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 connected to the adjusting handle part, and the delivery pipe part is connected to the radiofrequency ablation plug part; the adjusting handle part is used for connecting the needle head part and the conveying pipe part, the quick connector part is connected to the conveying pipe part, and the rewarming temperature measurement ablation plug part is connected with the radio frequency ablation plug part. On the basis of a cryoablation probe of a high-pressure nitrogen throttling freezing technology, the rewarming module and the radio frequency ablation module are added, central control switching of the three modules is achieved, the integrated structure design of the freezing module, the rewarming module and the radio frequency module is achieved, the integrated structure can be used in a multi-module combined mode and can also be used independently, and the cost is reduced. The cold ablation function and the thermal ablation function are mutually complemented.

Description

Technical Field

[0001] This invention belongs to the field of cryoablation technology, and particularly relates to a cryoradioablation 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. Summary of the Invention

[0004] This invention provides a cryoradioablation needle and system to solve the problems in the prior art.

[0005] 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 and temperature-measuring ablation plug, and a radiofrequency ablation plug. The needle tip is connected to the adjusting handle and, when applied to a target location on the patient's body, can simultaneously perform cryo-ablation and radiofrequency ablation functions. The adjusting handle connects the needle tip and the delivery tube. The delivery tube is used for long-distance delivery, primarily for the delivery and protection of electrical signals and gases. The quick connector is connected to the delivery tube and connects to a gas source to enable the entry and exit of high-pressure gas. The rewarming and temperature-measuring ablation plug is connected to the radiofrequency ablation plug for transmitting temperature and radiofrequency energy information.

[0006] Furthermore, the needle portion includes a needle sheath, an insulating tube, and an adjustable vacuum wall. The needle sheath is wrapped inside the insulating tube, and the insulating tube is entirely wrapped around the needle sheath and can slide along the needle sheath. The adjustable vacuum wall, as part of the vacuum insulation and gas delivery, is wrapped by the needle sheath and can slide inside the needle sheath.

[0007] Furthermore, the adjustment handle includes a left outer shell of the handle, a right outer shell of the handle, an adjustment push handle, and a radiofrequency ablation cable. The adjustment push handle is slidably connected to the left outer shell of the handle. The radiofrequency ablation cable is provided with a radiofrequency ablation cable sheath fixing device. The radiofrequency ablation cable provides the source of radiofrequency ablation energy and is fixed at its end to the proximal end of the needle sheath by the radiofrequency ablation cable sheath fixing device.

[0008] Furthermore, the adjustment gap between the needle sheath and the adjustable vacuum wall is sealed by a front rubber seal. The right and left outer shells of the handle are provided with an internal plastic fixing component. The gap between the vacuum wall structure inside the sealed internal plastic fixing component and the adjustable vacuum wall is provided with a rear rubber seal.

[0009] Furthermore, the left outer shell of the handle is provided with a range scale for the left outer shell of the handle.

[0010] Furthermore, the proximal end of the adjustable vacuum wall is fixedly connected to a push handle rear end fixing structure, and the left outer shell of the handle is designed with connecting ribs and sliding grooves to assist in fixing and adjusting the sliding of the push handle. The proximal end of the insulating tube is fixedly connected to a push handle front end fixing structure, and the push handle front end fixing structure, the insulating tube, the push handle rear end fixing structure, and the adjustable vacuum wall are fixed by adhesive bonding.

[0011] Furthermore, the sliding groove includes a front sliding groove for the left outer shell of the handle and a rear sliding groove for the left outer shell of the handle. The front sliding groove for the left outer shell of the handle and the rear sliding groove for the left outer shell of the handle serve as a slide rail structure, which facilitates the sliding of the protruding structures of the front fixing structure and the rear fixing structure of the push handle along the needle tube direction.

[0012] Furthermore, the front end of the adjustment push handle is designed with a scale protrusion structure, and the adjustment push handle is respectively provided with a radiofrequency ablation range adjustment push handle and a cryoablation range adjustment push handle.

[0013] Furthermore, the right outer shell of the handle is provided with a range scale for the right outer shell of the handle, a synchronization lock button, and a synchronization lock right outer shell mark.

