A radio frequency ablation needle assembly and ablation system comprising a multi-functional bowtie coaxial sheath

Abstract

The utility model discloses a kind of radiofrequency ablation needle assemblies and ablation systems containing multifunctional divining rod type coaxial sheath, which ablation assembly includes multipurpose double-channel divining rod type insulating coaxial sheath and ablation needle, divining rod type insulating coaxial sheath is detachably connected with handle, and position adjusting member on handle realizes self-adaptive adjustment of ablation needle working end length, divining rod type insulating coaxial sheath synchronously realizes ablation, biopsy, pericardial effusion drainage, cardiac conduction bundle position marking, myocardial drug injection, ICD implantation and cardiac ECG monitoring and other surgical auxiliary diagnosis and treatment, to ensure that integrated intramyocardial intervention diagnosis and treatment are safely and effectively completed, the ablation needle assembly containing multipurpose divining rod type sheath in the utility model breaks through the bottleneck of low efficiency, complicated operation and many complications of existing radiofrequency ablation technology, and provides an innovative solution for comprehensive interventional treatment of heart disease and various tumor diseases.

Description

Technical Field

[0001] This utility model belongs to the field of minimally invasive interventional medical devices for the heart, and relates to a radiofrequency ablation needle assembly and ablation system containing a multifunctional T-shaped coaxial sheath. Background Technology

[0002] Ultrasound-guided percutaneous intramyocardial radiofrequency ablation (Liwen procedure) is a significant technological innovation that provides a novel interventional treatment option for cardiac diseases, particularly hypertrophic cardiomyopathy (HCM). Under ultrasound guidance, the operator percutaneously inserts a radiofrequency electrode needle through the intercostal space to reach the hypertrophic area of ​​the interventricular septum. A radiofrequency generator produces high-frequency alternating current, which is then introduced into the hypertrophic myocardial tissue of the area to be ablated through the exposed tip of the electrode. This causes the positive and negative ions within the cells to rub against each other, generating heat and raising the tissue temperature above 80°C. This high temperature leads to dehydration and coagulative necrosis of the hypertrophic myocardial cells around the electrode needle. Simultaneously, the surrounding coronary arteries are blocked, and the ablated necrotic interventricular septum is gradually absorbed and thinned, increasing the left ventricular outflow tract diameter, reducing the outflow tract pressure gradient, relieving the obstruction, and significantly improving the patient's hemodynamics. Therefore, the Liwen procedure represents a third innovative approach for cardiac diagnosis and treatment in cardiology, following surgical procedures and cardiac catheterization. It has overcome the global challenge of minimally invasive myocardial diagnosis and treatment on a beating heart. It is recognized in the industry as having advantages such as minimal trauma, short path, no need for open chest, no reliance on peripheral blood vessels, and avoidance of X-ray radiation and contrast agent damage. Multiple clinical studies have shown that it has good safety and effectiveness.

[0003] However, although radiofrequency ablation technology has been successfully applied to the ablation of organs such as the liver and thyroid, due to important reasons such as the complex anatomy of the cardiac surgical area, the large myocardial mobility, the high surgical risk, and the limited operating space, the surgery requires avoiding repeated punctures as much as possible after establishing the approach. Therefore, in addition to performing the main radiofrequency ablation function, it is also necessary to integrate highly integrated modules such as pericardial effusion management, electrocardiographic activity monitoring, targeted drug injection, and tissue biopsy sampling, and to handle unexpected situations during the operation in order to safely, effectively, and smoothly complete the Liwen procedure.

[0004] The anatomical classification of the interventricular septum in HCM patients is complex and diverse, with uneven tissue thickness. Currently, fixed radiofrequency ablation electrodes cannot meet the requirements for conformal ablation. Based on the morphological changes of the interventricular septum, HCM is divided into: (1) Normal hypertrophy: complete hypertrophy of the interventricular septum, protruding into the left ventricular outflow tract, with a base thickness of ≥15mm; (2) Sigmoid hypertrophy: hypertrophy of the base of the interventricular septum, protruding into the left ventricular outflow tract; (3) Reverse C-type hypertrophy: abnormal hypertrophy of the middle wall of the left ventricle, protruding into the left heart chamber (section); (4) Apical hypertrophy: hypertrophy of the apex of the heart limited to below the level of the left ventricular papillary muscles. Currently, radiofrequency ablation needles are primarily indicated for minimally invasive interventional ablation treatment of solid organs such as the liver and thyroid, or tumors. Ablation treatment of myocardial tissue is still in the clinical trial exploration stage. At present, the exposed working end dimensions of radiofrequency ablation needles on the market are mainly fixed lengths of 1.0, 2.0, and 3.0 cm. The effective ablation range is relatively fixed due to the fixed electrode size, which limits the treatment of different types of hemorrhage. Since the exposed size of the radiofrequency ablation needle is directly related to the tissue ablation range, if the exposed working end size is too large, it can easily lead to an excessively large ablation range, exceeding the safety boundary and damaging the cardiac conduction system and normal myocardial tissue, causing serious risks such as malignant arrhythmias. Conversely, if the exposed working end size is too small, the actual ablation range is easily too small. To complete the ablation of all tissue within the target area of ​​the ventricular septum, the position of the radiofrequency ablation needle tip needs to be adjusted multiple times, and multiple stacking operations are required to effectively complete the ablation of all tissues, leading to prolonged operation time and increased risk of surgical complications.

[0005] Secondly, the main complication of the Liwen procedure for treating hypertrophic cardiomyopathy is hemorrhagic pericardial effusion. Treatment for hemorrhagic pericardial effusion typically involves pericardial effusion drainage or a small lateral incision. The puncture sites for pericardial effusion drainage and radiofrequency ablation are very close, often causing conflicts, and the drainage procedure is cumbersome and complex, requiring close coordination among multiple medical staff. Open-chest surgery, on the other hand, requires emergency intervention by an experienced cardiac surgeon and carries high risks and a large incision.

[0006] Secondly, since the cardiac conduction system is responsible for transmitting cardiac electrical signals, damage to the cardiac conduction system can cause various types of arrhythmias. Currently, the prevention of arrhythmias during surgery is achieved by using a 12-lead electrocardiogram to monitor the patient's cardiac changes in real time. However, this method cannot proactively mitigate the risks by avoiding the locations of the conduction system in advance. Therefore, during radiofrequency ablation of the interventricular septum, the location of the conduction system is marked during the procedure to ensure that the cardiac conduction bundles are not damaged. This is to avoid thermal damage to important conduction bundles that could lead to complications such as malignant arrhythmias.

[0007] In addition, in the drug treatment of cardiomyopathy and heart failure, oral or intravenous administration of drugs is commonly used. The drugs are metabolized through the patient's systemic circulation and enter the target tissue of the myocardium. However, this method cannot achieve accumulation within the target tissue of the myocardium, limiting its clinical use. Furthermore, during cardiac surgery, when a pseudoaneurysm occurs in the ventricular septum, blood enters the surrounding tissue through the rupture, forming a localized hematoma composed only of fibrous tissue and thrombus. This hematoma is prone to rupture or progressive expansion. If it is adjacent to the ventricular septum, the continued expansion of the hematoma may lead to serious complications such as ventricular septal perforation, requiring medication to close the thrombus.

[0008] In addition, obtaining myocardial tissue samples through myocardial biopsy is crucial for pathological examination, related analysis, diagnosis, and guiding the treatment of heart diseases. Currently, routine myocardial biopsy sampling uses a technique involving the use of a myocardial biopsy forceps to retrieve endocardial myocardial tissue via peripheral blood vessels (Endomyocardial Biopsy, EMB). This requires puncturing the right internal jugular vein, equipping a myocardial biopsy forceps, and traversing the vein through the ventricular cavity and valves to grasp the myocardial tissue on the right ventricular surface. This technique has drawbacks: small sample volume can lead to errors in biopsy results; the long path increases the risk of vascular injury; and it is also susceptible to limitations imposed by valvular disease and coronary atherosclerosis. Because important conduction systems are distributed in the subendocardium, complications associated with biopsy forceps sampling include myocardial septal perforation, pericardial effusion, valvular injury, malignant arrhythmias, and atrioventricular block. The Liwen procedure (Liwen Myocardial Biopsy, LMB) involves ultrasound-guided percutaneous and transthoracic puncture of a biopsy needle to reach the myocardium for biopsy sampling. LMB myocardial biopsy offers advantages such as sufficient sample volume, flexible biopsy location, minimal trauma, and independence from blood vessels, demonstrating significant clinical value. However, because the heart is richly supplied with blood vessels and conduction systems, multiple punctures during myocardial biopsy can easily damage blood vessels, leading to pericardial effusion, or cause conduction bundle damage resulting in arrhythmias. Therefore, minimizing the number of myocardial punctures while ensuring multiple tissue samples is crucial for improving surgical safety.

