Efficient freezing radiofrequency ablation catheter and ablation system

Abstract

The invention discloses an efficient freezing radiofrequency ablation catheter and ablation system, and belongs to the technical field of freezing ablation, the efficient freezing radiofrequency ablation catheter comprises a needle head part, a catheter part, a handle part, a water injection connector part, a catheter extension tube part and a plug assembly; the needle head part is of a metal head structure, and the near end of the needle head part is connected with the inner and outer multilayer structures of the catheter part; the catheter part is of a multi-layer flexible tube structure and is used for connecting the handle part and the needle head part; the handle part is held by a user, the near end of the handle part is connected with the catheter extension tube part and the water injection joint part, and the far end of the handle part is connected with the catheter part; the water injection joint part is used as a water quantity control water inlet; the catheter extension tube part expands the use range; the plug assembly realizes plugging and fixation of a product. The flexible ablation catheter can be widely applied to natural orifice ablation operations and has the advantages of integration of cold and hot ablation design, diversity of ablation application range, high ablation efficiency and the like.

Description

Technical Field

[0001] This invention belongs to the field of cryoablation technology, and particularly relates to a high-efficiency cryoradioablation catheter and ablation system. Background Technology

[0002] Cryotherapy and thermal ablation are two major minimally invasive surgical techniques for tumor treatment. They respectively use "supercooling" or "superheating" to inactivate and disable the target tissue, thereby eliminating tumor cells and achieving the goal of effectively treating patients.

[0003] Cryoablation primarily involves using cryo-instruments to controllably subject lesion tissue to a process of cooling, freezing, and rewarming, thereby causing irreversible damage or 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 toxicity 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. Cryoablation mainly involves freezing the water-containing components of the tissue; tissues with high water content are advantageous in terms of freezing range and cold conduction. Therefore, many doctors inject a certain amount of water into the target tissue area to increase the cryoablation range.

[0004] Direct thermal ablation, exemplified by radiofrequency ablation, is related to the temperature received by the tissue. When the tissue temperature rises to 60°C, the time for irreversible cell damage is significantly shortened. Above 60°C, protein denaturation occurs, and within this temperature range, coagulation necrosis occurs. When the temperature continues to rise to around 100°C, 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 or air cooling). Thermal ablation also typically leads to a decrease in the water content of surrounding tissue, causing increased resistance due to low water content, making further ablation impossible.

[0005] All of the aforementioned ablation procedures are highly dependent on the water content of the target tissue area. In actual ablation procedures, whether cryoablation or radiofrequency ablation, changes in the water content of the target tissue are involved. The amount of water content usually directly affects the ablation range and efficiency; sometimes, excessively low tissue water content may even prevent ablation from proceeding. Human lung tissue is a porous structure with generally low water content. After thermal ablation, it shrinks, forming a dense, eggshell-like structure around the needle tip. This affects the electrical conductivity of radiofrequency ablation, disrupts the matching conditions, and leads to a significant decrease in the performance of the distal part of the ablation catheter when ablating non-solid lung tumors. The impedance value fails to meet requirements, forcing the ablation procedure to be terminated. Generally, during thermal ablation, the tissue water content is highest at the beginning of the ablation process. However, as the ablation time increases, the temperature in the central part of the ablation zone rises above the boiling point of water, causing water vapor to evaporate and reducing the tissue water content. Lung tissue is characterized by high air content and high impedance, which significantly limits the application of ablation techniques (such as radiofrequency ablation and microwave ablation) in the lungs. In the natural cavities of the lungs (bronchioles), the water content is relatively low and uneven. Even if the tracheal wall initially contains some water for ablation, the water content in the bronchi decreases rapidly under thermal ablation, leading to excessively high impedance matching and reduced radiofrequency efficiency. Ultimately, this results in excessively high temperatures, severe damage and deformation of the central tissue structure, making further radiofrequency ablation impossible. Organs with high water content are known to facilitate large-scale ablation, which is beneficial for ablation conduction and improves ablation efficiency.

[0006] Existing technology 110074860A describes a radiofrequency ablation catheter, a lung radiofrequency ablation system, and a control method and device that facilitate heat exchange medium distribution. This invention systematically describes a flexible catheter instrument applicable to the natural cavities of the lungs. During radiofrequency ablation surgery, it can effectively utilize electrodes to infuse physiological saline into the ablated tissue, thereby improving the conductivity and thermal conductivity of the ablated tissue, maintaining impedance balance, and keeping the impedance in a relatively stable state, allowing for continuous output of radiofrequency energy and thus improving radiofrequency ablation efficiency. However, this technology only meets the requirements for radiofrequency ablation, its mode is singular, and even with proper control, it can only meet the conditions for thermal ablation, still failing to effectively solve some of the drawbacks of thermal ablation.

[0007] 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. Meanwhile, the ablation probe used in this probe system is a traditional hard needle structure. Therefore, the original system design is only suitable for percutaneous surgery, which significantly increases the risk of external trauma and pneumothorax bleeding for patients. It is limited compared to flexible catheter products that can pass through natural cavities.