[0014] Furthermore, the left outer shell of the handle is provided with a synchronization lock button and a synchronization lock left shell mark.

[0015] Furthermore, the insulating tube is fixed to the radiofrequency ablation pusher fixing structure of the radiofrequency ablation range adjustment pusher, and the adjustable vacuum wall is fixed to the cryoablation pusher fixing structure of the cryoablation range adjustment pusher.

[0016] Furthermore, the radiofrequency ablation range adjustment push handle is equipped with a radiofrequency ablation push handle rack, the cryoablation range adjustment push handle is equipped with a cryoablation push handle rack, and the right outer shell of the handle is equipped with a transmission gear serving as a fixed gear, the transmission gear meshing with the cryoablation push handle rack.

[0017] Furthermore, the synchronous locking button is provided with a locking button gear, which can rotate freely on the synchronous locking button, but cannot move along the adjustment direction of the synchronous locking button. The locking button gear can mesh with the transmission gear and the radiofrequency ablation pusher rack.

[0018] Furthermore, the insulating tube is selected from PI tubes.

[0019] A cryo-radiofrequency ablation needle system includes a cryo-radiofrequency ablation needle, a cryo-ablation module, a radiofrequency ablation module, and a rewarming module, wherein the cryo-ablation module, the radiofrequency ablation module, and the rewarming module can be freely switched through a control center.

[0020] The above-described at least one technical solution adopted in the embodiments of the present invention can achieve the following beneficial effects:

[0021] (1) By adding a rewarming module and a radiofrequency ablation module based on the cryoablation probe of high-pressure nitrogen throttling freezing technology, the central control switching of the three modules is realized, and the integrated structure design of cryoablation module + rewarming module + radiofrequency module is realized. This integrated structure can be used in combination with multiple modules or independently, and the functions of cold ablation and hot ablation are mutually complementary.

[0022] (2) 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 and cannot be effectively performed, it is generally necessary to wait for a long natural rewarming period before radiofrequency ablation can be performed. The introduced rewarming module relies on thermocouple heating to reach a high temperature in a short time, so that the target frozen tissue can melt and rewarm quickly to meet the conditions for radiofrequency ablation, thereby greatly shortening the time to switch from cryoablation to radiofrequency ablation and improving surgical efficiency.

[0023] (3) By introducing the original high-pressure nitrogen gas as a cooling circulation medium into the radio frequency module, this medium is shared with the gas source of the freezing module, which not only satisfies the effective control of excessive temperature during the radio frequency ablation process, but also improves the effective utilization of the same gas source, thus simplifying the structure of the freezing radio frequency ablation needle.

[0024] (4) By introducing a pressure proportional valve solenoid valve + 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 tissue, and excessively low temperatures can affect ablation efficiency, this type of temperature controller with feedback mechanism is needed.

[0025] The temperature control system enables dynamic control of the thermal ablation cooling cycle system, ensuring the stability of thermal ablation. (5) By introducing an adjustable insulating tube structure and an adjustable vacuum wall structure, the adjustable insulating tube structure is used to adjust the target of radiofrequency ablation.

[0026] The adjustable vacuum wall structure is used to adjust the target area for cryoablation, thus ensuring that both radiofrequency ablation and cryoablation are adjustable. Since the adjustable vacuum wall structure has been described in our earlier patents, details will not be repeated here.

[0027] (6) By adding an adjustable range on the handle, the target areas for cryoablation and radiofrequency ablation become visible, thus achieving precise control of the target areas for cryoablation and radiofrequency ablation.

[0028] (7) By designing a single adjustment push handle integrated design structure above the handle, the target areas of cryoablation and radiofrequency ablation are consistent. For the same target area, the structures of cold ablation and thermal ablation are completely overlapped, which replaces the problem that the original multi-needle ablation scheme is difficult to achieve physical structure overlap. Attached Figure Description

[0029] 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:

[0030] Figure 1 : A schematic diagram of a cryoradiofrequency ablation needle system;

[0031] Figure 2 A schematic diagram of a cryoablation module for a cryoradioablation needle;

[0032] Figure 3 A schematic diagram of a cryoablation needle radiofrequency ablation module;