[0009] Meanwhile, implantable cardioverter-defibrillators (ICDs) can prevent sudden cardiac death and are suitable for patients with poor cardiac function or a history of high risk for malignant arrhythmias, improving their long-term quality of life. ICDs also have remote monitoring capabilities, allowing for periodic data transmission to medical centers to detect abnormalities and adjust treatment plans. Furthermore, due to the high risks associated with cardiac surgery, intraoperative placement of an ICD can monitor cardiac electrical activity, providing immediate protection by delivering shocks or pacing therapy upon detecting abnormalities. ICD placement can reduce the risk of postoperative cardiac arrest and improve surgical safety. For patients at high risk of malignant arrhythmias, such as those with conduction block, atrial or ventricular fibrillation, ICD implantation can effectively prevent sudden death. However, current ICD implantation requires puncturing a blood vessel to insert the electrode lead into the heart, which can easily lead to bleeding or hematoma. Improper placement of the electrode lead may cause it to perforate the heart wall, leading to serious complications such as cardiac perforation. Implantable ICDs require the pulse generator and leads to be buried subcutaneously, posing a certain risk of infection. As a foreign body, the device may disrupt the local immune barrier, increasing the risk of bacterial colonization. Common pocket infections present with local redness, swelling, and effusion, which can progress to abscesses. Pocket infection is a serious complication after ICD surgery, potentially developing into endocarditis and threatening the patient's life. This innovatively designed α-shaped insulating coaxial sheath, following our center's original Liwen procedure, allows for percutaneous and transapical implantation of a miniature ICD into the myocardium, improving safety and ease of operation while reducing complications and the risk of surgical infection.

[0010] Furthermore, continuous intraoperative electrocardiogram (ECG) monitoring is a core measure to ensure patient safety in patients with hypertrophic cardiomyopathy. During Liwen's procedure for ablation of the interventricular septum, it is necessary to identify malignant arrhythmias in real time. Conventional ECG electrode patches suffer from signal quality interference, insufficient adhesion, and are prone to detachment due to high temperature / excessive sweating. Poor electrode adhesion and signal attenuation result in low accuracy of the test results.

[0011] Therefore, achieving precise adjustment of the exposed size of the working end of the radiofrequency ablation needle, emergency treatment of intraoperative hemorrhagic pericardial effusion, effective marking of the location of the electrocardiographic conduction system, targeted injection of myocardial drugs, efficient biopsy sampling of myocardial tissue, convenient and safe implantation of ICD, and accurate and effective monitoring of cardiac ECG, while effectively controlling the temperature of the radiofrequency ablation needle during the radiofrequency ablation process, are key to improving the safety and effectiveness of minimally invasive treatment for hypertrophic cardiomyopathy. Utility Model Content

[0012] To address the problems existing in the prior art, this utility model provides a radiofrequency ablation needle assembly and ablation system containing a multifunctional T-shaped coaxial sheath, thereby solving the technical problem that the exposed length of the working electrode of the radiofrequency ablation assembly is not adjustable in the prior art. At the same time, it solves the technical problems that the prior art cannot achieve one-stop efficient treatment of intraoperative hemorrhagic pericardial effusion, effective marking of the position of the electrocardiogram conduction system, targeted injection of myocardial drugs, efficient biopsy sampling of myocardial tissue, convenient and safe implantation of ICD, and accurate and effective monitoring of ECG.

[0013] This utility model is achieved through the following technical solution:

[0014] A radiofrequency ablation needle assembly with a multifunctional U-shaped coaxial sheath includes: a handle and an ablation needle, one end of which is fixed inside the handle and the other end extends to the outside of the handle;

[0015] The handle is provided with a position adjustment component, which includes a connecting part, a deformation part and a pressing adjustment part connected in sequence.

[0016] The handle is detachably provided with a type-1 insulating coaxial sheath; the type-1 insulating coaxial sheath includes a main sheath tube; one end of the main sheath tube is coaxially provided with an insulating sheath, and a secondary sheath interface is provided on the side wall of the main sheath tube; the outer wall of the insulating sheath is provided with an insulating layer;

[0017] In use, the free end of the main sheath is connected to the connecting part, and the insulating sheath is sleeved on the ablation needle. The A-shaped insulating coaxial sheath can move along the axial direction of the ablation needle under the drive of the position adjustment component to adjust the length of the distal end of the ablation needle extending out of the A-shaped insulating coaxial sheath.

[0018] Preferably, the free end of the main sheath is threadedly connected to the connecting part.

[0019] Preferably, the free end of the secondary sheath interface is provided with a tail cap.

[0020] Preferably, the radiofrequency ablation assembly with a multifunctional spherical sheath further includes at least one of a myocardial electrocardiogram conduction system monitoring assembly, a micro-implantable ICD assembly, and a myocardial biopsy assembly; in use, the myocardial electrocardiogram conduction system monitoring assembly or the micro-implantable ICD assembly is connected to the free end of the accessory sheath interface, and the myocardial biopsy assembly and the ablation needle are alternately inserted into the main sheath.

[0021] Preferably, the myocardial biopsy assembly includes a myocardial biopsy sampling unit and a myocardial biopsy tissue loading unit;

[0022] The myocardial biopsy sampling unit includes a biopsy needle core, and the biopsy needle core is provided with a sampling groove, the length of which along the axial direction of the biopsy needle core is 1 to 3 mm.

[0023] The myocardial biopsy tissue loading unit includes multiple independent tissue loading chambers.

[0024] Preferably, the radiofrequency ablation assembly with a multifunctional β-shaped sheath further includes a pericardial effusion drainage assembly and / or a drug injection assembly. In use, the pericardial effusion drainage assembly or the drug injection assembly is connected to the free end of the accessory sheath interface.

[0025] The insulating sheath is provided with multiple drainage holes; the distance between the drainage holes and the free end of the insulating sheath is greater than 6 cm; the outer wall of the ablation needle is provided with an insulating layer, and the insulating layer of the outer wall of the ablation needle is located in the non-working area of ​​the ablation needle.

[0026] Preferably, the outer wall of the insulating sheath is provided with an electrocardiogram (ECG) electrode patch; the ECG electrode patch includes a stacked insulating layer, a conductive thin film layer, and a pressure-sensitive adhesive layer; a plurality of myocardial ECG detection rings are provided on the outer side of the pressure-sensitive adhesive layer.

[0027] Preferably, the deformable part includes a support part and a locking part, and the locking part is provided with a locking member; the support part is slidably disposed inside the handle;

[0028] The handle has multiple slots inside, and the multiple slots are evenly spaced along the axial direction of the handle;

[0029] The snap-fit ​​component is configured to mate with the slot.

[0030] Preferably, the distance between two adjacent card slots is 0.1 to 5.0 mm.

[0031] Preferably, the support portion is provided with a position indicator and an elongated hole along the length of the handle; a scale indicator is provided on the outer wall of the handle near the elongated hole; the position indicator extends into the elongated hole.

[0032] Preferably, the handle is further provided with a cooling circulation system, and the cooling circulation system is provided with a circulating peristaltic pump; the tip of the ablation needle is provided with a thermocouple temperature measuring component.

[0033] An ablation system includes the aforementioned radiofrequency ablation assembly with a multifunctional U-shaped coaxial sheath and an energy generating device electrically connected to the ablation needle; the energy generating device is further connected to a negative electrode patch; the energy generating device is a radiofrequency generator, a microwave generator, a pulsed electric field generator, or an irreversible electroporation device.

[0034] Preferably, the power of the radio frequency generator is less than 300W.

