Radio frequency ablation electrode and its applications and radio frequency ablation system

Abstract

The application discloses a radio frequency ablation electrode, and relates to the technical field of medical devices, which mainly comprises an internal circulation structure and an external perfusion structure; the internal circulation structure can enable refrigerant medium in a liquid supply device to reach a working end of the radio frequency ablation electrode, so as to cool the working end of the radio frequency ablation electrode and surrounding lesion tissues, and can enable the refrigerant medium to flow back to the liquid supply device; the external perfusion structure can enable the refrigerant medium to reach the lesion tissues through micropores on the working end of the radio frequency ablation electrode. The application further discloses a radio frequency ablation system comprising the radio frequency ablation electrode, and application of the radio frequency ablation electrode in preparation of medical devices. The application can increase the electrical conductivity of the lesion tissues around the working end, reduce the working impedance, expand the cooling range, avoid carbonization of the lesion tissues, and thus expand the ablation range.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a radiofrequency ablation electrode and application thereof, and a radiofrequency ablation system. BACKGROUND

[0002] Ablation is a minimally invasive surgery, which is divided into chemical ablation and physical ablation; physical ablation is commonly used in clinical practice, which includes radiofrequency ablation, microwave ablation, cryoablation, ultrasonic ablation, laser ablation, etc.; radiofrequency ablation is a relatively mature and commonly used ablation method, which is mainly used for the treatment of diseases such as nodules, obstructions, and tumors in human tissues and organs; radiofrequency ablation treatment involves puncturing an ablation electrode into a lesion site to release radiofrequency energy, thereby increasing the temperature of cells in the lesion site, causing denaturation, and ultimately leading to the necrosis of the lesion site tissue, which is then absorbed and removed through normal human metabolism, thereby achieving the purpose of eliminating nodules, unblocking obstructions, and eliminating tumors. Radiofrequency ablation treatment requires a radiofrequency ablation system, which includes a radiofrequency ablation instrument and a radiofrequency ablation electrode.

[0003] With the popularization of health checkups, the number of cases detected with lung nodules is gradually increasing, while the means for treating lung nodules are still very limited and have many deficiencies. At present, the main means for treating lung nodules include surgical resection, radiofrequency ablation, and microwave ablation; among them, surgical resection is traumatic and expensive, and cannot be used for multiple treatments.

[0004] Microwave ablation has less trauma and lower cost compared to surgical resection, but the microwave needle has the following shortcomings:

[0005] (1) The microwave needle used in microwave ablation usually has a ceramic needle tip or a copper needle tip coated with Teflon, and the needle tip is generally blunt, which cannot be punctured percutaneously and needs to be punctured after breaking the skin with a skin-breaking needle; when performing lung puncture, lung nodules are hard and normal lung tissue is soft, and the blunt needle tip cannot be directly and accurately punctured into the lesion center, so multiple positioning punctures are required, which can easily cause lung bleeding.

[0006] (2) Before lung nodule ablation, positioning and biopsy are usually required; in order to reduce the puncture time and the number of punctures, a coaxial needle is usually used to puncture into the lesion tissue, a biopsy gun is inserted into the lesion along the coaxial needle cannula to take a biopsy, then an ablation needle is directly punctured into the lesion tissue along the coaxial needle cannula to perform ablation, and finally needle tract ablation is performed, which can avoid the risk of needle tract implantation and bleeding in the biopsy channel, so the ablation needle needs to be thin enough to pass through the coaxial needle cannula; the coaxial needle cannula cannot be too thick, otherwise it can easily cause pneumothorax, so a thin ablation needle is required, and the diameter of the microwave needle is relatively large, which cannot be well applied to lung nodule ablation.

[0007] (3) The principle of microwave ablation determines that the transmitting antenna itself will heat up. In particular, after the characteristic impedance near the working end changes, the microwave transmitting end will heat up severely, causing the ceramic needle on the transmitting antenna to break and fall off. There is a risk of the needle tip breaking during operation.

[0008] Radiofrequency ablation requires the formation of a current loop. Lung tissue is mostly composed of alveoli with low conductivity. When using a single needle for radiofrequency ablation, conventional cold-cycle radiofrequency ablation needles only have an internal circulation cooling system. That is, the cold medium travels from the reservoir to the outer needle tube and then returns to the reservoir through the internal circulation cooling system, without the cold medium entering the lesion tissue. The working end of the radiofrequency ablation needle is surrounded by alveoli, resulting in a small actual contact area between the working end and the lung tissue, and a high initial working impedance. The radiofrequency ablation host impedance recognition system identifies a high initial impedance of the tissue, resulting in no power output or low output power from the host. Even if there is output, a very high voltage is required to ensure output. Furthermore, because there is relatively little lung tissue in actual contact with the working end, the small portion of lung tissue in contact with the working end may undergo rapid carbonization, preventing energy transfer and creating a vicious cycle. The lesion appears as unablated or with a small ablation area on imaging.

[0009] Conventional radiofrequency ablation perfusion needles only have a perfusion system, meaning the liquid medium travels from the reservoir to the tip of the outer needle and into the lesion, increasing tissue conductivity. However, no liquid medium returns to the reservoir, making it impossible to effectively cool the working end. This leads to blockage of some injection holes on the working end during ablation due to blood coagulation and tissue carbonization. Blocked injection holes have no liquid outflow, causing rapid carbonization and a small ablation area. In unblocked injection holes, the flow rate increases, resulting in liquid medium jetting, irregular ablation shapes, and easy ablation of surrounding normal tissue.