[0008] Therefore, developing a flexible cryo-radiofrequency ablation catheter suitable for use through natural cavities is of great significance and can better expand its practical applications. Summary of the Invention

[0009] This invention provides a high-efficiency cryoradioablation catheter and ablation system to solve the problems in the prior art.

[0010] The present invention employs the following technical solution: a high-efficiency cryoradiofrequency ablation catheter, comprising a needle portion, a catheter portion, a handle portion, a water injection connector portion, a catheter extension tube portion, and a plug assembly; the needle head is a metal head structure containing multiple metal layers internally, serving as a target area for cryotherapy or radiofrequency ablation surgery; the proximal end of the needle portion connects to the multi-layered structure of the catheter portion; the catheter portion is a multi-layered flexible tube structure used to connect the handle portion and the needle portion, transmitting and recovering energy; the handle portion is for the user to hold, the proximal end of the handle portion connects to the catheter extension tube portion and the water injection connector portion, and the distal end of the handle portion connects to the catheter portion; the water injection connector portion serves as a water inlet for controlling water flow to the device; the catheter extension tube portion expands the application range, serving as a heat source or cold source channel; the plug assembly enables product insertion, removal, and fixation.

[0011] Furthermore, the conduit portion includes an outer conduit, an inner conduit, a JT groove, a water injection conduit, a rewarming wire, a temperature measuring wire, and a radio frequency wire; a vacuum layer is formed between the outer conduit and the inner conduit; the JT groove serves as an air intake channel to transport cold air, and forms a return air layer with the inner conduit to discharge refrigerated gas; the water injection conduit transports ablation injection fluid; the radio frequency wire is located between the outer conduit and the inner conduit, and its distal end is welded to the water injection head jacketed tube.

[0012] Furthermore, the needle portion includes an outer blade shell, an inner cap, a water-filled cap jacket, an inner gradient tube, and an embedded tube. The outer blade shell covers the target area on its outermost layer and is connected to the outer conduit at its proximal end. The inner gradient tube is located within the water-filled cap jacket and forms a gap with the embedded tube, connecting to the inner conduit. The water-filled cap jacket has a double-hole structure, separating the needle portion from the conduit portion, ensuring that the water-filled conduit enters the needle portion jacket. The inner cap, the embedded tube, and the inner gradient tube form a sealed space, ensuring air intake and exhaust in the JT tank. A rewarming wire and a temperature measuring wire are fixed on the JT tank and enter the embedded tube through the inner conduit.

[0013] Furthermore, the inner gradient tube of the needle and the inner embedded tube form a metal interlayer at the proximal end to wrap the inner conduit and form a crimping point. The distal end is welded and fixed and sealed with the inner end cap of the needle to form a sealed needle freezing target area, in which the freezing and ablation gas is throttled and frozen. The outer blade shell of the needle and the distal end of the outer conduit are fixed by a water-filled end cap interlayer tube. A crimping point is formed between the outer blade shell and the outer conduit. A crimping point is formed between the water-filled end cap interlayer tube and the inner gradient tube of the needle. After assembly, a needle water-filled layer is formed in the needle part, and a vacuum layer is formed between the outer conduit and the inner conduit.

[0014] Furthermore, the handle portion contains a bend protector, a first connector for the conduit, and a second connector for the conduit. The bend protector encloses the first connector for the conduit, the second connector for the conduit, and the internal structure, providing bend protection and support for the proximal end of the conduit portion. The first connector for the conduit and the second connector for the conduit are mechanically sealed together, forming a porous cavity structure inside, which has a water injection channel, a radio frequency line channel, and a vacuum channel. A side hole is reserved on the side of the second connector for communication with the vacuum tube extension tube.

[0015] Furthermore, the duct extension tube section includes an outer duct extension tube, an inlet duct extension tube, a return duct extension tube, a vacuum tube extension tube, a rewarming line extension tube, a temperature measuring line extension tube, and a radio frequency line extension tube; the distal end of the inlet duct extension tube is directly connected to the JT slot; the distal end of the return duct extension tube is directly connected to the inner duct via a T-junction structure at the handle; the vacuum tube extension tube is connected to the vacuum layer via the T-junction structure port; the rewarming line extension tube, temperature measuring line extension tube, and radio frequency line extension tube are directly connected to the rewarming line, temperature measuring line, and radio frequency line, respectively.

[0016] Furthermore, the cable plug assembly includes a quick plug, an upper plug handle, a lower plug handle, a vacuum plug, a cable plug, and a cable plug extension tube. The quick plug is assembled with the upper and lower plug handles via a snap-fit ​​structure, and the quick plug directly engages with a socket on the device. The lower plug handle has two pre-drilled holes through which the vacuum plug and the cable plug extension tube can pass, and are connected to the vacuum plug and the cable plug, respectively. The cable plug extension tube contains a reheating line extension, a temperature measuring line extension, and a radio frequency line extension, which are used to transmit reheating electric heating signals, temperature signals, and radio frequency transmission signals, respectively.

