Cardiac interatrial shunt system

Abstract

The present application provides a heart atrial septal shunt system, which comprises a stoma member for forming a stoma on an atrial septum, and an expansion member arranged in an inner space of the stoma member, the expansion member being capable of being filled with fluid, and the stoma member comprising a conductive part for ablation of tissue around the stoma. The expansion member changes the diameter of the stoma member by the amount of fluid filled, so as to adjust the stoma to a proper size; the conductive part contacts the atrial septum tissue near the stoma, and receives a radio frequency power source to ablate the tissue of the atrial septum at the stoma, so as to inactivate the atrial septum tissue near the stoma, prevent the stoma from being blocked by the repair of the tissue endothelial covering, and fix the shape after the stoma of the trans-septal stoma system.

Description

Technical Field

[0001] This invention relates to the field of interventional medical device technology, and in particular to a percutaneous interventional atrial septal shunt system. Background Technology

[0002] Heart failure (HF) is a complex clinical syndrome caused by any structural or functional abnormality of the heart that impairs ventricular filling or ejection. Its main clinical manifestations include dyspnea and fatigue (limited exercise tolerance), as well as fluid retention (pulmonary congestion and peripheral edema). HF is a severe and terminal stage of various heart diseases, with a high incidence rate, and is one of the most important cardiovascular diseases today. Based on the location of the heart failure, it can be classified as left ventricular, right ventricular, or biventricular heart failure.

[0003] Heart failure is a serious disease with a high incidence and mortality rate. In my country, the incidence rate of heart failure is 2-3%, affecting over 12 million people. The main causes of heart failure include hypertension, coronary heart disease, myocardial infarction, valvular heart disease, atrial fibrillation, and cardiomyopathy. Cardiovascular diseases cause damage to the left ventricle, leading to pathological remodeling of the left ventricle and resulting in decreased cardiac function. Every successful treatment of a myocardial infarction patient introduces a potential heart failure patient.

[0004] In terms of treatment, even after optimizing drug therapy, patients' symptoms still recur, and current drug therapy is almost only effective for patients with reduced ejection fraction, with less than ideal results for patients with preserved ejection fraction. Cardiac resynchronization therapy is not suitable for all heart failure patients; more than 20% of patients do not respond to cardiac resynchronization pacing. Left ventricular assist device (LVAD) surgery requires cardiopulmonary bypass, is highly invasive with a high complication rate, and is expensive and difficult to obtain. Heart transplantation is the ultimate solution, but the source of donors is very limited and expensive.

[0005] Atrial septal septal stomata is a procedure that creates an opening in the atrial septum to shunt the left and right atria. It can be used to treat pulmonary hypertension (right-to-left shunt) or left heart failure (left-to-right shunt) and has proven effective in clinical practice.

[0006] Traditional atrial septal puncture methods, such as balloon atrial septal puncture, often result in myocardial tissue rebound after the puncture site, leading to shrunk or even complete closure of the puncture site over time. To address this issue, existing technologies have provided a stoma stent and disclosed an implantable device for atrial shunts. The key feature is that, after percutaneous atrial septal puncture, an implant is percutaneously delivered to place the shunt device at the puncture site to maintain patency of the shunt opening.

[0007] Another type of stoma device includes a cutting device and a grasping device. When the device creates a stoma, the grasping device first positions and grasps the part of the tissue that needs 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.

[0008] The aforementioned technology has the following drawbacks: Implants used for atrial shunts leave instruments at the stoma site, which can easily lead to thrombosis or instrument dislodgement, causing embolism. Furthermore, endothelial adhesion can block the instrument opening, closing the channel and rendering the shunt ineffective. Additionally, cutting intracardiac tissue using mechanical or high-frequency electrosurgical methods during surgery carries a high risk; if the grasping device loosens during surgery or during retrieval, the cut tissue may dislodge and form an embolism. Moreover, loosening of the grasping device during cutting can easily damage other myocardial tissues. Summary of the Invention

[0009] The purpose of this invention is to provide a cardiac atrial septal shunt system that is not easily blocked and does not cause damage to other myocardial tissues.

[0010] To address the aforementioned technical problems, the present invention provides a cardiac atrial septal shunt system, comprising a stoma assembly for forming a stoma on the atrial septum, the cardiac atrial septal shunt system further comprising an expansion member disposed in the inner space of the stoma assembly, the expansion member being capable of being filled with fluid, and the stoma assembly comprising a conductive portion for ablating the tissue surrounding the stoma.

