Tumor ablation needle with gas-liquid channel for high-voltage steep pulse

Abstract

The invention discloses a high-voltage steep pulse tumor ablation needle with a gas-liquid channel, and relates to the field of ablation needles, the high-voltage steep pulse tumor ablation needle comprises a fixed cylinder, a second needle body with a gas channel is fixedly connected in the fixed cylinder, a third needle body with a gas-liquid channel is coaxially arranged in the second needle body, and the high-voltage steep pulse tumor ablation needle further comprises a sliding cylinder, the sliding cylinder is fixedly connected with a first needle body with a gas channel, the first needle body is sleeved outside a second needle body in a sliding manner, the sliding cylinder is connected to the end part of the fixed cylinder in a sliding manner, the first electrode column is arranged at the end part of the first needle body, the end part of the second needle body is fixedly connected with a second electrode column, and the second electrode column is arranged at the end part of the first needle body. And through holes are uniformly formed in the side walls of the first electrode column and the second electrode column. The single needle is used for achieving triple treatment of freezing, steep pulse and PD-1 inhibitor of tumor ablation, the tumor ablation effect is effectively improved, and meanwhile the surgical operation difficulty is lowered.

Description

Technical Field

[0001] The present invention relates to the field of ablation needles, in particular to a high-voltage steep pulse tumor ablation needle with a gas-liquid channel. Background Art

[0002] Steep pulse tumor ablation is a minimally invasive tumor treatment device based on irreversible electroporation technology. It releases high-voltage, ultra-short duration (microsecond or nanosecond) steep pulse electric fields to form irreversible nanoscale pores on the cell membrane, leading to tumor cell apoptosis while protecting surrounding healthy tissues and sensitive structures such as blood vessels and nerves to the greatest extent.

[0003] Tumor cryoablation is a minimally invasive treatment technology that uses extremely low temperatures (-40°C to -196°C) to destroy tumor tissue. Its core principle is to induce intracellular ice crystal formation, cell membrane rupture, microvascular embolism, and ultimately tumor cell necrosis through rapid freezing-thawing cycles.

[0004] The relevant Chinese patent with announcement number CN117204939B discloses an ablation system combining freezing and electroablation, including a freezing module and an electroablation module, the electroablation module is connected to at least two electrodes, the electrodes include at least one first electrode and at least one second electrode, the first electrode and the second electrode are insulated from each other and connected to two output ends of the electroablation module with opposite polarities; at least one first electrode portion is arranged in the shallow freezing area of the target tissue, and the second electrode portion is arranged in the freezing area of the target tissue, or in human tissue, or in electrical contact with human tissue.

[0005] Regarding the above-mentioned related technologies, the combination of cryoablation and steep pulse ablation can combine the advantages of the two ablation methods, but it often requires the coordinated use of multiple cryoablation needles and steep pulse ablation needles to achieve combined ablation. It is difficult to use multiple ablation needles to penetrate the lesion for surgery, and there is a risk of excessive ablation of the tissue around the lesion due to the influence of the insertion position of the steep pulse ablation needle. At the same time, the combined ablation range is limited by the coordinated insertion position of multiple needles, and the adjustment of the ablation range is not flexible enough.

[0006] The relevant Chinese patent with announcement number CN115444548A discloses an ablation structure and an ablation device for tumor treatment, including an electrode needle, whose proximal end is suitable for electrical connection with a power supply, and whose distal end is suitable for extending out of a receiving cavity. A liquid passage with openings at both ends is provided along the axis of the electrode needle. The liquid in the liquid passage is suitable for flowing from its proximal opening to the distal opening and is suitable for acting on the lesion.

[0007] Regarding the above-mentioned related technologies, a unidirectional flow channel is set in the ablation needle to deliver the drug solution to the lesion, but the ablation method of the ablation needle is single, which is not conducive to effective ablation of complex lesions. If the steep pulse ablation needle with a liquid channel is combined with the cryoablation method, problems such as the freezing gas interfering with the liquid flow in the liquid channel are likely to occur.

[0008] In summary, the existing high-voltage steep pulse tumor ablation needle is not easy to combine multiple ablation methods to achieve single-needle tumor ablation. Summary of the Invention

[0009] Based on this, the purpose of the present invention is to provide a high-voltage steep pulse tumor ablation needle with a gas-liquid channel to solve the technical problem that the existing high-voltage steep pulse tumor ablation needle is difficult to combine multiple ablation methods to achieve single-needle tumor ablation.

