Portable bipolar cold cycle ablation device and ablation needle

Abstract

The application discloses a portable bipolar cold cycle ablation device and an ablation needle, which comprises a handheld main body, an energy application unit, a cold cycle unit, an energy supply unit and a circulating refrigeration unit. The energy application unit is fixedly arranged on the outside of the handheld main body, and the cold cycle unit is arranged in the inside of the energy application unit. The energy application unit can be moved to the target tissue together with the handheld main body. The energy application unit comprises at least one first energy application element and at least one second energy application element. The cold cycle unit comprises a fluid circulation channel extending from the proximal end of the energy application unit to the distal end and returning from the distal end to the proximal end. The fluid circulation channel is provided with an insulation part on the channel wall of at least the part extending into the first energy application element and / or the second energy application element. The circulating refrigeration unit is in circulation communication with the first liquid inlet and the first liquid outlet at the proximal end of the fluid circulation channel, and is used for driving the fluid circulation flow and refrigerating the fluid circulation flow.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and in particular relates to a bipolar cold cycle ablation needle and device. Background Technology

[0002] The high incidence of cancer has made thermal ablation therapy an important research direction in clinical medicine. Radiofrequency ablation, with its advantages of precision and minimal invasiveness, has become one of the core methods for cancer thermal ablation treatment. With the continued rise in global cancer incidence, the clinical demand for cancer thermal ablation surgery is showing a rapid growth trend. According to industry data, the global radiofrequency ablation market exceeded US$2 billion in 2019 and is expected to expand at a compound annual growth rate of 8.5%, reaching approximately US$4 billion by 2027. This market growth potential highlights the broad application prospects of radiofrequency ablation technology in cancer treatment, while also placing higher demands on equipment performance, ease of operation, and treatment efficiency.

[0003] However, current thermal ablation electrode products on the market still face significant technical bottlenecks, making it difficult to meet the rapidly evolving clinical needs. Existing radiofrequency ablation electrodes generally rely on external radiofrequency or microwave hosts for energy supply, resulting in bulky equipment and high host procurement costs. This design not only increases the overall cost of the procedure but also imposes stringent requirements on the space layout and equipment configuration of the operating room, limiting its widespread application in primary healthcare institutions. Mainstream monopolar radiofrequency ablation electrodes require the use of a negative electrode plate, a cumbersome procedure with the potential risk of patient burns from the negative electrode plate. Furthermore, while some monopolar electrodes are equipped with cooling systems to control tissue temperature, they require complex piping to connect to an external coolant circulation device, leading to tangled wiring and limited operating space during surgery, increasing the difficulty and risk for doctors. Traditional bipolar radiofrequency ablation electrodes have flawed cooling designs; most products have only a single electrode with cooling functionality or lack cooling circulation altogether, causing a rapid increase in tissue temperature around the electrode during ablation, leading to tissue carbonization and a rapid increase in impedance. This phenomenon not only reduces ablation efficiency but may also result in uncontrollable ablation range due to uneven energy distribution, affecting treatment outcomes and increasing the risk of complications. Summary of the Invention

[0004] To address the aforementioned problems, the present invention aims to provide a bipolar cold cycle ablation needle and device that can achieve simultaneous bipolar cooling.

[0005] To achieve the above objectives, the technical solution of the present invention is as follows:

[0006] A portable bipolar cold cycle ablation device includes a handheld main body, an energy application unit, a cold cycle unit, an energy supply unit, and a circulating cooling unit. The energy application unit is fixed to the outside of the handheld main body, the cold cycle unit is disposed inside the energy application unit, and both the energy supply unit and the circulating cooling unit are disposed inside the handheld main body.

[0007] The energy application unit can be moved with the handheld body to the target tissue to apply energy to the target tissue for ablation. The energy application unit includes at least one first energy application element and at least one second energy application element. The first energy application element and the second energy application element are arranged alternately and spaced apart along the length of the energy application unit. One of them is connected to the negative terminal and the other is connected to the positive terminal. An insulating element is provided between adjacent first energy application elements and second energy application elements to prevent short circuit between them.

[0008] The energy supply unit is electrically connected to the circulating refrigeration unit, the first energy application element, and the second energy application element, and is used to provide energy.

[0009] The cooling circulation unit includes a fluid circulation channel extending from the proximal end of the energy application unit toward the distal end and returning from the distal end to the proximal end. Fluid is configured to flow unidirectionally along the fluid circulation channel, carrying away the heat generated by the fluid as it flows through the first and second energy application elements. The fluid circulation channel has an insulating portion on its channel wall, at least in the portion extending into the first and / or second energy application elements, through which the first and / or second energy application elements are insulated from the fluid.

[0010] The circulating refrigeration unit is circulated with the first liquid inlet and the first liquid outlet near the fluid circulation channel, and is used to drive the fluid to circulate and cool it.