[0011] The atrial septal shunt system of the present invention includes a stoma component that radially expands the atrial septum, an expander component disposed within the cavity of the stoma component for adjusting the diameter of the stoma component, and a conductive portion disposed on the stoma component. The expander component changes the diameter of the stoma component by the amount of fluid filling it, thereby adjusting the stoma to a suitable size; the conductive portion contacts the atrial septal tissue near the stoma, and receives radio frequency power to ablate the tissue of the atrial septum at the stoma site, thereby deactivating the atrial septal tissue near the stoma, preventing the stoma from being blocked by the endothelial regeneration of the tissue, and fixing the post-stoma morphology after being created by the atrial septal shunt system. Therefore, the stoma shape after being processed by the atrial septal shunt system is more regular and less prone to blockage, maintaining the patency of the stoma, thereby facilitating smooth blood flow between the left and right atria. Attached Figure Description

[0012] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0013] Figure 1 This is a schematic diagram of the room partition stoma system provided in the first embodiment of the present invention;

[0014] Figure 2 yes Figure 1 A schematic diagram of the stoma component in the cardiac atrial septal shunt system.

[0015] Figure 3 yes Figure 1 A schematic diagram of the expansion component of the room partition stoma system;

[0016] Figure 4 yes Figure 3 A cross-sectional view of the expansion part along line III-III;

[0017] Figure 5 This is a schematic diagram of the structure of the expansion component of the room partition stoma system provided in the second embodiment of the present invention;

[0018] Figure 6 yes Figure 5 A cross-sectional view of the expansion part along line VI-VI;

[0019] Figure 7 This is a schematic diagram of the room partition stoma system provided in the third embodiment of the present invention;

[0020] Figure 8 yes Figure 7 A schematic diagram of the structure of the expansion component of the room partition system;

[0021] Figure 9 This is a schematic diagram of the room partition stoma system provided in the fourth embodiment of the present invention;

[0022] Figure 10 yes Figure 9 A schematic diagram of the structure of the expansion component of the room partition system;

[0023] Figure 11 This is a schematic diagram of the structure of the expansion component of the room partition stoma system provided in the fifth embodiment of the present invention;

[0024] Figure 12 This is a schematic diagram of the structure of the expansion component of the room partition stoma system provided in the sixth embodiment of the present invention;

[0025] Figure 13This is a schematic diagram of the structure of the expansion component of the room partition stoma system provided in the seventh embodiment of the present invention;

[0026] Figure 14 This is a schematic diagram of the structure of the expansion component of the room partition stoma system provided in the eighth embodiment of the present invention;

[0027] Figure 15 This is a schematic diagram of the stoma component of the room partition stoma system provided in the ninth embodiment of the present invention;

[0028] Figure 16 This is a schematic diagram of the stoma component of the room partition stoma system provided in the tenth embodiment of the present invention;

[0029] Figure 17 This is a schematic diagram of the stoma component of the room partition stoma system provided in the eleventh embodiment of the present invention;

[0030] Figure 18 This is a schematic diagram of the stoma component of the room partition stoma system provided in the twelfth embodiment of the present invention;

[0031] Figure 19 This is a schematic diagram of the stoma component of the room partition stoma system provided in the thirteenth embodiment of the present invention;

[0032] Figure 20 This is a schematic diagram of the stoma component of the room partition stoma system provided in the fourteenth embodiment of the present invention;

[0033] Figure 21 This is a schematic diagram of the stoma component of the room partition stoma system provided in the fifteenth embodiment of the present invention. Detailed Implementation

[0034] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0035] In the description of this invention, the tissue between the left and right atria is referred to as the atrial septum. "Proximal end" refers to the end closer to the delivery device connection point, and "distal end" refers to the end farther from the delivery device connection point. Axial direction refers to the direction of the device's central axis, and radial direction is perpendicular to the central axis. This definition is for convenience only and should not be construed as a limitation of the invention.

