High and low temperature combined ablation surgical system

Abstract

This invention relates to a high-low temperature combined ablation surgical system, specifically in the field of cryotherapy technology, aimed at improving the safety and effectiveness of treatment. The high-low temperature combined ablation surgical system of this invention includes a main unit, which includes a cryogenic supply system. The cryogenic supply system includes a cryogenic pressure control system, which includes a cold container for delivering cryogenic fluid to the cryoablation needle. A pressurization pipeline is connected to the cold container, with both ends of the pipeline connected to the cold container to form a closed loop. The pressurization pipeline is used to self-pressurize the cryogenic fluid in the cold container.

Description

[0001] The present application is a divisional application of application No. CN201911229554.8, entitled "High-low temperature composite ablation operation system". TECHNICAL FIELD

[0002] The present application relates to the field of cryogenic treatment technology, in particular to a high-low temperature composite ablation operation system. BACKGROUND

[0003] At present, cryogenic treatment technology is becoming the main means of interventional tumor treatment. This technology is a pure physical treatment, which has the advantages of accurate treatment effect, no spread of tumor cells, minimally invasive and painless treatment process, rapid recovery, no damage to normal tissues, etc. compared with radiotherapy and chemotherapy. Clinical data shows that the immune function of patients treated by this technology is significantly improved compared with before treatment, and the long-term survival rate is significantly improved. It has significant advantages in the treatment of lung cancer, liver cancer, breast cancer, kidney cancer, prostate cancer and other solid tumors.

[0004] The mechanism of cryogenic treatment is as follows:

[0005] 1. Ice crystal growth, cell dehydration causes mechanical damage to tumor cells

[0006] 2. Blood embolism causes tumor tissue to die of hypoxia

[0007] 3. Reversible damage, causing cell apoptosis

[0008] 4. Cryogenic treatment can stimulate immune regulation and produce a cascade of ectopic tumor suppression effect

[0009] In the prior art, a typical low-temperature treatment device, represented by the Cryocare Surgical System developed by the U.S. Endocare Company and the VISUAL-ICE Cryoablation System developed by the Galil Company of Israel, is collectively referred to as an argon-helium knife because it uses argon and helium as working media. The low-temperature treatment device achieves the effect of cryogenic treatment through the Joule-Thomson effect (i.e., the temperature change phenomenon caused by the expansion of a gas through a porous plug). The low-temperature ablation temperature can reach as low as -150 to -160°C, and the rewarming temperature can reach as high as about 40°C. It can be found that the low-temperature treatment device described above only has one refrigeration mechanism, and the working temperature range is limited by the refrigeration principle and the characteristics of the working media, and only a single-function treatment can be provided. In addition, due to the working mechanism, the low-temperature treatment device has a relatively high working pressure (12-22 MPa), which poses a safety hazard during surgery, and has relatively large noise. The working media are relatively expensive. In addition, a high-pressure argon cylinder and a helium cylinder need to be connected during the surgical procedure, which is not convenient for use in a limited space such as an operating room. So far, there is no high-low temperature treatment device with full functions and a wide temperature range at home and abroad. SUMMARY

[0010] The present application provides a high-low temperature combined ablation surgical system, which can meet the basic requirements of cryogenic treatment and combine with higher strength heating treatment function, and provide the basis for improving the safety, economy and convenience of the operation.

[0011] The present application provides a high-low temperature combined ablation surgical system, which comprises a host unit and a cold-hot ablation needle connected to the host unit, the cold-hot ablation needle being used for treating a lesion of a patient.

[0012] The host unit comprises:

[0013] a cold working medium supply system for delivering a cold working medium to the cold-hot ablation needle;

[0014] a hot working medium supply system for delivering a hot working medium to the cold-hot ablation needle; and

[0015] a working medium distribution system connected to the cold working medium supply system and the hot working medium supply system, respectively, the working medium distribution system being used for controlling the cold working medium supply system to deliver the cold working medium to the cold-hot ablation needle and controlling the hot working medium supply system to deliver the hot working medium to the cold-hot ablation needle.

[0016] In one embodiment, the working medium distribution system comprises:

[0017] a phase separator connected to the cold working medium supply system; and

[0018] a pre-cooler, which is provided with a gas passage and a liquid passage, an input side of the gas passage is communicated with the gas outlet end of the phase separator, and an input side and an output side of the liquid passage are respectively communicated with the liquid outlet end of the phase separator and the cold-hot ablation needle;

[0019] wherein the gas in the gas passage is used to pre-cool the liquid in the liquid passage.

[0020] In an embodiment, the gas passage is configured as a labyrinth passage.

[0021] In an embodiment, the main unit further comprises a recovery system connected with the output port of the cold-hot ablation needle, the recovery system is connected with the cold working medium supply system and the hot working medium supply system respectively, and is used to collect the cold working medium or the hot working medium after treatment, or to collect the cold working medium discharged from the cold working medium supply system or the hot working medium discharged from the hot working medium supply system due to overpressure.

[0022] In an embodiment, the recovery system comprises a heat exchanger connected with the output port of the cold-hot ablation needle, and the heat exchanger is used to return the cold working medium output by the cold-hot ablation needle to the atmosphere after being warmed, or to recover the hot working medium output by the cold-hot ablation needle after being cooled.

[0023] In an embodiment, the cold working medium supply system comprises a cold tank for carrying the cold working medium, and the cold tank is used to deliver the cold working medium with pressure to the cold-hot ablation needle.

[0024] In an embodiment, a pressurizing pipeline is connected to the cold tank, and the pressurizing pipeline is used to realize self-pressurization of the cold working medium in the cold tank.