[0011] According to one embodiment of the present invention, the fluid circulation channel includes a fluid inlet channel and a fluid outlet channel, the fluid inlet channel extending from the proximal end of the energy application unit toward the distal end, the fluid outlet channel extending from the distal end of the energy application unit toward the proximal end, and the distal ends of the fluid inlet channel and the fluid outlet channel are interconnected.

[0012] At least one of the fluid inlet channel and the fluid outlet channel extends into the first energy applying element and the second energy applying element.

[0013] According to one embodiment of the present invention, the cold circulation unit includes a drainage tube, and the energy application unit is provided with a receiving cavity along its length direction, and the drainage tube is disposed in the receiving cavity;

[0014] The fluid inlet channel is the internal channel of the drainage tube, and the fluid outlet channel is the annular gap formed between the outer wall surface of the drainage tube and the inner cavity surface of the accommodating cavity.

[0015] According to one embodiment of the present invention, the energy application unit includes a needle tube and a needle tip, the insulating member is disposed between the needle tube and the needle tip, the first energy application element includes the needle tip, and the second energy application element includes the needle tube.

[0016] According to an embodiment of the present invention, the insulating element is an insulating isolation ring, and the energy application unit includes a first connecting ring and a second connecting ring. The first connecting ring is disposed between the needle tip and the insulating isolation ring and its two ends are respectively connected to both of them. The second connecting ring is disposed between the needle tube and the insulating isolation ring and its two ends are respectively connected to both of them.

[0017] The first energy application element includes the needle tip and the first connecting ring, and the second energy application element includes the needle tube and the second connecting ring.

[0018] According to one embodiment of the present invention, the needle tube is covered with an insulating sheath, and the second energy application element includes the portion of the distal end of the needle tube exposed at the distal end of the insulating sheath.

[0019] According to one embodiment of the present invention, a fixing member is provided inside the handheld body, and the proximal ends of the energy application unit and the cold cycle unit are connected to the fixing member;

[0020] The fixing component is provided with a liquid inlet channel and a liquid outlet channel, and the first liquid inlet and the first liquid outlet are respectively connected to the liquid inlet channel and the liquid outlet channel;

[0021] The fixing component is provided with a second liquid inlet and a second liquid outlet that are respectively connected to the liquid inlet channel and the liquid outlet channel. The liquid outlet end and the liquid return end of the circulating refrigeration unit are respectively connected to the second liquid inlet and the second liquid outlet.

[0022] According to an embodiment of the present invention, the circulating refrigeration unit includes a circulating pipeline and a liquid storage module, a driving module, and a refrigeration module disposed on the circulating pipeline. The liquid outlet and liquid return end of the circulating pipeline are respectively connected to the first liquid inlet and the first liquid outlet.

[0023] The liquid storage module stores the fluid, the drive module drives the fluid to circulate, and the refrigeration module cools the fluid.

[0024] According to an embodiment of the present invention, the cooling module includes:

[0025] A refrigeration circulation component, internally equipped with refrigeration piping for the flow of the fluid;

[0026] The semiconductor refrigeration chip has its cold end thermally connected to the refrigeration cycle component.

[0027] The heat sink is thermally connected to the hot end of the semiconductor cooling chip;

[0028] A cooling fan is mounted on the heat sink.

[0029] According to an embodiment of the present invention, the energy supply unit includes an energy storage module and a transformer module. The energy storage module is electrically connected to the transformer module, and the transformer module is electrically connected to the first energy application element and the second energy application element. The transformer module converts the electrical energy of the energy storage module and supplies it to the first energy application element and the second energy application element.

[0030] According to one embodiment of the present invention, a temperature detection module is included, disposed within the first energy applying element and / or the second energy applying element, for detecting temperature.

[0031] According to one embodiment of the present invention, the insulating portion is an insulating coating, which is applied to the channel wall of the fluid circulation channel in the portion extending into the first energy applying element and / or the second energy applying element, wherein the first energy applying element and / or the second energy applying element is insulated from the fluid by the insulating coating.

[0032] According to one embodiment of the present invention, an excitation unit is provided on the handheld body. The excitation unit is electrically connected to the energy supply unit. The user can control the energy supply unit to provide energy to the circulating cooling unit, the first energy application element, and the second energy application element by triggering the excitation unit.

[0033] Based on the same concept, the present invention also provides a bipolar cold-cycle ablation needle, comprising an energy application unit and a cold-cycle unit, wherein the cold-cycle unit is disposed within the energy application unit, wherein:

[0034] The energy application unit includes at least one first energy application element and at least one second energy application element. The first energy application element and the second energy application element are arranged alternately and at intervals along the length direction of the energy application unit, and one of the first energy application element and the second energy application element is connected to the negative electrode and the other is connected to the positive electrode.

[0035] An insulating element is provided between adjacent first energy applying elements and second energy applying elements, the insulating element being configured to prevent short circuits between adjacent first energy applying elements and second energy applying elements;

[0036] The cold circulation unit includes a fluid circulation channel that extends from the proximal end of the energy application unit toward the distal end and returns from the distal end of the energy application unit to its proximal end, and the fluid circulation channel extends into the first energy application element and the second energy application element;

[0037] The fluid is configured to flow unidirectionally along the fluid circulation channel, and as the fluid flows through the first energy application element and the second energy application element, it carries away the heat energy generated by applying energy to the target tissue.

