Direction-adjustable bending radio frequency ablation electrode needle

Abstract

The utility model discloses a direction-adjustable bending radiofrequency ablation electrode needle which comprises an ablation needle handle, a coaxial sheath, a steering electrode needle, an electrode wire, an outflow tube, an inflow tube and a negative electrode patch. The steering electrode needle is arranged in an inner cavity of the ablation needle handle and the coaxial sheath, the steering electrode needle made of shape memory alloy and the coaxial sheath are matched in a push-pull mode to synchronously adjust and control the length and the angle of the electrode needle, the needle point of the electrode needle is coated with the conductive nanometer coating, protein, tissue and the like are prevented from being adhered to the needle point, and carbonization is reduced. According to the ablation electrode needle, the direction of the ablation electrode needle and the length of the working end can be adjusted and controlled, a safer, more effective and more stable operation ablation treatment mode is achieved through the conductive ceramic coating on the needle tip portion, the ablation electrode needle can be suitable for Liwen operation type treatment of complex hypertrophic cardiomyopathy ventricular septal parting, and the safety, effectiveness and operability of the Liwen operation type operation process can be improved.

Description

Technical Field

[0001] The utility model belongs to the field of medical interventional devices and relates to a novel radiofrequency ablation electrode needle. Background Art

[0002] The anatomical classification of the ventricular septum in patients with hypertrophic cardiomyopathy is complex and diverse. According to the morphology of the ventricular septum, HCM is divided into: (1) asymmetric hypertrophy, (2) symmetric hypertrophy, and (3) hypertrophy in special parts, which are divided into apical hypertrophic type and other part hypertrophic type; further refine the sigmoid ventricular septum, reverse curvature type, mid-ventricular hypertrophy, and discontinuous hypertrophy in the complex classification.

[0003] As a major technological innovation in the new interventional path for heart diseases, the Liwen procedure provides a new solution for the treatment of HCM. Its principle is that under real-time ultrasound guidance, the radiofrequency needle is precisely punctured through the skin and myocardium to reach the hypertrophic part of the ventricular septum myocardium (thickness ≥ 15 mm). The high-frequency alternating current emitted by the working end of the radiofrequency electrode needle is used to make the ions in the hypertrophic myocardial tissue cells rub against each other to generate heat, and the local temperature can reach above 80 °C, causing the dehydration of the hypertrophic myocardial cells around the electrode needle, resulting in irreversible coagulative necrosis of the tissue cells, thinning the thickness of the ventricular septum, widening the inner diameter of the left ventricular outflow tract, relieving the obstruction of the left ventricular outflow tract, and improving the clinical symptoms of patients. The Liwen procedure has the advantages of small trauma, no thoracotomy, no cardiopulmonary bypass, rapid postoperative recovery of patients, significant improvement in clinical symptoms and quality of life, and has great clinical value and broad application prospects.

[0004] However, at present, the indications of radiofrequency ablation needles are mostly for minimally invasive treatment of solid organs such as the liver and thyroid and tumors. The minimally invasive treatment of myocardial tissue is still in the stage of clinical trial exploration. The few radiofrequency ablation needles used to treat hypertrophic cardiomyopathy mainly have the following problems:

[0005] (1) At present, the water-cooled circulating rigid radiofrequency ablation needles on the market are basically fixed in the needle tip direction and cannot be turned. As shown in Figure 1 (a), it is a conventional radiofrequency ablation straight needle. Since the electrode needle tip is fixed and cannot be turned, the Liwen procedure is inconvenient to operate when treating non-standard complex ventricular septum classifications. For example, when the sigmoid ventricular septum bulges out into the left ventricular outflow tract, the operator needs to turn the needle track multiple times during the operation, adjust the radiofrequency needle tip, and then superimpose the ablation necrosis areas multiple times to achieve complete ablation of the hypertrophic area of the sigmoid ventricular septum. However, the heart is full of blood vessels and conduction systems. Turning the needle track and adjusting the radiofrequency needle tip multiple times are likely to cause serious complications, increase the surgical risk, and at the same time, turning the needle track multiple times is likely to cause tearing of the radiofrequency needle at the myocardial needle insertion site, resulting in an increase in the wound size and the risk of pericardial effusion and bleeding. The moving distance of the radiofrequency needle at the myocardial needle insertion site: As shown in Figure 2As shown in the figure; when the water-cooled circulating radiofrequency hard needle is used for ablation with multiple needle path rotations during the ablation of the non-linear complex anatomical classification of HCM, the surgical operation difficulty is increased, and the risk of complications is increased. When the conventional radiofrequency straight needle faces the complex and diverse ventricular septum classifications, during the ablation with a non-linear needle insertion, it is necessary to rotate the needle path multiple times to adjust the position of the ablation needle tip, which is highly difficult to operate. Moreover, when a large-angle deflection of the needle tip position is required for ablation, it is easy to cause tearing at the needle insertion site at the apex of the heart, resulting in pericardial effusion. Therefore, while the conventional radiofrequency needle takes into account safety, when deflecting at a small angle, it may cause the needle tip to be unable to reach some areas, resulting in incomplete ablation or missed ablation problems.

[0006] (2) Currently, the common radiofrequency ablation needles on the market are mainly fixed in the working end size of the electrode needle. The common working ends are mainly 1.0, 2.0, and 3.0 cm; the length of the working end of the radiofrequency electrode needle is related to the size of the effective ablation tissue range. When ablating the ventricular septum of patients with hypertrophic cardiomyopathy using the Liwen technique, the appropriate ablation needle electrode length is selected according to the thickness of the ventricular septum in the area to be ablated before the operation. If the size of the electrode needle is selected to be too small, it is necessary to change the ablation position multiple times and overlap the ablation area, increasing the operation time; if the size of the electrode needle is selected to be too large, it is easy to have an overly large ablation area, exceeding the safety boundary and damaging the conduction system, resulting in risks such as malignant arrhythmia.

