Atrial septostomy device and atrial septostomy system

Abstract

The present invention discloses an atrial septostomy device and an atrial septostomy system thereof. The ostomy device includes a support portion, an extension portion connected to the support portion, and an ablation portion. The extension portion includes a compensation extension portion for extending the length of the support portion and / or a positioning extension portion for positioning the support portion. The ablation portion includes at least two groups of ablation elements for atrial septal tissue ablation electrically connected to an ablation power source provided on the support portion and / or the extension portion. Among them, the ablation elements provided on the support portion are arranged in a circle around the outer periphery of the support portion, and the ablation elements provided on the extension portion are located around the perforation and adhere to the atrial septal tissue after implantation. The atrial septostomy system includes at least an atrial septostomy device and a conductive connecting member. The device and system of the present invention are both recyclable, do not require tissue cutting, and are not prone to embolism formation.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and relates to a percutaneous interventional atrial septostomy device, and particularly to an atrial septostomy device and an atrial septostomy system thereof. Background Art

[0002] Heart failure (referred to as HF), is a group of complex clinical syndromes caused by any heart structure or functional abnormalities that lead to impaired ventricular filling or ejection ability. Its main clinical manifestations are dyspnea and fatigue (limited exercise tolerance), as well as fluid retention (pulmonary congestion and peripheral edema). HF is the severe and terminal stage of various heart diseases, with a high incidence rate and is one of the most important cardiovascular diseases today. According to the location of heart failure, it can be divided into left heart, right heart, and total heart failure.

[0003] Heart failure is a serious disease with high incidence and fatality rates. The incidence rate of heart failure in China is 2-3%, more than 12 million. The main causes of heart failure are hypertension, coronary heart disease, myocardial infarction, heart valve diseases, atrial fibrillation, cardiomyopathy, etc. Cardiovascular diseases cause damage to the left ventricle, leading to pathological remodeling of the left ventricle and reduced cardiac function. Each successful treatment of a myocardial infarction patient brings a potential heart failure patient.

[0004] In terms of treatment, after optimizing drug treatment, the symptoms of patients still recur frequently. And currently, drug treatment is almost only effective for patients with reduced ejection fraction, and the curative effect on patients with normal ejection fraction is not ideal. Cardiac resynchronization therapy is not suitable for all heart failure patients, and more than 20% of patients are ineffective for cardiac resynchronization pacing. The surgery of left ventricular assist device requires extracorporeal circulation, with large trauma, high complication incidence rate, high price and difficult to obtain, and it is not yet on the market in China. Heart transplantation is the ultimate solution, but the source of donors is very limited and the price is expensive.

[0005] On the other hand, pulmonary arterial hypertension is a group of diseases characterized by a progressive increase in the pulmonary vascular resistance of the pulmonary circulation system. Its pathological changes include pulmonary vasoconstriction and remodeling, abnormal proliferation of pulmonary vascular smooth muscle and endothelial cells, in-situ thrombosis, etc., ultimately leading to right heart failure and death. Currently, with the increasingly in-depth research on the pathogenesis of pulmonary arterial hypertension, there are more and more treatment methods. The treatment plan for pulmonary arterial hypertension should be individualized and systematic, and cannot be treated by a single drug. Its treatment methods include: general treatment, non-specific drug treatment, targeted drug treatment, NO inhalation treatment, gene treatment, interventional and surgical treatment. In the late stage of the disease in patients with pulmonary arterial hypertension, the effect is often not obvious, the survival rate is low, and the prognosis is extremely poor after the above comprehensive treatment. At this time, surgical treatment methods such as atrial septostomy, lung transplantation, and combined heart and lung transplantation can be tried to save the patient's life, but such treatment methods have many factors such as high surgical risks, lack of donors, transplant rejection reactions, and high subsequent treatment costs.

[0006] Atrial septostomy is to create an opening in the atrial septum of the patient, thereby forming a shunt between the left and right atria, which is used to treat pulmonary arterial hypertension (right-to-left shunt) or left heart failure (left-to-right shunt), and its effectiveness has been proven clinically.

[0007] Traditional atrial septostomy methods, such as balloon atrial septostomy, have a tendency for myocardial tissue to rebound after the opening is created, and the opening will shrink or even completely close after a period of time. To solve the problem of the opening shrinking or closing, a stoma stent is provided in the prior art, and an implant for atrial shunting is separately disclosed. Its characteristic is that after percutaneous atrial septal puncture, an implant is percutaneously delivered and implanted at the atrial septal puncture site to keep the shunt opening unobstructed.

[0008] There is a current stoma instrument, including a cutting device and a grasping device. When the instrument creates a stoma in the tissue, the grasping device first locates and grasps the part of the tissue to be cut; then the cutting part of the cutting device cuts the part of the tissue grasped by the grasping device, and the cut part of the tissue is taken out of the body by the grasping device, thereby forming a stoma.

[0009] The above technologies have the following defects: For the implant for atrial shunting, the instrument is left at the perforation, which is likely to cause thrombosis or the instrument to fall off and form an embolism. In addition, due to endothelial adhesion, the instrument opening may be blocked, and the channel closes and loses the shunting function. In addition, during the operation, the intracardiac tissue is cut by mechanical or high-frequency electrosurgery, which has a high risk. For example, during the operation, the grasping device may become loose or during recovery, it may cause the cut tissue to fall off and form an embolism. In addition, if the grasping device becomes loose during the cutting process, it is extremely easy to damage other myocardial tissues. Summary of the Invention

[0010] The technical problem to be solved by the present invention is to provide an atrial septostomy device and an atrial septostomy system which are recyclable, do not require tissue cutting, and are not prone to embolism, in view of the defects of the prior art.

[0011] The technical solution adopted by the present invention to solve its technical problem is:

[0012] An atrial septal stoma device comprises a support portion that passes through the atrial septum and expands radially to open the atrial septal tissue to form a perforation, an extension portion connected to the support portion, and an ablation portion;

[0013] The extension portion includes a compensating extension portion for extending the length of the support portion and / or a positioning extension portion for positioning the support portion;

[0014] The ablation portion includes at least two groups of ablation elements for ablation of atrial septal tissue, which are electrically connected to an ablation power source and are arranged on the support portion and / or the extension portion.

[0015] Furthermore, in the atrial septal stoma device, the compensating extension portion is preferably arranged in the axial direction of the supporting portion, and the positioning extension portion extends outward from the supporting portion and presses against the atrial septal tissue.

[0016] Furthermore, in the atrial septal stoma device, the compensating extension portion is preferably formed by extending axially outward from the proximal end or / and the distal end of the support portion;

[0017] Alternatively, the compensating extension portion is formed by extending axially outward from at least one position among the proximal end portion, the distal end portion, and the middle portion of the support portion.

[0018] Furthermore, in the atrial septal stoma device, the compensating extension part is preferably a self-expanding single-layer or multi-layer corrugated stent, a mesh stent, a rod-shaped stent, or a tubular structure or annular structure formed by a combination thereof.

[0019] Furthermore, in the atrial septal stoma device, preferably, the diameter of the compensating extension portion is equal to, slightly larger than, or slightly smaller than the diameter of the supporting portion.

[0020] Furthermore, in the atrial septal stoma device, the positioning extension portion is preferably formed by extending radially outward from the proximal end or / and the distal end of the support portion and is pressed against the atrial septal tissue around the perforation;

[0021] Alternatively, the positioning extension portion extends from at least one of the proximal end, the distal end, and the middle portion of the support portion toward the proximal end or the distal end and gradually turns radially outward to press against the atrial septum tissue.

[0022] Furthermore, in the atrial septal stoma device, the positioning extension portion is preferably a self-expanding single-layer or multi-layer corrugated stent, a mesh stent, a rod-shaped stent or a combination thereof.

[0023] Further, in the atrial septal ostomy device, preferably, the positioning and extending part is provided with a positioning surface, a positioning line or positioning points that are in contact with the surface of the atrial septum. The positioning surface is a plane, a conical surface, an arc surface or a combination thereof that surrounds or covers the perforation; the positioning line is a curve, a straight line or a combination thereof that forms a linear contact with the surface of the atrial septum around the perforation; the positioning points are a plurality of protrusions that are arranged around the perforation for at least one circle and form point contacts with the surface of the atrial septum.

[0024] Further, in the atrial septal ostomy device, preferably, the supporting part is a self-expanding corrugated stent, a reticular stent, a rod-shaped stent or a tubular structure or an annular structure formed by their combination.

[0025] Further, in the atrial septal ostomy device, preferably, the supporting part is provided with an adjusting mechanism for adjusting the radial dimension of the supporting part.

[0026] Further, in the atrial septal ostomy device, preferably, the adjusting mechanism includes at least one control line. The control line passes through different positions in the circumferential direction of the supporting part at the same time, and the dimension of the supporting part is adjusted by controlling the length of the line passing through the circumferential direction of the supporting part.

[0027] Further, in the atrial septal ostomy device, preferably, the adjusting mechanism includes at least two control lines. Both ends of each control line pass through different positions in the circumferential direction of the supporting part and converge into a bundle towards the center of the supporting part and are fixed to limit the radial dimension of the supporting part.

[0028] Further, in the atrial septal ostomy device, preferably, the ablation member provided on the supporting part is arranged in a circle around the outer periphery of the supporting part, and the ablation member provided on the extending part is located around the perforation and adheres to the atrial septal tissue after implantation.

