Portable bipolar cold circulation ablation device and ablation needle

Abstract

The portable bipolar cold circulation ablation device comprises a handheld body, an energy applying unit, a cold circulation unit, an energy supply unit and a circulation refrigeration unit, the energy applying unit is fixedly arranged outside the handheld body, and the cold circulation unit is arranged inside the energy applying unit; the energy applying unit can move to a target tissue along with the handheld main body; the energy applying unit comprises at least one first energy applying element and at least one second energy applying element; the cold circulation unit comprises a fluid circulation channel which extends from the near end of the energy applying unit to the far end and returns to the near end from the far end of the energy applying unit. The fluid circulation channel is at least provided with an insulating part on the channel wall of the part extending into the first energy applying element and / or the second energy applying element. And the circulating refrigeration unit is circularly communicated with the first liquid inlet and the first liquid outlet at the near end of the fluid circulating channel and is used for driving fluid to circularly flow and refrigerating the fluid.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of medical devices, and particularly relates to a bipolar cold circulation ablation needle and device. BACKGROUND

[0002] The high incidence of tumor diseases has made thermal ablation treatment technology an important research direction in the field of clinical medicine. Radiofrequency ablation has become one of the core methods of tumor thermal ablation treatment due to its advantages such as precision and minimally invasive. With the continuous rise of global tumor incidence, the clinical demand for tumor thermal ablation surgery is showing a rapid growth trend. According to industry data, the global radiofrequency ablation market size has exceeded 2 billion US dollars in 2019, and is expected to expand at a CAGR of 8.5% to reach about 4 billion US dollars by 2027. This market growth potential highlights the broad application prospects of radiofrequency ablation technology in the field of tumor treatment, and also puts forward higher requirements for device performance, operation convenience and treatment efficiency.

[0003] However, the current thermal ablation electrode products on the market still have significant technical bottlenecks, which are difficult to meet the rapid development of clinical demand. The existing radiofrequency ablation electrodes generally rely on external radiofrequency or microwave host for energy supply, resulting in large device size and high host procurement cost. This design not only increases the overall cost of the surgery, but also puts strict requirements on the space layout and equipment configuration of the operating room, limiting its popularization and application in primary medical institutions. The mainstream monopolar radiofrequency ablation electrode needs to be used with a negative plate, and its operation process is complicated and there is a potential risk of burning the patient with the negative plate. In addition, although some monopolar electrodes are equipped with cooling systems to control tissue temperature, they need to be connected to an external cooling liquid circulation device through complex pipelines, which causes line entanglement and limited operation space during the surgery, increasing the operation difficulty and risk of the doctor. The cooling design of traditional bipolar radiofrequency ablation electrodes has defects, most of which only have cooling function in monopolar or completely lack cooling circulation, resulting in a sharp rise in tissue temperature around the electrode during ablation, causing problems such as tissue carbonization and rapid impedance rise. This phenomenon not only reduces the ablation efficiency, but also may cause uncontrollable ablation range due to uneven energy distribution, affecting the treatment effect and increasing the risk of complications. SUMMARY

[0004] To solve the above problems, the purpose of the present application is to provide a bipolar cold circulation ablation needle and device, which can realize the effect of bipolar cooling at the same time.

[0005] To achieve the above-mentioned purposes, the technical solutions of the present application are as follows: A portable bipolar cold cycle ablation device comprises a hand-held main body, an energy application unit, a cold cycle unit, an energy supply unit and a circulating refrigeration unit, the energy application unit is fixed to the outside of the hand-held main body, the cold cycle unit is arranged in the inside of the energy application unit, and the energy supply unit and the circulating refrigeration unit are arranged in the inside of the hand-held main body; The energy application unit can be moved to the target tissue along with the hand-held main body to apply energy to the target tissue for ablation; the energy application unit comprises 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 along the length direction of the energy application unit, one of them is connected to the negative pole and the other is connected to the positive pole, and an insulating member is arranged between the adjacent first energy application element and the second energy application element to prevent short circuit between them; The energy supply unit is electrically connected with the circulating refrigeration unit, the first energy application element and the second energy application element for providing energy; The cold cycle unit comprises a fluid circulation channel extending from the proximal end to the distal end of the energy application unit and returning from the distal end to the proximal end, the fluid is configured to flow unidirectionally along the fluid circulation channel, and the fluid carries out the heat generated by the first energy application element and the second energy application element when flowing through them; the fluid circulation channel is provided with an insulating part on the channel wall of at least the part extending into the first energy application element and / or the second energy application element, and the first energy application element and / or the second energy application element is insulated from the fluid by the insulating part; 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 for driving the fluid circulation and refrigerating the fluid.