[0033] Figure 4 : A schematic diagram of a cryo-radiofrequency ablation needle rewarming module;

[0034] Figure 5 : A structural diagram of a synchronously adjustable cryoradiofrequency ablation needle;

[0035] Figure 6 Diagram of the internal structure of the synchronous adjustment handle and head;

[0036] Figure 7 Diagram of the internal structure of the synchronous adjustment handle;

[0037] Figure 8a : Diagram showing the maximum range of the synchronous adjustment handle function;

[0038] Figure 8b : Schematic diagram of the minimum range of the synchronous adjustment handle function;

[0039] Figure 9 : A structural diagram of a multifunctional adjustable cryoablation needle;

[0040] Figure 10 : Multifunctional adjustment handle and right side structure diagram of the head;

[0041] Figure 11 : Multifunctional adjustment handle and left side structure diagram of the head;

[0042] Figure 12 Internal structure diagram of the multi-functional adjustment handle;

[0043] Figure 13 : Synchronous adjustment structure diagram of the multi-functional adjustment handle;

[0044] Figure 14 Diagram of the split-type adjustment structure of the multi-functional adjustment handle;

[0045] Figure label:

[0046] Needle part 1: needle sheath 101, 102, adjustable vacuum wall 103;

[0047] Adjustment handle part 2: Left outer shell of the handle 201, range scale of the left outer shell of the handle 2011, front sliding groove of the left outer shell of the handle 2012, rear sliding groove of the left outer shell of the handle 2013, synchronous locking mark of the left outer shell 2014, adjustment push handle 202, scale protrusion at the front of the adjustment push handle 2021, front fixing structure of the push handle 2022, rear fixing structure of the push handle 2023, front rubber seal 203, rear rubber seal 204, internal plastic fixing part of the handle 205, right outer shell of the handle 206 The following components are included: a right outer shell of the handle with a range scale 2061, a right outer shell of the synchronous locking device 2062, a radiofrequency ablation cable 207, a radiofrequency ablation cable sheath fixing device 208, a radiofrequency ablation range adjustment push handle 209, a radiofrequency ablation push handle rack 2091, a radiofrequency ablation push handle fixing structure 2092, a cryoablation range adjustment push handle 210, a cryoablation push handle rack 2101, a cryoablation push handle fixing structure 2102, a synchronous locking button 211, a locking button gear 2111, and a transmission gear 212.

[0048] Delivery pipe section 3;

[0049] Quick connector part 4;

[0050] Part 5 of the reheat temperature measurement and ablation plug;

[0051] Radiofrequency ablation connector part 6; Detailed Implementation

[0052] 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.

[0053] 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.

[0054] Reference Figures 1 to 14As shown, this embodiment of the invention provides a cryo-radiofrequency ablation needle, including a needle tip, an adjusting handle, a delivery tube, a quick connector, a rewarming and temperature-measuring ablation plug, and a radiofrequency ablation plug. The needle tip is connected to the adjusting handle and can perform both cryo- and radiofrequency ablation functions when applied to a target location on the patient's body. The adjusting handle connects the needle tip and the delivery tube. The delivery tube is used for long-distance delivery, primarily for the transmission and protection of electrical signals and gases. The quick connector is connected to the delivery tube and connects to a gas source to allow the entry and exit of high-pressure gas. The rewarming and temperature-measuring ablation plug is connected to the radiofrequency ablation plug for transmitting temperature and radiofrequency energy information.

[0055] like Figure 6 The diagram shows the internal structure of the synchronous adjustment handle and head. The adjustment handle part 2 connects the needle part 1 and the delivery tube part 3. The needle sheath 101 connects to and extends into the left outer shell 201 of the handle, is fixed to the front rubber seal 203, and is encased inside the insulating tube 102102. The front rubber seal 203 seals the adjustment gap between the needle sheath 101 and the adjustable vacuum wall 103. The rear rubber seal 204 seals the gap between the vacuum wall structure inside the plastic fixing piece 205 of the handle and the adjustable vacuum wall 103. The range scale 2011 on the left outer shell of the handle displays the range of the adjustment push handle 202 sliding on the left outer shell 201 of the handle. The radio frequency ablation cable 207 provides the energy source for radio frequency ablation and is fixed at its end to the proximal end of the needle sheath 101 by the radio frequency ablation cable sheath fixing device 208. The fixing method can be elastic clamps or soldering, etc., to realize the circuit conduction function between the radio frequency ablation cable 207 and the needle sheath 101. The part of the insulating tube 102102 located near the distal end of the needle sheath 101 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 102102 on the needle sheath 101.