[0029] Further, in the atrial septal ostomy device, preferably, the ablation member is a conductive metal member exposed on the outer surface of the supporting part and / or the extending part. The remaining supporting part and extending part except the ablation member are at least insulated near or in contact with the outer surface of the atrial septum; or the position connected to the ablation member is at least insulated near or in contact with the outer surface of the atrial septum.

[0030] Further, in the atrial septal ostomy device, preferably, the outer surface insulation means that an insulating coating is coated on the outer surface, or an insulating film is covered on the outer surface, or an insulating sleeve is sleeved on the outer surface.

[0031] Further, in the atrial septal ostomy device, preferably, the ablation member is an electrode fixed on the outer surface of the supporting part and / or the extending part;

[0032] An insulator for preventing the electrode from conducting electricity at its fixed position is provided on the back of the electrode, or at least the outer surfaces of the support part and / or the extension part connected to the electrode are insulated.

[0033] Further, in the atrial septal ostomy device, preferably, the electrode is an annular electrode; or the electrode is a single electrode continuously or discontinuously arranged in a circle on the support part and / or the extension part.

[0034] Further, in the atrial septal ostomy device, preferably, two sets of electrodes are provided, and both sets of electrodes are monopolar ablation electrodes. One electrode is respectively provided on at least two of the support part, the compensation extension part or the positioning extension part, or two sets of electrodes are simultaneously provided on one of the support part, the compensation extension part or the positioning extension part.

[0035] Further, in the atrial septal ostomy device, preferably, two sets of electrodes are provided, and the two sets of electrodes are bipolar ablation electrodes. One set of electrodes is respectively provided on two of the support part, the compensation extension part or the positioning extension part. One set of electrodes is connected to the ablation power supply, and the other set of electrodes is grounded.

[0036] Further, in the atrial septal ostomy device, preferably, three sets of electrodes are provided; three sets of electrodes are simultaneously provided on one of the support part, the compensation extension part or the positioning extension part;

[0037] Or among the support part, the compensation extension part and the positioning extension part, two sets of electrodes are provided on one, one set of electrodes is provided on one, and no electrode is provided on one;

[0038] Or one set of electrodes is respectively provided on each of the support part, the compensation extension part and the positioning extension part.

[0039] Further, in the atrial septal ostomy device, preferably, all three sets of electrodes are monopolar ablation electrodes;

[0040] Or one set of the three sets of electrodes is a monopolar ablation electrode, and the other two sets are bipolar ablation electrodes;

[0041] Or the three sets of electrodes are respectively connected to the output ports of phase A, phase B and phase C of the three-phase voltage source of the ablation power supply.

[0042] Further, in the atrial septal ostomy device, preferably, the ablation parts provided on the positioning extension part and the compensation extension part are arranged in at least one circle in a manner that fits the proximal end and / or the distal end of the support part.

[0043] Further, in the atrial septal ostomy device, preferably, a cage-shaped thrombus capture mechanism is connected to the support part or the extension part.

[0044] Further, in the atrial septostomy device, it is preferred that a recovery part is provided on the support part or the extension part.

[0045] Further, in the atrial septostomy device, it is preferred that the ablation part is further provided with a temperature sensor in contact with the atrial septum tissue.

[0046] Further, in the atrial septostomy device, it is preferred that the ablation part is provided with at least one radiopaque point.

[0047] Further, in the atrial septostomy device, it is preferred that the surface of the support part is coated with a drug coating.

[0048] An atrial septostomy system includes the above atrial septostomy device and a conductive connector electrically connected to the ostomy device;

[0049] The conductive connector is of an integral structure with the ostomy device, detachably connected or fixedly connected.

[0050] An atrial septostomy system includes the above atrial septostomy device, a conductive connector, and a pusher. The conductive connector is electrically connected to the ablation member, and the pusher is detachably and fixedly connected to the atrial septostomy device.

[0051] An atrial septostomy system includes the above atrial septostomy device, a conductive connector, a pusher, and a sheath. The conductive connector is electrically connected to the ablation member in the atrial septostomy device. The pusher is detachably and fixedly connected to the atrial septostomy device, and the atrial septostomy device is radially contracted and received in the sheath.

[0052] An atrial septostomy system includes the above atrial septostomy device, a conductive connector, a pusher, and a sheath mechanism. The conductive connector is electrically connected to the ablation member in the atrial septostomy device. The pusher is detachably and fixedly connected to the atrial septostomy device. The sheath mechanism includes a sheath and a stylet sleeved with each other. The pusher and the sheath mechanism are proximally connected with a control handle, and the atrial septostomy device is radially contracted and received in the sheath.

[0053] In the atrial septostomy device and atrial septostomy system of the present invention, a support part is used to expand the atrial septum after puncture, and an ablation part is used to ablate the atrial septal tissue, avoiding the risk of embolism caused by tissue cutting. Moreover, the instrument after stoma formation can be retrieved, avoiding problems such as instrument detachment. At least two groups of ablation parts are provided, which can ablate at the perforation and around the perforation of the atrial septal tissue. On the one hand, the two groups of ablation structures can heat the tissue at the perforation, making the tissue lose its activity and preventing the perforation from being blocked by the repair and endothelial crawling of the tissue. On the other hand, they can also fix the shape of the enlarged perforation. The ablation part provided on the extension part can increase the heating range of the tissue around the perforation and also reduce the situation of incomplete ablation caused by inaccurate placement of the device. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] The present invention will be further described below in conjunction with the drawings and embodiments. In the drawings:

[0055] Figure 1 is a schematic structural diagram of Embodiment 1 of the present invention;

[0056] Figures 2-3 is a schematic diagram of the electrode structure of Embodiment 1 of the present invention;

[0057] Figure 4 is a schematic structural diagram of Embodiment 2 of the present invention;

[0058] Figure 5 is a schematic structural diagram of Embodiment 3 of the present invention;

[0059] Figure 6 is Figure 5 the A-A cross-sectional view of

[0060] Figure 7 is Figure 6 the partial enlarged view at B of

[0061] Figure 8 is a schematic structural diagram of Embodiment 4 of the present invention;

[0062] Figure 9 is the partial enlarged view of the installation position of the temperature sensor in Embodiment 4 of the present invention;

[0063] Figure 10 is a schematic structural diagram of Embodiment 5 of the present invention;

[0064] Figure 11 is Figure 10 the J-J cross-sectional view of

[0065] Figure 12 is a schematic structural diagram of Embodiment 6 of the present invention;

[0066] Figure 13 is a schematic structural diagram of Embodiment 7 of the present invention;

[0067] Figure 14 yes Figure 13 EE cross-sectional view;

[0068] Figure 15 yes Figure 13 FF cross-sectional view;

[0069] Figure 16 is a schematic diagram of the structure of Embodiment 8 of the present invention;

[0070] Figure 17 is a schematic structural diagram of Embodiment 9 of the present invention;

[0071] Figure 18 is a schematic diagram of the structure of Embodiment 10 of the present invention;

[0072] Figure 19 is a schematic structural diagram of Embodiment 11 of the present invention;

[0073] Figure 20 It is a structural diagram of embodiment 12 of the present invention. DETAILED DESCRIPTION

[0074] In order to have a clearer understanding of the technical features, purposes and effects of the present invention, specific embodiments of the present invention are now described in detail with reference to the accompanying drawings.

[0075] The distal end and the proximal end in the present invention are relative to the operator. The end of the atrial septostomy device closer to the operator is the proximal end, and the end farther from the operator is the distal end. The part close to the proximal end surface is called the proximal end portion, and the part close to the distal end surface is called the distal end portion. The structure and shape described in the present invention refer to the structure and shape in the fully released state.

[0076] Embodiment 1, as Figures 1-3 As shown, an atrial septal stoma device 100 includes a support portion 110 that passes through the atrial septum and expands radially to open the atrial septal tissue to form a perforation, an extension portion 120 connected to the support portion 110, and an ablation portion 130; the extension portion 120 includes a compensating extension portion 120a for extending the length of the support portion 110 and / or a positioning extension portion 120b for positioning the support portion 110. The ablation portion 130 includes at least two groups of ablators 130a and 130b for ablating the atrial septal tissue, which are electrically connected to the ablation power source and are provided on the support portion 110 or / and the extension portion. Among them, the compensating extension portion 120a is provided in the axial direction of the support portion 110, and the positioning extension portion 120b extends outward from the support portion 110 and presses against the atrial septal tissue; the ablation member 130a provided on the support portion 110 is provided in a circle around the outer periphery of the support portion 110, and the ablation member provided on the extension portion is located around the perforation and attached to the atrial septal tissue after implantation.

[0077] Among them, the support part 110 is the main structure of the device of the present invention. After puncture, the support part 110 passes through the atrial septum and can expand the atrial septum tissue to form a perforation. Based on this function, the support part 110 is a self-expandable structure that expands in all directions, that is, the support part 110 is an elastic stent that can radially contract and expand. When the support part 110 is transported through the sheath tube, its diameter can be contracted to a smaller state for transportation in the sheath tube. When released in the heart, it can automatically expand to the required shape and size and can exert a certain radial support on the tissue in contact with it.