[0038] The fluid circulation channel has an insulating portion on the channel wall at least in the portion extending into the first energy applying element and / or the second energy applying element, the first energy applying element and / or the second energy applying element being insulated from the fluid through the insulating portion to prevent short circuits between the first energy applying element and the second energy applying element through the fluid.

[0039] Because the present invention adopts the above technical solution, it has the following advantages and positive effects compared with the prior art:

[0040] This invention, through the ingenious design of insulating components and insulating parts, successfully prevents short circuits between the first and second energy application elements. This key design not only makes it possible to cool the two electrodes through the same water path but also truly realizes bipolar cooling circulation. The realization of bipolar cooling circulation is of great significance, as it helps reduce carbonization of surrounding tissues during bipolar ablation, lowers tissue impedance, and thus significantly improves the efficiency and effectiveness of ablation, providing a more stable and efficient treatment environment for ablation surgery.

[0041] The bipolar design eliminates the need for a negative electrode plate, avoiding the operational complexity and potential risks associated with negative electrode plate connections, simplifying the surgical procedure and improving its convenience.

[0042] The miniaturized power supply unit is built into the main body, eliminating the need for an additional RF or microwave host. The built-in power supply unit directly provides RF energy to the bipolar electrodes. This design reduces the number of connection and operation steps, making surgical procedures simpler and faster, and significantly shortening surgical time.

[0043] The built-in circulating cooling unit eliminates the need for external coolant, piping, and cooling pumps, avoiding the cumbersome operation of external equipment. Through the coordinated operation of the circulating cooling unit and the cold circulation unit, both electrodes are simultaneously circulated and cooled, resulting in lower fluid temperatures and effective cooling of the tissue surrounding the bipolar electrodes. This further reduces carbonization of the surrounding tissue caused by electrode ablation, lowers impedance, and improves ablation efficiency and effectiveness. This invention, by optimizing the cooling system and energy supply method, not only improves ablation efficiency but also increases the ablation area. The combined effect of bipolar cold circulation and cryogenic fluid enables faster and more thorough elimination of diseased tissue while minimizing damage to surrounding healthy tissue, providing patients with a safer and more effective treatment option.

[0044] The energy supply unit and the circulating cooling unit are both built into the main body, eliminating the need for radio frequency or microwave equipment. This reduces the cost of purchasing expensive radio frequency or microwave equipment for the user. Furthermore, the absence of external cables and conduits reduces the use of surgical consumables, further lowering surgical costs. This not only alleviates the financial burden on patients but also improves the efficiency of medical resource utilization. This invention can perform ablation surgery independently, and its integrated design allows doctors to operate more flexibly and conveniently during the procedure. Without the limitation of external equipment, doctors can adjust the surgical plan in a timely manner according to different surgical needs and patient conditions, improving the precision and safety of the surgery and providing strong support for the widespread application of ablation surgery. Attached Figure Description

[0045] The specific embodiments of the present invention will be further described in detail below with reference to the accompanying drawings, wherein:

[0046] Figure 1 Cross-section of the bipolar cold cycle ablation device in this invention Figure 1 ;

[0047] Figure 2 Cross-section of the bipolar cold cycle ablation device in this invention Figure 2 ;

[0048] Figure 3 This is a schematic diagram of the circulating refrigeration unit in this invention;

[0049] Figure 4 This is a cross-sectional view of the connection between the fixing member and the bipolar cold cycle ablation needle in this invention;

[0050] Figure 5 This is a schematic diagram of the bipolar cold cycle ablation needle in this invention. Figure 1 ;

[0051] Figure 6 This is a schematic diagram of the bipolar cold cycle ablation needle in this invention. Figure 2 ;

[0052] Figure 7 This is a schematic diagram of the first electrode in this invention;

[0053] Figure 8 This is a schematic diagram of the cooling module in this invention.

[0054] Explanation of reference numerals in the attached figures:

[0055] 01. Bipolar cold cycle ablation needle; 0101. Needle tip; 0102. Insulating isolation ring; 0103. First connecting ring; 0104. Second connecting ring; 0105. Needle tube; 0106. Insulating sheath; 0107. Drainage tube; 0108. First power line; 0109. Second power line; 0110. Temperature measuring line; 02. Handheld housing; 03. Energy storage module; 04. Water tank; 0401. Water tank outlet; 0402. Water tank return port; 05. Refrigeration cycle component; 0501. Cold cycle inlet; 0502. Cold cycle outlet; 0503. Refrigeration piping; 0 6. Semiconductor cooling chip; 0601. Cold end; 0602. Hot end; 07. Heat sink; 08. Cooling fan; 09. First fixing component; 0901. Second liquid outlet; 10. Second fixing component; 1001. Second liquid inlet; 1002. Cable outlet; 1003. Sealing port; 11. Transformer module; 12. Trigger button; 13. Switch module; 14. Water pump; 1401. Pump inlet; 1402. Pump outlet; 15. Power supply; 16. Charging module; 1701. First pipeline; 1702. Second pipeline; 1703. Third pipeline; 1704. Fourth pipeline. Detailed Implementation

[0056] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. The advantages and features of the present invention will become clearer from the following description. It should be noted that the drawings are all in a very simplified form and use non-precise ratios, and are only used to facilitate and clarify the illustration of the embodiments of the present invention.

