WO2024092945A1 - 射频消融电极及其应用以及射频消融系统 - Google Patents

射频消融电极及其应用以及射频消融系统 Download PDF

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WO2024092945A1
WO2024092945A1 PCT/CN2022/135833 CN2022135833W WO2024092945A1 WO 2024092945 A1 WO2024092945 A1 WO 2024092945A1 CN 2022135833 W CN2022135833 W CN 2022135833W WO 2024092945 A1 WO2024092945 A1 WO 2024092945A1
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Prior art keywords
cold medium
needle tube
ablation electrode
tube
radiofrequency ablation
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PCT/CN2022/135833
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English (en)
French (fr)
Inventor
马富
李勇生
姜珏
杨丽
张占超
赵勇
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绵阳立德电子股份有限公司
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Publication of WO2024092945A1 publication Critical patent/WO2024092945A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor

Definitions

  • the present invention relates to the technical field of medical devices, and in particular to a radio frequency ablation electrode and application thereof, and a radio frequency ablation system.
  • Ablation is a minimally invasive surgery, which is divided into chemical ablation and physical ablation.
  • Physical ablation is commonly used in clinical practice, including 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 to treat diseases such as nodules, blockages, and tumors in human tissues and organs.
  • Radiofrequency ablation treatment is to puncture the ablation electrode into the lesion site, release radiofrequency energy, increase the temperature of the cells in the lesion site, degenerate, and eventually cause necrosis of the tissues in the lesion site, which is absorbed and cleared through the normal metabolism of the human body, achieving the purpose of eliminating nodules, unblocking blockages, and eliminating tumors.
  • Radiofrequency ablation treatment requires a matching radiofrequency ablation system, including a radiofrequency ablation device and radiofrequency ablation electrodes.
  • the means of treating lung nodules are still very limited and there are many deficiencies.
  • the main means of treating lung nodules are surgical resection, radiofrequency ablation, and microwave ablation. Among them, surgical resection is traumatic, expensive, and cannot be treated multiple times.
  • microwave ablation is less invasive and less expensive, but microwave ablation has the following disadvantages:
  • the microwave needles used in microwave ablation are usually ceramic needle tips or copper needle tips coated with Teflon.
  • the needle tips are generally blunt and cannot be punctured percutaneously.
  • a skin-breaking needle is required to break the skin before puncturing.
  • lung puncture lung nodules are hard and normal lung tissue is soft.
  • the needle tip is blunt and cannot directly and accurately puncture the center of the lesion. Multiple positioning punctures are required, which can easily cause pulmonary hemorrhage.
  • the principle of microwave ablation determines that the transmitting antenna itself will heat up. Especially when 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, and there is a risk of the needle tip breaking during operation.
  • Radiofrequency ablation requires the formation of a current loop.
  • Lung tissue is mostly alveoli with low electrical conductivity.
  • the conventional cold-circulation radiofrequency ablation single needle only has an internal circulation cooling system, that is, the cold medium reaches the outer needle tube from the reservoir, and then returns to the reservoir through the internal circulation cooling system, and no cold medium enters the lesion tissue.
  • the working end of the radiofrequency ablation needle is mostly surrounded by alveoli, resulting in a small actual contact area between the working end and the lung tissue, a high initial working impedance, and a high initial impedance of the radiofrequency ablation host impedance recognition system. As a result, the host power does not output or the output power is low.
  • 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 provided with the outer needle tube 103.
  • the front end of the outer needle tube 103 is the needle tip 105.
  • the needle tip 105 is cut with an oblique edge.
  • the outer needle tube 103 is provided with the insulating layer 104.
  • the needle tip 105 is exposed and is used for skin and tissue puncture before ablation and needle tract ablation after ablation.
  • the sub-needle 101 is located in the outer needle tube 103. After puncturing the lesion, the sub-needle 101 is pushed out of the outer needle tube 103, and the sub-needle 101 is deployed in the lesion for ablation.
  • the claw needle can increase the contact area between the ablation electrode and the lung to a certain extent, the claw needle has the following disadvantages:
  • the outer needle tube needs to accommodate multiple needles, resulting in a larger diameter of the outer needle tube.
  • the tip of the outer needle tube is the outlet for the needles, which is hollow and often has an oblique incision, so the sharpness of the needle tip is poor.
  • the large diameter of the outer needle tube and the poor sharpness make it difficult to puncture lung nodules.
  • the claw needle main needle and its sub-needles usually do not have a cold circulation function, which can easily cause tissue adhesion after ablation, making it difficult to retract the sub-needles.
  • the purpose of the present invention is to provide a radiofrequency ablation electrode and its application and a radiofrequency ablation system to solve the problems existing in the above-mentioned prior art, which can increase the conductivity of the lesion tissue around the working end, reduce the working impedance, and expand the cooling range to avoid carbonization of the lesion tissue, thereby expanding the ablation range.
  • the present invention provides the following solutions:
  • the present invention provides a radiofrequency ablation electrode, comprising 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 microholes on the working end of the radiofrequency ablation electrode.
  • the internal circulation structure comprises an inner needle tube and an outer needle tube
  • the outer needle tube is sleeved on the inner needle tube
  • a fluid channel is formed between the outer needle tube and the inner needle tube
  • the cold medium can be passed into the fluid channel
  • the inner needle tube is provided with an inner needle tube flow channel that can pass the cold medium
  • the front end of the inner needle tube flow channel is communicated with the front end of the fluid channel
  • the rear end of the inner needle tube flow channel and the rear end of the fluid channel can be connected to 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 insulating layer
  • the outer needle tube can also be electrically connected to the radio frequency head
  • the external perfusion structure includes the micropore, which is arranged in the working end area of the outer needle tube;
  • the cold medium is electrically conductive, and after entering the fluid channel, the cold medium can flow out from the micropores.
  • the radiofrequency 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 to contain the cold medium, and the liquid cavity is communicated with the fluid channel and the inner needle tube flow channel;
  • the liquid supply device includes a cold medium source and a cold medium recovery device, the liquid chamber includes an inlet chamber and a return chamber, the inlet chamber is separated from the return chamber; the inlet chamber can be connected to the cold medium source through an inlet pipe, and the return chamber can be connected to the cold medium recovery device through a return pipe, the cold medium source can provide the cold medium, and the cold medium recovery device can recover the cold medium; the rear end of the inner needle tube extends into the water inlet chamber, so that the rear end of the inner needle tube flow channel is connected to the water inlet chamber, the front end of the inner needle tube flow channel is connected to the front end of the fluid channel, and the rear end of the fluid channel is connected to the return chamber.
  • a water volume regulating device is also installed on the water inlet pipe and/or the water return pipe, and the water volume regulating device is used to adjust the water inlet volume or water return volume of the cold medium, thereby adjusting the perfusion volume of the cold medium;
  • the cold medium is sterile saline or liquid medicine
  • the perfusion volume of the cold medium is the volume of the cold medium entering the human body per unit time
  • the perfusion volume of the cold medium is 0.1ml-2.0ml per minute.
  • the pore size of the micropores is 0.005 mm-0.05 mm.
  • the insulating layer is an insulating tube
  • the front end of the outer needle tube is also sleeved with an outer sleeve
  • the outer sleeve and the insulating tube are arranged in sequence from front to back along the axial direction of the outer needle tube to form a protective tube, and the outer wall of the protective tube is flush with the outer edge of the needle tip; wherein the front end outer wall of the outer sleeve is flush with the outer edge of the needle tip, and the rear end outer wall of the outer sleeve is flush with the front end outer wall of the insulating tube; the outer sleeve can be used for radio frequency energy release, and a developing hole is also provided on the outer sleeve.
  • the outer needle tube is provided with multiple circles of micropores along the axial direction
  • the outer sleeve is provided with multiple circles of developing holes
  • the micropores and the developing holes are staggered from front to back along the axial direction of the outer needle tube; after the cold medium flows out from the micropores, it can enter the gap between the outer needle tube and the outer sleeve and flow out from the developing holes.