[0017] A high-efficiency cryoradiofrequency ablation catheter system includes a cryoradiofrequency ablation catheter, as well as a cryoablation module, a radiofrequency ablation module, a rewarming module, a water volume control module, and a control center. Each module can be freely switched through the control center and can be used in combination or individually. The system uses high-pressure gas as a gas source for cryosurgery. The gas source is controlled by a solenoid valve. The distal flexible catheter part has a double-layer catheter structure with a vacuum insulation function in the middle layer.

[0018] Furthermore, the cryoablation module is equipped with a pressure proportional solenoid valve with temperature control function.

[0019] Furthermore, the radio frequency ablation module includes a radio frequency transmitting device and a probe. The radio frequency transmitting device generates radio frequency energy at the probe head, and a detector is connected to the outside of the probe head. A temperature control structure is connected to the system.

[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) Based on a cryoablation probe using high-pressure nitrogen or argon throttling freezing technology, the system incorporates a rewarming module, a radiofrequency ablation module, and an auxiliary water volume control module, enabling centralized control switching of multiple modules and achieving highly efficient cryoablation module +

[0022] The integrated structure design of the rewarming module and the radio frequency module allows multiple modules to be used together or independently, achieving mutual complementarity between cold ablation and thermal ablation functions and improving ablation efficiency.

[0023] 2) By adding a water volume control module to the cryoablation and radiofrequency ablation on the flexible ablation catheter, the application of ablation technology in the field of natural cavities can be effectively improved. It can be effectively combined with the development of imaging technologies such as endoscopy or ultrasound, which further improves the safety of surgical pathways, improves the limited use of the original invasive percutaneous ablation, and expands the application space of the product.

[0024] 3) By adding a water volume control module, the target frozen tissue can be frozen quickly, increasing the range of cryoablation. At the same time, for radiofrequency ablation, it can avoid problems such as the interruption of the procedure due to impedance changes caused by thermal ablation, so that radiofrequency ablation can always be kept in a stable and continuous process, thereby greatly increasing the range of cold and hot ablation and thus improving the efficiency of the operation.

[0025] 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 catheter 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 kind of temperature control system with feedback mechanism is needed. This enables dynamic control of the thermal ablation cooling cycle system, ensuring the stability of thermal ablation.

[0026] 5) By introducing the concept of a three-way structure, the vacuum layer can be separated from the inlet and outlet pipes, avoiding problems such as vacuum layer failure caused by the connection between the inlet and outlet pipes and the vacuum layer.

[0027] 6) By adding a water injection pipeline to the vacuum layer through the design embodiment, the present invention can ensure the end water injection function without affecting the high-pressure refrigeration throttling function, and achieve effective control of water volume.

[0028] 7) By designing the water injection line as an integral package on the cryo-RF ablation catheter, the product assembly becomes more convenient. Without affecting the original cryo-RF ablation catheter structure, only an outer package structure needs to be added to achieve precise water volume control at the end target area, thereby improving the ablation efficiency of the target area. Compared with the integrated structure, this structure is more flexible in product design while ensuring that all functions meet the requirements.

[0029] 8) This invention recommends a multi-layer processing structure for the needle tip housing. Specifically, the processing can be divided into a multi-layer needle tip housing end cap and a multi-layer needle tip housing. The top end cap is generally recommended to be machined, with a gradient tube used for connection in the middle. The multi-layer structure allows for welding installation of the tip from the inside out, with the needle tip housing end cap and needle tip housing connected by laser welding.

[0030] 9) In the design and connection of the catheter and needle parts, this invention typically employs a double-walled structure for the needle tip shell connector. The distal end of the connector is welded and sealed, while the proximal end is a double-layered sandwich structure formed by welding the gradient tube structure to the inner liner tube. This allows for a proper connection with the inner and outer walls of the catheter part, resulting in a more stable and robust vacuum layer seal. Furthermore, the dimensional fit between the inner and outer walls must be considered when designing the sandwich structure, allowing users to adjust according to different product specifications. The connection and fixation of the catheter and needle parts can generally be achieved through adhesive bonding or riveting.

[0031] 10) By using a shared blade shell structure for both cryoablation and radiofrequency ablation, the target areas of cryoablation and radiofrequency ablation are aligned. For the same target area, the structures of cold ablation and thermal ablation are completely overlapped, which replaces the problem that it is difficult to achieve physical structural overlap in the original multi-needle ablation scheme.

[0032] 11) The flexible outer tube of the needle portion can be made of PTFE or PEBAX. To ensure the internal vacuum structure, the inner tube can be made of braided tubing made of materials such as PEBAX, PI, or PEEK. This effectively ensures the integrity of the vacuum layer and meets the high-pressure environment requirements for internal operation. The size of the catheter can be adjusted appropriately according to the size of the surgical channel (e.g., the size of the endoscope channel) or the target surgical area. The overall specifications of the needle portion can be varied, ensuring a wider range of applicability. The remaining proximal structural parts generally use a universal size design. Attached Figure Description

[0033] 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:

[0034] Figure 1 : Schematic diagram of a high-efficiency cryoradiofrequency ablation catheter system;

[0035] Figure 2 : A schematic diagram of a high-efficiency cryoradioablation catheter cryoablation module;

[0036] Figure 3 : Schematic diagram of a high-efficiency cryoradioablation catheter radiofrequency ablation module;

