Freezing radiofrequency ablation needle and system

Abstract

The invention discloses a cryogenic radiofrequency ablation needle and system, and belongs to the technical field of cryoablation, the cryogenic radiofrequency ablation needle comprises a needle head part, an adjusting handle part, a delivery pipe part, a quick connector part, a rewarming temperature measurement ablation plug part and a radiofrequency ablation plug part; the needle head part is used for acting on a human body target position; the adjusting handle part is used for adjusting the ranges of a freezing target area and a radio frequency target area of the needle head part; the conveying pipe part is used for conveying electric signals and gas; the quick connector part is used for being connected with equipment to achieve inlet and outlet of high-pressure gas. The rewarming temperature measurement ablation plug part and the radio frequency ablation plug part are used for being connected with equipment. The front end of the probe is additionally provided with synchronous and asynchronous adjustable functions of freezing and radiofrequency ablation, the function can realize effective and accurate area adjustment aiming at a radiofrequency target area, and a user can be effectively helped to set an ablation target area aiming at a target area.

Description

Technical Field

[0001] This invention belongs to the field of processing technology, and in particular relates to a cryoradiotherapy needle and system. Background Technology

[0002] With the development of science and technology, especially the advancement of medical imaging technology, minimally invasive surgeries such as cryotherapy and thermal ablation for tumors have made significant progress. However, they still have their own limitations. Direct thermal ablation, represented by radiofrequency ablation, is temperature-dependent, typically between 41℃ and 45℃, which can cause irreversible cell damage. When the tissue temperature rises to 60℃, the time for irreversible cell damage is greatly shortened. Above 60℃, protein denaturation occurs, and within this temperature range, coagulation necrosis occurs. When the temperature continues to rise to around 100℃, the water within the tissue boils and vaporizes. If the temperature continues to rise, the tissue will carbonize and produce smoke. Once carbonization occurs, the temperature rises rapidly. Simultaneously, thermal resistance limits the extent of tissue damage, and carbonization increases interstitial pressure, potentially leading to the spread of cancer cells into the liver and blood vessels. The advantages of thermal ablation include the ability to inactivate target tissue within a defined temperature range, rapid hemostasis via the needle tract, and high thermal efficiency. However, thermal ablation requires addressing the issue of controlling the temperature to prevent it from becoming too high. Common control methods involve introducing a circulating cooling system (such as water cooling or air cooling). In addition, the disadvantages of radiofrequency thermal ablation include significant pain for patients during the procedure, poor visibility of the ablation area making it difficult to accurately determine the boundaries of the ablation zone, and the potential for tissue damage or needle sticking.

[0003] Cryoablation primarily involves the controlled cooling, freezing, and rewarming of lesion tissue using cryo-instruments, resulting in irreversible damage and even necrosis of tumor cells. The mechanisms by which cryoablation kills tumor cells include: cell dehydration and shrinkage; mechanical damage from intracellular ice crystal formation; cellular electrolyte concentration and pH changes; denaturation of cell membrane proteins; blood stasis and microthrombus formation; and immune effects. Cryoablation is not only minimally invasive but also offers advantages such as precise localization, hemostasis and analgesia, fewer postoperative complications, high safety, and activation of tissue immunity, making it highly popular among doctors and patients. However, cryoablation has drawbacks, including the potential for residual tumor cells due to incomplete ablation and poor hemostasis during and after the procedure. Therefore, designing a product compatible with both cryoablation and radiofrequency ablation, allowing for seamless switching between modes, can not only compensate for the shortcomings of single-method cryoablation and single-method thermoablation, but also facilitate thorough eradication of target tissue, improving tumor cure rates, while protecting normal tissue from damage, thus fully leveraging the advantages of each method.

[0004] Existing technology CN113558746A describes a multimodal tumor ablation probe system and its control method. This technology relies on low-pressure liquid nitrogen freezing as the freezing mode, adding a radiofrequency generator to the cryoablation device and achieving a certain degree of switching between cold and thermal ablation. During freezing, liquid nitrogen flows into the lumen of the treatment section through the inlet pipe, undergoes phase change heat, and then flows out of the probe through the return gas channel. During heating, the probe receives radiofrequency current through the radiofrequency signal line. However, this liquid nitrogen cooling technology, due to the use of a low-temperature medium, requires consideration of the insulation characteristics of the pipeline to prevent significant heat leakage and difficulties in effectively controlling the cooling rate. Furthermore, during radiofrequency thermal ablation, the liquid nitrogen system must be completely suspended and not participate in cooling; the radiofrequency energy is generated by the radiofrequency electrodes without using cooling cycle control (such as commonly used water cooling or air cooling). Switching from freezing mode to radiofrequency ablation mode requires the body to melt to meet the conditions for radiofrequency ablation before thermal ablation can be performed. Furthermore, the product design relies solely on analog signals to determine the product's input and output signals, without deeply optimizing the technical flexibility of the probe itself. The design of the probe's cryo-targeting region and radio frequency targeting region is limited in function and lacks flexible adjustment capabilities. Summary of the Invention

[0005] This invention provides a cryoradioablation needle and system to solve the problems in the prior art.

[0006] The present invention employs the following technical solution: a cryo-radiofrequency ablation needle, comprising a needle tip, an adjusting handle, a delivery tube, a quick connector, a rewarming temperature-measuring ablation plug, and a radiofrequency ablation plug; the needle tip is used to act on a target location on the human body, and has both cryo- and radiofrequency ablation functions; the adjusting handle is used to adjust the range of the cryo-targeting area and the radiofrequency-targeting area of ​​the needle tip; the delivery tube is used to deliver electrical signals and gas; the quick connector is used to connect to equipment to enable the entry and exit of high-pressure gas; the rewarming temperature-measuring ablation plug and the radiofrequency ablation plug are used to connect to equipment to realize the transmission of temperature signals and radiofrequency energy.

[0007] Furthermore, the needle portion includes a needle sheath, an insulating tube, an adjustable vacuum wall, and a needle tip seal; the insulating tube is entirely wrapped around the needle sheath and can slide along the needle sheath; the adjustable vacuum wall is located inside the needle sheath for vacuum insulation and gas transport, and can slide along the inside of the needle sheath; the needle tip seal is located at the distal end of the needle sheath; the temperature detector is a T-type thermocouple, which is located in the transition area between the insulating tube and the needle sheath; the insulating tube has a double-layer structure, including an inner insulating tube and an outer insulating tube; the T-type thermocouple is located in the interlayer between the inner and outer insulating tubes, and the outer insulating tube slightly protrudes from the inner insulating tube, so that the temperature measuring point of the T-type thermocouple is buried under the outer insulating tube.

