Radio frequency ablation needle assembly with multifunctional B-shaped coaxial sheath and ablation system

Abstract

The invention discloses a radiofrequency ablation needle assembly and ablation system comprising a multifunctional Bu-shaped coaxial sheath, the ablation assembly comprises a multipurpose double-channel Bu-shaped insulating coaxial sheath and an ablation needle, the Bu-shaped insulating coaxial sheath is detachably connected with a handle, and a position adjusting piece on the handle realizes self-adaptive adjustment of the length of the working end of the ablation needle. The B-shaped insulating coaxial sheath synchronously realizes auxiliary surgical diagnosis and treatment such as ablation, biopsy, pericardial effusion drainage, cardiac conduction bundle position marking, myocardial drug injection, ICD implantation and cardiac ECG monitoring, and ensures that integrated myocardial interventional diagnosis and treatment are safely and effectively completed. According to the ablation needle assembly containing the multipurpose B-shaped sheath, the bottleneck that an existing radio frequency ablation technology is low in efficiency, tedious in operation and multiple in complications is broken through, and an innovative solution is provided for comprehensive interventional therapy of heart diseases and various tumor diseases.

Description

Technical Field

[0001] The invention belongs to the technical field of minimally invasive medical interventional devices for heart use, and relates to a radiofrequency ablation needle assembly containing a multifunctional uniaxial coaxial sheath and an ablation system. Background Art

[0002] As a major technological innovation, ultrasound-guided percutaneous intramyocardial radiofrequency ablation (Liwen procedure) provides a new solution for interventional treatment of heart diseases represented by hypertrophic cardiomyopathy (HCM). Under ultrasound guidance, the operator inserts the radiofrequency electrode needle through the intercostal puncture to reach the hypertrophic part of the myocardial ventricular septum, and uses the radiofrequency generator to generate high-frequency alternating current. The exposed section of the radiofrequency electrode needle tip introduces the high-frequency alternating current into the hypertrophic myocardial tissue in the area to be ablated, so that the positive and negative ions in the cells rub against each other to generate heat, causing the tissue temperature to exceed 80°C. The high temperature causes the hypertrophic myocardial cells around the electrode needle to undergo dehydration coagulation necrosis, while blocking the surrounding coronary artery branches. The ablated necrotic ventricular septum area is gradually absorbed and thinned, which increases the inner diameter of the left ventricular outflow tract, reduces the outflow tract pressure difference, relieves the obstruction, and significantly improves the patient's hemodynamics. It can be seen that the Liwen procedure is the third innovative way to enter the heart for diagnosis and treatment in the cardiology field after the two existing ways of surgery and cardiac catheterization. It has broken through the global difficulty of minimally invasive transmyocardial diagnosis and treatment on a beating heart. It is recognized by the industry as having the advantages of less trauma, short path, no thoracotomy, no reliance on peripheral blood vessels, and avoidance of X-ray radiation and contrast agent damage. Many 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 gland, due to important reasons such as the complex anatomy of the cardiac surgical area, large myocardial motion, high surgical risk, and limited operating space, the surgery requires that repeated punctures be avoided as much as possible after the access route is established. Therefore, in addition to completing the main radiofrequency ablation function, it is also necessary to match the functional modules such as pericardial effusion treatment, ECG activity monitoring, targeted drug injection, tissue biopsy sampling, etc. with high integration, and handle unexpected situations during the operation, in order to safely, effectively and smoothly complete the Liwen procedure.

[0004] The anatomical classification of the ventricular septum in HCM patients is complex and diverse, with uneven tissue thickness. Currently, fixed radiofrequency ablation electrode needles cannot meet the requirements of conformal ablation. According to the morphological changes of the ventricular septum, HCM is divided into: (1) Normal type hypertrophy: The entire ventricular septum is hypertrophied and protrudes into the left ventricular outflow tract, and the thickness of the basal part of the ventricular septum is ≥15 mm; (2) Sigmoid type hypertrophy: The basal part of the ventricular septum is hypertrophied and protrudes into the left ventricular outflow tract; (3) Reverse C type hypertrophy: The ventricular wall in the middle of the left ventricle is abnormally hypertrophied and protrudes into the left heart cavity (section); (4) Apical hypertrophy: Limited to the apical part of the left ventricle below the level of the papillary muscle. Currently, the indications for radiofrequency electrode needles are mostly for minimally invasive interventional ablation treatment of solid organs or tumors such as the liver and thyroid. The ablation treatment of myocardial tissue is still in the stage of clinical trial exploration. At present, the exposed size of the working end of the radiofrequency electrode needle on the market is mainly fixed lengths of 1.0, 2.0, and 3.0 cm. The effective ablation range is also relatively fixed due to the fixed electrode size, and the treatment of different types of HCM is limited. Since the exposed size of the radiofrequency electrode needle is directly related to the size of the tissue ablation range, if the exposed size of the working end of the electrode needle is selected too large, it is easy to cause an excessive ablation range, exceeding the safety boundary and damaging the cardiac electroconductive system and normal myocardial tissue, leading to serious risks such as malignant arrhythmia; conversely, if the exposed size of the working end of the electrode needle is selected too small, it is easy to cause a relatively small actual ablation range. To complete the ablation of all tissues within the target ablation area of the ventricular septum, the position of the tip of the radiofrequency electrode needle needs to be adjusted multiple times, and multiple superpositions are required to effectively complete the complete coverage of all tissue ablation ranges, resulting in an extended operation time and an increased risk of surgical complications.

[0005] Secondly, the main complication of the Liwen procedure for the treatment of hypertrophic cardiomyopathy is hemorrhagic pericardial effusion. The treatment method for hemorrhagic pericardial effusion usually adopts pericardiocentesis drainage or surgical small lateral incision. The pericardiocentesis point is very close to the radiofrequency ablation puncture point and often conflicts, and the drainage operation process is cumbersome and complex, requiring the close cooperation of multiple medical staff; while surgical thoracotomy requires experienced cardiac surgeons to handle emergently, and there are also problems such as high risk and large incision.

[0006] Thirdly, since the cardiac electroconductive system is responsible for the transmission of cardiac electrical signals, damage to the cardiac conduction system will cause various types of arrhythmias. For the prevention of intraoperative arrhythmias, real-time monitoring of the electrocardiogram changes of patients during the operation is currently used with a 12-lead electrocardiogram, and it is impossible to move the risk forward to avoid the risk position of the conduction system in advance. Therefore, when radiofrequency ablating the ventricular septum of the myocardium, the position of the conduction system is marked during the operation to avoid thermal damage to important conduction bundles and cause complications such as malignant arrhythmia.

[0007] In addition, when treating heart diseases such as cardiomyopathy and heart failure with drugs, oral or intravenous drugs are generally used. The drugs are metabolized by the patient's systemic circulation and enter the myocardial target tissue for treatment. However, this method cannot achieve enrichment in the myocardial target tissue for treatment, limiting its clinical use. At the same time, when a pseudoaneurysm occurs in the ventricular septum during cardiac surgery, blood enters the surrounding tissue through the rupture to form a localized hematoma, which is composed only of fibrous tissue and thrombus and is prone to rupture or progressive expansion. If it is adjacent to the ventricular septum of the heart, the continued expansion of the hematoma may lead to serious complications such as ventricular septal perforation, and medication is required to close the thrombus.