[0037] Figure 4 : A structural diagram of a high-efficiency cryoradioablation catheter;

[0038] Figure 5 Cross-sectional view of the tip of a cryoradioablation catheter;

[0039] Figure 6Half-section view of the tip of the cryoradioablation catheter;

[0040] Figure 7 Diagram of the inner layer structure of the cryoradioablation catheter tip;

[0041] Figure 8 : Schematic diagram of the inner layer assembly of the cryoradioablation catheter tip;

[0042] Figure 9 Diagram of the outer layer structure of the cryoradioablation catheter tip;

[0043] Figure 10 : Schematic diagram of the outer layer assembly of the cryoradioablation catheter tip;

[0044] Figure 11 Schematic diagram of the working status of the cryoradioablation catheter;

[0045] Figure 12 Internal structure diagram of the catheter section;

[0046] Figure 13 : Structural diagram of the connection between the handle and the catheter;

[0047] Figure 14 External structure diagram of the handle;

[0048] Figure 15 : Structural diagram of the conduit extension tube

[0049] Figure 16 : Structural diagram of cryoradioablation catheter cable plug assembly;

[0050] Figure 17 Schematic diagram of cable plug assembly;

[0051] Figure 18 : Schematic diagram of the head structure of the cryoradiofrequency ablation catheter in a split-type embodiment;

[0052] Figure 19 : Schematic diagram of the assembly of the cryoradiofrequency ablation catheter tip in a split-type embodiment;

[0053] Figure label:

[0054] Needle part 1, needle outer shell 101, needle outer shell crimping point 1011, drain hole 1012, needle inner end cap 102, needle end cap welding point 1021, water injection end cap interlayer tube 103, water injection end cap interlayer tube crimping point 1031, needle inner gradient tube 104, needle inner gradient tube welding point 1041, needle inner gradient tube crimping point 1042, needle inner embedded tube 105, needle water injection layer 106, needle freezing target area 107, needle extrusion tube 108;

[0055] The conduit section 2 includes an outer conduit 201, an inner conduit 202, a JT tank 203, a cryoablation gas 2031, a water injection conduit 204, an ablation injection solution 2041, a rewarming wire 205, a temperature measuring wire 206, a radio frequency wire 207, a vacuum layer 208, an air inlet layer 209, and an air return layer 210.

[0056] Handle part 3, bend guard 301, first conduit connector 302, second conduit connector 303, handle 304, handle fixing part 305;

[0057] Water injection connector 4, water injection Luer connector 401, water injection conduit extension tube 402;

[0058] The conduit extension tube section 5, the conduit extension tube outer tube 501, the inlet tube extension tube 502, the return tube extension tube 503, the vacuum tube extension tube 504, the rewarming wire extension tube 505, the temperature measuring wire extension tube 506, and the radio frequency wire extension tube 507.

[0059] Plug assembly 6, quick plug 601, plug handle upper 602, plug handle lower 603, vacuum plug 604, cable plug 605, cable plug extension tube 606. Detailed Implementation

[0060] 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.

[0061] The following detailed description, in conjunction with the accompanying drawings, illustrates the technical solution of a high-efficiency cryoradiofrequency ablation catheter and ablation system provided by various embodiments of the present invention.

[0062] Reference Figures 1 to 19As shown, this embodiment of the invention provides a high-efficiency cryo-radiofrequency ablation catheter, including a needle portion 1, a catheter portion 2, a handle portion 3, a water inlet portion 4, a catheter extension tube portion 5, and a plug assembly 6. The needle portion 1 has a metal head structure containing multiple metal layers, serving as the target area for cryo- or radiofrequency surgery. The proximal end of the needle portion 1 connects with the multi-layered structure of the catheter portion 2, allowing for flexible adjustment of the product's tip within natural cavities. The catheter portion 2 is a multi-layered flexible tube structure used to connect the handle portion 3 and the needle portion 1, transmitting and recovering energy, including cold and heat sources. It can be inserted into the body's natural cavities along with the needle portion 1. The handle portion 3 is held by the user, with its proximal end connected to the catheter extension tube portion 5 and the water inlet portion 4, and its distal end connected to the catheter portion 2. The water inlet portion 4 serves as a water inlet for controlling the flow of water into the device, which is then delivered through the handle portion 304 and the catheter portion 2. The catheter extension tube 5 extends the usable range, serving as a heat or cold source channel. The distal end of the catheter extension tube 5 connects to the handle 3, and the proximal end connects to the plug assembly 6. This extends the product's usability, preventing situations where surgery cannot be performed due to the distance between the device and the patient. It also serves as an entry and exit channel for the heat or cold source. The plug assembly 6 enables product insertion, removal, and fixation. The distal end of the plug assembly 6 connects to the catheter extension tube 5, and the proximal end connects to the device socket. The vacuum plug 604 assembly 6 connects to the plug assembly 6 at its distal end and extends into the vacuum layer 208 of the catheter section 2. The proximal end connects to the device vacuum socket for evacuating the vacuum layer 208 of the catheter section 2. The cable plug 605 assembly 6 connects to the plug assembly 6 at its distal end and extends into the temperature measuring wire 206, the rewarming wire 205, and the radio frequency wire 207 of the catheter section 2. The three wires converge within the cable plug 605 assembly 6 and connect to the device's cable socket at its proximal end.

