High and low temperature combined ablation surgical system

Abstract

The present application relates to a kind of high-low temperature composite ablation surgical system, it is related to cryogenic therapy technical field, for improving the safety and effectiveness of treatment.The present application is a kind of high-low temperature composite ablation surgical system, including host unit and the cold and hot ablation needle connected with the host unit, the host unit includes cold working medium supply system, hot working medium supply system and working medium distribution system, working medium distribution system can respectively control cold working medium supply system to cold and hot ablation needle transport cold working medium, and control hot working medium supply system to cold and hot ablation needle transport hot working medium, so it can be quickly rewarming to treatment area after completing cryogenic therapy, to provide foundation for the promotion of surgical safety, economy and convenience.

Description

Technical Field

[0001] This invention relates to the field of cryotherapy technology, and particularly to a high-low temperature combined ablation surgical system. Background Technology

[0002] Currently, cryotherapy is increasingly becoming a major method of interventional cancer treatment. This purely physical therapy offers advantages over radiotherapy and chemotherapy, including definite therapeutic effects, no tumor cell spread, minimally invasive and painless treatment, rapid recovery, and no damage to normal tissues. Clinical data shows that patients treated with this technology experience significant improvements in immune function and long-term survival rates. It has significant advantages in treating solid tumors such as lung cancer, liver cancer, breast cancer, kidney cancer, and prostate cancer.

[0003] The mechanism of cryotherapy is as follows:

[0004] 1. Ice crystal growth and cell dehydration cause mechanical damage to tumor cells.

[0005] 2. Blood embolism causes tumor tissue to die from hypoxia.

[0006] 3. Reversible damage, inducing apoptosis.

[0007] 4. Cryotherapy can stimulate immune regulation and produce a cascade-like ectopic tumor-suppressing effect.

[0008] In existing technologies, typical cryotherapy devices, such as the Cryocare Surgical System developed by Endocare in the United States and the VISUAL-ICE Cryoablation System developed by Galil in Israel, are collectively referred to as argon-helium cryosurgery because they use argon and helium as working fluids. They achieve cryotherapy through the Joule-Thomson effect (the temperature change caused by the expansion of a gas through a porous plug). The cryoablation temperature can reach as low as -150 to -160°C, and the rewarming temperature can reach up to about 40°C. It is easy to see that the above-mentioned cryotherapy devices all possess only one cooling mechanism, and the operating temperature range is limited by the cooling principle and the characteristics of the working fluid itself, thus providing only a single function of treatment. Furthermore, due to limitations in their working mechanism, these cryotherapy devices operate at relatively high pressures (12–22 MPa), posing safety hazards during procedures and generating relatively high noise levels. The working fluids used are also expensive (high-purity argon and high-purity helium, with helium being a rare strategic material indispensable for national defense and high-tech industry development) and difficult to obtain, hindering widespread adoption. Additionally, the need to connect high-pressure argon and helium cylinders during procedures makes them inconvenient to use in confined operating rooms. To date, there is no fully functional, wide-temperature-range cryotherapy device available domestically or internationally. Summary of the Invention

[0009] This invention provides a high-low temperature composite ablation surgical system that, while meeting the basic requirements of cryotherapy, combines higher intensity heating therapy, and provides a foundation for improving surgical safety, economy, and convenience.

[0010] This invention provides a high-low temperature composite ablation surgical system, including a main unit and a cold and hot ablation needle connected to the main unit, wherein the cold and hot ablation needle is used to treat the lesion of the patient;

[0011] The host unit includes:

[0012] A cold working fluid supply system for supplying cold working fluid to the thermo-thermal ablation needle;

[0013] A heat transfer fluid supply system for supplying heat transfer fluid to the ablation needle; and

[0014] The working fluid distribution system is connected to the cold working fluid supply system and the hot working fluid supply system respectively. The working fluid distribution system is used to control the cold working fluid supply system to deliver cold working fluid to the cold and hot ablation needle, and to control the hot working fluid supply system to deliver hot working fluid to the cold and hot ablation needle.

[0015] In one embodiment, the working fluid distribution system includes:

[0016] A phase separator, which is connected to the cold working fluid supply system; and

[0017] The precooler is provided with a gas channel and a liquid channel. The input side of the gas channel is connected to the gas outlet end of the phase separator, and the input side and output side of the liquid channel are connected to the liquid outlet end of the phase separator and the hot and cold ablation needle, respectively.

[0018] The gas in the gas channel is used to pre-cool the liquid in the liquid channel.

[0019] In one embodiment, the gas channel is constructed as a labyrinthine channel.

[0020] In one embodiment, the host unit further includes a recovery system connected to the output port of the cold and hot ablation needle. The recovery system is connected to the cold working fluid supply system and the hot working fluid supply system respectively, and is used to collect the cold working fluid or hot working fluid after treatment, or to collect the cold working fluid discharged from the cold working fluid supply system or the hot working fluid discharged from the hot working fluid supply system due to overpressure.

[0021] In one embodiment, the recovery system includes a connected heat exchanger connected to the output port of the hot and cold ablation needle. The heat exchanger is used to heat up the cold working fluid output by the hot and cold ablation needle and return it to the atmosphere, or to cool down the hot working fluid output by the hot and cold ablation needle and recover it.

[0022] In one embodiment, the cold working fluid supply system includes a cold tank for carrying the cold working fluid, the cold tank being used to deliver pressurized cold working fluid to the thermo-thermal ablation needle.

[0023] In one embodiment, the cold tank is connected to a pressurization line, which is used to self-pressurize the refrigerant in the cold tank.

[0024] In one embodiment, the heat supply system includes a hot tank for carrying the heat, the hot tank being used to deliver pressurized heat to the hot and cold ablation needle.

[0025] In one embodiment, the hot tank is provided with a heating device for vaporizing and pressurizing the working fluid in the hot tank.

[0026] In one embodiment, the host unit further includes an electrical control system and an interactive system that are electrically connected. The electrical control system is electrically connected to the cold working fluid supply system, the hot working fluid supply system, and the working fluid distribution system, respectively, to control the working process of the working fluid.