[0008] Furthermore, the adjustment handle is a synchronous adjustment handle, which includes a left outer shell of the handle, an adjustment push handle, a front rubber seal, a rear rubber seal, and an internal plastic fixing component; the left outer shell of the handle is provided with a range scale, a front sliding groove, and a rear sliding groove; the front rubber seal is used to seal the gap between the needle sheath and the adjustable vacuum wall, and the rear rubber seal is used to seal the gap between the vacuum wall structure inside the internal plastic fixing component and the adjustable vacuum wall; when the adjustment push handle is pushed, the front fixing structure and the rear fixing structure of the push handle slide along the front sliding groove and the rear sliding groove, driving the insulating tube and the adjustable vacuum wall to move synchronously, thereby realizing the synchronous adjustment of the cryogenic target area and the radio frequency target area.

[0009] Furthermore, the adjusting push handle is provided with a scale protrusion at the front end of the adjusting push handle, a front end fixing structure and a rear end fixing structure. The front end fixing structure is fixed to the near end of the insulating tube, and the rear end fixing structure is fixed to the near end of the adjustable vacuum wall. The front end fixing structure and the rear end fixing structure are mechanically integrated.

[0010] Furthermore, the adjustment handle is a multi-functional adjustment handle, including a left outer shell, a right outer shell, a radiofrequency ablation range adjustment push handle, a cryoablation range adjustment push handle, a synchronization lock button, a transmission gear, and a locking button gear. The left outer shell has a range scale, a synchronization lock left shell marking, and a reserved hole. The right outer shell has a range scale, a synchronization lock right shell marking, and a reserved hole. The radiofrequency ablation range adjustment push handle has a radiofrequency ablation push handle fixing structure and a radiofrequency ablation push handle rack. The radiofrequency ablation push handle fixing structure is fixed to the proximal end of the insulating tube. The cryoablation range adjustment push handle has a cryoablation push handle fixing structure and a cryoablation push handle rack. The cryoablation push handle fixing structure is fixed to the proximal end of the adjustable vacuum wall. The transmission gear is fixed to the right outer shell of the handle and can rotate freely. The transmission gear meshes with the cryoablation push handle rack. The locking button gear is fixed to the synchronization lock button and can rotate freely. The locking button gear can mesh with the transmission gear and the radiofrequency ablation push handle rack.

[0011] Furthermore, the needle sheath has a JT groove opening at the corresponding position of the transition area between the insulating tube and the needle sheath. The JT groove opening is consistent with the temperature measuring point of the T-type thermocouple and is used to effectively cool the high-temperature area.

[0012] A cryo-radiofrequency ablation needle system includes a cryo-radiofrequency ablation needle, a cryo-ablation module, a radiofrequency ablation module, a rewarming module, and a control center. The control center controls the opening, closing, and mode switching of the cryo-ablation module, radiofrequency ablation module, and rewarming module, enabling individual module operation or multi-module joint operation in a preset sequence. The cryo-ablation module uses high-pressure gas as its gas source, and the gas source also provides a cooling medium for the radiofrequency ablation module. The cryo-ablation module includes a pressure proportional solenoid valve with temperature control function, which receives temperature feedback signals and adjusts the gas source pressure to achieve stable temperature control of the radiofrequency ablation module. The radiofrequency ablation module includes a radiofrequency transmitting device, a temperature detector, and a temperature control structure located at the probe head. The temperature detector detects the real-time temperature of the probe head and feeds it back to the temperature control structure. The temperature control structure adjusts the cryo-ablation module to switch to a cooling function module based on the temperature signal to balance the radiofrequency energy.

[0013] Furthermore, the cryoablation module also includes a solenoid valve II, a flow proportional valve, and a pre-cooling device. When the control center activates the cryoablation module, the gas source inputs a pressure of P1 through the solenoid valve II, which is then adjusted to the required cryoablation pressure P2 by the flow proportional valve. The gas then flows sequentially through the pre-cooling device and the probe tip to achieve the cryoablation operation. When the control center activates the radio frequency ablation module, the cryoablation module switches to a cooling function module. The gas source inputs a pressure of P2 through the solenoid valve II, which is then adjusted to a pressure of P3 by the pressure proportional valve, where P3 < P2. The output pressure of the pressure proportional valve is controlled by the real-time temperature signal T2 fed back from the temperature detector to achieve dynamic adjustment to balance the radio frequency energy.

[0014] Furthermore, the rewarming module is used to assist in rapid tissue rewarming after the cryoablation module ends, shortening the time for switching from cryoablation mode to radiofrequency ablation mode; when the control center starts the rewarming module, the cryoablation module and the radiofrequency ablation module stop operating.

[0015] Furthermore, the radiofrequency ablation module also includes a radiofrequency ablation cable and a radiofrequency ablation cable sheath fixing device; the radiofrequency ablation cable is used to provide radiofrequency energy, and its end is fixed to the proximal end of the needle sheath through the radiofrequency ablation cable sheath fixing device to realize the circuit conduction between the radiofrequency ablation cable and the needle sheath; the insulating tube is located at the distal end of the needle sheath and is not connected to the radiofrequency ablation cable sheath fixing device to facilitate the sliding adjustment of the insulating tube.

[0016] The above-described at least one technical solution adopted in the embodiments of the present invention can achieve the following beneficial effects: By using a cryoablation probe based on high-pressure nitrogen throttling freezing technology, and adding a rewarming module and a radiofrequency ablation module, the central control switching of the three modules is realized, achieving an integrated structural design of cryoablation module + rewarming module + radiofrequency module. This integrated structure can be used in combination with multiple modules or independently, realizing the mutual complementarity of cold ablation and thermal ablation functions.

[0017] By adding a rewarming module, a rapid transition from cryoablation to radiofrequency ablation is achieved. Since cryoablation can cause tissue impedance to be too high, making effective radiofrequency ablation impossible, a long period of natural rewarming is generally required before radiofrequency ablation can be performed. The introduced rewarming module relies on thermocouple heating to reach a high temperature in a short time, allowing the target frozen tissue to melt and rewarm quickly to meet the conditions for radiofrequency ablation. This greatly shortens the time required to switch from cryoablation to radiofrequency ablation and improves surgical efficiency.

[0018] By introducing high-pressure nitrogen gas as a cooling circulation medium into the radio frequency module, which is shared with the gas source of the cryo-module, the system can effectively control the excessively high temperature during radio frequency ablation and improve the effective utilization of the same gas source, thus simplifying the structure of the cryo-radio frequency ablation needle.

