention is capable of ensuring the cryogenic effect and reducing the gas reflux resistance so that the ablation needle operates at the deep cryogenic temperature, thereby increasing the cryogenic range and cryogenic efficiency and reducing the amount of gas consumed.When the helium temperature is increased by the second dynamic pressure control module, the temperature of the ablation needle can be raised above 100 °C, thereby coagulating proteins and stopping bleeding in the needle path. The multi-stage high-pressure protection effectively ensures the safety of both patients and operators. The multi-stage filtration system completely filters out particles, oil mist, moisture, and other contaminants in the gas, effectively preventing ablation needle clogging.

[0062] The preferred embodiment further describes in detail the objectives, technical scheme, and advantageous effects of the present invention. It should be clear that the foregoing description is intended only to illustrate a specific embodiment of the invention and not to limit the invention. All modifications, equivalent substitutions, or improvements to the embodiment that do not deviate from the spirit and principles of the invention shall fall within the scope of protection of the invention. REFERENCE MARK LIST 1 Display device 2 Input device 3 Host computers 4 Power supply 5 Control board 6 relay boards 7 Control Gas Route 8 ablation needles 9 Argon source 10 Helium source 21 First gas distribution branch line 22 Second gas distribution branch line 23 Third gas distribution branch line 24 Fourth gas distribution branch line 30 Heating interface 71 First dynamic pressure setting module 72 Pressure relief valve combination 73 Second dynamic pressure setting module 74 Reinforcement pump with valve combination 75 Air source 76 Gas outlet 91 Primary solenoid valve 93 Temperature sensor 95 Pulse Width Modulator 96 A / D converters 97 gas cylinders 98 relays 99 Gas Inlet 100 Starting the cryogenic operation 101 Procedure with constant pressure 102 Lowest temperature reached? 103 Dynamic setting 104 Reducing the pressure 105 Is the temperature rising? 106 Increasing the pressure 107 Maintain low temperature and stable condition 108 End of the cryogenic operation 120 Gas pressure too high 121 Message at the interface 122 First protection level 123 Dynamic pressure setting 124 Second protection level 125 Close gas supply 126 Open the blow-off solenoid valve 127 Third protection level 128 Safety valve opens automatically 801 Tip of the ablation needle 802 Temperature Thermocouple 803 Gas transmission pipeline 804 Vacuum insulating layer 810 Heat exchangers 811 Electric heating component 813 Temperature sensor 814 Ablation needle handle 1301 PID control unit 1302 Parallel communication interface 1303 Serial communication interface 1304 CPU 1305 Storage device 1306 DC-DC conversion module 1307 Optocouplers 7100 First gas distribution branch line 7101 Particle filter 7102 Oil vapor filter 7103 Safety valve 7104 Primary pressure transmitter 7105 Primary solenoid valve 7106 Gas cylinders (gas buffer pool) 7107 Secondary pressure transmitter 7108 Blow-off solenoid valve 7109 Secondary solenoid valve 7110 Three-stage solenoid valve 7111 Three-stage solenoid valve 7112 Three-stage solenoid valve 7113 Water vapor filter 7114 Water vapor filter 7115 Water vapor filter 7116 Gas flow meter 7117 Gas flow meter 7118 Gas flow meter 7201 Primary solenoid valve 7202 Check valve 7203 Pressure relief valve 7204 Pressure Transmitter 7205 Secondary solenoid valve 7206 Three-stage solenoid valve 7207 Three-stage solenoid valve 7208 Three-stage solenoid valve 7214 Check valve 7215 Check valve 7216 Check valve 7301 Particle filter 7302 Oil vapor filter 7303 Safety valve 7304 Pressure Transmitter 7305 Primary solenoid valve 7306 Secondary solenoid valve 7307 Solenoid valve 7308 Check valve 7309 Check valve 7310 Blow-off solenoid valve 7401 Particle filter 7402 Booster pump 7403 Oil vapor filter 7404 Safety valve 7405 Pressure Transmitter 7406 Primary solenoid valve 7407 Secondary solenoid valve 7408 Secondary solenoid valve 7409 Check valve 7410 Check valve 7411 Blow-off solenoid valve

Claims

