Ablation guide structure and ablation device

Abstract

The invention relates to an ablation guide structure and an ablation device, and the ablation guide structure comprises a spiral extension part which is used as a treatment part, is made of a deformable material, and is movably inserted into a blood vessel during use; the electric conductors are distributed along the spiral extension part at intervals, are combined with the spiral extension part and are electrically connected with a power supply for ablation treatment. Due to the arrangement of the spiral catheter / guide wire far-end structure and the multiple electrodes, the action range of ablation treatment is greatly widened; compared with an existing mainstream micro catheter (with a linear type and a single electrode mostly), the spiral far-section structure can be matched with multiple electrodes at different positions to cooperate to form an ellipsoidal damage range during ablation, the ablation range is greatly widened, and effective damage can be caused to target myocardial cells; the spiral guide wire structure is suitable for blood vessels which are narrower and have more complex passages, and the surgical range is greatly widened.

Description

Technical Field

[0001] This invention relates to the field of cardiac surgery, and more specifically, to a transcoronary artery approach for ventricular septal pulse ablation. Background Technology

[0002] Obstructive hypertrophic cardiomyopathy (HOCM) is a type of cardiomyopathy characterized by abnormal thickening of the ventricular walls, particularly asymmetrical thickening of the interventricular septum, which often leads to left ventricular outflow tract (LVOT) obstruction. When drug therapy is ineffective or patients experience severe symptoms, surgical treatment becomes a key approach to improve symptoms and prognosis. Current mainstream surgical methods aim to relieve LVOT obstruction, reduce the pressure gradient in the outflow tract, and thus restore normal hemodynamics.

[0003] Currently, the main surgical treatments for HOCM are as follows:

[0004] 1. Septal myectomy:

[0005] This is currently the "gold standard" procedure for treating HOCM, especially suitable for patients with other co-existing cardiac structural problems requiring surgical intervention (such as mitral valve disease) or those unsuitable for alcohol ablation. The surgery is typically performed under general anesthesia and cardiopulmonary bypass. The surgeon enters the heart through a median sternal incision or a minimally invasive incision, accessing the left ventricle via the aortic valve orifice. Under direct vision, one or more pieces of obstructing interventricular septum myocardial tissue are precisely removed, thereby widening the left ventricular outflow tract. Secondary mitral valve leaflet and chordae tendineae abnormalities (such as papillary muscle abnormalities) caused by the obstruction are often addressed concurrently during the procedure. This surgery is highly effective and long-lasting, directly and thoroughly relieving mechanical obstruction, with a significant reduction in postoperative pressure gradient. More than 90% of patients experience long-term and significant relief of symptoms such as angina, syncope, and dyspnea postoperatively. It can also repair mitral valve or other structural abnormalities simultaneously. However, ventricular septal myocardiectomy, as an open-chest surgery, is highly invasive and carries risks associated with cardiopulmonary bypass and the surgery itself, such as bleeding, infection, arrhythmias, and conduction block (which may require permanent pacemaker implantation). Postoperative myocardial damage leading to decreased cardiac function is relatively common. Therefore, it is often performed in clinical centers with extensive experience.

[0006] 2. Percutaneous Transluminal Septal Myocardial Ablation (PTSMA):

[0007] This is an interventional treatment technique that uses catheter technology to induce controlled necrosis of the target myocardium, causing it to thin and retract, thereby relieving obstruction. Under local anesthesia, the doctor inserts a catheter into the heart via the femoral artery. First, coronary angiography is used to identify the septal branch supplying the hypertrophied interventricular septum. Then, the catheter is superselectively placed into the target septal branch, and a certain amount of anhydrous alcohol is injected to cause chemical infarction of the myocardium in that area, causing it to shrink and thin in subsequent processes. This procedure does not require open-chest surgery or cardiopulmonary bypass, is minimally invasive, and allows for rapid patient recovery, making it suitable for high-risk patients. It is a good alternative for older patients with multiple comorbidities who cannot tolerate open-chest surgery. However, percutaneous septal alcohol ablation carries a significant risk of conduction block: there is a 10-20% chance of requiring a permanent pacemaker post-operatively. The effectiveness is uncertain: the completeness of obstruction relief may not be as good as surgical resection, and some patients may experience re-infarction due to the establishment of collateral circulation. The long-term effects of artificially induced myocardial infarction are still under investigation.