[0057] It should be noted that all directional indications (such as up, down, left, right, front, back, etc.) in the embodiments of the present invention are only used to explain the relative positional relationship and movement of each component in a certain specific posture (as shown in the figure). If the specific posture changes, the directional indication will also change accordingly.

[0058] The term "radio frequency" or "RF" refers to an alternating current applied to an electrode in the radio frequency range (from below 3 kHz to approximately 3 kHz GHz). In the context of activating a distal structure such as an electrode, "activation," "activatable," or "activation" means applying stimulation to the structure that can effectively remove tumor tissue in contact with it. Such activation may include RF, microwave, or current applied to the electrode or current applied to a resistive heating element.

[0059] The ablation device can be configured for tissue treatment, including but not limited to pulsed electric field ablation and electroporation ablation. More specifically, the energy delivery electrode needle can be configured to deliver electrical energy to the target tissue in an amount sufficient to ablate the target tissue. In one embodiment, the electrical energy can be radio frequency energy (RF) or an electrical pulse sufficient to reversibly or irreversibly electroporate (IRE) the target tissue.

[0060] Example 1

[0061] See Figures 1 to 8 The core of this invention is to provide a bipolar cold-cycle ablation needle 01, which includes an energy application unit and a cold-cycle unit. The cold-cycle unit is located inside the energy application unit. The energy application unit is used to apply radio frequency energy to the target tissue to achieve ablation. The cold-cycle unit is used to cool the energy application unit because the energy application unit generates heat when applying radio frequency energy to the target tissue.

[0062] The energy application unit includes at least one first energy application element and at least one second energy application element. The first energy application element and the second energy application element are arranged alternately and at intervals along the length direction of the energy application unit, and one of the first energy application element and the second energy application element is connected to the negative electrode and the other is connected to the positive electrode.

[0063] In this embodiment, a first energy applying element and a second energy applying element are respectively provided, and the first energy applying element is specifically a first electrode and the second energy applying element is specifically a second electrode.

[0064] An insulating element is provided between adjacent first and second electrodes, and the insulating element is configured to prevent short circuits between adjacent first and second electrodes.

[0065] The cold circulation unit includes a fluid circulation channel that extends from the proximal end of the energy application unit toward the distal end and returns from the distal end of the energy application unit to its proximal end, and the fluid circulation channel extends into the first electrode and the second electrode.

[0066] The fluid is configured to flow unidirectionally along the fluid circulation channel, and as the fluid flows through the first and second electrodes, it carries away the heat energy generated by the energy applied to the target tissue.

[0067] The fluid circulation channel has an insulating portion on the channel wall at least in the portion extending into the first electrode and / or the second electrode, and the first electrode and / or the second electrode are insulated from the fluid through the insulating portion to prevent short circuit between the first electrode and the second electrode through the fluid.

[0068] The fluid circulation channel specifically includes a fluid inlet channel and a fluid outlet channel. The fluid inlet channel extends from the proximal end to the distal end of the energy application unit, and the fluid outlet channel extends from the distal end to the proximal end of the energy application unit. The distal ends of the fluid inlet channel and the fluid outlet channel are interconnected.

[0069] At least one of the fluid inlet channel and the fluid outlet channel extends into the first electrode and the second electrode.

[0070] Furthermore, the cold circulation unit also includes a drainage pipe 0107, and the energy application unit has a accommodating cavity along its length, with the drainage pipe 0107 disposed within the accommodating cavity. The fluid inlet channel is the internal channel of the drainage pipe 0107, and the fluid outlet channel is the annular gap formed between the outer wall surface of the drainage pipe 0107 and the inner cavity surface of the accommodating cavity.

[0071] Furthermore, the energy application unit includes a needle tube 0105 and a needle tip 0101, with an insulating component disposed between the needle tube 0105 and the needle tip 0101. The first electrode includes the needle tip 0101, and the second electrode includes the needle tube 0105. The fluid outflow channel is an annular gap formed by the outer wall surface of the drainage tube 0107 and the inner wall surface of the needle tube 0105.