[0008] In addition, it is crucial to obtain myocardial tissue samples through myocardial biopsy in pathological examination, related analysis, diagnosis and treatment of heart diseases. At present, conventional myocardial biopsy sampling adopts the technique of clamping endocardial myocardial tissue through peripheral blood vessels (Endomyocardial biopsy, EMB), which requires puncturing the right internal jugular vein, equipped with myocardial biopsy forceps, and grabbing myocardial tissue along the vein through the ventricular cavity and valve to the right ventricular surface. There are small sampling amounts that are prone to errors in tissue biopsy results, and long paths that are prone to increase the risk of vascular damage; at the same time, it is easily restricted by valvular disease and coronary atherosclerosis. Due to the distribution of important conduction systems under the endocardium, complications of biopsy forceps sampling include myocardial septal perforation, pericardial effusion, valve damage, malignant arrhythmia, atrioventricular conduction block, etc. Liwen myocardial biopsy (Liwen Myocardial Biopsy, LMB) is to perform percutaneous transthoracic puncture of the biopsy needle under ultrasound guidance to reach the myocardium for biopsy sampling. LMB myocardial biopsy has the characteristics of sufficient sampling volume, flexible biopsy location, less trauma, and no reliance on blood vessels, showing important clinical application value. However, since the heart tissue is covered with blood vessels and conduction bundle system, multiple puncture sampling of myocardial biopsy is prone to damage blood vessels and cause pericardial effusion or conduction bundle damage leading to arrhythmia. Therefore, how to reduce the number of punctures of myocardial tissue under the premise of ensuring multiple tissue sampling is crucial to improve the safety of the operation.

[0009] Meanwhile, implantable ICDs can prevent sudden cardiac death, are suitable for patients with low cardiac function and a high risk of previous malignant arrhythmias, and can improve the long-term quality of life of patients. At the same time, implantable ICDs have a remote monitoring function, can regularly transmit data to the medical center, detect abnormalities and adjust treatment plans. At the same time, due to the high risks associated with cardiac surgery, placing an implantable cardioverter defibrillator (ICD) during the operation can monitor the electrical activity of the heart, and immediately perform defibrillation or pacing treatment once an abnormality is detected, providing immediate protection. Placing an ICD can reduce the risk of postoperative cardiac arrest and improve the safety of the surgery. For patients at high risk of malignant arrhythmias, such as those with conduction block, atrial and ventricular fibrillation, ICD implantation can effectively prevent sudden death. However, currently, ICD implantation requires puncturing blood vessels to insert electrode leads into the heart, which is likely to cause bleeding or hematoma. When placing the electrode leads, improper operation may cause the leads to pierce the heart wall, leading to serious complications such as cardiac perforation. The implantable ICD needs to bury the pulse generator and leads in the subcutaneous tissue, which poses a certain risk of infection. As a foreign body, the device may damage the local immune barrier and increase the risk of bacterial colonization. Common pocket infections present as local redness, exudation, and can progress to abscesses. Pocket infection is a serious complication after ICD implantation and may develop into endocarditis, threatening the patient's life safety. Through the innovative design of the T-shaped insulating coaxial sheath and along the original Liwen surgical approach of this center, a micro-ICD can be implanted into the myocardium through the percutaneous transapical approach, improving safety and operational convenience, while reducing the risk of complications and surgical infections.

[0010] Moreover, continuous intraoperative electrocardiogram (ECG) monitoring of patients with hypertrophic cardiomyopathy is a core measure to ensure patient safety. When ablating the ventricular septum of the myocardium using the Liwen surgical approach, it is necessary to identify malignant arrhythmias in real time. The signal quality of the conventional adhesive ECG electrode patches is interfered, the adhesion is insufficient, and high temperature / sweating is likely to cause the electrodes to fall off. The electrodes are not closely attached, resulting in signal attenuation and low accuracy of the detection results.

[0011] Therefore, how to achieve 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 position of the cardiac conduction system, targeted injection of myocardial drugs, efficient biopsy sampling of myocardial tissue, convenient and safe implantation of ICDs, and accurate and effective monitoring of cardiac ECG, and at the same time effectively control the temperature of the radiofrequency ablation needle during the radiofrequency ablation process, are the keys to improving the safety and effectiveness of minimally invasive treatment of hypertrophic cardiomyopathy. Summary of the Invention

[0012] In view of the problems existing in the prior art, the present invention provides a radiofrequency ablation needle assembly and an ablation system including a multifunctional T-shaped coaxial sheath, so as to solve the technical problem that the exposed length of the working end electrode of the radiofrequency ablation assembly in the prior art is not adjustable. 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 cardiac conduction system, myocardial drug targeted injection, efficient biopsy sampling of myocardial tissue, convenient and safe implantation of ICD, and accurate and effective monitoring of ECG.

[0013] The present invention is realized through the following technical solutions:

[0014] A radiofrequency ablation needle assembly including a multifunctional T-shaped coaxial sheath, comprising: a handle and an ablation needle, one end of the ablation needle is fixed inside the handle, and the other end extends outside the handle;

[0015] A position adjusting member is provided inside the handle, and the position adjusting member includes a connecting portion, a deforming portion, and a pressing and adjusting portion which are connected in sequence;

[0016] A T-shaped insulating coaxial sheath is detachably provided on the handle; the T-shaped insulating coaxial sheath includes a main sheath tube; one end of the main sheath tube is coaxially provided with an insulating sheath, and at the same time, a secondary sheath interface is provided on the side wall of the main sheath tube; an insulating layer is provided on the outer wall of the insulating sheath;

[0017] During use, the free end of the main sheath tube is connected to the connecting portion, and the insulating sheath is sleeved on the ablation needle. The T-shaped insulating coaxial sheath can move along the axial direction of the ablation needle under the drive of the position adjusting member to adjust the length of the distal end of the ablation needle protruding from the T-shaped insulating coaxial sheath.

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

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

[0020] Preferably, the radiofrequency ablation assembly including the multifunctional T-shaped sheath further includes at least one group of a myocardial cardiac conduction system monitoring component, a micro-implantable ICD component, and a myocardial biopsy component; during use, the myocardial cardiac conduction system monitoring component or the micro-implantable ICD component is connected to the free end of the secondary sheath interface, and the myocardial biopsy component and the ablation needle are alternately inserted into the main sheath tube.

[0021] Preferably, the myocardial biopsy component includes a myocardial biopsy sampling unit and a myocardial biopsy tissue accommodating unit;

[0022] The myocardial biopsy sampling unit includes a biopsy needle core, and a sampling inner groove is provided on the biopsy needle core. The length of the sampling inner groove along the axial direction of the biopsy needle core is 1-3 mm;

[0023] The myocardial biopsy tissue loading unit includes a plurality of independent tissue storage chambers.

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

[0025] A plurality of drainage holes are provided on the insulating sheath; the distance between the drainage holes and the free end of the insulating sheath is greater than 6 cm; an insulating layer is provided on the outer wall of the ablation needle, and the insulating layer on the outer wall of the ablation needle is provided in the non-working area of the ablation needle.

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

[0027] Preferably, the deformation part includes a support part and a clamping part, and a clamping member is provided on the clamping part; the support part is slidably arranged inside the handle.

[0028] A plurality of card slots are provided inside the handle, and the plurality of card slots are evenly spaced along the axial direction of the handle.

[0029] The clamping member is arranged in cooperation with the card slot.

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

[0031] Preferably, a position indicating member is provided on the support part, and a long strip hole is provided along the length direction of the handle; on the outer wall of the handle, and near the position of the long strip hole, a scale indicating position is provided; the position indicating member extends into the long strip hole.

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

[0033] An ablation system includes the above-mentioned radiofrequency ablation assembly with a multifunctional T-shaped coaxial sheath and an energy generating device electrically connected to the ablation needle; a negative electrode patch is further connected to the energy generating device; 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 radiofrequency generator is less than 300 W.