[0007] (3) During the radiofrequency ablation process, there is a common problem of "carbonization" of tissues caused by too high output power. During the ablation process, organic substances such as tissues and proteins adhered to the needle wall are easily converted into carbonized tissues during the rapid heating process. The carbonized tissues wrap the electrode needle, resulting in the obstruction of the alternating current conduction to the surrounding tissues. At the same time, it is easy to cause too high impedance of the surrounding tissues of the test needle of the main machine system, resulting in a "false dormancy" situation of misjudgment by the system. The ablation range is much smaller than the planned range. At the same time, the time required for the body to absorb the carbonized tissues is much longer than that of normal ablated necrotic tissues, resulting in errors in the ablation range and reduced effectiveness.

[0008] Therefore, for the conformal ablation of complex ventricular septum classifications using the Liwen technique, there is an urgent need for a radiofrequency ablation needle with precise adjustable angle and length and high stability. Summary of the Utility Model

[0009] In view of the deficiencies existing in the prior art, the purpose of the present utility model is to provide a radiofrequency ablation electrode needle with adjustable bending direction. For the currently conventional radiofrequency ablation water-cooled circulation single needle, which is mainly a straight needle, there is a lack of a radiofrequency ablation electrode single needle with adjustable direction on the market. It is difficult to insert the needle and perform ablation under non-linear conditions in clinical treatment. The present utility model can realize the regulation of the direction and the size of the working end of the radiofrequency ablation electrode needle, and at the same time improve the carbonization problem caused by the adhesion of the ablation electrode needle, etc., and solve the complication problem caused by multiple needle track rotations when treating hypertrophic cardiomyopathy with the Liwen technique in the face of complex ventricular septum typing. At the same time, the length adjustment of the push-pull type electrode needle can meet the ablation treatment of ventricular septum with different thicknesses, thus solving the clinical problems faced by the current radiofrequency ablation single needle when treating HCM patients with the Liwen technique.

[0010] In order to solve the above technical problems, the present utility model is realized by adopting the following technical solutions:

[0011] A radiofrequency ablation electrode needle with adjustable bending direction, comprising an ablation needle handle, a coaxial outer sheath, a steering electrode needle, an electrode wire, an outflow tube, an inflow tube, and a negative electrode patch;

[0012] The front end of the ablation needle handle is installed with a coaxial outer sheath through a coaxial sheath joint, and the inner cavity of the ablation needle handle is communicated with the central channel of the coaxial outer sheath; the steering electrode needle is an electrode needle prefabricated from a shape memory alloy and its front end can be deflected. The steering electrode needle is arranged in the inner cavity of the ablation needle handle and the coaxial outer sheath. By adjusting the axial telescopic movement of the steering electrode needle through the electrode length adjustment push-pull button on the ablation needle handle, the steering angle and length of the front end of the steering electrode needle after extending out of the coaxial outer sheath can be synchronously regulated, and the steering angle adjustment range is 0-180°;

[0013] An electrode needle welding point is provided at the rear part of the steering electrode needle and is connected to the electrode wire. The electrode wire is led out of the ablation needle handle and connected to the electrode host through an electrode host connection head;

[0014] A water tank is further arranged in the inner cavity of the ablation needle handle. The front port of the water tank is connected to the rear end of the steering electrode needle. The water tank is respectively communicated with an outflow hose and an inflow hose. After the outflow hose and the inflow hose extend out of the ablation needle handle, they are respectively connected to the outflow tube and the inflow tube;

[0015] The negative electrode patch connection head of the negative electrode patch is connected to the electrode host.

[0016] The present utility model further includes the following technical features:

[0017] Specifically, the electrode length adjustment push-pull button on the ablation needle handle is connected to a length adjustment moving slider in the inner cavity of the ablation needle handle, and the length adjustment moving slider is connected to the steering electrode needle. By pushing and pulling the electrode length adjustment push-pull button, the axial telescopic movement of the steering electrode needle can be adjusted.

[0018] Specifically, the outflow hose is connected to the outflow pipe through the Luer connector I connected thereto; the inflow hose is connected to the inflow pipe through the Luer connector II connected thereto.

[0019] Specifically, one end of the inflow pipe is connected to the inflow hose, and the other end is provided with an inflow needle port; an inflow direction indicator is provided on the outer wall of the inflow pipe.

[0020] Specifically, one end of the outflow pipe is connected to the outflow hose, and the other end is an outflow port.

[0021] Specifically, the negative electrode patch includes a negative electrode patch, a negative electrode patch wire clamping buckle, and a negative electrode patch connector connected in sequence.

[0022] Specifically, positioning etching lines are provided on the coaxial outer sheath.

[0023] Specifically, the inner wall of the ablation needle handle cavity is provided with a sliding card slot and a positioning card slot; the sliding card slot matches the electrode length adjustment push-pull button so that the electrode length adjustment push-pull button moves along the axial direction of the steering electrode needle; the positioning card slot can limit and position different positions of the length adjustment moving slider.

[0024] Specifically, the front-end deflection shape of the steering electrode needle includes, but is not limited to, arc-shaped bends at various angles, S-shaped bends, wavy lines, semi-circular rings, hook shapes, and hard fold-turns at various angles.

[0025] Specifically, the tip of the steering electrode needle is coated with a ceramic nano-coating with electrical conductivity; the outer wall of the coaxial outer sheath and the part of the steering electrode needle located inside the coaxial outer sheath are coated with a ceramic coating with insulation and non-adhesion properties.

[0026] Specifically, an insulating outer sheath for the electrode needle is sleeved on the steering electrode needle, and the position of the insulating outer sheath for the electrode needle on the steering electrode needle is adjustable. By controlling the length of the insulating outer sheath for the electrode needle covering and extending out of the coaxial outer sheath, the ablation range and position of the steering electrode needle can be adjusted, and dangerous areas can be protected from ablation.

[0027] Specifically, a three-way injection tube is provided between the coaxial sheath connector and the coaxial outer sheath. The nozzle I and nozzle II of the three-way injection tube and the connecting pipe therebetween are all coaxial. Nozzle I is coaxially connected to the coaxial sheath connector, nozzle II is coaxially connected to the coaxial outer sheath, and a knob cover is provided on the nozzle III of the three-way injection tube.