[0072] The insulating component is an insulating isolation ring 0102. The energy application unit includes a first connecting ring 0103 and a second connecting ring 0104. The first connecting ring 0103 is located between the needle tip 0101 and the insulating isolation ring 0102, with both ends coaxially connected to both. The second connecting ring 0104 is located between the needle tube 0105 and the insulating isolation ring 0102, with both ends coaxially connected to both. The first electrode includes the needle tip 0101 and the first connecting ring 0103, and the second electrode includes the needle tube 0105 and the second connecting ring 0104. The needle tip 0101 and the first connecting ring 0103 are made of conductive metal and are welded together to form the first electrode. The second connecting ring 0104 and the needle tube 0105 are made of conductive metal and are welded together.

[0073] In other words, the accommodating cavity of the energy application unit is composed of the inner cavity of the first connecting ring 0103, the insulating isolation ring 0102, the second connecting ring 0104, and the needle tube 0105. Furthermore, in this embodiment, the drainage tube 0107 extends into the insulating isolation ring 0102 but not into the first connecting ring 0103. That is, the drainage tube 0107 extends to the bottom of the accommodating cavity, allowing the distal ends of the fluid inlet channel and the fluid outlet channel to communicate with each other.

[0074] Furthermore, an insulating sheath 0106 is fitted over the needle tube 0105, and the second electrode includes the portion of the needle tube 0105 exposed at the distal end of the insulating sheath 0106. The insulating sheath 0106 is movable relative to the needle tube 0105 to adjust the length of the second electrode.

[0075] In this embodiment, the fluid circulation channel has an insulating portion on the channel wall extending into the first electrode. This insulating portion is an insulating coating, applied to the inner wall of the first connecting ring 0103 and the portion of the needle tip 0101 extending into the first connecting ring 0103. Of course, in other embodiments, an insulating coating can also be provided inside the first electrode.

[0076] It also includes a temperature detection module, located within the first electrode and / or the second electrode, for detecting temperature. In this embodiment, the temperature detection module is a temperature sensing wire 0110, which passes through the drainage tube 0107 and extends to the distal tip 0101 of the needle. The temperature sensing wire 0110 is used to provide feedback on the temperature at the distal end of the energy application unit.

[0077] Example 2

[0078] See Figures 1 to 8 Another core aspect of this invention is to provide a portable bipolar cold cycle ablation device, including the bipolar cold cycle ablation needle 01 of Embodiment 1, and a handheld body. The proximal end of the bipolar cold cycle ablation needle 01 is connected to the handheld body. The bipolar cold cycle ablation needle 01 can be moved to the target tissue with the handheld body. The handheld body is provided with a circulating cooling unit and an energy supply unit.

[0079] The near ends of the fluid inlet channel and the fluid outlet channel are respectively provided with a first liquid inlet and a first liquid outlet. The liquid outlet and return end of the circulating refrigeration unit are connected to the first liquid inlet and the first liquid outlet, respectively, and the fluid is cooled by the circulating refrigeration unit when it flows through it. The energy supply unit is electrically connected to the first electrode and the second electrode to provide energy to both.

[0080] In this embodiment, the handheld body is a handheld shell 02, and a fixing component is provided inside the handheld shell 02. The proximal ends of the needle tube 0105 in the energy application unit and the drainage tube 0107 in the cold circulation unit are connected to the fixing component.

[0081] Specifically, the fixing components include a first fixing component 09 and a second fixing component 10. The first fixing component 09 is located at the distal end of the second fixing component 10 and is fixedly connected to it. The first fixing component 09 has a liquid outlet channel, and the second fixing component 10 has a liquid inlet channel. The first fixing component 09 has a second liquid outlet 0901 communicating with the liquid outlet channel, and the second fixing component 10 has a second liquid inlet 1001 communicating with the liquid inlet channel. The liquid outlet and liquid return ends of the circulating refrigeration unit are respectively connected to the second liquid inlet 1001 and the second liquid outlet 0901.

[0082] The drainage tube 0107 passes through the first fixing member 09 and extends into the second fixing member 10, and the first inlet of the fluid inlet channel in the drainage tube 0107 is connected to the inlet channel; the needle tube 0105 extends into the second fixing member 10, and the first outlet of the fluid outlet channel between the needle tube 0105 and the drainage tube 0107 is connected to the outlet channel.

[0083] After the fluid flows in through the second inlet 1001, it passes through the inlet channel, the drainage tube 0107, the annular gap between the drainage tube 0107 and the needle tube 0105, the outlet channel, and finally flows out through the second outlet 0901.

[0084] The circulating refrigeration unit is circulated with the first liquid inlet and the first liquid outlet near the fluid circulation channel, and is used to drive the fluid circulation flow and cool it. The circulating refrigeration unit includes a circulation pipeline and a liquid storage module, a drive module, and a refrigeration module disposed on the circulation pipeline. The liquid outlet and the liquid return end of the circulation pipeline are respectively connected to the second liquid inlet 1001 and the second liquid outlet 0901.

[0085] The liquid storage module is specifically a water tank 04, which stores fluid used to cool the ablation needle. The drive module is specifically a water pump 14, which drives the fluid circulation, and the cooling module is used to cool the fluid.