[0008] 3. Other surgical procedures:

[0009] Liwen's procedure: transapical septal ablation under echocardiographic guidance, which is technically challenging, highly dependent on echocardiographic guidance, and carries a significant risk of myocardial resection.

[0010] Mitral valve replacement: In the past, this procedure was sometimes used for patients with severe mitral regurgitation. Removing the original mitral valve can eliminate its "Venturi effect" in forward blood flow, thereby relieving obstruction. However, it is currently believed that simple septal myocardectomy with preservation of the mitral valve (and repair if necessary) is a better option.

[0011] Pacemaker therapy: For a very small number of patients who are not suitable for the above two treatments, especially elderly patients, dual-chamber pacing (DDD) may reduce the outflow tract pressure gradient to some extent by changing the ventricular activation sequence, but the effect is usually limited and uncertain, and it is now rarely used as the first-line treatment option. Summary of the Invention

[0012] Given that existing surgical techniques cannot effectively treat ventricular septal hypertrophy minimally invasively, this paper proposes a minimally invasive and effective ventricular septal reduction scheme based on coronary intervention technology and via the radial artery approach. This scheme uses microcatheter / guidewire devices to intervene in the body and uses pulsed energy to selectively ablate myocardial cells to achieve the purpose of ventricular septal reduction, thus overcoming the shortcomings of existing technologies.

[0013] The object of this invention is achieved as follows: an ablation-guided structure comprising:

[0014] As a treatment component, the spiral extension is made of a deformable material and is movable and inserted into the blood vessel during use;

[0015] A plurality of conductors are spaced apart along a spiral extension, the conductors being combined with the spiral extension and electrically connected to a power source for ablation treatment.

[0016] Furthermore, it also includes a straight extension connected to the spiral extension, wherein the spiral extension is a distal portion and the straight extension is a proximal portion.

[0017] Furthermore, the straight extension is connected to a developing material.

[0018] Furthermore, the spiral extension and the straight extension are respectively configured as a distal tube body and a proximal tube body, and the distal tube body and the proximal tube body are combined into a microcatheter assembly, with several electrodes installed on the distal tube body.

[0019] Furthermore, both the spiral extension and the straight extension are configured as guide wire structures made of shape memory alloy material. The spiral extension is straight in shape on the conveying path, and the spiral extension deforms into a preset spiral shape after contact with human body temperature or when energized.

[0020] Furthermore, it also includes a number of metal braided wires for enhancing the structural strength of the tube body, the metal braided wires being arranged as follows:

[0021] The metal braided wires are embedded in both the distal and proximal sections of the tube;

[0022] Alternatively, the metal braided wires are embedded in the near section of the tube.

[0023] Furthermore, both the distal and proximal sections of the tube are dual-lumen tubes, with one lumen used to pass through the guide wire and the other lumen used to pass through the conductive wire.

[0024] Furthermore, the spiral extension is composed of a central metal wire and a conductive winding body, wherein the conductive winding body winds around and wraps the central metal wire; it also includes a plurality of protruding exposed electrodes distributed along the length direction of the spiral extension, wherein the exposed electrodes are set as independent components or as part of the conductive winding body.

[0025] Furthermore, the conductor includes an exposed electrode portion, which is equipped with a piezoelectric vibration portion. The exposed electrode portion is positioned relatively outside the piezoelectric vibration portion. The exposed electrode portion is electrically connected to the real-time monitoring system. When the exposed electrode portion adheres abnormally to the wall or the tissue it is attached to is abnormal, the impedance of the exposed electrode portion becomes abnormal, triggering the piezoelectric vibration portion to generate a certain amplitude of vibration, causing the exposed electrode portion to detach rapidly.

