Pathological tissue nondestructive testing sampling device and needle core electrode preparation and use method

Abstract

The invention provides a pathological tissue nondestructive testing sampling device and a needle core electrode preparation and use method, and relates to the field of medical instruments.The pathological tissue nondestructive testing sampling device comprises a radio frequency detection device and a needle core electrode, and the needle core electrode is electrically connected with the radio frequency detection device so as to be used for detecting the pathological property of tissue; a piston is further arranged at the position, close to the tail end, of the needle core electrode, outside the sleeve needle and inside the needle cylinder, and the piston is used for limiting the position, inside or outside the sleeve needle, of the front end of the needle core electrode; the needle core electrode is located in the through hole of the sleeve needle, and the front end of the needle core electrode is located at the position close to the front end of the sleeve needle. Through cooperation of the structures, the needle core electrode can accurately prick a person to a preset position and make contact with target tissue, accurate detection data are obtained, meanwhile, pressure control over the ejection component can be achieved, and non-injury minimally invasive detection is achieved.

Description

Technical Field

[0001] The invention relates to medical equipment, and in particular to a pathological tissue nondestructive detection sampling device, a needle core electrode preparation method and a use method. Background Art

[0002] Pathological tissue sampling refers to obtaining a small amount of tissue samples from the patient's body for pathological analysis during medical examinations. This helps doctors diagnose diseases such as cancer. Common sampling methods include needle aspiration biopsy (FNAB), excisional biopsy or incisional biopsy. Both excisional biopsy and incisional biopsy are destructive tests, which can cause great harm to patients, require more than 15 days to recover, and have the risk of infection. Summary of the invention

[0003] The technical problem to be solved by the present invention is to provide a pathological tissue non-destructive detection and sampling device, a needle core electrode preparation method and a use method, which can perform non-destructive detection before pathological tissue sampling to evaluate the necessity of sampling, thereby reducing the patient's wound recovery time and the risks brought by pathological tissue sampling and detection.

[0004] In order to solve the above technical problems, the technical solution adopted by the present invention is: a non-destructive detection and sampling device for pathological tissue, comprising a radio frequency detection device, a sleeve needle and a needle core electrode; During operation, the needle core electrode is used to penetrate into the sleeve needle, and the needle core electrode is electrically connected to the radio frequency detection device; The front end of the needle core electrode is provided with a tip, and the tip is made of a conductive material. The two electrodes at the tip form a group, and the two electrodes are insulated from each other. The rest of the needle core electrode is provided with an insulating coating. A limiting portion is provided at a distance behind the tip, and the limiting portion is slidably connected to the inner wall of the sleeve needle. The limiting portion is used to fill the gap between the needle core electrode and the inner wall of the sleeve needle. The limiting portion is also used to guide and limit the depth of the needle core electrode penetrating the target tissue to ensure that the detection signal of the needle core electrode comes from the target tissue.

[0005] In a preferred solution, the length from the limiting portion to the tip is greater than or equal to the length of the conductive portion of the tip, so as to ensure that the needle core electrode can fully penetrate the target tissue and will not be exposed to the outside to distort the detection signal.

[0006] In a preferred embodiment, a sampling device is also included, and the sampling device is used to penetrate into the sleeve needle to cut the target tissue; In the sampling device, the sampling needle core is arranged inside the sleeve needle, and its front end is a hollow structure, which can rotate relative to the sleeve needle and slide along the axis of the sleeve needle. A sampling groove is provided on the sampling needle core for intercepting target tissue. A handle is also provided at the tail end of the sampling needle core outside the syringe to drive the sampling needle core to rotate.

[0007] In a preferred solution, a movable or fixed connection structure is adopted between the limiting part and the needle core electrode; The limiting part is an annular structure, and a through hole is provided on the annular structure along the axis to facilitate air to pass through; When the limiting part is movably connected, a damping layer is provided on the inner wall of the limiting ring, and the damping layer contacts the outer wall of the needle core electrode. A through hole is provided on the limiting ring along the axis to facilitate air passage.

[0008] In the preferred embodiment, it also includes a syringe, which is sleeved with the sleeve needle; A piston is also provided at a position of the needle core electrode near the tail end outside the sleeve needle and inside the syringe, and the piston is used to limit the position of the front end of the needle core electrode inside or outside the sleeve needle; The end of the syringe away from the piston is connected to the gas source; The needle core electrode is located in the through hole of the sleeve needle, the front end of the needle core electrode is located close to the front end of the sleeve needle, and a space for accommodating tissue is provided between the front end of the sleeve needle and the front end of the needle core electrode. A pressure relief hole is provided at a distance in the middle front of the syringe, and the pressure relief hole is used to release excess compressed gas to ensure that the needle core electrode will not be continuously pushed by the compressed gas.