[0010] Currently, to reduce the operating impedance of radiofrequency ablation electrodes, it is common practice to increase the contact area between the ablation electrode and the lung. In clinical practice, claw needles are frequently used to increase the contact area between the ablation electrode and the lung; specifically, for example... Figures 1-2 As shown, the claw needle includes a sub-needle 101, an inner needle tube 102, an outer needle tube 103, an insulating layer 104, and a needle tip 105. Multiple sub-needles 101 are welded to the front end of the inner needle tube 102. The inner needle tube 102 is covered by the outer needle tube 103, and the front end of the outer needle tube 103 is the needle tip 105. The needle tip 105 is beveled. The outer needle tube 103 is covered by the insulating layer 104, and the needle tip 105 is exposed. It is used for skin and tissue puncture before ablation and needle tract ablation after ablation. During puncture, the sub-needle 101 is located inside the outer needle tube 103. After puncturing the lesion, the sub-needle 101 is pushed out of the outer needle tube 103. The sub-needle 101 unfolds within the lesion before ablation.

[0011] Although using claw needles can increase the contact area between the ablation electrode and the lung to some extent, claw needles have the following disadvantages:

[0012] (1) The outer needle tube needs to accommodate multiple sub-needles, resulting in a large diameter of the outer needle tube. The tip of the outer needle tube is the outlet of the sub-needles, which is hollow and often made at an oblique angle. Therefore, the sharpness of the needle tip is poor. The large diameter and poor sharpness of the outer needle tube make it difficult to puncture lung nodules.

[0013] (2) Due to the large number of sub-needles, the condition of each sub-needle cannot be seen simultaneously under imaging, and there is a risk that a sub-needle may damage normal tissue.

[0014] (3) When the sub-needles are spread in the lung nodules, because the lung nodules are hard and have great resistance, it may be possible that two or more sub-needles cannot be spread evenly. During ablation, the unspread parts of the sub-needles form a hollow state, resulting in incomplete ablation.

[0015] (4) The claw needle main needle and each of the sub-needles usually do not have a cold circulation function. After ablation, tissue adhesion is easily caused, making it difficult to retract the sub-needles.

[0016] It is evident that the current method of using claw needles to increase the contact area between the ablation electrode and the lung, thereby reducing the working impedance, has several drawbacks and poor clinical application results. Therefore, there is an urgent need to provide a new method to reduce the working impedance of radiofrequency ablation electrodes. Summary of the Invention

[0017] The purpose of this invention is to provide a radiofrequency ablation electrode and its application, as well as a radiofrequency ablation system, to solve the problems existing in the prior art. It can increase the conductivity of the lesion tissue around the working end, reduce the working impedance, expand the cooling range, avoid carbonization of the lesion tissue, and thus expand the ablation range.

[0018] To achieve the above objectives, the present invention provides the following solution:

[0019] This invention provides a radiofrequency ablation electrode, comprising an internal circulation structure and an external perfusion structure;

[0020] The internal circulation structure enables the cold medium in the liquid supply device to reach the working end of the radiofrequency ablation electrode to cool the working end of the radiofrequency ablation electrode and the surrounding lesion tissue, and enables the cold medium to flow back to the liquid supply device.

[0021] The external perfusion structure enables the cold medium to reach the lesion tissue through the micropores on the working end of the radiofrequency ablation electrode.

[0022] Preferably, the inner circulation structure comprises an inner needle tube and an outer needle tube, the outer needle tube is sleeved on the inner needle tube, and a fluid channel is formed between the inner needle tube and the outer needle tube, the fluid channel is capable of being filled with the refrigerant medium, the inner needle tube is provided with an inner needle tube flow channel capable of being filled with the refrigerant medium, the front end of the inner needle tube flow channel is in communication with the front end of the fluid channel, and the rear end of the inner needle tube flow channel and the rear end of the fluid channel are both capable of being connected with the liquid supply device; the front end of the outer needle tube is provided with a needle tip, and the rear end is provided with an insulation layer, and the outer needle tube is further capable of being electrically connected with the radio frequency head;

[0023] The external perfusion structure comprises the micropores, and the micropores are arranged in the working end region of the outer needle tube.

[0024] The refrigerant medium is capable of conducting electricity, and the refrigerant medium is capable of flowing out of the micropores after entering the fluid channel.

[0025] Preferably, the radio frequency ablation electrode further comprises a liquid cavity, the liquid cavity is located at the rear end of the outer needle tube, the liquid cavity is used for containing the refrigerant medium, and the liquid cavity is in communication with the fluid channel and the inner needle tube flow channel.

[0026] The liquid supply device comprises a refrigerant medium source and a refrigerant medium recovery device, the liquid cavity comprises a water inlet cavity and a water outlet cavity, and the water inlet cavity is separated from the water outlet cavity; the water inlet cavity is capable of being connected with the refrigerant medium source through a water inlet pipe, the water outlet cavity is capable of being connected with the refrigerant medium recovery device through a water outlet pipe, the refrigerant medium source is capable of providing the refrigerant medium, and the refrigerant medium recovery device is capable of recovering the refrigerant medium; the rear end of the inner needle tube extends into the water inlet cavity, so that the rear end of the inner needle tube flow channel is in communication with the water inlet cavity, the front end of the inner needle tube flow channel is in communication with the front end of the fluid channel, and the rear end of the fluid channel is in communication with the water outlet cavity.

[0027] Preferably, a water amount adjusting device is further mounted on the water inlet pipe and / or the water outlet pipe, the water amount adjusting device is used for adjusting the water inlet amount or the water outlet amount of the refrigerant medium, so as to adjust the perfusion amount of the refrigerant medium; the refrigerant medium is sterile normal saline or liquid medicine, the perfusion amount of the refrigerant medium is the volume of the refrigerant medium entering the human body per unit time, and the perfusion amount of the refrigerant medium is 0.1ml-2.0ml per minute.