[0026] As another aspect of the present invention, an ablation device is proposed, comprising a catheter body, a base, and a pulse generator. The aforementioned ablation guide structure is inserted into the catheter body, the catheter body is connected to the base, and the conductive wire of the energy output end of the pulse generator passes through the base and forms an electrical connection with the conductor.

[0027] The beneficial effects of this invention are as follows:

[0028] The spiral-shaped distal structure of the catheter / guidewire and the multi-electrode setup greatly improve the range of action of ablation therapy;

[0029] Among them, compared with the existing mainstream microcatheters (mostly linear and single-electrode), the spiral distal structure can work with multiple electrodes at different locations to form an ellipsoidal damage area during ablation, greatly increasing the ablation range and effectively damaging the target myocardial cells.

[0030] The spiral guidewire structure is suitable for narrower blood vessels with more complex access, greatly expanding the scope of surgical procedures. Attached Figure Description

[0031] Figure 1 This is a schematic diagram of the spiral pulse ablation microcatheter structure in Embodiment 1 of the present invention.

[0032] Figure 2 This is a cross-sectional view of the tube body in configuration A.

[0033] Figure 3 This is a cross-sectional view of the B-configuration tube.

[0034] Figure 4 This is a cross-sectional view of the C-configuration tube.

[0035] Figure 5 This is a cross-sectional view of the D-configuration tube.

[0036] Figure 6 This is a schematic diagram of an ablation device based on a microcatheter design.

[0037] Figure 7 This is a schematic diagram of the spiral pulse ablation microwire structure in Embodiment 2 of the present invention.

[0038] Figure 8 This is a schematic diagram of an ablation device based on a guidewire approach.

[0039] Figure 9 This is a schematic diagram of Embodiment 3 of the present invention.

[0040] Figure 10 This is a schematic diagram of Embodiment 4 of the present invention.

[0041] Figure 11 This is a schematic diagram of Embodiment 5 of the present invention.

[0042] Figure 12 This is a schematic diagram of Embodiment Six of the present invention.

[0043] Explanation of reference numerals in the attached figures:

[0044] 101 - Distal tube body, 102 - Distal end, 103 - Ring electrode, 104 - Development ring, 105 - Proximal tube body, 106 - Metal braided wire, 107 - Lead wire;

[0045] 201-Distal guide wire section, 202-Head electrode, 203-Exposed electrode, 204-Developing element, 205-Center metal wire, 206-Conductive winding body;

[0046] 301-Pulse generator, 302-Catheter body, 303-Guidewire inlet, 304-Base, 305-First inlet, 306-Second inlet, 307-Tail wire;

[0047] 901 - Exposed ring electrode; 902 - Piezoelectric vibrator; 903 - Conductive shielding coating; 9101 - Exposed electrode conductor; 9102 - Ring electrode; 9103 - Electrode body wire; 9201 - Conduit body; 9202 - Piezoelectric vibrator electrode wire; 9203 - Piezoelectric vibrator electrode; 9204 - Piezoelectric material layer; 9205 - Vibrator insulation layer; 9206 - Functional layer (piezoelectric vibrator / guide wire insulation layer); 9207 - Guide wire core; 9208 - Thermistor. Detailed Implementation

[0048] The following will refer to the appendices in the embodiments of the present invention. Figure 1-12 The technical solutions in the embodiments of the present invention are clearly and completely described herein. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0049] The device is divided into two parts: a pulse generator 301 (active device) and a passive consumable for the distal microcatheter / guidewire. To improve the range of pulse ablation, the distal portion used for treatment is designed as a helical extension made of deformable material, which is inserted into the blood vessel during use. Additionally, the device has several conductors spaced along the helical extension, which are connected to the helical extension and electrically connected to a power source for ablation treatment. The entire ablation guidance structure also includes a linear extension connected to the helical extension; the helical extension is the distal portion, and the linear extension is the proximal portion. A contrast-enhancing material is attached to the linear extension for positioning.

[0050] In response to the aforementioned guiding structure, an ablation device is also proposed. The device includes a catheter body 302, a base 304, and a pulse generator 301. The ablation guiding structure is inserted into the catheter body 302, and the catheter body 302 is connected to the base 304. The conductive wire at the energy output end of the pulse generator 301 passes through the base 304 and forms an electrical connection with the conductor.