[0009] In a preferred solution, a vibration-damping pad is provided at a position of the syringe near the front end of the inner wall and outside the blocking portion, and the vibration-damping pad absorbs the inertial impact generated by the movement of the piston through elastic deformation.

[0010] In a preferred embodiment, there are multiple pressure relief holes, which are evenly distributed along the circumference of the outer wall of the syringe to quickly discharge the compressed gas.

[0011] In a preferred embodiment, an auxiliary needle insertion device is also provided, which is connected to the needle core electrode and is used to drive the needle core electrode to puncture the target tissue at a preset speed or in a multi-step manner.

[0012] In a preferred embodiment, the auxiliary needle insertion device is a stepping pusher; The stepping pusher is a manual stepping pusher, and is composed of a scale push rod, a bevel rack, a movable block, an elastic clamping plate and a reset spring; The bevel rack is arranged on the inner wall of the syringe in a mirror-symmetrical manner, and the scale push rod is arranged inside the syringe. One end of the scale push rod passes through the tail end of the syringe and moves along the sleeve needle axis, and the other end is arranged on the movable block and moves with the thrust of the scale push rod. An elastic clamping plate is provided on the outer wall of the movable block to limit the reverse movement. When the elastic clamping plate is subjected to radial force, the movable block moves radially. When it is subjected to the reverse thrust of the first return spring, it engages with the movable block to limit its further movement.

[0013] In a preferred embodiment, the stepping pusher is an automatic stepping pusher, and is composed of a motor, a threaded rod, an internally threaded sleeve and a limit slider; The needle cylinder is provided with a groove for the limit slider to move; The motor is arranged at the rear end of the syringe to drive the threaded rod to rotate. The threaded rod is threadedly connected to the internal threaded sleeve and can rotate relative to the internal threaded sleeve. Under the thrust of the thread rotation, the internal threaded sleeve is pushed to move radially along the inner wall of the syringe. Wherein, the limit slider limits the moving distance of the internal thread sleeve.

[0014] In a preferred embodiment, the inner diameter of the through hole of the sleeve needle is 0.5 mm to 1.5 mm, the diameter of the sampling needle core is 0.4 mm to 1 mm, and the diameter of the needle core electrode is 0.33 mm to 0.6 mm.

[0015] A method for preparing the needle core electrode, the method comprising the following steps: S1: an insulating layer is provided between two electrode plates to obtain a composite electrode blank, and the composite electrode blank is straightened, passed through a mold, and polished into a round shape; and / or The two layers of electrode plates are bonded with an insulating adhesive, and then cut into strips, straightened, and pulled through the tapered hole to form a circle; S2: The double-layer electrode is obtained by extrusion, and it becomes the finished product after polishing and testing.

[0016] In a preferred solution, the step S1 is to provide an insulating layer on the outer wall of a single circular or cylindrical electrode and insert the composite electrode into the outer cylindrical electrode.

[0017] In a preferred solution, the step S1 is to arrange a flexible insulating layer between two layers of electrode plates to make a composite plate, and cut the composite plate into long strips.

[0018] In a preferred embodiment, the insulating adhesive in S1 is epoxy resin (C 11 H 12 O3) n or polyurethane (NHCOO) n ; The insulating adhesive contains one or more of silicon dioxide, calcium carbonate or barium titanate (BaTiO3).

[0019] In a preferred embodiment, the insulating layer in S1 is an insulating ceramic layer; The insulating ceramic layer is composed of one or a combination of silicon dioxide (SiO2), zirconium dioxide (ZrO2) and barium titanate (BaTiO3).

[0020] In a preferred embodiment, the electrode plate in S1 is made of silver-copper alloy (AgCu3, AgCu7.5), pure copper, silver-palladium alloy or nickel material.

[0021] In a preferred embodiment, in the silver-copper alloy layer, the ratio of silver to copper is 10:1, and one or more of zinc (Zn), nickel (Ni) or tin (Sn) is added as a reinforcing element, and the added ratio of the reinforcing element is 0.5% to 5% of the overall weight ratio.