[0028] The direction-adjustable bend radiofrequency ablation electrode needle is used for the minimally invasive ablation treatment of the ventricular septum of hypertrophic cardiomyopathy, cardiac tumors, liver, kidney, thyroid, vascular plaques, lungs, breasts, and uterine fibroids, realizing turnable ablation treatment under straight and non-straight needle insertion paths.

[0029] Compared with the prior art, the present utility model has the following technical effects:

[0030] The radiofrequency ablation electrode needle of the present utility model can achieve direction changes at different angles. The core of the present utility model uses a shape memory alloy material to prepare the electrode needle. By controlling the axial push-pull button of the electrode needle in the handle part, the electrode needle is driven to axially extend and retract in the coaxial sheath tube. The part of the shape memory alloy electrode extending out of the sheath tube will continue to recover and extend out of the coaxial sheath tube opening along the previously prefabricated angle, that is, the angle of the electrode needle is changed. The angle adjustment within 0° - 180° of the ablation electrode needle can be achieved, solving the effective implementation of non-linear radiofrequency ablation in clinical treatment, reducing the risk of myocardial tissue damage caused by changing the direction of the needle track during the operation, reducing complications and improving the safety of the operation.

[0031] The length of the radiofrequency electrode needle of the present utility model can be adjusted. The length of the turning electrode prefabricated to extend out of the coaxial sheath tube opening of the present utility model is 30 mm. By controlling the axial push-pull button of the electrode needle in the handle part, the electrode needle is driven to axially extend and retract in the coaxial sheath tube. When the extension length of the electrode needle meets the requirements, the push-pull control button is stopped. After slot positioning, the ablation treatment is immediately started, and the effective regulation of the electrode needle length within the range of 0 - 30 mm can be achieved, solving the risk difference of the ablation range caused by the length deviation of the ablation electrode needle. During the operation, the extension length of the electrode needle tip can be flexibly adjusted according to the clinical treatment requirements, realizing more precise and convenient surgical operations.

[0032] The present utility model prepares a ceramic coating material on the surface of the radiofrequency ablation needle to improve the surgical characteristics of the electrode needle. A layer of ceramic nano-coating material with conductive properties, such as a titanium suboxide conductive ceramic coating, is prepared at the tip of the ablation turning electrode; while a layer of ceramic coating material with good insulation and non-adhesion properties, such as an alumina ceramic coating, is prepared on the outer wall of the coaxial sheath and the front part of the radiofrequency needle wall. The prepared ceramic coating can significantly improve the adhesion characteristics between the needle body and proteins and tissues, and improve the stability and reliability of the radiofrequency ablation electrode needle.

[0033] The present utility model prepares an electrode needle with a deflected angle by using a shape memory alloy material. At the same time, by designing the axial push-pull button of the electrode needle, the electrode needle is driven to axially extend and retract in the coaxial sheath tube. The electrode needle extends out of the sheath tube opening along the prefabricated turning angle, synchronously realizing the regulation of the angle and length. At the same time, a ceramic coating material is prepared on the surface of the ablation needle to improve the tissue adhesion characteristics. The novel adjustable-bend radiofrequency ablation needle can overall achieve more precise, safe and convenient ablation treatment under non-linear conditions. This device has great clinical application prospects in the clinical treatment of hypertrophic cardiomyopathy and tumors. Description of the Drawings

[0034] Figure 1 For (a) a conventional radiofrequency ablation straight needle, (b) an adjustable-bend radiofrequency ablation needle can perform conformal ablation treatment on the sigmoid ventricular septum.

[0035] Figure 2 Schematic diagram of conventional radiofrequency ablation needle ablation of the sigmoid ventricular septum in patients with HCM.

[0036] Figure 3 This is a schematic diagram of the connection between the ablation needle handle, coaxial outer sheath and steering electrode needle of the direction-adjustable curved radiofrequency ablation electrode needle.

[0037] Figure 4 Schematic diagram of (a) inflow tube (b) outflow tube (c) negative electrode patch (d) ordinary puncture needle placed in the coaxial outer sheath.

[0038] Figure 5 Schematic diagram of an adjustable length radiofrequency ablation electrode needle at 0°.

[0039] Figure 6 Schematic diagram of the RF electrode needle steering at different deflection angles (a) 30° deflection angle (b) 60° deflection angle (c) 90° deflection angle.

[0040] Figure 7 Schematic diagram of RF electrode needle steering under different hard deflection angles (a) 30° deflection angle (b) 60° deflection angle (c) 90° deflection angle.

[0041] Figure 8 Schematic diagram of different turning needle angles and ablation ranges.

[0042] Figure 9 The effect diagram for the comparison of therapeutic effects is shown in (a) the conformal ablation effect of the new curved needle on the isolated ventricular septum of the pig heart, and (b) the conventional radiofrequency needle ablation effect.

[0043] Figure 10 This is a schematic diagram of the coating distribution at the radio frequency steering electrode needle, radio frequency needle coaxial outer sheath, and turning electrode needle.

[0044] Figure 11 This is a schematic diagram of the layout of the insulating outer sheath of the electrode needle.

[0045] Figure 12 Schematic diagram of the electrode needle insulating sheath cooperating with the steering electrode needle for non-linear needle insertion and conformal ablation.

[0046] Figure 13 This is the installation diagram and details of the three-way injection tube.

[0047] Figure 14 Schematic diagram of conformal ablation of the ventricular septum for different types of hypertrophic cardiomyopathy.

[0048] Figure 15 Schematic diagram of puncturing the radiofrequency ablation needle and coaxial sheath into the middle part of the sigmoid ventricular septum under ultrasound guidance.

[0049] Figure 16Schematic diagram for ablation treatment by adjusting the angle and length of the radiofrequency steering electrode needle.

[0050] Figure 17 Schematic diagram for conformal ablation in the area of the radiofrequency ablation steering electrode needle for adjustment.