[0010] To achieve the above-mentioned objectives, the present invention provides the following technical solutions: A high-voltage steep pulse tumor ablation needle with a gas-liquid channel, comprising a fixed tube, a second needle body with a gas channel fixedly connected to the fixed tube, a third needle body with a gas-liquid channel coaxially arranged inside the second needle body, and a sliding tube, wherein the sliding tube is fixedly connected to the first needle body with a gas channel, the first needle body is slidably sleeved on the outside of the second needle body, the sliding tube is slidably connected to the end of the fixed tube, and further comprising a first electrode column, the first electrode column is arranged at the end of the first needle body, the end of the second needle body is fixedly connected to the second electrode column, and the side walls of the first electrode column and the second electrode column are evenly provided with through holes.

[0011] By adopting the above technical solution, a single needle is used to achieve triple treatment of tumor ablation with cryotherapy, steep pulse and PD-1 inhibitors, which effectively improves the tumor ablation effect and reduces the difficulty of surgical operation.

[0012] The present invention is further configured such that a plug for sealing the end of the third needle body is slidably connected to the inside of the second electrode column, the end of the third needle body is connected to a bracket, a compression spring is arranged between the bracket and the plug, the compression spring is connected to a pull rope, and the pull rope passes through the fixed cylinder along the axis of the third needle body and is connected to a winding mechanism.

[0013] Preferably, cryoablation can be performed after the plug seals the end of the third needle body.

[0014] The present invention is further configured such that an end of the fixed cylinder away from the sliding cylinder is connected to an end cover, the end cover is rotatably connected to a rotary cover, a winding disk for winding up the cable is fixedly connected inside the rotary cover, and a locking mechanism for limiting the rotation of the rotary cover is provided between the rotary cover and the end cover.

[0015] Preferably, a locking mechanism is used to limit the rotation of the rotary cover.

[0016] The present invention is further configured such that the rotary cover is fixedly connected with a mounting post passing through the end cover in the direction toward the end cover, a winding disk is coaxially fixedly connected to the mounting post, the mounting post is rotatably connected to the end cover and can also slide relative to the end cover along its own axis, the end cover is fixedly connected with a positioning ring with a diameter larger than the rotary cover, a clamping block is fixedly connected to the edge of the rotary cover, a ring rail for the clamping block to rotate is provided in the positioning ring, and a plurality of through openings for the clamping block to pass through are opened on the edge, and positioning strips for preventing the rotary cover from rotating are provided at intervals along the circumferential direction on the surface of the positioning ring.

[0017] Preferably, the cable can be further tightened after the axial sliding cover is screwed on to prevent gas leakage from occurring at the plug.

[0018] The present invention is further configured such that the end of the third needle body is provided with a first receiving groove for fitting and receiving a plug, the diameter of the plug is the same as the inner diameter of the second electrode column, and a second receiving groove for receiving a compression spring is provided inside the direction facing the bracket.

[0019] Preferably, the plug can push the residue in the second electrode column into the third needle body while moving toward the first receiving groove, thereby preventing different injected substances from interfering with each other.

[0020] The present invention is further configured such that the sliding cylinder is provided with a first interface toward the first needle body, the first interface is connected to the space between the inner wall of the first needle body and the outer wall of the second needle body through a pipe, the inner wall of the first needle body is provided with a plurality of air inlet channels at annular intervals along the length direction, the end of the air inlet channel close to the first electrode column is provided with an exhaust port toward the outer wall of the second needle body, and the end of the air inlet channel away from the first electrode column is provided with an air inlet that passes through the side wall of the first needle body and is connected to the air.

[0021] Preferably, a heat-insulating layer is formed on the unexposed portion of the second needle body to prevent non-lesion areas from being frostbitten.

[0022] The present invention is further configured such that the fixed tube is provided with a second interface toward the second needle body, the second interface connects the space between the inner wall of the second needle body and the outer wall of the third needle body through a pipeline, and the fixed tube is provided with a third interface and a fourth interface toward the third needle body respectively, and the third interface and the fourth interface are both connected to the interior of the third needle body through a pipeline.

[0023] Preferably, the second interface and the third interface are used in conjunction with each other to implement gas delivery during cryoablation.

[0024] The present invention is further configured such that the outer diameter and length of the first electrode column and the second electrode column are the same, the inner diameter of the first electrode column and the first needle body are the same and both are larger than the outer diameter of the second needle body, and the air inlet channel does not contact the second needle body and does not interfere with the through hole on the side wall of the first electrode column.

[0025] Preferably, the first electrode column and the second electrode column are capable of generating a uniform electric field to cover the edge of the lesion and perform high-voltage steep pulse ablation.

[0026] The present invention is further configured such that an end of the side wall of the third needle body close to the second electrode column is provided with a one-way opening toward the inside of the third needle body.

[0027] Preferably, the fluid transported from the third needle body to the second electrode column is prevented from entering the interlayer between the third needle body and the second needle body.