[0063] In this embodiment, the conduit portion 2 includes an outer conduit 201, an inner conduit 202, a JT groove 203, a water injection conduit 204, a rewarming wire 205, a temperature measuring wire 206, and a radio frequency wire 207. A vacuum layer 208 is formed between the outer conduit 201 and the inner conduit 202 to ensure that cold air is isolated during the cryoablation process and to improve the freezing efficiency. The JT groove 203 serves as an air intake channel to transport cold air from the near end to the far end, and forms a return air layer 210 between it and the inner conduit 202 to discharge the frozen gas. The water injection conduit 204 delivers the ablation injection liquid 2041 to the target area. The radio frequency wire 207 is located between the outer conduit 201 and the inner conduit 202, and its far end is welded to the water injection head jacket tube 103. Since the entire needle portion 1 is a metal part, this design can ensure that the outermost area of ​​the needle portion 1 has a conductive effect, which can achieve the purpose of radio frequency ablation.

[0064] In this embodiment, the needle portion 1 includes an outer needle shell 101, an inner needle cap 102, a water-filled cap jacketed tube 103, an inner needle gradient tube 104, and an inner needle embedding tube 105; the outer needle shell 101 covers the target area on the outermost layer and is connected to the outer conduit 201 at its proximal end; the inner needle gradient tube 104 is inside the water-filled cap jacketed tube 103 and forms a gap with the inner needle embedding tube 105 to connect to the inner conduit 202; Figure 6 This is a partial cross-sectional view of the tip of the cryo-radiofrequency ablation catheter, which is the core target area for cryo-radiofrequency ablation surgery. The water-filled sealing tube 103 has a double-hole structure, which separates the needle part 1 and part of the catheter part 2, ensuring that the water-filled catheter 204 enters the interlayer of the needle part 1. The needle inner sealing tube 102, the needle inner embedded tube 105, and the needle inner layer gradient tube 104 form a sealed space to ensure air intake and exhaust in the JT groove 203. The rewarming wire 205 and the temperature measuring wire 206 are fixed on the JT groove 203 and enter the needle inner embedded tube 105 through the inner layer catheter 202.

[0065] Figure 7 This is a diagram of the inner layer structure of the cryoablation catheter tip, which ensures the functionality of the cryoablation procedure. Cryoablation gas 2031 flows out from inside the JT groove 203 and enters the needle cryotargeting area 107. Figure 8 This is a schematic diagram of the inner layer assembly of the cryoablation catheter tip. The needle inner layer gradient tube 104 and the needle inner tube 105 form a metal interlayer at the proximal end. This interlayer can wrap the inner catheter 202 and form a needle inner layer gradient tube crimping point 1042, making it a whole and ensuring that the vacuum interlayer is isolated from the cryoablation gas 2031. The needle inner layer gradient tube 104 and the needle inner tube 105 are fixed by welding at the distal end and welded to the needle inner cap 102 to form the needle inner layer gradient tube welding point 1041. This forms a sealed needle cryoablation target area 107, in which the cryoablation gas 2031 is throttled and frozen.

[0066] In this embodiment, Figure 9 This is a diagram of the outer layer structure of the cryoradioablation catheter tip. Figure 10This is a schematic diagram of the outer layer assembly of the cryoablation catheter head. The inner layer gradient tube 104 and the inner tube 105 of the needle form a metal sandwich at the proximal end, wrapping the inner catheter 202 and forming a crimping point. The distal end is welded and fixed and sealed with the inner cap 102 of the needle, forming a sealed needle cryoablation target area 107. The cryoablation gas 2031 is throttled and frozen in this target area. The outer layer blade shell 101 of the needle is fixed to the distal end of the outer catheter 201 by a water-filled cap sandwich tube 103. A crimping point is formed between the outer layer blade shell 101 and the outer catheter 201. A crimping point is formed between the water-filled cap sandwich tube 103 and the inner layer gradient tube 104 of the needle. After assembly, a needle water-filled layer 106 is formed in the needle part 1, and a vacuum layer 208 is formed between the outer catheter 201 and the inner catheter 202.

[0067] Figure 11 This is a schematic diagram of the cryo-radiofrequency ablation catheter in operation. The interior of the JT groove 203 is the air inlet layer 209, which is formed by... Figure 10 It is known that after the needle part 1 is assembled, cryoablation gas 2031 and ablation injection liquid 2041 are introduced. The cryoablation gas 2031 enters the needle cryotargeting area 107 from the air inlet layer 209 and returns to the air return layer 210. The ablation injection also enters the water injection layer from the water inlet layer and flows out from the drain hole 1012 on the outer blade shell 101 of the needle and enters the target tissue, thereby achieving the purpose of injecting water into the target area.