[0025] In an embodiment, the hot working medium supply system comprises a hot tank for carrying the hot working medium, and the hot tank is used to deliver the hot working medium with pressure to the cold-hot ablation needle.

[0026] In an embodiment, a heating device is arranged on the hot tank, and the heating device is used to vaporize and pressurize the hot working medium in the hot tank.

[0027] In an embodiment, the main unit further comprises an electrical control system and an interaction system which are electrically connected, the electrical control system is electrically connected with the cold working medium supply system, the hot working medium supply system and the working medium distribution system respectively, so as to control the working process of the working medium.

[0028] Compared with the prior art, the working medium distribution system can respectively control the cold working medium supply system to deliver cold working medium to the cold-hot ablation needle and control the hot working medium supply system to deliver hot working medium to the cold-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. BRIEF DESCRIPTION OF DRAWINGS

[0029] Hereinafter, the present application will be described in more detail based on the embodiments and with reference to the accompanying drawings.

[0030] Figure 1 is a structural schematic diagram of a high-low temperature combined ablation operation system in an embodiment of the present application;

[0031] Figure 2 is a connection schematic diagram of a cold working medium supply system and a hot working medium supply system in an embodiment of the present application;

[0032] Figure 3 is a connection schematic diagram of a cold working medium supply system in an embodiment of the present application;

[0033] Figure 4 is a connection schematic diagram of a hot working medium supply system in an embodiment of the present application;

[0034] Figure 5 is a principle block diagram of a high-low temperature combined ablation operation system in an embodiment of the present application;

[0035] Figure 6 and Figure 7 is a connection schematic diagram of a working medium distribution system in an embodiment of the present application;

[0036] Figure 8 and Figure 9 is a structural schematic diagram of a main unit in an embodiment of the present application;

[0037] Figure 10 and Figure 11 is a structural schematic diagram of a main unit after a hidden part of a shell in an embodiment of the present application;

[0038] Figure 12 is a pipeline connection schematic diagram of a working medium distribution system in an embodiment of the present application;

[0039] Figure 13 is a structural schematic diagram of a pre-cooler in an embodiment of the present application;

[0040] Figure 14 and Figure 15 is a structural schematic diagram of a heat exchanger in an embodiment of the present application.

[0041] Figure 16 is a structural schematic diagram of a cold-hot ablation needle in an embodiment of the present application;

[0042] Figure 17 is Figure 16 Enlarged view at I.

[0043] Reference signs:

[0044] 100 - main unit

[0045] 200 - cold-hot ablation needle; 201 - working medium input pipe; 202 - working medium return pipe; 203 - vacuum pipe; 204 - vacuum layer

[0046] 300 - cold working medium supply system; 400 - hot working medium supply system; 500 - working medium distribution system; 600 - recovery system

[0047] 700 - electrical control system; 800 - interactive system

[0048] 210 - probe delivery pipe; 220 - temperature measuring probe

[0049] 310 - cold working medium automatic filling system; 320 - cold working medium pressure control system

[0050] 311 - cold working medium storage tank; 312 - output valve; 313 - interface detection switch; 314 - filling interface; 315 - liquid adding valve; 316 - one-way valve

[0051] 321 - cold tank; 322 - pressurization pipeline; 323 - pressurization valve; 324, 426 - pressure sensor; 325, 425 - safety valve; 326 - liquid adding and gas releasing valve; 327, 428, 512 - manual valve; 328 - gas releasing valve; 329, 427 - pressure gauge; 330, 430 - liquid level meter; 331 - filter

[0052] 410 - hot working medium automatic filling system; 420 - hot working medium pressure control system

[0053] 411 - hot working medium storage tank; 412 - liquid adding port; 413 - filling pump; 414 - filling valve

[0054] 421 - hot tank; 422, 513 - temperature sensor; 423 - temperature switch; 424 - heater; 429 - gas releasing valve

[0055] 510 - phase separator; 511 - phase separation valve

[0056] 520 - pre-cooler; 521 - gas passage; 522 - upper plate; 523 - lower plate

[0057] 610 - heat exchanger; 611 - fin; 612 - fan; 613 - PTC heater; 620 - recovery tank; 621 - weighing sensor

[0058] 810 - Monitor; 820 - Function Keyboard;

[0059] 900 - Power steering system; 910 - Housing; 911 - Power steering wheel; 912 - Electric control wheel; 913 - Handle; 914 - Wireless tablet; 915 - Emergency stop button; 916 - Output port. Detailed Implementation

[0060] The invention will now be further described with reference to the accompanying drawings.

[0061] 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.

[0062] 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.

[0063] 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.

[0064] 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.

[0065] 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.

[0066] 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.

[0067] 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.

[0068] In addition, each pipeline for conveying cold or hot working fluid is equipped with an insulation section to ensure that a sufficient amount of cold working fluid is output to the tip of the cold and hot ablation needle 200.

[0069] The components of the present invention will be described below.

[0070] (I) Refrigerant Supply System 300

[0071] 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.

[0072] 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.

[0073] The pipeline connecting the cold working medium storage tank 311 and the cold tank 321 is provided with an output valve 312, an interface detection switch 313 and a filling interface 314 in sequence. The interface detection switch 313 is used to open or close the filling interface 314 to make the cold working medium storage tank 311 communicate with or disconnect from the cold tank 321.

[0074] The pipeline between the filling interface 314 and the cold tank 321 is further provided with a liquid adding valve 315 and a one-way valve 316 in sequence to prevent the backflow of the working medium.