[0086] The cooling module includes a cooling cycle component 05, a semiconductor cooling chip 06, a heat sink 07, and a cooling fan 08. The cooling cycle component 05 is made of a high thermal conductivity material and has an internal cooling pipe 0503 for fluid flow. The cooling pipe 0503 is a serpentine reciprocating pipe, which can extend the length of the cooling pipe 0503, allowing the fluid to stay in the cooling cycle component 05 for a longer time, enabling the fluid to drop to a lower temperature and improving the cooling cycle effect.

[0087] The cold end 0601 of the thermoelectric cooler 06 is thermally connected to the cooling cycle component 05 via thermally conductive adhesive. The heat sink 07 is thermally connected to the hot end 0602 of the thermoelectric cooler 06 via thermally conductive adhesive. Specifically, the heat sink 07 is a finned heat sink 07, and a cooling fan 08 is located on the finned end of the heat sink 07. The temperature of the cold end 0601 of the thermoelectric cooler 06 can be as low as -80℃. When fluid flows through the cooling cycle component 05, it can be rapidly cooled before being input to the first and second electrodes, improving electrode cooling efficiency. The heat sink 07 and the cooling fan 08 are used to dissipate heat from the hot end 0602 of the thermoelectric cooler 06, ensuring the normal operation of the thermoelectric cooler 06.

[0088] Specifically, the circulation pipeline includes a first pipeline 1701, a second pipeline 1702, a third pipeline 1703 and a fourth pipeline 1704, the water tank 04 is provided with a water tank return port 0402 and a water tank outlet 0401, the water pump 14 is provided with a pump inlet 1401 and a pump outlet 1402, and the refrigeration circulation component 05 includes a cold circulation inlet 0501 and a cold circulation outlet 0502.

[0089] The first pipe 1701 connects the water tank outlet 0401 and the pump inlet 1401; the second pipe 1702 connects the pump outlet 1402 and the cold circulation inlet 0501; the third pipe 1703 connects the cold circulation outlet 0502 and the second inlet 1001; and the fourth pipe 1704 connects the second outlet 0901 and the water tank return outlet 0402.

[0090] When the water pump 14 is working, the fluid in the water tank 04 is drawn out from the water tank outlet 0401. After being drawn out from the water tank outlet 0401, the fluid flows back to the water tank 04 in the following order: first pipeline 1701, pump inlet 1401, pump outlet 1402, second pipeline 1702, cold circulation inlet 0501, cold circulation outlet 0502, third pipeline 1703, second inlet 1001, inlet channel, fluid delivery channel, fluid outflow channel, outlet channel, second outlet 0901, fourth pipeline 1704, and water tank return port 0402, completing one cold cycle and providing a cooling effect for the first electrode and the second electrode.

[0091] The energy supply unit includes an energy storage module 03 and a transformer module 11. The energy storage module 03 is electrically connected to the transformer module 11, the water pump 14, the semiconductor cooling chip 06, the temperature measuring wire 0110, and the cooling fan 08. The transformer module 11 is connected to the proximal ends of the needle tip 0101 and the needle tube 0105 via the first power line 0108 and the second power line 0109, respectively. The first power line 0108 is inserted into the drainage tube 0107. The first power line 0108 and the temperature measuring line 0110 pass through the proximal end of the drainage tube 0107 and then pass through the outlet 1002 of the second fixing member 10. The outlet 1002 of the second fixing member 10 is provided with a sealing port 1003 on the outside. The sealing port 1003 is connected to the outlet 1002. After the proximal ends of the first power line 0108 and the temperature measuring line 0110 pass through the outlet 1002 and exit through the sealing port 1003, they are sealed with glue. At the same time, the proximal ends of the first power line 0108 and the temperature measuring line 0110 are fixed with glue. The transformer module 11 converts the electrical energy from the energy storage module 03 and supplies it to the first electrode and the second electrode.

[0092] It also includes a power supply 15, a charging module 16, and an excitation unit. The excitation unit includes a switch module 13 and an excitation button 12. The charging module 16 is electrically connected to the power supply 15, and the power supply 15 is electrically connected to the energy storage module 03. The energy storage module 03 can be charged through the charging module 16 and the power supply 15. The energy storage module 03 is electrically connected to the switch module 13, and the switch module 13 abuts against the excitation button 12. The switch module 13 can be triggered by pressing the excitation button 12, thereby controlling the output mode of the energy storage module 03 and the power supply to each structural component. For example: A. Pressing the excitation button 12 once activates the cold cycle ablation mode, supplying power only to the first and second electrodes and outputting energy; B. Pressing the excitation button 12 twice consecutively activates the cold cycle ablation mode and outputs energy; C. Pressing and holding the excitation button 12 stops operation.

[0093] This invention, through the ingenious design of the insulating isolation ring 0102 and the insulating coating, successfully prevents short circuits between the first and second electrodes. This key design not only makes it possible to cool both electrodes through the same water path but also truly achieves bipolar cooling circulation. The realization of bipolar cooling circulation is of great significance, as it helps reduce carbonization of surrounding tissues during bipolar ablation, lowers tissue impedance, and thus significantly improves the efficiency and effectiveness of ablation, providing a more stable and efficient treatment environment for ablation surgery.