[0068] In this embodiment, Figure 13 The diagram shows the structure of the connection between the handle 304 and the conduit. The conduit portion 22 is connected to the handle portion 33 at its proximal end. The handle portion 3 has a bend protector 301, a first conduit connector 302, and a second conduit connector 303 inside. The bend protector 301 encloses the first conduit connector 302, the second conduit connector 303, and the internal structure, providing bend protection and support to the proximal end of the conduit portion 2 to prevent stress bending and damage to the product during use. The first conduit connector 302 and the second conduit connector 303 are mechanically sealed together, forming a porous cavity structure inside, which has a water injection channel, an RF wire 207 channel, and a vacuum channel. The second conduit connector 303 has a side hole reserved on its side that communicates with the vacuum tube extension tube 504, which can facilitate vacuuming.

[0069] It should be noted that the first connector 302 and the second connector 303 of the catheter can be machined or injection molded from metal, and can be fixed by gluing or welding.

[0070] This invention does not demonstrate the specific structure of the T-junction. Adjustments can be made according to space and structural requirements during use. However, the design concept of the T-junction falls within the scope of this invention. The purpose of this design is to ensure the isolation between the inlet / outlet air and the vacuum layer 208, preventing the vacuum layer 208 from failing due to inlet / outlet air mixing into it. All other components are enclosed by the handle 304. Figure 14 As shown, the handle fixing part 305 connects the handle 304 and the outer tube 501 of the conduit extension tube. A water injection connector part 4 is also connected to the handle fixing part 305. This part consists of a water injection Luer connector 401 and a water injection conduit extension tube 402. The latter is hidden inside the handle 304, with only a small extension section remaining for easy insertion and removal of the water injection device.

[0071] In this embodiment, Figure 15 This is a structural diagram of the conduit extension tube section 5. The conduit extension tube section 5 includes an outer conduit extension tube 501, an inlet pipe extension tube 502, a return pipe extension tube 503, a vacuum tube extension tube 504, a rewarming line extension tube 505, a temperature measuring line extension tube 506, and a radio frequency line extension tube 507. The distal end of the inlet pipe extension tube 502 is directly connected to the JT groove 203. The distal end of the return pipe extension tube 503 is directly connected to the inner conduit 202 via a three-way connection at the handle 304. The vacuum tube extension tube 504 is connected to the vacuum layer 208 via a three-way connection. The rewarming line extension tube 505, temperature measuring line extension tube 506, and radio frequency line extension tube 507 are directly connected to the rewarming line 205, temperature measuring line 206, and radio frequency line 207, respectively. The radio frequency line 207 is fixed to the water-filled head jacket tube 103 by soldering or other methods; alternatively, the radio frequency cable can be directly connected to the top of the distal needle tip casing.

[0072] In this embodiment, Figure 16 This is a structural diagram of the catheter plug assembly 6. The cable plug assembly 6 includes a quick plug 601, an upper plug handle 602, a lower plug handle 603, a vacuum plug 604, a cable plug 605, and a cable plug extension tube 606. The quick plug 601 is assembled with the upper plug handle 602 and the lower plug handle 603 via a snap-fit ​​structure, and the quick plug 601 directly engages with the socket on the device. The lower plug handle 603 has two pre-drilled holes for the vacuum plug 604 and the cable plug extension tube 606 to pass through, and connect to the vacuum plug and the cable plug 605 respectively. The cable plug extension tube 606 contains a rewarming wire extension line 505, a temperature measuring wire extension line 506, and a radio frequency wire extension line 507, used to transmit rewarming electric heating signals, temperature signals, and radio frequency transmission signals, respectively. Each plug component must meet the requirements for cryo-radiofrequency ablation insertion / removal, vacuum insertion / removal, and cable insertion / removal functions. The temperature measuring wire extension line 506 is used to transmit temperature signals, which can monitor the temperature signal during the ablation procedure in real time and adjust the pressure through temperature signal feedback control. (See details...) Figure 1 and Figure 3 The RF extension cable 507 is used to transmit RF transmission signals and realize RF ablation function; to meet basic functional requirements, the cable plug 605 should be selected with at least 6 cores (including 6 cores).

[0073] Figures 18-19 This structure is an embodiment of a split-type needle tip design. Specifically, the structure adopts a split design between the outer water injection structure and the internal cryo-radiofrequency ablation structure. The internal cryo-radiofrequency ablation structure is designed as a whole. Without changing the original structure, a water injection structure is added externally. This involves welding the outer needle shell 101 to the needle extrusion tube 108 and crimping and sealing the water injection conduit 204 at the interlayer to form a single unit. This structure, together with the internal cryo-radiofrequency ablation structure, forms a needle water injection layer 106. This facilitates the direct injection of physiological saline into the outer needle shell 101, and the saline is discharged through the porous structure on the outer needle shell 101, achieving effective control of the water volume during the ablation process. Figure 19 As shown in the figure, this diagram illustrates the state of the two components when they are not fully assembled. To use them, simply assemble them as shown in the diagram.