[0027] Compared with the prior art, the advantages of the present invention are: the working fluid distribution system can control the cold working fluid supply system to deliver cold working fluid to the cold and hot ablation needle, and control the hot working fluid supply system to deliver hot working fluid to the cold and hot ablation needle, so that the treatment area can be quickly rewarmed after the low temperature treatment is completed, thereby providing a basis for improving the safety, economy and convenience of the operation. Attached Figure Description

[0028] The invention will now be described in more detail with reference to embodiments and the accompanying drawings.

[0029] Figure 1 This is a schematic diagram of the high and low temperature composite ablation surgical system in an embodiment of the present invention;

[0030] Figure 2 This is a schematic diagram showing the connection between the cold working fluid supply system and the hot working fluid supply system in an embodiment of the present invention;

[0031] Figure 3 This is a connection diagram of the refrigerant supply system in an embodiment of the present invention;

[0032] Figure 4 This is a connection diagram of the heat supply system in an embodiment of the present invention;

[0033] Figure 5 This is a schematic diagram of the high and low temperature composite ablation surgery system in an embodiment of the present invention;

[0034] Figure 6 and Figure 7 This is a connection diagram of the working fluid distribution system in an embodiment of the present invention;

[0035] Figure 8 and Figure 9 This is a schematic diagram of the host unit in an embodiment of the present invention;

[0036] Figure 10 and Figure 11 This is a schematic diagram of the main unit structure after the outer shell is hidden in an embodiment of the present invention;

[0037] Figure 12 This is a schematic diagram of the pipeline connection of the working fluid distribution system in an embodiment of the present invention;

[0038] Figure 13 This is a schematic diagram of the precooler in an embodiment of the present invention;

[0039] Figure 14 and Figure 15 This is a schematic diagram of the heat exchanger in an embodiment of the present invention.

[0040] Figure 16 This is a schematic diagram of the structure of the cold and hot ablation needle in an embodiment of the present invention;

[0041] Figure 17 yes Figure 16 Enlarged view at point I.

[0042] Figure label:

[0043] 100 - Main Unit;

[0044] 200 - Cold and hot ablation needle; 2010 - Working fluid inlet tube; 202 - Working fluid return tube; 203 - Vacuum tube; 204 - Vacuum layer;

[0045] 300 - Cold working fluid supply system; 400 - Hot working fluid supply system; 500 - Working fluid distribution system; 600 - Recovery system; 700 - Electrical control system; 800 - Interaction system;

[0046] 210 - Probe delivery tube; 220 - Temperature probe;

[0047] 310 - Automatic refrigerant filling system; 320 - Refrigerant pressure control system;

[0048] 311-Refrigerated refrigerant storage tank; 312-Output valve; 313-Interface detection switch; 314-Filling interface; 315-Liquid filling valve; 316-Check valve;

[0049] 321 - Cold tank; 322 - Pressure boosting pipeline; 323 - Pressure boosting valve; 324, 426 - Pressure sensor; 325, 425 - Safety valve; 326 - Liquid filling and venting valve; 327, 428, 512 - Manual valve; 328 - Venting valve; 329, 427 - Pressure gauge; 330, 430 - Level gauge; 331 - Filter;

[0050] 410 - Automatic heat transfer fluid filling system; 420 - Heat transfer fluid pressure control system;

[0051] 411-Heat medium storage tank; 412-Liquid filling port; 413-Filling pump; 414-Filling valve;

[0052] 421-Hot tank; 422, 513-Temperature sensors; 423-Temperature switch; 424-Heater; 429-Vent valve;

[0053] 510 - Phase separator; 511 - Phase separation valve;

[0054] 520 - Precooler; 521 - Gas passage; 522 - Upper plate; 523 - Lower plate;

[0055] 610-Heat exchanger; 611-Fins; 612-Fan; 613-PTC heater; 620-Recovery tank; 621-Weighing sensor;

[0056] 810 - Monitor; 820 - Function Keyboard;

[0057] 910 - Outer shell; 911 - Power wheel; 912 - Electric wheel; 913 - Handle; 914 - Wireless tablet; 915 - Emergency stop button. Detailed Implementation

[0058] The invention will now be further described with reference to the accompanying drawings.

[0059] like Figure 1 As shown, the present invention provides a high and low temperature composite ablation surgical system, which includes a main unit 100 and a cold and hot ablation needle 200 connected to the main unit 100. The cold and hot ablation needle 200 is used to treat the lesion of the patient.

[0060] The main unit 100 includes a cold working fluid supply system 300, a hot working fluid supply system 400, and a working fluid distribution system 500.

[0061] Specifically, the cold working fluid supply system 300 is used to deliver cold working fluid to the cold and hot ablation needle 200; the hot working fluid supply system 400 is used to deliver hot working fluid to the cold and hot ablation needle 200; the working fluid distribution system 500 is connected to the cold working fluid supply system 300 and the hot working fluid supply system 400 respectively, and the working fluid distribution system 500 is used to control the cold working fluid supply system 300 to deliver cold working fluid to the cold and hot ablation needle 200, or to control the hot working fluid supply system 400 to deliver hot working fluid to the cold and hot ablation needle 200.

[0062] The high-low temperature combined ablation surgical system provided by this invention demonstrates both low-temperature and rewarming functions in clinical practice. It comprises two treatment phases: a low-temperature treatment phase and a rewarming phase. Specifically, in the low-temperature treatment phase, a cryoablation needle 200 is inserted into the patient's lesion. A cryo-medium supply system 300 delivers a cryo-medium to the needle 200. The cryo-medium rapidly passes through the ablation needle and undergoes evaporation and heat absorption, instantly supplying a large amount of cold to the diseased tissue, rapidly freezing and destroying the tissue to achieve the therapeutic goal. After the low-temperature treatment phase is completed, a heat-medium supply system 400 delivers a heat-medium to the needle 200, allowing high-temperature heat transfer vapor to reach the treatment site of the needle 200, instantly releasing a large amount of heat to rapidly rewarm the treated area.