[0051] Figure 18 Schematic diagram for conformal ablation when the electrode needle deflects 45° and extends 30 mm.

[0052] The meanings of each label in the figure are as follows:

[0053] 1. Ablation needle handle, 2. Coaxial outer sheath, 3. Steering electrode needle, 4. Electrode wire, 5. Outflow tube, 6. Inflow tube, 7. Negative electrode patch, 8. Ordinary puncture needle; 11. Electrode length adjustment push-pull knob, 12. Water tank, 13. Outflow hose, 14. Inflow hose; 111. Length adjustment moving slider, 112. Sliding card slot, 113. Positioning card slot; 131. Luer connector I, 141. Luer connector II; 21. Coaxial sheath connector, 22. Positioning etching line, 23. Ceramic coating, 24. Three-way injection tube; 31. Electrode needle welding point, 32. Ceramic nano-coating, 33. Electrode needle insulation outer sheath; 41. Electrode mainframe connection head; 51. Outflow port; 61. Inflow needle port, 62. Inflow direction indicator; 71. Negative electrode patch, 72. Negative electrode patch wire clip, 73. Negative electrode patch connection head; 100. Ultrasonic probe, 200. Ablation necrosis area, 300. Conventional radiofrequency ablation straight needle, 400. Conformal ablation necrosis area, 500. Bendable radiofrequency ablation needle. Specific implementation method

[0054] The present utility model provides a direction-adjustable bendable radiofrequency ablation electrode needle, which is a surgical interventional medical device used for the Liwen procedure (ultrasound-guided percutaneous intramyocardial radiofrequency ablation) to treat diseases such as complex hypertrophic cardiomyopathy / tumors. It can realize the regulation of the direction of the radiofrequency ablation electrode needle and the size of the working end, and at the same time improve problems such as carbonization caused by the adhesion of the ablation electrode needle. By using shape memory alloy to prefabricate electrode needles within a certain angle range (30°, 60°, 90°, 180°); at the same time, a push-pull button structure is designed to push and pull the electrode needle to expand and contract axially, realizing the change of the size of the turning electrode at the working end of the radiofrequency needle. By preparing a nano-ceramic coating material on the outer wall of the ablation needle and a smooth conductive coating material at the tip of the needle, the stability of the ablation needle during the operation is improved. The main points are as follows: 1. A bendable radiofrequency electrode needle made of shape memory alloy, which can realize the regulation and turning of the angle during the operation of the radiofrequency ablation needle; 2. A push-pull type electrode needle working end length adjustable system, the radiofrequency ablation needle is equipped with a push-pull type turning electrode length adjustable system, and a synchronous gradual adjustment within a certain range of angles is realized with the change of the length of the shape memory alloy material electrode needle extending out of the coaxial sheath; 3. The application of nano-ceramic coating materials that can improve the ablation adhesion characteristics of the electrode needle, a new type of conductive nano-coating material is coated on the outer wall and the tip of the radiofrequency ablation electrode needle, which can avoid the adhesion of proteins, tissues, etc. at the tip of the needle and reduce the carbonization problem. Based on the above structure, the shape memory alloy material electrode needle, and the application of titanium suboxide coating in the new radiofrequency ablation needle, the radiofrequency ablation electrode needle has an angle-steerable regulation function; the push-pull type electrode length adjustment structure at the handle part of the radiofrequency ablation electrode needle can realize a synchronous gradual adjustment of the angle within a certain range; at the same time, conductive nano-coating materials are prepared on the tip and the wall of the radiofrequency ablation electrode needle, reducing the adhesion and tissue carbonization problems during ablation. The bendable radiofrequency ablation needle system of the present utility model can realize the regulation of the direction and the working end length of the ablation electrode needle, as well as the conductive ceramic coating at the tip of the needle, through the regulation of its external control system, realizing a safer, more effective, and more stable surgical ablation treatment method. The new radiofrequency ablation needle system can be applied to the Liwen procedure for treating the ventricular septum classification of complex hypertrophic cardiomyopathy, and can improve the safety, effectiveness, and ease of operation during the Liwen procedure.

[0055] The following are specific embodiments of the present utility model. It should be noted that the present utility model is not limited to the following specific embodiments, and all equivalent transformations made on the basis of the technical solutions of this application fall within the protection scope of the present utility model.

[0056] Embodiment:

[0057] This embodiment provides a direction-adjustable bendable radiofrequency ablation electrode needle, and its overall structure is as Figure 1 、 Figure 3 、 Figure 4 and Figure 5As shown in the figure, it includes an ablation needle handle 1, a coaxial outer sheath 2, a steering electrode needle 3, an electrode wire 4, an outflow tube 5, an inflow tube 6, and a negative electrode patch 7.

[0058] The front end of the ablation needle handle 1 is installed with a coaxial outer sheath 2 through a coaxial sheath joint 21, and the inner cavity of the ablation needle handle 1 is communicated with the central channel of the coaxial outer sheath 2; the steering electrode needle 3 is an electrode needle prefabricated with shape memory alloy and its front end can deflect. The steering electrode needle 3 is arranged in the inner cavity of the ablation needle handle 1 and the coaxial outer sheath 2. By adjusting the axial expansion and contraction of the steering electrode needle 3 through the electrode length adjustment push-pull button 11 on the ablation needle handle 1, the steering angle and length of the front end of the steering electrode needle 3 after extending out of the coaxial outer sheath 2 can be synchronously regulated. The steering angle adjustment range is 0 - 180°, and the steering angle is the angle between the tip of the steering electrode needle 3 and the central axis of the steering electrode needle 3 body.

[0059] The rear part of the steering electrode needle 3 is provided with an electrode needle welding point 31 and is connected to the electrode wire 4. The electrode wire 4 is led out of the ablation needle handle 1 and connected to the electrode host through an electrode host connection head 41.