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

[0036] The present invention discloses a radiofrequency ablation needle assembly with a multi-functional Y-shaped coaxial sheath. First, a Y-shaped coaxial sheath is detachably provided on a handle in the assembly. The Y-shaped 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 tube is provided on the side wall of the main sheath tube. The wall of the insulating sheath is provided with an insulating layer. The design of the Y-shaped coaxial sheath endows the radiofrequency ablation assembly with many functional characteristics. Among them, the secondary sheath tube can be used as a connection port for pericardial effusion aspiration and hemostasis operations and injection of hemostatic drugs. During the operation, it is not necessary to replace the instrument to complete the effusion clearance and hemostasis. At the same time, the secondary sheath tube can also be used as an implantation channel for marking the position of the myocardial electro-conduction system and implanting the ICD assembly, ensuring the safety and effectiveness of the diagnosis and treatment of heart diseases. At the same time, the main sheath tube can also be used as the installation channel of the myocardial biopsy assembly. By introducing a biopsy forceps needle through the Y-shaped coaxial sheath, direct sampling can be carried out in the lesion area, avoiding multiple punctures. Secondly, a position adjusting member is provided inside the handle. The position adjusting member includes a connecting portion, a deformation portion and a pressing and adjusting portion connected in sequence. Through this position adjusting member, the position movement of the Y-shaped coaxial sheath on the ablation needle is conveniently realized, so as to freely adjust the length of the working section of the ablation needle, making the radiofrequency ablation assembly applicable to various types of HCM patients, and the length of the working end of the ablation needle is adjustable, effectively improving the use flexibility of the radiofrequency ablation assembly and having broad clinical application prospects. Through the "one sheath with multiple functions" design of the Y-shaped insulating coaxial sheath, the present invention solves the problem of single function of traditional instruments through channel multiplexing. At the same time, by using the deformation driving mechanism of the position adjusting member, the sheath tube movement and the ablation needle length adjustment are combined into one, realizing the precise control of the electrode length. By means of a quick-disassembly and assembly interface, various intraoperative requirements are adapted to form a flexible cardiac intervention platform. The radiofrequency ablation assembly with a multi-functional Y-shaped insulating sheath in the present invention breaks through the bottlenecks of low efficiency, cumbersome operation and many complications of the existing radiofrequency ablation technology, and provides an innovative solution for the comprehensive interventional diagnosis and treatment of heart diseases.

[0037] A radiofrequency ablation needle assembly with a multi-functional Y-shaped coaxial sheath in the present invention is mainly used for minimally invasive interventional treatment of radiofrequency ablation of the intraventricular septum / heart tumor in the myocardium under ultrasound guidance, and is also applicable to the clinical applications of minimally invasive ablation treatment of the liver, thyroid, kidney, lung, breast, uterine fibroids, various soft tissues and vascular plaques.

[0038] Furthermore, the free end of the main sheath tube is threadedly connected to the connecting portion. First, the threaded connection fixes the main sheath tube and the position adjusting member through the friction force generated by tightening, avoiding accidental detachment or displacement of the sheath tube due to external forces during the operation, ensuring the coaxial stability of the ablation needle and the sheath tube. The self-locking characteristic of the threaded structure can offset the torque generated by rotating the ablation needle or biopsy needle during the operation, preventing relative rotation between the sheath tube and the handle and maintaining the overall structural stability of the instrument. Second, the threaded engagement surface forms a continuous and airtight contact, effectively isolating blood and tissue fluid from seeping into the interior of the handle, reducing the risk of circuit short-circuit or mechanical component corrosion. At the same time, the connection operation of the threaded structure is convenient, allowing the operator to quickly complete the disassembly and replacement of the T-shaped insulated coaxial sheath, adapting to the requirements of multiple scenarios such as aspiration, biopsy, and ICD implantation, and improving the flexibility of the operation.

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

[0040] Furthermore, the radiofrequency ablation component of the multifunctional T-shaped insulated sheath further includes at least one group of myocardial electrocardiographic conduction system monitoring components, miniature implantable ICD components, and myocardial biopsy needle components; during use, the myocardial electrocardiographic conduction system monitoring component or the miniature implantable ICD component is connected to the free end of the auxiliary sheath interface, and the myocardial biopsy component and the ablation needle can be alternately installed in the main sheath tube according to the actual clinical needs. Through the multi-channel multiplexing, modular rapid switching, and functional collaborative control of the sheath tube, the present invention breaks the functional boundaries of a single instrument through a four-in-one operation closed-loop of "ablation - monitoring - protection - diagnosis"; realizes an intraoperative instant response mechanism, transforms passive treatment into active intervention, and provides a technical platform for the precision medicine of heart diseases.

[0041] Further, the myocardial biopsy assembly includes a myocardial biopsy sampling unit and a myocardial biopsy tissue storage unit; the myocardial biopsy sampling unit includes a biopsy needle core, and a sampling inner groove is provided on the biopsy needle core. The length of the sampling inner groove along the axial direction of the biopsy needle core is 1-3 cm; the myocardial biopsy tissue storage unit includes a plurality of independent tissue storage chambers. First, the setting of the 1-3 cm inner groove enables flexible adjustment of the single sampling volume according to the actual situation and improvement of the amount of myocardial tissue obtained. At the same time, the strip-shaped sampling inner groove maintains the integrity and directionality of myocardial fibers, improves the accuracy of pathological diagnosis. At the same time, the coordinated use of this myocardial biopsy assembly and the U-shaped insulating coaxial sheath effectively reduces the number of punctures required for multiple samplings, improves the efficiency and safety of biopsy sampling; in addition, the myocardial biopsy tissue storage unit includes a plurality of independent tissue storage chambers, so that each tissue storage chamber independently stores samples from different lesion tissue sites, and radiofrequency markers or magnetic coding tags can be preset, and the sampling position can be associated during the operation to avoid confusion.

[0042] Further, the radiofrequency ablation assembly with a multi-functional U-shaped sheath further includes a pericardial effusion drainage assembly and / or a drug injection assembly. During use, the pericardial effusion drainage assembly or the drug injection assembly is connected to the free end of the auxiliary sheath interface; a plurality of drainage holes are provided on the insulating sheath; the distance between the drainage holes and the free end of the insulating sheath is greater than 6 cm; an insulating layer is provided on the ablation needle wall, and the insulating layer on the outer wall of the ablation needle (2) is arranged in the non-working area of the ablation needle. First, the drainage assembly is quickly connected through the auxiliary sheath interface. After fluid is found during the operation, the drainage operation can be urgently started to avoid the delay of traditional instrument replacement. The setting of a plurality of drainage holes also effectively improves the drainage efficiency of pericardial effusion; secondly, the distance between the drainage holes and the free end of the insulating sheath is greater than 6 cm to ensure that the drainage holes are located in the middle and rear parts of the pericardial cavity. In addition, for the design of the drainage holes, the number can be 3-5, and the diameter can be 0.2-0.5 mm. Therefore, even if some channels are blocked by fibrin or thrombus, effective drainage can still be maintained; through the U-shaped insulating coaxial sheath in the present invention, thrombin is directly injected into the pseudoaneurysm cavity to induce rapid coagulation of the blood in the cavity, thereby sealing the aneurysm neck and preventing blood flow from continuously entering the aneurysm cavity, effectively shrinking the aneurysm body, reducing the rupture risk, and avoiding further expansion of the hematoma and mechanical compression of the ventricular septum. Injecting thrombin through the U-shaped insulating coaxial sheath channel can quickly and conveniently handle the risk of ventricular septal perforation caused by intraoperative pseudoaneurysm and improve the safety of the operation. In addition, here due to the design of the drainage holes, since the outer wall of the insulating sheath is provided with an insulating layer, there is a risk of electric leakage. Therefore, an insulating layer can also be provided on the rest of the ablation needle core except for the maximum electrode working length to effectively avoid the electric leakage risk when using the insulating sheath with drainage holes and improve the safety of ablation.

