Ablation needle

Abstract

The invention belongs to the technical field of radiofrequency ablation instruments, and provides an ablation needle. The device comprises a puncture needle and a handle linkage assembly with an infusion tube, the puncture needle is a hollow needle, a sub-needle array of at least two sub-needles is carried in the puncture needle, radial outlets with the number not smaller than that of the sub-needles in the sub-needle array are formed in the side surface of the puncture needle, and a distance is formed between the radial outlets and the tail end of a needle point of the puncture needle; the sub-needles of the sub-needle array comprise a folded state and an unfolded state, the sub-needles in the folded state are folded in parallel and are filled in the puncture needle, and the sub-needles of the sub-needle array can extend out of the puncture needle through corresponding radial outlets and bend and deform towards the two sides relative to the puncture needle to reach the unfolded state. Through the arrangement, the solid needle and / or hollow needle array combination enables the ablation range to be closer to a regular sphere; a multi-point perfusion temperature measurement mode is adopted, conductive liquid is evenly distributed, and the temperatures of multiple points in an ablation area are monitored in cooperation with multiple temperature sensors.

Description

TECHNICAL FIELD

[0001] The application relates to the technical field of radio frequency ablation instruments, and provides an ablation needle. BACKGROUND

[0002] Radio frequency ablation is to cause electromagnetic field change through radio frequency current, so that positive and negative ions and other particles in cells rub against each other, biological heat effect is generated, and then tissue cells are inactivated in situ. In order to ensure the inactivation of tumor tissue, radio frequency ablation will increase the local temperature of the tissue, and the temperature around the electrode can reach more than 100 DEG C, but the ablation effect gradually decreases from the electrode outward, and generally only inactivates tumors with a diameter of 2 to 3 cm, and the actual ablation range is much smaller than the electromagnetic field range. In the prior art, in order to expand the range of radio frequency ablation, the electrode range is expanded through an umbrella-shaped structure or the conductivity is improved by injecting conductive liquid. The existing umbrella-shaped structure sets all the sub-needles to the same curvature and at the same horizontal line, and the final effective ablation range tends to be an elliptical spindle, and the elliptical ablation range cannot well cope with irregular tumors; the conductive liquid can improve the conductivity of the local tissue, but the existing equipment only sets a perfusion port in a single area, so that the conductive liquid is easy to accumulate near the perfusion port, and under the condition that the perfusion flow is large, the liquid molecules cannot offset the influence of gravity, and the liquid vertically diffuses along the gravity direction, deviating from the expected ablation range. Therefore, a radio frequency ablation device with more accurate ablation range and more close to a regular sphere is needed. SUMMARY

[0003] The application aims to provide a radio frequency ablation device with more accurate ablation range and more close to a regular sphere. The application makes the ablation range closer to a regular sphere through the combination of solid needle and / or hollow needle array; the multi-point perfusion mode makes the conductive liquid uniformly distributed, and the ablation range is more accurate; the multi-point temperature measurement mode is adopted, the sub-needle array cooperates with multiple temperature sensors to realize the monitoring of the temperature of multiple points in the ablation area, and the ablation range is conveniently and accurately adjusted.

[0004] An ablation needle includes a puncture needle and a handle linkage assembly with an infusion tube. The puncture needle is a hollow needle, and its interior contains an array of at least two sub-needles. The surface of the puncture needle has an outlet for the sub-needle array. The sub-needles of the array have a retracted state and an extended state. In the retracted state, the sub-needles are arranged side-by-side and filled inside the puncture needle. In the extended state, the sub-needles can extend out of the puncture needle through the outlet on the puncture needle surface and bend and deform relative to the puncture needle to both sides. With this configuration, when puncturing a solid tumor, the interior of the puncture needle is filled with the sub-needles of the array, ensuring the needle body has high rigidity and puncture capability, enabling it to penetrate the tumor capsule. After the puncture needle enters the tumor, the sub-needles of the array further puncture and extend within the tumor, effectively gripping the solid tumor tissue. Furthermore, the application of radiofrequency current creates a uniform ablation zone, preventing the survival of tumor cells due to low local temperatures and ensuring in-situ inactivation of tumor cells within the ablation zone.

[0005] Preferably, the puncture needle includes a radiofrequency working section and a non-radiofrequency working section covered with an insulating layer, and the sub-needles are all radiofrequency working sections.

[0006] Preferably, when the sub-needle is in the deployed state, the portion of the sub-needle extending beyond the puncture needle is curved, with the radius of curvature of the curve located on the side of the sub-needle furthest from the puncture needle tip. With this configuration, the deployed sub-needle becomes an anchor-shaped multi-pole sub-needle, which, when deployed within the tumor, can firmly grasp and hold the solid tumor tissue.

[0007] Preferably, the sub-needles of the sub-needle array are spaced at equal angles along the circumference in both the retracted and deployed states. The sub-needles include hollow sub-needles that extend along the direction of needle extension and are connected to the perfusion tube. The use of hollow sub-needles in the sub-needle array allows for multi-point perfusion of tumor tissue, and the presence of temperature sensors monitors the temperature of the corresponding sub-needles in real time, facilitating precise adjustment of the ablation range. Multi-point perfusion reduces the perfusion flow rate at each perfusion point, shrinking the area affected by each point and making the actual perfusion range more precise. It also solves the problem that when the perfusion flow rate is high, the attraction between liquid molecules cannot counteract the effect of gravity, causing the liquid to diffuse vertically along the direction of gravity, deviating from the expected ablation range.

[0008] Preferably, the side surface of the puncture needle is provided with radial outlets that are no less than the number of sub-needles in the sub-needle array. The radial outlets are spaced apart from the tip of the puncture needle. The sub-needles of the sub-needle array can extend out of the puncture needle through the corresponding radial outlets and bend and deform to both sides relative to the puncture needle to achieve an unfolded state.