[0051] The pulse generator 301 can adopt the same host structure as the current mainstream atrial fibrillation pulse ablation structure. Its typical clinical pulse energy value is in the range of 1500-2000V. Combined with specific pulse width (μs) and pulse number, it ensures that an electric field strength (>500V / cm) sufficient to achieve irreversible electroporation is generated in the myocardial tissue, while avoiding damage to vascular tissue, thereby achieving the purpose of precise, efficient and safe myocardial cell ablation.

[0052] Depending on the applicable scenario, two solutions were adopted: microcatheter (first embodiment) and guidewire (second embodiment).

[0053] Example 1

[0054] like Figure 1-6 The proposed solution is a microcatheter design. The spiral extension and the straight extension are respectively designated as the distal and proximal sections of the catheter body. The distal and proximal sections are combined to form a single microcatheter, and several electrodes are installed on the distal section.

[0055] The tube body is made of biocompatible materials such as TPU and Pebax. The outer diameter of the tube body is less than 3F, and the (total) inner diameter is at least 0.3mm, which is the typical size of a microcatheter.

[0056] like Figure 2 As shown, when both the distal tube body 101 and the proximal tube body 105 adopt the A-configuration braided tube body, a mesh braid or coil structure is formed by single or multiple layers of stainless steel or high-tension metal braided wires 106. The metal braided wires are embedded in both the distal tube body 101 and the proximal tube body 105 to provide good support for the entire tube. The wire 107 is embedded in the intermediate layer, and the braided layer protects the wire 107 from tangling, twisting, and bending during the microcatheter push.

[0057] The inner bore of the tube has two functions: it can be used as a guide wire channel to facilitate the insertion of the guide wire, and the bore wall is coated with a lubricating layer (such as PTFE) to reduce the resistance of the guide wire pushing; it can also be used as a channel for the infusion of contrast agents or for flushing.

[0058] If the distal portion of the catheter 101 needs to enter more complex vascular access or require further reduction in outer diameter, the catheter can be replaced with a B configuration (e.g., ...). Figure 3As shown in the figure, the metal braided wire 106 is removed to improve the flexibility of the tube body, while forming a gradual change in hardness with the proximal tube body 105, so that the microcatheter as a whole has good support and tracking performance.

[0059] To reduce the difficulty of microcatheter fabrication, the catheter body can be designed with a dual-lumen structure, and the following structural forms can be adopted:

[0060] Overall C configuration (such as) Figure 4 As shown), it may contain 106 metal braided wires;

[0061] The proximal tube 105 adopts a C-shaped configuration (containing metal braided wire 106), which has good support performance. The distal tube 101 adopts a D-shaped double-lumen tube, which has better flexibility, so as to enter some more complex vascular access.

[0062] Among them, such as Figure 4 , 5 As shown, the inner wall of the large hole in the tube is coated with a lubricating layer, which serves as a guide wire channel, while the small hole in the tube is used for the placement of the wire.

[0063] As a preferred structural design, the distal tube 101 is also coated with a hydrophilic coating, which becomes smooth upon contact with water to reduce friction between the catheter and the vessel wall, thereby improving the tracking ability of the microcatheter through tortuous blood vessels. The spiral shape of the distal tube 101 is prepared by a pre-forming process of a metal wire, i.e., a spiral-shaped metal wire is inserted into the tube.

[0064] As another preferred structural option, the distal end 102 is the distal soft tip of the microcatheter, which is made of a soft, biocompatible polymer material, such as silicone or Pebax, to avoid scratching the blood vessel wall or causing dissection during the microcatheter's delivery.

[0065] The distal end 102 can also be replaced with a head electrode as a pulse emitter to participate in ablation therapy.