[0028] Preferably, the pore diameter of the micropore is 0.005mm-0.05mm.

[0029] Preferably, the insulation layer is an insulation tube, and a sleeve tube is further sleeved on the front end of the outer needle tube, and the sleeve tube and the insulation tube are sequentially arranged from front to back along the axial direction of the outer needle tube to form a protection tube, and the outer wall of the protection tube is flush with the outer edge of the needle tip; the front end of the sleeve tube is flush with the outer edge of the needle tip, and the rear end of the sleeve tube is flush with the front end of the insulation tube; the sleeve tube can be used for radio frequency energy release, and the sleeve tube is further provided with a developing hole.

[0030] Preferably, a plurality of turns of the micro-holes are arranged on the outer needle tube along the axial direction, a plurality of turns of the developing holes are arranged on the sleeve tube, and the micro-holes and the developing holes are staggered arranged from front to back along the axial direction of the outer needle tube; after the refrigerant medium flows out of the micro-holes, the refrigerant medium can enter the gap between the outer needle tube and the sleeve tube and flow out of the developing holes.

[0031] Preferably, the sleeve tube is a stainless steel metal tube, the insulation tube is a high polymer plastic tube, and the wall thicknesses of the sleeve tube and the insulation tube are both 0.01mm-0.1mm; the needle tip is a three-edged needle tip with an open blade, and the needle tip is welded on the front end of the outer needle tube.

[0032] Preferably, the pore size of the micro-holes is 0.05mm-0.5mm, and the gap between the sleeve tube and the outer needle tube is 0.01mm-0.05mm.

[0033] Preferably, the diameter of the outer needle tube is at least 1.0mm.

[0034] The application further provides a radio frequency ablation system comprising a radio frequency ablation instrument and the radio frequency ablation electrode.

[0035] The application further provides application of the radio frequency ablation electrode in preparation of medical devices.

[0036] The application has the following beneficial technical effects relative to the prior art:

[0037] The radio frequency ablation electrode comprises an internal circulation structure and an external perfusion structure, the internal circulation structure can make the refrigerant medium in the liquid supply device reach the working end of the radio frequency ablation electrode to cool the working end of the radio frequency ablation electrode and the lesion tissue around the working end, and can make the refrigerant medium flow back to the liquid supply device; the refrigerant medium can realize internal circulation, realize the cooling function of the radio frequency ablation electrode, and also ensure that the small gap between the micro-holes, the outer needle tube and the sleeve tube is not blocked during the ablation process, blood does not enter the small gap and the micro-holes to cause carbonization adhesion, and the refrigerant medium can continuously and uniformly seep out of each hole to ensure the effective external perfusion of the refrigerant medium.

[0038] The external perfusion structure of the application can make the refrigerant medium reach the lesion tissue through the micropores on the working end of the radiofrequency ablation electrode, can cool the working end of the outer needle tube and the lesion tissue near it, and the refrigerant medium can be injected into the lesion tissue to increase the electrical conductivity of the tissue, expand the cooling range, effectively solve the problem of carbonization and adhesion of the lesion tissue or blood during energy injection, ensure that energy can be continuously input, and further expand the ablation range, and the patient recovers faster after ablation of the ablation site. BRIEF DESCRIPTION OF DRAWINGS

[0039] In order to more clearly illustrate the technical solutions in the embodiments of the application or the prior art, the drawings needed in the embodiments will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the application, and other drawings can be obtained by those skilled in the art without creative labor on the basis of these drawings.

[0040] Figure 1 It is a structure schematic diagram of the claw needle in the prior art;

[0041] Figure 2 It is an A-A sectional view of Figure 1

[0042] Figures 1-2 In the figure, 101 is a sub-needle; 102 is an inner needle tube; 103 is an outer needle tube; 104 is an insulation layer; and 105 is a needle tip.

[0043] Figure 3 It is a structure schematic diagram of the radiofrequency ablation electrode in the first embodiment of the application;

[0044] Figure 4 It is a structure schematic diagram of the radiofrequency ablation electrode in the second embodiment of the application;

[0045] Figure 5 It is a local enlarged view of the working end part of the radiofrequency ablation electrode in the second embodiment of the application;

[0046] Figure 6 It is a structure schematic diagram of the outer needle tube of the radiofrequency ablation electrode in the second embodiment of the application;

[0047] Figure 7 It is a structure schematic diagram of the outer sleeve tube of the radiofrequency ablation electrode in the second embodiment of the application;

[0048] Figure 8 It is an assembly schematic diagram of the outer sleeve tube and the outer needle tube of the radiofrequency ablation electrode in the second embodiment of the application;

[0049] Figure 9 It is a refrigerant medium flow schematic diagram in the embodiment of the application;

[0050] Figure 10 ​This is a schematic diagram of the cold medium injection in Embodiment 2 of the present invention;

[0051] Figure 11 This is a schematic diagram of a coaxial needle in an embodiment of the present invention;

[0052] Figure 12 for Figure 11 Cross-sectional view of the middle section (BB);

[0053] Figure 13 for Figure 11 CC section view;

[0054] Figures 3-13 In the middle, 1-outer needle tube; 2-solder joint; 3-handle; 4-water inlet chamber; 5-inner needle tube; 6-water return chamber; 7-inner wire; 8-RF wire; 9-RF head; 10-water inlet tube; 11-multi-position adjustment switch; 12-water return tube; 13-insulating tube; 14-outer tube; 15-micro-hole; 16-development hole; 17-needle tip; 18-coaxial needle core rod; 19-coaxial needle sleeve. Detailed Implementation

[0055] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0056] The purpose of this invention is to provide a radiofrequency ablation electrode and its application, as well as a radiofrequency ablation system, to solve the problems existing in the prior art. It can increase the conductivity of the lesion tissue around the working end, reduce the working impedance, expand the cooling range, avoid carbonization of the lesion tissue, and thus expand the ablation range.