[0075] The cold tank 321 can be used to deliver the cold working medium with pressure to the cold-hot ablation needle 200. An alternative way is that the cold tank 321 is connected with a pressurizing pipeline 322, which is used to realize self-pressurization of the cold working medium in the cold tank 321.

[0076] Specifically, the two ends of the pressurizing pipeline 322 are connected with the cold tank 321 to form a closed loop. The pressurizing pipeline 322 is provided with a pressurizing valve 323. When the pressurizing valve 323 is opened, the working medium in the cold tank 321 enters the pressurizing pipeline 322, vaporizes by heat exchange with the outside through the pipeline wall, and the volume expands sharply, thereby realizing self-pressurization.

[0077] The cold tank 321 is a vacuum-insulated stainless steel pressure container.

[0078] In addition, there are some alternative embodiments that can realize the delivery of the cold working medium with pressure from the cold tank 321 to the cold-hot ablation needle 200. For example, the cold tank 321 is pressurized by air compressor to press air into the cold tank 321; or the cold tank 321 is pressurized by filling high-pressure gas with a boiling point not higher than that of the cold working medium; or the cold tank 321 is pressurized by vaporizing the cold working medium by heating.

[0079] In addition, a more direct power supply way is to pump the cold working medium in the cold tank 321 by a cryogenic pump, and to adjust the mass flow rate of the delivered cold working medium by controlling the rotation speed or power of the pump.

[0080] The cold tank 321 is further provided with a pressure sensor 324 and two safety valves 325 to detect the pressure of the cold tank 321 and avoid the over-high pressure of the cold tank 321 through the safety valves 325. The setting of the two safety valves 325 can ensure a certain redundancy, thereby further improving the reliability of the cold tank 321.

[0081] The cold tank 321 is further connected with a recycling system 600 mentioned below.

[0082] Specifically, the liquid filling and gas releasing valve 326, the pressure sensor 324 and the safety valve 325 are sequentially arranged on the pipeline between the cold working medium automatic 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.

[0083] The manual valve 327 and the gas releasing valve 328 are arranged in parallel on the pipeline through which the cold tank 321 discharges pressure to the recovery system 600. The pressure gauge 329 is arranged in series on the pipeline where the manual valve 327 is arranged, so as to manually control the pressure of the pipeline through the pressure gauge 329 and the manual valve 327. The gas releasing valve 328 can be a conventional pressure control valve in the prior art, and the safety valve 325 can effectively discharge pressure when the gas releasing valve 328 fails.

[0084] The liquid filling and gas releasing valve 326 and the gas releasing valve 328 can be selected as a normally open valve, which can automatically open to discharge pressure when the equipment is powered off, so as to keep the equipment in a safe state without pressure.

[0085] During the process of filling the cold working medium from the cold working medium storage tank 311 into the cold tank 321, the pipeline pressure can be discharged through the liquid filling and gas releasing valve 326 when the pressure exceeds a certain value, and the safety valve 325 can be used for pressure discharge when the liquid filling and gas releasing valve 326 fails, so as to ensure the safety during the filling process. When the pressure sensor 324 and the safety valve 325 both fail, the pressure can be read through the pressure gauge 329, and the manual valve 327 can be operated in time to discharge pressure, so as to ensure the safety of the equipment.

[0086] Further, the liquid level meter 330 for indicating the liquid level in the cold tank 321 is arranged.

[0087] In addition, the filter 331 is arranged at the bottom of the output pipeline connected to the working medium distribution system 500 in the cold tank 321, so as to avoid impurities from entering the working medium distribution system 500 or the conveying pipeline to cause blockage, thereby improving the effectiveness of the equipment treatment.

[0088] The working process of the cold working medium automatic filling system 310 will be described in detail below.

[0089] Firstly, the cold working medium storage tank 311 is connected to the filling interface 314, and the liquid filling valve 315 is opened and the liquid filling and gas releasing valve 326 is closed after the filling interface 314 is detected to be connected through the interface detection switch 313.

[0090] Secondly, the output valve 312 of the cold working medium storage tank 311 is opened, and the cold working medium is continuously filled into the cold tank 321. When the liquid level meter 330 detects that the filling of the cold working medium is completed, the liquid filling valve 315 is closed, and the liquid filling and gas releasing valve 326 is opened at the same time, and the output valve 312 of the cold working medium storage tank 311 is closed. Then, the filling interface 314 is disconnected, so as to complete the filling operation.

[0091] The working process of the cold working medium pressure control system 320 is described in detail as follows.

[0092] When the device is ready for work, the pressure in the cold tank 321 needs to be increased to provide power for the output of the cold working medium for treatment.

[0093] Therefore, first of all, the pressure increasing valve 323 is opened, and the working medium in the cold tank 321 enters the pressure increasing pipeline 322, vaporizes by heat exchange with the outside through the pipeline wall, and the volume expands sharply, thereby realizing self-pressurization.

[0094] Secondly, in order to realize the effectiveness and consistency of treatment, the pressure of the cold working medium needs to be accurately controlled, and therefore the pressure in the cold tank 321 is monitored in real time, and when the pressure exceeds the working pressure, the pressure relief valve 328 is opened to release pressure. In order to achieve pressure stability, the opening of the pressure increasing valve 323 and the pressure relief valve 328 will have different control methods according to different strategies and working conditions.

[0095] An optional pressure control method is as follows: set the working pressure as P, when the pressure in the cold tank 321 is much less than P, the pressure increasing valve 323 is opened and the pressure relief valve 328 is closed; when the pressure reaches P-ΔP0, the pressure increasing valve 323 is closed, and after a certain time, the current pressure is checked, if it is far from the set pressure P, the pressure increasing valve 323 is opened again, and the above process is repeated to gradually approach the set pressure P.