[0060] A water tank 12 is also arranged in the inner cavity of the ablation needle handle 1. The front port of the water tank 12 is connected to the rear end of the steering electrode needle 3. The water tank 12 is respectively communicated with an outflow hose 13 and an inflow hose 14. After the outflow hose 13 and the inflow hose 14 extend out of the ablation needle handle 1, they are respectively connected to the outflow tube 5 and the inflow tube 6.

[0061] The negative electrode patch connection head 73 of the negative electrode patch 7 is connected to the electrode host.

[0062] The electrode length adjustment push-pull button 11 on the ablation needle handle 1 is connected to a length adjustment moving slider 111 in the inner cavity of the ablation needle handle 1. The length adjustment moving slider 111 is connected to the steering electrode needle 3. By pushing and pulling the electrode length adjustment push-pull button 11, the axial expansion and contraction of the steering electrode needle 3 can be adjusted.

[0063] The outflow hose 13 is connected to the outflow tube 5 through a Luer connector I131 connected thereto; the inflow hose 14 is connected to the inflow tube 6 through a Luer connector II141 connected thereto.

[0064] One end of the inflow tube 6 is connected to the inflow hose 14, and the other end is provided with an inflow needle port 61; an inflow direction indicator 62 is arranged on the outer wall of the inflow tube 6.

[0065] One end of the outflow tube 5 is connected to the outflow hose 13, and the other end is an outflow port 51.

[0066] The negative electrode patch 7 includes a negative electrode patch 71, a negative electrode patch wire clip 72, and a negative electrode patch connection head 73 connected in sequence.

[0067] A positioning etching line 22 is arranged on the coaxial outer sheath 2.

[0068] The inner wall of the ablation needle handle 1 cavity is provided with a sliding card slot 112 and a positioning card slot 113; the sliding card slot 112 is matched with the electrode length adjustment push-pull button 11 to enable the electrode length adjustment push-pull button 11 to move along the axial direction of the steering electrode needle 3; the positioning card slot 113 can limit and position different positions of the length adjustment moving slider 111.

[0069] The steerable radiofrequency ablation electrode needle can achieve the control of the direction and length of the ablation electrode needle through the operation of the axial push-pull button of the handle part, realizing more accurate and safe surgical treatment.

[0070] Figure 5 It is a schematic diagram of the adjustable-length radiofrequency ablation electrode needle when it is 0°. The steering electrode needle of the present invention can be adjusted between 0° and 180°. The most commonly used is the straight line with adjustable length. For the ablation of the ventricular septum in patients with hypertrophic cardiomyopathy, the conventional straight needle ablation can immediately meet the ablation requirements without the need for angle adjustment. By using the straight line adjustable length of the present invention, the defects of the fixed-length ablation needle can be avoided. If the selected radiofrequency needle length is too short, multiple ablations need to be superimposed, prolonging the operation time and increasing complications; if the selected radiofrequency needle length is too long, the ablation range may be too large and damage the conduction bundle, causing complications such as arrhythmia. Therefore, the most commonly used angle (0°) in the present invention can achieve safer and more accurate ablation treatment compared with the fixed radiofrequency needle.

[0071] The front-end deflection shape of the steering electrode needle 3 includes but is not limited to arc-shaped bends at various angles, S-shaped bends, wavy lines, semi-circular rings, hooks, and hard turns at various angles; such as Figure 6 It is a schematic diagram of the steering of the radiofrequency electrode needle at different deflection angles (a) 30° deflection angle (b) 60° deflection angle (c) 90° deflection angle. Figure 7 It is a schematic diagram of the steering of the radiofrequency electrode needle at different hard turn deflection angles (a) 30° deflection angle (b) 60° deflection angle (c) 90° deflection angle. Figure 8 They are respectively schematic diagrams of different turning needle angle forms and ablation ranges such as (a) S-shaped bend (b) wavy line (c) semi-circular ring (d) hook, etc.

[0072] The steering structure principle of the radiofrequency electrode needle: The core and utility model part of this radiofrequency ablation needle is the working electrode needle made of shape memory alloy. The shape memory alloy used in the prefabricated electrode needle of shape memory alloy is a conventional shape memory alloy. By prefabricating shape memory alloy electrode needles in different angle ranges (0°, 30°, 60°, 90°, 180°), such as Figure 5 , Figure 6 , Figure 7 and Figure 8As shown, a shape memory alloy that can be prefabricated at any angle within the adjustable range of 0-180° is used for steering to prepare a coaxial sheath tube for supporting the use of a radiofrequency electrode needle. During operation, the electrode needle with the prefabricated steering angle is inserted along the coaxial sheath. By controlling the axial push-pull knob of the electrode needle in the handle part, the electrode needle is driven to extend axially along the coaxial sheath. The part of the shape memory alloy electrode extending out of the sheath tube will continue to recover and extend out of the coaxial sheath orifice along the previously prefabricated angle, that is, the angle of the electrode needle is changed. Radiofrequency electrode needles with different steering angles are prepared based on the material characteristics of the shape memory alloy to meet the clinical ablation requirements under different complex ventricular septum classifications, meet the need for the ablation electrode needle to conveniently reach the myocardial target area that is difficult to reach under non-linear conditions, and achieve a more complete and thorough ablation treatment. The length of the turning electrode needle designed by the utility model is 30 mm. As the electrode length adjustment knob is pushed forward, the sliding card slot drives the electrode needle to extend forward along the coaxial sheath tube. When the electrode needle made of the shape memory alloy body extends out of the sheath orifice, it returns to the previously prefabricated steering angle. As the electrode needle is continuously pushed, the electrode needle extends continuously along the prefabricated angle, synchronously realizing the regulation of the angle and length. When the extension angle and length of the electrode needle both meet the requirements, the regulation knob is stopped pushing, and the sliding card slot will be stuck at the positioning card slot, and the radiofrequency host is immediately turned on to complete the ablation treatment of the electrode needle at the deflected angle. After the ablation treatment of this area is completed, the electrode length adjustment knob is pressed down and then pulled back, and the sliding card slot drives the length adjustment moving slider to move back, driving the turning electrode needle to retract into the coaxial sheath. The operator can continue to adjust the angle and length of the electrode needle according to the treatment requirements to complete the ablation treatment of the patient. According to the set deflection angle and length of the electrode needle, the angle steering adjustment of 0°-180° and the precise regulation of the electrode needle length within the range of 0-30 mm can be realized. Figure 9 For the efficacy comparison effect diagram, (a) shows the conformable ablation effect of the turning needle of the utility model on the ventricular septum of a pig heart in vitro, and (b) shows the ablation effect of a conventional radiofrequency needle.