[0019] By introducing a pressure proportional valve solenoid valve and a temperature controller, the temperature controller receives signal feedback from the temperature sensor at the front end of the cryo-radiofrequency ablation needle and controls the electronic pressure proportional valve to output the corresponding pressure and flow rate of gas. Since excessively high temperatures during radiofrequency ablation can damage tissues and excessively low temperatures can affect ablation efficiency, this temperature control system with a feedback mechanism is needed. This enables dynamic control of the thermal ablation cooling cycle system, ensuring the stability of thermal ablation.

[0020] The selection of temperature monitoring points is particularly important for signal feedback and control of the thermal ablation cooling cycle system. This invention provides multiple location options for temperature monitoring, making temperature selection more diverse. Users can make choices based on actual conditions, which is beneficial for achieving multiple internal and external detections.

[0021] By placing the temperature detection point at the internal needle tip, the product can collect data on the highest temperature peak of common radiofrequency ablation points without compromising its integrity and usability, thus ensuring temperature control of radiofrequency ablation.

[0022] By placing the temperature monitoring point on the internal JT tank, the internal temperature of the product can be detected, and the product assembly and processing can be facilitated more conveniently. This is beneficial for real-time feedback of the cooling system's real-time temperature and for better control of the corresponding temperature range by controlling the internal air source.

[0023] By designing a double-layer insulating film structure on the outside of the sheath, a feasible solution for monitoring the outer wall temperature can be ensured. This solution is beneficial for protecting the temperature-sensing thermocouple and can reflect the high temperature of the outer wall. At the same time, the double-layer insulating film structure provides favorable conditions for the subsequent adjustment of the radiofrequency ablation target area. Under the premise of ensuring that the double-layer insulating film and the temperature-sensing thermocouple are integrated into a whole structure, the sliding displacement of the needle can be achieved, thus ensuring the functional realization of the adjustable radiofrequency ablation target area.

[0024] By designing openings on the side of the JT slot, and aligning the cross-sectional position of these openings with the transition point between the insulation layer and the sheath, effective cooling of the near-end temperature peak is ensured, guaranteeing consistent near-end cooling. This feature also effectively ensures the realization of the synchronously adjustable functional structure.

[0025] By introducing an adjustable insulating tube structure and an adjustable vacuum wall structure, the adjustable insulating tube structure is used to adjust the target area of ​​radiofrequency ablation, and the adjustable vacuum wall structure is used to adjust the target area of ​​cryoablation. This ensures that both radiofrequency ablation and cryoablation have adjustable functions. Attached Figure Description

[0026] The accompanying drawings, which are included to provide a further understanding of the invention and form part of this invention, illustrate exemplary embodiments of the invention and are used to explain the invention, but do not constitute an undue limitation of the invention. In the drawings: Figure 1 : A schematic diagram of a cryoradiofrequency ablation needle system; Figure 2 A schematic diagram of a cryoablation module for a cryoradioablation needle; Figure 3 A schematic diagram of a cryoablation needle radiofrequency ablation module; Figure 4 : A schematic diagram of a cryo-radiofrequency ablation needle rewarming module; Figure 5 : A structural diagram of a synchronously adjustable cryoradiofrequency ablation needle; Figure 5a Schematic diagram of temperature monitoring scheme at needle tip end cap; Figure 5b Schematic diagram of the design scheme for monitoring the internal temperature of the sheath; Figure 5c Schematic diagram of the design scheme for monitoring the external temperature of the sheath; Figure 5d Schematic diagram of the double-layer insulation tube design; Figure 5e Schematic diagram of the internal structure of the double-layer insulation tube scheme; Figure 5f Schematic diagram of the synchronous adjustment function structure of the double-layer insulation tube scheme; Figure 6 Diagram of the internal structure of the synchronous adjustment handle and head; Figure 6a Temperature-time curves were collected at multiple points on the exposed end of the cryoablation needle. Figure 6b : Schematic diagram of the distribution of acquisition points at the exposed end of the cryo-radiofrequency ablation needle; Figure 7 Diagram of the internal structure of the synchronous adjustment handle; Figure 8a : Diagram showing the maximum range of the synchronous adjustment handle function; Figure 8b : Schematic diagram of the minimum range of the synchronous adjustment handle function; Figure 9 : A structural diagram of a multifunctional adjustable cryoablation needle; Figure 10 : Multifunctional adjustment handle and right side structure diagram of the head; Figure 11 : Multifunctional adjustment handle and left side structure diagram of the head; Figure 12 Internal structure diagram of the multi-functional adjustment handle; Figure 13 : Synchronous adjustment structure diagram of the multi-functional adjustment handle; Figure 14 Diagram of the split-type adjustment structure of the multi-functional adjustment handle; Figure label: Needle part 1, needle sheath 101, insulating tube 102, inner insulating tube 1021, outer insulating tube 1022, adjustable vacuum wall tube 103, needle tip end cap 104, temperature measuring thermocouple 105, JT groove 106; Adjustment handle part 2, handle left outer shell 201, handle left outer shell range scale 2011, handle left outer shell front sliding groove 2012, handle left outer shell rear sliding groove 2013, synchronous locking left shell mark 2014, adjustment push handle 202, adjustment push handle front section scale protrusion 2021, push handle front end fixing structure 2022, push handle rear end fixing structure 2023, front end rubber seal 203, rear end rubber seal 204, handle internal plastic fixing part 205, handle right outer shell 206, handle right outer shell range Scale 2061, Synchronous locking right shell mark 2062, Radiofrequency ablation cable 207, Radiofrequency ablation cable sheath fixing device 208, Radiofrequency ablation range adjustment push handle 209, Radiofrequency ablation push handle rack 2091, Radiofrequency ablation push handle fixing structure 2092, Cryoablation range adjustment push handle 210, Cryoablation push handle rack 2101, Cryoablation push handle fixing structure 2102, Synchronous locking button 211, Locking button gear 2111, Transmission gear 212; 3. Delivery tube section; 4. Quick connector section; 5. Reheating and temperature measurement ablation plug section; 6. Radiofrequency ablation plug section. Detailed Implementation

[0027] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. Obviously, the described embodiments are only a part of the embodiments of this invention, and not all of them. Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this invention.

[0028] The following detailed description, in conjunction with the accompanying drawings, illustrates the technical solutions of the cryo-radiofrequency ablation needle and system provided by various embodiments of the present invention.