[0057] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0058] Example 1

[0059] like Figure 3 As shown, this embodiment provides a radiofrequency ablation electrode, which mainly includes an internal circulation structure and an external perfusion structure. The internal circulation structure enables the cold medium in the liquid supply device to reach the working end of the radiofrequency ablation electrode to cool the working end of the radiofrequency ablation electrode and the surrounding lesion tissue, and enables the cold medium to flow back to the liquid supply device. The external perfusion structure enables the cold medium to reach the lesion tissue through the micropores on the working end of the radiofrequency ablation electrode.

[0060] In the embodiment, the inner circulation structure mainly comprises the inner needle tube 5 and the outer needle tube 1; wherein the outer needle tube 1 is sleeved on the inner needle tube 5, and a fluid passage is formed between the outer needle tube 1 and the inner needle tube 5, the fluid passage can be filled with the refrigerant medium, the inner needle tube 5 is provided with an inner needle tube flow channel capable of being filled with the refrigerant medium, the front end of the inner needle tube flow channel is in communication with the front end of the fluid passage, and the rear end of the inner needle tube flow channel and the rear end of the fluid passage can be connected with the liquid supply device; the front end of the outer needle tube 1 is provided with a needle tip 17, and the rear end is provided with an insulating layer, the insulating layer can insulate and protect the part of the outer needle tube 1 which does not need to release energy, so as to prevent the non-treatment part penetrated by the radiofrequency ablation electrode from being damaged by heat; further, the outer needle tube 1 is a conductive metal tube, the outer needle tube 1 can also be electrically connected with the radiofrequency head 9 through the inner lead wire 7, the radiofrequency line 8 and the radiofrequency head 9, and the radiofrequency head 9 sends current energy to the outer needle tube 1, specifically, the inner lead wire 7 is welded at the rear end of the outer needle tube 1 through the welding spot 2, the inner lead wire 7 is electrically connected with the radiofrequency head 9 through the radiofrequency line 8, the radiofrequency head 9 is connected with the radiofrequency host, and the radiofrequency energy is outputted.

[0061] The external perfusion structure mainly comprises the micropore 15, which is arranged at the working end region of the outer needle tube 1.

[0062] In the embodiment, the refrigerant medium can conduct electricity, and after the refrigerant medium enters the fluid passage, it can overflow from the micropore 15, the micropore 15 has a small aperture, which can ensure that only a small amount of refrigerant medium overflows from the micropore 15, and after the refrigerant medium overflows from the micropore 15, it forms high-temperature vapor after oscillation at the same frequency as the working frequency and under the action of high temperature, the high-temperature vapor only diffuses to the lesion tissue nearby, increases the electrical conductivity of the lesion tissue, and does not flow into other parts of the human body, thereby reducing the influence on the human body as much as possible.

[0063] In the embodiment, the radiofrequency ablation electrode, the outer needle tube 1 is sleeved on the inner needle tube 5, a fluid passage is formed between the outer needle tube 1 and the inner needle tube 5, the working end region of the outer needle tube 1 has a micropore 15, and the conductive refrigerant medium can overflow through the micropore 15, the overflowed refrigerant medium increases the electrical conductivity of the lung tissue around the working end of the radiofrequency ablation electrode, and reduces the working impedance; when radiofrequency ablation is performed, the lung tissue around the working end is damaged by heat, the alveoli in the lung tissue near the working end of the electrode needle are extruded after thermal damage, the lesion tissue of the lung shrinks and collapses, the collapsed lung tissue is tightly combined and wrapped on the surface of the working end of the radiofrequency ablation electrode, the contact area between the working end of the radiofrequency ablation electrode and the lung tissue is increased, the working impedance is further reduced, a low-impedance working environment is formed, the ablation range is expanded, and the problem that the impedance is high when the conventional radiofrequency single needle ablation is performed, and the radiofrequency energy of the host is not outputted or the output is small is overcome.

[0064] And the refrigerant medium in the flow channel, can be cooled to the outside needle tube 1 work end and near the lesion tissue, and the refrigerant medium can be injected into the lesion tissue, expand cooling range, effectively solve the energy injection process, lesion tissue or blood carbonization adhesion problem, ensure that the energy can be continuously input, and further expand the ablation range, the patient after the ablation site absorption fast.

[0065] In this embodiment, the radiofrequency ablation electrode also includes a liquid cavity, the liquid cavity is located at the rear end of the outer needle tube 1, the liquid cavity is used for containing refrigerant medium, and the liquid cavity is communicated with the fluid channel and the inner needle tube flow channel; specifically, the liquid supply device includes a refrigerant medium source and a refrigerant medium recovery device, the liquid cavity includes a water inlet cavity 4 and a water outlet cavity 6, the water inlet cavity 4 is separated from the water outlet cavity 6, that is, the water inlet cavity 4 is not communicated with the water outlet cavity 6; the water inlet cavity 4 can be connected with the refrigerant medium source through the water inlet pipe 10, the water outlet cavity 6 can be connected with the refrigerant medium recovery device through the water outlet pipe 12, the refrigerant medium source can provide refrigerant medium, and the refrigerant medium recovery device can recover refrigerant medium; the rear end of the inner needle tube 5 extends into the water inlet cavity 4, so that the rear end of the inner needle tube flow channel is communicated with the water inlet cavity 4, the front end of the inner needle tube flow channel is communicated with the front end of the fluid channel, and the rear end of the fluid channel is communicated with the water outlet cavity 6.