[0028] The present invention is further configured such that the outer wall of the sliding cylinder is fixedly connected to a guide slideway, and the end of the fixed cylinder is rotatably connected to a knob for limiting the sliding of the sliding cylinder.

[0029] Preferably, the positioning of the sliding cylinder is achieved by using a knob.

[0030] In summary, the present invention mainly has the following beneficial effects:

[0031] 1. The present invention adopts a multiple needle body sliding sleeve setting, and the sliding position of the sliding cylinder can be adjusted to achieve convenient adjustment of the cryoablation range. During the insertion and removal of the ablation needle, the channel inside the needle body is used to deliver nanoparticles and PD-1 inhibitors respectively. A single needle is used to achieve triple treatment of tumor ablation with freezing, steep pulse and PD-1 inhibitor, which effectively improves the tumor ablation effect and reduces the difficulty of surgical operation.

[0032] 2. The present invention respectively sets two different electrodes at the ends of the first needle body and the second needle body, and evenly sets perforations on the outer walls of the electrodes. The channel inside the needle body is used to generate negative pressure during the operation, which is beneficial to the positioning of the needle body at the lesion. At the same time, it can make the motor fit the lesion, avoid high-voltage sparks, and reduce the loss of ablation voltage.

[0033] 3. The present invention controls the plug to seal the end of the third needle body through a pull rope, thereby preventing the cryogenic gas from leaking into the patient's body during cryoablation. When the plug does not seal the end of the third needle body, the third needle body can be used as a delivery channel for nanoparticles and PD-1 inhibitors. At the same time, when the plug moves toward the end of the third needle body, the residue in the second electrode column can be pushed into the third needle body, effectively avoiding crosstalk between different injections.

[0034] 4. The present invention connects an end cap to the end of a fixed cylinder, and rotates a rotary cap on the end cap, and uses a winding disk inside the rotary cap to wind up the cable to pull the plug. At the same time, after the rotary cap rotates and tightens the cable, it can also move away from the plug to further tighten the cable and lock it, effectively avoiding gas leakage due to the elastic force of the cable itself during cryoablation.

[0035] 5. The present invention provides an air inlet channel on the inner wall of the first needle body. When the first interface is connected to the negative pressure pipe, it ensures negative pressure at the perforation of the first electrode column while allowing air to continuously flow in the space between the first needle body and the second needle body, forming a heat-insulating layer at the part of the ablation needle that does not require cryoablation, effectively preventing the freezing gas from freezing the normal tissues in the patient's body before reaching the lesion. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1 This is a three-dimensional diagram of the sliding cylinder of the present invention in a non-sliding state;

[0037] Figure 2 This is a three-dimensional diagram of the sliding cylinder of the present invention after sliding adjustment;

[0038] Figure 3 For the present invention Figure 2 A magnified view of middle A;

[0039] Figure 4 This is a three-dimensional diagram of the internal structure of the front end of the ablation needle when the sliding cylinder and the plug are not sliding;

[0040] Figure 5 For the present invention Figure 4 Enlarged view of middle B;

[0041] Figure 6 This is a three-dimensional diagram of the internal structure of the ablation needle in a state where the front end of the ablation needle does not show the compression spring and the cable after the sliding cylinder of the present invention is slid and adjusted;

[0042] Figure 7 For the present invention Figure 6 Enlarged view of middle C;

[0043] Figure 8 A three-dimensional diagram of the internal structure of the front end of the ablation needle after the sliding cylinder of the present invention is adjusted and the plug is pulled and slid by the cable;

[0044] Figure 9 For the present invention Figure 8 Enlarged view of middle D;

[0045] Figure 10 An exploded view of the present invention;

[0046] Figure 11 For the present invention Figure 10 Enlarged view of E in the middle;

[0047] Figure 12 A three-dimensional diagram of the internal structure of the fixing cylinder of the present invention;

[0048] Figure 13 For the present invention Figure 12 Enlarged view of middle F;

[0049] Figure 14 This is a three-dimensional view of the interior of the sliding cylinder of the present invention, with the end of the first needle body separated from the air inlet of the air inlet channel;

[0050] Figure 15 For the present invention Figure 14 Enlarged view of middle G;

[0051] Figure 16 A three-dimensional diagram of the plug of the present invention;

[0052] Figure 17 This is a three-dimensional diagram of the internal structure of the end portion of the first needle body of the present invention;

[0053] Figure 18 For the present invention Figure 17 Magnified view of H in the middle.