[0009] As preferred, the radial distance from the tip end of the sub-needle to the non-radio frequency working section of the puncture needle is X / 2, and the axial distance from the tip end of the puncture needle and / or the sub-needle to the non-radio frequency working section of the puncture needle is maximally X, when the sub-needle is in the unfolded state. The radio frequency working sections of the puncture needle and the sub-needle form a claw needle structure with a radial and axial maximum length of X after complete unfolding, so that the ablation range of the puncture needle and the sub-needle approximates to a sphere. Further, the value of X is in the range of 1-3 mm, and X can be any value in the range of 1-3 mm, such as 1.2, 1.4, 1.6, 1.8, 2, 2.2, 2.4, 2.6, and 2.8. The ablation range of the sphere can better adapt to irregularly shaped tumors compared to the existing elliptical ablation range, and the smaller the value of X, the better the adaptability to irregularly shaped tumors.

[0010] As preferred, the puncture needle further carries at least one main needle, the puncture needle is provided with a channel and an axial outlet through the extension direction of the puncture needle, and the main needle also includes a storage state and an unfolded state. The main needle in the storage state is stored in the channel of the puncture needle, and the main needle can be extended out of the puncture needle through the axial outlet and linearly displaced to the distal end relative to the puncture needle to reach the unfolded state. The linear displacement design of the main needle is more stable compared to the curved sub-needle, ensuring high positioning accuracy and small influence of tissue resistance. The doctor can observe the position of the tip of the main needle through the imaging device, and conveniently judge whether the ablation range covers the whole layer of the tumor. At the same time, when the tip end of the main needle is the farthest point from the non-radio frequency working section in the axial direction of the tip ends of the puncture needle, the sub-needle, and the main needle, the main needle can provide a clear positioning point for the ablation area. The main needle is linearly extended through the axial outlet, and the axial distance from the tip end to the non-radio frequency working section after unfolding is X, which can indirectly indicate the farthest boundary of the ablation area.

[0011] As preferred, the sub-needles of the sub-needle array in the storage state are arranged in parallel around the main needle at equal intervals in the circumferential direction, and the axial distance from the tip end of the main needle to the non-radio frequency working section of the puncture needle is maximally X, when the main needle is in the unfolded state. The equal interval arrangement of the sub-needles around the circumference of the main needle makes the structure compact in the storage state, ensures that the puncture needle still maintains the minimally invasive specification, and reduces the damage to normal tissues; and the equal interval arrangement ensures that the sub-needles are uniformly distributed in the circumferential direction, without energy blind area, and further improves the ablation uniformity.

[0012] As preferred, the main needle is a hollow needle, the side surface of the main needle is provided with at least two perfusion holes, and the perfusion holes of the main needle are communicated with the perfusion tube. The hollow main needle and the hollow sub-needle form a three-dimensional multi-point perfusion network. The multi-point perfusion formed by the main needle perfusion cooperating with the peripheral perfusion of the sub-needle can improve the perfusion protection of the tumor center, avoid carbonization caused by excessive concentration of radio frequency energy, reduce the heat conduction efficiency, and affect the ablation effect, or inject chemotherapeutic drugs to the center after the ablation is completed, to realize the synergy of thermal ablation and chemical ablation. In addition, the multi-perfusion hole design ensures uniform perfusion and avoids the accumulation of perfusion liquid caused by single-point perfusion. Meanwhile, the perfusion systems of the main needle and the sub-needle are independently controllable, and the perfusion amount can be accurately distributed according to the needs of different regions of the tumor, further optimizing the treatment effect.

[0013] As preferred, in the unfolded state of the main needle and / or the sub-needle, the radial distance from the tip end of the main needle and / or the sub-needle to the non-radio frequency working section of the puncture needle is X / 2, and the axial distance from the tip end of the main needle to the non-radio frequency working section of the puncture needle is at most X. The radio frequency working sections of the puncture needle and the sub-needle form a claw needle structure with a radial and axial maximum length of X after complete unfolding, so that the ablation range of the puncture needle and the sub-needle approaches a sphere.

[0014] As preferred, the sub-needles of the sub-needle array also include solid sub-needles, and the solid sub-needles and the hollow sub-needles are alternately arranged along the circumference. In the storage state of the sub-needles, both sides of each solid sub-needle are hollow sub-needles, and both sides of each hollow sub-needle are solid sub-needles. The solid sub-needles have higher rigid strength and stronger radio frequency current carrying capacity than the hollow sub-needles, the solid sub-needles are more accurately unfolded according to the predetermined curvature, and the fixed solid tumor tissue facilitates the insertion of the hollow sub-needles; different radio frequency current carrying capacities produce different ablation regions, and the alternation of the hollow sub-needles and the solid sub-needles makes the ablation regions complementary.

[0015] As preferred, the first curvature of the solid sub-needles of the sub-needle array in the unfolded state is smaller than the second curvature of the hollow sub-needles, and the puncture needle and / or the hollow sub-needle and / or the main needle are provided with a temperature sensor. The sub-needles with the above arrangement can reduce tissue adhesion. The smaller the curvature of the sub-needles, the lower the bending degree of the sub-needles, and the smaller the contact area with the tissue, avoiding the hooking of the needle tip to the tissue. The difference in curvature between the solid sub-needles and the hollow sub-needles makes the solid sub-needles and the hollow sub-needles form a distribution difference in space, further avoiding mutual interference between the sub-needles, and ensuring smooth unfolding process. In addition, the rigid support of the low-curvature solid sub-needles combined with the flexible adaptation of the high-curvature hollow sub-needles makes the overall structure not only resist tissue compression deformation during puncture, but also make the ablation regions between the sub-needles reasonably superimposed to fit the irregular contour of the tumor, improving the fitting degree of the ablation range. The temperature sensor in the puncture needle and / or the hollow sub-needle and / or the main needle can obtain the temperature information of the ablation regions corresponding to different sub-needles in real time, and when abnormal temperature information is obtained, the abnormal region can be adjusted individually.