[0096] Since the heat leakage of the cold tank 321 inevitably exists, the pressure in the cold tank 321 will also slowly increase, and when the pressure reaches P+ΔP0, the pressure relief valve 328 is opened to release pressure until the pressure is released to P. At the same time, there is a situation that during the treatment process, as the cold working medium is continuously consumed, the gas phase space in the cold tank 321 becomes larger, and the pressure in the tank may also continuously decrease, and therefore when the pressure is lower than P-ΔP1, the pressure increasing valve 323 of the cold tank 321 needs to be opened, and the pressure increasing valve 323 is closed when the pressure reaches P+ΔP1.

[0097] 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 the cold tank 321, and therefore the control strategy under different liquid levels can be adjusted according to needs.

[0098] (II) Hot working medium supply system 400

[0099] As shown in Figure 2 and 4 , the hot working medium supply system 400 includes a hot working medium automatic filling system 410 and a hot working medium pressure control system 420.

[0100] Specifically, the hot working medium automatic filling system 410 comprises a hot working medium storage tank 411 for storing hot working medium, and the hot working medium pressure control system 420 comprises a hot tank 421 for delivering hot working medium to the cold-hot ablation needle 200, and the hot working medium storage tank 411 is connected with the hot tank 421 through a pipeline to deliver the hot working medium therein to the hot tank 421.

[0101] The pipeline between the hot working medium storage tank 411 and the hot tank 421 is connected in sequence with a filling port 412, a filling pump 413 and a filling valve 414.

[0102] The hot tank 421 is used for delivering hot working medium with pressure to the cold-hot ablation needle 200. One optional way is to heat the hot tank 421 to make the hot working medium generate steam to increase the pressure. For example, a heating rod, a heating sheet or other heating device can be arranged inside the hot tank 421, or a ceramic covering the outer wall of the inner cylinder of the hot tank 421 and the delivery pipeline can be heated, or a microwave heating method directly heating the working medium can also be used.

[0103] In one embodiment of the present application, the hot tank 421 is provided with a temperature sensor 422, a temperature switch 423 and a heater 424. The heater 424 is used to heat the hot working medium in the hot tank 421 to increase the pressure. The temperature of the hot working medium is controlled by the temperature switch 423 and the temperature sensor 422. When the medium in the hot tank 421 is too little, if the heater 424 works, the temperature will rise to the opening temperature of the temperature switch 423, and the temperature switch 423 will be disconnected, forcibly stopping the heater 424 from working, thus preventing dry burning and improving the safety of the equipment.

[0104] In addition, the hot tank 421 is also provided with a liquid level meter 430 (liquid level sensor). During the automatic filling process of the hot working medium from the hot working medium storage tank 411 to the hot tank 421, the liquid level meter 430 will monitor the liquid level of the hot tank 421 at any time, and if the liquid level does not change for a period of time, the operator will be reminded to replace the hot working medium storage tank 411, so as to avoid the empty pumping of the filling pump 413 and reduce the wear and tear.

[0105] The hot tank 421 is a vacuum insulated stainless steel pressure container, which reduces heat leakage and improves the efficiency of the equipment.

[0106] The hot tank 421 is also connected with the recycling system 600 mentioned below.

[0107] The pipeline connecting the hot tank 421 with the recycling system 600 is connected in sequence with a safety valve 425, a pressure sensor 426, a pressure gauge 427 and a manual valve 428, and in addition, the manual valve 428 is also connected in parallel with a gas release valve 429.

[0108] The air release valve 429 is a conventional pressure control valve, and the safety valve 425 is effective in pressure release when the air release valve 429 fails. In addition, when both the pressure sensor 426 and the safety valve 425 fail, the pressure can be read by the pressure gauge 427, and the pressure can be released in time by operating the manual valve 428, so as to ensure the safety of the equipment.

[0109] The working process of the hot working medium automatic filling system 410 is described in detail as follows.

[0110] First, the hot working medium storage tank 411 is connected to the liquid inlet 412, and a common silica gel hose can be used for connection.

[0111] Second, the liquid filling operation is performed. The filling valve 414 is opened, and the filling pump 413 is started, so that the hot working medium is continuously filled into the hot tank 421. When the liquid level meter 430 detects that the hot working medium filling is completed, the filling valve 414 is closed, the filling pump 413 is closed, and then the liquid inlet 412 is disconnected, and the liquid filling operation is completed.

[0112] The working process of the hot working medium pressure control system 420 is described in detail as follows.

[0113] When the equipment is prepared, the pressure in the hot tank 421 needs to be increased, so as to provide power for the output treatment of the hot working medium.

[0114] According to the above optional scheme, the pressure in the hot tank 421 is increased by heating and vaporization, and the energy source for high-temperature treatment is hot steam.

[0115] In order to achieve the effectiveness and consistency of treatment, the pressure in the hot tank 421 needs to be accurately controlled. Therefore, the pressure in the hot tank 421 needs to be monitored in real time, and when the pressure exceeds the working pressure, the air release valve 429 needs to be opened for pressure release. In order to achieve stable pressure, the heater 424 and the opening of the air release valve 429 have different control methods according to different strategies and working conditions.

[0116] Since the saturated vapor pressure of the hot working medium is related to the temperature, one optional control method is to use temperature PID regulation to regulate the pressure.