[0029] Reference Figures 1 to 14 As shown, this embodiment of the invention provides a cryo-radiofrequency ablation needle, including a needle tip portion 1, an adjusting handle portion 2, a delivery tube portion 3, a quick connector portion 4, a rewarming temperature measurement ablation plug portion 5, and a radiofrequency ablation plug portion 6. The needle tip portion 1 is used to act on a target location on the human body and has both cryo- and radiofrequency ablation functions. The adjusting handle portion 2 is used to adjust the range of the cryo-targeting area and the radiofrequency targeting area of ​​the needle tip portion 1. The delivery tube portion 3 is used to deliver electrical signals and gas. The quick connector portion 4 is used to connect to equipment to realize the entry and exit of high-pressure gas. The rewarming temperature measurement ablation plug portion 5 and the radiofrequency ablation plug portion 6 are used to connect to equipment to realize the transmission of temperature signals and radiofrequency energy.

[0030] Figures 5a-5d To achieve the control of the radiofrequency ablation module in this invention, temperature detection is a core technical aspect. Therefore, the selection and setting of the temperature monitoring location will be emphasized. It is known that T-type thermocouples are generally recommended for temperature measurement. The specifications of the 105 thermocouple can be selected according to the specific specifications of the ablation needle to ensure proper assembly and accurate monitoring. It is known that both external and internal detection can be used during product installation. However, due to the limitations of surgery, the ablation needle cannot detect surrounding tissue or add temperature sensors to the bare needle surface to provide real-time ablation temperature feedback. Therefore, this invention, based on its own design, employs the following three methods for needle tip area temperature measurement.

[0031] like Figure 5aThe diagram shows the first temperature monitoring setup for the radio frequency ablation module, where the temperature measurement point is placed inside the needle tip end cap 104. This example uses a triangular pyramid structure, but other common structures can be selected as needed. This design is relatively complex to manufacture. The needle tip end cap 104 needs to be machined into a blank shape, making its interior a semi-cavity structure. A pre-drilled hole diameter (generally recommended to be centered) of 0.5mm to 0.8mm is suitable, and the depth should not exceed half the end cap's diameter. In actual use, the limits of the machinable depth and the required measurement depth need to be considered. The temperature-sensing thermocouple 105 is soldered into the hole of the needle tip 104. Spot soldering is recommended to ensure the soldering area is completely filled with solder, preventing weak welds or lack of conductivity. The corresponding sheath (straight section) is then soldered to the head tip to form a complete needle part 11. Laser welding is recommended. After the above structure is completed, the needle part 11 undergoes subsequent surface treatment, including polishing, needle tip grinding, and marking. These processes prevent weld seams from affecting the appearance and meet the functional requirements of puncture. The advantage of this temperature detection position is that it can detect the temperature of the most sensitive area of ​​the needle tip. When the radiofrequency ablation module is activated, this is generally the highest temperature point, ensuring real-time monitoring and feedback of the highest temperature, effectively suppressing excessively high temperatures. The feedback is sent to the cooling module via a PID controller, prompting the cooling function. However, the disadvantages are that the manufacturing process is more complex, requiring the pre-embedded temperature thermocouple in the needle part 11, increasing the manufacturing difficulty of the needle part 1. Furthermore, due to the pulling effect of the head, it is not conducive to the use of adjustable functions. Figure 5b The second temperature monitoring setup for the radiofrequency ablation module involves placing the temperature sensing point inside the sheath. This approach is simpler, maintaining the needle section 11 as a whole and eliminating the need for pre-embedded thermocouples 105. The thermocouple 105 simply needs to be installed and fixed in the JT groove 106 inside the cryoablation structure. The thermocouple wire can be fixed using spot soldering or adhesive bonding. The advantage of this approach is that it can be fixed to the JT groove 106, facilitating movement within the needle section 1 and allowing for adjustment. The disadvantage is that it can only detect the internal temperature, and during radiofrequency ablation, the monitoring point cannot reflect the high-temperature conditions (the external temperature of the sheath is much higher than the internal temperature during actual radiofrequency ablation). Using this approach requires external detection or theoretical derivation to predict the external ablation temperature, which introduces some distortion.

[0032] Figures 5c-5e Scheme 3 is used to set up temperature detection for the radio frequency ablation module, which involves placing the temperature measurement point in the transition area between the insulating tube 102 and the sheath. For example... Figure 5dTo ensure the temperature sensing wire can be placed at point 304°C, we have adopted the existing design scheme, namely, modifying the insulating tube 102 into a double-layer structure comprising an inner insulating tube 1021 and an outer insulating tube 1022. The inner insulating layer is tightly attached to the sheath, and the outer insulating layer is attached to the inner insulating layer, with the temperature sensing thermocouple 105 sandwiched in between. Since the thermocouple wire requires soldering connection at its distal end for conductivity, the gap between the inner diameter of the outer insulating layer and the sheath can be reserved for the soldering point at the head of the temperature sensing thermocouple 105 and buried below the distal end of the outer insulating layer. The size of the gap between the inner and outer insulating layers matches the wire diameter and thickness of the temperature sensing thermocouple 105, and a certain distance is reserved at their distal cross-sections, allowing the outer insulating layer to slightly protrude from the inner insulating layer. This design ensures that the temperature sensing point of the temperature sensing thermocouple 105 is precisely buried below the outer insulating layer. Figure 5d and Figure 5e This design ensures that the overall appearance of the product is not affected, while protecting the temperature-measuring thermocouple 105 from the risk of damage.

[0033] Figures 6a-6b : Figure 6a Temperature monitoring data were collected at four points on the exposed portion of the radiofrequency ablation needle tip, divided into three equal parts. The specific distribution of the four temperature acquisition points was as follows: Figure 6b As shown. By Figure 6a As shown, during radiofrequency ablation, the high-temperature peak area of ​​the needle part 11 is mainly distributed at two points: 301(C) and 304(C), with 304(C) being slightly lower than 301(C). Therefore, in actual use, it is necessary to monitor 301(C) and 304(C) in this embodiment and prioritize cooling these two locations. It is known that detection on the outer wall at 301(C) cannot meet the practical application requirements, and the detected temperature feedback signal is highly sensitive, which is also not conducive to effective detection feedback. Therefore, for the outer wall detection scheme, we prioritize the transition area between the insulating tube 102 and the sheath, i.e., point 304(C). Based on the actual experimental results, detection at position 304(C) can achieve effective monitoring of radiofrequency temperature. Figure 5c and Figure 5d This aligns with the design. Furthermore, to better meet the requirements of temperature monitoring and feedback, based on... Figure 5f As shown, a corresponding JT groove 106 opening is designed at the detection point 304(C). This ensures effective cooling of the high-temperature area and avoids insufficient cooling due to excessively high near-end temperatures. It also does not affect the subsequent synchronous adjustment design; it only requires ensuring that the position of the JT groove 106 opening matches the detection point position during installation.