[0035] Compared with the prior art, the present invention has the following beneficial technical effects:

[0036] This utility model discloses a radiofrequency ablation needle assembly with a multifunctional U-shaped coaxial sheath. Firstly, the assembly has a detachable U-shaped coaxial sheath on the handle, comprising a main sheath tube; one end of the main sheath tube is coaxially fitted with an insulating sheath, and a secondary sheath tube is provided on the side wall of the main sheath tube; the insulating sheath has an insulating layer on its wall. This U-shaped coaxial sheath design endows the radiofrequency ablation assembly with numerous functional features. The secondary sheath tube can serve as a connection port for pericardial effusion aspiration and hemostasis, as well as for injecting hemostatic drugs, allowing for effusion removal and hemostasis without changing instruments during the procedure. Simultaneously, the secondary sheath tube can also serve as an implantation channel for marking the position of the myocardial electrocardiographic conduction system and implanting an ICD component, ensuring... To ensure the safety and effectiveness of diagnosis and treatment of heart disease, the main sheath can also serve as an installation channel for the myocardial biopsy component. The biopsy needle is introduced through this U-shaped coaxial sheath, allowing direct sampling from the lesion area and avoiding multiple punctures. Secondly, the handle contains a position adjustment mechanism, which includes a connecting part, a deformation part, and a pressing adjustment part connected in sequence. This mechanism facilitates convenient movement of the U-shaped coaxial sheath on the ablation needle, enabling free adjustment of the working length of the ablation needle. This makes the radiofrequency ablation component suitable for various types of HCM patients, and the adjustable working length of the ablation needle effectively improves the flexibility of use, demonstrating broad clinical application prospects. This invention utilizes a multi-functional insulated coaxial sheath with a multi-functional design, solving the problem of single-function traditional instruments through channel reuse. Simultaneously, it combines sheath movement and ablation needle length adjustment using a deformation-driven mechanism of the position adjustment component, achieving precise control of electrode length. A quick-assembly interface adapts to various intraoperative needs, forming a flexible cardiac intervention platform. This invention's radiofrequency ablation component with a multi-functional insulated sheath overcomes the bottlenecks of low efficiency, cumbersome operation, and numerous complications in existing radiofrequency ablation technologies, providing an innovative solution for comprehensive interventional diagnosis and treatment of cardiac diseases.

[0037] The radiofrequency ablation needle assembly containing a multifunctional T-shaped coaxial sheath of this utility model is mainly used for minimally invasive interventional treatment of percutaneous intramyocardial septal / cardiac tumor radiofrequency ablation under ultrasound guidance. It is also suitable for clinical application of minimally invasive ablation of liver, thyroid, kidney, lung, breast, uterine fibroids, various soft tissues and vascular plaques.

[0038] Furthermore, the free end of the main sheath is threadedly connected to the connecting part. First, the threaded connection uses the friction generated by tightening to fix the main sheath and the position adjustment component, preventing the sheath from accidentally falling off or shifting due to external forces during the operation, ensuring the coaxial stability of the ablation needle and the sheath. The self-locking characteristic of the threaded structure can counteract the torque generated by rotating the ablation needle or biopsy needle during operation, preventing relative rotation between the sheath and the handle, and maintaining the overall structural stability of the instrument. Second, the threaded engagement surface forms a continuous and sealed contact, effectively isolating blood and tissue fluid from seeping into the handle, reducing the risk of short circuits or corrosion of mechanical parts. At the same time, the threaded connection is convenient, allowing the operator to quickly disassemble and replace the type-1 insulated coaxial sheath, adapting to the needs of multiple scenarios such as aspiration, biopsy, and ICD implantation, and improving surgical flexibility.

[0039] Furthermore, the free end of the accessory sheath interface is provided with a tail cap. First, through the tail cap, the surgeon can quickly switch between the aspiration device, the drug injection component, the cardiac ECG monitoring electrode, or the ICD implantation tool without interrupting the surgical procedure. The tail cap can adopt a snap-on or magnetic adsorption design, such as an ISO standard Luer connector, allowing the surgeon to complete the connection / disconnection with one hand, avoiding the risk of operation interruption or contamination.

[0040] Furthermore, the radiofrequency ablation assembly with a multifunctional T-shaped insulating sheath also includes at least one of a myocardial electrocardiogram conduction system monitoring assembly, a miniature implantable ICD assembly, and a myocardial biopsy needle assembly. In use, the myocardial electrocardiogram conduction system monitoring assembly or the miniature implantable ICD assembly is connected to the free end of the accessory sheath interface. The myocardial biopsy assembly and the ablation needle can be alternately inserted into the main sheath according to actual clinical needs. This invention breaks the functional boundaries of a single device through multi-channel reuse of the sheath, modular rapid switching, and functional synergistic control, and through a four-dimensional integrated operation closed loop of "ablation-monitoring-protection-diagnosis". It realizes an intraoperative real-time response mechanism, transforming passive treatment into active intervention, and provides a technical platform for precision medicine of heart diseases.

[0041] Furthermore, the myocardial biopsy assembly includes a myocardial biopsy sampling unit and a myocardial biopsy tissue loading unit. The myocardial biopsy sampling unit includes a biopsy needle core with a sampling groove. The sampling groove has a length of 1-3 cm along the axial direction of the biopsy needle core. The myocardial biopsy tissue loading unit includes multiple independent tissue storage chambers. Firstly, the 1-3 cm groove allows for flexible adjustment of the single sampling volume according to the actual situation and increases the amount of myocardial tissue obtained. At the same time, the elongated sampling groove maintains the integrity and directionality of myocardial fibers, improving the accuracy of pathological diagnosis. Furthermore, the synergistic use of this myocardial biopsy assembly with a type-1 insulating coaxial sheath effectively reduces the number of punctures required for multiple samplings, improving the efficiency and safety of biopsy sampling. Additionally, the myocardial biopsy tissue loading unit includes multiple independent tissue storage chambers, allowing each chamber to independently store samples from different lesion sites. Radiofrequency markers or magnetically coded tags can be pre-placed, enabling intraoperative association of sampling locations and avoiding confusion.

[0042] Furthermore, the radiofrequency ablation assembly with a multifunctional α-shaped sheath also includes a pericardial effusion drainage assembly and / or a drug injection assembly. In use, the pericardial effusion drainage assembly or drug injection assembly is connected to the free end of the accessory sheath interface. The insulating sheath has multiple drainage holes; the distance between the drainage holes and the free end of the insulating sheath is greater than 6 cm; the ablation needle wall has an insulating layer, and the insulating layer on the outer wall of the ablation needle (2) is located in the non-working area of ​​the ablation needle. First, the drainage assembly is quickly connected through the accessory sheath interface. If effusion is found during the procedure, the drainage operation can be initiated urgently, avoiding the delays caused by the traditional need to change instruments. The multiple drainage holes also effectively improve the heart... The drainage efficiency of the pericardial effusion is improved; secondly, the distance between the drainage hole and the free end of the insulating sheath is greater than 6 cm, ensuring that the drainage hole is located in the posterior part of the pericardial cavity. Furthermore, the number of drainage holes can be 3 to 5, with a diameter of 0.2 to 0.5 mm, so that even if some channels are blocked by fibrin or thrombus, effective drainage can still be maintained. Thrombin is directly injected into the pseudoaneurysm sac through the type-1 insulating sheath coaxial sheath of this invention, inducing rapid coagulation of the blood within the sac, thereby sealing the aneurysm neck and preventing continuous blood flow into the aneurysm cavity. This effectively reduces the aneurysm size, lowers the risk of rupture, and avoids further expansion of the hematoma and mechanical compression of the ventricular septum. Injecting thrombin through the type-1 insulating coaxial sheath channel can quickly and conveniently manage the risk of ventricular septal perforation caused by intraoperative pseudoaneurysms, improving the safety of the surgery. In addition, due to the design of the drainage hole and the insulation layer on the outer wall of the insulating sheath, there is a risk of leakage. Therefore, an insulation layer can also be provided on the rest of the ablation needle core except for the maximum electrode working length, which can effectively avoid the risk of leakage when using an insulating sheath with drainage holes and improve the safety of ablation.