[0043] Furthermore, an electrocardiogram electrode patch is provided on the outer wall of the insulating sheath; the electrocardiogram electrode patch includes an insulating layer, a conductive thin film layer, and a pressure-sensitive adhesive layer stacked; a plurality of myocardial electrocardiogram detection rings are provided on the outer side of the pressure-sensitive adhesive layer. Through the multi-layer stacked structure and the detection ring array, the present invention breaks through the spatial influence during the operation of traditional electrocardiogram electrode patches and ablation instruments, and also solves the technical problem of poor electrocardiogram stability caused by the poor fixing stability of electrocardiogram electrode patches in the prior art.

[0044] Furthermore, the deformation part includes a support part and a clamping part, and a clamping member is provided on the clamping part; the support part is slidably arranged inside the handle; a plurality of card slots are provided inside the handle, and the plurality of card slots are evenly spaced along the axial direction of the handle; the clamping member is arranged in cooperation with the card slot. Through the sliding guidance of the support part and the mechanical locking design of the clamping part and the card slot, the precise positioning and stable control of the ablation needle and the T-shaped insulating coaxial sheath are realized. First, the effective cooperation between the card slot and the clamping member realizes the fixation of the position adjusting member, realizes the fixation of the position of the T-shaped insulating coaxial sheath during the operation, that is, realizes the fixation of the position of the ablation needle during the operation. Then, the clamping part, as a part of the deformation part, realizes the separation of the clamping member and the card slot through its physical deformation, so as to further realize the position adjustment of the T-shaped insulating coaxial sheath, that is, realizes the adjustment of the working end length of the ablation needle. This position adjustment component has a simple structure, good stability, and convenient operation, enabling the operator to quickly operate with one hand, significantly improving the flexibility of the operation and the ablation efficiency.

[0045] Furthermore, the distance between two adjacent card slots is 0.1 - 5.0 mm. The adjustment accuracy of this ablation assembly is more precise. For thin-walled myocardium, it supports high-precision step-by-step adjustment to ensure that the ablation energy acts precisely on the target point and avoid accidentally injuring adjacent structures; when the ablation needle is at the central part of the thickened myocardial ventricular septum with high thickness or inside a tumor with a diameter greater than 5 cm, a fast-response adjustment with a larger step level can be designed according to needs to shorten the response time and reduce the risk of complications. Through the 0.1 - 5.0 mm wide-range adjustment, it covers the operation requirements from high precision to organ level, breaking through the mechanical limitations of the traditional fixed-length design of the radiofrequency needle electrode. This setting adjusts the working end length of the ablation needle with millimeter-level precision to adapt to different thickened myocardial thicknesses and avoid the limitations of over-ablation or the need for multiple overlapping ablation ranges.

[0046] Furthermore, a position indicator is provided on the support portion, and a long slot is provided along the length direction of the handle; on the outer wall of the handle, a scale indicator position is provided near the long slot; the position indicator extends into the long slot. First, a high-precision scale is arranged along the outer wall of the handle. The operator can directly read the protruding length of the ablation needle or the moving distance of the sheath tube through the displacement of the position indicator in the long slot, and the operator can intuitively and quickly obtain the length of the working end of the ablation needle, reducing the risk of misoperation. In addition, the long slot exposes the moving track of the position indicator, and the operator can perceive the operation progress through the peripheral vision, reducing the fatigue caused by frequent switching of the line of sight. Through scale quantization, dynamic feedback and digital linkage, the present invention upgrades the traditional empirical operation to a standardized process, improving the accuracy of intraoperative operation.

[0047] Furthermore, a cooling circulation system is also provided inside the handle. The cooling circulation system circulates the coolant. The radiofrequency electrode needle (electrode) forms an alternating electric field in the tissue through high-frequency alternating current, causing the cations and anions in the tissue to vibrate at high speed and generate heat by friction. If the temperature at the tip of the radiofrequency electrode needle is too high, the tissue will carbonize, forming a high-impedance eschar, which hinders the conduction of current and leads to a reduction in the ablation range. In order to prevent tissue carbonization, this radiofrequency ablation system adopts an efficient internal water cooling circulation, which reduces carbonization, maintains the stability of tissue impedance, enables the current to continuously penetrate, and improves the ablation efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following will briefly introduce the drawings required for the embodiments. It should be understood that the following drawings only show some embodiments of the present invention, and therefore should not be regarded as limiting the scope. For those of ordinary skill in the art, other related drawings can be obtained based on these drawings without creative efforts.

[0049] Figure 1 is a schematic diagram of the main structure of a radiofrequency ablation needle assembly with a multifunctional T-shaped coaxial sheath in the present invention;

[0050] Figure 2 is a schematic diagram of the internal component position of the handle when pressing the pressing adjustment part in a radiofrequency ablation needle assembly with a multifunctional T-shaped coaxial sheath in the present invention;

[0051] Figure 3 For the present invention Figure 2 is a partial enlarged view of area A;

[0052] Figure 4 is a schematic diagram of the internal component position of the handle when pushing forward or pulling backward the pressing adjustment part in a radiofrequency ablation needle assembly with a multifunctional T-shaped coaxial sheath in the present invention;

[0053] Figure 5Schematic diagram of the internal component position of the handle when pressing and adjusting part in a radiofrequency ablation needle assembly with a multi-functional T-shaped coaxial sheath in the present invention;

[0054] Figure 6 In the present invention Figure 5 Partial enlarged view of area B;

[0055] Figure 7 Front view of the position adjusting part in the present invention;

[0056] Figure 8 Side view of the position adjusting part in the present invention;

[0057] Figure 9 Schematic diagram of the structure of the T-shaped insulating coaxial sheath in the present invention;

[0058] Figure 10 Schematic diagram of the structure of the myocardial electrocardiogram conduction system monitoring component in the present invention;

[0059] Figure 11 Schematic diagram of marking the position of the myocardial conduction bundle by using the myocardial electrocardiogram conduction system monitoring component in the present invention in combination with the radiofrequency ablation component with a multi-functional T-shaped sheath;

[0060] Figure 12 Schematic diagram of performing radiofrequency ablation after marking the position of the myocardial conduction bundle;

[0061] Figure 13 Schematic diagram of the structure of the pericardial effusion drainage component in the present invention;

[0062] Figure 14 Schematic diagram of sudden pericardial effusion during the surgical ablation process using the radiofrequency ablation component with a multi-functional T-shaped sheath;

[0063] Figure 15 Schematic diagram of withdrawing the ablation needle from the main sheath tube when using the pericardial effusion drainage component in the present invention to handle pericardial effusion;

[0064] Figure 16 Schematic diagram of emergently aspirating pericardial effusion outward from the drainage hole when using the pericardial effusion drainage component in the present invention to handle pericardial effusion;

[0065] Figure 17 Schematic diagram of completely draining the pericardial effusion using the drainage bag when using the pericardial effusion drainage component in the present invention to handle pericardial effusion;

[0066] Figure 18 Schematic diagram of withdrawing the T-shaped insulating coaxial sheath after completely draining the pericardial effusion;

[0067] Figure 19Schematic diagram for realizing targeted drug delivery to myocardial tissue or other visceral lesion target areas by using the radiofrequency ablation component in the present invention;

[0068] Figure 20 Schematic structural diagram of the micro-implantable ICD component in the present invention;

[0069] Figure 21 Schematic diagram for introducing the micro-implantable ICD component by using the T-shaped insulated coaxial sheath in the present invention, where (A) shows introducing the micro-implantable ICD component into the right ventricular outflow tract; (B) shows introducing the micro-implantable ICD component into the right ventricular apex;