[0006] According to an embodiment of the present application, the fluid circulation channel comprises 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, the fluid outlet channel extends from the distal end to the proximal end of the energy application unit, and the distal ends of the fluid inlet channel and the fluid outlet channel are in communication with each other; At least one of the fluid inlet channel and the fluid outlet channel extends into the first energy application element and the second energy application element.

[0007] According to an embodiment of the present application, the cold cycle unit comprises a drainage tube, the energy application unit is provided with a receiving cavity along the length direction, and the drainage tube is arranged in the receiving cavity; The fluid feeding channel is an internal channel of the drainage tube, and the fluid flowing-out channel is an annular gap formed between an outer wall surface of the drainage tube and an inner cavity surface of the accommodating cavity.

[0008] According to an embodiment of the present application, the energy applying unit comprises a needle tube and a needle tip, the insulation member is arranged between the needle tube and the needle tip, the first energy applying element comprises the needle tip, and the second energy applying element comprises the needle tube.

[0009] According to an embodiment of the present application, the insulation member is an insulation partition ring, the energy applying unit comprises a first connecting ring and a second connecting ring, the first connecting ring is arranged between the needle tip and the insulation partition ring and connected to both of them at two ends, and the second connecting ring is arranged between the needle tube and the insulation partition ring and connected to both of them at two ends. The first energy applying element comprises the needle tip and the first connecting ring, and the second energy applying element comprises the needle tube and the second connecting ring.

[0010] According to an embodiment of the present application, an insulation sheath is arranged outside the needle tube, and the second energy applying element comprises a part of the needle tube at a distal end of the insulation sheath.

[0011] According to an embodiment of the present application, a fixing member is arranged in the hand-held main body, and the proximal ends of the energy applying unit and the cold circulation unit are connected to the fixing member. The fixing member is internally provided with a liquid inlet channel and a liquid outlet channel, and the first liquid inlet and the first liquid outlet are in communication with the liquid inlet channel and the liquid outlet channel, respectively. The fixing member is provided with a second liquid inlet and a second liquid outlet in communication with the liquid inlet channel and the liquid outlet channel, respectively, and the liquid outlet end and the liquid return end of the circulation refrigeration unit are in communication with the second liquid inlet and the second liquid outlet, respectively.

[0012] According to an embodiment of the present application, the circulation refrigeration unit comprises a circulation pipeline and a liquid storage module, a driving module and a refrigeration module arranged on the circulation pipeline, and the liquid outlet end and the liquid return end of the circulation pipeline are in communication with the first liquid inlet and the first liquid outlet, respectively. The liquid storage module stores the fluid, the driving module is used to drive the circulation of the fluid, and the refrigeration module is used to refrigerate the fluid.

[0013] According to an embodiment of the present application, the refrigeration module comprises: a refrigeration circulation member internally provided with a refrigeration pipeline for the circulation of the fluid; a semiconductor refrigeration piece with a cold end in thermal connection with the refrigeration circulation member; a heat sink in thermal contact with the hot end of the semiconductor refrigeration sheet; a heat dissipation fan arranged on the heat sink.

[0014] According to an embodiment of the present application, the energy supply unit comprises an energy storage module and a voltage conversion module, the energy storage module is electrically connected with the voltage conversion module, the voltage conversion module is electrically connected with the first energy applying element and the second energy applying element, and the voltage conversion module converts the electric energy of the energy storage module and provides the converted electric energy to the first energy applying element and the second energy applying element.

[0015] According to an embodiment of the present application, a temperature detection module is arranged in the first energy applying element and / or the second energy applying element, and is used for detecting temperature.

[0016] According to an embodiment of the present application, the insulation part is an insulation coating, the insulation coating is coated on the channel wall of the part of the fluid circulation channel 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 is insulated from the fluid through the insulation coating.