[0036] Please see Figure 1 , Figure 1This is a schematic diagram of the atrial septal stomata system provided in the first embodiment of the present invention. The present invention provides an atrial septal stomata system 100, which includes a cardiac atrial septal shunt system 20 and a stoma delivery mechanism 50 for delivering the cardiac atrial septal shunt system 20. The cardiac atrial septal shunt system 20 includes a stoma component 21 for forming a stoma on the atrial septum and an expansion component 22 disposed within the cavity of the stoma component 21. The expansion component 22 can be filled with fluid so that the radial expansion of the expansion component 22 is used to expand and adjust the diameter of the stoma component 21. The stoma component 21 includes a conductive portion 60 for ablating the tissue surrounding the stoma. The expansion component 22 is used to adjust the diameter of the stoma component 21 to open the stoma to a suitable size; the conductive portion 60 is attached to the atrial septal tissue at the stoma and is electrically connected to a radio frequency power supply. The conductive portion 60 receives energy output from the radio frequency power supply to ablate the tissue surrounding the stoma in the atrial septum.

[0037] In this embodiment, the fluid filling the expansion member 22 can be a gas or a liquid. In this invention, the fluid is brine; the conductive part 60 is an ablation electrode.

[0038] The atrial septal shunt system 100 of the present invention includes a stoma 20 forming the stoma on the atrial septum, an expander 22 disposed in the cavity of the stoma 21, and a conductive portion 60 disposed on the stoma 21. The expander 22, on the one hand, adjusts the diameter of the stoma 21 to a suitable size by changing the amount of fluid filling it; on the other hand, the fluid-filled expander 22 can provide a large radial support force, expanding the perforation on the atrial septum while providing support to the stoma 21, thus enlarging the perforation. Because of the radial support effect of the expander 22, the stoma 21 can be used only as a carrier of the conductive portion, rather than simultaneously as a force-providing structure for radial expansion, providing greater flexibility in the selection of materials and structures for the stoma 21, allowing for the selection of metals or non-metallic materials with better biocompatibility; moreover, because of the expansion of the expander 22, the stoma 22 can be made of a spherical expansion material, without being limited to self-expanding materials. The conductive part 60 contacts the atrial septum tissue near the stoma. The conductive part 60 receives radio frequency power to ablate the atrial septum tissue at the stoma site, thereby deactivating the atrial septum tissue near the stoma and preventing endothelial regeneration from blocking the stoma. Furthermore, after the atrial septum stoma is created by the atrial septum stoma system 100, its shape can be fixed. Therefore, the stoma shape after treatment by the cardiac atrial septum shunt system 20 is more regular and less prone to blockage, maintaining stoma patency and thus ensuring smooth blood flow between the left and right atria.

[0039] In the fully deployed state, the atrial septal shunt system 20 includes a stoma 21 with an internal lumen 230, which is radially contractible and expandable. An expander 22 is disposed on both sides of the internal lumen 230 and its proximal and distal ends. When fluid is introduced into the expander 22, it expands radially and pushes against the inner peripheral wall of the internal lumen 230 of the stoma 23 to adjust the diameter of the outer peripheral wall of the stoma 23, while simultaneously providing radial support to the stoma 23 to dilate the atrial septal perforation.

[0040] Please refer to the following: Figure 1 and Figure 2 , Figure 2 yes Figure 1 A schematic diagram of the stoma component in the cardiac atrial septal shunt system. The stoma component 21 is an expandable stoma device, which can be a ball-expanding type (e.g., made of stainless steel or cobalt-chromium alloy) or a self-expanding type (e.g., shape memory alloy such as nickel alloy) metal support frame or non-metallic support frame. In this embodiment, the stoma component 21 is an elastic metal stent, and further, the stoma component 21 is a nickel-titanium alloy stent. When the atrial septal shunt system 20 is delivered through a sheath, the diameter of the stoma 21 can be reduced to a smaller size for delivery within the sheath. When the atrial septal shunt system 20 is released within the heart, the stoma 21 can automatically expand to form an inner cavity 230. Fluid, such as saline, is then filled into the expander 22 located within the inner cavity 230 to expand and adjust the diameter of the inner cavity 230 of the stoma 21, so that the stoma 21 can open the perforation on the atrial septum to form a stoma. That is, the expander 22 generates a radial thrust on the inner peripheral wall of the stoma 21 within the inner cavity 230 of the stoma 21. The stoma portion 23 of the stoma 21 and the expander 22 provide radial support to the inner wall of the perforation within the perforation, thereby obtaining a stoma of appropriate size. At this time, the conductive part 60 on the stoma component 21 is attached to the atrial septum tissue near the perforation. The conductive part 60 receives radio frequency power to ablate the atrial septum tissue located at the perforation, so as to deactivate the atrial septum tissue near the perforation, prevent the stoma from being blocked by the endothelial regeneration of the tissue, and fix the morphology after the stoma is created by the atrial septum stoma system 100.