[0056] Figure 7 :like Figure 7As shown, the insulating tube 102102 is entirely wrapped around the needle sheath 101 and can slide along the needle sheath 101. The proximal end of the insulating tube 102102 is fixed to the front end fixing structure 2022 of the push handle. The adjustable vacuum wall 103, as part of the vacuum insulation and gas delivery, is wrapped around the needle sheath 101 and can slide inside the needle sheath 101. The proximal end of the adjustable vacuum wall 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 end sliding groove 2012 and the rear end sliding groove 2013 of the left outer shell of the handle) to assist in fixing and adjusting the sliding of the push handle 202. The front end fixing structure 2022 of the push handle and the insulating tube 102102, and the rear end fixing structure 2023 of the push handle and the adjustable vacuum wall 103 can be fixed by adhesive. Before assembly, they need to be fixed according to the required distance of the target area. When the adjusting handle 202 is pushed, since the front fixing structure 2022 and the rear fixing structure 2023 of the handle are a single mechanical structure, the insulating tube 102102 and the adjustable vacuum wall 103 structure can move synchronously, thus achieving synchronous adjustment. The front end of the adjusting handle 202 is designed with a scale protrusion 2021. When this protrusion aligns 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 adjusting handle 202. Based on the corresponding scale displayed on the left outer shell 201 of the handle, the minimum and maximum ranges can be adjusted. (Refer to...) Figure 8a and Figure 8b The diagram illustrates the adjustment effect.

[0057] Figures 8a-8b : Figure 8a To synchronize the maximum range L1 of the handle function, Figure 8b To synchronize the adjustment of the handle's minimum range L2, this invention recommends using a range increment of 5mm. The maximum and minimum ranges can be set from 10mm to 30mm according to actual needs, but practical use is not limited to this range. Furthermore, for ease of adjustment and fixation, the inner cavity of the left outer shell 201 of the handle is fitted with the needle sheath 101, a front rubber seal 203, a rear rubber seal 204, and a corresponding fixing structure is designed for the internal plastic fixing component 205 of the handle. The front sliding groove 2012 and rear sliding groove 2013 of the left outer shell of the handle serve as a slide rail structure, facilitating the sliding of the protruding structures of the front fixing structure 2022 and the rear fixing structure 2023 of the push handle along the needle tube direction. The right outer shell 206 and the left outer shell 201 of the handle together form the product handle structure.

[0058] Figure 9 A structural diagram of a multifunctional adjustable cryoablation needle, wherein the structure, except for the handle part 2, is similar to... Figure 5Same as before. The structure and function of each part are consistent with the former. Below, we will mainly introduce the main functions of handle part 2.

[0059] 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 features a range scale 2061 display and a corresponding slide groove. A synchronous locking button 211 has a pre-drilled hole for locking, and a synchronous locking label 2062 on the right outer shell indicates the locking and unlocking functions. Compared to the single button in structure 202, this invention designs two buttons: a radiofrequency ablation range adjustment push handle 209 and a cryoablation range adjustment push handle 210, used to adjust the radiofrequency ablation area and the cryoablation area respectively.

[0060] Figures 11-13 The diagram shows the structure of the multi-functional adjustment handle and the left side of the head. The left outer shell 201 of the handle has a pre-drilled hole for the synchronous locking button 211, and a synchronous locking left shell label 2014 is added next to it to indicate the locking and unlocking functions. The adjustment range of the radiofrequency ablation range adjustment push handle 209 is displayed on the left outer shell 201 of the handle (range scale 2011). The synchronous locking button 211 is adjustable at the corresponding hole positions on the left outer shell 201 and the right outer shell 206 of the handle, and its adjustment status is indicated by the synchronous locking left shell label 2014 and synchronous locking right shell label 2062.