[0022] The present invention provides a nondestructive detection and sampling device for pathological tissue, a method for preparing a needle core electrode, and a method for using the same. Through the coordination between the above structures, nondestructive detection can be performed with the detection electrode before sampling the pathological tissue to evaluate the necessity of sampling. If the detected tissue is normal, the sampling step with high damage can be eliminated, which can also save patient expenses, greatly reduce the patient's wound recovery time, and avoid the risks brought by pathological tissue sampling and detection, such as the risk of systemic spread caused by tumor rupture. According to clinical feedback, the nondestructive detection method of the present invention has a differential expression of more than 99%, that is, among the data of the target tissue obtained by radio frequency detection, 99% of the data of normal tissue, benign tumors, and malignant tumors are different, and the remaining 1% of the error is mainly caused by acquisition errors. That is, the scheme of the present invention can perform pre-sampling detection in a non-destructive manner. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The present invention will be further described below in conjunction with the accompanying drawings and embodiments: Figure 1 It is a structural schematic diagram of a preferred embodiment of the present invention; Figure 2 The present invention Figure 1 A partial enlarged view of part A; Figure 3 The present invention Figure 1 A partial enlarged view of part B; Figure 4 The present invention Figure 1 Schematic diagram of the state of gas release; Figure 5 The present invention Figure 1 Schematic diagram of medium rapid pressure relief state; Figure 6 It is a structural schematic diagram of another preferred embodiment of the present invention; Figure 7 The present invention Figure 6 A partial enlarged view of part C in the middle; Figure 8 The present invention Figure 6 A partial enlarged view of part D in the middle; Fig. 9 It is a structural schematic diagram of another preferred embodiment of the present invention; Fig.10 The present invention Fig. 9 A partial enlarged view of part E in the middle; Fig.11 It is a structural schematic diagram of a comparative scheme in the present invention; Fig.12 The present invention Fig.11 A partial enlarged view of part F in the middle; Fig.13 It is a schematic diagram of the structure of the sampling device in the present invention; Fig.14 The present invention Fig.13 A partial enlarged view of the middle G part; Fig.15 The present invention Fig.13 Schematic diagram of the sampling state; Fig.16 It is an evolution diagram of the target tissue of the present invention from benign to malignant; Fig.17 It is a schematic diagram of lossy detection of the present invention; Fig.18 It is a schematic diagram of nondestructive testing of the present invention; Fig.19 It is a process flow chart of the needle core electrode preparation method of the present invention; Fig. 20 The present invention Figure 4 Schematic diagram of the cross section during the preparation by the multi-layer method; Fig.21 The present invention Figure 4 Schematic diagram of the cross section during the preparation by the middle sleeve method; Fig. 22 It is a block diagram of the detection system of the present invention.

[0024] In the figure: sampling device 1, radio frequency detection device 2, syringe 3, sleeve needle 4, sampling needle core 5, sampling groove 6, handle 7, needle core electrode 8, servo system 9, detection device 91, auxiliary needle insertion device 92, air pressure ejection part 921, gas pressure tank 9211, hose 9212, manual valve 9213, mechanical ejection part 922, second return spring 9221, closed slide 9222, paddle part 9223, support block 9224, stepping pusher 923, scale push rod 9231, oblique rack 9232, movable block 9233, elastic clamping plate 9234, first return spring 9235, motor 9236, threaded rod 9237, internal threaded sleeve 9238, limit slider 9239, blocking part 10, piston 11, vibration damping pad 12, pressure relief hole 13, limit part 14, limit ring 141, damping layer 142. DETAILED DESCRIPTION

[0025] The technical solutions in the embodiments of the present application will be described below in conjunction with the accompanying drawings.

[0026] Embodiment 1: like Figures 1 to 5 , 16 and 18, comprising a radio frequency detection device 2, a sleeve needle 4 and a needle core electrode 8; Specifically, the radio frequency detection device 2 is used to send and receive radio frequency signals to detect the impedance value of the target tissue. The radio frequency detection device 2 transmits the excitation signal to the needle core electrode 8, and captures the signal fed back by the target tissue, and processes and analyzes it.

[0027] During operation, the needle core electrode 8 is used to penetrate into the sleeve needle 4, and the needle core electrode 8 is electrically connected to the radio frequency detection device 2; A tip is provided at the front end of the needle core electrode 8, and the tip is made of a conductive material. The two electrodes at the tip form a group, and the two electrodes are insulated from each other. Except for the tip, the rest of the needle core electrode 8 is provided with an insulating coating. A limiting portion 14 is provided at a distance behind the tip. The limiting portion 14 is slidably connected to the inner wall of the sleeve needle 4. The limiting portion 14 is used to fill the gap between the needle core electrode 8 and the inner wall of the sleeve needle 4. The limiting portion 14 is also used to guide and limit the depth of the needle core electrode 8 penetrating the target tissue to ensure that the detection signal of the needle core electrode 8 comes from the target tissue.

[0028] During implementation, when tissue needs to be detected, the doctor inserts the needle core electrode 8 through the sleeve needle 4 and into the target tissue. The radio frequency signal is emitted from the needle core electrode 8 and fed back to the radio frequency detection device 2 through the target tissue. The limiter 14 ensures that the needle core electrode 8 accurately reaches the detection depth to avoid misdiagnosis caused by being too deep or too shallow. The needle core electrode 8 is electrically connected to the radio frequency detection device 2, thereby realizing real-time detection of tissue characteristics.