[0078] Preferably, the support part 110 is a self-expandable single-layer or multi-layer corrugated stent, mesh stent, rod-shaped stent, or a tubular structure or annular structure formed by their combination. In order to evenly expand the perforation, it is preferred that the support part 110 as a whole is a rotary body to form a tubular structure or an annular structure. For example, the support part 110 can be a tubular structure formed by a rotary surface with a concave bus, an equal-diameter tubular structure, or a curved surface with a convex side wall. The curved surface forms a closed curved structure in the circumferential direction, and the positions of the convex and concave can be set according to needs. The convex or concave structure can be formed alone, or the convex or concave structures can be combined and arranged on the same support part 110. Convex structures such as: disc-shaped, spherical frustum-shaped, etc., concave structures such as: hourglass-shaped. In this embodiment, a cylindrical structure is adopted. The axial length of the support part 110 is set according to actual needs, and generally, it only needs to match the thickness of the atrial septum tissue. In addition, the corrugated stent is a wavy structure in which corrugated units are connected end to end in the circumferential direction and arranged axially. The mesh stent is a grid-like structure formed by weaving metal wires. The rod-shaped stent is a structure formed by radially radiating and extending struts. As Figure 1 shown, in this embodiment, the support part 110 is a rod-shaped structure made of nickel alloy. A nickel alloy tube can be cut into struts, and the struts are arranged in the circumferential direction and intersect with each other to form a mesh.

[0079] The extension part extends from the support part 110 and functions to compensate and position. According to different functions, the extension part includes two types: one is the compensation extension part 120a and the other is the positioning extension part 120b. The compensation extension part 120a is used to compensate for or avoid the deviation of the support part 110 from the perforation. According to different setting positions, one structure of the compensation extension part 120a is formed by axially extending outward from the proximal end or / and the distal end of the support part 110; that is, it is directly formed by extending from the end face of the support part 110, and there is no obvious distinction between the support part 110 and the compensation extension part 120a. Another structure of the compensation extension part 120a is formed by axially extending outward from at least one of the proximal end, the distal end, and the middle part of the support part 110. The extension position can be inside the support part 110 or outside the support part 110, that is, the support part 110 bifurcates at a certain position, one part extends to form the compensation extension part 120a, and the other part is the main body of the support part 110.

[0080] One or two extension parts 120 can be provided. When one is provided, it can be provided at the proximal end or the distal end of the support part 110. When two are provided, they can be provided at both the proximal end and the distal end. The extension part 120 can be provided as two compensation extension parts 120a, or two positioning extension parts 120b, or one compensation extension part 120a and one positioning extension part 120b. As Figure 1 shown, in this embodiment, one compensation extension part 120a is provided at the proximal end of the support part 110, and one positioning extension part 120b is provided at the distal end of the support part 110. That is, the extension part 120 includes a positioning extension part 120b with a proximal end connected to the support part 110 and a distal end extending radially, and a compensation extension part 120a with a distal end connected to the support part 110 and a proximal end extending axially. The positioning extension part 120b can prevent the support part 110 from extending distally and deviating from the perforation, resulting in the inability to expand the tissue at that location; the compensation extension part 120a can compensate for the adverse effects caused by the deviation of the support part 110 from the perforation.

[0081] According to the function of the extension part 120, the extension part 120 and the support part 110 can be an integral structure or a fixed connection structure.

[0082] The compensation extension part 120a is a self-expanding single-layer or multi-layer corrugated stent, mesh stent, rod-shaped stent, or a tubular or annular structure formed by combining them. The corrugated stent is a wavy structure in which corrugated units are connected end to end circumferentially and arranged axially. The mesh stent is a grid-like structure formed by weaving metal wires. The rod-shaped stent is a structure formed by radially radiating struts. The compensation extension part 120a can be selected as a single-layer or multi-layer structure according to needs, and its structure can be the same as or different from that of the support part 110. Generally, the compensation extension part 120a has the same or similar structure and shape as the support part 110. Preferably, the structure and shape of the compensation extension part 120a are the same, or the compensation extension part 120a is a shape and structure extended from the support part 110, so as to extend and lengthen the support part 110 axially. Preferably, the diameter of the compensation extension part 120a is equal to, slightly larger than, or slightly smaller than the diameter of the support part 110. If the diameters are the same, it is directly formed by extending the support part 110. If there is a difference in diameter, it can be formed through a transition component. For example: if the support part 110 is a cylindrical structure, then the compensation extension part 120a is also cylindrical, or a frustum-shaped structure formed by gradually reducing the diameter of the support part 110, or an elliptical cylinder structure, or a conical structure with a gradually decreasing diameter, etc.

[0083] The positioning extension part 120b is formed by radially extending outward from the proximal end or / and the distal end of the support part 110 and pressing against the atrial septal tissue around the perforation; or the positioning extension part 120b extends outward from at least one of the proximal end, distal end, and middle part of the support part 110 to the outside of the proximal end or the outside of the distal end and gradually turns outward radially to press against the atrial septal tissue.

[0084] The positioning extension part 120b is a self-expanding single-layer or multi-layer corrugated stent, mesh stent, rod-shaped stent, or a combination thereof. The corrugated stent is a wavy structure radially extending from the support part 110. The mesh stent is a grid-like structure formed by weaving metal wires. The rod-shaped stent is a structure formed by radially radiating struts. The specific structure can be the same as or different from that of the support part 110.

[0085] The positioning extension 120b is used to position and fix the atrial septum stoma device 100 to keep it stable. The positioning extension 120b is provided with a positioning surface, a positioning line or a positioning point that is in contact with the atrial septum wall surface. The positioning surface, the positioning line or the positioning point can protrude from other parts of the positioning extension 120b, or there is a part of the positioning extension 120b surrounding the perforation that can be attached to or close to the atrial septum tissue, and then the atrial septum tissue is clamped or pressed by the positioning surface, the positioning line or the positioning point. The positioning surface is a plane, a conical surface, an arc surface or a combination thereof that surrounds or covers the perforation; the positioning line is a curve, a straight line and a combination thereof that forms a linear contact with the atrial septum wall surface around the perforation; the positioning point is a plurality of protrusions that are arranged at least one circle around the perforation and form a point contact with the atrial septum wall surface. The positioning extension 120b that forms the positioning surface, the positioning line and the positioning point may not be limited in shape and structure.

[0086] like Figure 1 As shown, in this embodiment, the positioning extension part 120b is formed radially along the structure of the support part 110 itself, and the positioning extension part 120b is connected to the distal end of the support part 110. The positioning extension part 120b is a plurality of struts extending radially outward, and the main parts of the plurality of struts are in the same plane, forming a planar structure, forming a positioning surface. The end of the strut is folded toward the distal end to prevent the end of the positioning extension part 120b from piercing the atrial septal tissue when it is pressed against the atrial septal tissue.

[0087] A compensating extension portion 120 a is provided at the proximal end of the support portion 110 . The compensating extension portion 120 a is formed by extending the support portion 110 , and is consistent with the support portion 110 in shape and structure, and both adopt a rod-shaped structure.

[0088] The ablation part 130 is used to ablate the atrial septum tissue. According to the different positions of the ablation part 130, the functions are different. It includes at least two ablators 130a and 130b. When the ablation part 130a is set on the support part 110, the ablation part 130a at this position is installed in the perforation, which can heat the tissue at the perforation to make the tissue inactive and prevent the perforation from being blocked by the repair endothelium of the tissue; the ablation part 130b set on the extension part 120 has the function of heating the tissue around the perforation to make the tissue inactive and prevent the perforation from being blocked by the repair endothelium of the tissue. More importantly, it can fix the shape of the perforation after expansion and reduce the situation of inadequate ablation due to inaccurate placement of the device. At least two ablation parts 130a or two ablation parts 130b can be set on one of the support part 110 and the extension part 120, or ablation parts 130a and ablation parts 130b can be set on both the support part 110 and the extension part 120. In this embodiment, a group of ablating elements 130 a is disposed on the supporting portion 110 , and a group of ablating elements 130 b is disposed on the positioning extension portion 120 b .

[0089] In another embodiment, the ablation member 130b may be disposed only on the extension portion 120, particularly on the left atrial positioning extension portion 120b.

[0090] According to the different structures of the ablation members 130a and 130b, there are two cases: one is that the ablation members 130a and 130b are respectively conductive metal members exposed on the outer surfaces of the support portion 110 and / or the extension portion 120, and the other is that the ablation members 130a and 130b are respectively electrodes fixed on the outer surfaces of the support portion 110 and / or the extension portion 120. The conductive metal members and the electrodes can be both disposed on the same device, or one of the ways can be selected to be disposed on the device.

[0091] The ablation members 130a and 130b are exposed conductive metal members. The conductive metal members can be separately provided and fixed on the support portion 110 and / or the extension portion 120, or can be a part of the support portion 110 and / or the extension portion 120 or integrally formed therewith. When separately provided, the ablation members 130a and 130b made of metal are inlaid or pasted on the support portion 110 and / or the extension portion 120. When using a part of the support portion 110 and / or the extension portion 120, it directly utilizes the conductive characteristics of the metal material of the support portion 110 and / or the extension portion 120. The ablation members 130a and 130b are the metals exposed on the outer surfaces of the support portion 110 and / or the extension portion, and are directly used as the ablation members 130a and 130b. The ablation members 130a and 130b being made of exposed conductive metal members means that the ablation members 130a and 130b are directly made of metal. The shapes of the ablation members 130a and 130b can be respective independent sheet-like, network-like, rod-like, etc. shapes that match the shapes of the support portion 110 and / or the extension portion 120, and a plurality of them are arranged at intervals around the support portion 110 and / or the extension portion 120 for one week. The ablation members 130a and 130b can also be ablation members 130a and 130b having a continuous or discontinuous annular structure arranged in a circle around the support portion 110 and / or the extension portion 120 for one week. The annular structure in a circle is a structure that can contract towards the center or a soft and bendable structure, which is convenient for being received into the sheath tube.