[0063] The refrigerant described in this invention can be a single substance such as liquid nitrogen (-196℃, boiling point at normal pressure), liquid oxygen (-183℃, boiling point at normal pressure), liquid methane (-161℃, boiling point at normal pressure), liquid argon (-186℃, boiling point at normal pressure), liquid neon (-246℃, boiling point at normal pressure), liquid helium (-269℃, boiling point at normal pressure), liquefied nitrous oxide (-88.5℃, boiling point at normal pressure), liquefied carbon dioxide (-79℃, boiling point at normal pressure), and chlorofluorocarbon 22 (-50℃, boiling point at normal pressure), or a mixture of the above substances.

[0064] The heat transfer medium described in this invention can be a single substance such as water vapor (100℃, boiling point at normal pressure), methanol vapor (64.7℃, boiling point at normal pressure), formic acid vapor (100.8℃, boiling point at normal pressure), ethanol vapor (78℃, boiling point at normal pressure), acetic acid vapor (117.9℃, boiling point at normal pressure), ethyl acetate vapor (54.3℃, boiling point at normal pressure), propanol vapor (82.5℃, boiling point at normal pressure), propionic acid vapor (141.1℃, boiling point at normal pressure), or propylene acetate vapor (101.6℃, boiling point at normal pressure), or a mixture of the above substances. It should be noted that the boiling point temperatures mentioned above do not represent the rewarming temperature. In some embodiments, for example, steam pressurization is used as the power source to deliver the heat transfer medium to the ablation needle 200, and the treatment temperature can be higher than the boiling point of the selected heat transfer medium.

[0065] Therefore, the cold and hot working fluids of the present invention are widely available and inexpensive, and cover a wider temperature range, thus providing a basis for improving the safety, economy and convenience of surgical procedures.

[0066] In addition, each pipeline for delivering cold or hot working fluid is equipped with an insulation section to ensure that the minimum temperature when the cold working fluid is output to the tip of the cryoablation needle 200 can reach the required cryotherapy temperature.

[0067] The components of the present invention will be described below.

[0068] (I) Refrigerant Supply System 300

[0069] like Figure 2 and 3 As shown, the refrigerant supply system 300 includes an automatic refrigerant filling system 310 and a refrigerant pressure control system 320.

[0070] Specifically, the automatic cold working fluid filling system 310 includes a cold working fluid storage tank 311 for storing cold working fluid, and a cold working fluid pressure control system 320 includes a cold tank 321 for delivering cold working fluid to the cold and hot ablation needle 200. The cold working fluid storage tank 311 and the cold tank 321 are connected by a pipeline to deliver the cold working fluid therein to the cold tank 321.

[0071] An output valve 312, an interface detection switch 313, and a filling interface 314 are sequentially installed on the pipeline connecting the refrigerant storage tank 311 and the cold tank 321. The interface detection switch 313 is used to open or close the filling interface 314 to connect or disconnect the refrigerant storage tank 311 and the cold tank 321.

[0072] A liquid filling valve 315 and a one-way valve 316 are also installed in sequence on the pipeline between the filling port 314 and the cold tank 321 to prevent backflow of the working fluid.

[0073] The cold container 321 can be used to deliver pressurized cold working fluid into the cold and hot ablation needle 200. Alternatively, the cold container 321 is connected to a pressurization line 322, which is used to self-pressurize the cold working fluid in the cold container 321.

[0074] Specifically, the two ends of the pressurization pipeline 322 are connected to the cold tank 321 to form a closed loop. A pressurization valve 323 is installed on the pressurization pipeline 322. When the pressurization valve 323 is opened, the working fluid in the cold tank 321 enters the pressurization pipeline 322, vaporizes through heat exchange with the outside through the pipe wall, and expands dramatically in volume, thereby achieving self-pressurization.

[0075] Among them, cold tank 321 is a vacuum-insulated stainless steel pressure vessel.

[0076] In addition, there are several alternative implementation methods that enable the cold container 321 to deliver pressurized cold working fluid to the cold and hot ablation needle 200. For example, the cold container 321 can be pressurized by injecting air into it using an air compressor; or by filling the cold container 321 with a high-pressure gas whose boiling point is not higher than that of the cold working fluid; or by heating the cold working fluid to vaporize it.

[0077] In addition, a more direct way to provide power is to pump the refrigerant in the cold tank 321 through a cryogenic pump, and adjust the mass flow rate of the refrigerant by controlling the pump speed or power.

[0078] The cold tank 321 is also equipped with a pressure sensor 324 and two safety valves 325 to detect the pressure of the cold tank 321 and to prevent the pressure of the cold tank 321 from becoming too high through the safety valves 325. By setting two safety valves 325, a certain degree of redundancy can be ensured, thereby further improving the reliability of the cold tank 321.

[0079] Cold tank 321 is also connected to the recycling system 600 mentioned below.

[0080] Specifically, a liquid filling and venting valve 326, a pressure sensor 324, and a safety valve 325 are sequentially installed on the pipeline between the automatic refrigerant filling system 310 and the recovery system 600. The pressure sensor 324 is used to detect the pressure in the pipeline, and the safety valve 325 is used for overpressure protection.

[0081] A manual valve 327 and a vent valve 328 are connected in parallel on the pipeline from the cold tank 321 to the recovery system 600. A pressure gauge 329 is connected in series on the pipeline containing the manual valve 327 to manually control the pipeline pressure via the pressure gauge 329 and the manual valve 327. The vent valve 328 can be a conventional pressure control valve from the prior art; in the event of its failure, the safety valve 325 will effectively release pressure.

[0082] Both the liquid addition and venting valves 326 and venting valve 328 can be normally open valves, meaning they will automatically open to release pressure when the equipment is powered off, ensuring the equipment is in a safe, unpressurized state.

[0083] During the process of filling the cold working medium from the cold working medium storage tank 311 into the cold tank 321, if the pipeline pressure exceeds a certain value, it can be relieved through the liquid addition and venting valve 326; if the liquid addition and venting valve 326 fails, it can be relieved through the safety valve 325, thus ensuring safety during the filling process. Furthermore, if both the pressure sensor 324 and the safety valve 325 fail, the pressure can be read by the pressure gauge 329, and the manual valve 327 can be operated in a timely manner to release pressure, ensuring the safety of the equipment.