[0066] The setup of the conductors is as follows: multiple ring electrodes 103 are set on the distal tube body 101, the number of which can be 4-10; when the distal end 102 is a head electrode, the number of ring electrodes 103 can be odd; when the distal end 102 is a soft head, the number of ring electrodes 103 can be even. The electrodes form a circuit between each other, and a continuous ellipsoidal ablation damage area can be formed during treatment.

[0067] The proximal tube 105 is provided with one or more imaging rings 104. The imaging rings 104 are made of precious metals with good imaging properties such as platinum, iridium, and gold. They are used in conjunction with an X-ray angiography machine to locate the ablation site in the patient's body for precise ablation.

[0068] like Figure 6The diagram shows the system design of the ablation device. The distal tube 301 and proximal tube 302 constitute the main body of the microcatheter, and a Luer connector can be installed at the guidewire inlet 303. The base 304 can also be a handle or other control device for the operator to hold the instrument and control the microcatheter. The first inlet 305 is a flushing inlet, communicating with the guidewire lumen. Contrast agent can be introduced into the inlet when the guidewire inlet 303 is closed, giving the microcatheter an imaging function. It can also be injected with saline for flushing the lumen or removing air. The second inlet 306 is a cable interface, connected to a tail wire 307. The tail wire 307 is connected to the wire 107 of the distal electrode assembly (ring electrode 103) and to the pulse generator 301.

[0069] Compared to existing mainstream microcatheters (mostly linear and single-electrode), the spiral distal structure, combined with multiple electrodes at different locations, can create an ellipsoidal lesion area during ablation, significantly increasing the ablation range and effectively damaging target cardiomyocytes. Simultaneously, the aforementioned catheter structure improves space utilization efficiency, solving the problems of traditional multi-electrode catheters occupying large spaces and having limited catheter diameter due to wire allowance constraints, making them unsuitable for radial artery interventional procedures.

[0070] Example 2

[0071] like Figure 7 , 8 The diagram shows the guide wire design. Both the spiral extension and the straight extension of the guide structure are designed as guide wire structures, which are made of shape memory alloy. The spiral extension is straight in shape along the delivery path, and deforms into a preset spiral shape after contact with human body temperature or when energized.

[0072] The overall structure of the distal guidewire section 201 is as follows: Figure 7 As shown in the partial view, the structure is designed to have a conductive winding body 206 winding around and wrapping the central metal wire 205.

[0073] The central metal wire 205 is made of shape memory alloy material (such as nickel-titanium) so that the entire guide wire can present a spiral shape after being released at the target position;

[0074] Alternatively, a shape memory alloy material with electro-bending / thermal-bending properties can be used, and the critical point of deformation (corresponding to the phase transition voltage or phase transition temperature of the material) can be clearly defined so that the guidewire remains straight when moving in the guiding tube or angiography catheter, making it easier to deliver.

[0075] After the distal guidewire 201 reaches the target position and extends the catheter, it deforms into a preset helical shape upon contact with body temperature or the output current from the proximal pulse generator. The electroflexible material allows for adjustment of the helical degree (e.g., length, pitch) by regulating the current, adapting to blood vessels of varying widths. The distal guidewire 201 is externally coated with a hydrophilic coating to enhance its tracking ability.

[0076] Both the head electrode 202 and the bare electrode 203 are bare electrode bodies. The head electrode 202 can be set as a hemispherical metal sheet or other blunt surface shape, serving as the energy emission electrode for the pulse, while also providing adaptability and pushability for the guidewire, enabling it to move flexibly within complex vascular structures without puncturing blood vessels.

[0077] The scalp electrode 202 and the exposed electrode 203 can be formed from the exposed section and the area with higher winding density of the conductive winding body 206. That is, the electrode can be part of the conductive winding body 206, or the scalp electrode 202 and the exposed electrode 203 can be separate parts. Meanwhile, the exterior of the conductive winding body 206 in other non-electrode areas is insulated (e.g., coated in a straightened state, masked at the electrode area). Multiple wires are embedded within the conductive winding body 206 to power the distal electrode assembly. The number of electrodes is not limited and can be set to approximately 4 to 10 based on needs and the load of the tube. Except for the scalp electrode 202, which is the emitter, each of the other exposed electrodes 203 can be set as an emitter and / or receiver, adjusted according to the settings of the pulse generator 301. Depending on the different positive and negative electrode positions, an ellipsoidal lesion can be formed around the septal coronary artery in actual pulse ablation treatment.