[0070] Figure 22 Schematic structural diagram of the myocardial biopsy component in the present invention, where (A) is the myocardial biopsy sampling unit; (B) is the myocardial biopsy tissue storage unit;

[0071] Figure 23 Schematic diagram for biopsy sampling by using the myocardial biopsy component in combination with the T-shaped insulated coaxial sheath in the present invention, where (A) is biopsy sampling; (B) is the removed biopsy sample; (C) is using the myocardial biopsy tissue storage unit to store the removed biopsy sample;

[0072] Figure 24 Schematic structural diagram of the T-shaped insulated coaxial sheath with an electrocardiogram electrode patch on its outer wall in the present invention;

[0073] Figure 25 Schematic structural diagram of the electrocardiogram electrode patch in the present invention;

[0074] Figure 26 Schematic diagram for monitoring intracardiac electrical activities by using the radiofrequency ablation component with an electrocardiogram electrode patch on its outer wall in the present invention;

[0075] Figure 27 Schematic diagram for puncturing an ablation needle to the myocardial region to be ablated in the ventricular septum under ultrasonic guidance in an embodiment of the present invention;

[0076] Figure 28 Schematic diagram when adjusting the working end length of the ablation needle in an embodiment of the present invention;

[0077] Figure 29 Schematic diagram of the operation when completing the adjustment of the working end length of the ablation needle in an embodiment of the present invention.

[0078] Wherein: 1. Handle, 11. Card slot, 12. Long strip hole, 2. Ablation needle, 3. T-shaped insulating coaxial sheath, 31. Main sheath tube, 32. Insulating sheath, 33. Sub-sheath interface, 34. Tail cap, 35. Drainage hole, 36. Electrocardiogram electrode patch, 361. Insulating layer, 362. Conductive thin film layer, 363. Pressure-sensitive adhesive layer, 364. Myocardial electrocardiogram detection ring, 4. Position adjusting member, 41. Connecting portion, 42. Deformation portion, 43. Pressing and adjusting portion, 44. Supporting portion, 45. Engaging portion, 46. Engaging member, 47. Position indicating member, 5. Myocardial electrocardiogram conduction system monitoring assembly, 51. Electrocardiogram monitoring probe assembly, 52. Electrocardiogram conduction system main unit, 6. Pericardial effusion drainage assembly, 61. Drainage device, 62. Drainage bag, 63. Pericardial effusion, 64. Drug injection assembly, 7. Miniature implantable ICD assembly, 8. Myocardial biopsy assembly, 81. Myocardial biopsy sampling unit, 82. Myocardial biopsy tissue storage unit, 83. Biopsy needle core, 84. Sampling inner groove, 85. Tissue storage chamber, 9. Cooling circulation system, 91. Coolant inflow channel, 92. Coolant outflow channel. Detailed implementation manners

[0079] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are some but not all of the embodiments of the present invention. Components of the embodiments of the present invention generally described and illustrated in the accompanying drawings here can be arranged and designed in a variety of 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 present invention, but is merely representative of selected embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts fall within the scope of protection of the present invention.

[0081] It should be noted that: like reference numerals and letters denote like items in the following drawings. Therefore, once an item is defined in one drawing, it does not need to be further defined and explained in subsequent drawings.

[0082] In the description of the embodiments of the present invention, it should be noted that if terms such as "upper", "lower", "horizontal", "inner", etc. are used to indicate the orientation or positional relationship, it is based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the product of the invention is usually placed when in use. This is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation to the present invention. In addition, terms such as "first", "second", etc. are only used for distinguishing descriptions and cannot be understood as indicating or implying relative importance.

[0083] In addition, if the term "horizontal" appears, it does not mean that the component is required to be absolutely horizontal, but it can be slightly inclined. For example, "horizontal" only means that its direction is more horizontal relative to "vertical", and does not mean that the structure must be completely horizontal, but it can be slightly inclined.

[0084] In the description of the embodiments of the present invention, it should also be noted that unless otherwise clearly specified and limited, if terms such as "set", "installed", "connected", "connected" are used, they should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.

[0085] The following further describes the present invention in detail with reference to the drawings:

[0086] Embodiment 1

[0087] As Figures 1 - 6 shown, the present invention discloses a radiofrequency ablation needle assembly including a multifunctional bo-type coaxial sheath, which includes: 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 outside the handle 1; a position adjusting member 4 is provided inside the handle 1;

[0088] As Figures 7 - 8 shown, the position adjusting member 4 includes a connecting portion 41, a deformation portion 42, and a pressing adjustment portion 43 that are connected and arranged in sequence;

[0089] As Figure 1 、 9As shown in the figure, a T-shaped insulating coaxial sheath 3 is detachably provided on the handle 1; the T-shaped 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 at the same time, a secondary sheath interface 33 is provided on the side wall of the main sheath tube 31; an insulating layer is provided on the outer wall of the insulating sheath 32; of course, an insulating layer can also be provided on the inner wall of the insulating sheath 32 at the same time to improve the insulation effect, but the process of providing an insulating layer on the inner wall of the insulating sheath 32 is relatively complex. At the same time, the T-shaped insulating coaxial sheath 3, that is, the main sheath tube 31 and the secondary sheath interface 33, is made of frosted transparent medical plastic, which is convenient for observing the pericardial blood flow status in real time.

[0090] In the present invention, an insulating layer may or may not be provided on the outer wall of the ablation needle 2. When an insulating layer is provided on the outer wall of the ablation needle 2, the insulating layer is provided in its non-working area so as not to affect the ablation of the working area. When no insulating layer is provided on the outer wall of the ablation needle 2, it can be directly matched with the T-shaped insulating coaxial sheath 3 in the present invention for use.

[0091] During use, the free end of the main sheath tube 31 is connected to the connecting portion 41, and the insulating sheath 32 is sleeved on the ablation needle 2. The T-shaped insulating coaxial sheath 3 can be driven by the position adjusting member 4 to move along the axial direction of the ablation needle 2 so as to adjust the length of the distal end of the ablation needle 2 extending out of the T-shaped insulating coaxial sheath 3.

[0092] Among them, the materials of the insulating layer are preferably insulating materials such as Teflon PTFE, Parylene, Polyurethane, PET, and Polyetheretherketone PEEK, and also include insulating ceramic coatings prepared by PVD or CVD vapor deposition methods, etc.

[0093] In addition, the radiofrequency ablation assembly with the multifunctional T-shaped sheath further includes an electrode needle connecting wire provided inside the handle. The free end of the electrode needle connecting wire extending outside the handle is also provided with an electrode needle main machine connector. Rubber rings and fixing clips are also provided on the electrode needle connecting wire for fixing the electrode needle connecting wire. At the same time, a wire wrapping tube is provided at the tail of the handle, so that the structural integration degree of the ablation assembly is higher and the operation is more convenient. A first friction corrugation is also provided at the bottom of the handle to improve the grasping force during use; in order to more conveniently adjust the position of the T-shaped insulating coaxial sheath 3, a second friction corrugation is also provided on the top of the pressing adjustment portion 43.

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

[0095] Such as Figures 3 - 8As shown, the deformation part 42 includes a support part 44 and a clamping part 45, and a clamping member 46 is provided on the clamping part 45; the support part 44 is slidably arranged inside the handle 1; a plurality of clamping grooves 11 are provided inside the handle 1, and the plurality of clamping grooves 11 are uniformly spaced along the axial direction of the handle 1; the clamping member 46 is arranged in cooperation with the clamping grooves 11. The distance between two adjacent clamping grooves 11 is 0.1 - 5.0 mm.