[0117] (Three) Working medium distribution system 500

[0118] As shown in Figures 5-7 and Figure 13 and 14 The working medium distribution system 500 includes a phase separator 510. During the delivery of the cold working medium, the cold working medium is vaporized by heat exchange with the outside through the pipe wall. If the gaseous specific gravity of the cold working medium delivered to the cold-hot ablation needle 200 is large, the low-temperature treatment effect will be affected. Therefore, the cold working medium delivered to the cold-hot ablation needle 200 is mostly in a liquid state through the phase separator 510.

[0119] Specifically, the cold tank 321 is connected with the phase separator 510 through a pipeline, and the lower end of the phase separator 510 is connected with the cold-hot ablation needle 200 through a pipeline. The upper end of the phase separator 510 is sequentially provided with a phase separation valve 511 and a manual valve 512 on the pipeline between the upper end of the phase separator 510 and the recovery system 600, and the upper end of the phase separator 510 is provided with a hole. The gaseous cold working medium is discharged to the outside of the system through the phase separation valve 511 and the manual valve 512, and the liquid working medium is input into the cold-hot ablation needle 200, so as to achieve the purpose of gas-liquid separation.

[0120] The manual valve 512 can also adjust the flow resistance of the pipeline to achieve a balance between the consumption of liquid nitrogen and the gas-liquid separation.

[0121] In addition, a temperature sensor 513 is arranged downstream of the phase separation valve 511. When the nitrogen gas passing through the phase separator 510 is exhausted, the phase separation valve 511 can be closed to reduce the loss of liquid nitrogen at the phase separator 510.

[0122] The working medium distribution system 500 further comprises a pre-cooler 520 connected with the phase separator 510. The pre-cooler 520 is provided with a gas passage 521 and a liquid passage. The input side of the gas passage 521 is connected with the gas outlet end of the phase separator 510, and the input side and the output side of the liquid passage are respectively connected with the liquid outlet end of the phase separator 510 and the cold-hot ablation needle 200. The gas in the gas passage 521 is used to pre-cool the liquid in the liquid passage.

[0123] In other words, the gaseous working medium and the liquid working medium are separated by the phase separation valve 511. However, the gaseous working medium also has a certain amount of cold energy. Therefore, if the gaseous working medium is directly recovered or discharged, the cold energy will be wasted. Therefore, the gaseous working medium passes through the gas passage 521 of the pre-cooler 520, and the liquid working medium passes through the liquid passage of the pre-cooler. Since the gas passage 521 can cover at least part of the liquid passage, the cold energy of the gaseous working medium can be used to pre-cool the liquid working medium in the flow of the gaseous working medium and the liquid working medium, so that the liquid working medium input into the cold-hot ablation needle 200 can obtain a lower treatment temperature.

[0124] Further, the gas passage 521 is configured as a labyrinth-shaped passage to increase the flow path of the gas, so that the cold energy of the gas can be more fully utilized.

[0125] Specifically, as shown in FIG. 4, the gas passage 521 of the pre-cooler 520 is configured as a labyrinth-shaped passage. Figure 13As shown, the pre-cooler 520 comprises an upper plate 522 and a lower plate 523, which are connected by locking screws. The lower plate 523 is provided with a labyrinth-shaped passage, i.e. a gas passage 521. The upper plate 522 and the lower plate 523 are provided with liquid passages, through which the gaseous working medium can reach the cooling effect of the upper plate 522 and the lower plate 523, so as to use the cold energy of the gaseous working medium to pre-cool the liquid working medium, thereby improving the utilization efficiency of the cold working medium.

[0126] The liquid passages of the pre-cooler 520 are provided with a plurality of output joints (sleeve joints), so that the output of each passage can be independently controlled.

[0127] (Four) Recovery system 600

[0128] In the present application, the cold working medium or the hot working medium input into the cold-hot ablation needle 200 can be recovered through the output end after the treatment is completed, i.e. through the recovery system 600.

[0129] Specifically, as shown in Figure 2 The recovery system 600 comprises a heat exchanger 610 connected to the output end of the cold-hot ablation needle 200, which is used to heat the cold working medium output by the cold-hot ablation needle 200 and then discharge it into the atmosphere, or to cool the hot working medium output by the cold-hot ablation needle 200 and then recover it.

[0130] The cold working medium or the hot working medium output by the output end of the cold-hot ablation needle 200 is input into the heat exchanger 610 through a pipeline. For the cold working medium, the heat exchanger 610 heats it, thereby warming up the cold working medium to avoid excessive condensation of white mist. For the hot working medium, the steam is condensed by heat exchange between the fins 611 of the heat exchanger 610 and the air, so as to avoid the diffusion of the steam in the environment.

[0131] As shown in Figure 14 and 15 The heat exchanger 610 is a wind-cooled heat exchanger, which blows cold air to the fins 611 by a fan 612 to condense the hot working medium steam. The wind-cooled heat exchanger integrates a PTC heater 613. The PTC heater 613 adopts a U-shaped corrugated fin, which can improve its heat dissipation rate. It combines the advantages of adhesion and mechanical type, and fully considers various thermal and electrical phenomena of the PTC heater 613 during operation, so that it has strong bonding force, excellent heat conduction and heat dissipation performance, high efficiency, safety and reliability.

[0132] In addition, the PTC heater 613 has the advantages of small thermal resistance and high heat exchange efficiency, and is an automatic constant temperature and power saving electric heater. A prominent feature of the PTC heater 613 is safety. When the fan stops due to a fault, the PTC heater 613 cannot be fully cooled, and its power will automatically decrease sharply. At this time, the surface temperature of the heater is maintained at about the Curie temperature (generally about 250°C), so that the surface of the heater does not "red" like an electric heating tube heater, greatly improving the heat exchange efficiency and having high safety.