[0094] The bipolar design eliminates the need for a negative electrode plate, avoiding the operational complexity and potential risks associated with negative electrode plate connections, simplifying the surgical procedure and improving its convenience.

[0095] The miniaturized power supply unit is built into the handheld unit, eliminating the need for an additional RF or microwave host. The built-in power supply unit directly provides RF energy to the bipolar electrodes. This design reduces connection and operation steps, making surgical procedures simpler and faster, and significantly shortening surgical time.

[0096] With a built-in circulating cooling unit, there is no need for external coolant, piping, or cooling pumps, avoiding the cumbersome operation of external equipment. Through the coordinated operation of the circulating cooling unit and the cold circulation unit, both electrodes can be circulated and cooled simultaneously, resulting in a lower fluid temperature and effective cooling of the tissue surrounding the bipolar electrodes. This further reduces carbonization of the surrounding tissue caused by electrode ablation, lowers impedance, and improves the efficiency and effectiveness of ablation.

[0097] This invention improves ablation efficiency and increases ablation area by optimizing the cooling system and energy supply method. The combined effect of bipolar cooling cycle and cryogenic fluid can eliminate diseased tissue more quickly and thoroughly while reducing damage to surrounding normal tissue, providing patients with a safer and more effective treatment option.

[0098] The power supply unit and the circulating cooling unit are both built into the handheld unit, eliminating the need for radio frequency or microwave equipment. This reduces the cost of purchasing expensive radio frequency or microwave equipment for the user. Furthermore, the absence of external cables and tubing reduces the use of surgical consumables, further lowering surgical costs. This not only alleviates the financial burden on patients but also improves the efficiency of medical resource utilization.

[0099] This invention allows for standalone ablation surgery, and its integrated design enables surgeons to operate the device more flexibly and conveniently during the procedure. Without the need for external equipment, surgeons can adjust the surgical plan promptly according to different surgical needs and patient conditions, improving the precision and safety of the surgery and providing strong support for the widespread adoption of ablation procedures.

[0100] The embodiments of the present invention have been described in detail above with reference to the accompanying drawings, but the present invention is not limited to the above embodiments. Even if various changes are made to the present invention, if these changes fall within the scope of the claims of the present invention and their equivalents, they shall still fall within the protection scope of the present invention.

Claims

1. A portable bipolar cold cycle ablation device, characterized in that, It includes a handheld main body, an energy application unit, a cooling cycle unit, an energy supply unit, and a circulating cooling unit. The energy application unit is fixed to the outside of the handheld main body, the cooling cycle unit is located inside the energy application unit, and both the energy supply unit and the circulating cooling unit are located inside the handheld main body. The energy application unit can be moved with the handheld body to the target tissue to apply energy to the target tissue for ablation; The energy application unit includes at least one first energy application element and at least one second energy application element. The first energy application element and the second energy application element are arranged alternately and at intervals along the length direction of the energy application unit. One of them is connected to the negative terminal and the other is connected to the positive terminal. An insulating element is provided between adjacent first energy application elements and second energy application elements to prevent short circuit between them. The energy supply unit is electrically connected to the circulating refrigeration unit, the first energy application element, and the second energy application element, and is used to provide energy. The cooling cycle unit includes a fluid circulation channel extending from the proximal end of the energy application unit toward the distal end and returning from the distal end to the proximal end, wherein fluid is configured to flow unidirectionally along the fluid circulation channel, and the fluid carries away the heat energy generated by the first energy application element and the second energy application element as it flows through them; The fluid circulation channel has an insulating portion on the channel wall at least in the portion extending into the first energy applying element and / or the second energy applying element, and the first energy applying element and / or the second energy applying element are insulated from the fluid through the insulating portion; The circulating refrigeration unit is circulated with the first liquid inlet and the first liquid outlet near the fluid circulation channel, and is used to drive the fluid to circulate and cool it.

2. The portable bipolar cold cycle ablation device according to claim 1, characterized in that, The fluid circulation channel includes a fluid inlet channel and a fluid outlet channel. The fluid inlet channel extends from the proximal end of the energy application unit toward the distal end, and the fluid outlet channel extends from the distal end of the energy application unit toward the proximal end. The distal ends of the fluid inlet channel and the fluid outlet channel are interconnected. At least one of the fluid inlet channel and the fluid outlet channel extends into the first energy applying element and the second energy applying element.

3. The portable bipolar cold cycle ablation device according to claim 2, characterized in that, The cold circulation unit includes a drain tube, and the energy application unit has a receiving cavity along its length, with the drain tube disposed within the receiving cavity; The fluid inlet channel is the internal channel of the drainage tube, and the fluid outlet channel is the annular gap formed between the outer wall surface of the drainage tube and the inner cavity surface of the accommodating cavity.