[0092] Since the ablation member 130a is conductive and used to ablate a part of the tissue of the support portion 110, it can only be energized and conducted through the corresponding perforated atrial septum tissue, and cannot affect other parts of the heart. Therefore, the remaining support portion 110 and the extension portion 120 other than the ablation member 130a are at least insulated near or in contact with the outer surface of the atrial septum wall; or the position where it is connected to the ablation member 130a is at least insulated near or in contact with the outer surface of the atrial septum wall. Or it is required that an insulating member for preventing energization and conduction between the ablation member 130a and the support portion 110 be provided. The outer surface insulation means that an insulating coating is applied to the outer surface, or an insulating film is covered on the outer surface, or an insulating sleeve is sleeved on the outer surface. The insulating coating is selected from parylene coating, PTFE coating, PI coating, etc. The insulating film is selected from PTFE film, PU film, etc., and the insulating sleeve is selected from PTFE, PU sleeve, etc.

[0093] When the ablation members 130a and 130b are selected as electrodes fixed on the outer surface of the support portion 110 and / or the extension portion 120; based on the same requirement, an insulator for preventing conduction between the electrode and its fixed position is provided on the back of the electrode, or the support portion 110 and / or the extension portion 120 connected to the electrode is at least insulated on the outer surface.

[0094] When the ablation members 130a and 130b are selected as electrodes, the electrodes can be ring electrodes; or the electrodes are single electrodes continuously or intermittently arranged in a circle on the support portion 110 and / or the extension portion 120.

[0095] The ablation members 130a and 130b are electrodes provided in two or more groups. According to different electrode structures, the first structure is that two groups of electrodes are provided. The first implementation manner of the electrodes in this structure is: preferably, both groups of electrodes are monopolar ablation electrodes, and one of the electrodes is respectively provided on at least two of the support portion 110, the compensation extension portion 120a or the positioning extension portion 120b, or two groups of electrodes are simultaneously provided on one of the support portion 110, the compensation extension portion 120a or the positioning extension portion 120b.

[0096] The second implementation manner of the electrodes in this structure is: the two groups of electrodes are bipolar ablation electrodes, and one group of electrodes is respectively provided on two of the support portion 110, the compensation extension portion 120a or the positioning extension portion 120b, and one group of electrodes is connected to the ablation power supply, and the other group of electrodes is grounded.

[0097] The second structure is as follows: It is preferable that three sets of electrodes are provided; three sets of electrodes are simultaneously provided on one of the support part 110, the compensation extension part 120a, and the positioning extension part 120b; or among the support part 110, the compensation extension part 120a, and the positioning extension part 120b, two sets of electrodes are provided on one, one set of electrodes is provided on one, and no electrodes are provided on one; or one set of electrodes is respectively provided on each of the support part 110, the compensation extension part 120a, and the positioning extension part 120b.

[0098] The first implementation manner of the electrodes in this structure is: It is preferable that all the three sets of electrodes are monopolar ablation electrodes;

[0099] The second implementation manner of the electrodes in this structure is: One of the three sets of electrodes is a monopolar ablation electrode, and the other two are bipolar ablation electrodes;

[0100] The third implementation manner of the electrodes in this structure is: The three sets of electrodes are respectively connected to the output ports of phase A, phase B, and phase C of the three-phase voltage source of the ablation power supply.

[0101] In this embodiment, as Figure 1 shown, the ablation part 130 includes two sets of ablation members 130a, 130b. One set is to provide a plurality of electrodes around the support part 110 as the ablation member 130a, and one set is to also provide a plurality of electrodes on the positioning extension part 120b as the ablation member 130b. Specifically, the ablation members 130a, 130b are selected to be flexible metal electrodes. The two sets of ablation members 130a, 130b can be respectively connected to the ablation power supply as monopolar electrodes and used in cooperation with an external neutral electrode plate, or one of the two sets of ablation members 130a, 130b is connected to the ablation power supply, and the other is grounded to form bipolar ablation.

[0102] The surfaces of the support part 110, the positioning extension part 120b, and the compensation extension part 120a are all coated with a PI insulating coating.

[0103] As Figures 2-3 shown, the ablation members 130a, 130b are composed of flexible electrodes 190. The flexible electrodes 190 are connected to the support part 110 through an adhesive layer 191. The flexible electrodes 190 are composed of an adhesive layer 191, a PI bottom lining 192, an electrode copper layer 193, and a PI covering layer 194. Its contour mainly includes an electrode part 195, a wire part 196, and a connection part 197. The electrode part 195 is composed of an adhesive layer 191, a PI bottom lining 192, and an electrode copper layer 193; the wire part 196 is composed of an adhesive layer 191, a PI bottom lining 192, an electrode copper layer 193, and a PI covering layer 194; the connection part 197 is composed of an electrode copper layer 193.

[0104] As Figure 1As shown, in order to achieve the recovery of the atrial septostomy device 100, the proximal end of the compensating extension portion 120a is preferably connected with a recovery portion 140. In this embodiment, the recovery portion is conical, and its proximal end is contracted to form a connecting port 141. The connecting port 141 is a tubular structure and has 8 fixing holes 142 evenly distributed along the circumference.

[0105] Embodiment 2, as Figure 4 As shown, this embodiment is improved on the basis of embodiment 1.

[0106] An atrial septal stoma device 100 includes a support portion 110 that passes through the atrial septum and expands radially to open the atrial septum tissue to form a perforation, and an extension portion 120 connected to the support portion 110.

[0107] The difference between this embodiment and embodiment 1 is that the extension portion 120 described in this embodiment includes two positioning extension portions 120b for positioning the support portion 110; that is, a positioning extension portion 120b is respectively provided at the distal end and the proximal end of the support portion 110, and a group of ablation elements 130a and 130b for ablation of atrial septal tissue that are electrically connected to the ablation power supply are respectively provided on the support portion 110 and the extension portion 120.

[0108] like Figure 4 As shown, in this embodiment, the support portion 110 and the positioning extension portion 120b are both mesh structures formed by weaving metal wires, and the support portion 110 and the positioning extension portion 120b can be woven into an integral structure. Both positioning extension portions 120b are planar structures, which are perpendicular or substantially perpendicular to the support portion 110 to form a positioning surface for clamping the atrial septum tissue.

[0109] The support portion 110 is short cylindrical, and a group of ablators 130a are arranged on its outer wall. In this embodiment, multiple electrodes are arranged around the support portion 110 in a circle as the ablators 130a. The electrodes are arranged vertically, and the length of the electrodes is from the proximal end to the distal end of the support portion 110. Alternatively, a ring electrode is selected as the ablator 130a. Preferably, the electrode of the support portion 110 is a continuous ring-shaped, highly elastic, soft metal wire or metal sheet. The electrode of the support portion is attached to the support portion 110 by suture suturing and (or) binding.

[0110] Among the two positioning extension parts 120b, a set of ablation elements 130b is arranged on one positioning extension part 120b. The ablation elements 130b can select multiple electrodes arranged at intervals in a circle. The electrodes of the positioning extension part 120b are also a continuous annular, highly elastic and soft metal wire or metal sheet. The electrodes of the positioning extension part 120b are attached to the positioning extension part 120b by suture and / or binding. The electrodes arranged on the positioning extension part 120b are electrically exposed electrodes and are insulated from each other between the electrodes and the positioning extension part 120b. The ablation elements 130a of the support part 110 and the ablation elements 130b of the positioning extension part 120b are respectively connected to the ablation power supply through the welding connection wires 211 and 212 for power-on, and the outer surfaces of the wires 211 and 212 are insulated.

[0111] The polarity selection of the ablation elements 130a of the support part 110 and the ablation elements 130b of the positioning extension part 120b includes but is not limited to the following three schemes:

[0112] 1. The electrodes of the support part 110 and the electrodes of the positioning extension part 120b are both connected to the same ablation power supply output port through wires, and the neutral electrode plate is grounded.

[0113] 2. The electrode 130a of the support part 110 is connected to the ablation power supply output port through a wire, and the electrode 130b of the positioning extension part 120b is grounded through a wire, without a neutral electrode plate.

[0114] 3. The electrode of the positioning extension part 120b is connected to the ablation power supply output port through a wire, and the electrode of the support part 110 is grounded through a wire, without a neutral electrode plate.

[0115] In the present invention, grounding means connecting to the input end of the ablation power supply.

[0116] Except for the electrodes of the support part 110 and the electrodes of the positioning extension part 120b, the surfaces of the remaining support part 110 and the positioning extension part 120b are plated with a polytetrafluoroethylene insulation coating.

[0117] In addition to the above structure, in this embodiment, it is preferable that the positioning and extending portion 120b is connected to thrombus capture mechanisms 170 and 180. The thrombus capture mechanisms 170 and 180 are cage-like structures. The thrombus capture mechanisms 170 and 180 adopt a braided structure, and can be integrally formed with the positioning and extending portion 120b by co-braiding, or the thrombus capture mechanisms 170 and 180 can be separately provided and then welded to form an integral structure. In this embodiment, the structures of the thrombus capture mechanisms 170 and 180 and the support portion 110 can be the same or different, that is, the sizes of the braided mesh holes, the diameters of the metal wires, etc., can be the same or different. In this embodiment, the thrombus capture mechanisms 170 and 180 are conical cage structures, and their bottoms share the positioning and extending portion 120b. When the stoma device in this embodiment is in use, the thrombus capture mechanisms 170 and 180 located in the two atrial cavities are deployed to enclose the three-dimensional space area near the heating area, preventing emboli formed by heating of the blood from entering the circulatory system and preventing embolism.