  • the outer sleeve is a stainless steel metal tube
  • the insulating tube is a polymer plastic tube
  • the wall thickness of the outer sleeve and the insulating tube are both 0.01mm-0.1mm
  • the needle tip is a sharpened triangular needle tip, and the needle tip is welded to the front end of the outer needle tube.
  • the diameter of the micropores is 0.05 mm-0.5 mm, and the gap between the outer sleeve and the outer needle tube is 0.01 mm-0.05 mm.
  • the minimum diameter of the outer needle tube is 1.0 mm.
  • the present invention also provides a radiofrequency ablation system, comprising a radiofrequency ablation apparatus and the radiofrequency ablation electrode.
  • the present invention also provides the use of the radio frequency ablation electrode in the preparation of medical devices.
  • the radiofrequency ablation electrode of the present invention comprises 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 cold medium of the present invention can realize internal circulation and realize the cooling function of the radiofrequency ablation electrode, while also ensuring that the tiny gaps between the micropores, the outer needle tube and the outer sleeve are not blocked during the ablation process, and that blood will not enter the tiny gaps and micropores to cause carbonization adhesion, thereby ensuring that the cold medium can continuously and evenly seep out from each hole, and ensuring effective external perfusion of the cold medium.
  • the external perfusion structure of the present invention enables the cold medium to reach the lesion tissue through the micropores on the working end of the radiofrequency ablation electrode, and can cool the working end of the external needle tube and the nearby lesion tissue.
  • the cold medium can be injected into the lesion tissue to increase the conductivity of the tissue and expand the cooling range, effectively solving the problem of carbonization and adhesion of lesion tissue or blood during the energy injection process, ensuring continuous energy input, and further expanding the ablation range.
  • the ablation site absorbs quickly after the patient recovers.
  • FIG1 is a schematic diagram of the structure of a claw needle in the prior art
  • Fig. 2 is a cross-sectional view taken along line A-A of Fig. 1;
  • FIG3 is a schematic diagram of the structure of a radiofrequency ablation electrode in Embodiment 1 of the present invention.
  • FIG4 is a schematic diagram of the structure of a radiofrequency ablation electrode in Embodiment 2 of the present invention.
  • FIG5 is a partial enlarged view of the working end portion of the radiofrequency ablation electrode in the second embodiment of the present invention.
  • FIG6 is a schematic diagram of the outer needle tube structure of the radiofrequency ablation electrode in the second embodiment of the present invention.
  • FIG7 is a schematic diagram of the outer sleeve structure of the radiofrequency ablation electrode in the second embodiment of the present invention.
  • FIG8 is a schematic diagram of the assembly of the outer sleeve and the outer needle tube of the radiofrequency ablation electrode in the second embodiment of the present invention.
  • FIG9 is a schematic diagram of the flow of a refrigerant medium in an embodiment of the present invention.
  • FIG10 is a schematic diagram of cold medium perfusion in Embodiment 2 of the present invention.
  • FIG11 is a schematic diagram of a coaxial needle in an embodiment of the present invention.
  • Fig. 12 is a cross-sectional view taken along line B-B in Fig. 11;
  • Fig. 13 is a cross-sectional view taken along line C-C in Fig. 11;
  • the purpose of the present invention is to provide a radiofrequency ablation electrode and its application and a radiofrequency ablation system to solve the problems existing in the above-mentioned prior art, which can increase the conductivity of the lesion tissue around the working end, reduce the working impedance, and expand the cooling range to avoid carbonization of the lesion tissue, thereby expanding the ablation range.
  • 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.
  • the internal circulation structure mainly comprises an inner needle tube 5 and an outer needle tube 1; wherein, the outer needle tube 1 is sleeved on the inner needle tube 5, and a fluid channel is formed between the outer needle tube 1 and the inner needle tube 5, a cold medium can be passed into the fluid channel, an inner needle tube flow channel for passing the cold medium is arranged in the inner needle tube 5, the front end of the inner needle tube flow channel is connected 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 can be connected with the liquid supply device; a needle tip 17 is arranged at the front end of the outer needle tube 1, and an insulating layer is arranged at the rear end, the insulating layer can insulate and protect the part of the outer needle tube 1 that does not need to release energy, and prevent the non-treatment part passed by the radio frequency ablation electrode from being thermally damaged; further, the outer needle tube 1 is a conductive metal tube, and the outer needle tube 1 can also be electrically connected to the radio
  • the inner wire 7 is welded to the rear end of the outer needle tube 1 through the welding point 2, the inner wire 7 is electrically connected to the radio frequency head 9 through the radio frequency line 8, and the radio frequency head 9 is connected to the radio frequency host to output radio frequency energy;
  • the external perfusion structure mainly includes micropores 15 , which are arranged in the working end area of the outer needle tube 1 .
  • the cold medium is conductive, and after entering the fluid channel, it can overflow from the micropores 15.
  • the micropores 15 have a small aperture, which can ensure that only a small amount of the cold medium overflows from the micropores 15.
  • the high-temperature steam will only diffuse to the vicinity of the lesion tissue, increasing the conductivity of the lesion tissue, and will not flow into other parts of the human body, thereby minimizing the impact on the human body.
  • the outer needle tube 1 is sleeved on the inner needle tube 5, and a fluid channel is formed between the outer needle tube 1 and the inner needle tube 5.
  • the working end area of the outer needle tube 1 has a micropore 15, and the conductive cold medium can overflow through the micropore 15.
  • the overflowed cold medium increases the conductivity of the lung tissue around the working end of the radiofrequency ablation electrode, reducing the working impedance; when performing radiofrequency ablation, the lung tissue around the working end accumulates heat, and the alveoli in the lung tissue near the working end of the electrode needle are squeezed out after heat damage, and the lung lesion tissue shrinks and collapses.
  • the shrunken and collapsed lung tissue is tightly combined and wrapped around 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, so that the working impedance is further reduced, forming a low-impedance working environment, expanding the ablation range, and overcoming the problems of high impedance and no or low output of radiofrequency energy of the host during conventional radiofrequency single-needle ablation;
  • the cold medium circulates in the fluid channel, which can cool the working end of the outer needle tube 1 and the nearby lesion tissue, and the cold medium can be injected into the lesion tissue to expand the cooling range, effectively solving the problem of carbonization and adhesion of lesion tissue or blood during energy injection, ensuring continuous energy input, and further expanding the ablation range.
  • the ablation site is absorbed quickly after the patient recovers.
  • the radiofrequency ablation electrode also includes a liquid cavity, which is located at the rear end of the outer needle tube 1.
  • the liquid cavity is used to accommodate a cold medium, and the liquid cavity is connected to the fluid channel and the inner needle tube flow channel;
  • the liquid supply device includes a cold medium source and a cold medium recovery device, and the liquid cavity includes an inlet chamber 4 and a return chamber 6, and the inlet chamber 4 is separated from the return chamber 6, that is, the inlet chamber 4 is not connected to the return chamber 6;
  • the inlet chamber 4 can be connected to the cold medium source through the inlet pipe 10, and the return chamber 6 can be connected to the cold medium recovery device through the return pipe 12, the cold medium source can provide cold medium, and the cold medium recovery device can recover cold medium;
  • the rear end of the inner needle tube 5 extends into the inlet chamber 4, so that the rear end of the inner needle tube flow channel is connected to the inlet chamber 4, the front end of the inner needle tube flow channel is connected to the front end of the fluid channel, and the rear end of the fluid channel is connected
  • the cold medium in the cold medium source enters the water inlet chamber 4 in the liquid chamber through the water inlet pipe 10, and enters the inner needle tube flow channel from the rear end of the inner needle tube 5, and 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 from the rear end of the fluid channel through the return water chamber 6 and the return water pipe 12 into the cold medium recovery device for recovery; during the flow of the cold medium, the working end of the radiofrequency ablation electrode and the nearby lesion tissue can be effectively cooled, and a small amount of cold medium can overflow from the micropores 15, which can increase the electrical conductivity of the lung tissue and effectively transmit radiofrequency current energy.