[0041] The stoma component 21 can also be made by cutting tubing. After being released into the body, the stoma component 21 has a cylindrical frame structure to maintain the patency of the interatrial septum. The stoma component 21 can also be made by weaving wire, or by a combination of partial weaving and partial tubing cutting. Different parts can be welded or fixed together by connectors. The tubing material can be stainless steel, cobalt-chromium alloy, shape memory metal, or biocompatible non-metallic material, such as nickel-titanium alloy. The overall shape of the stoma component 21 can also be cylindrical, disc-shaped, conical, or other applicable shapes, and is not limited here.

[0042] like Figure 2 As shown, in this embodiment, with the atrial septal shunt system 20 fully deployed, the stoma portion 23 of the stoma component 21 is generally cylindrical, and the inner cavity 230 of the stoma portion 23 is a circular hole. With the atrial septal shunt system 20 fully deployed, the stoma component 21 also includes an extension portion 25 disposed at the distal end of the stoma portion 23 and a connecting portion 27 disposed at the proximal end of the stoma portion 23. The extension portion 25 and the connecting portion 27 are used to position the stoma component 21 on the atrial septum. Specifically, when the stoma component 21 is implanted on the atrial septum, the stoma portion 23 is inserted into the perforation of the atrial septum, the extension portion 25 is located in the left atrium and abuts against the atrial septal tissue surrounding the perforation, and the connecting portion 27 is located in the right atrium and abuts against the atrial septal tissue surrounding the perforation.

[0043] The extension 25 includes a first positioning part 251 connected to the distal end of the stoma 23, and the connecting part 27 includes a second positioning part 271 connected to the proximal end of the stoma 23. When the stoma 23 is located within the perforation of the atrial septum, the first positioning part 251 and the second positioning part 271 are respectively positioned on opposite sides of the atrial septum. The diameter of the first positioning part 251 is larger than the diameter of the stoma 23, and the first positioning part 251 is provided with a positioning surface, positioning line, or positioning point that contacts the atrial septum. Specifically, the side of the first positioning part 251 facing the stoma 23 is provided with a positioning surface, positioning line, or positioning point that can press against the atrial septum tissue. The positioning surface, positioning line, or positioning point abuts against the atrial septum tissue to prevent the cardiac atrial septal shunt system 20 from moving proximally. The conductive part 60 may be provided on the positioning point, positioning line, or positioning surface of the first positioning part 251.

[0044] The diameter of the second positioning part 271 is larger than the diameter of the stoma 23. The second positioning part 271 is provided with a positioning surface, positioning line, or positioning point that contacts the atrial septum. Specifically, the side of the second positioning part 271 facing the stoma 23 is provided with a positioning surface, positioning line, or positioning point that can press against the atrial septum tissue. The positioning surface, positioning line, or positioning point abuts against the atrial septum tissue to prevent the atrial septal shunt system 20 from moving distally, thereby positioning the atrial septal shunt system 20 on the atrial septum. The conductive part 60 may be provided on the positioning point, positioning line, or positioning surface of the second positioning part 271.

[0045] In other embodiments, the conductive part 60 may be disposed on the positioning surface, positioning line or positioning point of the first positioning part 251 and the second positioning part 271 respectively.

[0046] In this embodiment, the stoma 23 consists of several circumferentially arranged support plates 232. Specifically, the support plates 232 are arranged in a ring around the axis of the stoma 23, with each support plate 232 extending along the axis of the stoma 23 and having its center recessed in an arc shape towards the axis of the stoma 23. The stoma 23 is provided with developing points or developing wires, which are fixed by embedding and hot pressing. Specifically, each support plate 232 has a mounting hole 2320 in its center, and a developing point is provided within the mounting hole 2320. The developing points within the mounting holes 2320 form a ring, facilitating the positioning of the stoma 23 into the perforation of the interatrial septum. The developing points or developing wires can be made of materials such as gold, platinum, or tantalum.