[0078] The imaging element 204 is made of precious metals with good imaging properties such as platinum, iridium, and gold. It is used in conjunction with an X-ray angiography machine to locate the guidewire in the patient's body for precise ablation.

[0079] like Figure 8 As shown, the ablation device adapted to Embodiment 2 is similar to that of Embodiment 1, namely, a single-hole catheter body 302 for angiography / guidance in the proximal section, and a base snap at the tail of the catheter body 302 for connection with the guidewire, and can be connected to the pulse generator 301 by a cable.

[0080] Compared to Example 1, Example 2 addresses the problem in Example 1 where the microcatheter, due to its large size, is difficult to insert into or traverse smaller blood vessels. The pulsed ablation guidewire is much smaller and more flexible than a catheter, significantly increasing the range of surgical procedures.

[0081] In summary, the spiral-shaped distal catheter / guidewire structure and the multi-electrode configuration significantly improve the range of ablation therapy. The microcatheter structure in Example 1 optimizes the routing while maintaining the spiral shape, reducing size compared to the complex distal structure of 8-12F catheters with the same function, thus enabling feasibility of radial artery intervention and coronary artery treatment. The guidewire structure in Example 2 is suitable for narrower vessels with more complex access routes, greatly expanding the operable range at the anatomical level.

[0082] like Figure 9-12 As shown, the spiral extension can be constructed from an "exposed electrode portion + a piezoelectric vibration portion," with specific embodiments three to six. The exposed electrode portion and the piezoelectric vibration portion have several optional forms, and the forms listed in embodiments three to six are preferred embodiments. Other possible variations in form are not excluded.

[0083] The brief descriptions of Examples 3-6 are as follows: Figure 9 The structure shown in Figure A1 on the left is simple in process, effective and reliable. Figure 9 The structure shown in Figure B1 on the right can achieve precise control over the direction and shape of the pulse ablation electric field; Figure 10 The C1 / D1 configuration shows a simple structure with readily available materials. Figure 11 The collaborative solutions shown in the E1 / F1 configuration are highly efficient and intelligent. These solutions can be combined in four ways to meet the needs of many practical application scenarios.

[0084] In order to control the directionality of the pulsed electric field and make it safer to use, the exposed electrode part is combined with the piezoelectric vibration part, so that the treatment part of the device has the function of electric field direction control or wall detachment, thereby making the treatment more precise and safer.

[0085] Regarding the combination of "exposed electrode portion + piezoelectric vibration portion", the exposed electrode portion is positioned relatively outside the piezoelectric vibration portion. The exposed electrode portion is electrically connected to the real-time monitoring system. Specifically, when the exposed electrode 901 is placed against the wall of human tissue for pulsed ablation treatment, the impedance of the electrode contact is monitored in real-time by the ablation device through the electrode body wire 9103. When the real-time monitoring system detects abnormal wall adhesion (such as tilted adhesion) or abnormal tissue adhesion (incorrect target tissue or carbonization, etc.), the impedance also becomes abnormal. This triggers the piezoelectric vibration pad 902 to operate, generating a certain amplitude of mechanical vibration that causes the electrode to detach rapidly, prompting the operator to disconnect the power in time to avoid tissue adhesion. The following describes the preferred structure and the mechanism for implementing this mechanism.