[0074] A high-efficiency cryoradiofrequency ablation catheter system includes a cryoradiofrequency ablation catheter, as well as a cryoablation module, a radiofrequency ablation module, a rewarming module, a water volume control module, and a control center. Each module can be freely switched through the control center, thus satisfying both combined use and individual use. Medical staff can select the appropriate surgical plan according to actual needs. The system uses high-pressure gas as a gas source for cryoablation surgery, and the gas source is controlled by a solenoid valve. The distal flexible catheter part has a double-layer catheter structure, with the middle layer having vacuum insulation function.

[0075] The cryoablation module, rewarming module, and radiofrequency ablation module are used sequentially. A water volume control module serves as an auxiliary module and can be used in conjunction with either the cryoablation or radiofrequency ablation modules. This system uses high-pressure gas as the cryoablation source, which is controlled and regulated via a solenoid valve. The distal flexible catheter section 2 has a double-layer structure with a vacuum insulation layer in between, effectively improving freezing efficiency and isolating the cold source. This vacuum function remains active during the switching between the three modules.

[0076] In this embodiment, the cryoablation module is equipped with a pressure proportional solenoid valve with temperature control adjustment. This function can achieve adjustment and control based on the temperature signal, and also achieve stable control of the radiofrequency ablation module. The water control module, as an auxiliary module, can ensure real-time closed-loop control of water content during the radiofrequency ablation process, and also provide sufficient water content before the cryoablation module is turned on, providing a strong guarantee for efficient ablation.

[0077] The schematic diagram of the cryoablation module is as follows Figure 2 shown. When the control center activates the cryoablation module, the gas source inputs a gas pressure of P1 through solenoid valve II. After passing through the flow proportional valve, it meets the cryoablation gas pressure usage condition P2. At this time, the gas source reaches the probe tip after passing through the precooling device and performs cryoablation operations. The water volume control module, as an auxiliary module, can supplement the water loss during each ablation cycle, thereby improving the cryoablation efficiency.

[0078] In this embodiment, the radiofrequency ablation module includes a radiofrequency emitting device and a probe. The radiofrequency emitting device generates radiofrequency energy at the probe head. A detector is connected to the outside of the probe head, and a temperature control structure is connected in the system.

[0079] The schematic diagram of the radiofrequency ablation module is as follows Figure 3 shown. When the control center activates the radiofrequency ablation module, the radiofrequency emitting 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, tissue damage, and even carbonization. Therefore, we connect a detector to the outside of 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 pressure input from the gas source remains P2 after passing through solenoid valve II, and the gas pressure 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 receiving the feedback temperature signal T2, which can meet the dynamic adjustment function and ultimately achieve a stable balance under the radiofrequency function module. At the same time, during each radiofrequency ablation process, the position of the target area at the end of the device of the present invention will be replenished with water in real time to ensure that the water content of the inner wall of the cavity during the ablation process meets the tissue impedance range requirements. This can not only assist in cooling but also enable the ablation to be maintained stably.

[0080] It should be noted that the gas in the gas cylinder can be selected from high-pressure nitrogen, argon, or a nitrogen-argon mixture.

[0081] The above are only embodiments of the present invention and are not used to limit the present invention. For those skilled in the art, the present invention can have various changes and modifications. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included within the scope of the claims of the present invention.

Claims

1. A high-efficiency cryoradiofrequency ablation catheter, characterized in that, The device includes a needle part (1), a catheter part (2), a handle part (3), a water injection connector part (4), a catheter extension tube part (5), and a plug assembly (6). The needle part (1) is a metal head structure containing multiple metal layers inside, serving as a target area for cryotherapy or radiofrequency surgery. The proximal end of the needle part (1) is connected to the multi-layer structure inside and outside the catheter part (2). The catheter part (2) is a multi-layer flexible tube structure used to connect the handle part (3) and the needle part (1) for transmitting and recovering energy. The handle part (3) is for the user to hold, and the proximal end of the handle part (3) is connected to the catheter extension tube part (5) and the water injection connector part (4), while the distal end of the handle part (3) is connected to the catheter part (2). The water injection connector part (4) serves as a water inlet for controlling the water volume and supplying water to the device. The catheter extension tube part (5) expands the scope of use, serving as a heat source or cold source channel. The plug assembly (6) enables the product to be plugged in, unplugged, and fixed.

2. The high-efficiency cryoradiofrequency ablation catheter according to claim 1, characterized in that: The conduit section (2) includes an outer conduit (201), an inner conduit (202), a JT groove (203), a water injection conduit (204), a rewarming wire (205), a temperature measuring wire (206), and a radio frequency wire (207). A vacuum layer (208) is formed between the outer conduit (201) and the inner conduit (202) to isolate cold air and improve freezing efficiency. The interior of the JT groove (203) is an air intake layer (209). The JT groove (203) serves as an air intake channel to transport cold air and forms a return air layer (210) between it and the inner conduit (202) to discharge frozen gas. The water injection conduit (204) transports ablation injection liquid (2041). The radio frequency wire (207) is located between the outer conduit (201) and the inner conduit (202), and its distal end is welded to the water injection head jacketed tube (103).