[0054] Description of reference numerals:

[0055] 1. Fixed cylinder; 2. Sliding cylinder; 201. Guide slide; 3. First needle body; 4. Second needle body; 5. Third needle body; 501. Bracket; 502. First accommodating groove; 6. First electrode column; 7. Second electrode column; 8. Needle; 9. Plug; 901. Second accommodating groove; 10. Compression spring; 11. Pull rope; 12. One-way opening; 13. Air inlet channel; 1301. Air inlet; 1302. Exhaust port; 14. First interface; 15. Second interface; 16. Third interface; 17. Fourth interface; 18. End cover; 19. Rotary cover; 20. Mounting column; 21. Winding reel; 22. Block; 23. Positioning ring; 24. Through port; 25. Positioning strip; 26. Knob. DETAILED DESCRIPTION

[0056] The following will be combined with the accompanying drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and should not be understood as limiting the present invention.

[0057] The following describes an embodiment of the present invention based on its overall structure.

[0058] First embodiment:

[0059] A high-pressure steep pulse tumor ablation needle with a gas-liquid channel, please refer to Figure 1-18 , including a fixed cylinder 1, which serves as the holding part of the ablation needle for the doctor to hold. A second needle body 4 with a gas channel is fixedly connected inside the fixed cylinder 1. The gas channel of the second needle body 4 is specifically the space between the inner wall of the second needle body 4 and the outer wall of the third needle body 5. The interior of the second needle body 4 is coaxially arranged with a third needle body 5 with a gas-liquid channel. Specifically, the interior of the third needle body 5 can transport gas or liquid.

[0060] It also includes a sliding cylinder 2, which is fixedly connected to a first needle body 3 having a gas channel. Specifically, the gas channel of the first needle body 3 is the space between the inner wall of the first needle body 3 and the outer wall of the second needle body 4. The first needle body 3 is slidably sleeved on the outside of the second needle body 4. Both ends of the first needle body 3 are slidably connected to the outer wall of the second needle body 4, and a sliding sealing ring is provided at the contact position. The sliding cylinder 2 is slidably connected to the end of the fixed cylinder 1. Specifically, in order to clearly observe the sliding amount of the sliding cylinder 2 and the penetration depth of the first needle body 3 and other information, metering scales are provided on the outer wall of the first needle body 3 and the outer wall of the sliding cylinder 2. This is a commonly used method in the prior art and will not be elaborated here.

[0061] It also includes a first electrode column 6, which is arranged at the end of the first needle body 3. When the sliding cylinder 2 is not sliding, the first electrode column 6 and the second electrode column 7 are in contact with each other, which makes it convenient to calculate the length of the exposed portion of the outer wall of the second needle body 4 by the sliding amount of the sliding cylinder 2. The end of the second needle body 4 is fixedly connected to the second electrode column 7. The side walls of the first electrode column 6 and the second electrode column 7 are evenly provided with through holes, and the through holes provided on the side walls of the second electrode column 7 can be used to evenly disperse the agent to the lesion.

[0062] Specifically, the first needle body 3 and the second needle body 4 are both conductive, wherein the outer walls of the first needle body 3 and the second needle body 4 are coated with an insulating coating, and the first electrode column 6 and the second electrode column 7 are not covered with an insulating coating. When the first electrode column 6 slides away from the second electrode column 7 and the ablation needle is energized, the first electrode column 6 and the second electrode column 7 can cooperate with each other to achieve high-voltage steep pulse ablation of the lesion.

[0063] In the above embodiment, please refer to Figure 4-9 A plug 9 for sealing the end of the third needle body 5 is slidably connected to the second electrode column 7. The end of the third needle body 5 is connected to a bracket 501. A compression spring 10 is arranged between the bracket 501 and the plug 9. The compression spring 10 is connected to a pull rope 11. The pull rope 11 passes through the fixed tube 1 along the axis of the third needle body 5 and is connected to a winding mechanism. Cryoablation can be performed after the plug 9 seals the end of the third needle body 5.

[0064] Specifically, when the cable 11 is wound by the winding mechanism, the plug 9 will compress the compression spring 10 when it moves toward the bracket 501, causing the compression spring 10 to accumulate elastic potential energy. When the cable 11 is released, the elastic potential energy accumulated in the compression spring 10 is released, which can push the plug 9 to slide away from the bracket 501.

[0065] Furthermore, in order to prevent the compression spring 10 from moving randomly, the bracket 501 is provided with a flange facing the compression spring 10 for positioning the compression spring 10 , and a through hole for the cable 11 to pass through is provided at the center of the bracket 501 .

[0066] In the above embodiment, please refer to Figure 2-3 、 Figure 12-15 、 Figure 17-18 The sliding cylinder 2 is provided with a first interface 14 toward the first needle body 3. The first interface 14 is connected to the space between the inner wall of the first needle body 3 and the outer wall of the second needle body 4 through a pipeline. The first interface 14 is used to connect an external negative pressure pipeline to extract the air between the inner wall of the first needle body 3 and the inner wall of the second needle body 4.