[0133] At the same time, 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 input into the heat exchanger 610 for recycling.

[0134] The recycling system 600 further comprises a recycling tank 620 arranged below the heat exchanger 610. The hot working fluid condensed after the hot working fluid vapor exchanges heat with air through the fins of the heat exchanger 610 and enters the recycling tank 620 for recycling.

[0135] The recycling tank 620 is provided with a weighing sensor 621 below. When the condensed hot working fluid in the recycling tank 620 reaches a certain amount, the weighing sensor 621 alarms to prompt the user to handle in time, avoiding overflow of the working fluid.

[0136] (Five) Electrical control system 700 and interactive system 800

[0137] As shown in Figures 8-13 The host unit 100 further comprises an electrical control system 700 and an interactive system 800 electrically connected, and the electrical control system 700 is electrically connected with the cold working fluid supply system 300, the hot working fluid supply system 400 and the working fluid distribution system 500 to control the working process of the working fluid.

[0138] The electrical control system 700 comprises a power supply system and a computer control system, wherein the power supply system comprises an air switch, a filter, a soft start circuit, an isolation transformer and a switching power supply, and is powered by a lithium battery. The computer control system is in communication connection with electrical equipment such as pressure sensors 324, 426, temperature sensors 422, 513, liquid level meters 330, 430 and weighing sensors 621 to collect signals such as pressure, temperature, liquid level, weight and position. In addition, the computer control system is also in communication connection with the switches of the above-mentioned valves, pumps, heaters 424 and fans 612.

[0139] The electrical control system 700 can be realized by PCBA or PLC and the like.

[0140] 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 a tri-color indicator light, battery level display, surgical output status display, and RFID identification functions to help users better utilize the system and improve its usability.

[0141] 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.

[0142] In addition, an emergency stop button 915 is also provided on the outer casing 910.

[0143] 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.

[0144] 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.

[0145] 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.

[0146] (vi) Cold and hot ablation needles 200

[0147] 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.

[0148] 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.

[0149] 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.

[0150] The host unit 100 is also connected with a temperature measuring probe 220, which is used to detect the temperature of the tissue during the operation, and a temperature sensor (for example, a T-type thermocouple) is arranged in the needle tube of the temperature measuring probe 220.

[0151] The diameter of the needle tube of the temperature measuring probe 220 is 0.5mm-3mm; the interface between the lead and the host unit 100 is a coupling type multi-core connector, which is convenient to plug and unplug, and also has a design of anti-loosening.

[0152] The cold and hot ablation needle 200 and the temperature measuring probe 220 are both disposable sterile products, and an electronic encryption chip is integrated on the cold and hot ablation needle 200 and the temperature measuring probe 220, so that the RFID card reader of the interactive system 800 can effectively identify and limit the use time of the cold and hot ablation needle 200 and the temperature measuring probe 220, thereby avoiding the multiple use of the disposable sterile products. The chip can also record the production batch number, validity period, specification and other parameters of the cold and hot ablation needle 200 or the temperature measuring probe 220.

[0153] In addition, the diameter of the needle tube of the cold and hot ablation needle 200 is generally 1mm-8mm.

[0154] Specifically, as shown in Figure 16 and 17 , the cold and hot ablation needle 200 includes a working medium input pipe 201 and a working medium return pipe 202 sleeved outside the working medium input pipe 201, wherein the working medium input pipe 201 is connected with the cold working medium supply system 300 or the hot working medium supply system 400, and the cold working medium or the hot working medium can be input into the working medium input pipe 201 through the cold working medium supply system 300 or the hot working medium supply system 400 (as indicated by the arrows). Figure 17

[0155] The cold working medium or the hot working medium in the working medium input pipe 201 reaches the needle tip part of the cold and hot ablation needle 200 to treat the treatment area, and after the treatment is completed, the cold working medium or the hot working medium is output to the recovery system 600 along the working medium return pipe 202 (as indicated by the arrows). That is, the flow directions of the working medium in the working medium return pipe 202 and the working medium input pipe 201 are opposite. Figure 17

[0156] Therefore, the cold and hot ablation needle 200 in the present application can collect the input (inflow) and the output (return flow) through the pipe sleeve connection, so that the external connection pipes for the working medium input pipe 201 and the working medium return pipe 202 do not need to be matched; thereby greatly simplifying the structure of the connection pipes and the storage medium equipment.

[0157] In addition, the working medium input pipe 201 and the working medium return pipe 202 are both configured as elbow structures, that is, the extension directions of the working medium input pipe 201 and the working medium return pipe 202 are changed, as shown in Figure 16 ​​As shown, the cold-hot ablation needle 200 as a whole forms an L-shaped structure, so that the cold-hot ablation needle 200 as a whole does not have an excessively large size in one direction; in addition, it is particularly important that even if a sudden disturbance or vibration acts on the handle part of the cold-hot ablation needle 200, the force will not be immediately transmitted to the needle tip part of the cold-hot ablation needle 200 to affect the patient, so that through the above-mentioned bent pipe structure, the disturbance of the needle tip part of the cold-hot ablation needle 200 by the disturbance and other unstable factors can be reduced, thereby improving the treatment stability of the cold-hot ablation needle 200.