[0118] As Figure 4 shown, at the outer edge of the positioning and extending portion 120b in the left atrium of this embodiment, a cylindrical left atrial thrombus capture mechanism 180 extending distally is connected, and the two are of an integral structure. The distal end of the left atrial thrombus capture mechanism 180 is closed, and a conical surface 182 is provided on the distal closing surface 181. At the outer edge of the positioning and extending portion 120b in the right atrium, a cylindrical right atrial thrombus capture mechanism 170 extending proximally is connected, and the two are of an integral structure. The proximal end of the right atrial thrombus capture mechanism 170 is closed, and a conical surface 172 is provided on the distal closing surface 171, and the tip of the cone faces proximally and can be connected to a metal nut. The metal nut serves as a recovery portion and a conductive connecting member.

[0119] The surface of the support portion 110 is coated with a drug coating. This drug coating uses the method of adding a drug to a carrier to deliver the required drug to a designated position. The types of drugs are attached to the carrier according to actual needs.

[0120] As Figure 4 shown, the ablation portion 130 is provided with at least one visualization point 113, that is, at least one visualization point hole is opened on or near the ablation members 130a and 130b, and the visualization material is filled in the visualization point hole to form the visualization point 113. In this embodiment, a gold visualization point 113 is used, and the filling method can be mechanical deformation inlaying, welding, bonding, etc. The visualization point 113 is used to show the positions of the ablation members 130a and 130b during the operation, so as to accurately place the ablation members 130a and 130b at the atrial septal tissue perforation.

[0121] The remaining structures of this embodiment are the same as those of Embodiment 1 and will not be elaborated here.

[0122] Embodiment 3, this embodiment is an improvement based on Embodiment 2.

[0123] like Figures 5-7 As shown, an atrial septal stoma device 100 comprises a support portion 110 that penetrates the atrial septum and expands radially to open the atrial septum tissue to form a perforation, and an extension portion 120 connected to the support portion 110. The main difference from the structure of embodiment 2 is that no thrombus capture mechanism is provided.

[0124] like Figure 5 As shown, another different structure is: the support portion 110 is a waist drum-shaped structure formed by a revolving curved surface with a generatrix concave, and the extension portion 120 includes two positioning extension portions 120b for positioning the support portion 110. The two positioning extension portions 120b are respectively located at the far end and the proximal end of the support portion 110. The support portion 110 and the positioning extension portion 120b of this embodiment are both woven mesh structures, and the extension portion 120 is a single-layer woven mesh structure. The support portion 110 and the two positioning extension portions 120b are an integrated structure.

[0125] The two positioning extensions 120b both include a planar portion extending radially outward and a curved portion whose outer edge is curved toward the distal end, and the planar portion is perpendicular or substantially perpendicular to the central axis of the support portion 110 to form a positioning surface. The positioning extension 120b disposed at the proximal end of the support portion 110 is connected to a recovery portion 140, which is conical and extends from the curved portion of the positioning extension 120b toward the proximal end and converges toward the center and converges at a convergence point 141 to connect to the distal end of the pusher.

[0126] like Figures 5-7 As shown, this embodiment includes two groups of ablators 130b, one group of which is arranged on the positioning extension 120b at the distal end of the support portion 110, and the other group of which is arranged on the positioning extension 120b at the proximal end of the support portion 110. The two groups of ablators 130b are arranged in a circle respectively at the proximal end and the distal end of the support portion 110. Since the proximal end and the distal end of the support portion 110 are located at the perforation, the ablators 130b arranged around the proximal end and the distal end of the support portion 110 are conducive to ablating and fixing the tissue around the perforation.

[0127] like Figures 5-7 As shown, of the two groups of ablating elements 130b, one group of ablating elements 130b uses a flexible metal electrode, and the other group of ablating elements 130b uses a conductive metal element with a bare outer surface, specifically: the ablating element 130b disposed on the positioning extension portion 120b at the proximal end of the support portion 110 is an electrode, and the ablating element 130b disposed on the positioning extension portion 120b at the distal end of the support portion 110 is a conductive metal element. All of the support portion 110, the positioning extension portion 120b, and the recovery portion except the ablating element 130b are provided with an insulating coating or are covered with an insulating sleeve.

[0128] likeFigures 6-7 Shown is the positioning extension portion 120b at the distal end of the support portion 110. It can be seen from the figure that the exposed conductive metal part can be the side of the surface close to the atrial septum tissue, or it can be completely exposed. The metal wire can be selected from memory alloy or stainless steel, preferably memory alloy, preferably nickel-titanium alloy.

[0129] The ablation element 130b on the positioning extension part 120b disposed at the proximal end of the support part 110 is an electrode, which is insulated from the positioning extension part 120b. The electrode is a continuous ring-shaped, highly elastic, soft metal wire or metal sheet, and is attached to the positioning extension part 120b at the proximal end of the support part 110 by suture suturing and (or) binding.

[0130] The polarity selection of the two groups of ablators 130b includes but is not limited to the following three schemes:

[0131] 1. The ablation element 130b disposed at the distal end of the support portion 110 and the ablation element 130b disposed at the proximal end of the support portion 110 are both connected to the same ablation power output port, and the neutral electrode plate is grounded.

[0132] 2. The ablation component 130b disposed at the distal end of the support portion 110 is connected to the ablation power output port, and the ablation component 130b disposed at the proximal end of the support portion 110 is grounded without a neutral electrode plate.

[0133] 3. The ablation component 130b disposed at the distal end of the support portion 110 is connected to the ablation power output port, and the ablation component 130b disposed at the proximal end of the support portion 110 is grounded without a neutral electrode plate.

[0134] The remaining structures of this embodiment are the same as those of Embodiments 1-2 and will not be described again here.

[0135] Embodiment 4: This embodiment is improved on the basis of embodiment 3.

[0136] like Figures 8-9 As shown, an atrial septal stoma device 100 includes a support portion 110 that passes through the atrial septum and radially expands to open the atrial septum tissue to form a perforation, and an extension portion 120 connected to the support portion 110 .

[0137] The main difference from the structure of embodiment 3 is that the support portion 110 and the two positioning extension portions 120b of this embodiment are both woven mesh structures, and the two positioning extension portions 120b are both double-layer woven mesh structures. The support portion 110 and the positioning extension portions 120b are an integrated structure.

[0138] Both of the two positioning extension parts 120b are in a conical structure or an approximately conical structure. Their bottom surfaces 121b are planar or conical or arc-shaped surfaces that are approximately planar. The bottom surface 121b is a positioning surface for clamping the atrial septal tissue, and its side walls 122b are in a conical structure. The distal ends of the side walls 122b of one of the positioning extension parts 120b are braided and converge at the convergence point 144, and the distal ends of the side walls 122b of the other positioning extension part 120b are braided and converge at the convergence point 154. Both of the two positioning extension parts 120b are woven from nitinol wires.

[0139] In this embodiment, the ablation part 130 adopts three groups of ablation elements 130a and 130b. One group of the ablation elements 130a is arranged on the support part 110, and the other two groups of the ablation elements 130b are respectively arranged on the two positioning extension parts 120b. These two groups of the ablation elements 130b are arranged oppositely and can respectively adhere to the two side wall surfaces near the atrial septal tissue perforation to ablate and fix the perforation. The specific structures of the ablation elements 130a and 130b are the same as those in Embodiments 1-3 and will not be elaborated here.

[0140] Except for the outer surfaces of the three groups of ablation elements 130a and 130b that come into contact with the atrial septal tissue, all the braided wires have insulating coatings or insulating sleeves on their surfaces.

[0141] The specific implementation manner of the ablation part 130 can be selected from bare metal wires, rods or electrodes. In this embodiment, the two ablation elements 130b on the positioning extension part 120b are bare metal wires, and the ablation element 130a on the support part 110 is a flexible electrode.

[0142] As Figure 8 shown, at least a part of the ablation element 130b on the positioning extension part 120b corresponding to the proximal end of the support part 110 is a metal wire material that is electrically exposed on at least one side of the distal end face. Looking from the proximal end towards the distal end, the spiral direction of these wires is clockwise. At least a part of the ablation element 130b on the proximal end face is a metal wire material that is electrically exposed on at least one side. Looking from the proximal end towards the distal end direction, the spiral direction of these wires is counterclockwise.

[0143] The ablation element 130a is a flexible electrode attached to the support part 110 and insulated from the support part 110. The flexible electrode is a continuous annular, highly elastic and soft metal wire or metal sheet. The flexible electrode is attached to the support part 110 by suture and / or bundling.

[0144] The polarity selection of the ablation element 130a and the ablation element 130b includes but is not limited to the following six schemes:

[0145] 1. Both the ablation element 130a and the ablation element 130b are connected to the same ablation power output port, and the neutral electrode plate is grounded.

[0146] 2. Two sets of ablation elements 130b are connected to the output port of the ablation power supply, the ablation element 130a is grounded, and there is no neutral electrode plate.

[0147] 3. The ablation element 130a is connected to the output port of the ablation power supply, two sets of ablation elements 130b are grounded, and there is no neutral electrode plate.

[0148] 4. One ablation element 130b and the ablation element 130a are connected to the output port of the ablation power supply, the other ablation element 130b is grounded, and there is no neutral electrode plate.

[0149] 5. Two ablation elements 130b and the ablation element 130a are respectively connected to the output ports of the three-phase voltage sources A, B, and C of the ablation power supply. The three ports output three sinusoidal alternating currents with equal amplitudes, the same frequency, and phase angles that differ by 120° in sequence. The neutral electrode plate is grounded.