[0084] Furthermore, the cold tank 321 is equipped with a level gauge 330 for indicating its liquid level.

[0085] In addition, a filter 331 is installed at the bottom of the output pipeline in the cold tank 321 that connects to the working fluid distribution system 500 to prevent impurities from entering the working fluid distribution system 500 or the delivery pipeline and causing blockage, thereby improving the effectiveness of the treatment.

[0086] The working process of the automatic cold working fluid injection system 310 is described in detail below.

[0087] First, connect the refrigerant storage tank 311 to the filling port 314. After the interface detection switch 313 detects that the filling port 314 is connected, open the liquid filling valve 315 and close the liquid filling and venting valve 326.

[0088] Next, the output valve 312 of the refrigerant storage tank 311 is opened, and the refrigerant is continuously added to the cold tank 321. When the level gauge 330 detects that the refrigerant has been added, the filling valve 315 will close, and the filling vent valve 326 will open. At the same time, the output valve 312 of the refrigerant storage tank 311 will close. Then, the filling port 314 is disconnected, thus completing the filling operation.

[0089] The working process of the cold working fluid pressure control system 320 is described in detail below.

[0090] When the equipment is ready to operate, the pressure inside the cold tank 321 needs to be increased to provide power for the output of the cold working fluid for treatment.

[0091] Therefore, firstly, the pressure boosting valve 323 is opened, and the working fluid in the cold tank 323 enters the pressure boosting pipeline 322. It vaporizes through heat exchange with the outside world through the pipe wall, and its volume expands dramatically, thereby achieving self-pressurization.

[0092] Secondly, to ensure the effectiveness and consistency of treatment, precise control of the refrigerant pressure is necessary. Therefore, the pressure inside the refrigerant tank 323 is monitored in real time. When the pressure exceeds the working pressure, the vent valve 328 is opened to release the pressure. To achieve pressure stability, the opening methods of the pressure boosting valve 323 and the vent valve 328 vary depending on the strategy and operating conditions.

[0093] An optional pressure control method is as follows: Set the working pressure to P. When the pressure inside the cold tank 321 is much less than P, the pressure boosting valve 323 is opened and the venting valve 328 is closed. When the pressure reaches P-ΔP0, the pressure boosting valve 323 is closed. After a certain period of time, the current pressure is checked. If it is far from the set pressure P, the pressure boosting valve 323 is reopened, and the above process is repeated to gradually approach the set pressure P.

[0094] Since heat leakage is inevitable in the cold tank 321, the pressure inside the cold tank 321 will slowly increase. When the pressure reaches P+ΔP0, the vent valve 328 opens to release pressure until the pressure is released to P and then closes. Simultaneously, as the cold working fluid is continuously consumed during treatment, the gas phase space inside the cold tank 321 increases, and the pressure inside the tank may continuously decrease. Therefore, when the pressure is lower than P-ΔP1, the pressure boosting valve 323 of the cold tank 321 needs to open until the pressure reaches P+ΔP1 and then closes.

[0095] The values ​​of ΔP0 and ΔP1 need to be determined through a large number of experiments, and ΔP1 is less than ΔP0. In addition, the values ​​of ΔP0 and ΔP1 are also related to the liquid level of cold tank 321. Therefore, the control strategy under different liquid levels can be adjusted as needed.

[0096] (II) Heat supply system 400

[0097] like Figure 2 and 4 As shown, the heat supply system 400 includes an automatic heat injection system 410 and a heat pressure control system 420.

[0098] Specifically, the automatic hot working fluid filling system includes a hot working fluid storage tank 411 for storing hot working fluid, and a hot working fluid pressure control system 420 includes a hot tank 421 for delivering hot working fluid to the hot and cold ablation needle 200. The hot working fluid storage tank 411 and the hot tank 421 are connected by a pipeline to deliver the hot working fluid therein to the cold tank 421.

[0099] A liquid filling port 412, a filling pump 413, and a filling valve 414 are connected in series on the pipeline between the heat working medium storage tank 411 and the heat tank 421.

[0100] The heating vessel 421 is used to deliver pressurized thermal fluid to the hot and cold ablation needle 200. One option is to heat the heating vessel 421 to generate steam from the thermal fluid, thereby pressurizing it. For example, heating devices such as heating rods or heating plates can be installed inside the heating vessel 421, or ceramic can be used to cover the inner cylinder of the heating vessel 421 and the outer wall of the delivery pipeline for heating, or microwave heating can be used to directly heat the working fluid.

[0101] In one embodiment illustrated in the present invention, a temperature sensor 422, a temperature switch 423, and a heater 424 are provided in the heating tank 421. The heater 424 heats the working medium in the heating tank 421 to pressurize it. The temperature of the working medium is controlled by the temperature switch 423 and the temperature sensor 422. When the medium in the heating tank 421 is too low, if the heater 424 is operating, the temperature switch 422 will disconnect when the temperature rises to the opening temperature of the temperature switch 422, forcibly stopping the heater 424 from operating, thus preventing dry burning and improving the safety of the equipment.

[0102] In addition, a level gauge 430 (level sensor) is installed in the hot tank 421. During the automatic filling process of the working medium from the working medium storage tank 411 to the hot tank 421, the level gauge 430 will monitor the level of the hot tank 421 at any time. If the level does not change within a period of time, it will remind the operator to replace the working medium storage tank 411 to avoid the filling pump 413 from running dry and reduce wear.

[0103] The hot tank 421 is a vacuum-insulated stainless steel pressure vessel, which reduces heat leakage and improves equipment efficiency.

[0104] The hot tank 421 is also connected to the recovery system 600 mentioned below.

[0105] A safety valve 425, a pressure sensor 426, a pressure gauge 427, and a manual valve 428 are connected in series on the pipeline connecting the hot tank 421 to the recovery system 600. In addition, a vent valve 429 is connected in parallel to the manual valve 428.