[0043] Furthermore, the outer wall of the insulating sheath is provided with an electrocardiogram (ECG) electrode patch; the ECG electrode patch includes a stacked insulating layer, a conductive film layer, and a pressure-sensitive adhesive layer; multiple myocardial ECG detection rings are provided on the outer side of the pressure-sensitive adhesive layer. This utility model, through its multi-layer stacked structure and detection ring array, overcomes the spatial influence of traditional ECG electrode patches and ablation instruments during surgery, and also solves the technical problem of poor ECG stability caused by poor fixation stability of existing ECG electrode patches.

[0044] Furthermore, the deformable part includes a support part and a locking part, with a locking member on the locking part; the support part is slidably disposed inside the handle; the handle has multiple slots inside, which are evenly spaced along the axial direction of the handle; the locking member cooperates with the slots. The deformable part, through the sliding guidance of the support part and the mechanical locking design of the locking part and the slots, achieves precise positioning and stable control of the ablation needle and the A-type insulating coaxial sheath. First, the effective cooperation between the slots and the locking member fixes the position adjustment component, thus fixing the position of the A-type insulating coaxial sheath during the operation, i.e., fixing the position of the ablation needle during the operation. Then, the locking part, as part of the deformable part, separates the locking member from the slot through its physical deformation, further realizing the position adjustment of the A-type insulating coaxial sheath, i.e., adjusting the length of the working end of the ablation needle. This position adjustment component has a simple structure, good stability, and convenient operation, allowing the operator to operate quickly with one hand, significantly improving the flexibility of the operation and the ablation efficiency.

[0045] Furthermore, the distance between two adjacent slots is 0.1–5.0 mm, allowing for more precise adjustment of the ablation component. For thin-walled myocardium, it supports high-precision step adjustment to ensure that the ablation energy is accurately applied to the target point and avoids damage to adjacent structures. When the ablation needle is located in the center of the interventricular septum of thick hypertrophic myocardium or inside a tumor with a diameter greater than 5 cm, a rapid response adjustment with a larger step size can be designed as needed to shorten the response time and reduce the risk of complications. With a wide adjustment range of 0.1–5.0 mm, it covers the operational needs from high precision to a large range at the organ level, breaking through the mechanical limitations of the fixed length design of traditional radiofrequency needle electrodes. This setting allows for millimeter-level precision adjustment of the working end length of the ablation needle to adapt to different thicknesses of hypertrophic myocardium and avoid the limitations of over-ablation or the need for multiple superimposed ablation range coverage.

[0046] Furthermore, the support is equipped with a position indicator and an elongated hole along the length of the handle; a scale indicator is located on the outer wall of the handle, near the elongated hole; the position indicator extends into the elongated hole. First, a high-precision scale is set along the outer wall of the handle. The surgeon can directly read the length of the ablation needle extension or the distance the sheath moves by observing the displacement of the position indicator within the elongated hole. The surgeon can intuitively and quickly obtain the length of the working end of the ablation needle, reducing the risk of misoperation. In addition, the elongated hole exposes the movement trajectory of the position indicator, allowing the surgeon to perceive the operation progress with peripheral vision, reducing fatigue caused by frequent switching of eyes. This utility model upgrades traditional experience-based operations into a standardized process through scale quantification, dynamic feedback, and digital linkage, improving the accuracy of intraoperative operations.

[0047] Furthermore, the handle is internally equipped with a cooling circulation system. This system circulates coolant, and the radiofrequency electrode needle (electrode) generates an alternating electric field in the tissue using high-frequency alternating current, causing the anions and cations within the tissue to vibrate at high speed, generating heat through friction. If the tip temperature of the radiofrequency electrode needle becomes too high, the tissue will carbonize, forming a high-impedance eschar that hinders current conduction, resulting in a reduced ablation area. To prevent tissue carbonization, this radiofrequency ablation system employs a highly efficient internal water-cooling circulation system. This cooling reduces carbonization, maintains stable tissue impedance, allows for continuous current penetration, and improves ablation efficiency. Attached Figure Description

[0048] To more clearly illustrate the technical solutions of the embodiments of this utility model, the drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this utility model and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0049] Figure 1 This is a schematic diagram of the main structure of a radiofrequency ablation needle assembly containing a multifunctional T-shaped coaxial sheath according to the present invention.

[0050] Figure 2 This is a schematic diagram showing the internal component position of the handle when the pressing adjustment part of the radiofrequency ablation needle assembly containing a multifunctional T-shaped coaxial sheath is pressed down in this utility model.

[0051] Figure 3 This utility model Figure 2 A magnified view of a portion of region A in the middle;

[0052] Figure 4 This is a schematic diagram showing the internal component position of the handle in a radiofrequency ablation needle assembly with a multifunctional T-shaped coaxial sheath, when the adjustment part is pressed, for pushing forward or pulling back.

[0053] Figure 5 A schematic diagram showing the internal component position of the handle when the pressing adjustment part of the radiofrequency ablation needle assembly containing a multifunctional T-shaped coaxial sheath in this utility model is released;

[0054] Figure 6 In this utility model Figure 5 A magnified view of a portion of region B in the middle;

[0055] Figure 7 This is a front view of the position adjustment component in this utility model;

[0056] Figure 8 This is a side view of the position adjustment component in this utility model;

[0057] Figure 9 This is a schematic diagram of the structure of the type-1 insulating coaxial sheath in this utility model;

[0058] Figure 10 This is a schematic diagram of the structure of the myocardial electrocardiogram conduction system monitoring component in this utility model;

[0059] Figure 11 This is a schematic diagram illustrating the use of the myocardial conduction system monitoring component of this invention combined with a radiofrequency ablation component containing a multifunctional dodecagonal sheath for marking the position of the myocardial conduction bundle.

[0060] Figure 12 A schematic diagram illustrating radiofrequency ablation performed after marking the location of the myocardial conduction bundle;

[0061] Figure 13 This is a schematic diagram of the structure of the central sac fluid drainage component of this utility model;

[0062] Figure 14 This is a schematic diagram of a sudden pericardial effusion during the surgical ablation process using a radiofrequency ablation assembly with a multifunctional dovetail sheath.

[0063] Figure 15 This is a schematic diagram showing the ablation needle being pulled out of the main sheath when using the pericardial effusion drainage assembly of this utility model to treat pericardial effusion.

[0064] Figure 16 This is a schematic diagram showing the emergency suction of pericardial effusion from the drainage hole when using the pericardial effusion drainage assembly of this utility model to treat pericardial effusion;

[0065] Figure 17 This is a schematic diagram showing how to drain all the pericardial effusion using a drainage bag when treating pericardial effusion with the pericardial effusion drainage component of this utility model;

[0066] Figure 18 A schematic diagram showing the removal of the type-1 insulating coaxial sheath after all pericardial effusion has been drained;

[0067] Figure 19 A schematic diagram illustrating targeted drug delivery to myocardial tissue or other organ lesions using the radiofrequency ablation component of this invention;

[0068] Figure 20 This is a schematic diagram of the structure of the miniature implantable ICD component in this utility model;

[0069] Figure 21 This is a schematic diagram of introducing a miniature implantable ICD component using the α-shaped insulating coaxial sheath of this invention, wherein (A) shows the miniature implantable ICD component being introduced into the right ventricular outflow tract; and (B) shows the miniature implantable ICD component being introduced into the apex of the right ventricle.

[0070] Figure 22 This is a schematic diagram of the myocardial biopsy assembly of the present invention, wherein (A) is a myocardial biopsy sampling unit; and (B) is a myocardial biopsy tissue loading unit.

[0071] Figure 23 This is a schematic diagram of biopsy sampling using the myocardial biopsy component of this invention combined with a type-1 insulating coaxial sheath, wherein (A) is biopsy sampling; (B) is the extracted biopsy sample; and (C) is the biopsy sample collected using the myocardial biopsy tissue storage unit.

[0072] Figure 24 This is a schematic diagram of the structure of the T-shaped insulating coaxial sheath with electrocardiogram electrode patches on the outer wall in this utility model;

[0073] Figure 25 This is a schematic diagram of the structure of the central electrograph electrode patch of this utility model;

[0074] Figure 26 This is a schematic diagram of a radiofrequency ablation assembly with electrocardiogram electrode patches on its outer wall for monitoring myocardial electrophysiological activity.