  • the cold medium source and the cold medium recovery device in order to realize the circulation of the cold medium, can be connected; or, the cold medium source and the cold medium recovery device are set as one body, such as a liquid bottle; as a preferred embodiment, the cold medium source and the cold medium recovery device in this embodiment are set as one body. Further, in order to enable the cold medium to circulate smoothly, a circulation pump is provided between the liquid bottle and the water inlet pipe 10 to provide power for the circulation of the cold medium.
  • the radiofrequency ablation electrode realizes the cold circulation function, which can ensure that the micropores 15 are not blocked during the ablation process, and no blood will enter the micropores 15 to cause carbonization adhesion, thereby ensuring that the cold medium can continuously and evenly seep out from each micropore 15.
  • the cold medium is sterile saline or liquid medicine, preferably cooled sterile saline.
  • Sterile saline can increase tissue conductivity and effectively transmit radio frequency current energy. After the sterile saline is cooled, the temperature of the tissue near the working end can be reduced; and increasing tissue conductivity and reducing tissue temperature can both expand the ablation range.
  • a water volume regulating device is also installed on the water inlet pipe 10 and/or the water return pipe 12, and the water volume regulating device is used to adjust the water inlet or return volume of the refrigerant medium, and then adjust the filling volume of the refrigerant medium; wherein, the water volume regulating device can be selected according to specific work needs, such as selecting a multi-level regulating switch 11 or a multi-level hose buckle, etc.
  • a water volume regulating device is only installed on the water return pipe 12, and the filling volume of the refrigerant medium is controlled by controlling the return water; when the filling volume of the refrigerant medium is insufficient, the return water is reduced and the filling volume is increased; when the filling volume is large, the opposite is true.
  • the infusion volume of the cold medium is preferably 0.1ml-2.0ml per minute, wherein the infusion volume of the cold medium is the volume of the cold medium entering the human body per unit time.
  • This embodiment adopts micro-infusion, and the infusion volume of the cold medium can be adjusted by the multi-speed adjustment switch 11.
  • the micro-amount of cold medium infused during the working process forms high-temperature water vapor after oscillating at the same frequency as the working frequency, and will not cause poor recovery due to the injection of a large amount of liquid into the human body.
  • the needle tip 17 is a sharpened triangular needle tip, and the needle tip 17 is welded to the front end of the outer needle tube 1; the needle tip 17 is sharp and can easily puncture harder skin or tissues such as skin and lung nodules; wherein, the outer diameter of the outer needle tube 1 can be as small as 1.0 mm, which overcomes the problem of pneumothorax caused by a thick needle tube during lung puncture.
  • the aperture of the micropores 15 should be relatively small, preferably 0.005 mm-0.05 mm.
  • a handle 3 is provided 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 is ergonomic and convenient for the operator to hold. It does not slip and is effortless to hold for a long time.
  • This embodiment provides a radiofrequency ablation electrode, which is an improvement on the basis of the first embodiment. Compared with the first embodiment, the improvements in this embodiment are mainly as follows:
  • the insulating layer is an insulating tube 13, which is sleeved on the rear end of the outer needle tube 1.
  • the front end of the outer needle tube 1 is also sleeved with an outer sleeve 14.
  • the outer sleeve 14 and the insulating tube 13 are arranged in sequence from front to back along the axial direction of the outer needle tube 1 to form a protective tube.
  • the outer wall of the protective tube is flush with the outer edge of the needle tip 17; wherein, the outer sleeve 14 can be used for radio frequency energy release, and the outer sleeve 14 is also provided with a developing hole 16.
  • the insulating tube 13 can insulate and protect the part of the outer needle tube 1 that does not need energy release, thereby preventing the non-treatment part passed by the radio frequency ablation electrode from being thermally damaged.
  • the inner needle tube 5, the outer needle tube 1 and the protective tube are preferably round tubes, or square tubes or other polygonal prism tubes can be selected as needed.
  • a plurality of circles of micropores 15 are axially arranged on the outer needle tube 1, and a plurality of circles of developing holes 16 are axially arranged on the outer sleeve 14, and the micropores 15 and the developing holes 16 are staggered from front to back along the axial direction of the outer needle tube 1, that is, along the axial direction, the position of the micropores 15 on the outer needle tube 1 corresponds to the tube wall of the outer sleeve 14 (the position where the developing holes 16 are not arranged), and the micropores 15 can be blocked by the tube wall of the outer sleeve 14 to prevent the cold medium from being sprayed; however, as shown in FIG.
  • the gap between the outer sleeve 14 and the outer needle tube 1 is preferably 0.01 mm-0.05 mm.
  • the cold circulation function of the radiofrequency ablation electrode in this embodiment also ensures that the tiny gaps between the micropores 15, the outer needle tube 1 and the outer sleeve 14 are not blocked during the ablation process, and no blood enters the tiny gaps and micropores 15 to cause carbonization and adhesion, thereby ensuring that the cold medium can continuously and evenly seep out of each hole.
  • the micropore 15 can have a larger aperture relative to the first embodiment, and micro-perfusion can also be achieved under a larger aperture; wherein, the aperture of the micropore 15 is preferably 0.05mm-0.5mm, and setting a micropore 15 with a larger aperture can reduce the processing difficulty of the outer needle tube 1 to a certain extent.
  • a developing hole 16 is provided on the outer sleeve 14, which can form an uneven working end surface and has a developing function under the imaging device, thereby overcoming the problem of unclear development of the working end under the imaging device, and especially avoiding the problem that each sub-needle of the claw needle in the prior art cannot be seen under the imaging device at the same time; in this embodiment, by judging the position of the working end during the puncture process, accurate puncture can be achieved, avoiding accidental puncture caused by the inability to develop the working end.
  • three circles of micropores 15 are provided, and the three circles of micropores 15 are respectively opened on the outer needle tube 1 and the distance from the front end of the needle tip 17 is a, a+b, and a+b+c.
  • the center of the micropore 15 is located on the corresponding circumference, and each circle of micropores 15 is provided with 3, and the 3 micropores 15 are evenly distributed on the circumference, a total of 9 micropores 15, each circle of 3 micropores 15 are corresponding, and the centers of the corresponding micropores 15 are 1/4 of the same.
  • the connecting line is parallel to the axis of the outer needle tube 1; further, three circles of developing holes 16 are correspondingly arranged, and the three circles of developing holes 16 are respectively opened on three groups of circumferences at a distance of d, e, and f from the front end of the outer sleeve 14. The front ends of the developing holes 16 are located on the corresponding circumferences. Three developing holes 16 are arranged in each circle, and the three developing holes 16 are evenly distributed on the circumference, totaling 9 developing holes 16. The three developing holes 16 in each circle are corresponding, 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 micropores 15 in each circle correspond to the three developing holes 16 in each circle, and the plane where the connecting line between the centers of the corresponding micropores 15 and the developing holes 16 is located is parallel to the axis of the outer needle tube 1.
  • 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
  • f is preferably 15.75mm-19.75mm; wherein, the distance between each microhole 15 and the front end tip of the needle tip 17, and the distance between each developing hole 16 and the front end of the outer sleeve 14 can be selected according to work needs, specifically, can be selected according to the length of the working end of the radiofrequency ablation electrode.
  • the number of circles of the micropores 15 and the developing holes 16 and the number of holes in each circle can be selected as needed, such as 4 or 5 circles can be provided, and each circle can be provided with 4 or 5 holes; wherein, the number of circles of the micropores 15 and the developing holes 16 and the number of holes in each circle can be the same or different.
  • the shapes of the micropores 15 and the developing holes 16 can also be selected according to specific work needs, such as square holes or round holes, etc.