[0158] Further, the cold-hot ablation needle 200 further comprises a vacuum pipe 203, wherein the vacuum pipe 203 is sleeved outside the working medium return pipe 202 and the vacuum pipe 203 can cover at least part of the outer wall of the working medium return pipe 202, so that a vacuum layer 204 is formed between at least part of the outer wall of the working medium return pipe 202 and at least part of the inner wall of the vacuum pipe 203, as shown. Figure 17 The vacuum layer 204 can better achieve good vacuum heat insulation performance of the cold-hot ablation needle 200 in the non-treatment area part (so as to prevent the normal skin tissue of the human body from being frozen or the surgical operator touching the non-treatment area part of the ablation needle from being frozen when the low-temperature cryotherapy targets the tissue).

[0159] In addition, as shown, Figure 5 A temperature sensor is arranged at the inlet of the working medium input pipe 201 and a temperature sensor is also arranged at the outlet of the working medium return pipe 202 to detect the temperature of the working medium.

[0160] The high-low temperature composite ablation surgical system of the present application can use working medium below the critical point, if the temperature is also low enough, the working medium is in liquid state; if the temperature is high enough, the working medium is in gas state. Understandably, working medium above the critical point can also be used, at this time the working medium is in supercritical state.

[0161] Taking nitrogen as the working medium for example:

[0162] The critical temperature Tc of nitrogen is 126.2K (-147℃), the critical pressure Pc is 3.4MPa, and the critical density is 313.3kg / m 3 Near the critical point, nitrogen has an abnormally large thermal expansion coefficient, specific heat capacity and relatively small viscosity, and a high heat transfer coefficient can be obtained when the temperature difference is small. In the supercritical nitrogen transmission process, the cold loss along the way is small because the temperature is higher than that of liquid nitrogen. Due to the high working pressure, the overall density is high, and the mass flow is large. Therefore, the present application preferably uses nitrogen as the cold working medium.

[0163] The circulation path of the cold working medium in the present application is as follows:

[0164] The cold working medium in the cold working medium storage tank 311 passes through the output valve 312, the filling interface 314, the liquid adding valve 315 and the one-way valve 316 in sequence to enter the cold tank 321 to complete liquid adding.

[0165] The cold working medium in the cold tank 321 is input to the cold-hot ablation needle 200 along a main pipeline for treatment and is input to the heat exchanger 610 along a branch pipeline for recovery.

[0166] Specifically, the cold working medium in the cold tank 321 passes through the output valve, the phase separator 510 and the pre-cooler 520 in sequence along the main pipeline to enter the probe delivery pipe 210, and then enters the cold-hot ablation needle 200 through the input port of the cold-hot ablation needle 200. The cold working medium entering the cold-hot ablation needle 200 returns to the output port after completing treatment in the treatment area. The cold working medium at the output port of the cold-hot ablation needle 200 enters the heat exchanger 610 to be warmed up, and the warmed-up cold working medium is discharged after being treated.

[0167] The cold working medium (in a gaseous state) in the cold tank 321 passes through the manual valve 327 or the gas release valve 328 along the branch pipeline to enter the heat exchanger 610 to release overpressure.

[0168] The flow path of the hot working medium in the application is as follows:

[0169] The hot working medium in the hot working medium storage tank 411 passes through the liquid adding port 412, the filling pump 413 and the filling valve 414 in sequence to enter the hot tank 421 to complete liquid adding.

[0170] The hot working medium in the hot tank 421 is input to the cold-hot ablation needle 200 along a main pipeline for treatment and is input to the heat exchanger 610 along a branch pipeline for recovery.

[0171] Specifically, the hot working medium in the hot tank 421 passes through the output valve, the phase separator 510 and the pre-cooler 520 in sequence along the main pipeline to enter the probe delivery pipe 210, and then enters the cold-hot ablation needle 200 through the input port of the cold-hot ablation needle 200. The hot working medium entering the cold-hot ablation needle 200 returns to the output port after completing treatment in the treatment area. The hot working medium at the output port of the cold-hot ablation needle 200 enters the heat exchanger 610 to be cooled, and the cooled hot working medium enters the recovery tank 620.

[0172] The hot working medium (in an overpressure state) in the hot tank 421 passes through the manual valve 428 or the gas release valve 429 along the branch pipeline to enter the heat exchanger 610 to be recovered.

[0173] While the present application has been described with reference to the preferred embodiments, it is to be understood that various modifications can change the scope of the present application to which they are not intended to deviate. In particular, the technical features mentioned in the various embodiments can be combined in any manner, provided that there is no structural conflict. The present application 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 combined ablation surgical system, characterized by, The system comprises a host unit (100), wherein the host unit (100) comprises a cold working medium supply system (300); The cold working medium supply system (300) comprises a cold working medium pressure control system (320), wherein the cold working medium pressure control system (320) comprises a cold tank (321), a booster pipeline (322) is connected to the cold tank (321), and two ends of the booster pipeline (322) are connected to the cold tank (321) to form a closed loop, so that the cold working medium in the cold tank (321) is self-boosted; and the cold working medium in the cold tank (321) after self-boosting is delivered to a cold-hot ablation needle (200) for cryotherapy; The cold working medium after self-boosting has a working pressure, and the working pressure is a working pressure at which the cold working medium is in a liquid state or a supercritical state, wherein the temperature at which the cold working medium is in the liquid state or the supercritical state is a temperature at which cryotherapy can be performed; The cold working medium pressure control system is configured to: When the pressure in the cold tank (321) is lower than P-ΔP1, a booster valve (323) on the booster pipeline (322) is opened, and when the pressure in the cold tank (321) reaches P+ΔP1, the booster valve (323) is closed; When the pressure in the cold tank (321) reaches P-ΔP0, the booster valve (323) is closed; When the pressure in the cold tank (321) reaches P+ΔP0, a gas discharge valve (328) connected to the cold tank (321) is opened to release the pressure in the cold tank (321), and when the pressure in the cold tank (321) is released to P, the gas discharge valve (328) is closed; ΔP1 is less than ΔP0, and the values of ΔP0 and ΔP1 are related to the liquid level of the cold tank (321).