[0073] A ceramic nano-coating 32 with electrical conductivity is coated at the tip of the steering electrode needle 3 to reduce the adhesion of the turning needle tip to proteins and tissues. The nano-conductive ceramic coating 23 material has good hardness, electrical conductivity, and non-adhesion characteristics, such as materials like titanium suboxide conductive ceramic coating; the outer wall of the coaxial outer sheath 2 and the part of the steering electrode needle 3 located inside the coaxial outer sheath 2 are coated with a ceramic coating 23 with insulation and non-adhesion characteristics, such as materials like alumina ceramic coating.

[0074] Principle of coating modification for radiofrequency ablation needles: Since the commonly used electrode needle material in the market is stainless steel, during radiofrequency ablation, proteins and tissues often adhere to the electrode tip. During the rapid increase in power, the heat accumulated at the electrode tip cannot be dissipated in time to generate carbonized tissue. The carbonized tissue wraps the electrode tip, resulting in the inability to transfer the electric current to distant tissues. At the same time, the high impedance feedback from the tip is likely to cause the mainframe system to judge complete ablation, resulting in "false dormancy". The time for the absorption of carbonized tissue in the further ablation area will increase significantly, affecting the prognosis of the patient. Therefore, as Figure 10 shown, in the present utility model, a ceramic nano-coating material with electrical conductivity is prepared at the ablation turning electrode tip to reduce the adhesion of proteins and tissues to the turning tip. This nano-conductive ceramic coating material has good hardness, electrical conductivity, and non-adhesion properties, such as materials like titanium suboxide conductive ceramic coatings; while a ceramic coating material with good insulation and non-adhesion properties is prepared on the outer wall of the coaxial sheath and the part of the radiofrequency needle wall located inside the coaxial sheath, such as materials like alumina ceramic coatings.

[0075] As Figure 11 shown, an electrode needle insulation outer sheath 33 is sleeved on the steering electrode needle 3. The position of the electrode needle insulation outer sheath 33 on the steering electrode needle 3 is adjustable. By controlling the length of the steering electrode needle 3 covered by the electrode needle insulation outer sheath 33 that extends out of the coaxial outer sheath 2, the ablation range and position of the steering electrode needle 3 can be adjusted, and the dangerous area can be protected from ablation; the working end of the steering electrode needle is equipped with an electrode needle insulation outer sheath. By controlling the length of the electrode needle insulation outer sheath of the exposed deflection electrode needle, the control of the working length of the exposed electrode needle can be realized, and thus a safer and more intelligent ablation treatment can be achieved.

[0076] Figure 12 It is a schematic diagram of the cooperation between the electrode needle insulation outer sheath and the non-linear needle insertion and conformal ablation of the steering electrode needle. (a) is a schematic diagram of the non-linear needle insertion of the electrode needle, and (b) is a schematic diagram of the non-linear conformal ablation. Adjust the electrode length adjustment push-pull knob, select the appropriate deflection angle and shape of the electrode needle according to the dangerous area 1 and the dangerous area 2 to avoid the two areas. Adjust the length of the electrode needle insulation outer sheath that extends out to ensure that the actual ablation length and range of the electrode needle are the target values. When the deflection direction and position of the electrode needle are the ablation target area, the length of the electrode needle insulation outer sheath that extends out can protect the dangerous area from ablation, and at the same time ensure that the actual ablation range is the target required target area. Start the electrode needle to complete the tissue ablation treatment in the non-linear case.

[0077] As Figure 13 shown, a three-way injection tube 24 is provided between the coaxial sheath joint 21 and the coaxial outer sheath 2. The nozzle I, nozzle II of the three-way injection tube 24 and the connecting tube between them are all coaxial. The nozzle I is coaxially connected to the coaxial sheath joint 21, the nozzle II is coaxially connected to the coaxial outer sheath 2, a knob cover is provided on the nozzle III of the three-way injection tube 24, and the nozzle III can be connected to a syringe. Figure 13(a) is a schematic diagram of the overall structure after installing the three-way injection tube 24, and (b) is a partially enlarged detailed view of the three-way injection tube 24.

[0078] Specifically, during the cardiac ablation surgery, when complications such as pericardial effusion are encountered and need to be treated, and at the same time, combined drug treatment is required during the treatment process, there is a problem of difficult myocardial drug administration. Based on the above clinical needs, the radiofrequency ablation electrode needle of the present utility model is paired with a three-way injection tube 24, specifically an injectable three-way Y-shaped sheath tube, which can achieve a safer and more convenient surgical treatment. When a complication of pericardial effusion occurs during radiofrequency ablation, the knob cover on the coaxial injectable three-way Y-shaped sheath tube can be opened. The Y-shaped sheath tube orifice is matched with a conventional pericardial effusion drainage device during the operation. Pericardial effusion can be aspirated with a syringe through the Y-shaped sheath tube orifice for emergency treatment to avoid serious complications such as cardiac tamponade. At the same time, hemostatic agents can be injected through the Y-shaped sheath tube orifice to enable the hemostatic drug to reach the bleeding site conveniently, without surgical treatments such as thoracotomy and small lateral incision, achieving rapid intraoperative hemostasis of the patient. At the same time, during radiofrequency ablation, targeted injection of hydrogel, isolation fluid, and myocardial treatment drugs can be carried out through the Y-shaped sheath tube orifice to achieve combined treatment of radiofrequency and drugs during the operation. Especially for drugs that are difficult to target to the myocardium, more convenient and effective drug delivery treatment can be achieved. Further, for patients with end-stage heart failure due to hypertrophic cardiomyopathy, hydrogel drugs can be injected through the three-way Y-shaped sheath tube orifice of the coaxial sheath to achieve a more comprehensive and effective treatment. The utility model has great clinical application prospects in the process of myocardial drug administration treatment, and at the same time shows convenient and effective curative effects in dealing with intraoperative complications.