[0150] 6. Two ablation elements 130b and the ablation element 130a are respectively connected to the output ports of the three-phase voltage sources A, B, and C of the ablation power supply. The three ports output three sinusoidal alternating currents with equal amplitudes, the same frequency, and phase angles that differ by 120° in sequence. There is no neutral electrode plate.

[0151] As Figures 8-9 shown, another structure different from Embodiment 3 is that: the ablation part 130 is provided with a temperature sensor 250 in contact with the atrial septal tissue, and the temperature sensor 250 is electrically connected to the control mechanism of the ablation power supply. Specifically, on the support part 110, a micro thermistor is provided as the temperature sensor 250, and two mutually insulated metal wires 251 and 252 are welded to both ends of the thermistor. The micro thermistor is wrapped in two PI films with good insulation performance. The two films are fused together by welding around the thermistor and completely encapsulate the thermistor. Through the suture 254, the PI film is sutured to the support part 110. The wires 251 and 252 extend out of the PI film package through the fusion zone and are respectively connected with elastic connectors, which can be electrically conducted to the temperature detection system of the control mechanism of the ablation power supply.

[0152] The remaining structures of this embodiment are the same as those of Embodiment 3 and will not be elaborated here.

[0153] Embodiment 5, this embodiment is an improvement based on Embodiments 1-4.

[0154] As Figures 10-11As shown, an atrial septal stoma device 100 includes a support portion 110 that passes through the atrial septum and expands radially to open the atrial septum tissue to form a perforation, and an extension portion 120 connected to the support portion 110. The support portion 110 and two positioning extension portions 120b of this embodiment are both rod-shaped structures, and the two positioning extension portions 120b are both composed of struts. The support portion 110 and the positioning extension portion 120b are an integrated structure.

[0155] The main difference from the structures of Examples 1-4 is that: Figures 10-11 As shown, the support portion 110 is provided with an adjustment mechanism 119 for adjusting the radial size of the support portion 110. The radial adjustment mechanism 119 can have a variety of implementations, and any structure that can achieve radial constraint is applicable to the present invention. And because the sheath needs to be inserted, the adjustment mechanism 119 needs to achieve radial contraction. Generally, a soft structure or a telescopic structure is adopted, and the soft structure can be a control line. The adjustment mechanism 119 includes at least two control lines 119a, and the two ends of the control line 119a pass through different positions of the support portion 110 in the circumference and converge into a bundle at the center of the support portion 110. In this embodiment, the adjustment mechanism 119 includes 4 equal-length control lines 119a, and the two ends of each control line 119a pass through two adjacent control holes 119c from the outside of the support portion 110 to the inside, and each control hole 119c has two thread ends passing through. All the thread ends converge at the axis of the support portion 110 and are formed by tying a knot to form a connection ring 119b. As shown Figures 10-11 As shown, the atrial septal stoma device 100 has a support portion 110 with a revolution curved surface whose generatrix is ​​concave inwards in a fully released state. Four control holes 119c are evenly distributed on the circumference of the support portion 110 at the minimum diameter.

[0156] In addition to the above structure, the adjustment mechanism includes at least one control line, which passes through different positions of the support part in the circumference at the same time, and the size of the support part is adjusted by controlling the length of the control line passing through the circumference of the support part.

[0157] For example, in another embodiment, the adjustment mechanism includes a control line; the control line passes through different circumferential positions of the support portion 110 at the same time and is fixed at both ends to limit the radial dimension of the support portion 110 .

[0158] In another embodiment, the adjustment mechanism includes at least one control wire; the control wire passes through different positions of the support portion 110 in the circumferential direction, one end of each control wire is fixed to the support portion 110 or the distal end of the delivery system connected to the atrial septostomy device 100, and the other end of the control wire is connected to a control mechanism for controlling the implantation of the atrial septostomy device 100, so as to control the radial size of the support portion 110;

[0159] In another embodiment, the adjusting mechanism includes at least one control line; the control line passes through different positions in the circumferential direction of the support portion 110, and at least one end of each of the two ends of the control line passes through the conveying system and is manually operated to control the radial dimension of the support portion 110.

[0160] The adjusting mechanism can also adopt an elastic telescopic structure, which can be an elastic ring, a spiral spring, etc. By adjusting the length or diameter of the elastic ring or spiral spring, the radial adjustment of the support portion 110 is realized.

[0161] As Figure 10 shown, the difference from other embodiments is also that only two groups of ablation members 130a are provided on the outer wall surface of the support portion 110. In this embodiment, a plurality of electrodes are selected to be arranged around the support portion 110 at intervals of one or two circles as the ablation members 130a. As Figure 11 shown, except for the electrodes of the support portion 110 and the positioning extension portion 120b, the surfaces of the remaining support portion 110 and the positioning extension portion 120b are coated with a polytetrafluoroethylene insulating coating 102.

[0162] The remaining structures of this embodiment are the same as those of Embodiments 1-4 and will not be described in detail here.

[0163] Embodiment 6, an atrial septostomy system, includes the atrial septostomy device 100 described in Embodiment 1 and a conductive connector electrically connected to the atrial septostomy device 100; the conductive connector is an integral structure, a detachable connection or a fixed connection with the atrial septostomy device 100. The atrial septostomy device 100 and the conductive connector are the basic structures of the atrial septostomy system. The conductive connector connects the ablation power supply and the control device. The ablation power supply is used for power supply, and the control device is used for ablation control.

[0164] As Figure 1 shown, the proximal converging connection port 141 of the recovery portion 140 of the atrial septostomy device 100, the connection port 141 is a tubular structure, and 8 fixing holes 142 are uniformly distributed in the circumferential direction. A conductive connector is provided at the connection port 141. In this embodiment, the connection port 141 and the conductive connector are of an integral structure, and the connection port 141 is the conductive connector.

[0165] As Figure 12 shown in another embodiment, the conductive connector 160 provided in the recovery portion 140 of the atrial septostomy device 100 is electrically connected to the ablation portion 130. Then, the nut 162 serving as the conductive connector 160 is not coated with an insulating layer, that is, the internal thread 163 in the nut 162 is not coated with an insulating layer, and is screwed to the pusher in the conveying system, and the ablation members 130a and 130b are electrically connected to the ablation power supply through the conductive conveying system.

[0166] Example 7. An atrial septostomy device system, which includes the atrial septostomy device 100 of Examples 1-5, a conductive connection member, and a pusher 200. On the basis of Example 6, the pusher 200 is added.

[0167] In this embodiment, taking the structure of the atrial septostomy device 100 in Example 1 as an example, a detailed description is given as follows:

[0168] As Figure 13 shown, the pusher 200 is a tubular structure with a cavity, and is fixedly connected or detachably connected to the atrial septostomy device 100. The conductive connection member is the connection port 141, and connection and power conduction are achieved through the connection port 141.

[0169] As Figures 13-15 shown, in this embodiment, a double lumen tube 210 with a cavity 201 and a cavity 202 is used. The distal end of the pusher 200 and the connection port 141 at the proximal end of the ostomy device 100 are connected by a hot melting method in the mechanical connection area 203. The connection method is to sleave the connection port 141 at the proximal end of the ostomy device 100 on the distal end of the pusher 200, and a protective tube 220 is sleaved outside the tubular connection port 141 of the ostomy device 100. At the same time, as Figure 2 shown, the wire portion 195 of the flexible electrode 190 passes through between the tubular connection port 141 and the protective tube 220.

[0170] Below the mechanical connection area 203, an electrical connection area 204 is provided. A connection ring 230 with a relatively thick wall thickness is provided in the electrical connection area 204. As Figure 2 shown, the connection portion 196 of the flexible electrode 190 and the connection ring 230 are electrically connected by welding. A wire 240 is provided in the cavity 202 of the pusher 200. The front end of the wire 240 passes through the tube wall 205 at the connection ring 230 and is electrically connected to the connection ring 230 by soldering. The protective tube 220 extends backward from the front end of the pusher 200 until it covers a section of length behind the connection ring 230. In the electrical connection area 204, the material of the protective sleeve 220 and the pusher 200 is fused together by hot melting, and the welding part is completely melted inside the material, so as to ensure the safety and reliability of the electrical connection.

[0171] Example 8. In this embodiment, a sheath tube is added on the basis of Example 7.

[0172] As Figure 16 shown, an atrial septostomy system includes an atrial septostomy device 100, a conductive connection member, a pusher 200, and a sheath tube 400. The conductive connection member is electrically connected to the ablation members 130a and 130b of the atrial septostomy device 100. The pusher is detachably and fixedly connected to the atrial septostomy device 100, and the atrial septostomy device 100 is radially contracted and received in the sheath tube.

[0173] Among them, the structures of the atrial septal ostomy device 100, the conductive connecting member, and the pusher 200 are the same as those in Embodiment 7, and will not be elaborated here.

[0174] The sheath 400 includes a sheath lumen 401, and the pusher 200 is located within the sheath lumen 401.

[0175] Embodiment 9. This embodiment adds a sheath mechanism on the basis of Embodiment 8.

[0176] As Figure 17 shown, there are an atrial septal ostomy device 100, a conductive connecting member, a pusher 200, and a sheath mechanism. The conductive connecting member is electrically connected to the ablation elements 130a and 130b. The pusher 200 is detachably and fixedly connected to the atrial septal ostomy device 100. The sheath mechanism includes a sheath 400 and a sheath core 300 that are sleeved with each other. The pusher 200 and the proximal end of the sheath mechanism are connected to a control handle 500. The atrial septal ostomy device 100 is radially contracted and stored in the sheath 400.