[0066] In this embodiment, as shown in Figure 9 The refrigerant medium in the refrigerant medium source enters the water inlet cavity 4 in the liquid cavity through the water inlet pipe 10, enters the inner needle tube flow channel from the rear end of the inner needle tube 5, then enters the front end of the fluid channel between the inner needle tube 5 and the outer needle tube 1 from the front end of the inner needle tube flow channel, and finally flows into the refrigerant medium recovery device through the water outlet cavity 6 and the water outlet pipe 12 for recovery; during the flow of the refrigerant medium, the working end of the radiofrequency ablation electrode and the lesion tissue near the working end can be effectively cooled, and a small amount of refrigerant medium can overflow from the micro holes 15, which can increase the electrical conductivity of the lung tissue and effectively transmit the radiofrequency current energy.

[0067] In this embodiment, in order to realize the circulation of the refrigerant medium, the refrigerant medium source and the refrigerant medium recovery device can be communicated; or the refrigerant medium source and the refrigerant medium recovery device are integrated, for example, a liquid bottle; as a preferred embodiment, the refrigerant medium source and the refrigerant medium recovery device are integrated in this embodiment. Further, in order to enable the refrigerant medium to circulate smoothly, a circulating pump is arranged between the liquid bottle and the water inlet pipe 10 to provide power for the circulation of the refrigerant medium. In this embodiment, the radiofrequency ablation electrode realizes the cold circulation function, which can ensure that the micro holes 15 are not blocked during the ablation process, blood does not enter the micro holes 15, and carbonization adhesion does not occur, thereby ensuring that the refrigerant medium can continuously and uniformly seep out of each micro hole 15.

[0068] In the embodiment, the refrigerant medium is sterile normal saline or liquid medicine, preferably cooled sterile normal saline, which can increase tissue conductivity, effectively transmit radio frequency current energy, and reduce the temperature of the tissue near the working end after being cooled.

[0069] In the embodiment, the water inlet pipe 10 and / or the water return pipe 12 is further provided with a water amount adjusting device for adjusting the water inlet amount or the water return amount of the refrigerant medium, thereby adjusting the perfusion amount of the refrigerant medium; wherein the water amount adjusting device can be selected according to specific working needs, such as a multi-grade adjusting switch 11 or a multi-grade hose buckle. As a preferred embodiment, the water amount adjusting device is only installed on the water return pipe 12 in the embodiment, and the perfusion amount of the refrigerant medium is controlled by controlling the water return; when the perfusion amount of the refrigerant medium is insufficient, the water return is reduced to increase the perfusion amount; when the perfusion amount is large, the opposite is true.

[0070] Further, the perfusion amount of the refrigerant medium is preferably 0.1-2.0 ml per minute, wherein the perfusion amount of the refrigerant medium is the volume of the refrigerant medium entering the human body per unit time. The micro-perfusion is adopted in the embodiment, and the perfusion amount of the refrigerant medium can be adjusted by the multi-grade adjusting switch 11. After the micro-perfusion refrigerant medium is oscillated at the same frequency as the working frequency, high-temperature water vapor is formed, which will not cause adverse effects after a large amount of liquid is injected into the human body.

[0071] In the embodiment, the needle tip 17 is an open blade three-prong needle tip, and the needle tip 17 is welded to the front end of the outer needle tube 1; the needle tip 17 has high sharpness and can easily puncture the skin, hard skin or tissue such as lung nodules; wherein the outer diameter of the outer needle tube 1 can be at least 1.0 mm, which overcomes the problem of pneumothorax caused by thick needle tubes during lung puncture.

[0072] In the embodiment, since the refrigerant medium flows out of the micro-hole 15 and directly flows into the human body, in order to ensure that only a small amount of refrigerant medium flows into the human body, the pore size of the micro-hole 15 should be small, preferably 0.005-0.05 mm.

[0073] In the embodiment, in order to facilitate the operator to hold the radio frequency ablation electrode during operation, shield and protect the circuit and pipeline of the electrode, a handle 3 is arranged at the rear end of the outer needle tube 1, the handle 3 can cover the liquid cavity, and the tail of the handle 3 has an arc structure, which conforms to ergonomics, is convenient for the operator to hold, does not slip for a long time, and does not require much effort.

[0074] Embodiment Two

[0075] The embodiment provides a radio frequency ablation electrode, which is an improvement on the basis of the embodiment one, and the improvement mainly lies in that, compared with the embodiment one,

[0076] In the embodiment, as shown in the figure, Figures 4-8 The insulation layer is an insulation tube 13, which is sleeved on the rear end of the outer needle tube 1, and the outer sleeve tube 14 is also sleeved on the front end of the outer needle tube 1, and the outer sleeve tube 14 and the insulation tube 13 are sequentially arranged along the axial direction of the outer needle tube 1 from front to rear, forming a protection tube, and the outer wall of the protection tube is flush with the outer edge of the needle tip 17; wherein the outer sleeve tube 14 can be used for radio frequency energy release, and the outer sleeve tube 14 is also provided with a developing hole 16, and the insulation tube 13 can insulate and protect the part of the outer needle tube 1 which does not need to release energy, so as to prevent the non-treatment part through which the radio frequency ablation electrode passes from being damaged by heat.