[0034] In this embodiment, the needle portion 1 includes a needle sheath 101, an insulating tube 102, an adjustable vacuum wall tube 103, and a needle tip end cap 104. The insulating tube 102 is entirely wrapped around the needle sheath 101 and can slide along the needle sheath 101. The adjustable vacuum wall tube 103 is located inside the needle sheath 101 and is used for vacuum insulation and gas transport, and can slide along the inside of the needle sheath 101. The needle tip end cap 104 is located at the distal end of the needle sheath 101. The temperature detector is a type T thermocouple in this embodiment. In this embodiment, the T-type thermocouple is disposed in the transition area between the insulating tube 102 and the needle sheath 101. The insulating tube 102 has a double-layer structure, including an inner insulating tube 1021 and an outer insulating tube 1022. In this embodiment, the T-type thermocouple is disposed in the interlayer between the inner insulating tube 1021 and the outer insulating tube 1022, and the outer insulating tube 1022 protrudes slightly from the inner insulating tube 1021, so that the temperature measuring point of the T-type thermocouple in this embodiment is buried under the outer insulating tube 1022.

[0035] In this embodiment, the adjustment handle part 2 is a synchronous adjustment handle, which includes a left outer shell 201, an adjustment push handle 202, a front rubber seal 203, a rear rubber seal 204, and an internal plastic fixing part 205. The left outer shell 201 is provided with a range scale, a front sliding groove, and a rear sliding groove. The front rubber seal 203 is used to seal the gap between the needle sheath tube 101 and the adjustable vacuum wall tube 103, and the rear rubber seal 204 is used to seal the gap between the vacuum wall structure inside the internal plastic fixing part 205 and the adjustable vacuum wall tube 103. When the adjustment push handle 202 is pushed, the front fixing structure 2022 and the rear fixing structure 2023 slide along the front sliding groove and the rear sliding groove, respectively, driving the insulating tube 102 and the adjustable vacuum wall tube 103 to move synchronously, thereby realizing the synchronous adjustment of the cryo-targeting area and the radio frequency targeting area.

[0036] In this embodiment, the adjusting push handle 202 is provided with a scale protrusion 2021 at the front end of the adjusting push handle, a front end fixing structure 2022 and a rear end fixing structure 2023. The front end fixing structure 2022 is fixed to the near end of the insulating tube 102, and the rear end fixing structure 2023 is fixed to the near end of the adjustable vacuum wall tube 103. The front end fixing structure 2022 and the rear end fixing structure 2023 are mechanically integrated.

[0037] In this embodiment, the adjustment handle part 2 is a multi-functional adjustment handle, including a left outer shell 201, a right outer shell 206, a radiofrequency ablation range adjustment push handle 209, a cryoablation range adjustment push handle 210, a synchronization lock button 211, a transmission gear 212, and a locking button gear 2111; the left outer shell 201 is provided with a range scale, a synchronization lock left shell mark 2014, and a reserved hole; the right outer shell 206 is provided with a range scale, a synchronization lock right shell mark 2062, and a reserved hole; the radiofrequency ablation range adjustment push handle 209 is provided with a radiofrequency ablation push handle fixing structure 2092 and a radiofrequency ablation push handle rack 2091, the radiofrequency... The ablation push handle fixing structure 2092 is fixed to the proximal end of the insulating tube 102; the cryoablation range adjustment push handle 210 is provided with a cryoablation push handle fixing structure 2102 and a cryoablation push handle rack 2101, and the cryoablation push handle fixing structure 2102 is fixed to the proximal end of the adjustable vacuum wall tube 103; the transmission gear 212 is fixed to the right outer shell 206 of the handle and can rotate freely, and the transmission gear 212 meshes with the cryoablation push handle rack 2101; the locking button gear 2111 is fixed to the synchronous locking button 211 and can rotate freely, and the locking button gear 2111 can mesh with the transmission gear 212 and the radiofrequency ablation push handle rack 2091.

[0038] In this embodiment, the needle sheath 101 has a slot opening (JT) at the corresponding position of the transition area between the insulating tube 102 and the needle sheath 101. The slot opening (JT) is consistent with the temperature measuring point position of the T-type thermocouple in this embodiment, and is used to effectively cool the high-temperature area.

[0039] Figure 6 :like Figure 6 The diagram shows the internal structure of the synchronous adjustment handle and head. The adjustment handle part 2 is used to connect the needle part 1 and the delivery tube part 3. The needle sheath tube 101 is connected to and extends into the left outer shell 201 of the handle, is fixed to the front rubber seal 203, and is wrapped inside the insulating tube 102.

[0040] The front rubber seal 203 is used to seal the adjustment gap between the needle sheath tube 101 and the adjustable vacuum wall tube 103; the rear rubber seal 204 is used to seal the gap between the vacuum wall structure inside the plastic fixing part 205 of the handle and the adjustable vacuum wall tube 103.

[0041] The range scale 2011 on the left outer shell of the handle is used to display the range of the adjustment push handle 202 sliding on the left outer shell 201 of the handle.

[0042] The radiofrequency ablation cable 207 provides the energy source for radiofrequency ablation and is fixed at its end to the proximal end of the needle sheath 101 by the radiofrequency ablation cable sheath fixing device 208. The fixing method can be elastic clamps or soldering, etc., to achieve the circuit conduction function between the radiofrequency ablation cable 207 and the needle sheath 101. The insulating tube 102 is located at the distal end of the needle sheath 101 and cannot be connected or fixed to the radio frequency ablation cable sheath fixing device 208. This design facilitates the sliding and adjustment of the insulating tube 102 on the needle sheath 101.

[0043] like Figure 7 As shown, the insulating tube 102 is completely wrapped around the needle sheath tube 101 and can slide along the needle sheath tube 101. The proximal end of the insulating tube 102 is fixed to the front end fixing structure 2022 of the push handle.

[0044] The adjustable vacuum wall tube 103, as part of the vacuum insulation and gas delivery, is wrapped by the needle sheath tube 101 and can slide inside the needle sheath tube 101. The proximal end of the adjustable vacuum wall tube 103 is fixed to the rear end fixing structure 2023 of the push handle. The left outer shell 201 of the handle is designed with connecting ribs and sliding grooves, including the front sliding groove 2012 and the rear sliding groove 2013 of the left outer shell of the handle, to assist in fixing and adjusting the sliding of the push handle 202.

[0045] The front end fixing structure 2022 of the push handle and the insulating tube 102, and the rear end fixing structure 2023 of the push handle and the adjustable vacuum wall tube 103 can be fixed by adhesive. Before assembly, they need to be fixed according to the required distance of the target area.

[0046] When the adjusting push handle 202 is pushed, since the front end fixing structure 2022 and the rear end fixing structure 2023 of the push handle are a mechanical structure, the insulating tube 102 and the adjustable vacuum wall tube 103 can move synchronously, thus achieving synchronous adjustment.