  • the micropores 15 are round holes
  • the developing holes 16 are square holes.
  • the fluid channel between the inner needle tube 5 and the outer needle tube 1 can be an annular fluid channel, and the annular gap between the inner needle tube 5 and the outer needle tube 1 is the fluid channel; or, the fluid channel is an axial channel, and a plurality of axial channels are evenly distributed along the circumference between the inner needle tube 5 and the outer needle tube 1, and the axial channels correspond one-to-one to the micropores 15 on each circle; as a preferred embodiment, the fluid channel in this embodiment is an annular fluid channel.
  • the outer sleeve 14 and the insulating tube 13 can be arranged in one piece or separately, preferably separately; wherein the outer sleeve 14 is sleeved on the front end of the outer needle tube 1, and the insulating tube 13 is sleeved on the part of the outer needle tube 1 that does not need to release energy.
  • the front end outer wall of the outer sleeve 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 insulating tube 13.
  • the front end of the insulating tube 13 can be prevented from being squeezed and wrinkled by the skin tissue, causing the exposed working end to become longer and damaging normal tissue.
  • the outer sleeve 14 is preferably a thin-walled stainless steel metal tube, the front end of which is welded to the rear end of the needle tip 17, and the welding point a1 between the outer sleeve 14 and the needle tip 17 and the welding point a1 between the outer needle tube 1 and the needle tip 17 coincide with each other.
  • the front end of the outer sleeve 14 and the front end of the outer needle tube 1 are welded, and while being connected, the outer needle tube 1 and the outer sleeve 14 can be connected, so that the outer sleeve 14 can be used for radio frequency energy release; and the insulating tube 13 is preferably a thin-walled insulating polymer plastic tube; wherein the wall thickness of the insulating tube 13 and the outer sleeve 14 are preferably 0.01mm-0.1mm, and the insulating tube 13 is preferably made of Teflon, or materials such as PEEK or polyimide can be selected as needed.
  • the outer sleeve 14 may also be made of insulating material.
  • the radio frequency energy may be released through the developing hole 16 on the outer sleeve 14 ; and the front end of the outer sleeve 14 may be connected to the needle tip 17 by means of snap connection or bonding.
  • This embodiment provides a radiofrequency ablation system, including a radiofrequency ablation apparatus and the radiofrequency ablation electrode in the first or second embodiment.
  • the present embodiment provides an application of the radiofrequency ablation electrode in the first embodiment or the second embodiment in the preparation of a medical device; specifically, the radiofrequency ablation electrode in the present embodiment can be prepared together with a coaxial needle and a biopsy gun into a biopsy ablation device, as shown in Figures 11-13, the coaxial needle cannula 19 and the coaxial needle core rod 18 are matched. During the operation, the coaxial needle core rod 18 is first inserted into the coaxial needle cannula 19, and the skin is punctured to the lesion.
  • the coaxial needle core rod 18 is pulled out, and the biopsy gun is inserted from the coaxial needle cannula 19 to lesion, take a biopsy, and then take out the biopsy gun; insert the radiofrequency ablation electrode through the coaxial needle cannula 19 to ablate the lesion.
  • the coaxial needle cannula 19 and the radiofrequency ablation electrode are withdrawn together, and the needle tract is ablated with the radiofrequency ablation electrode; it should be noted that when performing radiofrequency ablation, the working end of the radiofrequency ablation electrode passes through the coaxial needle cannula 19, and the front end of the insulating tube 13 on the outer needle tube 1 is more than 1 cm away from the front end of the coaxial needle cannula 19, and they cannot touch, otherwise the coaxial needle cannula 19 will be conductive.