[0075] Figure 27 This is a schematic diagram of an embodiment of the present invention in which an ablation needle is inserted into the area of ​​myocardium to be ablated in the ventricular septum under ultrasound guidance;

[0076] Figure 28 This is a schematic diagram illustrating the adjustment of the working end length of the ablation needle in one embodiment of this utility model;

[0077] Figure 29 This is a schematic diagram illustrating the operation of adjusting the length of the working end of the ablation needle in one embodiment of this utility model.

[0078] The components include: 1. Handle; 11. Slot; 12. Elongated hole; 2. Ablation needle; 3. Type-B insulating coaxial sheath; 31. Main sheath tube; 32. Insulating sheath; 33. Secondary sheath interface; 34. Tail cap; 35. Drainage hole; 36. ECG electrode patch; 361. Insulating layer; 362. Conductive thin film layer; 363. Pressure-sensitive adhesive layer; 364. Myocardial ECG detection ring; 4. Position adjustment component; 41. Connecting part; 42. Deformation part; 43. Press adjustment part; 44. Support part; 45. Engaging part; 46. Snap-fit ​​component; 47. Position indicator; 5. 51. Cardiac ECG Conduction System Monitoring Component; 52. Cardiac ECG Monitoring Probe Component; 6. Cardiac ECG Conduction System Main Unit; 6. Pericardial Effusion Drainage Component; 61. Drainage Device; 62. Drainage Bag; 63. Pericardial Effusion; 64. Drug Injection Component; 7. Miniature Implantable ICD Component; 8. Myocardial Biopsy Component; 81. Myocardial Biopsy Sampling Unit; 82. Myocardial Biopsy Tissue Loading Unit; 83. Biopsy Needle Core; 84. Sampling Inner Tank; 85. Tissue Storage Chamber; 9. Cooling Circulation System; 91. Coolant Inflow Channel; 92. Coolant Outflow Channel. Detailed Implementation

[0079] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, and not all embodiments. The components of the embodiments of this utility model described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0080] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0081] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0082] In the description of the embodiments of this utility model, it should be noted that if terms such as "upper," "lower," "horizontal," or "inner" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the utility model product is in use, they are only for the convenience of describing the utility model 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, and therefore should not be construed as a limitation on the utility model. Furthermore, terms such as "first" and "second" are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0083] Furthermore, the use of the term "horizontal" does not imply that the component must be absolutely horizontal, but rather that it can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal than "vertical," and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0084] In the description of the embodiments of this utility model, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.

[0085] The present invention will now be described in further detail with reference to the accompanying drawings:

[0086] Example 1

[0087] like Figures 1-6 As shown, this utility model discloses a radiofrequency ablation needle assembly with a multifunctional T-shaped coaxial sheath, including: a handle 1 and an ablation needle 2, one end of the ablation needle 2 is fixed inside the handle 1, and the other end extends to the outside of the handle 1; a position adjustment component 4 is provided inside the handle 1;

[0088] like Figures 7-8 As shown, the position adjustment component 4 includes a connecting part 41, a deformation part 42, and a pressing adjustment part 43 that are connected in sequence.

[0089] like Figure 1 , 9As shown, the handle 1 is detachably equipped with a type-1 insulating coaxial sheath 3; the type-1 insulating coaxial sheath 3 includes a main sheath tube 31; an insulating sheath 32 is coaxially provided at one end of the main sheath tube 31, and a secondary sheath interface 33 is provided on the side wall of the main sheath tube 31; the outer wall of the insulating sheath 32 is provided with an insulating layer; of course, an insulating layer can also be provided on the inner wall of the insulating sheath 32 to improve the insulation effect, but the process of providing an insulating layer on the inner wall of the insulating sheath 32 is more complicated. Meanwhile, the type-1 insulating coaxial sheath 3, i.e., the main sheath tube 31 and the secondary sheath interface 33, is made of frosted transparent medical plastic, which facilitates real-time observation of pericardial blood flow.

[0090] The outer wall of the ablation needle 2 described in this utility model may or may not have an insulating layer. When the outer wall of the ablation needle 2 has an insulating layer, the insulating layer is located in its non-working area so that it does not affect the ablation of the working area. When the outer wall of the ablation needle 2 does not have an insulating layer, it can be directly matched with the type-1 insulating coaxial sheath 3 in this utility model.

[0091] In use, the free end of the main sheath 31 is connected to the connecting part 41, and the insulating sheath 32 is sleeved on the ablation needle 2. The A-shaped insulating coaxial sheath 3 can move along the axial direction of the ablation needle 2 under the drive of the position adjustment member 4 to adjust the length of the distal end of the ablation needle 2 extending out of the A-shaped insulating coaxial sheath 3.

[0092] Among them, the preferred materials for the insulation layer are Teflon PTFE, Parylene, Polyurethane, PET, and Polyether ether ketone (PEEK), as well as insulating ceramic coatings prepared by PVD or CVD vapor deposition methods.

[0093] In addition, the radiofrequency ablation assembly with a multifunctional 1 / 2-shaped sheath also includes an electrode needle connecting line disposed inside the handle. The free end of the electrode needle connecting line extending to the outside of the handle is also provided with an electrode needle main unit connector. The electrode needle connecting line is also provided with a rubber ring and a fixing clip for fixing the electrode needle connecting line. At the same time, the tail of the handle is also provided with a wire wrapping tube, which makes the structure of the ablation assembly more integrated and easier to operate. The bottom of the handle is also provided with a first friction wave to improve the grip during use. In order to make it easier to adjust the position of the 1 / 2-shaped insulating coaxial sheath 3, a second friction wave is also provided on the top of the pressing adjustment part 43.

[0094] Preferably, in a specific embodiment, the free end of the main sheath 31 is threadedly connected to the connecting part 41, and the free end of the secondary sheath interface 33 is provided with a tail cap 34.

[0095] like Figures 3-8As shown, the deformable part 42 includes a support part 44 and a locking part 45, and the locking part 45 is provided with a locking member 46; the support part 44 is slidably disposed inside the handle 1; the handle 1 is provided with a plurality of slots 11, which are evenly spaced along the axial direction of the handle 1; the locking member 46 is engaged with the slots 11. The distance between two adjacent slots 11 is 0.1 to 5.0 mm.

[0096] Multiple slots 11 are provided on the top of the handle 1. The side wall of any slot 11 can be set as "n"-shaped, that is, the side wall is a flat structure. In a more preferred embodiment, in order to prevent the retaining member 46 from falling out of the slot 11 during the operation, the side wall is preferably set as "s"-shaped, that is, the size of the slot 11 outlet gradually decreases. Of course, the size of the slot 11 opening is set so that the retaining member 46 can be smoothly dislodged from the slot 11 when the surgeon applies pressure with one hand, but the retaining member 46 cannot be dislodged from the slot 11 by itself when there is no external force.

[0097] In addition, such as Figures 1-8 As shown, the support part 44 is provided with a position indicator 47, and an elongated hole 12 is provided along the length direction of the handle 1; a scale indicator 13 is provided on the outer wall of the handle 1, near the elongated hole 12; the position indicator 47 extends into the elongated hole 12.

[0098] This invention relates to a novel insulated coaxial sheath 3 paired with a radiofrequency ablation electrode needle, enabling the diagnosis and treatment of complex types of hypertrophic cardiomyopathy and tumors of various organs, as well as the management of complications. The handle of the radiofrequency ablation needle features a slotted push-pull adjustment button. The handle is connected to the insulated coaxial sheath via a Luer connector. Pressing and pulling the adjustment button moves the insulated coaxial sheath along the outer wall of the electrode needle, allowing for precise adjustment of the exposed length of the electrode needle's working end. The working end length can be precisely adjusted in intervals of 0.1 to 5.0 mm from 0 to 50 mm, enabling more precise conformal ablation treatment of irregular thickness ventricular septal lesions in hypertrophic cardiomyopathy or multiple tumors in other organs.

[0099] Example 2

[0100] In addition, such as Figure 10 As shown, the radiofrequency ablation assembly with a multifunctional α-shaped sheath also includes a myocardial electrocardiogram conduction system monitoring assembly 5. The myocardial electrocardiogram conduction system monitoring assembly 5 includes an electrocardiogram monitoring probe assembly 51 and an electrocardiogram conduction system host 52. In use, one end of the electrocardiogram monitoring probe assembly 51 is connected to the free end of the accessory sheath interface 33, and the other end is connected to the electrocardiogram conduction system host 52.