[0067] Furthermore, the fixed cylinder 1 is provided with a second interface 15 toward the second needle body 4, and the second interface 15 connects the space between the inner wall of the second needle body 4 and the outer wall of the third needle body 5 through a pipeline. The fixed cylinder 1 is respectively provided with a third interface 16 and a fourth interface 17 toward the third needle body 5, and both the third interface 16 and the fourth interface 17 are connected to the interior of the third needle body 5 through pipelines. The second interface 15 and the third interface 16 are used in conjunction with each other to implement gas delivery during cryoablation. Specifically, the fourth interface 17 is used to deliver fluid media such as nanoparticles or PD-1 inhibitors into the third needle body 5. In other undisclosed embodiments, other drugs that are beneficial to tumor ablation can also be delivered, and the third interface 16 is connected to the negative pressure pipeline, which is used to extract gas or liquid in the third needle body 5 in different use steps of the ablation needle.

[0068] In the above embodiment, please refer to Figure 4-7 、 Figure 14-15 A one-way opening 12 facing into the third needle body 5 is provided at one end of the side wall of the third needle body 5 close to the second electrode column 7 to prevent the fluid transported from the third needle body 5 to the second electrode column 7 from entering the interlayer between the third needle body 5 and the second needle body 4.

[0069] Specifically, the specific structure of the one-way opening 12 includes a frame arranged in the opening and a one-way diaphragm slidably connected to the frame. When gas flows from the space between the second needle body 4 and the third needle body 5 into the third needle body 5, the one-way diaphragm will be pushed open to keep the one-way opening 12 unobstructed. On the contrary, when gas or liquid wants to flow from the third needle body 5 to the space between the third needle body 5 and the second needle body 4, the one-way diaphragm will be pushed to make it close to the frame, thereby realizing one-way flow at the one-way opening 12.

[0070] Furthermore, a guide slide 201 is fixedly connected to the outer wall of the sliding cylinder 2. The guide slide 201 is used to respond to the sliding of the sliding cylinder 2, so that the sliding cylinder 2 can slide along the axial direction of the first needle body 3. The end of the fixed cylinder 1 is rotatably connected to a knob 26 for limiting the sliding of the sliding cylinder 2. The knob 26 is used to achieve the positioning of the sliding cylinder 2. Specifically, the knob 26 is fixedly connected to the direction of the surface of the guide slide 201. The screw is threadedly connected to the fixed cylinder 1 and contacts the surface of the guide slide 201 after passing through the fixed cylinder 1. When it is necessary to limit the relative sliding between the fixed cylinder 1 and the sliding cylinder 2, the knob 26 can be turned to utilize the friction between the screw and the guide slide 201 and the friction between the fixed cylinder 1 and the sliding cylinder 2 to limit the relative sliding between the two.

[0071] Second embodiment:

[0072] A high-pressure steep pulse tumor ablation needle with a gas-liquid channel, please refer to Figure 1-18 Based on the first embodiment, the difference from the first embodiment is that the end of the fixed cylinder 1 away from the sliding cylinder 2 is connected to the end cover 18, the end cover 18 is rotatably connected to the rotary cover 19, and the rotary cover 19 is fixedly connected to the winding drum 21 for winding up the cable 11. A locking mechanism for limiting the rotation of the rotary cover 19 is provided between the rotary cover 19 and the end cover 18, and the rotation of the rotary cover 19 is limited by the locking mechanism.

[0073] Specifically, the rotary cover 19 is fixedly connected to a mounting post 20 passing through the end cover 18 in the direction of the end cover 18, and a winding disk 21 is coaxially fixedly connected to the mounting post 20. While the mounting post 20 is rotatably connected to the end cover 18, it can also slide relative to the end cover 18 along its own axis. Specifically, after the cable 11 passes through the end of the third needle body 5, it passes through the end cover 18 and is wound around the winding disk 21. The radius of the winding disk 21 is smaller than the distance between its own axis and the axis of the third needle body 5, so as to avoid blocking the hole through which the cable 11 passes.

[0074] Furthermore, the end cover 18 is fixedly connected to a positioning ring 23 having a diameter larger than that of the rotary cover 19, and a clamping block 22 is fixedly connected to the edge of the rotary cover 19. In the present embodiment, there are two clamping blocks 22, which are arranged one hundred and eighty degrees apart from each other on the annular surface. A circular rail for the clamping block 22 to rotate is provided in the positioning ring 23, and a plurality of through openings 24 for the clamping block 22 to pass through are provided on the edge. Positioning strips 25 for preventing the rotary cover 19 from rotating are provided at intervals along the annular direction on the surface of the positioning ring 23. After the rotary cover 19 is axially slid, the cable 11 can be further tightened to prevent gas leakage at the plug 9.