  • the outer diameter of the outer needle tube 1 can be as small as 1.0 mm, and the overall diameter of the radiofrequency ablation electrode is relatively small, so it can be inserted into the coaxial needle sleeve 19 for radiofrequency ablation, which solves the problem in the prior art that the microwave needle or claw needle cannot penetrate the coaxial needle due to the thick needle tube.
  • Biopsy and ablation are completed in the same puncture channel to avoid secondary puncture. After ablation, the puncture channel is ablated to avoid bleeding and needle tract implantation after multiple punctures.
  • the radiofrequency ablation electrode can also be used in conjunction with other medical instruments besides the biopsy gun according to specific work needs.
  • the present invention is based on the basic principle of radiofrequency ablation (radiofrequency ablation is to cause thermal damage to tissues through the resistive thermal effect and the principle of heat conduction, and then coagulate and necrotize them to achieve the purpose of ablating nodules, tumors, etc.).
  • radiofrequency ablation is to cause thermal damage to tissues through the resistive thermal effect and the principle of heat conduction, and then coagulate and necrotize them to achieve the purpose of ablating nodules, tumors, etc.
  • the conductivity of the lesion tissue is increased, and the lesion temperature is reduced through cold circulation to prevent tissue carbonization. This can reduce the impedance of the lesion, facilitate the continuous output of radiofrequency energy, and expand the scope of radiofrequency ablation.
  • the present invention in addition to the cold circulation function and liquid perfusion function, also has an adjustable perfusion flow function.
  • the present invention has a small diameter and is clearly visualized under imaging equipment. It is a safe and effective radiofrequency ablation electrode that can be applied to diseases such as lung tumors and lung nodules. Among them, it should be further explained that the present invention includes but is not limited to the treatment of diseases such as lung tumors and nodules. Radiofrequency ablation electrodes for other lesions derived from the principles and structures of the present invention can all be understood to be within the scope of protection of the patent of the present invention.

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Abstract

本发明公开一种射频消融电极，涉及医疗器械技术领域，主要包括内循环结构和外部灌注结构；所述内循环结构能够使供液装置中的冷媒介质到达所述射频消融电极的工作端，以对所述射频消融电极的工作端及周围的病灶组织进行冷却，并能够使所述冷媒介质流回所述供液装置；所述外部灌注结构能够使所述冷媒介质通过所述射频消融电极的工作端上的微孔到达病灶组织。本发明还公开一种包括上述射频消融电极的射频消融系统，以及上述射频消融电极在制备医疗器械中的应用。本发明能够增加工作端周围病灶组织的电导率，降低工作阻抗，还能够扩大冷却范围，避免病灶组织碳化，从而扩大消融范围。

Description

射频消融电极及其应用以及射频消融系统 技术领域
本发明涉及医疗器械技术领域，特别是涉及一种射频消融电极及其应用以及射频消融系统。
背景技术
消融是一种微创手术，分为化学消融和物理消融；临床常用物理消融，物理消融包括射频消融、微波消融、冷冻消融、超声消融、激光消融等等；射频消融是较为成熟且常用的消融方式，射频消融主要用于人体组织器官结节、阻塞、肿瘤等疾病的治疗；射频消融治疗是将消融电极穿刺到病灶部位，释放射频能量，使病灶部位细胞温度升高，发生变性，最终使病变部位组织坏死，通过人体正常代谢吸收清除，达到消除结节、疏通阻塞、消除肿瘤的目的。射频消融治疗需要配套射频消融系统，包含射频消融仪和射频消融电极。
随着健康体检的普及，被检测出肺结节的病例逐渐增多，相反，治疗肺结节的手段还非常有限，存在较多不足。目前，治疗肺结节的主要手段有手术切除、射频消融、微波消融；其中，手术切除创伤大，费用高，无法多次治疗。
微波消融相对于手术切除，创伤小，费用低，但微波针存在以下缺点：
(1)微波消融所采用的微波针通常为陶瓷针尖或铜表面镀特氟龙的针尖，针尖普遍较钝，无法经皮穿刺，需要用破皮针破皮后再穿刺；在进行肺穿刺时，肺结节较硬，正常肺组织较软，针尖钝，无法直接精准穿刺到病灶中心，需要多次定位穿刺，从而容易造成肺出血。
(2)肺结节消融前通常需要定位取活检，为减少穿刺时间和穿刺次数，临床通常先通过同轴针穿刺到病灶组织，将活检枪沿着同轴针套管进入病灶取活检，然后消融针沿着同轴针套管直接穿刺到病灶组织，进行消融，最后进行针道消融，这样可以避免取活检通道的针道种植以及针道出血风险，因此要求消融针较细，才能通过同轴针套管，同轴针套管不能太 粗，太粗容易造成气胸，所以需要较细的消融针，而微波针的直径较大，并不能很好地适用于肺结节消融。
(3)微波消融原理决定了发射端天线本身会发热，特别是工作端附近特征阻抗变化后，微波发射端就会发热严重，导致套在发射天线上的陶瓷针断裂脱落，工作时针尖有断针的风险。