[0029] The preferred solution is Figures 13 to 17The method further comprises a sampling device 1, which is used to penetrate into the sleeve needle 4 and cut the target tissue; In the sampling device 1, the sampling needle core 5 is arranged inside the sleeve needle 4, and its front end is a hollow structure. It can rotate relative to the sleeve needle 4 and slide axially along the sleeve needle 4. A sampling groove 6 is provided on the sampling needle core 5 for intercepting the target tissue, so that the doctor can cut and accommodate the target tissue during the rotation process. A handle 7 is also provided at the tail end of the sampling needle core 5 outside the syringe 3 to drive the sampling needle core 5 to rotate, providing a good grip and facilitating the doctor to apply appropriate force and angle.

[0030] During specific implementation, the doctor first determines the area where sampling is required through the radio frequency detection device 2, and then drives the sampling needle core 5 to rotate through the handle 7 so that the groove 6 at the front end cuts into the tissue. Then, the doctor slides the needle core along the sleeve needle 4 to bring out the tissue sample, ensuring the accuracy and efficiency of the sampling process.

[0031] The preferred solution is Figure 1 , 3 In the embodiment, the length from the limit portion 14 to the tip is greater than or equal to the length of the conductive portion of the tip to ensure that the needle core electrode 8 can fully penetrate the target tissue, and the tip portion is completely located inside the tissue and is not exposed to the outside to distort the detection signal, thereby ensuring the reliability and consistency of each detection result.

[0032] The preferred solution is Figure 1 , 3 In the embodiment, the limiting portion 14 and the needle core electrode 8 are connected by a movable or fixed connection structure; The limiting part 14 is an annular structure, and a through hole is provided on the annular structure along the axis to facilitate air passage and reduce resistance during operation; Among them, the through hole allows the air in the tissue to be discharged smoothly during the insertion process, preventing the formation of bubbles that affect the test results.

[0033] When the limiting part 14 is movably connected, a damping layer 142 is provided on the inner wall of the limiting ring 141. The damping layer 142 contacts the outer wall of the needle core electrode 8, allowing the needle core electrode 8 to have a certain movable space while reducing friction. A through hole is provided on the limiting ring 141 along the axis to facilitate air passage.

[0034] Preferably, the damping layer 142 may be made of rubber or other materials with a high friction coefficient, which provides a certain resistance when the needle core electrode 8 is inserted into the tissue to prevent over-insertion.

[0035] The preferred solution is Figure 1 The invention also includes a syringe 3, which is sleeved with a sleeve needle 4; A piston 11 is also provided near the tail end of the needle core electrode 8 outside the sleeve needle 4 and inside the syringe 3. The piston 11 is used to limit the position of the front end of the needle core electrode 8 inside or outside the sleeve needle 4. The end of the syringe 3 away from the piston is connected to the gas source; The needle core electrode 8 is located in the through hole of the sleeve needle 4, and the front end of the needle core electrode 8 is located near the front end of the sleeve needle 4. A space for accommodating tissue is also provided between the front end of the sleeve needle 4 and the front end of the needle core electrode 8. A pressure relief hole 13 is provided at a distance in the middle front of the syringe 3. The pressure relief hole 13 is used to release excess compressed gas to ensure that the needle core electrode 8 will not be continuously pushed by the compressed gas.

[0036] The preferred solution is Figure 2 , 11 In the embodiment, a vibration-damping pad 12 is provided at a position near the front end of the inner wall of the syringe 3 and outside the blocking portion 10. When the piston 11 moves rapidly, the vibration-damping pad 12 absorbs the inertial impact generated by the movement of the piston 11 through elastic deformation, thereby reducing the vibration and noise inside the device and protecting the device from damage.

[0037] Preferably, the vibration-damping pad 12 may be made of rubber or other highly elastic material, which can play a buffering role when the piston 11 moves quickly.

[0038] The preferred solution is Figure 2 , 4 In , 5, and 12, there are multiple pressure relief holes 13, and the multiple pressure relief holes 13 are evenly distributed along the circumference of the outer wall of the syringe 3, which are used to quickly discharge the compressed gas and reduce the occurrence of gas blockage.

[0039] The gas source involved in the present application may be a pneumatic ejection part 921. The gas used by the pneumatic ejection part (921) is an ideal gas in a broad sense, which may be nitrogen (nitrogen is an inert gas with stable chemical properties and is not easy to react with other substances. Nitrogen is often used for pressurization to prevent the substance in the container from reacting with oxygen), oxygen (oxygen is an active gas that is easy to react with other substances and is usually not used for pressurization. It is used for pressurization in special circumstances, such as in the medical field), carbon dioxide (carbon dioxide is a colorless and odorless gas that is easily soluble in water and is often used for pressurization), helium (helium is an inert gas with stable chemical properties and is not easy to react with other substances and is often used for pressurization). The examples of the present application do not specifically limit the type of gas source.

[0040] For ease of understanding, the embodiments of the present application take helium as an example to explain the present application accordingly.