[0075] Specifically, the rotary cover 19 is rotated to allow the winding disc 21 to reel in the cable 11. When the rotary cover 19 is rotated to have obvious resistance, the block 22 is aligned with the through-hole 24, and the rotary cover 19 is slid in the direction away from the end cover 18. When the block 22 passes through the through-hole 24, the rotary cover 19 is continued to be rotated until it can no longer be rotated, and then the rotary cover 19 is loosened. The block 22 at the end of the rotary cover 19 is between the positioning strips 25 on the outer wall of the positioning ring 23, so that the rotary cover 19 cannot continue to rotate. At the same time, the rotary cover 19 is tightly attached to the outer surface of the positioning ring 23 by the elastic force of the cable 11 itself, so that the sealing at the plug 9 can be effectively guaranteed.

[0076] In the above embodiment, please refer to Figure 4-9 The end of the third needle body 5 is provided with a first receiving groove 502 for fitting and accommodating the plug 9. The diameter of the plug 9 is the same as the inner diameter of the second electrode column 7, and a second receiving groove 901 for accommodating the compression spring 10 is provided inside the bracket 501. When the plug 9 moves toward the first receiving groove 502, it can push the residue in the second electrode column 7 into the third needle body 5. The high-pressure gas during the cryoablation process will drive the small amount of residue pushed into the third needle body 5 to flow, and finally be discharged along the third interface 16, so as to avoid crosstalk between different subsequent injections.

[0077] The third embodiment:

[0078] A high-pressure steep pulse tumor ablation needle with a gas-liquid channel, please refer to Figure 1-18 Based on the second embodiment, the present invention differs from the second embodiment in that a plurality of air inlet channels 13 are provided on the inner wall of the first needle body 3 at annular intervals along the length direction. Specifically, in this embodiment, four air inlet channels 13 are provided. An exhaust port 1302 facing the outer wall of the second needle body 4 is provided at one end of the air inlet channel 13 close to the first electrode column 6. An air inlet port 1301 passing through the side wall of the first needle body 3 and communicating with the air is provided at one end of the air inlet channel 13 away from the first electrode column 6. This forms an insulation layer on the unexposed portion of the second needle body 4 to prevent frostbite in non-lesion areas.

[0079] Specifically, when the first interface 14 is connected to the negative pressure pipeline, a negative pressure environment is created between the inner wall of the first needle body 3 and the outer wall of the second needle body 4. When the first electrode column 6 absorbs the tissue at the lesion through the through hole provided on the outer wall, the through hole on the side wall of the first electrode column 6 is blocked by the lesion. At this time, the air in the space between the fixed cylinder 1 and the sliding cylinder 2 enters the air inlet channel 13 through the air inlet port 1301, flows along the air inlet channel 13 toward the first electrode column 6, and is discharged from the exhaust port 1302 to the space between the inner wall of the first needle body 3 and the outer wall of the second needle body 4. Since the pipeline connected to the first interface 14 is in a continuous negative pressure state, the gas leaving the air inlet channel 13 through the exhaust port 1302 will immediately flow along the length direction of the first needle body 3 toward the sliding cylinder 2 until it passes through the first interface 14 and enters the negative pressure pipeline. During the cryoablation process, the gas between the first needle body 3 and the second needle body 4 is always in a flowing state, thereby achieving the effect of protecting other tissues in the patient's body.

[0080] Furthermore, the outer diameter and length of the first electrode column 6 and the second electrode column 7 are the same, the inner diameter of the first electrode column 6 and the first needle body 3 are the same, and both are larger than the outer diameter of the second needle body 4. The air inlet channel 13 does not contact the second needle body 4 and does not interfere with the through hole on the side wall of the first electrode column 6, so that the first electrode column 6 and the second electrode column 7 can generate a uniform electric field, covering the edge of the lesion for high-voltage steep pulse ablation.

[0081] The ablation needle of the present invention is specifically used for tumor ablation:

[0082] The fourth interface 17 is connected to the nanoparticle delivery pipeline, which pre-delivers nanoparticles into the third needle body 5. After the air in the third needle body 5 is expelled, the delivery of nanoparticles is suspended, and then the ablation needle is inserted into the patient's body. During the process of the ablation needle inserting into the patient's body, when the needle head 8 reaches one end at the edge of the lesion, the fourth interface 17 continues to deliver nanoparticles while the ablation needle continues to penetrate the patient, so that the nanoparticles are evenly distributed to the lesion through the through holes in the side wall of the second electrode column 7 until the needle head 8 reaches the other end at the edge of the lesion and stops delivering nanoparticles. The nanoparticles evenly distributed in the lesion can effectively enhance the efficiency of ice crystal formation, thereby expanding the range of cryoablation.