[0106] The vent valve 429 is a conventional pressure control valve. When it fails, the safety valve 425 will effectively release the pressure. Additionally, if both the pressure sensor 426 and the safety valve 425 fail, the pressure can be read by the pressure gauge 426, and the pressure can be released promptly by operating the manual valve 428 to ensure equipment safety.

[0107] The working process of the automatic thermal fluid injection system 410 is described in detail below.

[0108] First, connect the heat working fluid storage tank 411 to the liquid filling port 412. Ordinary silicone hoses can be used for the connection.

[0109] Next, the liquid addition action is performed. The filling valve 414 is opened and the liquid addition pump 413 is started at the same time, and the working medium is continuously added into the heating tank 421. When the liquid level gauge 430 detects that the liquid addition of the working medium is completed, the filling valve 414 will be closed, the liquid addition pump 413 will be turned off, and then the liquid addition port 412 will be disconnected to complete the liquid addition action.

[0110] The working process of the thermal fluid pressure control system 420 is described in detail below.

[0111] When the equipment is ready to operate, the pressure inside the hot tank 421 needs to be increased to provide power for the output of the heat medium for treatment.

[0112] According to the above-mentioned optional solutions, the present invention uses heating and vaporization to increase the pressure of the hot tank 421, and the energy source for high-temperature treatment is hot steam.

[0113] To achieve effective and consistent treatment, precise pressure control of the heating tank 421 is required. Therefore, the pressure inside the heating tank 421 needs to be monitored in real time. When the pressure exceeds the working pressure, the vent valve 429 needs to be opened to release the pressure. To achieve stable pressure, the opening of the heater 424 and the vent valve 429 will have different control methods depending on the strategy and operating conditions.

[0114] Since the saturated vapor pressure of the heat working fluid is temperature-dependent, one possible control method is to use temperature PID regulation to adjust the pressure.

[0115] (III) Working fluid distribution system 500

[0116] like Figure 5-7 and Figure 14 As shown, the working fluid distribution system 500 includes a phase separator 510. During the delivery of the cold working fluid, it vaporizes through heat exchange with the outside environment via the pipe wall. If the gaseous component of the cold working fluid delivered to the cryoablation needle 200 is too large, it will affect the effect of cryotherapy. Therefore, the phase separator 510 ensures that most of the cold working fluid delivered to the cryoablation needle 200 is in a liquid state.

[0117] Specifically, the cold tank 321 is connected to the phase separator 510 via a pipeline, and the lower end of the phase separator 510 is connected to the hot and cold ablation needle 200 via a pipeline. A phase separation valve 511 and a manual valve 512 are sequentially installed on the pipeline between the upper end of the phase separator 510 and the recovery system 600. The upper end of the phase separator 510 is provided with an orifice. The vaporized cold working fluid is discharged outside the system through the phase separation valve 511 and the manual valve 512, while the liquid working fluid is fed into the hot and cold ablation needle 200 through the valve, thereby achieving the purpose of gas-liquid separation.

[0118] The manual valve 512 can also adjust the flow resistance of the pipeline to achieve a balance between liquid nitrogen consumption and gas-liquid separation.

[0119] In addition, a temperature sensor 513 is installed downstream of the phase separation valve 511. When the nitrogen gas passing through the phase separator 510 is completely vented and liquid nitrogen is discharged, the phase separation valve 510 can be closed to reduce the loss of liquid nitrogen at the phase separator 510.

[0120] The working fluid distribution system 500 also includes a precooler 520 connected to the phase separator 510. The precooler 520 is provided with a gas channel 521 and a liquid channel. The input side of the gas channel 521 is connected to the gas outlet end of the phase separator 510. The input side and the output side of the liquid channel are respectively connected to the liquid outlet end of the phase separator 510 and the hot and cold ablation needle 520. The gas in the gas channel 521 is used to precool the liquid in the liquid channel.

[0121] In other words, the gaseous and liquid working fluids are separated by the phase separation valve 511. However, since the gaseous working fluid also carries a certain amount of cooling energy, directly recovering or discharging this portion of the gaseous working fluid would waste this cooling energy. Therefore, the gaseous working fluid is passed through the gas channel 521 of the precooler 520, while the liquid working fluid is passed through the liquid channel of the precooler. Since the gas channel 521 can at least cover a portion of the liquid channel, the cooling energy of the gaseous working fluid can be utilized during the flow of the gaseous and liquid working fluids to ensure the temperature of the liquid working fluid entering the hot and cold ablation needle 200.

[0122] Furthermore, the gas channel 521 is constructed as a labyrinthine channel to increase the gas flow path and make fuller use of the gas's cooling capacity.

[0123] Specifically, such as Figure 15 As shown, the precooler 520 includes an upper plate 522 and a lower plate 523, which are connected by locking screws. The lower plate 523 has a labyrinthine channel, namely a gas channel 521. Liquid channels are provided in the upper plate 522 and the lower plate 523. A gaseous working fluid is used to cool the upper plate 522 and the lower plate 523, thereby utilizing the cooling capacity of the gaseous working fluid to precool the liquid working fluid and improve the utilization efficiency of the cooling working fluid.

[0124] The liquid passage of the precooler 520 is equipped with multiple output connectors (ferrule connectors), so the output of each channel can be controlled independently.

[0125] (iv) Recycling System 600

[0126] In this invention, the cold or hot working medium input into the cold and hot ablation needle 200 can be recovered through its output end after treatment, that is, recovered through the recovery system 600.

[0127] Specifically, such as Figure 2 As shown, the recovery system 600 includes a connected heat exchanger 610, which is connected to the output end of the hot and cold ablation needle 200. The heat exchanger 610 is used to heat up the cold working fluid output by the hot and cold ablation needle 200 and then discharge it into the atmosphere, or to cool down the hot working fluid output by the hot and cold ablation needle 200 and then recover it.