[0041] The preferred solution is Figures 1 to 5In the embodiment, the gas source is preferably a gas pressure ejection component 921, which is composed of a gas pressure tank 9211, a vent pipe 9212, and a manual valve 9213; The hose 9212 is used to connect the gas pressure tank 9211 to the cavity of the syringe 3. The manual valve 9213 is arranged on the gas pressure tank 9211 and the pressure charging operation is performed by starting the manual valve 9213. Under the action of the high-pressure gas, the pressure is quickly charged and the piston 11 is driven to move axially at a preset speed. When it is necessary to use the pneumatic ejection part 921, the operator first opens the manual valve 9213 to allow the high-pressure gas to enter the syringe 3 from the gas pressure tank 9211 through the ventilation tube 9212, and under the action of the high-pressure gas, the pressure in the syringe 3 increases rapidly, and the piston 11 has a certain curvature. When the air pressure fills the inner cavity of the syringe 3, a Coanda effect will be generated, causing the air flow to adhere to the wall of the piston 11, thereby pushing the piston 11 to move axially at a preset speed. When the piston 11 moves to the pressure relief hole 13, the syringe 3 will release excess air pressure to control the pressure and prevent the needle core electrode 8 from penetrating the target tissue after continuous pressurization. Under the action of inertia, the piston 11 will continue to move forward. When it moves to a certain position, the piston 11 will drive the needle core electrode 8 to move and push it out of the syringe 3, thereby achieving puncture and detection of the target tissue.

[0042] The preferred solution is Figures 6 to 10 In the apparatus, an auxiliary needle insertion device 92 is also provided, and the auxiliary needle insertion device 92 is connected to the needle core electrode 8 and is used to drive the needle core electrode 8 to puncture the target tissue at a preset speed or in a multi-step manner.

[0043] The preferred solution is Figure 6 , 7 and 8, the auxiliary needle insertion device 92 is a stepping pusher 923; The stepping pusher 923 is manually step-pushed and consists of a scale push rod 9231, a bevel rack 9232, a movable block 9233, an elastic clamping plate 9234 and a first return spring 9235; The bevel rack 9232 is arranged on the inner wall of the syringe 3 in a mirror-symmetrical manner, and the scale push rod 9231 is arranged inside the syringe 3 to mark the pushing distance to ensure that each push is a preset step length. One end of the scale push rod 9231 passes through the tail end of the syringe 3 and moves axially along the sleeve needle 4, and the other end is arranged on the movable block 9233 and moves with the thrust of the scale push rod 9231. An elastic clamping plate 9234 for limiting reverse movement is provided on the outer wall of the movable block 9233. The cooperation between the bevel rack 9232 and the movable block 9233 allows the needle core electrode to move only in a predetermined direction. When the elastic clamping plate 9234 is subjected to radial force, the movable block 9233 moves radially. When subjected to the reverse thrust of the first return spring 9235, it engages with the movable block 9233 to limit its further movement, ensuring that the movable block 9233 remains fixed when there is no radial force. The first return spring 9235 can prevent the movable block from retreating due to gravity or other reasons when the push stops.

[0044] The preferred solution is Fig. 9 , 10 In the figure, the stepping pusher 923 is an automatic stepping pusher, and is composed of a motor 9236, a threaded rod 9237, an internal threaded sleeve 9238 and a limit slider 9239; The needle cylinder 3 is provided with a groove for the limit slider 9239 to move; The motor 9236 is arranged at the rear end of the syringe 3 to drive the threaded rod 9237 to rotate. The threaded rod 9237 is threadedly connected to the internal threaded sleeve 9238, and can rotate relative to the internal threaded sleeve 9238. Under the thrust of the thread rotation, the internal threaded sleeve 9238 is pushed to move radially along the inner wall of the syringe 3. Furthermore, the motor 9236 can adopt a DC servo motor, and the speed and torque can be adjusted as needed. The limit slider 9239 limits the moving distance of the internal threaded sleeve 9238 to ensure precise control. The limit slider 9239 can make the internal threaded sleeve 9238 move only within a limited range to prevent excessive advancement or retreat.

[0045] In a feasible comparison scheme such as Fig.11 , 12 In the embodiment, the auxiliary needle insertion device 92 is a mechanical ejection member 922, which is composed of a return spring 9221, a closing slide 9222, a plate member 9223 and a support block 9224; Among them, the return spring 9221 and the closed slide 9222 are both built into the syringe 3 and are in a limited compression state. A rectangular structure with inner and outer openings is provided on the syringe 3 for being hinged with the paddle 9223. The support block 9224 is provided on the outer wall of the syringe 3 close to the rectangular structure, and one end of the support block abuts against the paddle 9223 to keep the paddle 9223 and the syringe 3 in a parallel state, so that the needle core electrode 8 can puncture the target tissue at a preset speed under the drive of the reaction force after the limit is released; When the mechanical ejection member 922 is needed to release the needle core electrode 8, the operator operates the paddle member 9223 to move it in the direction away from the support block 9224. At this time, the energy stored in the reset spring 9221 and the closed slide 9222 will be released to generate a reaction force. Under the ejection power provided by the reset spring 9221 and the closed slide 9222, the piston 11 is given an initial velocity and moves axially at a preset speed. When the piston 11 moves to the pressure relief hole 13, the syringe 3 will release excess air pressure to control the pressure and prevent the needle core electrode 8 from penetrating the target tissue after continuous pressurization. Under the action of inertia, the piston 11 will continue to move forward. When it moves to a certain position, the piston 11 will drive the needle core electrode 8 to move and push it out of the syringe 3, thereby achieving puncture and detection of the target tissue. However, compared with the aforementioned embodiment, the mechanical ejection member 922 used in this embodiment cannot accurately control the insertion force and depth.