而射频消融需要形成电流回路，肺组织中多为肺泡，电导率不高，采用单针进行射频消融时，常规冷循环射频消融单针只有内循环冷却系统，即冷媒介质从储液罐到达外针管，然后通过内循环冷却系统回到储液罐，而无冷媒介质进入病灶组织，射频消融针工作端周围多为肺泡，导致工作端与肺组织实际接触面积小，初始工作阻抗高，射频消融主机阻抗识别系统识别组织初始阻抗高，导致主机功率不输出或输出功率小，即使有输出，也需要很高电压才能保证输出；又由于与工作端实际接触的肺组织较少，导致与工作端接触的少部分肺组织可能会产生快速碳化，能量传递不出去，形成恶性循环，病灶在影像下体现为未消融或消融范围不大。
常规射频消融灌注单针只有灌注系统，即液体介质从储液罐到达外针管前端并进入病灶，增加组织导电性，而无液体介质回到储液罐，无法对工作端进行有效冷却，导致工作端上的注液孔在消融时因血液凝固、组织碳化造成部分注液孔的堵塞，堵塞的注液孔没有液体流出，引起急剧碳化，消融范围小，未堵塞的注液孔流量增大，造成液体介质喷射，消融形状不规则，容易消融到周围的正常组织。
目前，为了降低射频消融电极的工作阻抗，通常会选择增加消融电极与肺的接触面积。而在临床中，常采用爪针增加消融电极与肺的接触面积，具体地，如图1-图2所示，爪针包含子针101、内针管102、外针管103、绝缘层104、针尖105，多枚所述子针101焊接在所述内针管102前端，所述内针管102外套设有所述外针管103，所述外针管103前端为所述针尖105，所述针尖105做斜口开刃，所述外针管103外套设有所述绝缘层104，所述针尖105裸露，用于消融前皮肤、组织穿刺和消融后针道消融；穿刺时，子针101位于外针管103内，穿刺到病灶后，将子针101推出外针管103，子针101在病灶内展开，再进行消融。
虽然采用爪针能够在一定程度上增加消融电极与肺的接触面积，但爪针存在以下缺点：
(1)外针管需容纳多枚子针，导致外针管直径较大，而外针管针尖为子针出口，镂空，常做斜切口，因此针尖锋利度差；外针管直径大，锋利度差，造成肺结节穿刺困难。
(2)由于子针多，影像下不能同时看到每一个子针的情况，存在某个子针损毁正常组织的风险。
(3)子针在肺结节中展开时，因为肺结节较硬、阻力大，可能导致某两个以上子针不能均匀展开，消融时，子针未展开的部位形成镂空状态，导致消融不彻底。
(4)爪针主针及各个子针通常不带冷循环功能，消融后容易造成组织粘连，导致子针收回困难。
可见，目前采用爪针增加消融电极与肺的接触面积，从而降低工作阻抗的方式，存在上述多个缺点，临床应用效果较差；因此，亟需提供一种新的方式，来降低射频消融电极的工作阻抗。
发明内容
本发明的目的是提供一种射频消融电极及其应用以及射频消融系统，以解决上述现有技术存在的问题，能够增加工作端周围病灶组织的电导率，降低工作阻抗，还能够扩大冷却范围，避免病灶组织碳化，从而扩大消融范围。
为实现上述目的，本发明提供了如下方案：
本发明提供一种射频消融电极，包括内循环结构和外部灌注结构；
所述内循环结构能够使供液装置中的冷媒介质到达所述射频消融电极的工作端，以对所述射频消融电极的工作端及周围的病灶组织进行冷却，并能够使所述冷媒介质流回所述供液装置；
所述外部灌注结构能够使所述冷媒介质通过所述射频消融电极的工作端上的微孔到达病灶组织。
优选的，所述内循环结构包括内针管和外针管，所述外针管套设于所 述内针管上，且与所述内针管之间形成流体通道，所述流体通道内能够通入所述冷媒介质，所述内针管内设置有能够通入所述冷媒介质的内针管流道，所述内针管流道的前端与所述流体通道的前端连通，所述内针管流道的后端以及所述流体通道的后端均能够与所述供液装置连接；所述外针管的前端设置有针尖，后端设置有绝缘层，所述外针管还能够与射频头电连接；
所述外部灌注结构包括所述微孔，所述微孔设置于所述外针管的工作端区域；
其中，所述冷媒介质能够导电，且所述冷媒介质进入所述流体通道后，能够从所述微孔流出。
优选的，所述射频消融电极还包括液体腔，所述液体腔位于所述外针管的后端，所述液体腔内用于容纳所述冷媒介质，且所述液体腔与所述流体通道以及所述内针管流道连通；
所述供液装置包括冷媒介质源和冷媒介质回收装置，所述液体腔包括进水腔和回水腔，所述进水腔与所述回水腔隔开；所述进水腔能够通过进水管与所述冷媒介质源连接，所述回水腔能够通过回水管与所述冷媒介质回收装置连接，所述冷媒介质源能够提供所述冷媒介质，所述冷媒介质回收装置能够回收所述冷媒介质；所述内针管的后端伸入所述进水腔，以使所述内针管流道的后端与所述进水腔连通，所述内针管流道的前端与所述流体通道的前端连通，所述流体通道的后端与所述回水腔连通。
优选的，所述进水管和/或所述回水管上还安装有水量调节装置，所述水量调节装置用于调节所述冷媒介质的进水量或回水量，从而调节所述冷媒介质的灌注量；其中，所述冷媒介质为无菌生理盐水或液体药物，所述冷媒介质的灌注量为单位时间内冷媒介质进入人体内的体积，所述冷媒介质的灌注量为每分钟0.1ml-2.0ml。
优选的，所述微孔的孔径为0.005mm-0.05mm。
优选的，所述绝缘层为绝缘管，所述外针管的前端还套设有外套管，所述外套管和所述绝缘管沿所述外针管的轴向由前至后依次设置，形成保护管，所述保护管的外壁与所述针尖的外缘平齐；其中，所述外套管的前 端外壁与所述针尖的外缘平齐，所述外套管的后端外壁与所述绝缘管的前端外壁平齐；所述外套管能够用于射频能量释放，且所述外套管上还设置有显影孔。
优选的，所述外针管上沿轴向设置有多圈所述微孔，所述外套管上设置有多圈所述显影孔，且所述微孔和所述显影孔沿所述外针管的轴向由前至后错开设置；所述冷媒介质从所述微孔流出后，能够进入所述外针管与所述外套管之间的间隙，并从所述显影孔流出。
优选的，所述外套管为不锈钢金属管，所述绝缘管为高分子塑料管，所述外套管和所述绝缘管的壁厚均为0.01mm-0.1mm；所述针尖为开刃的三棱针尖，且所述针尖焊接在所述外针管的前端。
优选的，所述微孔的孔径为0.05mm-0.5mm，所述外套管与所述外针管之间的间隙为0.01mm-0.05mm。
优选的，所述外针管的直径最小为1.0mm。
本发明还提供一种射频消融系统，包括射频消融仪以及上述的射频消融电极。
本发明还提供了上述射频消融电极在制备医疗器械中的应用。
本发明相对于现有技术取得了以下有益技术效果：
本发明射频消融电极包括内循环结构和外部灌注结构，内循环结构能够使供液装置中的冷媒介质到达射频消融电极的工作端，以对射频消融电极的工作端及周围的病灶组织进行冷却，并能够使冷媒介质流回所述供液装置；本发明冷媒介质能够实现内循环，实现射频消融电极的冷却功能，同时也保证了微孔、外针管与外套管之间微小间隙在消融过程中不堵塞，不会有血液进入微小间隙以及微孔，引起碳化粘连，保证了冷媒介质能够持续、均匀的从每个孔中渗出，保证了冷媒介质的有效外部灌注。
本发明外部灌注结构能够使冷媒介质通过射频消融电极工作端上的微孔到达病灶组织，能够对外针管工作端及附近病灶组织进行冷却，且冷媒介质能够注入病灶组织内，增加组织的电导率，扩大冷却范围，有效解决能量注入过程中，病灶组织或血液碳化粘连问题，保证了能量能够持续输入，且进一步扩大了消融范围，患者愈后消融部位吸收快。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1为现有技术中爪针的结构示意图；
图2为图1的A-A剖面图；
图1-图2中，101-子针；102-内针管；103-外针管；104-绝缘层；105-针尖；
图3为本发明实施例一中射频消融电极的结构示意图；
图4为本发明实施例二中射频消融电极的结构示意图；
图5为本发明实施例二中射频消融电极的工作端部分的局部放大图；
图6为本发明实施例二中射频消融电极的外针管结构示意图；
图7为本发明实施例二中射频消融电极的外套管结构示意图；
图8为本发明实施例二中射频消融电极的外套管和外针管的组装示意图；
图9为本发明实施例中冷媒介质流动示意图；
图10为本发明实施例二中冷媒介质灌注示意图；
图11为本发明实施例中同轴针示意图；
图12为图11中B-B剖面图；
图13为图11中C-C剖面图；
图3-图13中，1-外针管；2-焊点；3-手柄；4-进水腔；5-内针管；6-回水腔；7-内导线；8-射频线；9-射频头；10-进水管；11-多档调节开关；12-回水管；13-绝缘管；14-外套管；15-微孔；16-显影孔；17-针尖；18-同轴针芯棒；19-同轴针套管。
具体实施方式
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例， 而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
本发明的目的是提供一种射频消融电极及其应用以及射频消融系统，以解决上述现有技术存在的问题，能够增加工作端周围病灶组织的电导率，降低工作阻抗，还能够扩大冷却范围，避免病灶组织碳化，从而扩大消融范围。
为使本发明的上述目的、特征和优点能够更加明显易懂，下面结合附图和具体实施方式对本发明作进一步详细的说明。
实施例一
如图3所示，本实施例提供一种射频消融电极，主要包括内循环结构和外部灌注结构；内循环结构能够使供液装置中的冷媒介质到达射频消融电极的工作端，以对射频消融电极的工作端及周围的病灶组织进行冷却，并能够使冷媒介质流回供液装置；外部灌注结构能够使冷媒介质通过射频消融电极的工作端上的微孔到达病灶组织。