[0047] The front end of the adjustment push handle 202 is designed with a scale protrusion 2021. When it is aligned with the corresponding scale displayed on the range scale 2011 on the left outer shell of the handle, it reflects the current position of the adjustment push handle 202.

[0048] The minimum and maximum ranges can be adjusted according to the corresponding scale displayed on the left outer shell 201 of the handle. (Refer to...) Figure 8a and Figure 8b The diagram illustrates the adjustment effect.

[0049] Figures 8a-8b : Figure 8a To synchronize the maximum range L1 of the handle function, Figure 8b The minimum range L2 is used to synchronize the adjustment handle function.

[0050] The recommended range for this invention is 5mm increments. The maximum and minimum ranges can be set from 10mm to 30mm according to actual needs, but the actual use is not limited to this range.

[0051] The recommended adjustment range is 5mm increments. Depending on actual needs, the commonly used range is 10mm-30mm, with a total of 5 ranges. However, since the adjustment lever is a linear adjustment method, the adjustment scale can be changed to a smaller millimeter scale to achieve a more diverse range of adjustments.

[0052] The scale can be adjusted by printing, injection molding, engraving, or pasting scale labels.

[0053] The gas cylinder can be filled with high-pressure nitrogen, argon, or a mixture of nitrogen and argon.

[0054] In addition, for easy adjustment and fixation, the inner cavity of the left outer shell 201 of the handle is fitted with the needle sheath 101, the front rubber seal 203, the rear rubber seal 204, and the plastic fixing part 205 inside the handle is designed with corresponding fixing structures. The front sliding groove 2012 and the rear sliding groove 2013 of the left outer shell of the handle serve as slide rail structures to facilitate the sliding of the protruding structures of the front fixing structure 2022 and the rear fixing structure 2023 of the push handle along the direction of the needle tube. The right outer shell 206 and the left outer shell 201 of the handle work together to form the product handle structure.

[0055] Figure 9 The diagram shows a multifunctional adjustable cryoablation needle. Except for the handle, the rest of the structure is identical to the previous diagram. The functions of each part are consistent with the previous diagram.

[0056] Below, we will mainly introduce the main functions of the handle. In this embodiment... Figure 10 The diagram shows the structure of the multi-functional adjustment handle and the right side of the head. The right outer shell 206 of the handle has an added range scale 20616 display and a corresponding slide. The synchronous locking button 211 has a reserved hole as a locking button. The synchronous locking right shell mark 2062 is used to display the locking and unlocking functions.

[0057] Instead of using a single button, this invention features two buttons: a radiofrequency ablation range adjustment lever 209 and a cryoablation range adjustment lever 210, used to adjust the radiofrequency ablation area and the cryoablation area respectively.

[0058] Figures 11-13 : Multi-function adjustment handle and left side structure diagram of the head, wherein the left outer shell 201 of the handle has a reserved hole for the synchronous locking button 211 and a synchronous locking left shell mark 2014 is added next to it to indicate the locking and unlocking functions.

[0059] The adjustment range of the radiofrequency ablation range adjustment push handle 209 is displayed on the scale on the left outer shell 201 of the handle, the range scale 2011 on the left outer shell of the handle; the synchronous locking button 211 can be adjusted at the corresponding position of the hole on the left outer shell 201 and the right outer shell 206 of the handle, and the adjustment status is reflected by its display mark synchronous locking left shell mark 2014 and synchronous locking right shell mark 2062.

[0060] Figure 12 The internal structure of the multi-functional adjustment handle is similar to the former design. The insulating tube 102 is fixed to the radiofrequency ablation push handle fixing structure 2092 of the radiofrequency ablation range adjustment push handle 209, and the adjustable vacuum wall tube 103 is fixed to the cryoablation push handle fixing structure 2102 of the cryoablation range adjustment push handle 210. The fixing method can be adhesive.

[0061] To enable separate adjustment functions for the radiofrequency ablation range adjustment pusher 209 and the cryoablation range adjustment pusher 210, a radiofrequency ablation pusher rack 2091 structure is added to the radiofrequency ablation range adjustment pusher 209, and a cryoablation pusher rack 2101 structure is added to the cryoablation range adjustment pusher 210.

[0062] The transmission gear 212 is fixed to the right outer shell 206 of the handle as a fixed gear and can rotate freely. The transmission gear 212 meshes with the rack 2101 of the cryoablation push handle. The locking button gear 2111 is fixed to the synchronous locking button 211 and can rotate freely, but cannot be moved along the adjustment direction of the synchronous locking button 211. The locking button gear 2111 can mesh with the transmission gear 212 and the rack 2091 of the radiofrequency ablation push handle.

[0063] In this invention, the tooth structure of the gears and racks must meet the meshing standard requirements, and the gears and racks should be selected with the same specifications as much as possible, which makes it easier to synchronize the transmission between gears and between gears and racks.

[0064] like Figure 13 As shown, when the protruding structure synchronous locking button 211 on one side of the right outer shell 206 of the handle is pressed to make it in the low position, the teeth on the locking button gear 2111 mesh with the radiofrequency ablation push handle rack 2091 and the transmission gear 212 respectively. The locking button gear 2111 is in the gear transmission state. Whether the radiofrequency ablation range adjustment push handle 209 or the cryoablation range adjustment push handle 210 is pushed, under the synchronous gear transmission, when the active push handle (for example, the radiofrequency ablation range adjustment push handle 209 is the active push handle) is pushed, the other push handle becomes the driven push handle (the cryoablation range adjustment push handle 210 becomes the driven push handle). The two move forward or backward synchronously, so the function of synchronously adjusting the radiofrequency ablation range or the cryoablation range can meet the requirements.

[0065] like Figure 14 As shown, when the synchronous locking button 211 on the protrusion structure on the left outer shell 201 of the handle is pressed to make it in the low position, the teeth on the locking button gear 2111 disengage from the radiofrequency ablation pusher rack 2091 and the transmission gear 212, and the locking button gear 2111 is in the gear stop state. Whether the radiofrequency ablation range adjustment pusher 209 or the cryoablation range adjustment pusher 210 is pushed, since the dual gear transmission is in the disconnected state, when the active pusher (e.g., the radiofrequency ablation range adjustment pusher 209 is used as the active pusher) is pushed, the other pusher is in the stop state because it is not affected by external force. At this time, the two are asynchronously adjusted. If you want to achieve the adjustment of both, you need to manually adjust the radiofrequency ablation range adjustment pusher 209 and the cryoablation range adjustment pusher 210 simultaneously.