[0086] Example 3

[0087] like Figure 9As shown, configurations A1 and B1 illustrate two macroscopic assembly methods, both usable in ablation catheter and ablation guidewire solutions. In configuration A1, the annular exposed electrode 901 is fitted onto an annular piezoelectric vibrating pad 902, with the catheter body or guidewire (not shown) inside the piezoelectric vibrating pad 902. When AC current is applied, the piezoelectric vibrating pad 902 vibrates slightly, causing the external annular exposed electrode 901 to vibrate, detaching it from the tissue wall from its original position close to the tissue wall. This effect is consistent across all electrode positions. Configuration B1, based on configuration A1, reduces the coverage area of ​​the piezoelectric vibrating pad 902 and covers the outer side of the annular exposed electrode 901 (excluding the piezoelectric vibrating pad 902) with a conductive shielding coating 903. This shielding layer is made of a highly insulating adhesive applied as a coating, or a flexible insulating material coating such as PI or Pyralin. During electrode discharge, this shielding layer prevents external discharge, ensuring that only the electrode area not covered by the shielding layer discharges. In practical applications, the shielding layer can cover a pre-defined inward-facing area (such as a spiral-shaped centripetal area), i.e., an area not used for wall contact, reducing adverse events such as hemolysis caused by discharge to blood or other non-target tissues. The B1 configuration only demonstrates a semi-circular shielding design, where the shielding layer occupies 180° / 360° (half a circumference). In practice, it can be modified to cover 30° / 360°, 60° / 360°, 200° / 360°, etc., to adapt to different electric field patterns or different wall contact areas.

[0088] Example 4

[0089] like Figure 10As shown, the C1 / D1 configuration is an independent configuration scheme of the axial cross-section indicated in the A1 / B1 configuration. The C1 / D1 configurations represent the structures of the ablation catheter / guidewire schemes, both applicable to the A1 and B1 configurations. In the C1 / D1 configuration, the exposed annular electrode 901 is separated from the piezoelectric vibrator body by the vibrator insulation layer 9205, and is independently powered by the electrode body wire 9103 and the piezoelectric vibrator electrode wire 9202. The vibrator insulation layer 9205 can be made of a flexible material with good insulation properties. The triggering mechanism of the piezoelectric vibrator 902 originates from the algorithm of the ablation device (not detailed here): when the electrode impedance detection of the ablation device detects an anomaly, i.e., the resistance value is higher or lower than the threshold, the electrode conductivity is cut off, triggering the piezoelectric vibrator 902 to operate, generating a certain amplitude vibration for a fixed time. Specifically, current is conducted from the wire 9202 to the piezoelectric vibrator electrode 9203, triggering the inverse piezoelectric effect in the piezoelectric material layer 9204 between the two electrodes, i.e., mechanical deformation induced by the alternating electric field. The piezoelectric vibrating electrode 9203 can be made of metals with good conductivity such as silver or copper, and the piezoelectric material 9204 can be prepared using piezoelectric materials with inverse piezoelectric effect such as lead zirconate titanate (PZT). In the embodiment, the conduit body 9201 is made of a non-conductive polymer material, but the guide wire core 9207 at the center is made of metal. Therefore, a functional layer 9206 (piezoelectric vibrating plate / guide wire insulation layer) is added to improve the insulation performance. The material used for the functional layer 9206 can be the same as that used for the vibrating plate insulation layer 9205.

[0090] The C1 / D1 configuration is a collaborative configuration scheme for the axial cross-section indicated in the A1 / B1 configuration. The E1 / F1 configurations are the structures for the ablation catheter / guidewire schemes, respectively. Both are also applicable to the A1 and B1 configurations.

[0091] Example 5

[0092] like Figure 11As shown, in the E1 / F1 configuration, the exposed annular electrode 901 is connected to the piezoelectric vibrator body via a thermistor 9208, and the wire 9103 can simultaneously supply power to the exposed electrode conductor 9101 / annular electrode 9102 and the piezoelectric vibrator 902. The triggering mechanism of the piezoelectric vibrating pad 902 originates from the device itself: the thermistor 9208 is made of a material with a negative temperature coefficient, such as a certain proportion of iron-cobalt-manganese oxide ceramic material. When the exposed ring electrode 901 is working normally, the thermal effect generated by the current in the exposed ring electrode 901 is not obvious, and the thermistor 9208 exhibits a high impedance, and the current passing through it is very small, even negligible. When the impedance is less than the normal operating range, under the premise that the voltage output at the ablation device is set to be constant, the current increases abnormally, causing the exposed ring electrode 901 to heat up violently, thereby causing the resistance value of the thermistor 9208 to decrease sharply. A current with a significant intensity passes through the thermistor 9208 and is transmitted to the piezoelectric vibrating pad electrode 9203, and finally conducted to the piezoelectric material layer 9204 to produce the inverse piezoelectric effect, generating mechanical vibration, realizing separation from the wall, until the current is cut off at the ablation device.