[0016] As preferred, the main needle comprises a first main needle and a second main needle, which are solid needles arranged adjacent to the axis, and the extension and contraction of the first main needle and the second main needle can be independently controlled by the handle linkage assembly.

[0017] As preferred, the sub-needles of the sub-needle array are divided into at least two sub-needle combinations according to the number of main needles, and each sub-needle combination is linked with the main needle relatively close to the sub-needle combination. Each group of sub-needles is linked with the corresponding main needle, and different regions can be operated differently: when the temperature at the front end of the tumor is too high, the perfusion amount of the sub-needle group corresponding to the main needle close to the front end of the tumor can be increased, and the rear end remains unchanged. Each sub-needle combination is linked with the main needle relatively close to the sub-needle combination, so that the accommodation and expansion of the sub-needle combination attached to the first main needle and the second main needle can be respectively controlled on the basis of independently controlling the first main needle and the second main needle by the handle linkage assembly. The main needle extends to position the distal end of the ablation, and cooperates with the sub-needle to form a three-dimensional perfusion network, covers the tumor core and the periphery, and improves the uniformity of perfusion. The surface of the sub-needle has an amorphous carbon film, and the amorphous carbon film layer makes the surface friction coefficient of the sub-needle ≤0.02, the water contact angle ≥120°, and the hardness >35GPa. The amorphous carbon film coating is prepared by physical vapor deposition, which gives the sub-needle surface excellent mechanical and surface properties, significantly improving the clinical applicability. The friction coefficient ≤0.02 reduces the tissue resistance when the sub-needle is punctured, reduces the tearing damage to the tumor and the surrounding tissue, and reduces the risk of postoperative tumor cell metastasis; the water contact angle ≥120° makes it difficult for blood, tissue fluid and the like to adhere to the surface, avoids the ablation adhesion phenomenon, facilitates smooth pulling out of the sub-needle, and avoids the risk that the sub-needle cannot be smoothly withdrawn to the puncture needle so as to be unable to withdraw the needle.

[0018] As preferred, the surface of the radio frequency working section of the sub-needle has an amorphous carbon film, and the amorphous carbon film layer makes the surface friction coefficient of the sub-needle ≤0.02, the water contact angle ≥120°, and the hardness >35GPa. The amorphous carbon film coating is prepared by physical vapor deposition, which gives the sub-needle surface excellent mechanical and surface properties, significantly improving the clinical applicability. The friction coefficient ≤0.02 reduces the tissue resistance when the sub-needle is punctured, reduces the tearing damage to the tumor and the surrounding tissue, and reduces the risk of postoperative tumor cell metastasis; the water contact angle ≥120° makes it difficult for blood, tissue fluid and the like to adhere to the surface, avoids the ablation adhesion phenomenon, facilitates smooth pulling out of the sub-needle, and avoids the risk that the sub-needle cannot be smoothly withdrawn to the puncture needle so as to be unable to withdraw the needle.

[0019] The present application realizes the synergistic improvement of puncture performance, ablation accuracy and clinical safety, and has the following beneficial effects: during puncture, the sub-needle array fills the inside of the puncture needle, significantly enhancing the rigidity of the needle body and ensuring effective penetration of the tumor capsule; after expansion, a spherical ablation range is formed, which is more suitable for irregular tumors than the traditional elliptical range; the sub-needle adopts an anchor-like curve design and solid / hollow alternating arrangement, the solid sub-needle provides high-rigidity positioning and anchoring, and the hollow sub-needle carries temperature sensors and perfusion channels, realizing multi-point accurate temperature measurement, micro-perfusion and complementary ablation areas, avoiding perfusion deviation and local low-temperature survival caused by gravity; the main needle is axially extended to position the distal end of the ablation, cooperates with the sub-needle to form a three-dimensional perfusion network, covers the tumor core and the periphery, and improves the uniformity of perfusion; the amorphous carbon film on the surface of the sub-needle reduces the tissue resistance and the risk of adhesion, and enhances the wear resistance. BRIEF DESCRIPTION OF DRAWINGS

[0020] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following will briefly introduce the drawings needed to be used in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only exemplary, and for those skilled in the field, other drawings can be obtained from the provided drawings without creative labor.

[0021] Figure 1 It is a structure diagram of a three-pronged needle of an ablation needle.

[0022] Figure 2 It is a side view of a three-pronged needle of an ablation needle.

[0023] Figure 3 It is a sectional view of a three-pronged needle of an ablation needle.

[0024] Figure 4 It is a partial enlarged view of a three-pronged needle of an ablation needle.

[0025] Figure 5 It is a structure diagram of a four-pronged needle of an ablation needle.

[0026] Figure 6 It is a side view of a four-pronged needle of an ablation needle.

[0027] Figure 7 It is a partial enlarged view of a four-pronged needle of an ablation needle.

[0028] Figure 8 It is a structure diagram of a five-pronged needle of an ablation needle.

[0029] Figure 9 It is a partial enlarged view of a five-pronged needle of an ablation needle.

[0030] Figure 10 It is a structure diagram of an eight-pronged needle of an ablation needle.

[0031] Figure 11 It is a side view of an eight-pronged needle of an ablation needle.

[0032] Figure 12 It is a partial enlarged view of an eight-pronged needle of an ablation needle.

[0033] Figure 13 It is a structure diagram of a ten-pronged needle of an ablation needle.

[0034] Figure 14 It is a structure diagram of a needle tip of a puncture needle of an ablation needle.

[0035] Figure 15 It is a top view of a needle tip structure of a puncture needle of an ablation needle.