[0061] Figure 12 The internal structure of the multi-functional adjustment handle is similar to the former design. The insulating tube 102102 is fixed to the radiofrequency ablation pusher fixing structure 2092 of the radiofrequency ablation range adjustment pusher 209, and the adjustable vacuum wall 103 is fixed to the cryoablation pusher fixing structure 2102 of the cryoablation range adjustment pusher 210. The fixing method can be adhesive. In order to meet the separate adjustment functions of 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. The transmission gear 212 is fixed to the right outer casing 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 move 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. In this invention, the tooth structure of the gear and rack must meet the meshing standard requirements, and the gear and rack should be selected with the same specifications as much as possible, which facilitates the synchronous transmission between gears and between gears and racks. Figure 13As shown, when the protruding structure on one side of the right outer shell 206 of the handle is pressed to synchronously lock the button 211 to its 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 a 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 (e.g., 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, thus the function of synchronously adjusting the radiofrequency ablation range or the cryoablation range can meet the requirements. Figure 14 As shown, when the protrusion structure on one side of the left outer shell 201 of the handle is pressed to lock the button 211 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 at the same time.

[0062] Specifically, the insulating tube 102102 can be a PI tube. To facilitate adjustment, the PI tube and the sheath tube at the head end are loosely fitted with a small tolerance. Generally, a single-sided tolerance of 0.01-0.02 is recommended.

[0063] A cryo-radiofrequency ablation needle system includes a cryo-radiofrequency ablation needle. This system is designed with three modules: a cryo-ablation module, a radiofrequency ablation module, and a rewarming module. These modules can be freely switched via a control center, allowing for both combined and individual use. Medical personnel can select the appropriate surgical plan according to actual needs. In this embodiment, the cryo-ablation module, rewarming module, and radiofrequency ablation module are recommended to be used sequentially. This system uses high-pressure gas as the gas source for cryo-ablation surgery. This gas source is controlled and regulated by a solenoid valve. Specifically, the cryo-ablation module incorporates a pressure proportional solenoid valve with temperature control, enabling temperature signal regulation and ensuring stable control of the radiofrequency ablation module. While traditional radiofrequency ablation may use water cooling or air cooling, this system design utilizes a single gas source, simplifying the system structure and improving the utilization of the gas / cold source.

[0064] Figure 2 : The schematic diagram of the cryoablation module is as shown in Figure 2 . When the control center activates the cryoablation module, the gas source inputs a pressure of P1 through solenoid valve II. After passing through the flow proportional valve, it meets the cryoablation air pressure usage condition P2. At this time, the gas source reaches the probe tip after passing through the precooling device and performs cryoablation operations.

[0065] Figure 3 : The schematic diagram of the radiofrequency ablation module is as shown in Figure 3 . When the control center activates the radiofrequency ablation module, the radiofrequency transmitting device generates radiofrequency energy information at the probe head, causing a local temperature increase in the tissue to achieve thermal ablation. If the temperature continues to rise, it will inevitably cause risks such as excessive temperature resulting in tissue damage or even carbonization. Therefore, we connect a detector outside the probe head and a temperature control structure in the system to detect and feedback real-time temperature signals. At this time, the original cryoablation module becomes a cooling function module to balance the radiofrequency energy. When using this function, the gas source input pressure remains P2 after passing through solenoid valve II and is adjusted to P3 after passing through the pressure proportional valve. It is known that P3 < P2, and the pressure output of P3 needs to be controlled and adjusted by the feedback temperature signal T2 to meet the dynamic adjustment function, ultimately achieving a stable balance under the radiofrequency function module.

[0066] Figure 4 : The schematic diagram of the rewarming module is as shown in Figure 4 . When the control center activates the rewarming module, the cryoablation module and the rewarming module stop. At this time, it mainly helps the tissue to quickly rewarm after the cryoablation module ends. This function can be used in conjunction with cryoablation. At the same time, we know that after freezing the tissue first, it is difficult to reach the radiofrequency ablation conditions (such as too high impedance value) in a short time and the tissue needs to be thawed as soon as possible. Therefore, the use of this function can help shorten the time from cryoablation to thermal ablation and improve the surgical efficiency.