在本实施例中，内循环结构主要包括内针管5和外针管1；其中，外针管1套设于内针管5上，且与内针管5之间形成流体通道，流体通道内能够通入冷媒介质，内针管5内设置有能够通入冷媒介质的内针管流道，内针管流道的前端与流体通道的前端连通，内针管流道的后端以及流体通道的后端均能够与供液装置连接；外针管1的前端设置有针尖17，后端设置有绝缘层，绝缘层能够对不需要进行能量释放的外针管1部分进行绝缘保护，防止射频消融电极穿过的非治疗部位受到热损伤；进一步地，外针管1为导电金属管，外针管1还能够通过内导线7、射频线8与射频头9电连接，通过射频头9向外针管1发送电流能量，具体地，内导线7通过焊点2焊接在外针管1后端，内导线7与射频头9通过射频线8电连接，射频头9连接射频主机，输出射频能量；
外部灌注结构主要包括微孔15，微孔15设置于外针管1的工作端区域。
在本实施例中，冷媒介质能够导电，且冷媒介质进入流体通道后，能够从微孔15溢出，微孔15的孔径较小，能够保证仅有微量的冷媒介质从 微孔15溢出，且冷媒介质从微孔15溢出后，在经过与工作频率相同的频率震荡后以及高温作用下形成高温蒸气，高温蒸气只会扩散到病灶组织附近，增加病灶组织的电导率，而不会流入到人体的其他部位，尽可能地降低了对人体的影响。
本实施例中射频消融电极，将外针管1套设于内针管5上，外针管1与内针管5之间形成流体通道，外针管1的工作端区域有微孔15，导电的冷媒介质能够通过微孔15溢出，溢出的冷媒介质增加了射频消融电极工作端周围肺组织的电导率，降低工作阻抗；进行射频消融时，工作端周围的肺组织因为热量聚集，热损毁后电极针工作端附近肺组织中的肺泡被挤出，肺病灶组织收缩塌陷，收缩塌陷的肺组织紧密结合，包裹在射频消融电极工作端表面，射频消融电极工作端与肺组织接触面积增大，使工作阻抗进一步降低，形成了一个低阻抗的工作环境，扩大了消融范围，克服了常规射频单针消融时阻抗高，主机的射频能量不输出或输出小的问题；
而且冷媒介质在流体通道中流通，能够对外针管1工作端及附近病灶组织进行冷却，且冷媒介质能够注入病灶组织内，扩大冷却范围，有效解决能量注入过程中，病灶组织或血液碳化粘连问题，保证了能量能够持续输入，且进一步扩大了消融范围，患者愈后消融部位吸收快。
在本实施例中，射频消融电极还包括液体腔，液体腔位于外针管1的后端，液体腔用于容纳冷媒介质，且液体腔与流体通道以及内针管流道连通；具体地，供液装置包括冷媒介质源和冷媒介质回收装置，液体腔包括进水腔4和回水腔6，进水腔4与回水腔6隔开，即进水腔4不与回水腔6连通；进水腔4能够通过进水管10与冷媒介质源连接，回水腔6能够通过回水管12与冷媒介质回收装置连接，冷媒介质源能够提供冷媒介质，冷媒介质回收装置能够回收冷媒介质；内针管5的后端伸入进水腔4，以使内针管流道的后端与进水腔4连通，内针管流道的前端与流体通道的前端连通，流体通道的后端与回水腔6连通。
在本实施例中，如图9所示，冷媒介质源中的冷媒介质通过进水管10进入到液体腔中的进水腔4内，并从内针管5的后端进入到内针管流道，然后从内针管流道的前端进入到内针管5与外针管1之间流体通道的前端，最后从流体通道的后端经回水腔6、回水管12流入到冷媒介质回 收装置进行回收；在冷媒介质流动过程中，能够对射频消融电极的工作端及附近的病灶组织进行有效冷却，而且微量的冷媒介质能够从微孔15中溢出，可增加肺组织电导率，有效传送射频电流能量。
在本实施例中，为了实现冷媒介质的循环，冷媒介质源和冷媒介质回收装置能够连通；或者，冷媒介质源与冷媒介质回收装置设置为一体，如可以为一液体瓶；作为一种优选的实施方式，本实施例中冷媒介质源与冷媒介质回收装置设置为一体。进一步地，为使冷媒介质能够顺利循环，液体瓶与进水管10之间设置有循环泵，为冷媒介质的循环提供动力。本实施例中，射频消融电极实现了冷循环功能，能够保证微孔15在消融过程中不堵塞，不会有血液进入微孔15，引起碳化粘连，保证了冷媒介质能够持续、均匀的从每个微孔15中渗出。
在本实施例中，冷媒介质为无菌生理盐水或液体药物，优选为冷却后的无菌生理盐水，无菌生理盐水可增加组织电导率，有效传送射频电流能量，无菌生理盐水冷却后，可降低工作端临近组织温度；且增加组织电导率以及降低组织温度，均能扩大消融范围。
在本实施例中，进水管10和/或回水管12上还安装有水量调节装置，水量调节装置用于调节冷媒介质的进水量或回水量，进而调节冷媒介质的灌注量大小；其中，水量调节装置可以根据具体工作需要进行选择，如可以选择多档调节开关11或多档软管扣等。作为一种优选的实施方式，本实施例中仅在回水管12上安装有水量调节装置，通过控制回水来控制冷媒介质的灌注量；当冷媒介质的灌注量不足时，则减小回水，提高灌注量；当灌注量较大时，则相反。
进一步地，冷媒介质的灌注量优选为每分钟0.1ml-2.0ml，其中，冷媒介质的灌注量为单位时间内冷媒介质进入人体内的体积。本实施例采用微量灌注，冷媒介质的灌注量大小可通过多档调节开关11进行调节，在工作过程中灌注的微量冷媒介质，经过与工作频率相同的频率震荡后形成高温水蒸气，不会因大量液体注入人体造成愈后不良。
在本实施例中，针尖17为开刃的三棱针尖，且针尖17焊接在外针管1的前端；针尖17锋利度高，可轻松穿刺皮肤、肺结节等较硬的皮肤或 组织；其中，外针管1的外径最小可为1.0mm，克服了粗针管在进行肺穿刺时引起的气胸问题。
在本实施例中，因冷媒介质从微孔15流出后直接流入到人体内，为保证仅有微量的冷媒介质流入到人体内，微孔15的孔径应较小，优选为0.005mm-0.05mm。
在本实施例中，为方便操作者术中握持射频消融电极，屏蔽和保护电极的电路及管道，在外针管1的后端设有手柄3，手柄3能够包覆液体腔，且手柄3的尾部具有弧形结构，符合人体工学，便于操作者握持，且长时间握持不打滑，不费力。
实施例二
本实施例提供一种射频消融电极，是在实施例一的基础上进行的改进，相对于实施例一，本实施例中的改进之处主要在于：
在本实施例中，如图4-图8所示，绝缘层为绝缘管13，套设于外针管1的后端，外针管1前端还套设有外套管14，外套管14和绝缘管13沿外针管1的轴向由前至后依次设置，形成保护管，保护管的外壁与针尖17的外缘平齐；其中，外套管14能够用于射频能量释放，且外套管14上还设置有显影孔16，绝缘管13能够对不需要进行能量释放的外针管1部分进行绝缘保护，防止射频消融电极穿过的非治疗部位受到热损伤。
在本实施例中，内针管5、外针管1以及保护管均优选为圆管，或者还可以根据需要选择方管或者其它的多边形棱柱管等。
在本实施例中，外针管1上沿轴向设置有多圈微孔15，外套管14上沿轴向设置有多圈显影孔16，且微孔15和显影孔16沿外针管1的轴向由前至后错开设置，即沿轴向方向上，外针管1上微孔15所在位置对应的是外套管14的管壁(未设置显影孔16的位置)，通过外套管14的管壁能够对微孔15进行遮挡，防止冷媒介质喷射；但是，如图10所示，外套管14与外针管1之间留有微小间隙，冷媒介质从微孔15流出后，能够进入外针管1与外套管14之间的间隙，并从显影孔16渗出；其中，为了保证冷媒介质的微量灌注，外套管14与外针管1之间的间隙优选为0.01mm-0.05mm。
本实施例中射频消融电极的冷循环功能，同时也保证了微孔15、外针管1与外套管14之间微小间隙在消融过程中不堵塞，不会有血液进入微小间隙以及微孔15，引起碳化粘连，保证了冷媒介质能够持续、均匀的从每个孔中渗出。
进一步地，因冷媒介质从微孔15中流出后，需要经外针管1与外套管14之间的间隙、显影孔16，才能渗出到人体内，本实施例中微孔15相对于实施例一可以具有较大的孔径，在较大的孔径下同样能够实现微量灌注；其中，微孔15的孔径优选为0.05mm-0.5mm，设置较大孔径的微孔15，能够在一定程度上降低外针管1的加工难度。
而且，在外套管14上设置有显影孔16，可以形成凹凸不平的工作端表面，在影像设备下具有显影功能，克服了在影像设备下工作端显影不清晰的问题，特别是避免了现有技术中爪针的每一个子针不能同时在影像设备下看到的问题；本实施例中，在穿刺过程中通过判断工作端位置，能够实现精准穿刺，避免工作端无法显影导致的误穿刺。
作为一种优选的实施方式，在本实施例中，如图6-图7所示，微孔15设置有三圈，三圈微孔15分别开设在外针管1上与针尖17前端尖部的距离为a、a+b、a+b+c的三组圆周上，微孔15的中心位于对应的圆周上，且每圈微孔15均设置3个，3个微孔15均布在圆周上，共计9个微孔15，每圈的3个微孔15均相对应，且相对应的微孔15中心之间的连线与外针管1的轴线平行；进一步地，显影孔16对应设置有三圈，三圈显影孔16分别开设在距外套管14前端距离为d、e、f的三组圆周上，显影孔16的前端位于对应的圆周上，每圈显影孔16均设置3个，3个显影孔16均布在圆周上，共计9个显影孔16，每圈的3个显影孔16均相对应，且相对应的显影孔16中心之间的连线与外套管14轴线平行。其中，每圈的3个微孔15与每圈的3个显影孔16一一对应，且相对应的微孔15和显影孔16的中心连线所在的平面与外针管1的轴线平行。