[0128] The cold or hot working fluid output from the output end of the hot and cold ablation needle 200 is introduced into the heat exchanger 610 through a pipeline. For the cold working fluid, the heat exchanger 610 heats it to raise its temperature and prevent excessive condensation mist from forming. For the hot working fluid, the heat exchanger 610's fins 611 exchange heat with the air, causing the hot working fluid vapor to condense and prevent the vapor from spreading in the environment.

[0129] like Figure 16 and 17 As shown, heat exchanger 610 is an air-cooled heat exchanger. Hot air is blown onto fins 611 by a fan 612 to condense the working fluid vapor. The air-cooled heat exchanger integrates a PTC heater 613. The PTC heater 613 uses U-shaped corrugated fins to improve its heat dissipation rate. It combines the advantages of adhesive and mechanical bonding, and fully considers various thermal and electrical phenomena during operation of the PTC heater 613. It has strong bonding force, excellent thermal conductivity and heat dissipation performance, high efficiency, and is safe and reliable.

[0130] Furthermore, this type of PTC heater 613 has the advantages of low thermal resistance and high heat exchange efficiency, making it an automatic temperature-controlled and energy-saving electric heater. A key feature is its safety performance: when the fan fails and stops, the PTC heater 613, unable to dissipate heat sufficiently, will automatically and rapidly reduce its power. At this time, the surface temperature of the heater will remain around the Curie temperature (generally around 250℃), thus preventing the surface from "reddening" as seen in electric heating tube heaters. This significantly improves heat exchange efficiency and provides high safety.

[0131] Meanwhile, the cold working fluid discharged from the cold working fluid supply system 300 due to overpressure or the hot working fluid discharged from the hot working fluid supply system 400 due to overpressure can be fed into the heat exchanger 610 for processing and recovery.

[0132] The recovery system 600 also includes a recovery tank 620 located below the heat exchanger 610. The heat working medium vapor condenses after heat exchange with the air through the fins of the heat exchanger 610 and enters the recovery tank 620 for recovery processing.

[0133] A weighing sensor 621 is installed under the recovery tank 620. When the condensed hot working fluid in the recovery tank 620 reaches a certain amount, the weighing sensor 621 will alarm to prompt the user to deal with it in time and avoid the overflow of the working fluid.

[0134] (V) Electrical Control System 700 and Interactive System 800

[0135] like Figure 8-13As shown, the host unit 100 also includes an electrical control system 700 and an interactive system 800 that are electrically connected. The electrical control system 700 is electrically connected to the cold working fluid supply system 300, the hot working fluid supply system 400 and the working fluid distribution system 500, respectively, to control the working process of the working fluid.

[0136] The electrical control system 700 includes a power supply system and a computer control system. The power supply system includes circuit breakers, filters, soft-start circuits, isolation transformers, and switching power supplies, and is powered by a lithium battery. The computer control system communicates with electrical devices such as pressure sensors 324 and 426, temperature sensors 422 and 513, level gauges 330 and 430, and load cells 621 to collect signals such as pressure, temperature, level, weight, and position. In addition, the computer control system also communicates with the switches of actuators such as valves, pumps, heaters 424, and fans 512 mentioned above.

[0137] The electrical control system 700 can be implemented using PCBA or PLC, etc.

[0138] The interactive system 800 includes a display (touchscreen) 810 on the housing 910, a function keypad 820, and a wireless tablet 914 for surgical operations, each of which can be operated independently. It also features tri-color indicator lights, battery level display, surgical output status display, and RFID identification functions to help users better utilize the system and improve its usability.

[0139] The interactive system 800 can integrate a 5G communication module. After connecting to the Internet, medical device manufacturers can monitor the system's usage status through the enterprise server, collect data on devices already on the market, and provide conditions for device maintenance and optimization.

[0140] In addition, an emergency stop button 915 is also provided on the outer casing 910.

[0141] The rear side of the housing 910 is also provided with four output ports 916, which are respectively connected to the temperature probe 220 and the probe delivery tube 210.

[0142] The main unit 100 also includes an assist system 900. The assist system 900 includes an assist wheel 911, an electronically controlled wheel 912, a lithium battery, and a handle 913 mounted on the housing 910. The assist wheel 911 provides power for the movement of the main unit 100, the electronically controlled wheel 912 automatically locks the housing 910 when it stops, and the handle 913 integrates a torque sensor to enable hospital nurses to easily move the equipment.

[0143] The aforementioned cold working fluid supply system 300, hot working fluid supply system 400, working fluid distribution system 500, recovery system 600, and electrical control system 700 are all integrated into the housing 910, which, together with the mobility assistance system 900, enables convenient movement of mobile devices.

[0144] (vi) Cold and hot ablation needles 200

[0145] like Figure 1 As shown, the cold and hot ablation needle 200 is connected to the cold working medium supply system 300 and the hot working medium supply system 400 through the probe delivery tube 210. The probe delivery tube 210 has a vacuum insulation layer, so the operator will not be affected by low or high temperature during use.

[0146] The probe delivery tube 210 enables the delivery and recovery of the working fluid within it. The probe delivery tube 210 is flexible, allowing the operator to easily rotate and bend it during use, greatly improving operability during the surgical procedure.

[0147] Furthermore, the connection between the probe delivery tube 210 and the cold / hot ablation needle 200, as well as the cold working fluid supply system 300 and the hot working fluid supply system 400, is a quick-connect connection, which facilitates the operator's operation and connection confirmation, ensuring a secure connection.

[0148] The main unit 100 is also connected to a temperature probe 220, which is used to detect the temperature of tissues during surgery. A temperature sensor (e.g., a T-type thermocouple) is arranged inside the probe tube.

[0149] The diameter of the temperature probe 220 needle tube is 0.5mm to 3mm; its lead wire interface with the main unit 100 is a coupling multi-core connector, which is convenient for insertion and removal and also has an anti-loosening design.

[0150] Both the thermal ablation needle 200 and the temperature probe 220 are disposable sterile products. They are equipped with an electronic encryption chip, which can be used in conjunction with the RFID reader of the interactive system 800 to effectively identify and limit their use within a specified time, thus avoiding the repeated use of disposable sterile products. The chip can also record parameters such as the production batch number, expiration date, and specifications of the thermal ablation needle 200 or the temperature probe 220.