[1] Cryosurgery system comprising a display device (1), an input device (2), a host computer (3), a power supply (4), a control board (5), a relay board (6), a control gas route (7), an ablation needle (8), an argon source (9) and a helium source (10), wherein the control gas route (7) comprises a first dynamic pressure control module (71), a pressure relief valve combination (72), a second dynamic pressure control module (73) and a booster pump together with its valve combination (74), wherein the display device (1) and the input device (2) are each electrically connected to the host computer (3), wherein the control board (5) is electrically connected to the host computer (3), wherein an input end of the control board (5) is electrically connected to the first dynamic pressure setting module (71), the pressure relief valve combination (72), the second dynamic pressure setting module (73), the booster pump together with its valve combination (74) and the ablation needle (8), wherein an output end of the control board (5) is electrically connected to an input end of the relay board (6), wherein an output end of the relay board (6) is electrically connected to the first dynamic pressure setting module (71), the pressure relief valve combination (72), the second dynamic pressure setting module (73), solenoid valves in the booster pump together with their valve combination (74) and the ablation needle (8), wherein the power supply (4) is electrically connected to the host computer (3), the control board (5) and the relay board (6), and the argon source (9) is connected to gas inlets of the first dynamic pressure setting module (71) and the pressure relief valve combination (72), wherein the helium source (10) is connected to a gas inlet of the second dynamic pressure control module (73), and wherein gas outlets of the first dynamic pressure setting module (71), the pressure relief valve combination (72), the second dynamic pressure setting module (73) and the booster pump together with their valve combination (74) are each connected to a gas inlet of the ablation needle (8). [2] Cryosurgery system according to claim 1, wherein the first dynamic pressure control module (71) comprises a particle filter (11), an oil vapor filter (12), a safety valve (13), a primary pressure transmitter (14), a primary solenoid valve (15), a gas cylinder (16), a secondary pressure transmitter (17), a blow-off solenoid valve (18), a secondary solenoid valve (19) and a first gas distribution branch line (21), wherein the argon source (9) is connected to an inlet of the particulate filter (11), an outlet of the particulate filter (11) is connected to an inlet of the oil vapor filter (12), an outlet of the oil vapor filter (12) is connected to an inlet of the safety valve (13), an outlet of the safety valve (13) is connected to the primary pressure transmitter (14) and an inlet of the primary solenoid valve (15), an outlet of the primary solenoid valve (15) is connected to an inlet of the gas cylinder (16), an outlet of the gas cylinder (16) is connected to the secondary pressure transmitter (17) and an inlet of the secondary solenoid valve (19), an outlet of the secondary solenoid valve (19) is connected to an inlet of the first gas distribution branch line (21), and an outlet of the first gas distribution branch line (21) is connected to a gas inlet is connected to the ablation needle (8), wherein outlets of the primary pressure transmitter (14) and the secondary pressure transmitter (17) are each electrically connected to the input end of the control board (5), an outlet of the safety valve (13) is connected to an inlet of the blow-off solenoid valve (18), and an outlet of the blow-off solenoid valve (18) is connected to a gas outlet (76), wherein the output end of the relay board (6) is electrically connected to the primary solenoid valve (15), the blow-off solenoid valve (18), the secondary solenoid valve (19) and solenoid valves in the first gas distribution branch line (21), and wherein the gas flow meter in the first gas distribution branch line (21) is electrically connected to the control board (5). [3] Cryosurgery system according to claim 2, wherein the first gas distribution branch line (21) consists of several gas distribution units which are parallel to each other and connected to each other, wherein each gas distribution unit comprises a gas distribution solenoid valve (22, 23, 24), a water vapor filter (25, 26, 27) and a gas flow meter (28, 29, 30), wherein an inlet of the gas distribution solenoid valve (22, 23, 24) is connected to the outlet of the secondary solenoid valve (19), an outlet of the gas distribution solenoid valve (22, 23, 24) is connected to an inlet of the water vapor filter (25, 26, 27), an outlet of the water vapor filter (25, 26, 27) is connected to an inlet of the gas flow meter (28, 29, 30), an outlet of the gas flow meter (28, 29, 30) is connected to a gas inlet of the ablation needle (8), and the gas flow meter (28, 29, 30) is electrically connected to the