在本实施例中，a优选为4.5mm-8.5mm，b优选为5mm-9mm，c优选为5.5mm-9.5mm，d优选为2.25mm-4.25mm，e优选为8.5mm-12.5mm，f优选为15.75mm-19.75mm；其中，各微孔15距针尖17的前端尖部的距 离，以及各显影孔16距外套管14前端的距离，可以根据工作需要进行选择，具体地，可以根据射频消融电极的工作端长度进行选择。
在本实施例中，微孔15和显影孔16的圈数以及每圈的数量均可以根据需要进行选择，如可以设置有4圈或5圈，每圈可以设置有4个或5个孔；其中，微孔15和显影孔16的圈数以及每圈数量可以相同也可以不同。进一步地，微孔15和显影孔16的形状也可以根据具体工作需要进行选择，如可以是方孔或圆孔等，作为一种优选的实施方式，微孔15为圆孔，显影孔16为方孔。
在本实施例中，内针管5与外针管1之间的流体通道可以为环形的流体通道，内针管5与外针管1之间的环形间隙即为该流体通道；或者，流体通道为轴向通道，在内针管5与外针管1之间沿圆周均布有多条轴向通道，该轴向通道与每圈上的微孔15一一对应；作为一种优选的实施方式，本实施例中流体通道为环形的流体通道。
在本实施例中，外套管14和绝缘管13可以一体设置或者分体设置，优选分体设置；其中，外套管14套设在外针管1的前端，绝缘管13套设在不需要进行能量释放的外针管1部分，外套管14的前端外壁与针尖17的外缘平齐，后端外壁与绝缘管13的外壁齐平，在穿刺时，能够防止绝缘管13前端口与皮肤组织挤压起皱，导致裸露工作端变长，损伤正常组织。
在本实施例中，外套管14优选为薄壁的不锈钢金属管，其前端与针尖17后端焊接，且外套管14与针尖17的焊接点a1以及外针管1与针尖17的焊接点a1重合，将外套管14的前端和外针管1的前端进行焊接，在进行连接的同时，能够实现外针管1和外套管14的连通，从而能够使外套管14用于射频能量释放；而绝缘管13优选为薄壁绝缘的高分子塑料管；其中，绝缘管13和外套管14的壁厚均优选为0.01mm-0.1mm，绝缘管13优选为特氟龙材质，或者根据需要选择PEEK或聚酰亚胺等材质。
在本实施例中，外套管14还可以采用绝缘材质，此时，可以通过外套管14上的显影孔16释放射频能量；而外套管14的前端则可以通过卡接或者粘接等方式与针尖17连接。
实施例三
本实施例提供了一种射频消融系统，包括射频消融仪以及实施例一或实施例二中的射频消融电极。
实施例四
本实施例提供了实施例一或实施例二中射频消融电极在制备医疗器械中的应用；具体地，本实施例中射频消融电极可以与同轴针、活检枪共同制备成活检消融装置，如图11-图13所示，同轴针套管19与同轴针芯棒18是配套的，手术时，先将同轴针芯棒18穿入同轴针套管19，穿刺皮肤到病灶，穿刺到病灶后，抽出同轴针芯棒18，将活检枪从同轴针套管19穿入到病灶，取活检，然后取出活检枪；将射频消融电极从同轴针套管19穿入对病灶进行消融，消融完成后，同轴针套管19与射频消融电极一起退针，并用射频消融电极进行针道消融；需注意的是，在进行射频消融时，射频消融电极的工作端穿出同轴针套管19，外针管1上的绝缘管13前端口与同轴针套管19前端间距1cm以上，不能接触，否则同轴针套管19就会导电。
本实施例中，外针管1的外径最小可为1.0mm，射频消融电极的整体直径较小，可以穿设在同轴针套管19内进行射频消融，解决了现有技术中微波针或爪针因针管较粗无法穿入同轴针的问题，在同一个穿刺通道完成活检和消融，避免二次穿刺，消融后对穿刺通道进行消融，避免多次穿刺后的出血和针道种植。
在本实施例中，射频消融电极还可以根据具体工作需要，与除活检枪之外的其它医疗器械配合使用。
本发明基于射频消融的基础原理(射频消融是通过电阻热效应和热传导原理使组织热损伤，进而凝固坏死，达到消融结节、肿瘤等目的)，通过灌注微量冷媒介质，增加病灶组织的电导率，以及通过冷循环降低病灶温度，防止组织碳化，能够降低病灶阻抗，有利于射频能量的持续输出，且扩大了射频消融的范围。
而且，本发明除了具有冷循环功能、液体灌注功能之外，还具有灌注流量可调功能，且本发明直径小、在影像设备下显影清晰，是安全、有效的可应用于肺肿瘤、肺结节等疾病的射频消融电极；其中，需要进一步说明的是，本发明包括但不限于用于肺部肿瘤、结节等疾病的治疗，根据本 发明的原理、结构引申出来的用于其他病位病灶等的射频消融电极，均可理解为在本发明专利的保护范围内。
需要说明的是，对于本领域技术人员而言，显然本发明不限于上述示范性实施例的细节，而且在不背离本发明的精神或基本特征的情况下，能够以其他的具体形式实现本发明。因此，无论从哪一点来看，均应将实施例看作是示范性的，而且是非限制性的，本发明的范围由所附权利要求而不是上述说明限定，因此旨在将落在权利要求的等同要件的含义和范围内的所有变化囊括在本发明内，不应将权利要求中的任何附图标记视为限制所涉及的权利要求。
本发明中应用了具体个例对本发明的原理及实施方式进行了阐述，以上实施例的说明只是用于帮助理解本发明的方法及其核心思想；同时，对于本领域的一般技术人员，依据本发明的思想，在具体实施方式及应用范围上均会有改变之处。综上所述，本说明书内容不应理解为对本发明的限制。

Claims (11)

  1. 一种射频消融电极，其特征在于：包括内循环结构和外部灌注结构；
    所述内循环结构能够使供液装置中的冷媒介质到达所述射频消融电极的工作端，以对所述射频消融电极的工作端及周围的病灶组织进行冷却，并能够使所述冷媒介质流回所述供液装置；
    所述外部灌注结构能够使所述冷媒介质通过所述射频消融电极的工作端上的微孔到达病灶组织。
  2. 根据权利要求1所述的射频消融电极，其特征在于：
    所述内循环结构包括内针管和外针管，所述外针管套设于所述内针管上，且与所述内针管之间形成流体通道，所述流体通道内能够通入所述冷媒介质，所述内针管内设置有能够通入所述冷媒介质的内针管流道，所述内针管流道的前端与所述流体通道的前端连通，所述内针管流道的后端以及所述流体通道的后端均能够与所述供液装置连接；所述外针管的前端设置有针尖，后端设置有绝缘层，所述外针管还能够与射频头电连接；
    所述外部灌注结构包括所述微孔，所述微孔设置于所述外针管的工作端区域；
    其中，所述冷媒介质能够导电，且所述冷媒介质进入所述流体通道后，能够从所述微孔流出。
  3. 根据权利要求2所述的射频消融电极，其特征在于：所述射频消融电极还包括液体腔，所述液体腔位于所述外针管的后端，所述液体腔内用于容纳所述冷媒介质，且所述液体腔与所述流体通道以及所述内针管流道连通；
    所述供液装置包括冷媒介质源和冷媒介质回收装置，所述液体腔包括进水腔和回水腔，所述进水腔与所述回水腔隔开；所述进水腔能够通过进水管与所述冷媒介质源连接，所述回水腔能够通过回水管与所述冷媒介质回收装置连接，所述冷媒介质源能够提供所述冷媒介质，所述冷媒介质回收装置能够回收所述冷媒介质；所述内针管的后端伸入所述进水腔，以使所述内针管流道的后端与所述进水腔连通，所述流体通道的后端与所述回水腔连通。
  4. 根据权利要求3所述的射频消融电极，其特征在于：所述进水管和/或所述回水管上还安装有水量调节装置，所述水量调节装置用于调节所述冷媒介质的进水量或回水量，从而调节所述冷媒介质的灌注量；其中，所述冷媒介质为无菌生理盐水或液体药物，所述冷媒介质的灌注量为单位时间内冷媒介质进入人体内的体积，所述冷媒介质的灌注量为每分钟0.1ml-2.0ml。
  5. 根据权利要求2所述的射频消融电极，其特征在于：所述微孔的孔径为0.005mm-0.05mm。
  6. 根据权利要求2所述的射频消融电极，其特征在于：所述绝缘层为绝缘管，所述外针管的前端还套设有外套管，所述外套管和所述绝缘管沿所述外针管的轴向由前至后依次设置，形成保护管，所述保护管的外壁与所述针尖的外缘平齐；其中，所述外套管的前端外壁与所述针尖的外缘平齐，所述外套管的后端外壁与所述绝缘管的前端外壁平齐；所述外套管能够用于射频能量释放，且所述外套管上还设置有显影孔。
  7. 根据权利要求6所述的射频消融电极，其特征在于：所述外针管上沿轴向设置有多圈所述微孔，所述外套管上设置有多圈所述显影孔，且所述微孔和所述显影孔沿所述外针管的轴向由前至后错开设置；所述冷媒介质从所述微孔流出后，能够进入所述外针管与所述外套管之间的间隙，并从所述显影孔流出。
  8. 根据权利要求6所述的射频消融电极，其特征在于：所述外套管为不锈钢金属管，所述绝缘管为高分子塑料管，所述外套管和所述绝缘管的壁厚均为0.01mm-0.1mm；所述针尖为开刃的三棱针尖，且所述针尖焊接在所述外针管的前端；所述微孔的孔径为0.05mm-0.5mm，所述外套管与所述外针管之间的间隙为0.01mm-0.05mm。
  9. 根据权利要求2所述的射频消融电极，其特征在于：所述外针管的直径最小为1.0mm。
  10. 一种射频消融系统，其特征在于：包括射频消融仪以及如权利要求1-9任意一项所述的射频消融电极。
  11. 一种如权利要求1-9任意一项所述的射频消融电极在制备医疗器 械中的应用。
PCT/CN2022/135833 2022-10-31 2022-12-01 射频消融电极及其应用以及射频消融系统 WO2024092945A1 (zh)

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