[0093] Example 6

[0094] like Figure 12 The diagram shows the G configuration. In cases where the ablation guide wire scheme requires the wire to be wound around the outside of the guide wire, the electrode body wire 9103 and the piezoelectric vibrating plate electrode wire 9202 are arranged in two sets of alternating wounds in opposite directions. This improves the overall strength of the guide wire and also enhances its torsional response.

[0095] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "front," and "rear," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention. In this invention, it should also be noted that the terms "installation" and "connection" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, an integrally formed connection, a mechanical connection, or an indirect connection through intermediate connecting parts. The specific meaning of the terms in this utility model can be understood according to the specific circumstances.

[0096] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered illustrative and non-limiting in all respects, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within the present invention, and no reference numerals in the claims should be construed as limiting the scope of the claims.

[0097] Furthermore, it should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This narrative style is merely for clarity. Those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. An ablation guiding structure, characterized in that, include: As a treatment component, the spiral extension is made of a deformable material and is movable and inserted into the blood vessel during use; A plurality of conductors are spaced apart along a spiral extension, the conductors being combined with the spiral extension and electrically connected to a power source for ablation treatment.

2. The ablation guiding structure according to claim 1, characterized in that, It also includes a straight extension connected to the spiral extension, wherein the spiral extension is a distal portion and the straight extension is a proximal portion.

3. The ablation guiding structure according to claim 2, characterized in that, The straight extension is connected to developing material.

4. The ablation guiding structure according to claim 2, characterized in that, The spiral extension and the straight extension are respectively designated as the distal tube body and the proximal tube body. The distal tube body and the proximal tube body are combined to form a microcatheter as a whole. Several electrodes are installed on the distal tube body.

5. The ablation guiding structure according to claim 2, characterized in that, Both the spiral extension and the straight extension are configured as guide wire structures made of shape memory alloy. The spiral extension is straight in shape on the conveying path and deforms into a preset spiral shape after contact with human body temperature or when energized.

6. The ablation guiding structure according to claim 4, characterized in that, It also includes several metal braided wires for enhancing the structural strength of the tube body, the metal braided wires being arranged as follows: The metal braided wires are embedded in both the distal and proximal sections of the tube; Alternatively, the metal braided wires are embedded in the near section of the tube.

7. The ablation guiding structure according to claim 4, characterized in that, Both the distal and proximal sections of the tube are dual-lumen tubes, with one lumen used to pass through the guide wire and the other lumen used to pass through the conductive wire.

8. The ablation guiding structure according to claim 5, characterized in that, The spiral extension is composed of a central metal wire and a conductive winding body, wherein the conductive winding body winds around and wraps the central metal wire; it also includes a number of protruding exposed electrodes distributed along the length direction of the spiral extension, wherein the exposed electrodes are set as independent components or as part of the conductive winding body.

9. An ablation guiding structure according to claim 1 or 2, characterized in that, The conductor includes an exposed electrode portion, which is equipped with a piezoelectric vibration portion. The exposed electrode portion is positioned on the outer side of the piezoelectric vibration portion. The exposed electrode portion is connected to the electrical signal of the real-time monitoring system. When the exposed electrode portion adheres abnormally to the wall or the tissue it is attached to is abnormal, the impedance of the exposed electrode portion becomes abnormal, triggering the piezoelectric vibration portion to generate a certain amplitude of vibration, causing the exposed electrode portion to detach quickly.

10. An ablation device, characterized in that, The device includes a catheter body, a base, and a pulse generator. The ablation guide structure of claim 1 is inserted into the catheter body, the catheter body is connected to the base, and the conductive wire at the energy output end of the pulse generator passes through the base and forms an electrical connection with the conductor.

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