[0047] A conductive part 60 is provided on the side of the stoma portion 23 opposite to the axis of the stoma component 21. Specifically, each support piece 232 has a conductive part 60 on its side opposite to the axis of the stoma component 21, and these conductive parts 60 form a circle around the circumference of the stoma portion 23. When the stoma component 21 is released into the perforation within the interatrial septum tissue, the expander 22 is filled with fluid to expand and adjust the diameter of the stoma component 21. The stoma component 21 and the expander 22 are used to open the perforation to a suitable size to form a stoma of appropriate size. The conductive part 60 is connected to a radio frequency power supply, thereby transferring radio frequency energy to the conductive part 60 at the perforation to ablate the tissue at the stoma site, preventing the tissue at the stoma site from rebounding and better maintaining the shape of the stoma.

[0048] The first positioning part 251 includes two first positioning rods 2510 that radiate outwards from the distal ends of each support piece 232 of the stoma part 23, bending along both sides away from the axis of the stoma member 21. The distal ends of two adjacent first positioning rods 2510 on two adjacent support pieces 232 converge to form a connecting piece 2511. Each connecting piece 2511 is inclined distally, and the distal end of each connecting piece 2511 is rounded. Specifically, the distal outer peripheral surface of the connecting piece 2511 is provided as an arc surface or a rounded corner, or the distal end of the connecting piece 2511 is provided as a circular piece, a spherical structure, or a similar spherical structure. In this embodiment, the distal end of each connecting piece 2511 is rounded. The rounded distal end of each connecting piece 2511 can prevent the connecting piece 2511, as a free end, from scratching the myocardial tissue when it enters the cardiac atrial septal shunt system 20, thereby improving safety.

[0049] The second positioning part 271 includes a plurality of positioning elements, each corresponding to a plurality of support pieces 232. The distal end of each positioning element is connected to the proximal end of the corresponding support piece 232. Each positioning element includes two second positioning rods 2710 branching off from the proximal end of the corresponding support piece 232 toward the axis away from the stoma piece 21. The proximal ends of the two adjacent second positioning rods 2710 of two adjacent positioning elements intersect to form an intersection portion. The proximal end of the intersection portion is further away from the axis of the stoma piece 21 than the proximal end of the corresponding support piece 232.

[0050] At least one ring of developing dots or developing wires is provided on one of the three parts: stoma 23, first positioning part 251 and second positioning part 271; that is, at least one ring of developing dots or developing wires is provided on stoma 23, at least one ring of developing dots or developing wires is provided on first positioning part 251, or at least one ring of developing dots or developing wires is provided on second positioning part 271.

[0051] In other embodiments, the conductive part 60 is an ablation electrode disposed on one of the stoma portion 23, the first positioning part 251, and the second positioning part 271. Specifically, the conductive part 60 may also be at least one ring of ablation electrodes disposed on the side of the first positioning part 251 facing the second positioning part 271. Preferably, the at least one ring of the ablation electrodes is disposed on the side of the plurality of first positioning rods 2510 away from the axis of the stoma component 21. Alternatively, the conductive part 60 may also be at least one ring of ablation electrodes disposed on the side of the second positioning part 271 facing the first positioning part 251. Preferably, the at least one ring of the ablation electrodes is disposed on the side of the plurality of second positioning rods 2710 away from the axis of the stoma component 21. When the stoma component 21 is released into the perforation in the interatrial septum tissue, the expander 22 is filled with fluid to expand and adjust the diameter of the stoma component 21. The stoma component 21 expands the perforation to a suitable size to form a stoma. The conductive part 60 is connected to the radio frequency power supply, thereby transferring radio frequency energy to the conductive part 60 at the stoma to ablate the tissue at the stoma, preventing the tissue at the stoma from rebounding and better maintaining the shape of the stoma.