[0101] like Figures 11-12As shown, the usage process of the radiofrequency ablation component including the multifunctional 1-shaped sheath of the myocardial electrocardiogram conduction system monitoring component 5 is as follows: Under ultrasound guidance, the 1-shaped insulating coaxial sheath 3 is punctured to reach the risk target area of ​​the myocardial tissue to be ablated. The ablation needle 2 is withdrawn from the 1-shaped insulating coaxial sheath 3. The knob at the tail of the main sheath tube 31 is tightened. According to the surgical needs, the monitoring marker micro probe of the myocardial electrocardiogram conduction system monitoring component 5 can be placed from the secondary sheath interface 33 of the 1-shaped insulating coaxial sheath 3. It extends through the tip of the main sheath tube 31 and the insulating sheath 32 to reach the periphery of the myocardial conduction bundle. The position of the conduction bundle and the risk area of ​​the surrounding tissue are marked. Through the monitoring marker, the operator can control the distribution of the myocardial conduction system in the ablation area, mark the risk area of ​​the conduction bundle, and reduce the complications caused by the ablation range affecting the conduction bundle during the operation. In this embodiment, by marking the position of the conduction bundle in the myocardium during surgery, the operator can avoid the ablation risk area according to the marked conduction bundle position and rationally place the needle for ablation, which greatly improves the safety of myocardial tissue ablation treatment. In this embodiment, a myocardial electrocardiogram conduction system monitoring component is inserted into the insulated coaxial sheath 3, which can monitor the distribution of the intramyocardial conduction site in advance, optimize and avoid the risk of ablation injury and conduction bundle, and improve the safety of the operation.

[0102] Example 3

[0103] In addition, such as Figure 13 As shown, the radiofrequency ablation assembly with a multifunctional α-shaped sheath may further include a pericardial effusion drainage assembly 6, which includes a drain 61 and a drainage bag 62. In use, the drain 61 is first connected to the free end of the auxiliary sheath interface 33, and then the drainage bag 62 is connected to the free end of the auxiliary sheath interface 33.

[0104] like Figure 9 As shown, based on the drainage efficiency of pericardial effusion, the insulating sheath 32 is provided with multiple drainage holes 35; the distance between the drainage holes 35 and the free end of the insulating sheath 32 is greater than 6 cm; the outer wall of the ablation needle 2 is provided with an insulating layer. The arrangement of the drainage holes 35 facilitates the rapid implementation of the drainage process. The multiple drainage holes 35 are asymmetrically and scattered near the handle end, ensuring that the radiofrequency electrode needle has an adjustable length function and can also be used for emergency treatment of pericardial effusion. In addition, since the insulating sheath 32 is provided with drainage holes 35, an insulating layer must be provided on the outer wall of the ablation needle 2 to avoid the risk of leakage at the drainage holes 35.

[0105] like Figure 14 As shown, if pericardial effusion 63 suddenly occurs during the surgical ablation process, the radiofrequency ablation component of the multifunctional β-shaped sheath, which includes a pericardial effusion drainage component 6, is used to drain the pericardial effusion 63. The process is as follows: Figures 15-18 As shown, specifically:

[0106] The specific procedure for treating pericardial effusion is as follows:

[0107] S1: As Figure 15 As shown, the ablation needle 2 is pulled out of the main sheath 31 and the cap at the tail of the main sheath 31 is tightened.

[0108] S2: As Figure 16 As shown, the interface of the accessory sheath 33 is connected to the drainage device 61, and pericardial effusion is urgently aspirated outward through the drainage hole 35.

[0109] S3: As Figure 17 As shown, after emergency aspiration, the interface of the accessory sheath 33 is connected to the drainage bag 62 to drain all the pericardial effusion.

[0110] S3: As Figure 18 As shown, after all pericardial effusion drainage is completed, the type-1 insulating coaxial sheath 3 is removed.

[0111] Following the above procedures, emergency drainage of pericardial effusion 63 can be achieved. Preferably, the connection port of the type-1 insulating coaxial sheath 3, i.e., the interface 33 of the secondary sheath, is made of frosted transparent plastic, allowing for observation and monitoring of hemorrhagic pericardial effusion and emergency management of pericardial drainage. In other words, this embodiment utilizes the type-1 insulating coaxial sheath to observe and monitor hemorrhagic pericardial effusion and to manage emergency pericardial drainage.

[0112] Example 4

[0113] Based on the type-1 insulating coaxial sheath 3 in this invention, the radiofrequency ablation component in this invention can also achieve targeted drug delivery to myocardial tissue or other organ lesion target areas. Specific operation is as follows: Figure 19 As shown, after the 1 / 2-shaped insulating coaxial sheath 3 is punctured to reach the target area of ​​the myocardial tissue, the drug injection component 64 can be connected to the secondary sheath interface 33 according to the drug administration requirements. Under ultrasound guidance, the tip of the insulating sheath 32 is moved to the desired drug administration position in the myocardial target area. Pressing the drug injection component 64 causes the drug to flow into the main sheath tube 31 along the secondary sheath interface 33 and out through the front end of the insulating sheath 32, achieving targeted enrichment and drug administration of the therapeutic drug in the myocardial target area. The above operation can be repeated to achieve multiple drug administrations to the myocardial target area according to the actual drug injection volume requirements. Furthermore, the therapeutic hydrogel can be targetedly injected for heart failure treatment and repair, etc. This embodiment realizes targeted injection of myocardial drugs along the 1 / 2-shaped insulating coaxial sheath, improving drug administration efficiency. The drug injection component 64 can be a syringe or an injection catheter.

[0114] Example 5

[0115] For all cardiac patients requiring ICD implantation for protection, including those assessed as high-risk hypertrophic cardiomyopathy, to prevent sudden death due to malignant arrhythmias in daily life, and to monitor and prevent cardiac arrest during surgery, especially given the risk of unstable cardiac activity and malignant arrhythmias such as ventricular fibrillation during surgery, intraoperative ICD implantation can provide immediate protection and reduce intraoperative cardiac arrest-related mortality for those with extremely high risk as indicated by preoperative assessment. Figure 20 As shown, the radiofrequency ablation assembly with a multifunctional spherical sheath may further include a miniature implantable ICD assembly 7, which is connected to the free end of the secondary sheath 33 during use.

[0116] Specifically, such as Figure 21 As shown, a miniature implantable ICD component 7 is introduced along the accessory sheath interface 33 and monitored in real time. The electrode leads of the miniature implantable ICD component 7 are extended along the insulating sheath 32 into the right ventricular outflow tract 71. Figure 21 (A) diagram or right ventricular apex 72 Figure 21 The pacemaker location shown in Figure (B) can improve the success rate of lead placement and reduce the risk of myocardial perforation. This method of ICD implantation allows for continuous monitoring of cardiac electrical activity, automatic identification and management of malignant arrhythmias, and avoids the delays associated with external defibrillation. In this embodiment, for hypertrophic cardiomyopathy with high surgical risk, intraoperative ICD placement can monitor and protect against the risk of cardiac arrest. The ICD electrode lead is inserted along the coaxial sheath into the apex of the right ventricle, at the pacemaker location in the right ventricular outflow tract, providing patients with safer daily life or surgical protection.

[0117] Example 6

[0118] like Figure 22 As shown, the radiofrequency ablation assembly with a multifunctional α-shaped sheath may also include a myocardial biopsy assembly 8. In use, the myocardial biopsy assembly 8 and the ablation needle 2 are alternately inserted into the main sheath 31.

[0119] In addition, such as Figure 22 As shown, the myocardial biopsy assembly 8 includes a myocardial biopsy sampling unit 81 and a myocardial biopsy tissue loading unit 82; the myocardial biopsy sampling unit 81 includes a biopsy needle core 83, and the biopsy needle core 83 is provided with a sampling inner groove 84, the length of the sampling inner groove 84 along the axial direction of the biopsy needle core 83 is 1-3 mm; the myocardial biopsy tissue loading unit 82 includes multiple independent tissue storage chambers 85.

[0120] The myocardial biopsy component 8 in this invention overcomes the limitations of traditional myocardial biopsy, such as small sample volume and high risk. It is matched with a type-1 insulating coaxial sheath 3 to ensure that multiple tissue samples can be taken while reducing the number of punctures. It has the advantages of sufficient sample volume, flexible position, minimal trauma, and reduced complications such as pericardial effusion or arrhythmia caused by multiple punctures.