[0079] The adjustable-bend radiofrequency ablation electrode needle of the present utility model breaks through the ablation limitation that the conventional radiofrequency ablation needle cannot be steered, realizes ablation treatment under straight and non-straight needle insertion paths, and can be used for the minimally invasive ablation treatment of the ventricular septum of hypertrophic cardiomyopathy, cardiac tumors, the liver, the kidneys, the thyroid gland, vascular plaques, the lungs, the breasts, and uterine fibroids, realizing turnable ablation treatment under non-straight needle insertion paths.

[0080] For the application of the direction-adjustable radiofrequency ablation electrode needle of the present utility model in the minimally invasive treatment of myocardial tissue, the following is the conformal ablation of various different complex hypertrophic types of ventricular septum using the radiofrequency ablation electrode needle of the present utility model:

[0081] Based on the characteristics of the complex and diverse types of the ventricular septum of hypertrophic cardiomyopathy during real-time radiofrequency ablation treatment under ultrasonic guidance, the present utility model uses an electrode ablation needle with a prefabricated deflection angle and shape made of shape memory alloy. According to the preoperative multimodal imaging examination images of the patient, such as imaging images such as echocardiogram (TTE), cardiac magnetic resonance (CMR), cardiac CT, etc. and the cardiac 3D printing model, radiofrequency electrode tips with different deflection angles and morphologies are used to achieve conformal ablation treatment; Figure 14It is a schematic diagram of conformal ablation treatment for the ventricular septum of hypertrophic cardiomyopathy. The common classification types shown in the figure are (a) asymmetric hypertrophy, (b) middle hypertrophy, (c) sigmoid hypertrophy, and (d) apical hypertrophy. According to the ventricular septum classification and ablation range plan, the most suitable deflection angles and shapes of the radiofrequency electrode tips of four types of shape memory alloys are respectively formulated to achieve the optimal conformal ablation treatment for different patients.

[0082] For the adjustable radiofrequency ablation needle of the present utility model to complete the ablation treatment of sigmoid hypertrophic cardiomyopathy with complex classification, the operation steps and ablation effects under different curvature conditions are given in this embodiment:

[0083] Case 1, Angle requirement: Turn 30°, Length requirement: 20 mm. The direction and length regulation during the ablation needle operation process include the following steps:

[0084] Step 1, Under ultrasonic guidance, the steering electrode needle is punctured to the middle area of the sigmoid ventricular septum with a coaxial outer sheath. As Figure 15 , the coaxial outer sheath is paired with the ablation needle handle, and the tip of the steering electrode needle is punctured to reach the middle part of the sigmoid ventricular septum under ultrasonic guidance; specifically, before the steering electrode needle performs ablation treatment, a common puncture needle as shown in Figure 4 (d) can be used with a coaxial outer sheath for puncture under ultrasonic guidance. After reaching the position, the common puncture needle is taken out, and then the steering electrode needle is inserted and the ablation needle handle is installed to puncture the steering electrode needle to the middle area of the sigmoid ventricular septum;

[0085] Step 2, Adjust the electrode length adjustment push-pull button. When the angle and length of the steering electrode needle extending out of the coaxial outer sheath both meet the requirements, ablation treatment can be carried out. As Figure 16 , by controlling the electrode length adjustment push-pull button, the steering electrode needle is driven to move coaxially along the coaxial outer sheath. The part of the shape memory alloy steering electrode needle extending out of the coaxial outer sheath will continue to recover and extend out of the coaxial outer sheath mouth along the previously prefabricated angle. When the angle of the extended electrode needle is 30° and the electrode length is 20 mm, stop pushing the electrode length adjustment push-pull button, and then the radiofrequency ablation main machine can be started for ablation treatment;

[0086] Step 3, After ablation is completed, retract the steering electrode needle, and move the position of the coaxial outer sheath to repeat and stack to complete the treatment of all myocardial regions to be ablated. As Figure 17 , after the previous needle is completely ablated, by pulling back the electrode length adjustment push-pull button, the steering electrode needle is driven to contract into the coaxial outer sheath. Move the coaxial outer sheath to the next ablation area, repeat Step 2 to adjust the angle and length of the steering electrode needle, stack the ablation areas, and complete the ablation treatment of all myocardial regions to be ablated.

[0087] Case 2, Angle requirement: 45° deflection, Length requirement: 30 mm extension. During the ablation needle operation, the direction and length are adjusted. The ablation process includes the following steps:

[0088] Step 1 is the same as the 30° deflection operation in the above Scheme 1;

[0089] Step 2, Adjust the electrode length adjustment push-pull knob. When the angle and length of the steering electrode needle extending out of the coaxial outer sheath meet the requirements, ablation treatment can be carried out. By controlling the electrode length adjustment push-pull knob, the steering electrode needle is driven to move coaxially along the coaxial outer sheath. The part of the shape memory alloy steering electrode needle extending out of the coaxial outer sheath will continue to recover and extend out of the coaxial outer sheath opening along the previously preformed angle, as Figure 18 , when the angle of the extended electrode needle is 45° and the electrode length is 30 mm, stop pushing the electrode length adjustment push-pull knob, and then the radiofrequency ablation host can be started for ablation treatment;

[0090] Step 3 is the same as the 30° deflection operation in the above Scheme 1.

[0091] The preferred embodiments of the present invention have been described in detail above with reference to the accompanying drawings. However, the present invention is not limited to the specific details in the above embodiments. Within the scope of the technical concept of the present invention, various simple modifications can be made to the technical solutions of the present invention, and these simple modifications all fall within the protection scope of the present invention.