[0052] In other embodiments, the conductive part 60 may be an ablation electrode disposed on two of the three: the stoma portion 23, the first positioning part 251, and the second positioning part 271. That is, at least one ring of ablation electrode is disposed on the side of the stoma portion 23 away from its axis and at least one ring of ablation electrode is disposed on the side of the first positioning part 251 facing the second positioning part 271; or at least one ring of ablation electrode is disposed on the side of the stoma portion 23 away from its axis and at least one ring of ablation electrode is disposed on the side of the second positioning part 271 facing the first positioning part 251; or at least one ring of ablation electrode is disposed on the side of the first positioning part 251 facing the second positioning part 271 and at least one ring of ablation electrode is disposed on the side of the second positioning part 271 facing the first positioning part 251. Specifically, at least one ring of ablation electrodes is provided on the side of several support plates 232 away from the axis of the stoma component 21, and at least one ring of ablation electrodes is provided on the side of several first positioning rods 2510 away from the axis of the stoma component 21; or at least one ring of ablation electrodes is provided on the side of several support plates 232 away from the axis of the stoma component 21, and at least one ring of ablation electrodes is provided on the side of several second positioning rods 2710 away from the axis of the stoma component 21; or at least one ring of ablation electrodes is provided on the side of several first positioning rods 2510 away from the axis of the stoma component 21, and at least one ring of ablation electrodes is provided on the side of several second positioning rods 2710 away from the axis of the stoma component 21. When the stoma component 21 is released into the perforation in the interatrial septum tissue, the expander 22 is filled with fluid to expand and adjust the diameter of the stoma component 21, so as to open the perforation to a suitable size to form a stoma. Both conductive parts 60 are connected to the radio frequency power supply, thereby transferring radio frequency energy to the conductive parts 60 to ablate the tissue at the stoma site, preventing the tissue at the stoma site from rebounding, and better maintaining the shape of the stoma.

[0053] In other embodiments, the conductive part 60 may also be an ablation electrode respectively disposed on the stoma portion 23, the first positioning part 251, and the second positioning part 271. That is, at least one ring of ablation electrodes is disposed on the side of the stoma portion 23 away from its axis, at least one ring of ablation electrodes is disposed on the side of the first positioning part 251 facing the second positioning part 271, and at least one ring of ablation electrodes is disposed on the side of the second positioning part 271 facing the first positioning part 251. Specifically, at least one ring of ablation electrodes is disposed on the side of a plurality of support pieces 232 away from the axis of the stoma member 21, at least one ring of ablation electrodes is disposed on the side of a plurality of first positioning rods 2510 away from the axis of the stoma member 21, and at least one ring of ablation electrodes is disposed on the side of a plurality of second positioning rods 2710 away from the axis of the stoma member 21. When the stoma component 21 is released into the perforation in the interatrial septum tissue, the expander 22 is filled with fluid to expand and adjust the diameter of the stoma component 21, so as to open the perforation to a suitable size to form a stoma. All three conductive parts 60 are connected to the radio frequency power supply, thereby transferring radio frequency energy to the conductive parts 60 to ablate the tissue at the stoma site, preventing the tissue at the stoma site from rebounding, and better maintaining the shape of the stoma.

[0054] In other embodiments, at least one ring of developing dots or developing wires is provided on two of the three parts: the stoma portion 23, the first positioning portion 251, and the second positioning portion 271; that is, the stoma portion 23 and the first positioning portion 251 are each provided with at least one ring of developing dots or developing wires, or the stoma portion 23 and the second positioning portion 271 are each provided with at least one ring of developing dots or developing wires, or the first positioning portion 251 and the second positioning portion 271 are each provided with at least one ring of developing dots or developing wires.

[0055] In other embodiments, the stoma portion 23, the first positioning portion 251 and the second positioning portion 271 are each provided with at least one ring of developing dots or developing wires.

[0056] Furthermore, the developing point or developing filament is disposed at the conductive part 60 or on the surrounding structure to mark the position of the conductive part and accurately locate the ablation area.