[0077] In the embodiment, the inner needle tube 5, the outer needle tube 1 and the protection tube are preferably circular tubes, or can also be square tubes or other polygonal prism tubes according to the needs.

[0078] In the embodiment, a plurality of micro-holes 15 are arranged on the outer needle tube 1 along the axial direction, a plurality of developing holes 16 are arranged on the outer sleeve tube 14 along the axial direction, and the micro-holes 15 and the developing holes 16 are staggered arranged along the axial direction of the outer needle tube 1 from front to rear, that is, along the axial direction, the position of the micro-holes 15 on the outer needle tube 1 corresponds to the tube wall of the outer sleeve tube 14 (the position where the developing hole 16 is not arranged), and the tube wall of the outer sleeve tube 14 can shield the micro-holes 15 to prevent the refrigerant medium from being sprayed; however, as shown in the figure, Figure 10 A small gap is left between the outer sleeve tube 14 and the outer needle tube 1, and after the refrigerant medium flows out of the micro-holes 15, it can enter the gap between the outer needle tube 1 and the outer sleeve tube 14 and seep out of the developing hole 16; wherein in order to ensure the micro-perfusion of the refrigerant medium, the gap between the outer sleeve tube 14 and the outer needle tube 1 is preferably 0.01mm-0.05mm.

[0079] The cold circulation function of the radio frequency ablation electrode in the embodiment also ensures that the small gap between the micro-holes 15, the outer needle tube 1 and the outer sleeve tube 14 is not blocked during the ablation process, and blood cannot enter the small gap and the micro-holes 15 to cause carbonization adhesion, so that the refrigerant medium can continuously and uniformly seep out of each hole.

[0080] Further, since the refrigerant medium needs to pass through the gap between the outer needle tube 1 and the outer sleeve tube 14 and the developing hole 16 to seep into the human body after flowing out of the micro-holes 15, the micro-holes 15 in the embodiment can have a larger aperture than those in the embodiment one, and the micro-perfusion can also be achieved under the condition of a larger aperture; wherein the aperture of the micro-holes 15 is preferably 0.05mm-0.5mm, and the micro-holes 15 with a larger aperture can reduce the processing difficulty of the outer needle tube 1 to a certain extent.

[0081] Moreover, the outer sleeve 14 is provided with the developing hole 16, which can form a concave-convex working end surface and has a developing function under the imaging device, thereby overcoming the problem of unclear developing of the working end under the imaging device, and particularly avoiding the problem that each sub-needle of the claw needle cannot be simultaneously seen under the imaging device in the prior art. In the embodiment, accurate puncture can be achieved by judging the position of the working end during puncture, thereby avoiding mis-puncture caused by the working end that cannot be developed.

[0082] As a preferred embodiment, in the embodiment, as shown in Figures 6-7 the micro-holes 15 are provided with three circles, and the three circles of micro-holes 15 are respectively arranged on three groups of circumferences with a distance of a, a+b, a+b+c from the front end of the needle tip 17 on the outer needle tube 1. The center of the micro-hole 15 is located on the corresponding circumference, and each circle of micro-holes 15 is provided with three micro-holes 15, which are uniformly distributed on the circumference, and a total of nine micro-holes 15 are provided. The three micro-holes 15 of each circle correspond to each other, and the connecting line between the centers of the corresponding micro-holes 15 is parallel to the axis of the outer needle tube 1. Further, the developing holes 16 are correspondingly provided with three circles, and the three circles of developing holes 16 are respectively arranged on three groups of circumferences with a distance of d, e, f from the front end of the outer sleeve 14. The front end of the developing hole 16 is located on the corresponding circumference, and each circle of developing holes 16 is provided with three developing holes 16, which are uniformly distributed on the circumference, and a total of nine developing holes 16 are provided. The three developing holes 16 of each circle correspond to each other, and the connecting line between the centers of the corresponding developing holes 16 is parallel to the axis of the outer sleeve 14. Among them, the three micro-holes 15 of each circle and the three developing holes 16 of each circle correspond to each other, and the connecting line between the centers of the corresponding micro-holes 15 and developing holes 16 is parallel to the axis of the outer needle tube 1.

[0083] In the embodiment, a is preferably 4.5mm-8.5mm, b is preferably 5mm-9mm, c is preferably 5.5mm-9.5mm, d is preferably 2.25mm-4.25mm, e is preferably 8.5mm-12.5mm, and f is preferably 15.75mm-19.75mm. Among them, the distance of each micro-hole 15 from the front end of the needle tip 17, and the distance of each developing hole 16 from the front end of the outer sleeve 14, can be selected according to the work requirement, and specifically, can be selected according to the length of the working end of the radiofrequency ablation electrode.

[0084] In the embodiment, the number of circles and the number of each circle of the micro-holes 15 and the developing holes 16 can be selected as required, such as being provided with 4 circles or 5 circles, and each circle can be provided with 4 or 5 holes. Among them, the number of circles and the number of each circle of the micro-holes 15 and the developing holes 16 can be the same or different. Further, the shape of the micro-holes 15 and the developing holes 16 can also be selected according to the specific work requirement, such as being a square hole or a round hole, and as a preferred embodiment, the micro-holes 15 are round holes and the developing holes 16 are square holes.

[0085] In the embodiment, the fluid passage between the inner needle tube 5 and the outer needle tube 1 can be an annular fluid passage, and the annular gap between the inner needle tube 5 and the outer needle tube 1 is the fluid passage; or the fluid passage is an axial passage, and a plurality of axial passages are uniformly distributed along the circumference between the inner needle tube 5 and the outer needle tube 1, and the axial passage corresponds to the micropore 15 on each circle one by one; as a preferred embodiment, the fluid passage in the embodiment is an annular fluid passage.