[0066] A cryo-radiofrequency ablation needle system includes a cryo-radiofrequency ablation needle, a cryo-ablation module, a radiofrequency ablation module, a rewarming module, and a control center. The control center controls the opening, closing, and mode switching of the cryo-ablation module, radiofrequency ablation module, and rewarming module, enabling single-module operation or multi-module operation in a preset sequence. Medical personnel can select appropriate surgical plans according to actual needs. The cryo-ablation module uses high-pressure gas as its gas source, and the gas source also provides a cooling medium for the radiofrequency ablation module. The cryo-ablation module includes a pressure proportional solenoid valve with temperature control function, which receives temperature feedback signals and adjusts the gas source pressure to achieve stable temperature control of the radiofrequency ablation module. The radiofrequency ablation module includes a radiofrequency transmitting device, a temperature detector, and a temperature control structure located at the probe head. The temperature detector detects the real-time temperature of the probe head and feeds it back to the temperature control structure. The temperature control structure switches the cryo-ablation module to a cooling function module based on the temperature signal to balance the radiofrequency energy.

[0067] Traditional radio frequency ablation may use water cooling or air cooling, but this system design uses the same air source, which simplifies the system structure and improves the utilization of the air source / cooling source.

[0068] In this embodiment, Figure 2: Schematic diagram of the cryoablation module; The cryoablation module also includes a solenoid valve II in this embodiment, a flow proportional valve, and a precooling device; When the control center activates the cryoablation module, the gas source is input to the solenoid valve II in this embodiment at a pressure of P1, and is adjusted to the required gas pressure for cryoablation, P2, by the flow proportional valve, and then flows sequentially through the precooling device and the probe tip to realize the cryoablation operation; When the control center activates the radio frequency ablation module, the cryoablation module switches to a cooling function module, the gas source is input to the solenoid valve II in this embodiment at a pressure of P2, and is adjusted to a pressure of P3, where P3 < P2, and the output pressure of the pressure proportional valve is controlled by the real-time temperature signal T2 fed back by the temperature detector in this embodiment to achieve dynamic adjustment to balance the radio frequency energy.

[0069] In this embodiment, Figure 4 The diagram illustrates the principle of the rewarming module. This module assists in the rapid rewarming of tissue after the cryoablation module is completed, shortening the time required to switch from cryoablation to radiofrequency ablation. When the control center activates the rewarming module, both the cryoablation and radiofrequency ablation modules cease operation. This function primarily assists in the rapid rewarming of tissue after the cryoablation module is completed. This function can be used in conjunction with cryoablation. Furthermore, it is known that after freezing tissue, it is difficult to reach the conditions for radiofrequency ablation in a short time (e.g., the impedance value is too high), necessitating rapid thawing. Therefore, the use of this function can help shorten the time required to switch from cold ablation to hot ablation, improving surgical efficiency.

[0070] In this embodiment, the radiofrequency ablation module further includes a radiofrequency ablation cable 207 and a radiofrequency ablation cable sheath fixing device 208; the radiofrequency ablation cable 207 is used to provide radiofrequency energy, and its end is fixed to the proximal end of the needle sheath 101 through the radiofrequency ablation cable sheath fixing device 208 to realize the circuit conduction between the radiofrequency ablation cable 207 and the needle sheath 101; the insulating tube 102 is located at the distal end of the needle sheath 101 and is not connected to the radiofrequency ablation cable sheath fixing device 208, so as to facilitate the sliding adjustment of the insulating tube 102.

[0071] This invention utilizes high-pressure nitrogen throttling cryotherapy as the freezing mode, eliminating the need to consider the insulation characteristics of all pipelines, only the pressure resistance and local insulation of the pipelines and connectors. Simultaneously, a rewarming module and a radiofrequency ablation module are added to the cryoablation probe, enabling central control switching of these three modules. The rewarming module can be used independently with the cryoablation module or as a switching medium between the cryoablation and radiofrequency ablation modules. This module significantly improves the speed of switching from the cryoablation to the radiofrequency module, resulting in a shorter switching time compared to commercially available methods, thus enhancing surgical efficiency. By adding a pressure proportional valve with temperature feedback control, radiofrequency ablation can be achieved at a lower pressure gas source than cryoablation, while ensuring cooling circulation (gas cooling) for the radiofrequency probe. Temperature monitoring and feedback in the ablation module are among the core aspects of this control module. Selecting accurate acquisition points and achieving effective closed-loop control from ablation temperature to cooling gas source inlet pressure is a key challenge and pain point in this technology. This invention proposes three design schemes based on experiments and comparisons of multiple test results, analyzing and elaborating on each, and optimizing the relevant structures. These three methods can be used individually or combined to achieve multi-angle temperature monitoring and mutual complementarity, significantly improving the performance of temperature feedback control. This invention adds a synchronous and asynchronous adjustable function for cryoablation and radiofrequency ablation to the probe tip. This function allows for effective and precise regional adjustment of the radiofrequency target area, effectively helping users set the ablation target area. This invention truly achieves an integrated cryo-thermal design, fundamentally solving the shortcomings of single ablation modes, and truly realizing the multi-functional use and flexibility of a single gas source, improving the convenience and safety of surgery.

[0072] The above description is merely an embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principle of the present invention should be included within the scope of the claims of the present invention.

Claims

1. A cryoradiofrequency ablation needle, characterized in that, It includes a needle part (1), an adjusting handle part (2), a delivery tube part (3), a quick connector part (4), a rewarming temperature measurement and ablation plug part (5), and a radiofrequency ablation plug part (6); the needle part (1) is used to act on the target position of the human body and has both freezing and radiofrequency ablation functions; the adjusting handle part (2) is used to adjust the range of the freezing target area and the radiofrequency target area of ​​the needle part (1); the delivery tube part (3) is used to deliver electrical signals and gas; the quick connector part (4) is used to connect the equipment to realize the entry and exit of high-pressure gas; the rewarming temperature measurement and ablation plug part (5) and the radiofrequency ablation plug part (6) are used to connect the equipment to realize the transmission of temperature signals and radiofrequency energy.

2. The cryoradiotherapy needle according to claim 1, characterized in that: The needle portion (1) includes a needle sheath (101), an insulating tube (102), an adjustable vacuum wall tube (103), a needle tip cap (104), and a temperature-measuring thermocouple (105). The insulating tube (102) is entirely wrapped around the needle sheath (101) and can slide along the needle sheath (101). The adjustable vacuum wall tube (103) is located inside the needle sheath (101) for vacuum insulation and gas transport, and can slide along the inside of the needle sheath (101). The needle tip cap (104) is located at the distal end of the needle sheath (101). (105) is a T-type thermocouple. The temperature measuring thermocouple (105) is located in the transition area between the insulating tube (102) and the needle sheath (101). The insulating tube (102) has a double-layer structure, including an inner insulating tube (1021) and an outer insulating tube (1022). The temperature measuring thermocouple (105) is located in the interlayer between the inner insulating tube (1021) and the outer insulating tube (1022), and the outer insulating tube (1022) protrudes slightly from the inner insulating tube (1021), so that the temperature measuring point of the temperature measuring thermocouple (105) is buried under the outer insulating tube (1022).