[0036] Figure 16 This is a cross-sectional view of the tip structure of a puncture needle for an ablation needle.

[0037] Figure 17 Comparison of images of the surface of the radio frequency working section of the needle under a scanning electron microscope at an accelerating voltage of 20kV, a working distance of 11.3mm, and a magnification of 5000x (left is before processing, right is after processing with amorphous carbon film).

[0038] Legend: 1 Handle linkage assembly; 11 Infusion tube; 2 Puncture needle; 21 Infusion port; 22 Axial outlet; 23 Radial outlet; 3 Sub-needle array; 31 Sub-needle; 32 Main needle; 33 Solid sub-needle; 34 Hollow sub-needle. Detailed Implementation

[0039] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0040] like Figure 1 , Figure 3 and Figure 4 As shown, an ablation needle includes a puncture needle 2 and a handle linkage assembly 1 with an infusion tube 11. The puncture needle 2 is a hollow needle, and the interior of the puncture needle 2 is equipped with a sub-needle array 3 of at least two sub-needles 31. The surface of the puncture needle 2 is provided with an outlet of the sub-needle array 3. The sub-needles 31 of the sub-needle array 3 include a retracted state and an extended state. The retracted sub-needles 31 are arranged side by side and filled inside the puncture needle 2. The sub-needles 31 of the sub-needle array 3 can extend out of the puncture needle 2 through the outlet on the surface of the puncture needle 2 and bend and deform to both sides relative to the puncture needle 2 to achieve the extended state. With the above settings, when the puncture needle 2 punctures a solid tumor, the interior of the puncture needle 2 is filled with the sub-needles 31 of the sub-needle array 3, ensuring that the needle body of the puncture needle 2 has high puncture capability and can penetrate the tumor capsule; after the puncture needle 2 enters the tumor, the sub-needles 31 of the sub-needle array 3 puncture and expand inside the tumor, which can grasp the solid tumor tissue, and after the radiofrequency current is passed through, a uniform ablation area is formed, avoiding the survival of solid tumor cells due to low local temperature, and ensuring that the solid tumor cells in the ablation area are inactivated in situ.

[0041] The puncture needle 2 includes a radiofrequency working section and a non-radiofrequency working section covered with an insulating layer, while the sub-needles 31 are all radiofrequency working sections. When the sub-needles 31 are in the deployed state, the portion extending beyond the puncture needle 2 is curved, with the radius of curvature of the curve located on the side of the sub-needle 31 furthest from the needle tip of the puncture needle 2. Through this configuration, the deployed sub-needles 31 form an anchor-shaped multipolar sub-needle, which, when deployed within the tumor, can firmly grasp and stabilize solid tumor tissue.

[0042] As Figure 1 shown, the sub-needles 31 of the sub-needle array 3 are arranged at equal angular intervals along the circumference in the accommodation state and the unfolded state, and the sub-needles 31 of the sub-needle array 3 include hollow sub-needles 34 that are conductive along the extension direction of the sub-needles 31, and the hollow sub-needles 34 are in communication with the perfusion tube 11. The sub-needles 31 of the sub-needle array 3 adopt the hollow sub-needles 34 to perform multi-point perfusion on the tumor tissue, and carry a temperature sensor to monitor the temperature of the corresponding sub-needle 31 in real time, facilitating accurate adjustment of the ablation range; multi-point perfusion can reduce the perfusion flow of each perfusion point, reduce the required impact area of a single perfusion point, make the actual perfusion range more accurate, and at the same time solve the defect that the gravitational force between liquid molecules cannot offset the influence of gravity, and the liquid vertically diffuses along the gravity direction, deviating from the expected ablation range, in the case of a larger perfusion flow.

[0043] As Figure 14 , 15 and Figure 16 shown, the side surface of the puncture needle 2 is provided with a radial outlet 21 which is not less than the number of sub-needles 31 in the sub-needle array 3, and the radial outlet 21 has a distance from the tip end of the puncture needle 2, and the sub-needles 31 of the sub-needle array 3 can extend out of the puncture needle 2 by using the corresponding radial outlet 21 and bend and deform to the two sides relative to the puncture needle 2 to reach the unfolded state.

[0044] When the sub-needles 31 are in the unfolded state, the radial distance from the tip end of the sub-needles 31 to the non-radio frequency working section of the puncture needle 2 is X / 2, and the axial distance from the tip end of the puncture needle 2 and / or the sub-needles 31 to the non-radio frequency working section of the puncture needle 2 is at most X. The radio frequency working sections of the puncture needle 2 and the sub-needles 31 form a claw needle structure with a radial and axial maximum length of X after complete unfolding, so that the ablation range of the puncture needle 2 and the sub-needles 31 approaches a sphere. Further, the value of X is in the range of 1-3 mm, and X can be any value within 1-3 mm, for example, 1.2, 1.4, 1.6, 1.8, 2, 2.2, 2.4, 2.6, 2.8. The ablation range of the sphere can better adapt to irregularly shaped tumors compared to the existing elliptical ablation range, and the smaller the value of X, the better the adaptability to irregularly shaped tumors.

[0045] As Figure 8 , Figure 10 and Figure 13As shown, the inside of the puncture needle 2 also carries at least one main needle 32, the puncture needle 2 is provided with a channel and an axial outlet 22 through the extension direction of the puncture needle 2, the main needle 32 also includes a storage state and a deployment state, the main needle 32 in the storage state is stored in the channel of the puncture needle 2, and the main needle 32 can be stretched out of the puncture needle 2 through the axial outlet 22 and linearly displaced to the distal end relative to the puncture needle 2 to reach the deployment state. Compared with the curved sub-needle 31, the linear displacement design of the main needle 32 is more stable, ensures high positioning accuracy, is less affected by tissue resistance, and the doctor can observe the position of the main needle 32 through the image device, so as to conveniently judge whether the ablation range covers the whole layer of the tumor. At the same time, when the needle tip end of the main needle 32 is the point farthest from the axial distance of the non-radio frequency working section of the puncture needle 2, the sub-needle 31 and the main needle 32, the main needle 32 can provide a clear positioning point for the ablation area, and the main needle 32 is linearly stretched out through the axial outlet 22, and the axial distance from the needle tip end to the non-radio frequency working section after deployment is X, which can indirectly indicate the farthest boundary of the ablation area.