[0017] According to an embodiment of the present application, an excitation part is arranged on the handheld main body, the excitation part is electrically connected with the energy supply unit, and a user triggers the excitation part to control the energy supply unit to provide energy to the circulating refrigeration unit, the first energy applying element and the second energy applying element.

[0018] Based on the same concept, the present application further provides a bipolar cold circulation ablation needle, comprising an energy applying unit and a cold circulation unit, the cold circulation unit is arranged in the energy applying unit, wherein: the energy applying unit comprises at least one first energy applying element and at least one second energy applying element, the first energy applying element and the second energy applying element are sequentially and alternately arranged along the length direction of the energy applying unit, and one of the first energy applying element and the second energy applying element is connected with a negative electrode and the other is connected with a positive electrode; an insulation part is arranged between adjacent first energy applying elements and second energy applying elements, and the insulation part is configured to prevent short circuit between adjacent first energy applying elements and second energy applying elements; the cold circulation unit comprises a fluid circulation channel, the fluid circulation channel extends from the proximal end of the energy applying unit to the distal end, and returns from the distal end of the energy applying unit to the proximal end, and the fluid circulation channel extends into the first energy applying element and the second energy applying element; The fluid is configured to flow unidirectionally along the fluid circulation channel, and the fluid carries away the heat generated by the first energy application element and the second energy application element when the fluid flows through the first energy application element and the second energy application element, and the heat is applied to the target tissue to generate energy; The fluid circulation channel is provided with an insulation part on the channel wall of at least a portion extending into the first energy application element and / or the second energy application element, and the first energy application element and / or the second energy application element is insulated from the fluid through the insulation part, so as to prevent short circuit between the first energy application element and the second energy application element through the fluid.

[0019] Compared with the prior art, the present application has the following advantages and positive effects: By means of the ingenious design of the insulation part and the insulation part, the short circuit between the first energy application element and the second energy application element is successfully prevented. This key design not only makes it possible to cool the double electrodes in the same waterway, but also truly realizes bipolar cold circulation. The realization of bipolar cold circulation is of great significance, which helps to reduce the phenomenon of carbonization of surrounding tissues during double electrode ablation, reduces the tissue impedance, and thus significantly improves the ablation efficiency and effect, and provides a more stable and efficient treatment environment for ablation surgery.

[0020] By adopting the bipolar design, the negative plate does not need to be connected, the operation complexity and potential risks caused by the connection of the negative plate are avoided, the operation process is simplified, and the convenience of the operation is improved.

[0021] The energy supply unit is miniaturized and built-in in the main body, does not need to be additionally connected to a radio frequency or microwave host, and directly provides radio frequency energy for the bipolar by the built-in energy supply unit. Such a design reduces the connection and operation steps of the equipment, makes the operation more simple and fast, and greatly shortens the operation time.

[0022] The built-in circulating refrigeration unit does not need to be externally connected to a cooling liquid, a pipeline and a cooling pump, and avoids the cumbersome operation of the external equipment. Through the cooperation of the circulating refrigeration unit and the cold circulation unit, two electrodes can be simultaneously cooled, the temperature of the fluid is lower, the surrounding tissues of the bipolar are effectively cooled, the carbonization of the surrounding tissues caused by electrode ablation is further reduced, the impedance is reduced, and the ablation efficiency and effect are improved. By optimizing the cooling system and the energy supply mode, the ablation efficiency is improved, and the ablation area is increased. The combined action of bipolar cold circulation and low-temperature fluid can more quickly and completely eliminate the diseased tissues, while reducing the damage to the surrounding normal tissues, and provides a safer and more effective treatment scheme for the patient.