3. The cryoradiofrequency ablation needle according to claim 2, characterized in that: The adjustment handle part (2) is a synchronous adjustment handle, including a left outer shell (201), an adjustment push handle (202), a front rubber seal (203), a rear rubber seal (204), and an internal plastic fixing part (205); the left outer shell (201) of the handle is provided with a range scale, a front sliding groove, and a rear sliding groove; the front rubber seal (203) is used to seal the gap between the needle sheath tube (101) and the adjustable vacuum wall tube (103), and the rear rubber seal (204) is used to seal the gap between the vacuum wall structure in the internal plastic fixing part (205) of the handle and the adjustable vacuum wall tube (103); when the adjustment push handle (202) is pushed, the front fixing structure (2022) and the rear fixing structure (2023) of the push handle slide along the front sliding groove and the rear sliding groove, driving the insulating tube (102) and the adjustable vacuum wall tube (103) to move synchronously, so as to realize the synchronous adjustment of the cryo-targeting area and the radio frequency targeting area.

4. The cryoradiofrequency ablation needle according to claim 3, characterized in that: The adjusting push handle (202) is provided with a scale protrusion (2021) at the front end of the adjusting push handle, a front end fixing structure (2022) and a rear end fixing structure (2023). The front end fixing structure (2022) is fixed to the near end of the insulating tube (102), and the rear end fixing structure (2023) is fixed to the near end of the adjustable vacuum wall tube (103). The front end fixing structure (2022) and the rear end fixing structure (2023) are mechanically integrated.

5. The cryoradiofrequency ablation needle according to claim 4, characterized in that: The adjustment handle part (2) is a multi-functional adjustment handle, including a left outer shell (201), a right outer shell (206), a radiofrequency ablation range adjustment push handle (209), a cryoablation range adjustment push handle (210), a synchronization lock button (211), a transmission gear (212), and a locking button gear (2111); the left outer shell (201) of the handle is provided with a range scale, a synchronization lock left shell mark (2014), and a reserved hole; the right outer shell (206) of the handle is provided with a range scale, a synchronization lock right shell mark (2062), and a reserved hole; the radiofrequency ablation range adjustment push handle (209) is provided with a radiofrequency ablation push handle fixing structure (2092) and a radiofrequency ablation push handle rack (2091); the radiofrequency ablation push handle... The fixed structure (2092) is fixed to the near end of the insulating tube (102); the cryoablation range adjustment push handle (210) is provided with a cryoablation push handle fixing structure (2102) and a cryoablation push handle rack (2101), and the cryoablation push handle fixing structure (2102) is fixed to the near end of the adjustable vacuum wall tube (103); the transmission gear (212) is fixed to the right outer shell (206) of the handle and can rotate freely, and the transmission gear (212) meshes with the cryoablation push handle rack (2101); the locking button gear (2111) is fixed to the synchronous locking button (211) and can rotate freely, and the locking button gear (2111) can mesh with the transmission gear (212) and the radiofrequency ablation push handle rack (2091).

6. The cryoradiotherapy needle according to claim 5, characterized in that: The needle sheath (101) has a slotted opening at the corresponding position of the transition area between the insulating tube (102) and the needle sheath (101).

7. A cryoradiofrequency ablation needle system, characterized in that: The cryoablation needle according to any one of claims 1-6 further includes a cryoablation module, a radiofrequency ablation module, a rewarming module, and a control center; the control center is used to control the opening, closing, and mode switching of the cryoablation module, the radiofrequency ablation module, and the rewarming module, enabling single-module operation or multi-module joint operation in a preset order; the cryoablation module uses high-pressure gas as a gas source, and the gas source also provides a cooling medium for the radiofrequency ablation module; the cryoablation module includes a pressure proportional solenoid valve with temperature control function, the pressure proportional solenoid valve is used to receive temperature feedback signals and adjust the gas source pressure to achieve stable temperature control of the radiofrequency ablation module; the radiofrequency ablation module includes a radiofrequency transmitting device, a temperature detector, and a temperature control structure disposed on the probe head; the temperature detector is used to detect the real-time temperature of the probe head and feed it back to the temperature control structure; the temperature control structure adjusts the cryoablation module to switch to a cooling function module according to the temperature signal to balance the radiofrequency energy.

8. The cryoradiotherapy needle according to claim 7, characterized in that: The cryoablation module also includes a solenoid valve (II) in this embodiment, a flow proportional valve, and a precooling device. When the control center activates the cryoablation module, the gas source is input at pressure P1 via the solenoid valve (II) in this embodiment, and then adjusted to the required gas pressure P2 for cryoablation via the flow proportional valve. The gas then flows sequentially through the precooling device and the probe tip to achieve the cryoablation operation. When the control center activates the radio frequency ablation module, the cryoablation module switches to a cooling function module. The gas source is input at pressure P2 via the solenoid valve (II) in this embodiment, and then adjusted to pressure P3 via the pressure proportional valve, where P3 < P2. The output pressure of the pressure proportional valve is controlled by the real-time temperature signal T2 fed back from the temperature detector in this embodiment, achieving dynamic adjustment to balance the radio frequency energy.

9. A cryoradiotherapy needle according to claim 8, characterized in that: The rewarming module is used to assist in rapid tissue rewarming after the cryoablation module ends, shortening the time for switching from cryoablation mode to radiofrequency ablation mode; when the control center starts the rewarming module, the cryoablation module and the radiofrequency ablation module stop operating.

10. A cryoradiotherapy needle and system according to claim 9, characterized in that: The radiofrequency ablation module also includes a radiofrequency ablation cable (207) and a radiofrequency ablation cable sheath fixing device (208); the radiofrequency ablation cable (207) is used to provide radiofrequency energy, and its end is fixed to the proximal end of the needle sheath (101) through the radiofrequency ablation cable sheath fixing device (208) to realize the circuit conduction between the radiofrequency ablation cable (207) and the needle sheath (101); the insulating tube (102) is located at the distal end of the needle sheath (101) and is not connected to the radiofrequency ablation cable sheath fixing device (208) to facilitate the sliding adjustment of the insulating tube (102).

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