[0086] In the embodiment, the outer sleeve tube 14 and the insulation tube 13 can be integrally arranged or separately arranged, and are preferably separately arranged; wherein the outer sleeve tube 14 is sleeved at the front end of the outer needle tube 1, the insulation tube 13 is sleeved at the part of the outer needle tube 1 which does not need to release energy, the front end outer wall of the outer sleeve tube 14 is flush with the outer edge of the needle tip 17, and the rear end outer wall is flush with the outer wall of the insulation tube 13, so that the front end port of the insulation tube 13 is prevented from being squeezed and wrinkled with the skin tissue during puncture, so that the length of the exposed working end is increased, and the normal tissue is damaged.

[0087] In the embodiment, the outer sleeve tube 14 is preferably a thin-walled stainless steel metal tube, the front end of which is welded with the rear end of the needle tip 17, and the welding point a1 of the outer sleeve tube 14 and the welding point a1 of the outer needle tube 1 and the needle tip 17 coincide, the front end of the outer sleeve tube 14 and the front end of the outer needle tube 1 are welded, the connection is realized, the communication between the outer needle tube 1 and the outer sleeve tube 14 is realized, and thus the outer sleeve tube 14 can be used for releasing radio frequency energy; and the insulation tube 13 is preferably a thin-walled high polymer plastic tube; wherein the wall thickness of the insulation tube 13 and the outer sleeve tube 14 is preferably 0.01mm-0.1mm, the insulation tube 13 is preferably made of Teflon material, or PEEK or polyimide material according to needs.

[0088] In the embodiment, the outer sleeve tube 14 can also be made of an insulating material, and radio frequency energy can be released through the developing hole 16 on the outer sleeve tube 14; and the front end of the outer sleeve tube 14 can be connected with the needle tip 17 through clamping or bonding.

[0089] Embodiment three

[0090] The embodiment provides a radio frequency ablation system, which comprises a radio frequency ablation instrument and the radio frequency ablation electrode in the embodiment one or the embodiment two.

[0091] Embodiment four

[0092] The embodiment provides an application of the radio frequency ablation electrode in the embodiment one or the embodiment two in the preparation of a medical instrument; specifically, the radio frequency ablation electrode in the embodiment can be prepared into a biopsy ablation device together with a coaxial needle and a biopsy gun, such as Figures 11-13As shown, the coaxial needle cannula 19 is matched with the coaxial needle mandrel 18, and during surgery, the coaxial needle mandrel 18 is first inserted into the coaxial needle cannula 19 to puncture the skin to the lesion, after puncturing the lesion, the coaxial needle mandrel 18 is withdrawn, the biopsy gun is inserted into the coaxial needle cannula 19 to the lesion to take biopsy, and then the biopsy gun is taken out; the radiofrequency ablation electrode is inserted into the coaxial needle cannula 19 to ablate the lesion, after ablation is completed, the coaxial needle cannula 19 is withdrawn together with the radiofrequency ablation electrode, and needle channel ablation is performed by using the radiofrequency ablation electrode; it should be noted that when radiofrequency ablation is performed, the working end of the radiofrequency ablation electrode is inserted into the coaxial needle cannula 19, the front end of the insulating tube 13 on the outer needle tube 1 is spaced apart from the front end of the coaxial needle cannula 19 by more than 1 cm, and cannot be in contact, otherwise the coaxial needle cannula 19 will conduct electricity.

[0093] In the embodiment, the outer diameter of the outer needle tube 1 can be at least 1.0 mm, and the overall diameter of the radiofrequency ablation electrode is small, so that the radiofrequency ablation electrode can be inserted into the coaxial needle cannula 19 to perform radiofrequency ablation, thereby solving the problem that the microwave needle or the claw needle cannot be inserted into the coaxial needle in the prior art due to the thick needle tube, and completing biopsy and ablation in the same puncture channel to avoid secondary puncture, and ablation is performed on the puncture channel after ablation to avoid bleeding and needle channel implantation after multiple punctures.

[0094] In the embodiment, the radiofrequency ablation electrode can also be used in cooperation with other medical devices other than the biopsy gun according to specific working needs.

[0095] Based on the basic principle of radiofrequency ablation (radiofrequency ablation is to cause thermal damage to tissue through resistance heating and heat conduction principle, and then to cause coagulation necrosis to achieve the purpose of ablation of nodules, tumors and the like), by perfusing a small amount of refrigerant medium, the electrical conductivity of the lesion tissue is increased, and by cold circulation, the temperature of the lesion is reduced to prevent tissue carbonization, the impedance of the lesion can be reduced, the continuous output of radiofrequency energy is facilitated, and the range of radiofrequency ablation is expanded.

[0096] Moreover, the present application has the functions of cold circulation, liquid perfusion, and adjustable perfusion flow, and has the advantages of small diameter and clear development under imaging equipment, and is a safe and effective radiofrequency ablation electrode that can be applied to lung tumors, lung nodules and the like; it should be further noted that the present application includes but is not limited to the treatment of lung tumors, nodules and the like, and the radiofrequency ablation electrode for other lesion sites and the like derived from the principle and structure of the present application can be understood as being within the protection scope of the present application.

[0097] It is to be understood that the application is not limited to the details of the above-exemplified embodiments and that the present application can be carried out in other concrete ways without departing from the spirit or essential characteristics of the application. Consequently, all changes and modifications that can suggest themselves to one skilled in the art have to be seen as being within the scope of the present application as defined by the following claims. The embodiments are to be considered in all respects as illustrative only and not restrictive of the application described and claimed herein. The application is therefore not to be limited to the specific embodiments described herein, but only by the scope of the appended patent claims and their equivalents.