[0046] The preferred solution is Figures 1 to 8 In the present invention, the inner diameter of the through hole of the sleeve needle 4 is 0.5mm to 1.5mm, the diameter of the sampling needle core 5 is 0.4mm to 1mm, and the diameter of the needle core electrode 8 is 0.33mm to 0.6mm, which is used to smoothly penetrate human tissue, such as human skin. The skin has certain resistance and capacitance characteristics. Using sleeve needles 4 and needle core electrodes 8 of appropriate sizes can reduce the attenuation and interference of the skin to the electrical signal, ensuring that the electrical signal can be accurately transmitted to the target tissue. Further preferably, the electrode has a sufficient length and can also penetrate into the human body and contact with the target tissue, such as for auxiliary detection of the intestine and other locations.

[0047] The preferred solution is Figure 2 In the embodiment, the detection device 91 can be used to switch to different invasive electrodes through a reference calibration and switching circuit to form a variety of detection paths, and collect a bioelectrical impedance data matrix. The DDS signal source of the detection system generates an analog sinusoidal signal, which is output to one of the invasive electrodes through a low-pass filter and an amplifier after reference calibration and a switching circuit, and the other invasive electrodes perform current sampling and / or voltage sampling respectively; further preferably, an adjacent electrode drive detection method is adopted, that is, an adjacent electrode pair injects an excitation current into the field to establish a sensitive field, and measures the boundary voltage on other adjacent electrodes; then switches to the next adjacent electrode pair for excitation, and then measures the voltage on other adjacent, non-excited electrode pairs, and repeats the above process until all adjacent electrode pairs are excited, thereby obtaining a mesh of sensitive RF detection data.

[0048] It is to be understood that the structure illustrated in the embodiment of the present application does not constitute a specific limitation on the pathological tissue nondestructive detection and sampling device. In other embodiments of the present application, the pathological tissue nondestructive detection and sampling device may include more or fewer components than shown in the figure, or combine certain components, or split certain components, or arrange the components differently. The components shown in the figure may be implemented in hardware, software, or a combination of software and hardware.

[0049] Embodiment 2: Next, further description will be given based on the above-mentioned embodiment 1, and combined with Figures 19 to 21 The method for preparing the needle core electrode is introduced as shown in the following. Fig.19 , 20 ) and sleeve process (see Fig.19 , 21 ) to illustrate.

[0050] In the preferred Fig.19 , 20 In the multi-layer process, the following steps are included: S1: Adhere two layers of electrode plates with an insulating adhesive to obtain a composite electrode blank, and then cut into strips, straighten them, and pull them through the tapered hole to form a circle; wherein the composite plate is prepared by cutting, preferably by laser cutting, and the insulating adhesive is epoxy resin ((C11H12O3) n )、Polyurethane((NHCOO) n ) or other special adhesives, preferably epoxy resin ((C11H12O3) n ) is added with one or more of zirconium dioxide (ZrO2), mica (KAl2 (AlSi3O10) (OH)2) and boron nitride (BN) to improve the dielectric properties, and the electrode plate is made of silver-copper alloy layer (AgCu3, AgCu7.5) or other conductive materials; Further preferably, the electrode plate is made of silver-copper alloy (AgCu3, AgCu7.5), pure copper, silver-palladium alloy or nickel material; Among them, in the silver-copper alloy layer, the silver:copper ratio is 10:1, and one or more of zinc (Zn), nickel (Ni) or tin (Sn) are added as strengthening elements. The added ratio of the strengthening elements is 0.5% to 5% of the overall weight ratio, which improves the mechanical strength and corrosion resistance of the alloy and extends the service life of the electrode.

[0051] S2: A double-layer electrode is obtained by extrusion; wherein the long strip electrode is extruded by an extrusion tool, such as a press, an extrusion die, etc., to extrude the electrode and the insulating layer so that they are tightly combined.