4. The portable bipolar cold cycle ablation device according to claim 1, characterized in that, The energy application unit includes a needle tube and a needle tip, and the insulating member is disposed between the needle tube and the needle tip. The first energy application element includes the needle tip, and the second energy application element includes the needle tube.

5. The portable bipolar cold cycle ablation device according to claim 4, characterized in that, The insulating component is an insulating isolation ring, and the energy application unit includes a first connecting ring and a second connecting ring. The first connecting ring is disposed between the needle tip and the insulating isolation ring and its two ends are respectively connected to both of them. The second connecting ring is disposed between the needle tube and the insulating isolation ring and its two ends are respectively connected to both of them. The first energy application element includes the needle tip and the first connecting ring, and the second energy application element includes the needle tube and the second connecting ring.

6. The portable bipolar cold cycle ablation device according to claim 4, characterized in that, The needle is covered with an insulating sheath, and the second energy application element includes the portion of the distal end of the needle that is exposed at the distal end of the insulating sheath.

7. The portable bipolar cold cycle ablation device according to claim 1, characterized in that, The handheld body is provided with a fixing member, and the proximal ends of the energy application unit and the cold cycle unit are connected to the fixing member; The fixing component is provided with a liquid inlet channel and a liquid outlet channel, and the first liquid inlet and the first liquid outlet are respectively connected to the liquid inlet channel and the liquid outlet channel; The fixing component is provided with a second liquid inlet and a second liquid outlet that are respectively connected to the liquid inlet channel and the liquid outlet channel. The liquid outlet end and the liquid return end of the circulating refrigeration unit are respectively connected to the second liquid inlet and the second liquid outlet.

8. The portable bipolar cold cycle ablation device according to claim 1, characterized in that, The circulating refrigeration unit includes a circulating pipeline and a liquid storage module, a drive module, and a refrigeration module disposed on the circulating pipeline. The liquid outlet and liquid return end of the circulating pipeline are respectively connected to the first liquid inlet and the first liquid outlet. The liquid storage module stores the fluid, the drive module drives the fluid to circulate, and the refrigeration module cools the fluid.

9. The portable bipolar cold cycle ablation device according to claim 8, characterized in that, The cooling module includes: A refrigeration circulation component, with internal refrigeration piping for the flow of the fluid; The semiconductor refrigeration chip has its cold end thermally connected to the refrigeration cycle component. The heat sink is thermally connected to the hot end of the semiconductor cooling chip; A cooling fan is mounted on the heat sink.

10. The portable bipolar cold cycle ablation device according to claim 1, characterized in that, The energy supply unit includes an energy storage module and a transformer module. The energy storage module is electrically connected to the transformer module, and the transformer module is electrically connected to the first energy application element and the second energy application element. The transformer module converts the electrical energy from the energy storage module and supplies it to the first energy application element and the second energy application element.

11. The portable bipolar cold cycle ablation device according to claim 1, characterized in that, It includes a temperature detection module, which is disposed within the first energy application element and / or the second energy application element, for detecting temperature.

12. The portable bipolar cold cycle ablation device according to claim 1, characterized in that, The insulating portion is an insulating coating applied to the channel wall of the fluid circulation channel in the portion extending into the first energy applying element and / or the second energy applying element, wherein the first energy applying element and / or the second energy applying element are insulated from the fluid by the insulating coating.

13. The portable bipolar cold cycle ablation device according to claim 1, characterized in that, The device includes an excitation unit disposed on the handheld body. The excitation unit is electrically connected to the energy supply unit. The user can control the energy supply unit to provide energy to the circulating cooling unit, the first energy application element, and the second energy application element by triggering the excitation unit.

14. A bipolar cold-cycle ablation needle, characterized in that, It includes an energy application unit and a cooling cycle unit, wherein the cooling cycle unit is disposed within the energy application unit, wherein: The energy application unit includes at least one first energy application element and at least one second energy application element. The first energy application element and the second energy application element are arranged alternately and at intervals along the length direction of the energy application unit, and one of the first energy application element and the second energy application element is connected to the negative electrode and the other is connected to the positive electrode. An insulating element is provided between adjacent first energy applying elements and second energy applying elements, the insulating element being configured to prevent short circuits between adjacent first energy applying elements and second energy applying elements; The cold circulation unit includes a fluid circulation channel that extends from the proximal end of the energy application unit toward the distal end and returns from the distal end of the energy application unit to its proximal end, and the fluid circulation channel extends into the first energy application element and the second energy application element; The fluid is configured to flow unidirectionally along the fluid circulation channel, and as the fluid flows through the first energy application element and the second energy application element, it carries away the heat energy generated by applying energy to the target tissue. The fluid circulation channel has an insulating portion on the channel wall at least in the portion extending into the first energy applying element and / or the second energy applying element, the first energy applying element and / or the second energy applying element being insulated from the fluid through the insulating portion to prevent short circuits between the first energy applying element and the second energy applying element through the fluid.

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