[0046] As shown in Figure 9 , Figure 11 and Figure 12 , the sub-needles 31 of the sub-needle array 3 in the storage state are arranged in parallel along the circumference around the main needle 32, and the axial distance from the needle tip end of the main needle 32 to the non-radio frequency working section of the puncture needle 2 is the maximum X when the main needle 32 is in the deployment state. The equal-interval arrangement of the sub-needles 31 around the circumference of the main needle 32 makes the structure compact in the storage state, ensures that the puncture needle 2 still maintains the minimally invasive specification, and reduces the damage to normal tissues; the equal-interval arrangement ensures that the sub-needles 31 are uniformly distributed in the circumferential direction, there is no energy blind area, and the ablation uniformity is further improved.

[0047] As shown in Figure 8 , Figure 10 and Figure 13 , the main needle 32 is a hollow needle, and the side surface of the main needle 32 is provided with at least two perfusion holes, and the perfusion holes of the main needle 32 are communicated with the perfusion pipe 11. The hollow main needle 32 and the hollow sub-needle 34 form a three-dimensional multi-point perfusion network. The multi-point perfusion formed by the perfusion of the main needle 32 and the peripheral perfusion of the sub-needle 31 can improve the perfusion protection of the tumor center, avoid carbonization caused by excessive concentration of radio frequency energy, reduce the heat conduction efficiency, and affect the ablation effect, or inject chemotherapy drugs to the center after ablation, to realize the cooperation of thermal ablation and chemical ablation. In addition, the multi-perfusion hole design ensures uniform perfusion and avoids the aggregation of perfusion liquid caused by single-point perfusion, and the perfusion systems of the main needle 32 and the sub-needle 31 are independently controllable, so that the perfusion amount can be accurately distributed according to the needs of different regions of the tumor, and the treatment effect is further optimized.

[0048] As shown in Figure 11As shown, in the unfolded state of the main needle 32 and / or the sub-needle 31, the radial distance from the tip end of the main needle 32 and / or the sub-needle 31 to the non-radio frequency working section of the puncture needle 2 is X / 2, and the axial distance from the tip end of the main needle 32 to the non-radio frequency working section of the puncture needle 2 is maximally X. The radio frequency working sections of the puncture needle 2 and the sub-needle 31 form a claw needle structure with a radial and axial maximum length of X after complete unfolding, so that the ablation range of the puncture needle 2 and the sub-needle 31 approximates to a sphere. Further, the value range of X is 1-3 mm, and X can be any value within 1-3 mm, for example, 1.2, 1.4, 1.6, 1.8, 2, 2.2, 2.4, 2.6, and 2.8. The ablation range of the sphere can better adapt to irregularly shaped tumors compared to the existing elliptical ablation range, and the smaller the value of X, the better the adaptability to irregularly shaped tumors.

[0049] As shown in Figure 12 and Figure 13 The sub-needle 31 of the sub-needle array 3 further includes solid sub-needles 33, and the solid sub-needles 33 and the hollow sub-needles 34 are alternately arranged along the circumference. In the storage state of the sub-needle 31, both sides of each solid sub-needle 33 are hollow sub-needles 34, and both sides of each hollow sub-needle 34 are solid sub-needles 33. The solid sub-needles 33 have higher rigid strength and stronger radio frequency current carrying capacity than the hollow sub-needles 34, the solid sub-needles 33 are more accurately unfolded according to the predetermined curvature, and the fixed solid tumor tissue facilitates the insertion of the hollow sub-needles 34; different radio frequency current carrying capacities produce different ablation areas, and the alternation of the hollow sub-needles 34 and the solid sub-needles 33 makes the ablation areas complementary.

[0050] As shown in Figure 12 and Figure 13As shown, the first curvature of the solid sub-needle 33 of the sub-needle array 3 in the unfolded state is smaller than the second curvature of the hollow sub-needle 34, and the temperature sensor is arranged inside the puncture needle 2 and / or the hollow sub-needle 34 and / or the main needle 32. The sub-needle 31 with the above arrangement can reduce tissue adhesion. The smaller the curvature, the lower the bending degree of the sub-needle 31, and the smaller the contact area with the tissue, avoiding the hooking of the needle tip to the tissue. The curvature difference causes the solid sub-needle 33 to be close to the axis of the puncture needle 2, that is, close to the ablation boundary, and the hollow sub-needle 34 to be away from the axis of the puncture needle 2, that is, away from the ablation boundary, further avoiding the mutual interference between the sub-needles 31, and ensuring the smooth unfolding process. In addition, the rigid support of the low-curvature solid sub-needle 33 combined with the flexible adaptation of the high-curvature hollow sub-needle 34 makes the overall structure not only resist the deformation of the tissue during puncture, but also make the ablation areas between the sub-needles 31 reasonably superimposed to fit the irregular contour of the tumor, improving the fitting degree of the ablation range. The temperature sensor (not shown in the figure) inside the puncture needle 2 and / or the hollow sub-needle 34 and / or the main needle 32 can obtain the temperature information of the ablation area corresponding to different sub-needles 31 in real time. When abnormal temperature information is obtained, the abnormal area can be adjusted individually.