[0052] In the preferred Fig.19 , 21In the process of sleeve method, the following steps are included: S1: an insulating layer is provided on the outer wall of a single circular or cylindrical electrode, a composite electrode is inserted into the outer cylindrical electrode to obtain a composite electrode blank, the composite electrode blank is straightened, passed through a mold, and polished into a circular shape; wherein the insulating layer is prepared by an insulating ceramic layer or other insulating materials, preferably an insulating ceramic layer; Among them, it is further preferred that the insulating ceramic layer is composed of one or more of silicon oxide (SiO2), zirconium dioxide (ZrO2) and barium titanate (BaTiO3); S2: passing the composite electrode through the tapered hole; S3: A double-layer electrode is obtained by extrusion and stretching; wherein, the long strip electrode uses an extrusion tool, such as a press, an extrusion die, etc., to extrude the electrode and the insulating layer so that they are tightly combined; the long strip electrode uses a stretching tool, such as a stretching machine, a stretching die, etc., to stretch the electrode and the insulating layer to form the shape of a double-layer electrode.

[0053] The above embodiments are only preferred technical solutions of the present invention and should not be regarded as limiting the present invention. The protection scope of the present invention shall be the technical solutions recorded in the claims, including equivalent replacement solutions of the technical features in the technical solutions recorded in the claims. That is, equivalent replacement improvements within this scope are also within the protection scope of the present invention.

Claims

1. A pathological tissue nondestructive detection and sampling device, characterized in that: It comprises a radio frequency detection device (2), a sleeve needle (4) and a needle core electrode (8); During operation, the needle core electrode (8) is used to penetrate into the sleeve needle (4), and the needle core electrode (8) is electrically connected to the radio frequency detection device (2); The front end of the needle core electrode (8) is provided with a tip, the tip is made of a conductive material, the two electrodes at the tip form a group, the two electrodes are insulated from each other, the rest of the needle core electrode (8) is provided with an insulating coating, a limiting portion (14) is provided at a distance behind the tip, the limiting portion (14) is slidably connected to the inner wall of the sleeve needle (4), the limiting portion (14) is used to fill the gap between the needle core electrode (8) and the inner wall of the sleeve needle (4), and the limiting portion (14) is also used to guide and limit the depth of the needle core electrode (8) penetrating into the target tissue, so as to ensure that the detection signal of the needle core electrode (8) comes from the target tissue.

2. The pathological tissue nondestructive detection and sampling device according to claim 1, characterized in that: The length from the limiting portion (14) to the tip is greater than or equal to the length of the conductive portion of the tip, so as to ensure that the needle core electrode (8) can fully penetrate the target tissue and will not be exposed to the outside to distort the detection signal.

3. The pathological tissue nondestructive detection and sampling device according to claim 1, characterized in that: It also includes a sampling device (1), which is used to penetrate into the sleeve needle (4) to cut the target tissue; In the sampling device (1), the sampling needle core (5) is arranged inside the sleeve needle (4), and its front end is a hollow structure, which can rotate relative to the sleeve needle (4) and slide along the axial direction of the sleeve needle (4). The sampling needle core (5) is provided with a sampling groove (6) for intercepting the target tissue. A handle (7) is also provided at the rear end of the sampling needle core (5) outside the syringe (3) to drive the sampling needle core (5) to rotate.

4. The pathological tissue nondestructive detection and sampling device according to claim 1, characterized in that: The limiting portion (14) and the needle core electrode (8) are connected by a movable or fixed connection structure; The limiting portion (14) is an annular structure, and a through hole is provided along the axis of the annular structure to facilitate air passage; When the limiting portion (14) is movably connected, the inner wall of the limiting ring (141) is provided with a damping layer (142), the damping layer (142) is in contact with the outer wall of the needle core electrode (8), and a through hole is provided on the limiting ring (141) along the axis to facilitate the passage of air.

5. The pathological tissue nondestructive detection and sampling device according to claim 2, characterized in that: It also includes a syringe (3), the syringe (3) being sleeve-connected with the sleeve needle (4); A piston (11) is also provided at a position of the needle core electrode (8) near the rear end thereof, which is located outside the sleeve needle (4) and inside the syringe (3), and the piston (11) is used to limit the position of the front end of the needle core electrode (8) inside or outside the sleeve needle (4); The end of the syringe (3) away from the piston is connected to the gas source; The needle core electrode (8) is located in the through hole of the sleeve needle (4), the front end of the needle core electrode (8) is located close to the front end of the sleeve needle (4), and a space for accommodating tissue is provided between the front end of the sleeve needle (4) and the front end of the needle core electrode (8). The syringe (3) is provided with a pressure relief hole (13) at a distance in the middle and front, and the pressure relief hole (13) is used to release excess compressed gas to ensure that the needle core electrode (8) is not continuously pushed by the compressed gas.

6. The pathological tissue nondestructive detection and sampling device according to claim 5, characterized in that: A vibration damping pad (12) is provided at a position of the syringe (3) close to the front end of the inner wall and outside the blocking portion (10). The vibration damping pad (12) absorbs the inertial impact generated by the movement of the piston (11) through elastic deformation.