[0083] After the ablation needle is inserted into the lesion to an appropriate depth, the third interface 16 is connected to the negative pressure pipeline. After the excess nanoparticles in the third needle body 5 and the second electrode column 7 are extracted, the interior of the third needle body 5 and the second electrode column 7 are kept in a negative pressure state. The second electrode column 7 absorbs the tissue at the lesion through the through-hole provided in the side wall, thereby achieving the positioning of the second electrode column 7. Then, the sliding cylinder 2 is retracted to cause the first needle body 3 to slide in the opposite direction. Since the second electrode column 7 is in a positioned state by adsorbing the lesion, the length of the exposed section of the second needle body 4 can be conveniently adjusted so that the outer wall of the exposed section of the second needle body 4 can directly contact the lesion.

[0084] After rotating the knob 26 to limit the relative sliding between the sliding cylinder 2 and the fixed cylinder 1, the first interface 14 is connected to the negative pressure line, so that a negative pressure state is formed between the inner wall of the first needle body 3 and the outer wall of the second needle body 4. The first electrode column 6 absorbs the tissue at the lesion through the through hole provided in the side wall, thereby achieving the positioning of the first electrode column 6;

[0085] Then, the rotary cover 19 is rotated to reel in the cable 11, so that the plug 9 moves toward the first receiving groove 502, and finally the end of the third needle body 5 is sealed. During this process, the third interface 16 is not connected to the negative pressure pipeline.

[0086] The second interface 15 is connected to the high-pressure argon gas supply pipeline. The high-pressure argon gas flows toward the needle tip 8 through the space between the inner wall of the second needle body 4 and the outer wall of the third needle body 5, passes through the one-way opening 12, enters the interior of the third needle body 5, flows back in the opposite direction, and is finally discharged through the third interface 16, rapidly cooling the exposed portion of the second needle body 4, thereby achieving cryoablation at the center of the lesion. The rewarming process is similar, except that the high-pressure argon gas is replaced by helium.

[0087] After a cooling and heating process of cryoablation, the rotary cover 19 is rotated to release the cable 11, and the compression spring 10 releases its elastic potential energy to reset the plug 9. The third interface 16 is connected to the negative pressure pipeline, allowing the second electrode column 7 to resume adsorption on the lesion. Then, the first electrode column 6 and the second electrode column 7 are energized to perform high-voltage steep pulse ablation. Cryoablation and high-voltage steep pulse ablation are performed alternately in this way. Specific parameters such as ablation time and voltage can be adaptively adjusted according to the conditions of different patients.

[0088] After the last high-voltage steep pulse ablation is completed, the first interface 14 and the third interface 16 are disconnected from the negative pressure pipeline, and the fourth interface is connected to the supply pipeline of the PD-1 inhibitor. The PD-1 inhibitor is delivered to the lesion through the third needle body 5 and the through-hole on the side wall of the second electrode column 7. The ablation needle is slowly withdrawn during the delivery of the PD-1 inhibitor. When the needle head 8 moves to the edge of the lesion, the delivery of the PD-1 inhibitor is stopped. The PD-1 inhibitor evenly distributed in the lesion can effectively enhance the systemic immune response, thereby indirectly expanding the treatment effect.

[0089] Although an embodiment of the present invention has been shown and described, this specific embodiment is merely an explanation of the present invention and is not a limitation of the invention. The specific features, structures, materials or characteristics described may be combined in an appropriate manner in any one or more embodiments or examples. After reading this specification, those skilled in the art may make modifications, substitutions and variations to the embodiment without creative contribution as needed without departing from the principles and purpose of the present invention. However, as long as they are within the scope of the claims of the present invention, they are protected by patent law.

Claims

1. A high-voltage steep pulse tumor ablation needle with a gas-liquid channel, characterized in that: include: A fixed cylinder (1), wherein a second needle body (4) having a gas passage is fixedly connected to the fixed cylinder (1), and a third needle body (5) having a gas-liquid passage is coaxially arranged inside the second needle body (4); A sliding cylinder (2), wherein the sliding cylinder (2) is fixedly connected to a first needle body (3) having a gas passage, the first needle body (3) is slidably sleeved on the outside of the second needle body (4), and the sliding cylinder (2) is slidably connected to the end of the fixed cylinder (1); A first electrode column (6) is provided at the end of the first needle body (3); the end of the second needle body (4) is fixedly connected to a second electrode column (7); and through holes are evenly provided on the side walls of the first electrode column (6) and the second electrode column (7).