[0096] A plurality of the clamping grooves 11 are arranged at the top of the handle 1. The side wall of any one clamping groove 11 can be set as an "n" shape, that is, the side wall is a flat structure. In a more preferred solution, in order to prevent the clamping member 46 from disengaging from the clamping groove 11 during the operation, the side wall is preferably set as an "s" structure, that is, the size of the outlet of the clamping groove 11 gradually decreases. Of course, when the opening size of the clamping groove 11 is set, under the pressing force applied by the operator with one hand, the clamping member 46 can smoothly disengage from the clamping groove 11, but when there is no external force acting on the clamping member 46, it cannot disengage from the clamping groove 11 by itself.

[0097] In addition, as Figures 1 - 8 shown, a position indicating member 47 is provided on the support part 44, and a long slot 12 is provided along the length direction of the handle 1; on the outer wall of the handle 1 and near the position of the long slot 12, a scale indicating position 13 is provided; the position indicating member 47 extends into the long slot 12.

[0098] The T-shaped insulating coaxial sheath 3 of the present invention is matched with a radiofrequency ablation electrode needle, and can realize the diagnosis, treatment and complication treatment of complexly classified hypertrophic cardiomyopathy and various organ tumors. In the present invention, the handle part of the radiofrequency ablation needle adopts a clamping groove push-pull type adjustment button, and the two are connected by rotating the Luer joint between the handle and the T-shaped insulating coaxial sheath. By pressing and pushing the adjustment button, the T-shaped insulating coaxial sheath is driven to move along the outer wall of the electrode needle, so as to realize the precise adjustment of the exposed length of the working end of the electrode needle. The working end range of the electrode needle can be accurately adjusted at intervals of 0.1 - 5.0 mm within the range of 0 - 50 mm, so as to realize more precise conformal ablation treatment for the irregular thickness ventricular septum of hypertrophic cardiomyopathy or multiple tumor lesions of other organs.

[0099] Example 2

[0100] In addition, as Figure 10 shown, the radiofrequency ablation assembly including the multifunctional T-shaped sheath further 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. During use, one end of the electrocardiogram monitoring probe assembly 51 is connected to the free end of the auxiliary sheath interface 33, and the other end is connected to the electrocardiogram conduction system host 52.

[0101] As Figures 11 - 12As shown, the process of using the radiofrequency ablation component of the multifunctional T-shaped sheath including the myocardial electrocardiogram conduction system monitoring component 5 is as follows: Under ultrasonic guidance, the T-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 T-shaped insulating coaxial sheath 3, and the tail knob of the main sheath tube 31 is tightened. According to the surgical requirements, the monitoring marker microprobe of the myocardial electrocardiogram conduction system monitoring component 5 can be placed through the secondary sheath interface 33 of the T-shaped insulating coaxial sheath 3, and it extends through the tips of the main sheath tube 31 and the insulating sheath 32 to reach the periphery of the myocardial conduction bundle, marking the position of the conduction bundle and the risk area of the surrounding tissue. Through the monitoring marker, the surgeon can master the distribution of the myocardial tissue conduction system in the ablation area, mark the risk area of the conduction bundle, reduce the complications caused by the ablation range affecting the conduction bundle during the operation. In this embodiment, the position of the intracardiac conduction bundle is marked during the operation, and the surgeon avoids the ablation risk area according to the marked position of the conduction bundle, arranges the needles for ablation reasonably, and greatly improves the safety of myocardial tissue ablation treatment. In this embodiment, by inserting the myocardial electrocardiogram conduction system monitoring component into the T-shaped insulating coaxial sheath 3, the distribution of the intracardiac conduction position can be monitored in advance, the risk of ablation injury to the conduction bundle can be optimized and avoided, and the surgical safety can be improved.

[0102] Embodiment 3

[0103] In addition, as Figure 13 shown, the radiofrequency ablation component including the multifunctional T-shaped sheath may further include a pericardial effusion drainage component 6, and the pericardial effusion drainage component 6 includes a drainage device 61 and a drainage bag 62. When in use, first connect the drainage device 61 to the free end of the secondary sheath interface 33, and then connect the drainage bag 62 to the free end of the secondary sheath interface 33.

[0104] As Figure 9 shown, based on the drainage efficiency of the pericardial effusion, a plurality of drainage holes 35 are provided on the insulating sheath 32; the distance between the drainage holes 35 and the free end of the insulating sheath 32 is greater than 6 cm; an insulating layer is provided on the outer wall of the ablation needle 2. The arrangement of the drainage holes 35 is conducive to the rapid implementation of the drainage process. The plurality of drainage holes 35 are arranged asymmetrically and scatteredly near the handle end, ensuring that the radiofrequency electrode needle has the function of adjustable length and taking into account the emergency treatment of pericardial effusion. In addition, since the drainage holes 35 are provided on the insulating sheath 32, an insulating layer must be provided on the outer wall of the ablation needle 2 to avoid the risk of electric leakage at the drainage holes 35.

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

[0106] The specific process of dealing with pericardial effusion is:

[0107] S1: As shown in Figure 15 , withdraw the ablation needle 2 from the main sheath tube 31, and tighten the screw cap at the tail of the main sheath tube 31;

[0108] S2: As shown in Figure 16 , connect the interface of the auxiliary sheath interface 33 to the drainage device 61, and urgently aspirate the pericardial effusion outward through the drainage hole 35;

[0109] S3: As shown in Figure 17 , after the urgent aspiration treatment, connect the interface of the auxiliary sheath interface 33 to the drainage bag 62 to drain all the pericardial effusion;

[0110] S3: As shown in Figure 18 , after draining all the pericardial effusion, withdraw the T-shaped insulated coaxial sheath 3.

[0111] According to the above operations, the urgent drainage treatment of the pericardial effusion 63 during the operation can be realized. At the same time, preferably, the connection port of the T-shaped insulated coaxial sheath 3, that is, the interface of the auxiliary sheath interface 33, is made of frosted transparent plastic, which can observe and detect hemorrhagic pericardial effusion and the urgent treatment of pericardial drainage. That is, in this embodiment, the T-shaped insulated coaxial sheath can observe and monitor hemorrhagic pericardial effusion and the urgent treatment of pericardial drainage.

[0112] Example 4

[0113] Based on the T-shaped insulated coaxial sheath 3 in the present invention, the radiofrequency ablation assembly in the present invention can also realize the directional administration of drugs to the target area of myocardial tissue or other organ lesions. The specific operation is as shown in Figure 19 . After the T-shaped insulated coaxial sheath 3 is punctured to reach the target area of myocardial tissue, according to the drug administration requirements, the drug injection assembly 64 can be connected to the auxiliary sheath interface 33. Under the guidance of ultrasound, the tip of the insulated sheath 32 is moved to the position where the drug needs to be administered in the myocardial target area. Press the drug injection assembly 64, and the drug will flow into the main sheath tube 31 along the auxiliary sheath interface 33 and flow out from the front end of the insulated sheath 32, realizing the directional enrichment administration of the therapeutic drug in the myocardial target area. According to the actual drug injection volume requirements, the above operations can be repeated to realize multiple drug administrations in the myocardial target area. Further, the therapeutic hydrogel can be directionally injected for heart failure treatment and repair, etc. This embodiment realizes the targeted injection of myocardial drugs along the T-shaped insulated coaxial sheath, improving the drug administration efficiency. The drug injection assembly 64 can be a syringe or an injection catheter.