[0151] In addition, the diameter of the needle tube of the cold and hot ablation needle 200 is generally 1mm-8mm.

[0152] Specifically, such as Figure 16 and 17As shown, the cold / hot ablation needle 200 includes a working fluid inlet pipe 201 and a working fluid return pipe 202 sleeved outside the working fluid inlet pipe 201. The working fluid inlet pipe 201 is connected to either a cold working fluid supply system 300 or a hot working fluid supply system 400, allowing either a cold or hot working fluid (such as...) to be supplied to the working fluid inlet pipe 201. Figure 17 The arrows indicate the flow direction of the working fluid during input.

[0153] After the cold or hot working medium in the working medium input pipe 201 reaches the tip of the thermo-thermal ablation needle 200, it treats the treatment area. After treatment, the cold or hot working medium is output to the recovery system 600 along the working medium return pipe 202 (e.g., Figure 17 The arrows indicate the flow direction of the working fluid at the output. In other words, the flow directions of the working fluid in the working fluid return pipe 202 and the working fluid input pipe 201 are opposite.

[0154] Therefore, the cold and hot ablation needle 200 of the present invention can combine the input (inflow) and output (return) by means of tubing connection, so there is no need to match external connection pipes to the working fluid input pipe 201 and the working fluid return pipe 202 respectively; thereby greatly simplifying the structure of the connection pipeline and the storage medium device.

[0155] Furthermore, both the working fluid inlet pipe 201 and the working fluid return pipe 202 are constructed as bent pipes, meaning that the extension directions of both the working fluid inlet pipe 201 and the working fluid return pipe 202 have been changed. Figure 16 As shown, the cold and hot ablation needle 200 has an overall L-shaped structure, which prevents the overall size of the cold and hot ablation needle 200 from being too large in one direction. In addition, and more importantly, even if a sudden disturbance or vibration is applied to the handle of the ablation needle body, the force will not be immediately transmitted to the needle tip of the ablation needle 200 and thus affect the patient. Therefore, through the above-mentioned curved tube structure, the disturbance of unstable factors such as disturbances to the needle tip of the ablation needle 200 can be reduced, thereby improving the treatment stability of the ablation needle 200.

[0156] Furthermore, the hot and cold ablation needle 200 also includes a vacuum tube 203, wherein the vacuum tube 203 is sleeved outside the working fluid return tube 202 and the vacuum tube 203 can at least cover a portion of the outer wall of the working fluid return tube 202, so that a vacuum layer 204 is formed between at least a portion of the outer wall of the working fluid return tube 202 and at least a portion of the inner wall of the vacuum tube 203, such as Figure 17 As shown. The vacuum layer 204 can effectively achieve good vacuum insulation performance of the cold and hot ablation needle 200 in the non-treatment area (to prevent frostbite to normal human skin tissue or to the surgeon who touches the non-treatment area of ​​the ablation needle during cryotherapy of the target tissue).

[0157] In addition, such as Figure 5 As shown, a temperature sensor is installed at the inlet of the working fluid input pipe 201 and a temperature sensor is also installed at the outlet of the working fluid return pipe 202 to detect the temperature of the working fluid.

[0158] The high-low temperature composite ablation surgical system of the present invention can use a working pressure below the critical point of the working fluid. If the temperature is also low enough, the working fluid is in a liquid state; if the temperature is high enough, the working fluid is in a gaseous state. Understandably, a working pressure above the critical point of the working fluid can also be used, in which case the working fluid is in a supercritical state.

[0159] Let's take nitrogen as an example to illustrate:

[0160] Nitrogen has a critical temperature Tc = 126.2 K (-147 °C), a critical pressure Pc = 3.4 MPa, and a critical density of 313.3 kg / m³. Near its critical point, nitrogen exhibits an exceptionally high coefficient of thermal expansion, specific heat capacity, and relatively low viscosity, resulting in a high heat transfer coefficient when the temperature difference is small. During supercritical nitrogen transport, the cooling loss along the path is minimal due to the higher temperature compared to liquid nitrogen. Furthermore, the high operating pressure and overall high density lead to a large mass flow rate. Therefore, nitrogen is the preferred refrigerant in this invention.

[0161] The flow path of the cooling working fluid in this invention is as follows:

[0162] The refrigerant in the refrigerant storage tank 311 enters the cold tank 321 through the output valve 312, the filling port 314, the liquid filling valve 315 and the one-way valve 316 to complete the liquid filling.

[0163] The cold working fluid in the cold tank 321 is introduced into the cold and hot ablation needle 200 for treatment along the main pipeline; and is introduced into the heat exchanger 610 for recovery along the branch pipeline.

[0164] Specifically, the refrigerant in the cold tank 321 flows sequentially through the output valve, phase separator 510, and precooler 520 along the main pipeline into the probe delivery pipe 210, and then enters the cold and thermal ablation needle 200 through its input port. After completing treatment in the treatment area, the refrigerant in the cold and thermal ablation needle 200 returns to its output port. The refrigerant at the output port of the cold and thermal ablation needle 200 enters the heat exchanger 610 for heating, and the heated refrigerant is then treated before being discharged.

[0165] The cold working fluid (gaseous) in the cold tank 321 enters the heat exchanger 610 through the branch via the manual valve 327 or the vent valve 328 for overpressure relief.

[0166] The flow path of the heat working fluid in this invention is as follows:

[0167] The heat working medium in the heat working medium storage tank 411 is added to the heat tank 421 through the liquid filling port 412, the filling pump 413 and the filling valve 414 in sequence.

[0168] The heat medium in the hot tank 421 is introduced into the cold and hot ablation needle 200 for treatment along the main pipeline; and is introduced into the heat exchanger 610 for recovery along the branch pipeline.

[0169] Specifically, the working fluid in the hot tank 421 flows sequentially through the output valve, phase separator 510, and precooler 520 along the main pipeline into the probe delivery pipe 210, and then enters the cold and hot ablation needle 200 through its input port. After completing treatment in the treatment area, the working fluid in the cold and hot ablation needle 200 returns to its output port. The working fluid at the output port of the cold and hot ablation needle 200 enters the heat exchanger 610 for cooling, and the cooled working fluid enters the recovery tank 620.