2. The high-voltage steep pulse tumor ablation needle with a gas-liquid channel according to claim 1, characterized in that: A plug (9) for sealing the end of the third needle body (5) is slidably connected inside the second electrode column (7), the end of the third needle body (5) is connected to a bracket (501), a compression spring (10) is provided between the bracket (501) and the plug (9), the compression spring (10) is connected to a cable (11), and the cable (11) passes through the fixed cylinder (1) along the axis of the third needle body (5) and is connected to a winding mechanism.

3. The high-pressure steep pulse tumor ablation needle with a gas-liquid channel according to claim 2, characterized in that: An end of the fixed cylinder (1) away from the sliding cylinder (2) is connected to an end cover (18), and the end cover (18) is rotatably connected to a rotary cover (19). A reel (21) for reeling in the cable (11) is fixedly connected inside the rotary cover (19), and a locking mechanism for limiting the rotation of the rotary cover (19) is provided between the rotary cover (19) and the end cover (18).

4. The high-pressure steep pulse tumor ablation needle with a gas-liquid channel according to claim 3, characterized in that: The rotary cover (19) is fixedly connected to a mounting post (20) passing through the end cover (18) in the direction toward the end cover (18), and a winding disk (21) is coaxially fixedly connected to the mounting post (20). The mounting post (20) is rotatably connected to the end cover (18) and can also slide relative to the end cover (18) along its own axis. The end cover (18) is fixedly connected to a positioning ring (23) having a diameter larger than that of the rotary cover (19). A clamping block (22) is fixedly connected to the edge of the rotary cover (19). A circular rail for the clamping block (22) to rotate is provided in the positioning ring (23), and a plurality of through openings (24) for the clamping block (22) to pass through are provided on the edge. Positioning strips (25) for preventing the rotary cover (19) from rotating are provided on the surface of the positioning ring (23) at intervals along the circumferential direction.

5. The high-voltage steep-pulse tumor ablation needle with a gas-liquid channel according to claim 2, characterized in that: The end of the third needle body (5) is provided with a first receiving groove (502) for fitting and receiving a plug (9); the diameter of the plug (9) is the same as the inner diameter of the second electrode column (7), and a second receiving groove (901) for receiving a compression spring (10) is provided inside the plug (9) in a direction toward the bracket (501).

6. The high-voltage steep-pulse tumor ablation needle with a gas-liquid channel according to claim 1, characterized in that: The sliding cylinder (2) is provided with a first interface (14) toward the first needle body (3), and the first interface (14) is connected to the space between the inner wall of the first needle body (3) and the outer wall of the second needle body (4) through a pipeline. The inner wall of the first needle body (3) is provided with a plurality of air inlet channels (13) at annular intervals along the length direction. The end of the air inlet channel (13) close to the first electrode column (6) is provided with an exhaust port (1302) toward the outer wall of the second needle body (4), and the end of the air inlet channel (13) away from the first electrode column (6) is provided with an air inlet (1301) that passes through the side wall of the first needle body (3) and is connected to the air.

7. The high-voltage steep pulse tumor ablation needle with a gas-liquid channel according to claim 1, characterized in that: The fixed cylinder (1) is provided with a second interface (15) facing the second needle body (4), and the second interface (15) is connected to the space between the inner wall of the second needle body (4) and the outer wall of the third needle body (5) through a pipeline. The fixed cylinder (1) is provided with a third interface (16) and a fourth interface (17) facing the third needle body (5), respectively, and the third interface (16) and the fourth interface (17) are both connected to the interior of the third needle body (5) through a pipeline.

8. The high-voltage steep-pulse tumor ablation needle with a gas-liquid channel according to claim 6, characterized in that: The outer diameter and length of the first electrode column (6) and the second electrode column (7) are the same, the inner diameter of the first electrode column (6) and the first needle body (3) are the same, and both are larger than the outer diameter of the second needle body (4), and the air inlet channel (13) does not contact the second needle body (4) and does not interfere with the through hole on the side wall of the first electrode column (6).

9. The high-voltage steep-pulse tumor ablation needle with a gas-liquid channel according to claim 1, characterized in that: One end of the side wall of the third needle body (5) close to the second electrode column (7) is provided with a one-way opening (12) facing into the third needle body (5).

10. The high-voltage steep pulse tumor ablation needle with a gas-liquid channel according to claim 1, characterized in that: The outer wall of the sliding cylinder (2) is fixedly connected to a guide slideway (201), and the end of the fixed cylinder (1) is rotatably connected to a knob (26) for limiting the sliding of the sliding cylinder (2).

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