[0114] Example 5

[0115] For all heart disease patients who need to be implanted with an ICD for protection, including patients with hypertrophic cardiomyopathy evaluated as high-risk, in order to avoid sudden death caused by malignant arrhythmias in the daily life of various heart disease patients, and to implant an implantable cardioverter-defibrillator (ICD) during the operation to monitor and prevent cardiac arrest in real time, and the electrocardiogram activity is unstable during the operation, and there is a risk of malignant arrhythmias such as ventricular fibrillation. For those who are extremely high-risk according to the preoperative evaluation, ICD implantation during the operation can provide immediate protection and reduce the mortality related to cardiac arrest during the operation. As Figure 20 shown, the radiofrequency ablation component with a multi-functional sheath can further include a micro-implantable ICD component 7. When in use, the micro-implantable ICD component 7 is connected to the free end of the auxiliary sheath tube 33.

[0116] Specifically, as Figure 21 shown, the micro-implantable ICD component 7 is introduced along the auxiliary sheath interface 33 and monitored in real time. The electrode wire of the micro-implantable ICD component 7 extends into the right ventricular outflow tract 71 along the insulating sheath 32 Figure 21 as shown in (A) figure or the right ventricular apex 72 Figure 21 as shown in (B) figure of the pacing point position, which can improve the success rate of wire placement and reduce the risk of myocardial perforation. Implanting the ICD in this way can continuously monitor the electrocardiogram activity, automatically identify and process malignant arrhythmias, and avoid the delay of relying on external defibrillation. In this embodiment, for hypertrophic cardiomyopathy with high surgical risk, placing an ICD during the operation can monitor and protect the risk of cardiac arrest. Extending the ICD electrode wire along the coaxial sheath into the right ventricular apex and the pacing point position of the right ventricular outflow tract provides a safer guarantee for the patient's daily life or operation.

[0117] Embodiment 6

[0118] As Figure 22 shown, the radiofrequency ablation component with a multi-functional sheath can further include a myocardial biopsy component 8. When in use, the myocardial biopsy component 8 and the ablation needle 2 are alternately inserted into the main sheath tube 31.

[0119] In addition, as Figure 22 shown, the myocardial biopsy component 8 includes a myocardial biopsy sampling unit 81 and a myocardial biopsy tissue storage unit 82; the myocardial biopsy sampling unit 81 includes a biopsy needle core 83, and a sampling inner groove 84 is provided on the biopsy needle core 83. 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 storage unit 82 includes a plurality of independent tissue storage chambers 85.

[0120] The myocardial biopsy assembly 8 in the present invention breaks through the limitations of traditional myocardial biopsies, such as small sample size and high risk. Matching with the T-shaped insulating coaxial sheath 3 can reduce the number of punctures while ensuring multiple tissue samplings. It has sufficient sample size, flexible positioning, small trauma, and reduces complications such as pericardial effusion or arrhythmia caused by multiple punctures.

[0121] The present invention further adopts an independent myocardial biopsy tissue loading unit 82, which can place different tissue fixing solutions according to needs. 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 assembly 8 in the present invention is as Figure 23 shown. Specifically: Take out the ablation needle 2, insert the biopsy needle core 83 of the myocardial biopsy sampling unit 81 through the insulating sheath 32 into the target sampling tissue site, obtain the tissue sample 86 using the sampling inner groove 84, and then collect the taken-out tissue sample 86 into the myocardial biopsy tissue loading unit 82.

[0123] In this embodiment, myocardial tissue biopsy sampling is performed by matching the myocardial biopsy needle with the T-shaped insulating coaxial sheath, reducing the number of punctures of the myocardial tissue during multiple myocardial biopsy needle samplings and improving the surgical safety.

[0124] Example 7

[0125] In patients with hypertrophic cardiomyopathy, due to abnormal myocardial structure such as ventricular septal hypertrophy, left ventricular outflow tract obstruction, and unstable electrical activity, the risks of intraoperative arrhythmia, myocardial ischemia, and hemodynamic deterioration are significantly increased. Intraoperative continuous ECG monitoring is the core measure to ensure patient safety. When ablating the ventricular septum of the myocardium using the Liwen technique, it is necessary to identify life-threatening arrhythmias in real time. The conventional adhesive ECG electrode patch is a commonly used non-invasive monitoring tool in clinical practice. During adhesion, skin irritation and allergic reactions are likely to occur. Long-term adhesion leads to skin damage, signal quality interference, insufficient adhesion, and easy electrode detachment due to high temperature / sweating; in obese patients, it is likely to cause insufficient electrode adhesion and signal attenuation.

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

[0127] As Figure 26 shown, inserting the radiofrequency ablation assembly with the ECG electrode patch 36 on its outer wall into the myocardial tissue can monitor the intracardiac electroactivity in real time, avoiding the limitations of conventional electrocardiogram monitoring and improving the real-time performance and accuracy of electrocardiogram monitoring.

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

[0129] Example 8

[0130] Through this example, the ablation treatment process of the radiofrequency ablation component with a multi-functional T-shaped sheath in the present invention for achieving complex classification of different regional thicknesses of hypertrophic cardiomyopathy of the ventricular septum is further explained. The thickness change requires adjusting the working end length of the ablation needle 2 from 20 mm to 10 mm.

[0131] The regulation process of the working end length of the ablation needle 2 in the radiofrequency ablation component with a multi-functional T-shaped sheath in the present invention is as follows:

[0132] S1: As Figure 27 shown, under ultrasonic guidance, the ablation needle 2 is punctured into the myocardial region of the ventricular septum to be ablated. Specifically, the main sheath tube 31 and the connecting portion 41 are rotationally connected by their Luer rotation interfaces. Under ultrasonic guidance, the ablation needle 2 is punctured to reach the target area of the myocardium to be ablated, and ablation treatment is performed with a suitable power matched according to the 20 mm exposed length of the ablation needle 2. After confirming that the myocardial tissue in this area has been ablated and necrosed, the ablation needle 2 is moved to the next area to be ablated under ultrasonic guidance.

[0133] S2: As Figures 2 - 6 and Figures 28 - 29 shown, pressing down the pressing and adjusting portion 43 realizes the adjustment of the working end length of the ablation needle 2, so that the working length of the working end of the ablation needle 2 is adjusted from 20 mm to 10 mm. Specifically, clinically, when it is desired to reduce the size of the ablation needle 2, it is achieved through the position adjusting member 4. The specific process is as follows: pressing down the pressing and adjusting portion 43 drives the engaging portion 45 to deform, so that the engaging member 46 disengages from the card slot 11. At this time, under the forward and backward push and pull of the thumb, the axial movement of the position adjusting member 4 is realized, and synchronously drives the T-shaped insulating coaxial sheath 3 to move along the outer wall of the ablation needle 2. Pushing the position adjusting member 4 forward causes the T-shaped insulating coaxial sheath 3 to move forward along the outer wall of the ablation needle 2, and the exposed area of the electrode of the ablation needle 2 is shortened, realizing the reduction of the working end length of the ablation needle 2. When it is moved to 10 mm, the thumb releases the pressing and adjusting portion 43, and the deformation of the engaging portion 45 is restored, and the engaging member 46 is snapped into the card slot 11 to lock it, realizing the positioning of the T-shaped insulating coaxial sheath 3 at the 10 mm working length on the outer wall of the ablation needle 2.

[0134] S3: After the working end length and position of the ablation needle 2 are adjusted, repeat the superposition to complete the treatment of the myocardium in all the septal regions to be ablated. After the working end length of the exposed area of the radiofrequency ablation needle 2 in the previous step is adjusted to 10 mm, turn on the radiofrequency host to complete the radiofrequency ablation treatment of the myocardium in this area. At the same time, referring to the above steps, press the position adjusting member 4 with the thumb to drive the T-shaped insulating coaxial sheath 3 to move radially along the ablation needle 2, so as to adjust the working end length of the ablation needle 2, and move the position at the tip of the ablation needle 2 to complete the radiofrequency ablation treatment of all the myocardium tissues to be ablated by superposition.