[0170] The heat medium in the hot tank 421 (when under overpressure) enters the heat exchanger 610 for recovery via the manual valve 428 or the vent valve 429 along the branch.

[0171] Although the invention has been described with reference to preferred embodiments, various modifications can be made and components can be replaced with equivalents without departing from the scope of the invention. In particular, the technical features mentioned in the various embodiments can be combined in any manner as long as there is no structural conflict. The invention is not limited to the specific embodiments disclosed herein, but includes all technical solutions falling within the scope of the claims.

Claims

1. A high-low temperature composite ablation surgical system, characterized in that, The device includes a host unit (100), a hot and cold ablation needle (200) connected to the host unit (100), and a retrieval system (600) connected to the output port of the hot and cold ablation needle (200), the hot and cold ablation needle (200) being used to treat the lesion of a patient; The host unit (100) includes: A cold working fluid supply system (300) for supplying cold working fluid to the ablation needle (200), the cold working fluid supply system (300) including an automatic cold working fluid filling system (310) and a cold working fluid pressure control system (320), the automatic cold working fluid filling system (310) including a cold working fluid storage tank (311), the cold working fluid pressure control system (320) including a cold tank (321), the cold working fluid storage tank (311) and the cold tank (321) being connected by a pipeline to fill the cold working fluid therein into the cold tank (321), the cold tank (321) being used to supply pressurized cold working fluid to the ablation needle (200); and A heat transfer fluid supply system (400) is used to supply heat transfer fluid to the ablation needle (200). The heat transfer fluid supply system (400) includes an automatic heat transfer fluid filling system (410) and a heat transfer fluid pressure control system (420). The automatic heat transfer fluid filling system (410) includes a heat transfer fluid storage tank (411), and the heat transfer fluid pressure control system (420) includes a heat tank (421). The heat transfer fluid storage tank (411) and the heat tank (421) are connected by a pipeline to transport the heat transfer fluid therein to the heat tank (421). The heat tank (421) is used to supply pressurized heat transfer fluid to the ablation needle (200). The working fluid distribution system (500) is connected to the cold working fluid supply system (300) and the hot working fluid supply system (400) respectively. The working fluid distribution system (500) is used to control the cold working fluid supply system (300) to deliver cold working fluid to the cold and hot ablation needle (200) and to control the hot working fluid supply system (400) to deliver hot working fluid to the cold and hot ablation needle (200). The pipeline connecting the refrigerant storage tank (311) and the cold tank (321) is provided with an interface detection switch (313) and a filling port (314) in sequence. The interface detection switch (313) is used to open or close the filling port (314) so ​​that the refrigerant storage tank (311) and the cold tank (321) are connected or disconnected. A liquid pump (413) is installed on the pipeline between the heat working medium storage tank (411) and the heat tank (421). A level gauge (430) is installed in the heat tank (421). During the automatic filling process of the heat working medium from the heat working medium storage tank (411) to the heat tank (421), the level gauge (430) monitors the liquid level of the heat tank (421) at any time. A first vent valve (328) is provided on the pipeline from the cold tank (321) to the recovery system (600) to release pressure. When the pressure in the cold tank (321) exceeds the working pressure, the first vent valve (328) is opened to release the pressure. The cold working fluid under the working pressure can perform low-temperature treatment. A pressure sensor (426) and a second vent valve (429) are installed on the pipeline connecting the hot tank (421) and the recovery system (600). The pressure sensor (426) collects the pressure signal inside the hot tank (421). When the pressure inside the hot tank (421) exceeds the working pressure, the second vent valve (429) opens, and the working medium under the working pressure can perform a reheating operation.

2. The high and low temperature combined ablation surgical system according to claim 1, characterized in that, The working fluid distribution system (500) includes: Phase separator (510), which is connected to the refrigerant supply system (300); and The precooler (520) is provided with a gas channel (521) and a liquid channel. The input side of the gas channel (521) is connected to the gas outlet end of the phase separator (510). The input side and output side of the liquid channel are respectively connected to the liquid outlet end of the phase separator (510) and the hot and cold ablation needle (200). The gas in the gas channel (521) is used to pre-cool the liquid in the liquid channel.

3. The high and low temperature combined ablation surgical system according to claim 2, characterized in that, The gas channel (521) is constructed as a labyrinthine channel.

4. The high and low temperature combined ablation surgical system according to any one of claims 1-3, characterized in that, The recovery system (600) is connected to the cold working fluid supply system (300) and the hot working fluid supply system (400) respectively, and is used to collect the cold working fluid or hot working fluid after treatment, or to collect the cold working fluid discharged from the cold working fluid supply system (300) or the hot working fluid discharged from the hot working fluid supply system (400) due to overpressure.

5. The high and low temperature combined ablation surgical system according to claim 4, characterized in that, The recovery system (600) includes a connected heat exchanger (610), which is connected to the output port of the hot and cold ablation needle (200). The heat exchanger (610) is used to heat up the cold working fluid output by the hot and cold ablation needle (200) and return it to the atmosphere, or to cool down the hot working fluid output by the hot and cold ablation needle (200) and recover it.

6. The high and low temperature combined ablation surgical system according to claim 1, characterized in that, The cold tank (321) is connected to a pressurization pipeline (322), which is used to enable the cold working fluid in the cold tank (321) to self-pressurize.

7. The high and low temperature combined ablation surgical system according to claim 1, characterized in that, The hot tank (421) is equipped with a heating device, which is used to vaporize and pressurize the working fluid in the hot tank (421).

8. The high and low temperature combined ablation surgical system according to any one of claims 1-3, characterized in that, The host unit (100) also includes an electrical control system (700) and an interactive system (800) that are electrically connected. The electrical control system (700) is electrically connected to the cold working fluid supply system (300), the hot working fluid supply system (400), and the working fluid distribution system (500) respectively to control the working process of the working fluid.

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