[0121] This invention further adopts an independent myocardial biopsy tissue storage unit 82, which can hold different tissue fixatives as needed. Each tissue corresponds to an independent tissue storage chamber 85, avoiding confusion and contamination between tissue samples.

[0122] The usage process of the myocardial biopsy component 8 in this utility model is as follows: Figure 23 As shown, specifically: the ablation needle 2 is removed, the biopsy needle core 83 of the myocardial biopsy sampling unit 81 is inserted into the target sampling tissue site through the insulating sheath 32, the tissue sample 86 is obtained using the sampling groove 84, and then the removed tissue sample 86 is collected into the myocardial biopsy tissue holding unit 82.

[0123] This embodiment uses a myocardial biopsy needle matched with a type-1 insulating coaxial sheath for myocardial tissue biopsy sampling, which reduces the number of myocardial punctures required for multiple myocardial biopsy needle samplings and improves surgical safety.

[0124] Example 7

[0125] Patients with hypertrophic cardiomyopathy have a significantly increased risk of intraoperative arrhythmias, myocardial ischemia, and hemodynamic deterioration due to myocardial structural abnormalities such as interventricular septal hypertrophy, left ventricular outflow tract obstruction, and unstable electrical activity. Continuous intraoperative ECG monitoring is a core measure to ensure patient safety. During Liwen's procedure for ablation of the interventricular septum, real-time identification of life-threatening arrhythmias is crucial. While routinely applying ECG electrode patches is a commonly used non-invasive monitoring tool in clinical practice, it is prone to skin irritation and allergic reactions during application. Long-term application can lead to skin damage, signal quality interference, insufficient adhesion, and electrode detachment due to high temperatures or excessive sweating. Obese patients are also more likely to experience loose electrode adhesion and signal attenuation.

[0126] To reduce errors caused by interference, such as Figures 24-25 As shown, the outer wall of the insulating sheath 32 of this utility model is provided with an electrocardiogram electrode patch 36; the electrocardiogram electrode patch 36 includes an insulating layer 361, a conductive film layer 362 and a pressure-sensitive adhesive layer 363 stacked together; a plurality of myocardial electrocardiogram detection rings 364 are provided on the outer side of the pressure-sensitive adhesive layer 363.

[0127] like Figure 26 As shown, the radiofrequency ablation assembly with ECG electrode patches 36 on its outer wall can be inserted into the myocardial tissue to monitor the myocardial electrical activity in real time, which can avoid the limitations of conventional ECG monitoring and improve the real-time performance and accuracy of ECG monitoring.

[0128] In addition, such as Figure 1 As shown, the handle 1 is further equipped with a cooling circulation system 9; the cooling circulation system 9 includes a coolant inflow channel 91 and a coolant outflow channel 92. The cooling circulation system 9 is equipped with a circulating peristaltic pump; the tip of the ablation needle 2 is equipped with a thermocouple temperature measuring component.

[0129] Example 8

[0130] This embodiment further explains the ablation treatment process for complex subtypes of hypertrophic septal cardiomyopathy with varying thicknesses in the radiofrequency ablation assembly containing a multifunctional β-shaped sheath, as described in this invention. The thickness variation requires adjusting the working end length of the ablation needle 2 from 20mm to 10mm.

[0131] The process for adjusting the working end length of the ablation needle 2 in the radiofrequency ablation assembly containing a multifunctional dove-shaped sheath of this invention is as follows:

[0132] S1: As Figure 27 As shown, under ultrasound guidance, the ablation needle 2 is punctured into the myocardial region to be ablated in the interventricular septum. Specifically, the main sheath 31 and the connecting part 41 are rotated together via their Luer rotating interface. Under ultrasound guidance, the ablation needle 2 is punctured to reach the target area of ​​the myocardium to be ablated, and ablation treatment is performed with appropriate power, 20mm of the ablation needle 2 protruding. After confirming that the myocardial tissue in this area has been ablated and necrotic, the ablation needle 2 is moved to the next area to be ablated under ultrasound guidance.

[0133] S2: As Figures 2-6 as well as Figures 28-29 As shown, the pressing adjustment part 43 adjusts the length of the working end of the ablation needle 2 from 20mm to 10mm. Specifically, when the size of the ablation needle 2 needs to be reduced clinically, it is achieved through the position adjustment part 4. The specific process is as follows: pressing down the pressing adjustment part 43 causes the locking part 45 to deform, causing the locking part 46 to disengage from the locking groove 11. At this time, the position adjustment part 4 moves axially under the forward and backward push and pull of the thumb, and simultaneously drives the A-shaped insulating coaxial sheath 3 to move along the outer wall of the ablation needle 2. Pushing the position adjustment component 4 forward causes the A-shaped insulating coaxial sheath 3 to move forward along the outer wall of the ablation needle 2, shortening the exposed area of ​​the electrode of the ablation needle 2 and reducing the length of the working end of the ablation needle 2. When it moves to 10mm, the thumb releases the pressure of the adjustment part 43, the deformation of the locking part 45 is restored, and the locking component 46 is locked into the slot 11, thus locking it in place and positioning the A-shaped insulating coaxial sheath 3 at the 10mm working length on the outer wall of the ablation needle 2.

[0134] S3: After adjusting the length and position of the working end of ablation needle 2, repeat the process to complete the treatment of all myocardial tissue in the ventricular septum to be ablated. After adjusting the length of the exposed working end of radiofrequency ablation needle 2 to 10mm in the previous step, turn on the radiofrequency host to complete the radiofrequency ablation treatment of the myocardium in that area. At the same time, referring to the above steps, press the position adjustment component 4 with your thumb to drive the A-shaped insulating coaxial sheath 3 to move radially along ablation needle 2, thereby adjusting the length of the working end of ablation needle 2 and moving the position of the needle tip of ablation needle 2, and completing the radiofrequency ablation treatment of all myocardial tissue to be ablated.

[0135] Example 9

[0136] This invention also includes an ablation system, comprising a radiofrequency ablation assembly with a multifunctional U-shaped coaxial sheath as described in this invention, and an energy generating device electrically connected to the ablation needle 2; the energy generating device is further connected to a negative electrode patch; the energy generating device is a radiofrequency generator, a microwave generator, a laser generator, or a focused ultrasound generator. The power of the radiofrequency generator is 1-300W. In use, the power setting of the energy generating device is matched with the size of the ablation needle 2 to achieve the best ablation effect.

[0137] In summary, this invention solves the problem of achieving more precise and safe ablation treatment for hypertrophic cardiomyopathy when targeting different thicknesses of the interventricular septum to be ablated. The adjustable ablation needle, matched with a type-1 insulating coaxial sheath 3, enables observation and detection of hemorrhagic pericardial effusion and emergency management of pericardial drainage. It is matched with a cardiac conduction system monitoring and marking probe to mark the location of the intramyocardial conduction bundle. It allows for targeted myocardial drug injection, improving drug accumulation at the myocardial target site. The type-1 insulating coaxial sheath, designed to match the myocardial biopsy needle, reduces complications such as pericardial effusion, bleeding, and arrhythmias caused by multiple punctures, achieving safer and more effective myocardial tissue biopsy sampling. The myocardial biopsy needle is equipped with a regionally independent tissue collection box. Surgical micro-ICD implantation protects the patient, avoiding real-time monitoring and preventing cardiac arrest. Simultaneously, the type-1 insulating ECG monitoring sheath, inserted into the myocardial tissue, allows for real-time monitoring of myocardial electrical activity, improving the real-time nature and accuracy of ECG monitoring.

[0138] Specifically, firstly, the working length of the radiofrequency electrode needle of this invention can be precisely adjusted via a slot-pull mechanism. The core of this invention uses a slot-pull sliding adjustment button. The sliding block moves along the outer wall of the radiofrequency ablation needle, allowing for fine interval adjustments of 0.1 to 5.0 mm within the range of 0 to 50 mm. The adjustment button is integrally molded, enabling more stable, convenient, precise, and rapid adjustment of the electrode needle's working length, achieving conformal ablation treatment for different interventricular septal thicknesses in the myocardium. In other words, this invention employs a slot-pull moving adjustment mechanism, connecting the rotating coaxial sheath and the handle via a Luer rotary interface. The push-pull adjustment button drives the sliding block to move radially along the slot in a stable, step-by-step manner, simultaneously moving the coaxial sheath radially along the radiofrequency electrode needle, thus achieving precise adjustment of the working length of the exposed area of ​​the electrode needle.