[0135] Embodiment 9

[0136] Meanwhile, the present invention further includes an ablation system, which includes the radiofrequency ablation assembly with the multifunctional T-shaped coaxial sheath described in the present invention and an energy generating device electrically connected to the ablation needle 2; a negative electrode patch is also connected to the energy generating device; 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 - 300 W. When 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, the present invention solves the problem of achieving more precise and safe ablation treatment for different thicknesses of the septal range to be ablated during the treatment of hypertrophic cardiomyopathy by the Liwen technique; the T-shaped insulating coaxial sheath 3 matched with the adjustable ablation needle can realize the observation and detection of hemorrhagic pericardial effusion and the emergency treatment of pericardial drainage, and match the electrocardiogram conduction system monitoring and marking probe to mark the position of the intramyocardial conduction bundle; perform drug myocardial targeted injection to improve the enrichment effect of drugs at the myocardial target; for the T-shaped insulating coaxial sheath designed to match the myocardial biopsy needle, it can reduce complications such as pericardial effusion, bleeding and arrhythmia caused by multiple punctures, and achieve safer and more effective myocardial tissue biopsy sampling. At the same time, this myocardial biopsy needle is equipped with a partitioned independent tissue collection box; implanting a surgical miniaturized ICD to protect the patient and avoid real-time monitoring and preventing cardiac arrest; at the same time, inserting the T-shaped insulating electrocardiogram monitoring sheath into the myocardial tissue can real-time monitor the intracardiac electrocardiogram activity, improving the real-time performance and accuracy of electrocardiogram monitoring.

[0138] Specifically, first, the working end length of the radiofrequency electrode needle of the present invention can be precisely adjusted in a card slot push-pull manner. The core of the present invention adopts a card slot push-pull sliding adjustment button. By pushing and pulling the slider, the T-shaped insulating sheath is driven to move along the outer wall of the radiofrequency ablation needle, realizing a fine interval adjustment of 0.1 - 5.0 mm within the range of 0 - 50 mm. The adjustment button is prepared by integral molding, which can achieve a more stable, convenient, accurate and rapid adjustment of the working end length of the electrode needle, and realize conformal ablation treatment for different ventricular septal thicknesses of the myocardium. That is, the present invention adopts a card slot push-pull moving adjustment mechanism. The T-shaped insulating coaxial sheath and the handle Luer rotary interface are connected by rotation, and the push-pull adjustment button drives the moving slider to move radially along the card slot grid by grid stably, synchronously driving the T-shaped insulating coaxial sheath to move radially along the radiofrequency electrode needle, realizing precise adjustment of the working end size of the exposed area of the electrode needle;

[0139] Secondly, the multifunctional T-shaped insulating coaxial sheath and the matched device in the present invention can realize the observation and detection of hemorrhagic pericardial effusion and the emergency treatment of pericardial drainage; perform drug myocardial targeted injection to improve the enrichment of drugs at myocardial targets; match the electrocardiogram conduction system monitoring marker probe to mark the position of the myocardial conduction bundle; match the dedicated myocardial biopsy and the independent biopsy tissue collection box to reduce the number of punctures on the premise of multiple tissue samplings, with sufficient sampling volume, flexible position, small trauma, and reducing complications such as pericardial effusion or arrhythmia caused by multiple punctures. The independent myocardial tissue biopsy collection box can avoid confusion and contamination between tissue samples; match the implanted micro-ICD electrode wire to extend into the right ventricular apex or the right ventricular outflow tract pacing point position along the coaxial sheath, which can improve the success rate of wire placement, reduce the risk of myocardial perforation, and reduce the mortality related to cardiac arrest during the operation. The T-shaped insulating electrocardiogram monitoring sheath can be inserted into the myocardial tissue to monitor the intracardiac electrocardiogram activity in real time, improving the timeliness and accuracy of electrocardiogram monitoring. Compared with the conventional single-channel conventional coaxial sheath, it shows great clinical application value.

[0140] The present invention adopts a radiofrequency ablation component containing a multifunctional T-shaped sheath to realize stable, convenient and precise adjustment of the length of the exposed working area of the electrode needle, providing a safer, more stable and convenient solution for the treatment of hypertrophic cardiomyopathy and various multiple organ tumors, and showing great application prospects in the clinical treatment of hypertrophic cardiomyopathy and various organ tumors.

[0141] The above are only the preferred embodiments of the present invention and are not used to limit the present invention. For those skilled in the art, the present invention can have various changes and modifications. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. A radiofrequency ablation needle assembly with a multifunctional T-shaped coaxial sheath, characterized in that, Comprising: 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 outside the handle (1); A position adjusting member (4) is provided inside the handle (1), and the position adjusting member (4) includes a connecting portion (41), a deformation portion (42), and a pressing adjustment portion (43) connected in sequence; A T-shaped insulating coaxial sheath (3) is detachably provided on the handle (1); the T-shaped 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 at the same time, a secondary sheath interface (33) is provided on the side wall of the main sheath tube (31); an insulating layer is provided on the outer wall of the insulating sheath (32); During use, the free end of the main sheath tube (31) is connected to the connecting portion (41), and the insulating sheath (32) is sleeved on the ablation needle (2). The T-shaped insulating coaxial sheath (3) can move along the axial direction of the ablation needle (2) under the drive of the position adjusting member (4) to adjust the length of the distal end of the ablation needle (2) extending out of the T-shaped insulating coaxial sheath (3).

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

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

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

5. A radiofrequency ablation needle assembly with a multifunctional T-shaped coaxial sheath according to claim 1, characterized in that, The radiofrequency ablation assembly with a multifunctional T-shaped sheath further includes at least one group of a myocardial electrocardiogram conduction system monitoring assembly (5), a micro-implantable ICD assembly (7), and a myocardial biopsy assembly (8); during 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 tube (31).

6. The radiofrequency ablation needle assembly with a multifunctional T-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 accommodating unit (82); The myocardial biopsy sampling unit (81) includes a biopsy needle core (83), and a sampling inner groove (84) is provided on the biopsy needle core (83). 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 accommodating unit (82) includes a plurality of independent tissue accommodating chambers (85).

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

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

9. The radiofrequency ablation needle assembly with a multifunctional T-shaped coaxial sheath according to claim 1, characterized in that, The deformation part (42) includes a support part (44) and a clamping part (45), and a clamping member (46) is provided on the clamping part (45); the support part (44) is slidably arranged inside the handle (1); A plurality of clamping grooves (11) are provided inside the handle (1), and the plurality of clamping grooves (11) are evenly spaced along the axial direction of the handle (1); The clamping member (46) is arranged in cooperation with the clamping groove (11).

10. The radiofrequency ablation needle assembly with a multifunctional T-shaped coaxial sheath according to claim 1, wherein, The distance between two adjacent clamping grooves (11) is 0.1 - 5.0 mm.

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

12. The radiofrequency ablation needle assembly with a multifunctional T-shaped coaxial sheath according to claim 1, characterized in that, A cooling circulation system (9) is further provided inside the handle (1), and a circulating peristaltic pump is provided on the cooling circulation system (9); a thermocouple temperature measurement component is provided inside the tip of the ablation needle (2).

13. An ablation system, characterized in that, It includes the radiofrequency ablation assembly with the multi-functional Y-shaped coaxial sheath according to any one of claims 1 - 12 and an energy generating device electrically connected to the ablation needle (2); a negative electrode patch is further connected to the energy generating device; the energy generating device is a radiofrequency generator, a microwave generator, a pulsed electric field generator, or an irreversible electroporation device.

14. An ablation system according to claim 13, wherein, The power of the radiofrequency generator is less than 300 W.

Images