[0051] As shown in Figure 17 , the surface of the radio frequency working section of the sub-needle 31 has an amorphous carbon film. The amorphous carbon film layer makes the surface friction coefficient of the sub-needle 31 ≤0.02, the water contact angle ≥120°, and the hardness >35GPa. The amorphous carbon film coating is prepared by physical vapor deposition, which gives the surface of the sub-needle 31 excellent mechanical and surface properties, significantly improving the clinical applicability. The friction coefficient ≤0.02 reduces the tissue resistance when the sub-needle 31 punctures, reduces the tearing damage to the tumor and surrounding tissue, and reduces the risk of postoperative tumor cell metastasis; the water contact angle ≥120° makes it difficult for blood, tissue fluid, etc. to adhere to the surface, avoiding the adhesion phenomenon during ablation, facilitating the smooth pulling out of the sub-needle 31, and avoiding the risk that the sub-needle 31 cannot be smoothly withdrawn to the puncture needle 2 so that the needle cannot be withdrawn; the hardness >35GPa significantly improves the wear resistance of the sub-needle 31, avoids the needle tip blunting caused by repeated puncture, and improves the structural strength of the hollow sub-needle 34, while enhancing the corrosion resistance.

[0052] Example one As shown in Figure 1 , Figure 2 , Figure 3 and Figure 4As shown, in this embodiment, a three-claw radiofrequency ablation needle is provided, including a puncture needle 2, a handle linkage assembly 1, an infusion connector, and a sub-needle array 3, wherein: the puncture needle 2 is a hollow needle with an internal channel for accommodating the sub-needle array 3, and its surface has channel outlets for a number of sub-needles of the sub-needle array 3; the puncture needle 2 includes a radiofrequency working section and a non-radiofrequency working section, and the surface of the non-radiofrequency working section is provided with an insulating layer; the handle linkage assembly 1 controls the linkage deployment of the sub-needle array 3; the infusion connector is disposed on the handle linkage assembly 1, and the infusion connector and the puncture needle 2 are infused with... The infusion tubes 11 are sealed together, and the infusion fluid is infused through the infusion connector and the infusion tubes 11; the sub-needle array 3 is a metal electrode array with puncture performance. The sub-needles 31 have two states: retracted and extended. In the retracted state, the sub-needles 31 are retracted into the puncture needle 2 with the same interval between them. During the extension process, the sub-needles 31 are extended circumferentially with the puncture needle 2 as the axis, through the channel outlet on the shell. Each sub-needle corresponds to one channel outlet; there are three sub-needle arrays 3. The sub-needle arrays 3 are solid needles with a first curvature. All sub-needle arrays 3 are extended synchronously, which is suitable for small lesions.

[0053] Example 2 like Figure 5 , Figure 6 and Figure 7 As shown, in this embodiment, a four-claw radiofrequency ablation needle is provided, including a puncture needle 2, a handle linkage assembly 1, and a sub-needle array 3, wherein: the puncture needle 2 is a hollow needle with an internal channel for accommodating the sub-needle array 3, and its surface has channel outlets for a number of sub-needles of the sub-needle array 3; the puncture needle 2 includes a radiofrequency working section and a non-radiofrequency working section, and the shell surface of the non-radiofrequency working section is provided with an insulating layer; the handle linkage assembly 1 controls the linkage deployment of the sub-needle array 3, and the handle linkage assembly 1 has an internal infusion tube 11, through which the infusion fluid extends from the handle linkage assembly 1. Infusion is performed through the infusion tube 11 at the end of the puncture needle 2; the sub-needle array 3 is a metal electrode array with puncture performance. The sub-needles have two states: retracted and extended. In the retracted state, the sub-needles are retracted into the puncture needle 2 with the same interval between them. During the extension process, the sub-needles are extended circumferentially around the puncture needle 2 as the axis, through the channel outlet on the housing. Each sub-needle corresponds to one channel outlet; there are four sub-needles 31. The electrodes of the sub-needle array 3 are hollow needles with a second curvature. All the electrodes of the sub-needle array 3 are extended synchronously. In this embodiment, a temperature sensor can be provided inside the hollow needle.

[0054] Example 3 like Figure 8 and Figure 9As shown, in this embodiment, a five-claw radiofrequency ablation needle is provided, including a puncture needle 2, a handle linkage assembly 1, and an infusion tube 11, wherein: the puncture needle 2 is a hollow needle with a channel for accommodating the sub-needle array 3 inside; the puncture needle 2 includes a radiofrequency working section and a non-radiofrequency working section, and an insulating layer is provided on the shell surface of the non-radiofrequency working section; the handle linkage assembly 1 is used to control the linkage deployment of the sub-needle array 3; the infusion fluid is infused through the infusion tube 11, and the main needle 32 is retracted or extended, and the sub-needles 31 are retracted or deployed through the linkage assembly 1.

[0055] The differences from Embodiment 2 include: the main needle 32 is a metal electrode with puncture capabilities; the main needle 32 has two states: retracted and extended. In the retracted state, the main needle 32 is retracted within the channel of the puncture needle 2; during the extended state, the main needle 32 moves longitudinally along the axis and is displaced distally relative to the puncture needle 2; the main needle 32 is a hollow needle, and its surface is provided with a plurality of infusion holes 21; the sub-needle array 3 is a metal electrode array with puncture capabilities, and the sub-needles have two states: retracted and extended. In the retracted state, the sub-needles 31... The main needle 32 is retracted into the puncture needle 2 channel at the same interval with the main needle 32 as the axis. During the unfolding process, the sub-needles 31 unfold circumferentially with the main needle 32 as the axis, maintaining a certain distance. There are four sub-needles 31. The electrodes of the sub-needle array 3 are hollow needles with a second curvature. All sub-needle array 3 electrodes unfold synchronously. During the deformation process, the main needle 32 and the sub-needle array 3 remain synchronized. When the main needle 32 is retracted, the sub-needle array 3 is retracted synchronously. When the main needle 32 is extended, the sub-needle array 3 unfolds synchronously. A temperature sensor is installed inside the hollow needle.