[0057] like Figure 2As shown, the connecting part 27 further includes a plurality of connecting rods 272 connected to the proximal end of the second positioning part 271, a support member 273 disposed at the proximal end of each connecting rod 272, an extension rod 276 disposed at the proximal end of each support member 273, and a connector 278 disposed at the proximal end of the extension rod 276. The plurality of connecting rods 272 are respectively connected to a plurality of intersecting parts at the proximal end of the second positioning part 271. The plurality of connecting rods 272 are arranged circumferentially along the second positioning part 271. The distal end of each connecting rod 272 is connected to the corresponding intersecting part. The proximal end of the connecting rod 272 is connected to the distal end of the corresponding support member 273. The middle part of each connecting rod 272 protrudes in a direction away from the axis of the stoma member 21 to form an arc rod. Each support member 273 includes two supporting branch rods 2730 that radiate outwards from the proximal end of the corresponding connecting rod 272 toward the axis of the stoma 21. The proximal ends of the two adjacent supporting branch rods 2730 of each pair of adjacent support members 273 intersect to form an intersection. The proximal end of the intersection is closer to the axis of the stoma 21a than the proximal end of the connecting rod 272. The proximal end of each intersection continues to extend proximally to form the extension rod 276. The proximal ends of the extension rods 276 converge at the connector 278 to form a roughly lantern-shaped structure. The connector 278 is a cylindrical or elliptical cylindrical structure with an axial length of approximately 1–3 mm and smooth edges without sharp corners. The connector 278 can be fixedly or detachably connected to the stoma device delivery mechanism 50.

[0058] Please refer to the following: Figure 1 , Figure 3 and Figure 4 The expansion member 22 is an elastic balloon structure made of a polymer material, the diameter of which changes with the filling of fluid. Preferably, the polymer material may include, but is not limited to, polyethylene (PE), polyethylene terephthalate (PET), nylon, and polyurethane. When the balloon structure is filled with fluid, such as saline, the volume of the balloon structure expands with the increase of the filling fluid, causing the outer peripheral wall of the balloon structure to press against the inner peripheral wall of the cavity of the stoma 23, so as to facilitate adjustment of the diameter of the perforation into which the stoma 23 is inserted.

[0059] The atrial septal shunt system 20 also includes a support tube 24, which is axially inserted into the lumen 230 of the stoma 23. An expansion member 22 is disposed on the support tube 24 and is located between the support tube 24 and the stoma 23. In this embodiment, the axis of the support tube 24 coincides with the axis of the stoma 21, and the expansion member 22 surrounds the support tube 24. The support tube 24 can be made of high-strength thin-walled tubing such as polyimide to reduce the space occupied by the tube wall and increase the inner diameter of the support tube 24. The support tube 24 is used to deliver saline from an external saline source into the expansion member 22.

[0060] In this embodiment, the expansion member 22 includes an outer wall 221 surrounding the support tube 24. The proximal and distal ends of the outer wall 221 are respectively sealed and connected to the support tube 24. The outer wall 221 and the outer peripheral wall of the support tube 24 form an expansion cavity 223. An infusion hole 242 communicating with the expansion cavity 223 is opened on the outer wall of the support tube 24. The saline from an external saline source is delivered to the expansion cavity 223 through the inner cavity of the support tube 24 to the infusion hole 242, causing the expansion cavity 223 to expand and radially push against the inner peripheral wall of the inner cavity 230 of the stoma 23, thereby increasing the diameter of the stoma 23. When the saline in the expansion cavity 223 is discharged outward through the inner cavity of the support tube 24, the expansion cavity 223 contracts radially, thereby reducing the diameter of the stoma 23.

[0061] The outer wall 221 of the expansion member 22 is made of polymer materials such as polyethylene (PE), polyethylene terephthalate (PET), nylon and polyurethane. The proximal and distal ends of the outer wall 221 can be sealed and connected to the support tube 24 by means of hot pressing, gluing or other methods.

[0062] When the stoma component 21 is made of conductive material, a portion of the stoma component 21 can be directly used as the ablation electrode 60. The ablation electrode can be positioned at the location where the stoma portion 23, the first positioning portion 24, or the second positioning portion 26 contacts the tissue surrounding the perforation. Because the stoma component 21 itself is conductive, insulation treatment is required on the outer surface of the stoma component 21, except for the location serving as the ablation electrode 60, to prevent the remaining outer surface from contacting blood and conducting electricity, reducing impedance, and thus preventing the ablation of the atrial septum tissue at a specific location. The insulation treatment can be achieved by applying an insulating coating to the outer surface of the supporting frame or by inserting an insulating sleeve onto the supporting frame. Because the stoma component 21 itself is conductive, it can be directly connected to the radio frequency power supply via the stoma device delivery mechanism 50 through the connector 278, thereby transferring radio frequency energy to the conductive portion 60. To further concentrate energy on the atrial septum tissue in the stoma portion 23, an insulating coating can be applied to the outer surface of the remaining locations of the stoma component 21 that are in contact with the atrial septum tissue. Furthermore, the insulating coating used is a perylene-coated insulating coating.