[0139] Secondly, the multifunctional 1 / 2-shaped insulated coaxial sheath and its matching design in this invention enable observation and detection of hemorrhagic pericardial effusion and emergency treatment of pericardial drainage; targeted myocardial drug injection to enhance drug accumulation at the myocardial target site; matching the electrocardiogram conduction system monitoring and marking probe to mark the position of the conduction bundle within the myocardium; and matching the dedicated myocardial biopsy and independent biopsy tissue collection box to reduce the number of punctures while allowing for multiple tissue sampling, resulting in sufficient sample volume, flexible placement, minimal trauma, and reduced complications such as pericardial effusion or arrhythmia caused by multiple punctures. The independent myocardial tissue biopsy collection box avoids confusion and contamination between tissue samples; matching the implanted micro-ICD electrode lead inserted along the coaxial sheath into the apex of the right ventricle or the pacemaker position of the right ventricular outflow tract improves the success rate of lead placement, reduces the risk of myocardial perforation, and lowers the mortality rate related to intraoperative cardiac arrest. The 1 / 2-shaped insulated electrocardiogram monitoring sheath can monitor myocardial electrical activity in real time upon insertion into the myocardial tissue, improving the real-time performance and accuracy of electrocardiogram monitoring, demonstrating significant clinical value compared to conventional single-channel coaxial sheaths.

[0140] This invention employs a radiofrequency ablation assembly with a multifunctional dovetail sheath to achieve stable, convenient, and precise adjustment of the length of the bare working area of ​​the electrode needle. It provides a safer, more stable, and convenient solution for the treatment of hypertrophic cardiomyopathy and multiple tumors in various organs, showing great application potential in the clinical treatment of hypertrophic cardiomyopathy and tumors in various organs.

[0141] The above are merely preferred embodiments of this utility model and are not intended to limit the scope of this utility model. Various modifications and variations can be made to this utility model by those skilled in the art. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of this utility model should be included within the protection scope of this utility model.

Claims

1. A radiofrequency ablation needle assembly containing a multifunctional U-shaped coaxial sheath, characterized in that, include: The handle (1) and the ablation needle (2) are provided, with one end of the ablation needle (2) fixed inside the handle (1) and the other end extending to the outside of the handle (1). The handle (1) is provided with a position adjustment component (4) inside. The position adjustment component (4) includes a connecting part (41), a deformation part (42) and a pressing adjustment part (43) connected in sequence. The handle (1) is detachably provided with a type-1 insulating coaxial sheath (3); the type-1 insulating coaxial sheath (3) includes a main sheath tube (31); one end of the main sheath tube (31) is coaxially provided with an insulating sheath (32), and a secondary sheath interface (33) is provided on the side wall of the main sheath tube (31); the outer wall of the insulating sheath (32) is provided with an insulating layer; In use, the free end of the main sheath (31) is connected to the connecting part (41), and the insulating sheath (32) is sleeved on the ablation needle (2). The 1-shaped insulating coaxial sheath (3) can move along the axial direction of the ablation needle (2) under the drive of the position adjustment member (4) to adjust the length of the distal end of the ablation needle (2) extending out of the 1-shaped insulating coaxial sheath (3).

2. The radiofrequency ablation needle assembly with a multifunctional U-shaped coaxial sheath according to claim 1, characterized in that, The free end of the main sheath (31) is threadedly connected to the connecting part (41).

3. The radiofrequency ablation needle assembly with a multifunctional U-shaped coaxial sheath according to claim 1, characterized in that, The free end of the secondary sheath interface (33) is provided with a tail cap (34).

4. The radiofrequency ablation needle assembly with a multifunctional U-shaped coaxial sheath according to claim 1, characterized in that, The insulated coaxial sheath (3) is made of frosted transparent material.

5. The radiofrequency ablation needle assembly containing a multifunctional U-shaped coaxial sheath according to claim 1, characterized in that, The radiofrequency ablation assembly with a multifunctional spherical sheath also includes at least one of a myocardial electrocardiogram conduction system monitoring assembly (5), a micro implantable ICD assembly (7), and a myocardial biopsy assembly (8); in use, the myocardial electrocardiogram conduction system monitoring assembly (5) or the micro implantable ICD assembly (7) is connected to the secondary sheath interface (33), and the myocardial biopsy assembly (8) and the ablation needle (2) are alternately inserted into the main sheath (31).

6. The radiofrequency ablation needle assembly containing a multifunctional U-shaped coaxial sheath according to claim 5, characterized in that, The myocardial biopsy assembly (8) includes a myocardial biopsy sampling unit (81) and a myocardial biopsy tissue loading unit (82). The myocardial biopsy sampling unit (81) includes a biopsy needle core (83), and the biopsy needle core (83) is provided with a sampling inner groove (84). The length of the sampling inner groove (84) along the axial direction of the biopsy needle core (83) is 1~3 cm. The myocardial biopsy tissue loading unit (82) includes multiple independent tissue loading chambers (85).

7. The radiofrequency ablation needle assembly with a multifunctional U-shaped coaxial sheath according to claim 1, characterized in that, The radiofrequency ablation assembly with a multifunctional β-shaped sheath also includes a pericardial effusion drainage assembly (6) and / or a drug injection assembly (64). In use, the pericardial effusion drainage assembly (6) or the drug injection assembly (64) is connected to the accessory sheath interface (33). The insulating sheath (32) is provided with a plurality of drainage holes (35); the drainage holes (35) are located at a distance greater than 6 cm from the free end of the insulating sheath (32); the outer wall of the ablation needle (2) is provided with an insulating layer, and the insulating layer on the outer wall of the ablation needle (2) is located in the non-working area of ​​the ablation needle (2).

8. A radiofrequency ablation needle assembly with a multifunctional U-shaped coaxial sheath according to claim 1, characterized in that, The outer wall of the insulating sheath (32) is provided with an electrocardiogram electrode patch (36); the electrocardiogram electrode patch (36) includes an insulating layer (361), a conductive film layer (362) and a pressure-sensitive adhesive layer (363) stacked together; a plurality of myocardial electrocardiogram detection rings (364) are provided on the outer side of the pressure-sensitive adhesive layer (363).

9. A radiofrequency ablation needle assembly with a multifunctional U-shaped coaxial sheath according to claim 1, characterized in that, The deformable part (42) includes a support part (44) and a locking part (45), and the locking part (45) is provided with a locking member (46); the support part (44) is slidably disposed inside the handle (1); The handle (1) has multiple slots (11) inside, and the multiple slots (11) are evenly spaced along the axial direction of the handle (1). The snap-fit ​​component (46) is configured to cooperate with the slot (11).

10. A radiofrequency ablation needle assembly with a multifunctional U-shaped coaxial sheath according to claim 9, characterized in that, The distance between two adjacent slots (11) is 0.1~5.0 mm.

11. A radiofrequency ablation needle assembly with a multifunctional U-shaped coaxial sheath according to claim 9, characterized in that, The support (44) is provided with a position indicator (47) and an elongated hole (12) is provided along the length of the handle (1); a scale indicator (13) is provided on the outer wall of the handle (1) near the elongated hole (12); the position indicator (47) extends into the elongated hole (12).

12. The radiofrequency ablation needle assembly with a multifunctional U-shaped coaxial sheath according to claim 1, characterized in that, The handle (1) is also equipped with a cooling circulation system (9), and the cooling circulation system (9) is equipped with a circulating peristaltic pump; the tip of the ablation needle (2) is equipped with a thermocouple temperature measuring component.

13. An ablation system, characterized in that, The radiofrequency ablation assembly with a multifunctional T-shaped coaxial sheath as described in any one of claims 1 to 12, and an energy generating device electrically connected to the ablation needle (2); the energy generating device is also connected to a negative electrode patch; the energy generating device is a radiofrequency generator, a microwave generator, a pulse electric field generator, or an irreversible electroporation device.

14. An ablation system according to claim 13, characterized in that, The power of the radio frequency generator is less than 300W.

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