[0056] Example 4 like Figure 10 , Figure 11 and Figure 12 As shown, in this embodiment, an octagonal radiofrequency ablation needle is provided, including a puncture needle 2 and a handle linkage assembly 1, wherein: the puncture needle 2 is a hollow needle with a channel for accommodating the sub-needle array 3 inside; the puncture needle 2 includes a radiofrequency working section and a non-radiofrequency working section, and an insulating layer is provided on the shell surface of the non-radiofrequency working section; the handle linkage assembly 1 is used to control the linkage deployment of the sub-needle array 3; the perfusion fluid is perfused through the perfusion tube 11; the main needle 32 is retracted or extended, and the sub-needles 31 are retracted or deployed through the linkage assembly 1.

[0057] The main needle 32 is a metal electrode with puncture capability. The main needle 32 has two states: retracted and extended. In the retracted state, the main needle 32 is retracted into the channel of the puncture needle 2. During the extension process, the main needle 32 moves longitudinally along the axis and moves distally relative to the puncture needle 2. The main needle 32 is a hollow needle, and a plurality of injection holes 21 are provided on the surface of the main needle 32.

[0058] The sub-needle array 3 is a metal electrode array with puncture capabilities. The sub-needles 31 have two states: retracted and extended. In the retracted state, the sub-needles 31 are retracted into the puncture needle 2 channel at equal intervals around the main needle 32. During the extended state, the sub-needles 31 are extended circumferentially around the main needle 32 at a certain distance. The number of sub-needles 31 is an even number of 8. The difference from Embodiment 3 is that 4 sub-needles 31 are solid needles and 4 sub-needles 33 are hollow needles. The 4 solid sub-needles 33 form the first sub-needle array 3, which has a first curvature. The 4 hollow sub-needles 34 form the second sub-needle array 3. 3 has a second curvature, and the first curvature is smaller than the second curvature; the first sub-needle array 3 and the second sub-needle array 3 are arranged alternately, and in the retracted state, each first sub-needle is adjacent to the second sub-needles on both sides, and in the retracted state, each second sub-needle is adjacent to the first needles on both sides; the first sub-needle array 3 is a solid needle, and the second sub-needle array 3 is a hollow needle, and the second sub-needle array 3 and the infusion assembly are sealed together; during the deformation process, the sub-needle array 3 and the main needle 32 are kept synchronized, and when the main needle 32 is retracted, the sub-needle array 3 is retracted synchronously, and when the main needle 32 is extended, the sub-needle array 3 is extended synchronously; a temperature sensor can be set inside the hollow needle.

[0059] Example 5 like Figure 13 As shown, in this embodiment, a ten-claw radiofrequency ablation needle is provided, including a puncture needle 2 and a handle linkage assembly 1, wherein: the puncture needle 2 is a hollow needle with a channel for accommodating the sub-needle array 3 inside; the puncture needle 2 includes a radiofrequency working section and a non-radiofrequency working section, and an insulating layer is provided on the shell surface of the non-radiofrequency working section; the handle linkage assembly 1 is used to control the linkage deployment of the sub-needle array 3; the perfusion fluid is perfused through the perfusion tube 11; the main needle 32 is retracted or extended, and the sub-needles 31 are retracted or deployed through the linkage assembly 1.

[0060] The main needle 32 is a metal electrode with puncture capabilities. The main needle 32 has two states: retracted and extended. In the retracted state, the main needle 32 is housed within the channel of the puncture needle 2. During the extension process, the main needle 32 moves longitudinally along its axis, displacing distally relative to the puncture needle 2. Differences from Embodiment 4 include, for example... Figure 13 As shown, the main needle 32 includes a first main needle and a second main needle. The first main needle and the second main needle are solid needles and are arranged adjacent to each other along the axis. They can be independently controlled by the handle linkage component.

[0061] The sub-needle array 3 is a metal electrode array with puncture performance, the sub-needle 31 includes two states of storage and expansion, in the storage state, the sub-needle 31 is kept in the channel of the puncture needle 2 with the same interval as the main needle 32 as the axis, in the expansion process, the sub-needle 31 keeps a certain distance and expands circumferentially with the main needle 32 as the axis; the number of sub-needles 31 is even, which is 10, of which 5 sub-needles form a first sub-needle combination, and the other 5 sub-needles form a second sub-needle combination; the sub-needles of the first sub-needle combination and the second sub-needle combination are both hollow sub-needles 34 and solid sub-needles 33, the solid sub-needles 33 and the hollow sub-needles 34 are arranged alternately, the solid sub-needles 33 form a first sub-needle array 3, the first sub-needle array 3 has a first curvature, the hollow sub-needles 34 form a second sub-needle array 3, the second sub-needle array 3 has a second curvature, the first curvature is smaller than the second curvature, in the storage state, each solid sub-needle is adjacent to the hollow sub-needles on both sides, and in the storage state, each hollow sub-needle is adjacent to the solid sub-needles on both sides; the 5 sub-needles in the first sub-needle combination are closer to the first main needle, and keep synchronization with the first main needle in the deformation process, the 5 sub-needles are synchronously stored when the first main needle is stored, and the 5 sub-needles are synchronously expanded when the first main needle is extended; the other 5 sub-needles in the sub-needle array are closer to the second main needle, the 5 sub-needles include solid needles and hollow needles, and keep synchronization with the second main needle in the deformation process, the 5 sub-needles are synchronously stored when the second main needle is stored, and the 5 sub-needles are synchronously expanded when the second main needle is extended; the sub-needle array 3 keeps synchronization with the main needle 32 in the deformation process, the sub-needle array 3 is synchronously stored when the main needle 32 is stored, and the sub-needle array 3 is synchronously expanded when the main needle 32 is extended; a temperature sensor can be arranged in the hollow needle.