7. The pathological tissue nondestructive detection and sampling device according to claim 5, characterized in that: There are a plurality of pressure relief holes (13), which are evenly distributed along the circumference of the outer wall of the syringe (3) and are used to quickly discharge compressed gas.

8. The pathological tissue nondestructive detection and sampling device according to any one of claims 1 to 4, characterized in that: An auxiliary needle insertion device (92) is also provided. The auxiliary needle insertion device (92) is connected to the needle core electrode (8) and is used to drive the needle core electrode (8) to puncture the target tissue at a preset speed or in a multi-step manner.

9. The pathological tissue nondestructive detection and sampling device according to claim 8, characterized in that: The auxiliary needle insertion device (92) is a stepping pusher (923); The stepping pusher (923) is manually step-pushed and consists of a scale push rod (9231), a bevel rack (9232), a movable block (9233), an elastic clamping plate (9234) and a first return spring (9235); The oblique rack (9232) is arranged on the inner wall of the syringe (3) in a mirror-symmetrical manner. The scale push rod (9231) is arranged inside the syringe (3). One end of the scale push rod (9231) passes through the rear end of the syringe (3) and moves axially along the sleeve needle (4). The other end is arranged on the movable block (9233) and moves with the push force of the scale push rod (9231). An elastic clamping plate (9234) for limiting reverse movement is provided on the outer wall of the movable block (9233). When the elastic clamping plate (9234) is subjected to radial force, the movable block (9233) moves in the radial direction. When the elastic clamping plate (9234) is subjected to reverse push force of the first return spring (9235), it meshes with the movable block (9233) to limit its further movement.

10. The pathological tissue nondestructive detection and sampling device according to claim 8, characterized in that: The stepping pusher (923) is an automatic stepping pusher and is composed of a motor (9236), a threaded rod (9237), an internal threaded sleeve (9238) and a limit slider (9239); The needle cylinder (3) is provided with a groove for the limit slider (9239) to move; The motor (9236) is arranged at the rear end of the syringe (3) to drive the threaded rod (9237) to rotate. The threaded rod (9237) is threadedly connected to the internal threaded sleeve (9238) and can rotate relative to the internal threaded sleeve (9238). Under the thrust of the thread rotation, the internal threaded sleeve (9238) is pushed to move radially along the inner wall of the syringe (3); Among them, the limit slider (9239) limits the moving distance of the internal threaded sleeve (9238).

11. The pathological tissue nondestructive detection and sampling device according to any one of claims 1 to 4, characterized in that: The inner diameter of the through hole of the sleeve needle (4) is 0.5 mm to 1.5 mm, the diameter of the sampling needle core (5) is 0.4 mm to 1 mm, and the diameter of the needle core electrode (8) is 0.33 mm to 0.6 mm.

12. A method for preparing the needle core electrode according to any one of claims 1 to 11, characterized in that: The method comprises the following steps: S1: an insulating layer is provided between two electrode plates to obtain a composite electrode blank, and the composite electrode blank is straightened, passed through a mold, and polished into a round shape; and / or The two layers of electrode plates are bonded with an insulating adhesive, and then cut into strips, straightened, and pulled through the tapered hole to form a circle; S2: The double-layer electrode is obtained by extrusion, and it becomes the finished product after polishing and testing.

13. The method for preparing a needle core electrode according to claim 12, characterized in that: The step S1 is to provide an insulating layer on the outer wall of a single circular or cylindrical electrode and insert the composite electrode into the outer cylindrical electrode.

14. The method for preparing a needle core electrode according to claim 12, characterized in that: The step S1 is to arrange a flexible insulating layer between two layers of electrode plates to make a composite plate, and cut the composite plate into long strips.

15. The method for preparing a needle core electrode according to claim 12, characterized in that: The insulating adhesive in S1 is epoxy resin ((C 11 H 12 O3) n ) or polyurethane ((NHCOO) n ); The insulating adhesive contains one or more of silicon dioxide, calcium carbonate or barium titanate (BaTiO3).

16. The method for preparing a needle core electrode according to claim 12, characterized in that: The insulating layer in S1 is an insulating ceramic layer; The insulating ceramic layer is composed of one or a combination of silicon dioxide (SiO2), zirconium dioxide (ZrO2) and barium titanate (BaTiO3).

17. The method for preparing a needle core electrode according to claim 12, characterized in that: The electrode plate in S1 is made of silver-copper alloy (AgCu3, AgCu7.5), pure copper, silver-palladium alloy or nickel material.

18. The method for preparing a needle core electrode according to claim 17, characterized in that: in, In the silver-copper alloy layer, the ratio of silver to copper is 10:1, and one or more of zinc (Zn), nickel (Ni) or tin (Sn) are added as reinforcing elements, and the added proportion of the reinforcing elements is 0.5% to 5% of the overall weight ratio.

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