[0177] Among them, the structures of the atrial septal ostomy device 100, the conductive connecting member, the pusher 200, and the sheath 400 are the same as those in Embodiment 8, and will not be elaborated here.

[0178] In the sheath mechanism, the sheath core 300 is located in the cavity 201 of the pusher 200. The sheath core 300 is composed of a PEEK tube 310 having a cavity and a TIP head 320 connected to the front end of the sheath core and matching the sheath 400.

[0179] The rear ends of the pusher 200, the sheath 400, and the sheath core 300 are respectively connected to the handle 500. A connector 510 connected to the ablation power supply is provided at the proximal end of the handle 500. The proximal end of the wire 240 of the pusher 200 is electrically connected to the connector 510. The handle 500 is provided with independent movement mechanisms, which can realize the independent movement of the pusher 200, the sheath 400, and the sheath core 300.

[0180] In this embodiment, the atrial septal ostomy device 100, the pusher 200, the sheath core 300, the sheath 400, and the handle 500 form a complete system and are assembled into one body before use. The usage method of the ostomy instrument is as follows:

[0181] 1. After atrial septal puncture, send the guide wire into the left superior pulmonary vein and withdraw the puncture kit.

[0182] 2. Connect the connector 510 at the proximal end of the handle to the ablation power supply output port, and push the ostomy instrument along the guide wire into the body and make the front end of the sheath located in the left atrium.

[0183] 3. Retract the sheath tube 400 to fully deploy the left atrial positioning extension 120b of the atrial septostomy device 100. The left atrial positioning extension 120b is fully expanded (judged by ultrasound or DSC). During this process, ensure that the distal end of the sheath tube remains in the left atrium all the time. Then, keep no relative movement between the instruments and pull the sheath tube 400 backward to make the left atrial positioning extension 120b closely adhere to the atrial septum.

[0184] 4. Retract the sheath tube 400 to fully deploy the support part 110 of the atrial septostomy device 100 (judged by ultrasound or DSC), and expand a small hole in the atrial septal tissue.

[0185] 5. Observe and ensure good contact between the electrode and the atrial septal tissue, then set the heating parameters (such as power 30W, duration 120S), and then start heating.

[0186] 6. After heating stops, retract the push rod 200 to make the right atrial positioning extension 120b contract to a smaller size and retract it into the sheath tube. Then, push the sheath tube forward to completely recover the instrument into the sheath tube, and withdraw the whole into the right atrium. Then, measure whether the size of the stoma reaches the clinical requirement by ultrasound or DSC.

[0187] Example 10, this example is an improvement of Example 7.

[0188] As Figure 18 shown, the difference from Example 7 is that in this example, the atrial septostomy device 100 of Example 3 is adopted, and the pusher 200 in this example is of solid structure. The main body 210 of the pusher is made of an insulating polymer material. The proximal conical surface 145 of the recovery part of the stoma device 100 is connected to the distal end of the main body 210 of the pusher by hot melting or adhesive. The wires 211 and 212 extend through the inside of the pusher 200 to the tail end of the pusher and are electrically connected to the tail end connector 220.

[0189] When the stoma instrument in this example is used, it needs to be used in combination with a loader, a sheath tube, a stylet, an ablation power source and a power connection wire, a neutral electrode plate, etc. The usage method is as follows:

[0190] After atrial septum puncture, send the guide wire into the left superior pulmonary vein, and remove the puncture kit. Push the stylet and the sheath tube along the guide wire into the left atrium, and remove the guide wire and the stylet.

[0191] Select an appropriately sized stoma device 100. Pass the pusher through the proximal end of the loader, and connect the proximal end of the stoma device 100 to the distal end of the pusher. Retract the pusher to receive the stoma device 100 into the loader.

[0192] Connect the distal end of the loader to the proximal end of the sheath tube. Push the pusher forward to deliver the atrial septostomy device 100 to the distal end of the sheath tube. Then, slowly push the pusher or retract the sheath tube to fully open the positioning part of the atrial septostomy device 100 and the left atrial thrombus capture cage (judged by ultrasound or DSA). Then, keep no relative movement between the instruments and pull the sheath tube backward so that the positioning extension part 120b in the left atrium closely adheres to the atrial septum. Then, keep the position of the ostomy device and the pusher unchanged, and retract the sheath tube to fully open the support part 110, the positioning extension part 120b in the right atrium and the right atrial thrombus capture cage, and make the positioning extension part 120b in the right atrium closely adhere to the atrial septum.

[0193] After confirming that the electrodes of the positioning part are fully attached to the atrial septum, connect the proximal end of the pusher to the ablation power supply and set the heating parameters (such as power 50W, duration 30S), and then start heating.

[0194] After the heating stops, the instrument can be retrieved into the sheath tube and removed from the body, and measure whether the ostomy diameter reaches the expectation.

[0195] Example 11, as Figure 19 shown, the atrial septostomy system described in this embodiment includes an atrial septostomy device 100 and a pusher 200.

[0196] The pusher 200 is a solid structure, and the specific structure of the atrial septostomy device 100 is the same as that in Example 2.

[0197] The proximal conical surface 172 of the thrombus capture mechanism 170 is connected to the distal end of the pusher 200 by heat melting. The pusher body 210 is made of an insulating polymer material and includes two mutually insulated wires 211 and 212 inside. At the connection between the pusher body 210 and the atrial septostomy device 100, the front end of the wire 211 is electrically connected to the ablation part 130a of the ostomy device 100, and the rear end is electrically connected to the tail end connector 220. The front end of the wire 212 is electrically connected to the ablation part 130b of the positioning extension part 120b, and the rear end is electrically connected to the tail end connector 220.

[0198] When the ostomy instrument in this embodiment is used, it also needs to be used in combination with a loader, a sheath tube, a sheath core, a conductive pusher, an ablation power supply and a power connection wire, a neutral electrode plate, etc. The usage method is as follows:

[0199] After atrial septum puncture, send the guide wire into the left superior pulmonary vein. Push the sheath core and the sheath tube along the guide wire into the left atrium, and remove the guide wire and the sheath core.

[0200] Select an atrial septostomy device 100 of appropriate size. Put the atrial septostomy device 100 into the loader.

[0201] Connect the distal end of the loader to the proximal end of the sheath tube 400. Push the pusher forward to deliver the atrial septostomy device 100 to the distal end of the sheath tube 400. Then slowly push the pusher forward (or retract the sheath tube 400 while ensuring that the distal end of the sheath tube 400 is located in the left atrium) to fully open the positioning extension portion 120b in the left atrium of the atrial septostomy device 100 (judged by ultrasound or DSA). Then keep no relative movement between the instruments and pull the sheath tube 400 backward to make the positioning extension portion 120b in the left atrium closely adhere to the atrial septum. Then keep the positions of the atrial septostomy device 100 and the pusher 200 unchanged, retract the sheath tube 400 to fully open the support portion 110 and the positioning extension portion 120b in the right atrium and make the positioning extension portion 120b in the right atrium closely adhere to the atrial septum. At this time, it can be observed through DSA or ultrasound whether the position of the atrial septum and the ablation portion 130 is fully fitted.

[0202] After confirming that the perforated tissue is fully fitted with the ablation member 130a, connect the proximal end of the pusher to the ablation power supply, set the heating mode to the temperature control mode, select parameters (such as temperature 70 degrees, duration 30S), and then start heating.

[0203] After the heating stops, the instrument can be retrieved into the sheath tube and removed from the body, and measure whether the diameter of the stoma reaches the expectation.

[0204] Example 12, as Figure 20 shown, the atrial septostomy system described in this embodiment includes an atrial septostomy device 100, a pusher 200, and a sheath tube mechanism. The sheath tube mechanism includes a sheath core 300, a sheath tube 400, and a handle 500.

[0205] Among them, the atrial septostomy device 100 is the same as that in Example 4 and will not be elaborated here.

[0206] As Figure 20 shown, the pusher 200 is a tubular structure with a cavity. The proximal tip of the atrial septostomy device 100 is connected to the distal end of the pusher tube body 210 by hot melting. Inside the hot melting connection, all the clockwise rotating filaments are welded to the front end of the wire 211 in the tube wall 210, and the support portion 110 electrode is welded to the front end of the wire 212 in the tube wall 210.

[0207] The sheath core 300 is located in the cavity of the pusher 200. The sheath core 300 is composed of a PEEK tube 310 with a cavity and a TIP head 320 connected to the front end of the sheath core and matching the sheath tube 400. The distal tip of the atrial septostomy device 100 is connected to the proximal end of the TIP head 320 by hot melting. Inside the hot melting connection, all the counterclockwise rotating filaments are welded to the front end of the wire 311 in the PEEK tube 310.

[0208] The sheath tube 400 is a tubular structure, and the pusher 200 is located in the inner cavity of the sheath tube 400. The rear ends of the pusher 200, the sheath tube 400, and the sheath core 300 are respectively connected to the handle 500. The proximal end of the handle 500 is provided with a connector 510 connected to the ablation power source. The wires 211 and 212 of the pusher 200 and the proximal ends of the wires 311 in the PEEK tube are electrically connected to the connector 510.

[0209] The handle 500 is provided with mutually independent movement mechanisms, which can realize mutually independent movements among the pushing member 200 , the sheath tube 400 , and the sheath core 300 .

[0210] The method of using the stoma system in this embodiment is as follows:

[0211] After the atrial septum is punctured, the guide wire is inserted into the left upper pulmonary vein, and the puncture kit is removed. The sheath core 300 and the sheath tube 400 are pushed into the left atrium along the guide wire, and the guide wire and the sheath core 300 are removed.