[0092] In addition, it should be noted that, in the above specific embodiments, the various specific technical features described can be combined in any suitable manner without conflict. To avoid unnecessary repetition, the present invention will not separately describe various possible combination methods.

[0093] In addition, any combination can be made between various different embodiments of the present invention, as long as it does not violate the idea of the present invention, and it should also be regarded as the content disclosed by the present invention.

Claims

1. A direction-adjustable curved radiofrequency ablation electrode needle, characterized in that: It comprises an ablation needle handle (1), a coaxial outer sheath (2), a steering electrode needle (3), an electrode wire (4), an outflow tube (5), an inflow tube (6), and a negative electrode patch (7); The front end of the ablation needle handle (1) is provided with a coaxial outer sheath (2) via a coaxial sheath joint (21), and the inner cavity of the ablation needle handle (1) is connected to the central channel of the coaxial outer sheath (2); the steering electrode needle (3) is an electrode needle prefabricated with a shape memory alloy and its front end can be deflected, the steering electrode needle (3) is arranged in the inner cavity of the ablation needle handle (1) and the coaxial outer sheath (2), and the steering electrode needle (3) can be adjusted by adjusting the axial extension and contraction of the steering electrode needle (3) by means of the electrode length adjustment push-pull button (11) on the ablation needle handle (1), so as to synchronously realize the steering angle and length control after the front end of the steering electrode needle (3) extends out of the coaxial outer sheath (2), and the steering angle adjustment range is 0-180°; The rear part of the steering electrode needle (3) is provided with an electrode needle welding point (31) and is connected to an electrode wire (4); the electrode wire (4) is led out of the ablation needle handle (1) and is connected to the electrode host through an electrode host wiring head (41); A water tank (12) is also provided in the inner cavity of the ablation needle handle (1), the front end of the water tank (12) is connected to the rear end of the steering electrode needle (3), the water tank (12) is connected to the outflow hose (13) and the inflow hose (14), respectively, and the outflow hose (13) and the inflow hose (14) are connected to the outflow tube (5) and the inflow tube (6) respectively after extending out of the ablation needle handle (1); The negative electrode patch connector (73) of the negative electrode patch (7) is connected to the electrode host.

2. The direction-adjustable curved radiofrequency ablation electrode needle according to claim 1, characterized in that: The electrode length adjustment push-pull button (11) on the ablation needle handle (1) is connected to a length adjustment movable slider (111) in the inner cavity of the ablation needle handle (1), and the length adjustment movable slider (111) is connected to the steering electrode needle (3). By pushing and pulling the electrode length adjustment push-pull button (11), the axial extension and retraction of the steering electrode needle (3) can be adjusted.

3. The direction-adjustable curved radiofrequency ablation electrode needle according to claim 1, characterized in that: The outflow hose (13) is connected to the outflow tube (5) via the connected Luer connector I (131); the inflow hose (14) is connected to the inflow tube (6) via the connected Luer connector II (141).

4. The direction-adjustable curved radiofrequency ablation electrode needle according to claim 1, characterized in that: One end of the inflow pipe (6) is connected to the inflow hose (14), and the other end is provided with an inflow needle port (61); an inflow direction indicator (62) is provided on the outer wall of the inflow pipe (6).

5. The direction-adjustable curved radiofrequency ablation electrode needle according to claim 1, characterized in that: One end of the outflow pipe (5) is connected to the outflow hose (13), and the other end is an outflow outlet (51).

6. The direction-adjustable curved radiofrequency ablation electrode needle according to claim 1, characterized in that: The negative electrode patch (7) comprises a negative electrode patch (71), a negative electrode patch clamp (72) and a negative electrode patch connector (73) which are connected in sequence.

7. The direction-adjustable curved radiofrequency ablation electrode needle according to claim 1, characterized in that: The coaxial outer sheath (2) is provided with a positioning etching line (22).

8. The direction-adjustable curved radiofrequency ablation electrode needle according to claim 2, characterized in that: The inner wall of the inner cavity of the ablation needle handle (1) is provided with a sliding slot (112) and a positioning slot (113); the sliding slot (112) matches the electrode length adjustment push-pull button (11) so that the electrode length adjustment push-pull button (11) moves axially along the steering electrode needle (3); the positioning slot (113) can limit and position different positions of the length adjustment movable slider (111).

9. The direction-adjustable curved radiofrequency ablation electrode needle according to claim 1, characterized in that: The deflection shape of the front end of the steering electrode needle (3) includes, but is not limited to, arc-shaped bends at various angles, S-shaped bends, wavy lines, semicircular rings, hooks, and hard folds at various angles.

10. The direction-adjustable curved radiofrequency ablation electrode needle according to claim 1, characterized in that: The tip of the steering electrode needle (3) is coated with a ceramic nano-coating (32) having conductive properties; the outer wall of the coaxial outer sheath (2) and the portion of the steering electrode needle (3) located inside the coaxial outer sheath (2) are coated with a ceramic coating (23) having insulating and non-adhesive properties.

11. The direction-adjustable curved radiofrequency ablation electrode needle according to claim 1, characterized in that: The steering electrode needle (3) is covered with an electrode needle insulating outer sheath (33), and the position of the electrode needle insulating outer sheath (33) on the steering electrode needle (3) is adjustable. By controlling the length of the steering electrode needle (3) that the electrode needle insulating outer sheath (33) covers and extends out of the coaxial outer sheath (2), the ablation range and position of the steering electrode needle (3) can be adjusted, and the dangerous area can be protected from ablation.

12. The direction-adjustable curved radiofrequency ablation electrode needle according to claim 1, characterized in that: A three-way injection tube (24) is provided between the coaxial sheath joint (21) and the coaxial outer sheath (2); a tube opening I and a tube opening II of the three-way injection tube (24) and a connecting tube therebetween are all coaxial; the tube opening I is coaxially connected to the coaxial sheath joint (21); the tube opening II is coaxially connected to the coaxial outer sheath (2); and a knob cover is provided on the tube opening III of the three-way injection tube (24).

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