[0023] The energy supply unit and the circulating refrigeration unit are both built in the main body, without the need to cooperate with radio frequency or microwave equipment, so that the use unit does not need to purchase expensive radio frequency or microwave equipment, and the equipment procurement cost is effectively reduced. Moreover, no additional cable and pipeline are externally connected, the use of surgical consumables is reduced, and the surgical cost is further reduced. This not only reduces the economic burden of patients, but also improves the utilization efficiency of medical resources. The ablation surgery treatment can be completed alone, and the integrated design enables the doctor to operate more flexibly and conveniently during the surgery. Without the limitation of external equipment, the doctor can adjust the surgical plan in time according to different surgical needs and patient conditions, improve the precision and safety of the surgery, and provide strong support for the wide development of ablation surgery. BRIEF DESCRIPTION OF DRAWINGS

[0024] The specific embodiments of the present application will be further described in detail below in combination with the drawings, in which: Figure 1 A cross section of the bipolar cold circulation ablation device in the present application Figure 1 ; Figure 2 A cross section of the bipolar cold circulation ablation device in the present application Figure 2 ; Figure 3 A schematic diagram of the circulating refrigeration unit in the present application Figure 4 A cross section of the connection between the fixing member and the bipolar cold circulation ablation needle in the present application Figure 5 A schematic diagram of the bipolar cold circulation ablation needle in the present application Figure 1 ; Figure 6 A schematic diagram of the bipolar cold circulation ablation needle in the present application Figure 2 ; Figure 7 A schematic diagram of the first electrode in the present application Figure 8 A schematic diagram of the refrigeration module in the present application

[0025] Explanation of reference signs: 01, bipolar cold cycle ablation needle; 0101, needle tip; 0102, insulation break ring; 0103, first connection ring; 0104, second connection ring; 0105, needle tube; 0106, insulation sheath tube; 0107, drainage tube; 0108, first power line; 0109, second power line; 0110, temperature measurement line; 02, handheld shell; 03, energy storage module; 04, water tank; 0401, water tank liquid outlet; 0402, water tank liquid return; 05, refrigeration cycle component; 0501, cold cycle liquid inlet; 0502, cold cycle liquid outlet; 0503, refrigeration pipeline; 06, semiconductor refrigeration sheet; 0601, cold end; 0602, hot end; 07, heat sink; 08, heat dissipation fan; 09, first fixing component; 0901, second liquid outlet; 10, second fixing component; 1001, second liquid inlet; 1002, outlet; 1003, blocking port; 11, voltage conversion module; 12, trigger button; 13, switch module; 14, water pump; 1401, pump liquid inlet; 1402, pump liquid outlet; 15, power supply; 16, charging module; 1701, first pipeline; 1702, second pipeline; 1703, third pipeline; 1704, fourth pipeline. DETAILED DESCRIPTION

[0026] The present application will be further described with reference to the drawings and specific examples. The advantages and features of the present application will be more apparent from the following description in conjunction with the drawings. It should be noted that the drawings are in a very simplified form and are not drawn to precise scale. They are used only to facilitate the understanding of the embodiments of the present application.

[0027] It should be noted that all directional references (e.g., upper, lower, right, left, rear, front, rearward, forward, under, above, etc.) are in relation to the exemplary embodiment of the present application, as illustrated in the drawings, and are used only to facilitate understanding of the present application.

[0028] The term "radio frequency" or "RF" refers to an alternating current of electrical current in the radio frequency range (extending from below 3 kHz to about 3 kHz gigahertz). In the context of activating a distal structure, such as an electrode, "activation," "activatable," or "activating" means applying a stimulus to the structure that is effective to ablate tumor tissue in contact with the structure. Such activation can include applying RF, microwave, or electrical current to the electrode or electrical current to a resistive heating element.

[0029] 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 a target tissue in an amount sufficient to ablate the target tissue. In one embodiment, the electrical energy can be radio frequency energy (RF) or electrical pulses sufficient to reversibly or irreversibly electroporate (IRE) the target tissue.

[0030] Embodiment 1 Referring to Figures 1 to 8 The core of the present application is to provide a bipolar cold cycle ablation needle 01, comprising an energy application unit and a cold cycle unit, the cold cycle unit is arranged in the energy application unit, the energy application unit is used to apply radio frequency energy to the target tissue to achieve ablation, and the cold cycle unit is used to cool the energy application unit because the energy application unit will generate heat when applying radio frequency energy to the target tissue.

[0031] The energy application unit comprises 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 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 pole and the other is connected to the positive pole.

[0032] In this embodiment, the first energy application element and the second energy application element are respectively provided with one, and the first energy application element is specifically a first electrode, and the second energy application element is specifically a second electrode.