input end of the control board (5), wherein the gas distribution solenoid valve (22, 23, 24) is electrically connected to the output end of the relay board (6). [4] Cryosurgery system according to claim 1, wherein the pressure relief valve combination (72) comprises a primary solenoid valve (31), a check valve (32), a pressure relief valve (33), a pressure transmitter (34), a secondary solenoid valve (35) and a second gas distribution branch line (36), wherein the argon source (9) is connected to an inlet of the primary solenoid valve (31), an outlet of the primary solenoid valve (31) is connected to an inlet of the check valve (32), an outlet of the check valve (32) is connected to an inlet of the pressure relief valve (33), an outlet of the pressure relief valve (33) is connected to the pressure transmitter (34) and an inlet of the secondary solenoid valve (35), an outlet of the secondary solenoid valve (35) is connected to an inlet of the second gas distribution branch line (36), and an outlet of the second gas distribution branch line (36) is connected to a gas inlet of the ablation needle (8), wherein an outlet of the pressure transmitter (34) is electrically connected to the input end of the control board (5), wherein the output end of the relay board (6) is electrically connected to the primary solenoid valve (31), the secondary solenoid valve (35) and solenoid valves in the second gas distribution branch line (36). [5] Cryosurgery system according to claim 1, wherein the second dynamic pressure control module (73) comprises a particle filter (37), an oil vapor filter (38), a safety valve (39), a pressure transmitter (40), a primary solenoid valve (41), a blow-off solenoid valve (42) and a third gas distribution branch line (43), wherein the helium source (10) is connected to an inlet of the particulate filter (37), an outlet of the particulate filter (37) is connected to an inlet of the oil vapor filter (38), an outlet of the oil vapor filter (38) is connected to an inlet of the safety valve (39), an outlet of the safety valve (39) is connected to the pressure transmitter (40) and an inlet of the primary solenoid valve (41), an outlet of the primary solenoid valve (41) is connected to an inlet of the third gas distribution branch line (43), and an outlet of the third gas distribution branch line (43) is connected to a gas inlet of the ablation needle (8), wherein an outlet of the pressure transmitter (40) is electrically connected to the input end of the control board (5), wherein an outlet of the safety valve (39) is connected to an inlet of the blow-off solenoid valve (42), and an outlet of the blow-off solenoid valve (42) is connected to a gas outlet (76), wherein the output end of the relay board (6) is electrically connected to the primary solenoid valve (41), the blow-off solenoid valve (42) and solenoid valves in the third gas distribution branch line (43). [6] Cryosurgery system according to claim 1, wherein the booster pump together with its valve assembly (74) comprises a particle filter (44), a booster pump (45), an oil vapor filter (46), a safety valve (47), a pressure transmitter (48), a primary solenoid valve (49), a blow-off solenoid valve (50) and a fourth gas distribution branch line (51), wherein an inlet of the particulate filter (44) is connected to an air source (75), an outlet of the particulate filter (44) is connected to an inlet of the booster pump (45), an outlet of the booster pump (45) is connected to an inlet of the oil vapor filter (46), an outlet of the oil vapor filter (46) is connected to an inlet of the safety valve (47), an outlet of the safety valve (47) is connected to the pressure transmitter (48) and an inlet of the primary solenoid valve (49), an outlet of the primary solenoid valve (49) is connected to an inlet of the fourth gas distribution branch line (51), and an outlet of the fourth gas distribution branch line (51) is connected to a gas inlet of the ablation needle (8), wherein an outlet of the pressure transmitter (48) is electrically connected to the input end of the control board (5), wherein an outlet of the safety valve (47) is connected to an inlet of the blow-off solenoid valve (50), and an outlet of the blow-off solenoid valve (50) is connected to a gas outlet (76), wherein the output end of the relay board (6) is electrically connected to the booster pump (45), the primary solenoid valve (49), the blow-off solenoid valve (50) and solenoid valves in the fourth gas distribution branch line (51). [7] Cryosurgery system according to claim 4, wherein the second gas distribution branch line (36) consists of several gas distribution units which are parallel to each other and connected to each other, wherein each gas distribution unit comprises a gas distribution solenoid valve (52, 53, 54) and a check valve (55, 56, 57), wherein an inlet of the gas distribution solenoid valve (52, 53, 54) is connected to a gas transfer pipeline, an outlet of the gas distribution solenoid valve (52, 53, 54) is connected to an inlet of the check valve (55, 56, 57), and an outlet of the check valve (55, 56, 57) is connected to a gas inlet of the ablation needle (8), wherein the gas distribution solenoid valve (52, 53, 54) is electrically connected to the output end of the relay board (6). [8] Cryosurgery system according to claim 5, wherein the third gas distribution branch line (43) consists of several gas distribution units which are parallel to each other and connected to each other, wherein each gas distribution unit comprises a gas distribution solenoid valve (58, 59) and a check valve (60, 61), wherein an inlet of the gas distribution solenoid valve (58, 59) is connected to a gas transmission pipeline, an outlet of the gas distribution solenoid valve (58, 59) is connected to an inlet of the check valve (60, 61), and an outlet of the check valve (60, 61) is connected to a gas inlet of the ablation needle (8), wherein the gas distribution solenoid valve (58, 59) is electrically connected to the output end of the relay board (6). [9] Cryosurgery system according to claim 6, wherein the fourth gas distribution branch line (51) consists of several gas distribution units which are parallel to each other and connected to each other, wherein each gas distribution unit comprises a gas distribution solenoid valve (62, 63) and a check valve (64, 65), wherein an inlet of the gas distribution solenoid valve (62, 63) is connected to a gas transmission pipeline, an outlet of the gas distribution solenoid valve (62, 63) is connected to an inlet of the check valve (64, 65), and an outlet of the check valve (64, 65) is connected to a gas inlet of the ablation needle (8), wherein the gas distribution solenoid valve (62, 63) is electrically connected to the output end of the relay board (6). [10] Cryosurgery system according to claim 1, wherein the ablation needle (8) comprises an ablation needle tip (66), a temperature thermocouple (67), a gas transfer piping (68), a vacuum insulating layer (69), a heat exchanger (70), an electrical heating component (77), a temperature sensor (78) and an ablation needle holding handle (79), wherein the ablation needle tip (66) is connected to the ablation needle holding handle (79), wherein a throttle opening is fixed in the front end of the gas transmission pipeline (68), wherein the vacuum insulating layer (69) is fixed to the inner wall of the ablation needle handle (79), wherein the gas transfer pipeline (68) is connected to the heat exchanger (70), wherein the temperature thermocouple (67) is fixed in the ablation needle holding handle (79), wherein the electrical heating component (77) is mounted on the heat exchanger (70) and electrically connected to the relay board (6) via a heating interface (80), wherein the temperature sensor (78) is fixed to the electrical heating component (77), wherein the temperature thermocouple (67) and the temperature sensor (78) are each electrically connected to the input end of the control board (5). [11] Cryosurgery system according to claim 10, wherein the electrical heating component (77) is a quartz heating element or a foil heating element, wherein the temperature sensor (78) is a thermocouple or a thermistor. [12] Cryosurgery system according to claim 1, wherein the input device (2) comprises a keyboard or a mouse, wherein the display device (1) comprises an LCD screen or a touch-controlled LCD screen, wherein the control board (5) comprises a PID controller (81), a parallel communication interface (82), a serial communication interface (83), a CPU (84), a memory device (85), a DC-DC conversion module (86) and an optocoupler (87), wherein the CPU (84) is electrically connected to the parallel communication interface (82), the serial communication interface (83), the storage device (85) and the optocoupler (87), wherein the PID control unit (81) is electrically connected to the optocoupler (87), wherein the DC-DC conversion module (86) is electrically connected to the PID control unit (81), the parallel communication interface (82), the serial communication interface (83), the CPU (84), the storage device (85) and the optocoupler (87).

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