[0067] It should be noted that

[0068] The integrated push handle structure can be integrally formed by injection molding. This structure has two front and rear hole positions, and the two hole positions must be coaxial, which are respectively used to connect and fix the adjustable insulating tube 102 and the adjustable vacuum wall structure. The fixing method of this structure can be adhesive bonding or integral molding.

[0069] To facilitate the smooth sliding of the integrated push handle structure, corresponding chute structures need to be designed on the left and right outer shell structures of the handle to limit the sliding area and avoid problems such as unstable sliding of the overall adjustment structure or exceeding the adjustment range.

[0070] In another embodiment, two adjustment handles 202 are added to the top and side of the handle. The upper handle controls the adjustment range of radiofrequency ablation, and the side handle controls the adjustment range of cryoablation, which makes the adjustment more flexible and allows the user to use it more flexibly in actual operation.

[0071] In another embodiment, a synchronous locking mechanism is added to the side of the handle. This locking mechanism itself has a gear, and locking is achieved by the meshing of the upper and lower gears. Both the upper push handle and the side push handle have a matching rack structure. An additional fixed gear is added to the inside of the handle. When the gear on the locking mechanism is pushed forward, the gear on the locking structure connects with the fixed gear and the rack structure on the two push handles. At this time, the entire gear and rack mechanism is mechanically connected, achieving mutual meshing and realizing the synchronous forward or backward movement of the two push handles. When the gear on the locking mechanism is disengaged, the gear and rack are disconnected, and the two adjusting push handles 202 are disconnected to form a separate adjustment state.

[0072] The left and right handle shells of the multi-functional handle are designed with corresponding structural through holes to facilitate the assembly of the synchronous locking mechanism. To prevent accidental operation, press status indicators should be designed near the holes on both sides of the multi-functional handle.

[0073] Pinch method: The synchronous locking mechanism adopts an integrated design with round ends and a rotatable gear in the middle. It works with the left and right handle shells to form a limit. Press the button on the side closer to the gear to lock, and press the button on the side farther away from the gear to release the lock.

[0074] Pinch method: The synchronous locking mechanism needs to limit the gear. This gear is generally not centered and needs to be close to the fixed gear on the handle shell for easy locking and adjustment. The gear can only rotate in a direction perpendicular to the axis and cannot have significant displacement or sliding along the axis. The diameter of the gear is larger than the diameter of the round hole in the handle shell and forms a limit.

[0075] Squeezing method: The synchronous locking mechanism involved in this invention can be circular, but is not limited to a square or other regular polygonal structure. The left and right outer shells of the handle that cooperate with it need to have holes of corresponding shapes. The inner side of the synchronous locking mechanism generally adopts double-sided limiting, which can prevent problems such as gear damage or improper adjustment caused by excessive pressing.

[0076] The connection and fixing method between the adjusting push handle 202 and the insulating tube 102, and between the adjusting push handle 202 and the adjustable vacuum wall, can be adhesive bonding or integral molding.

[0077] 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, The device includes a needle part (1), an adjustment handle part (2), a delivery tube part (3), a quick connector part (4), a rewarming and temperature measurement ablation plug part (5), and a radiofrequency ablation plug part (6). The needle part (1) is connected to the adjustment handle part (2), and the needle part (1) can perform both freezing and radiofrequency ablation functions when applied to the target position on the patient's body. The adjustment handle part (2) is used to connect the needle part (1) and the delivery tube part (3). The delivery tube part (3) is used for long-distance delivery, mainly for the delivery and protection of electrical signals and gases. The quick connector part (4) is connected to the delivery tube part (3) and is used to connect the gas source to realize the entry and exit of high-pressure gas. The rewarming and temperature measurement ablation plug part (5) is connected to the radiofrequency ablation plug part (6) and is used to realize the transmission of temperature and radiofrequency energy information.

2. The cryoradiotherapy needle according to claim 1, characterized in that: The needle portion (1) includes a needle sheath (101), an insulating tube (102), and an adjustable vacuum wall (103). The needle sheath (101) is wrapped inside the insulating tube (102). The insulating tube (102) is entirely wrapped around the needle sheath (101) and can slide along the needle sheath (101). The adjustable vacuum wall (103), as part of vacuum insulation and gas delivery, is wrapped around the needle sheath (101) and can slide inside the needle sheath (101).