[0033] An insulating piece is arranged between adjacent first electrodes and second electrodes, and the insulating piece is configured to prevent short circuit between adjacent first electrodes and second electrodes.

[0034] The cold cycle unit comprises a fluid circulation channel, the fluid circulation channel extends from the proximal end of the energy application unit to the distal end, and returns from the distal end of the energy application unit to the proximal end, and the fluid circulation channel extends into the first electrode and the second electrode.

[0035] The fluid is configured to flow unidirectionally along the fluid circulation channel, and the fluid carries out the heat generated by the first electrode and the second electrode when the fluid flows through the first electrode and the second electrode.

[0036] The fluid circulation channel is provided with an insulating part on the channel wall of at least the part extending into the first electrode and / or the second electrode, and the first electrode and / or the second electrode is insulated from the fluid by the insulating part, so as to prevent short circuit between the first electrode and the second electrode through the fluid.

[0037] The fluid circulation channel specifically comprises a fluid inlet channel and a fluid outlet channel, the fluid inlet channel extends from the proximal end of the energy application unit to the distal end, the fluid outlet channel extends from the distal end of the energy application unit to the proximal end, and the distal ends of the fluid inlet channel and the fluid outlet channel are communicated with each other.

[0038] At least one of the fluid inlet channel and the fluid outlet channel extends into the first electrode and the second electrode.

[0039] Further, the cold circulation unit further comprises a drainage tube 0107, and the energy applying unit is provided with a receiving cavity in the length direction of the energy applying unit, and the drainage tube 0107 is arranged in the receiving cavity. The fluid inlet channel is an internal channel of the drainage tube 0107, and the fluid outlet channel is an annular gap between the outer wall surface of the drainage tube 0107 and the inner cavity surface of the receiving cavity.

[0040] Further, the energy applying unit comprises a needle tube 0105 and a needle tip 0101, and an insulating member is arranged between the needle tube 0105 and the needle tip 0101, the first electrode comprises the needle tip 0101, and the second electrode comprises the needle tube 0105. The fluid outlet channel is an annular gap between the outer wall surface of the drainage tube 0107 and the inner wall surface of the needle tube 0105.

[0041] The insulating member is an insulating partition ring 0102, the energy applying unit comprises a first connecting ring 0103 and a second connecting ring 0104, the first connecting ring 0103 is arranged between the needle tip 0101 and the insulating partition ring 0102 and coaxially connected to both ends thereof, and the second connecting ring 0104 is arranged between the needle tube 0105 and the insulating partition ring 0102 and coaxially connected to both ends thereof. The first electrode comprises the needle tip 0101 and the first connecting ring 0103, and the second electrode comprises the needle tube 0105 and the second connecting ring 0104. The needle tip 0101 and the first connecting ring 0103 are made of metal conductive material, and the needle tip 0101 and the first connecting ring 0103 are welded to form the first electrode. The second connecting ring 0104 and the needle tube 0105 are made of metal conductive material, and the second connecting ring 0104 and the needle tube 0105 are welded.

[0042] That is, the receiving cavity of the energy applying unit is composed of the inner cavities of the first connecting ring 0103, the insulating partition ring 0102, the second connecting ring 0104 and the needle tube 0105. In this embodiment, the drainage tube 0107 extends into the insulating partition ring 0102 and does not extend into the first connecting ring 0103, that is, the drainage tube 0107 extends into the bottom of the receiving cavity, so that the distal ends of the fluid inlet channel and the fluid outlet channel can communicate with each other.

[0043] Further, the needle tube 0105 is externally sleeved with an insulating sheath tube 0106, and the second electrode comprises the part of the distal end of the needle tube 0105 exposed by the distal end of the insulating sheath tube 0106. The insulating sheath tube 0106 can move relative to the needle tube 0105 to adjust the length of the second electrode.

[0044] In this embodiment, the fluid circulation channel is provided with an insulating part on the channel wall of the part extending into the first electrode, and in this embodiment, the insulating part is an insulating coating, which is coated on the inner wall of the first connecting ring 0103 and the part of the needle tip 0101 extending into the first connecting ring 0103. Of course, in other embodiments, an insulating coating can also be provided in the first electrode.

[0045] The temperature detection module is a temperature detection wire 0110 in this embodiment, which is arranged in the drainage tube 0107 and extends to the needle tip 0101 at the distal end, and is used to feedback the temperature at the distal end of the energy application unit.