2. The high-low temperature combined ablation surgical system of claim 1, wherein, The gas discharge valve (328) is located on a pipeline through which the cold tank (321) releases pressure to a recovery system (600); After a certain period of time, if the current pressure in the cold tank (321) is less than the working pressure P, the booster valve (323) is re-opened; and the above process is repeated to gradually approach the working pressure P in the cold tank (321).

3. The high-low temperature composite ablation procedure system of claim 1 or 2, wherein, The cold working medium supply system (300) further comprises a cold working medium automatic perfusion system (310), wherein the cold working medium automatic perfusion system (310) comprises a cold working medium storage tank (311) for storing cold working medium, the cold working medium storage tank (311) is connected to the cold tank (321), and an output valve (312), an interface detection switch (313) and a perfusion interface (314) are sequentially arranged on a pipeline connecting the cold working medium storage tank (311) and the cold tank (321). Wherein, after the connection between the filling interface (314) and the cold working medium storage tank (311) is detected to be completed by the interface detection switch (313), the liquid adding valve (315) on the pipeline between the filling interface (314) and the cold tank (321) is opened, the liquid adding and gas releasing valve (326) between the cold working medium automatic filling system (310) and the recovery system (600) is closed, the output valve (312) is opened, and the cold working medium in the cold working medium storage tank (311) is continuously added to the cold tank (321); When the liquid level meter (330) in the cold tank (321) detects that the cold working medium is added to the full, the liquid adding valve (315) is closed, the liquid adding and gas releasing valve (326) is opened, the output valve (312) is closed, and the connection between the filling interface (314) and the cold working medium storage tank (311) is disconnected.

4. The high-low temperature composite ablation procedure system of claim 1 or 2, wherein, The cold tank (321) is a vacuum insulated stainless steel pressure container.

5. The high-low temperature combined ablation surgical system of claim 2, wherein, The main unit (100) further comprises a hot working medium supply system (400), and the hot working medium supply system (400) comprises a hot working medium automatic filling system (410) and a hot working medium pressure control system (420). The hot working medium automatic filling system (410) comprises a hot working medium storage tank (411) for storing hot working medium. The hot working medium pressure control system (420) comprises a hot tank (421) for carrying hot working medium, and the hot tank (421) is used for delivering hot working medium with pressure to the cold-hot ablation needle (200). The hot working medium storage tank (411) and the hot tank (421) are connected by a pipeline to deliver hot working medium in the hot working medium storage tank (411) to the hot tank (421).

6. The high-low temperature combined ablation procedure system of claim 5, wherein, The hot tank (421) is internally provided with a heating device, and the heating device is used for heating the hot tank (421) to increase the pressure in the hot tank (421). The inner cylinder of the hot tank (421) and the outer wall of the delivery pipeline are coated with ceramic, and the pressure in the hot tank (421) is increased by heating the ceramic; or The pressure in the hot tank (421) is increased by using a microwave heating method to directly heat the working medium.

7. The high-low temperature combined ablation procedure system of claim 5, wherein, The hot tank (421) is provided with a temperature sensor (422), a temperature switch (423) and a heater (424). When the temperature in the hot tank (421) rises to the opening temperature of the temperature switch (423), the temperature switch (423) is disconnected, so as to forcibly stop the heater (424) from working.

8. The high-low temperature combined ablation procedure system of claim 6, wherein, The pressure of the hot tank (421) is adjusted by using temperature PID regulation.

9. The high-low temperature combined ablation procedure system of claim 5, wherein, The recovery system (600) comprises a heat exchanger (610) connected with the output port of the cold-hot ablation needle (200), and the heat exchanger (610) is used for heating the cold working medium output by the cold-hot ablation needle (200) to return to the atmosphere or cooling the hot working medium output by the cold-hot ablation needle (200) to be recovered; and The cold working medium discharged from the cold working medium supply system (300) due to overpressure or the hot working medium discharged from the hot working medium supply system (400) due to overpressure can be input into the heat exchanger (610) for recovery treatment.

10. The high-low temperature combined ablation procedure system of claim 9, wherein, The heat exchanger (610) is a wind-cooled heat exchanger, and the wind-cooled heat exchanger is integrated with a PTC heater (613) having a U-shaped corrugated fin.

11. The high-low temperature combined ablation procedure system of claim 9, wherein, The recovery system (600) further comprises a recovery tank (620) arranged below the heat exchanger (610), and the hot working medium entering the recovery tank (620) after condensation by heat exchange between the fin of the heat exchanger (610) and air is recovered. A weighing sensor (621) is arranged below the recovery tank (620), and the weighing sensor (621) alarms when the condensed hot working medium in the recovery tank (620) reaches a certain amount.

12. The high-low temperature composite ablation procedure system of claim 1 or 2, wherein, The main unit (100) further comprises an assisting system (900), and the assisting system (900) comprises an assisting wheel (911), an electric control wheel (912), a lithium battery and a handle (913) arranged on a shell (910). The assisting wheel (911) provides power for the movement of the main unit (100). The electric control wheel (912) is used for automatically locking the shell (910) when the shell (910) stops moving. The handle (913) is integrated with a torque sensor.

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