3. The cryoradiofrequency ablation needle according to claim 2, characterized in that: The adjustment handle part (2) includes a left handle housing (201), a right handle housing (206), an adjustment push handle (202), and a radiofrequency ablation cable (207). The adjustment push handle (202) is slidably connected to the left handle housing (201). The radiofrequency ablation cable (207) is provided with a radiofrequency ablation cable sheath fixing device (208). The radiofrequency ablation cable (207) provides a source of radiofrequency ablation energy and is fixed at its end to the proximal end of the needle sheath (101) by the radiofrequency ablation cable sheath fixing device (208).

4. The cryoradiofrequency ablation needle according to claim 3, characterized in that: The adjustment gap between the needle sheath (101) and the adjustable vacuum wall (103) is sealed by the front rubber seal (203). The right outer shell (206) and the left outer shell (201) of the handle are provided with an internal plastic fixing part (205). The gap between the vacuum wall structure inside the sealed internal plastic fixing part (205) and the adjustable vacuum wall is provided with a rear rubber seal (204).

5. The cryoradiofrequency ablation needle according to claim 3, characterized in that: The handle left outer shell (201) is provided with a handle left outer shell range scale (2011).

6. A cryoradiotherapy needle according to claim 3 or 5, characterized in that: The adjustable vacuum wall (103) is fixedly connected to the proximal end of the push handle rear end fixing structure (2023). The left outer shell (201) of the handle is designed with connecting ribs and sliding grooves to assist in fixing and adjusting the sliding of the push handle (202). The proximal end of the insulating tube (102) is fixedly connected to the push handle front end fixing structure (2022). The push handle front end fixing structure (2022), the insulating tube (102), the push handle rear end fixing structure (2023), and the adjustable vacuum wall are fixed by adhesive bonding.

7. The cryoradiofrequency ablation needle and system according to claim 6, characterized in that: The sliding groove includes a front sliding groove (2012) of the left outer shell of the handle and a rear sliding groove (2013) of the left outer shell of the handle. The front sliding groove (2012) and the rear sliding groove (2013) of the left outer shell of the handle serve as a slide rail structure, which facilitates the sliding of the protruding structures of the front fixing structure (2022) and the rear fixing structure (2023) of the push handle along the needle tube direction.

8. The cryoradiotherapy needle according to claim 7, characterized in that: The front end of the adjustment push handle (202) is designed with a scale protrusion (2021) structure. The adjustment push handle (202) is provided with a radiofrequency ablation range adjustment push handle (209) and a cryoablation range adjustment push handle (210). The right outer shell (206) of the handle is provided with a right outer shell range scale (2061), a synchronization lock button (211), and a synchronization lock right shell mark (2062); the left outer shell (201) of the handle is provided with a synchronization lock button (211) and a synchronization lock left shell mark (2014); 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 (103) is fixed to the cold The cryoablation range adjustment push handle (2100) is located at the cryoablation push handle fixing structure (2102); the radiofrequency ablation range adjustment push handle (209) is provided with a radiofrequency ablation push handle rack (2091), the cryoablation range adjustment push handle (210) is provided with a cryoablation push handle rack (2101), and the right outer shell (206) of the handle is provided with a transmission gear (212) as a fixed gear, and the transmission gear (212) meshes with the cryoablation push handle rack (2101).

9. A cryoradiotherapy needle according to claim 8, characterized in that: The synchronous locking button (211) is provided with a locking button gear (2111). The locking button gear (2111) can rotate freely on the synchronous locking button (211), but cannot move along the adjustment direction of the synchronous locking button (211). The locking button gear (2111) can mesh with the transmission gear (212) and the radiofrequency ablation pusher rack (2091). The insulating tube (102) is selected as a PI tube.

10. A cryoradiofrequency ablation needle system, characterized in that: The device includes the cryo-radiofrequency ablation needle as described in any one of claims 1-9, and further includes a cryo-ablation module, a radiofrequency ablation module, and a rewarming module, wherein the cryo-ablation module, the radiofrequency ablation module, and the rewarming module can be freely switched through a control center.

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