[0046] Embodiment 2 Referring to Figures 1 to 8 Another core of the present application is to provide a portable bipolar cold circulation ablation device, which comprises the bipolar cold circulation ablation needle 01 of embodiment 1, and further comprises a handheld body, the proximal end of the bipolar cold circulation ablation needle 01 is connected with the handheld body, the bipolar cold circulation ablation needle 01 can be moved to the target tissue together with the handheld body, and the handheld body is provided with a circulating refrigeration unit and an energy supply unit.

[0047] The proximal 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 end and the liquid return end of the circulating refrigeration unit are respectively communicated with the first liquid inlet and the first liquid outlet, and the fluid is refrigerated by the circulating refrigeration unit when flowing through the circulating refrigeration unit. The energy supply unit is electrically connected with the first electrode and the second electrode, and is used to supply energy to the two electrodes.

[0048] In this embodiment, the handheld body is a handheld shell 02, and the handheld shell 02 is provided with a fixing member, the proximal end of the needle tube 0105 in the energy application unit and the proximal end of the drainage tube 0107 in the circulating refrigeration unit are connected with the fixing member.

[0049] Specifically, the fixing member comprises a first fixing member 09 and a second fixing member 10, the first fixing member 09 is located at one end of the second fixing member 10 towards the distal end and is fixedly connected with the second fixing member 10. The first fixing member 09 is provided with a liquid outlet channel, the second fixing member 10 is provided with a liquid inlet channel, and the first fixing member 09 is provided with a second liquid outlet 0901 communicated with the liquid outlet channel, and the second fixing member 10 is provided with a second liquid inlet 1001 communicated with the liquid inlet channel. The liquid outlet end and the liquid return end of the circulating refrigeration unit are respectively communicated with the second liquid inlet 1001 and the second liquid outlet 0901.

[0050] The drainage tube 0107 penetrates through the first fixing member 09 and extends into the second fixing member 10, and the first liquid inlet of the fluid inlet channel in the drainage tube 0107 is communicated with the liquid inlet channel; the needle tube 0105 extends into the second fixing member 10, and the first liquid outlet of the fluid outlet channel between the needle tube 0105 and the drainage tube 0107 is communicated with the liquid outlet channel.

[0051] The fluid flows into the second liquid inlet 1001, then sequentially passes through the liquid inlet channel, the drainage tube 0107, the annular gap between the drainage tube 0107 and the needle tube 0105, and the liquid outlet channel, and finally flows out from the second liquid outlet 0901.

[0052] The circulating refrigeration unit is in circulation communication with the first liquid inlet and the first liquid outlet proximal to the fluid circulation channel, for driving the fluid circulation flow and refrigerating the same. The circulating refrigeration unit comprises a circulating pipeline and a liquid storage module, a driving module and a refrigeration module arranged on the circulating pipeline, and the liquid outlet end and the liquid return end of the circulating pipeline are in communication with the second liquid inlet 1001 and the second liquid outlet 0901 respectively.

[0053] The liquid storage module is specifically a water tank 04, which stores fluid for cooling the ablation needle. The driving module is specifically a water pump 14, for driving the fluid circulation flow, and the refrigeration module is for refrigerating the fluid.

[0054] The refrigeration module comprises a refrigeration cycle part 05, a semiconductor refrigeration sheet 06, a heat sink 07 and a heat dissipation fan 08. The refrigeration cycle part 05 is made of high thermal conductivity material, and has a refrigeration pipeline 0503 inside for fluid circulation. The refrigeration pipeline 0503 is a serpentine reciprocating pipeline, which can extend the length of the refrigeration pipeline 0503, so that the fluid stays in the refrigeration cycle part 05 for a longer time, and the fluid can be cooled to a lower temperature, so that the refrigeration cycle is more effective.