[0062] The present application realizes the synergistic improvement of puncture performance, ablation accuracy and clinical safety, and has the following beneficial effects: during puncture, the sub-needle array 3 fills the inside of the puncture needle 2, significantly enhancing the rigidity of the needle body and ensuring effective penetration of the tumor capsule; after expansion, a spherical ablation range is formed, which is more suitable for irregular tumors than the traditional elliptical range; the sub-needles adopt an anchor-shaped curve design and are arranged alternately in solid / hollow, the solid sub-needles 33 provide high-rigidity positioning and fixation, the hollow sub-needles 34 carry temperature sensors and perfusion channels, realizing multi-point accurate temperature measurement, micro-perfusion and complementary ablation areas, and avoiding perfusion deviation and local low-temperature survival caused by gravity; the main needle 32 extends axially to position and ablate the distal end, cooperates with the sub-needles to form a three-dimensional perfusion network, covers the tumor core and periphery, and improves perfusion uniformity; the amorphous carbon film on the surface of the sub-needles reduces tissue resistance and adhesion risk, and enhances wear resistance.

[0063] The above embodiments and / or implementations are only used to illustrate the preferred embodiments and / or implementations of the present application, and do not limit the embodiments of the present application in any form, and any person skilled in the art can make some changes to other equivalent embodiments without departing from the technical means disclosed in the present application, but should be regarded as the same technology or embodiment as the present application.

Claims

1. An ablation needle comprising a puncture needle (2) and a handle linkage assembly (1) with a perfusion tube (11), characterized in that, The puncture needle (2) is a hollow needle, the inside of the puncture needle (2) is provided with a sub-needle array (3) of at least two sub-needles (31), the surface of the puncture needle (2) is provided with an outlet of the sub-needle array (3), the sub-needles (31) of the sub-needle array (3) include a storage state and a deployed state, the sub-needles (31) in the storage state are parallel and collected and filled in the inside of the puncture needle (2), the sub-needles (31) of the sub-needle array (3) can be stretched out of the puncture needle (2) through the outlet on the surface of the puncture needle (2) and bent and deformed to the deployed state relative to the puncture needle (2) to two sides.

2. An ablation needle according to claim 1, wherein, The puncture needle (2) includes a radio frequency working section and a non-radio frequency working section covered with an insulating layer, and the sub-needles (31) are all radio frequency working sections.

3. An ablation needle according to claim 2, wherein, In the deployed state of the sub-needles (31), the part of the sub-needles (31) stretched out of the puncture needle (2) is a curve, and the radius of curvature of the curve is located on the side of the sub-needles (31) away from the needle tip end of the puncture needle (2).

4. An ablation needle according to claim 3, wherein, In the deployed state of the sub-needle array (3), the radial distance from at least one needle tip end of the sub-needle array (3) to the non-radio frequency working section of the puncture needle (2) is X / 2, and the axial distance from at least one needle tip end of the puncture needle (2) and / or the sub-needle array (3) to the non-radio frequency working section of the puncture needle (2) is at most X.

5. An ablation needle according to claim 4, wherein, The sub-needles (31) of the sub-needle array (3) are arranged at equal angles along a circumference in the storage state and the deployed state, the sub-needles (31) of the sub-needle array (3) include hollow sub-needles (34) which are conductive along the extension direction of the sub-needles (31), and the hollow sub-needles (34) are communicated with the perfusion tube (11).

6. An ablation needle according to claim 5, wherein, The side surface of the puncture needle (2) is provided with radial outlets (23) which are not less than the number of the sub-needles (31) in the sub-needle array (3), the radial outlets (23) have a distance from the needle tip end of the puncture needle (2), and the sub-needles (31) of the sub-needle array (3) can stretch out of the puncture needle (2) by using the corresponding radial outlets (23) and bent and deformed to the deployed state relative to the puncture needle (2) to two sides.

7. An ablation needle according to claim 5, wherein, The inside of the puncture needle (2) is further provided with at least one main needle (32), the puncture needle (2) is provided with a channel and an axial outlet (22) which pass through along the extension direction of the puncture needle (2), the main needle (32) also includes a storage state and a deployed state, the main needle (32) in the storage state is stored in the channel of the puncture needle (2), and the main needle (32) can stretch out of the puncture needle (2) by using the axial outlet (22) and linearly displace to the distal end relative to the puncture needle (2) to reach the deployed state.

8. An ablation needle according to claim 7, wherein, The sub-needles (31) of the sub-needle array (3) in the storage state are arranged at equal intervals along a circumference around the main needle (32).

9. An ablation needle according to claim 9, wherein, The sub-needles (31) of the sub-needle array (3) further include solid sub-needles (33), the solid sub-needles (33) and the hollow sub-needles (34) are alternately arranged along a circumference, in the storage state of the sub-needles (31), both sides of each solid sub-needle (33) are hollow sub-needles (34), and both sides of each hollow sub-needle (34) are solid sub-needles (33).

10. An ablation needle according to claim 9, wherein, The first curvature of the solid sub-needle (33) of the sub-needle array (3) in the unfolded state is smaller than the second curvature of the hollow sub-needle (34).

11. An ablation needle according to claim 10, wherein, The main needle (32) is a hollow needle, and a side surface of the main needle (32) is provided with at least two perfusion holes (21).

12. An ablation needle according to claim 10, wherein, The main needle (32) comprises a first main needle and a second main needle, which are solid needles arranged adjacent to each other along an axis and can be independently controlled to be accommodated and unfolded by the handle linkage assembly (1).

13. An ablation needle according to claim 12, wherein, The sub-needles of the sub-needle array (3) are divided into at least two sub-needle combinations according to the number of the main needles (32), and each sub-needle combination is linked to the main needle (32) relatively close to the sub-needle combination.

Images