[0212] Select an atrial septostomy device 100 of suitable size, pass the pusher through the proximal end of the loader, connect the proximal end of the atrial septostomy device 100 with the distal end of the pusher, and withdraw the pusher to store the atrial septostomy device 100 in the loader.

[0213] Connect the distal end of the loader to the proximal end of the sheath 400, and push the pusher forward to deliver the stoma device 100 to the distal end of the sheath 400. Then slowly push the pusher or withdraw the sheath 400 to fully open the positioning extension of the atrial septal stoma device 100 (judged by ultrasound or DSA). Then keep the instruments without relative movement and pull the sheath 400 backward to make the positioning extension 120b of the left atrium close to the atrial septum. Then keep the stoma device and the pusher 200 in place, withdraw the sheath 400, and fully open the support portion 110 and the positioning extension 120b of the right atrium and open the atrial septum tissue.

[0214] After confirming that the ablation electrode of the positioning extension is completely in contact with the atrial septum, connect the proximal end of the pusher to the ablation power source, set the heating parameters (such as power 50W, duration 30S), and then start heating. After heating stops, the device can be retracted into the sheath and removed from the body, and the stoma diameter can be measured to see if it meets the expectations.

Claims

1. An atrial septostomy device, characterized in that, It includes an elastic support part that passes through the atrial septum and expands radially to open the atrial septum tissue to form a perforation, an extension part connected to the support part, and an ablation part; The extension portion includes a compensating extension portion for extending the length of the support portion and / or a positioning extension portion for positioning the support portion; The ablation part includes at least two groups of ablation elements for ablation of atrial septal tissue, which are electrically connected to the ablation power source and are provided on the support part and the extension part; In the case where the ablation element is disposed on the support portion, the ablation element disposed on the support portion is disposed in a circle around the outer circumference of the support portion; in the case where the ablation element is disposed on the extension portion, the ablation element disposed on the extension portion is located around the perforation and adheres to the atrial septal tissue after implantation; The positioning extension portion extends outward from the supporting portion and presses against the atrial septal tissue; The positioning extension portion is formed by extending radially outward from the proximal end and / or the distal end of the support portion and presses against the atrial septum tissue around the perforation; or the positioning extension portion extends proximally or distally from at least one position among the proximal end, the distal end, and the middle portion of the support portion and gradually turns radially outward to press against the atrial septum tissue.

2. The atrial septostomy device according to claim 1, characterized in that, The compensating extension portion is arranged in the axial direction of the support portion.

3. The atrial septostomy device according to claim 2, wherein, The compensating extension portion is formed by extending the proximal end or / and the distal end of the support portion outwardly and axially upward; Alternatively, the compensating extension portion is formed by extending axially outward from at least one position among the proximal end portion, the distal end portion, and the middle portion of the support portion.

4. The atrial septostomy device according to claim 1, characterized in that, The compensating extension part is a self-expanding single-layer or multi-layer corrugated stent, a mesh stent, a rod-shaped stent, or a tubular structure or annular structure formed by a combination thereof.

5. The atrial septostomy device according to claim 1, characterized in that, The diameter of the compensating extension portion is equal to, slightly larger than, or slightly smaller than the diameter of the supporting portion.

6. The atrial septostomy device according to claim 1, wherein The positioning extension part is a self-expanding single-layer or multi-layer corrugated stent, a mesh stent, a rod-shaped stent or a combination thereof.

7. The atrial septostomy device according to claim 2, characterized in that, The positioning extension portion is provided with a positioning surface, a positioning line or a positioning point that is in contact with the atrial septum surface. The positioning surface is a plane, a cone, an arc surface or a combination thereof that surrounds or covers the perforation; the positioning line is a curve, a straight line or a combination thereof that forms a linear contact with the atrial septum surface around the perforation; The positioning points are a plurality of protrusions which are arranged at least one circle around the perforation and form point contact with the atrial septum wall surface.

8. The atrial septostomy device according to any one of claims 1-7, characterized in that, The support part is a self-expanding corrugated stent, a mesh stent, a rod-shaped stent, or a tubular structure or an annular structure formed by a combination of these.

9. The atrial septostomy device according to claim 8, wherein, The support portion is provided with an adjustment mechanism for adjusting the radial dimension of the support portion.

10. The atrial septostomy device according to claim 9, characterized in that, The adjustment mechanism includes at least one control line, and the control line passes through different positions of the support part in the circumference at the same time. The size of the support part is adjusted by controlling the length of the control line passing through the circumference of the support part.

11. The atrial septostomy device according to claim 9, wherein, The adjustment mechanism includes at least two control wires, and two ends of each control wire pass through different positions on the circumference of the support part and converge into a bundle toward the center of the support part, and are fixed to limit the radial size of the support part.

12. The atrial septostomy device according to claim 1, characterized in that, The ablation element is a conductive metal element with the outer surface of the support part and / or the extension part exposed, and the remaining support parts and extension parts except the ablation element are insulated at least close to or in contact with the outer surface of the atrial septum; or the position connected to the ablation element is insulated at least close to or in contact with the outer surface of the atrial septum.

13. The atrial septostomy device according to claim 12, wherein The outer surface insulation means that an insulating coating is applied on the outer surface, or an insulating film is covered on the outer surface, or an insulating sleeve is sleeved on the outer surface.

14. The atrial septostomy device according to claim 1, characterized in that, The ablation member is an electrode fixed on the outer surface of the support part and / or the extension part; An insulator for preventing the electrode from conducting electricity with its fixed position is provided on the back of the electrode, or at least the outer surface of the support part and / or the extension part connected to the electrode is insulated.

15. The atrial septostomy device according to claim 14, characterized in that, The electrode is an annular electrode; or the electrode is a single electrode continuously or intermittently arranged in a circle on the support part and / or the extension part.

16. The atrial septostomy device according to claim 14, wherein Two groups of electrodes are provided, and both groups of electrodes are monopolar ablation electrodes. One electrode is respectively provided on at least two of the support part, the compensation extension part or the positioning extension part, or two groups of electrodes are simultaneously provided on one of the support part, the compensation extension part or the positioning extension part.

17. The atrial septostomy device according to claim 14, wherein, Two groups of electrodes are provided, and the two groups of electrodes are bipolar ablation electrodes. One group of electrodes is respectively provided on two of the support part, the compensation extension part or the positioning extension part. One group of electrodes is connected to the ablation power supply, and the other group of electrodes is grounded.

18. The atrial septostomy device according to claim 14, characterized in that, Three groups of electrodes are provided; three groups of electrodes are simultaneously provided on one of the support part, the compensation extension part, and the positioning extension part; Or among the support part, the compensation extension part, and the positioning extension part, one is provided with two groups of electrodes, one is provided with one group of electrodes, and one is not provided with electrodes; Or one group of electrodes is respectively provided on each of the support part, the compensation extension part, and the positioning extension part.

19. The atrial septostomy device according to claim 18, characterized in that, All the three groups of electrodes are monopolar ablation electrodes; Or one group of the three groups of electrodes is a monopolar ablation electrode, and the other two groups are bipolar ablation electrodes; Or the three groups of electrodes are respectively connected to the output ports of phase A, phase B, and phase C of the three-phase voltage source of the ablation power supply.

20. The atrial septostomy device according to any one of claims 1-7, characterized in that, The ablation members provided on the positioning extension part and the compensation extension part are arranged in at least one circle in contact with the proximal end or / and the distal end of the support part.

21. The atrial septostomy device according to any one of claims 1-7, characterized in that, The support part or the extension part is connected with a cage-shaped thrombus capture mechanism.

22. The atrial septostomy device according to any one of claims 1-7, characterized in that, The support part or the extension part is provided with a recovery part.

23. The atrial septostomy device according to any one of claims 1-7, characterized in that, The ablation part is further provided with a temperature sensor in contact with the atrial septum tissue.

24. The atrial septostomy device according to any one of claims 1-7, characterized in that, The ablation part is provided with at least one imaging point.

25. The atrial septostomy device according to any one of claims 1-7, characterized in that, The surface of the support part is coated with a drug coating.

26. An atrial septostomy system, characterized in that, It includes the atrial septostomy device according to any one of claims 1-25, and a conductive connector electrically connected to the stoma device; The conductive connector is an integral structure, a detachable connection or a fixed connection with the stoma device.

27. An atrial septostomy system, characterized in that, It includes the atrial septostomy device according to any one of claims 1-25, a conductive connector, and a pusher. The conductive connector is electrically connected to the ablation member in the atrial septostomy device, and the pusher is detachably and fixedly connected to the atrial septostomy device.

28. An atrial septostomy system, characterized in that, It includes the atrial septostomy device according to any one of claims 1-25, a conductive connector, a pusher and a sheath. The conductive connector is electrically connected to the ablation member in the atrial septostomy device, the pusher is detachably and fixedly connected to the atrial septostomy device, and the atrial septostomy device is radially contracted and stored in the sheath.

29. An atrial septostomy system, characterized in that, Comprising the atrial septostomy device according to any one of claims 1-25, a conductive connecting member, a pushing member and a sheath mechanism, the conductive connecting member is electrically connected to the ablation member, the pushing member is detachably and fixedly connected to the atrial septostomy device, the sheath mechanism includes a sheath and a sheath core sleeved with each other, a control handle is connected to the proximal ends of the pushing member and the sheath mechanism, and the atrial septostomy device is radially contracted and received in the sheath.

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