[0055] The cold end 0601 of the semiconductor refrigeration sheet 06 is connected to the refrigeration cycle part 05 by thermal conductive glue, the heat sink 07 is connected to the hot end 0602 of the semiconductor refrigeration sheet 06 by thermal conductive glue, and the heat sink 07 is specifically a fin heat sink 07, and the heat dissipation fan 08 is arranged on the fin end of the heat sink 07. The temperature of the cold end 0601 of the semiconductor refrigeration sheet 06 can be as low as -80℃, and the fluid flowing through the refrigeration cycle part 05 can be quickly cooled before being input into the first electrode and the second electrode, thereby improving the cooling efficiency of the electrodes. The heat sink 07 and the heat dissipation fan 08 are used to dissipate heat from the hot end 0602 of the semiconductor refrigeration sheet 06, so as to ensure that the semiconductor refrigeration sheet 06 can work normally.

[0056] Specifically, the circulating pipeline comprises 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 liquid return port 0402 and a water tank liquid outlet port 0401, the water pump 14 is provided with a pump liquid inlet port 1401 and a pump liquid outlet port 1402, and the refrigeration cycle part 05 comprises a cold cycle liquid inlet port 0501 and a cold cycle liquid outlet port 0502.

[0057] The first pipeline 1701 connects the water tank liquid outlet port 0401 and the pump liquid inlet port 1401, the second pipeline 1702 connects the pump liquid outlet port 1402 and the cold cycle liquid inlet port 0501, the third pipeline 1703 connects the cold cycle liquid outlet port 0502 and the second liquid inlet 1001, and the fourth pipeline 1704 connects the second liquid outlet 0901 and the water tank liquid return port 0402.

[0058] When the water pump 14 is working, the fluid in the water tank 04 is pumped out from the water tank outlet 0401, and then flows back to the water tank 04 along the first pipeline 1701, the pump inlet 1401, the pump outlet 1402, the second pipeline 1702, the cold circulation inlet 0501, the cold circulation outlet 0502, the third pipeline 1703, the second inlet 1001, the inlet channel, the fluid feeding channel, the fluid flowing-out channel, the outlet channel, the second outlet 0901, the fourth pipeline 1704, and the water tank return port 0402, completing a cold circulation and providing cooling effect for the first electrode and the second electrode.

[0059] The energy supply unit includes an energy storage module 03 and a voltage conversion module 11, and the energy storage module 03 is electrically connected with the voltage conversion module 11, the water pump 14, the semiconductor refrigeration sheet 06, the temperature measuring wire 0110, and the cooling fan 08. The voltage conversion module 11 is connected with the needle tip 0101 and the proximal end of the needle tube 0105 through the first power line 0108 and the second power line 0109 respectively, and the first power line 0108 is arranged in the drainage tube 0107. The first power line 0108 and the temperature measuring wire 0110 are arranged out of the drainage tube 0107 through the outlet 1002 of the second fixing member 10, and the outside of the outlet 1002 of the second fixing member 10 is provided with a sealing port 1003 which is communicated with the outlet 1002. The proximal end of the first power line 0108 and the temperature measuring wire 0110 is arranged out of the sealing port 1003 through the outlet 1002, and is simultaneously sealed by glue and fixed by glue at the proximal end. The voltage conversion module 11 converts the electric energy of the energy storage module 03 and provides it to the first electrode and the second electrode.

[0060] The device further includes a power supply 15, a charging module 16, and an excitation part including a switch module 13 and an excitation button 12. The charging module 16 is electrically connected with the power supply 15, and the power supply 15 is electrically connected with 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 with the switch module 13, and the switch module 13 is in abutment with the excitation button 12. The switch module 13 can be triggered by pressing the excitation button 12, so as to control the output mode of the energy storage module 03 and the power supply on-off of each structural component. For example: A, press the excitation button 12 for one time to start the ablation mode without cold circulation, and only supply power to the first electrode and the second electrode; B, press the excitation button 12 for two times to start the cold circulation ablation mode; and C, press the excitation button 12 for a long time to stop working.

[0061] 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.

[0062] 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.

[0063] 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.

[0064] 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.

[0065] 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.

[0066] 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.

[0067] 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.

[0068] The embodiments of the present application are explained in detail above with reference to the accompanying drawings, but the present application is not limited to the above-described embodiments. Even if various changes are made to the present application, if the changes fall within the scope of the claims of the present application and equivalents thereof, they are still within the protective scope of the present application.

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 component, and the proximal ends of the energy application unit and the cold cycle unit are connected to the fixing component; 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.

Images