3. The high-efficiency cryoradiofrequency ablation catheter according to claim 2, characterized in that: The needle portion (1) includes an outer needle shell (101), an inner needle cap (102), a water-filled cap jacketed tube (103), an inner needle gradient tube (104), and an inner needle insert (105); the outer needle shell (101) covers the target area on its outermost layer and is connected to the outer conduit (201) at its proximal end; the inner needle gradient tube (104) is inside the water-filled cap jacketed tube (103) and forms a gap with the inner needle insert (105) to connect to the inner conduit (202); the water-filled cap jacket... The layer tube (103) has a double-hole structure, which separates the needle part (1) and the conduit part (2) to ensure that the water injection conduit (204) enters the interlayer of the needle part (1); the needle inner cap (102), the needle inner tube (105) and the needle inner layer gradient tube (104) form a sealed space to ensure air intake and return in the JT groove (203). The rewarming wire (205) and the temperature measuring wire (206) are fixed on the JT groove (203) and enter the needle inner tube (105) through the inner conduit (202).

4. The high-efficiency cryoradiofrequency ablation catheter according to claim 3, characterized in that: The inner tapered tube (104) and the inner tube (105) of the needle form a metal interlayer at the proximal end, encasing the inner conduit (202) and forming a crimping point. The distal end is welded and fixed, and welded and sealed with the inner cap (102) of the needle, forming a sealed needle freezing target area (107). The freezing and ablation gas (2031) is throttled and frozen in this target area. The distal end of the outer blade shell (101) and the outer conduit (201) are connected by a water-filled cap interlayer tube (1). 03) Fixing: A needle outer blade shell (101) is formed between the needle outer blade shell (101) and the outer guide tube (201), and a water injection head jacket tube (103) is formed between the needle inner gradient tube (104) and the water injection head jacket tube (1031). After assembly, a needle water injection layer (106) is formed in the needle part (1), and a vacuum layer (208) is formed between the outer guide tube (201) and the inner guide tube (202).

5. The high-efficiency cryoradiofrequency ablation catheter according to claim 4, characterized in that: The handle part (3) has a bend protector (301), a first connector of the conduit (302), and a second connector of the conduit (303) inside. The bend protector (301) wraps the first connector of the conduit (302), the second connector of the conduit (303) and the internal structure, and provides bend protection support for the proximal end of the conduit part (2). The first connector of the conduit (302) and the second connector of the conduit (303) are mechanically sealed together, forming a cavity porous structure inside, which has a water injection channel, a radio frequency line (207) channel and a vacuum channel. The side hole of the second connector of the conduit (303) is reserved and communicates with the conduit extension tube part (5).

6. The high-efficiency cryoradiofrequency ablation catheter according to claim 5, characterized in that: The conduit extension tube section (5) includes an outer conduit extension tube (501), an inlet pipe extension tube (502), a return pipe extension tube (503), a vacuum tube extension tube (504), a rewarming line extension tube (505), a temperature measuring line extension tube (506), and a radio frequency line extension tube (507); the distal end of the inlet pipe extension tube (502) is directly connected to the JT slot (203); the distal end of the return pipe extension tube (503) is directly connected to the inner conduit tube (202) through a three-way structure at the handle (304); the vacuum tube extension tube (504) is connected to the vacuum layer (208) through the three-way structure port; the rewarming line extension tube (505), the temperature measuring line extension tube (506), and the radio frequency line extension tube (507) are directly connected to the rewarming line (205), the temperature measuring line (206), and the radio frequency line (207), respectively.

7. The high-efficiency cryoradiofrequency ablation catheter according to claim 6, characterized in that: The cable plug assembly (6) includes a quick plug (601), a plug handle upper (602), a plug handle lower (603), a vacuum plug (604), a cable plug (605), and a cable plug extension tube (606). The quick plug (601) is assembled with the plug handle upper (602) and the plug handle lower (603) through a snap-fit ​​structure. The quick plug (601) is directly used with the socket on the device. The plug handle lower (603) has two pre-drilled holes through which the vacuum plug (604) and the cable plug extension tube (606) can pass, and are connected to the vacuum plug and the cable plug (605). The cable plug extension tube (606) contains a reheating line extension line (505), a temperature measuring line extension line (506), and a radio frequency line extension line (507), which are used to transmit reheating electric heating signals, temperature signals, and radio frequency transmission signals, respectively.

8. A high-efficiency cryoradiofrequency ablation catheter system, characterized in that: The cryoradiofrequency ablation catheter included in any one of claims 1-7 further includes a cryoablation module, a radiofrequency ablation module, a rewarming module, a water volume control module, and a control center. Each module can be freely switched through the control center and can be used in combination or individually. The system uses high-pressure gas as a gas source for cryoablation surgery. The gas source is controlled by a solenoid valve. The distal flexible catheter part has a double-layer catheter structure with a vacuum insulation function in the middle layer.

9. The high-efficiency cryoradiofrequency ablation catheter system according to claim 8, characterized in that: The cryoablation module is equipped with a pressure proportional solenoid valve with temperature control function.

10. A high-efficiency cryoradiofrequency ablation catheter system according to claim 9, characterized in that: The radio frequency ablation module includes a radio frequency transmitting device and a probe. The radio frequency transmitting device generates radio frequency energy at the probe head, and a detector is connected to the outside of the probe head. A temperature control structure is connected to the system.

Images