[0098] The above examples are illustrative of the principles and embodiments of the application. They are not meant to limit the scope of the application, which is defined by the claims. The application is not limited to the specific details described herein.

Claims

1. A radio frequency ablation electrode, characterized by: The inner circulation structure and the external perfusion structure are provided; The inner circulation structure can make the refrigerant medium in the liquid supply device reach the working end of the radio frequency ablation electrode to cool the working end of the radio frequency ablation electrode and the lesion tissue around the working end, and can make the refrigerant medium flow back to the liquid supply device; The external perfusion structure can make the refrigerant medium reach the lesion tissue through the micropores on the working end of the radio frequency ablation electrode; The inner circulation structure comprises an inner needle tube and an outer needle tube, the outer needle tube is sleeved on the inner needle tube, and a fluid channel is formed between the outer needle tube and the inner needle tube, the refrigerant medium can be introduced into the fluid channel, an inner needle tube flow channel capable of introducing the refrigerant medium is arranged in the inner needle tube, the front end of the inner needle tube flow channel is in communication with the front end of the fluid channel, and the rear end of the inner needle tube flow channel and the rear end of the fluid channel are both capable of being connected with the liquid supply device; the liquid supply device comprises a refrigerant medium source and a refrigerant medium recovery device, the inner needle tube flow channel can be connected with the refrigerant medium source through a water inlet pipe, the fluid channel can be connected with the refrigerant medium recovery device through a water outlet pipe, the refrigerant medium source can provide the refrigerant medium, and the refrigerant medium recovery device can recover the refrigerant medium; a water amount adjusting device is further arranged on the water inlet pipe and / or the water outlet pipe, the water amount adjusting device is used for adjusting the water inlet amount or the water outlet amount of the refrigerant medium, so as to adjust the perfusion amount of the refrigerant medium; The front end of the outer needle tube is provided with a needle tip, and the rear end is provided with an insulating layer, and the outer needle tube can be electrically connected with a radio frequency head; The external perfusion structure comprises the micropores, and the micropores are arranged in the working end region of the outer needle tube; The front end of the outer needle tube is further sleeved with an outer sleeve tube, the outer sleeve tube can be used for radio frequency energy release, and a developing hole is further arranged on the outer sleeve tube, a plurality of circles of the micropores are arranged on the outer needle tube along the axial direction, a plurality of circles of the developing holes are arranged on the outer sleeve tube along the axial direction, and the micropores and the developing holes are arranged staggeredly from front to back along the axial direction of the outer needle tube; after the refrigerant medium flows out of the micropores, the refrigerant medium can enter the gap between the outer needle tube and the outer sleeve tube and flow out of the developing holes; the pore diameter of the micropores is 0.05mm-0.5mm, and the gap between the outer sleeve tube and the outer needle tube is 0.01mm-0.05mm.

2. The radio frequency ablation electrode of claim 1, wherein: The refrigerant medium can conduct electricity, and after the refrigerant medium enters the fluid channel, the refrigerant medium can flow out of the micropores.

3. The radio frequency ablation electrode of claim 2, wherein: The radio frequency ablation electrode further comprises a liquid cavity, the liquid cavity is located at the rear end of the outer needle tube, the liquid cavity is used for containing the refrigerant medium, and the liquid cavity is in communication with the fluid channel and the inner needle tube flow channel; The liquid cavity comprises a water inlet cavity and a water return cavity, the water inlet cavity is separated from the water return cavity; the water inlet cavity is connected with the refrigerant medium source through a water inlet pipe, the water return cavity is connected with the refrigerant medium recovery device through a water return pipe, the refrigerant medium source can provide the refrigerant medium, and the refrigerant medium recovery device can recover the refrigerant medium; the rear end of the inner needle tube extends into the water inlet cavity, so that the rear end of the inner needle tube flow channel communicates with the water inlet cavity, and the rear end of the fluid channel communicates with the water return cavity.

4. The radio frequency ablation electrode of claim 3, wherein: The refrigerant medium is sterile normal saline or liquid medicine, the perfusion volume of the refrigerant medium is the volume of the refrigerant medium entering the human body per unit time, and the perfusion volume of the refrigerant medium is 0.1-2.0 ml per minute.

5. The radio frequency ablation electrode of claim 2, wherein: The pore size of the micropore is 0.005-0.05 mm.

6. The radio frequency ablation electrode of claim 2, wherein: The insulation layer is an insulation tube, the outer sleeve tube and the insulation tube are sequentially arranged along the axial direction of the outer needle tube from front to back to form a protection tube, and the outer wall of the protection tube is flush with the outer edge of the needle tip; wherein the front end outer wall of the outer sleeve tube is flush with the outer edge of the needle tip, and the rear end outer wall of the outer sleeve tube is flush with the front end outer wall of the insulation tube.

7. The radio frequency ablation electrode of claim 6, wherein: The outer sleeve tube is a stainless steel metal tube, the insulation tube is a high polymer plastic tube, and the wall thickness of the outer sleeve tube and the insulation tube is 0.01-0.1 mm; the needle tip is a three-edged needle tip with an open blade, and the needle tip is welded to the front end of the outer needle tube.

8. The radio frequency ablation electrode of claim 2, wherein: The diameter of the outer needle tube is at least 1.0 mm.

9. A radio frequency ablation system, characterized by: The radio frequency ablation electrode according to any one of claims 1-8.

10. Use of the radio frequency ablation electrode according to any one of claims 1-8 in the preparation of a medical device.

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