[0063] like Figure 1As shown, the stoma delivery mechanism 50 includes a loader, a support tube, a conductive pusher 56, and an ablation power source. The support tube includes a pusher tube 52, an outer tube 54 sleeved outside the pusher tube 52, and an inner tube 55 disposed within the pusher tube 52. The distal end of the pusher tube 52 is fixedly or detachably connected to a connector 278; the distal end of the inner tube 55 is axially connected to the support tube 24, and the inner tube 55 has an axially formed infusion channel 550 communicating with the inner cavity of the support tube 24. External saline is injected into the expansion cavity 223 through the infusion channel 550, the inner cavity of the support tube 24, and the infusion port 242, or saline in the expansion cavity 223 is discharged through the infusion port 242, the inner cavity of the support tube 24, and the infusion channel 550. A wire is disposed inside the pusher tube 52, one end of which is electrically connected to the conductive part 60 of the atrial septal shunt system 20; the other end of which is electrically connected to the ablation power source.

[0064] The room-septal stoma system 100 of this invention needs to be used in conjunction with a support tube, a conductive pusher, an ablation power supply and power connection wire, and a neutral electrode plate. The method of use is as follows:

[0065] 1. After atrial septal puncture, the guidewire is inserted into the left superior pulmonary vein, and the puncture kit is removed. The support tube is pushed along the guidewire into the left atrium, and the guidewire is removed.

[0066] 2. Select an appropriately sized atrial septal shunt system 20, push the pusher 56 forward to deliver the stoma 21 to the atrial septum, observe and ensure the imaging point is located in the atrial septal tissue. Then slowly push the pusher 56 or withdraw the outer tube 54, ensuring the imaging point is located in the atrial septal tissue during the process, so that the stoma 23 of the stoma 21 is fully opened.

[0067] 3. Fluid is filled into the expansion cavity 223 of the expansion member 22 through the infusion channel 550 of the inner tube 55, the inner cavity of the support tube 24 and the irrigation hole 242. The expansion stoma member 21 expands the interstitial septum tissue at the stoma to form a shunt channel of a specific size (determined by ultrasound or DSC).

[0068] 4. After confirming that the tissue at the stoma site is completely in contact with the stoma, connect the proximal end of the pusher to the radio frequency power supply and set the heating parameters (e.g., power 50W, duration 30S), and then start heating the conductive part 60.

[0069] 5. After heating stops, the fluid in the expansion cavity 223 is discharged through the infusion hole 242, the inner cavity of the support tube 24 and the infusion channel 550 of the inner tube 55. Then, the expansion component 22 and the stoma component 21 are recycled into the outer tube 54 and removed from the body. The stoma diameter is then measured to see if it meets expectations.

[0070] In this embodiment, the stoma component 21 of the atrial septum stoma system 100 is inserted into the perforation of the atrial septum. By injecting fluid into the expansion cavity 223 of the expansion component 22, the outer wall 221 of the expansion component 22 pushes against the inner peripheral wall of the inner cavity 230 of the stoma portion 23, thereby adjusting the diameter of the outer peripheral wall of the stoma portion 23 so that the stoma portion 23 can open the perforation on the atrial septum to form a stoma of appropriate diameter. The conductive part 60 contacts the atrial septum tissue near the stoma. The conductive part 60 receives radio frequency power to ablate the tissue of the atrial septum at the stoma site, thereby deactivating the atrial septum tissue near the stoma and preventing the stoma from being blocked by the endothelial regeneration of the tissue. After the stoma is created by the atrial septum stoma system 100, the shape of the stoma can be fixed. Therefore, the stoma shape after being processed by the cardiac atrial septum shunt system 20 is more regular and less prone to blockage, which can keep the stoma open and thus facilitate smooth blood flow between the left and right atria.

[0071] In other embodiments, the inner tube 55 and the support tube 24 can be integrally formed.

[0072] Please refer to the following: Figure 5 and Figure 6 , Figure 5 This is a schematic diagram of the structure of the expansion component of the room partition stoma system provided in the second embodiment of the present invention; Figure 6 yes Figure 5 The expansion member is shown in a cross-sectional view along line VI-VI. The structure of the room-partition stoma system provided in the second embodiment of the present invention is similar to that of the first embodiment, except that in the second embodiment, the expansion member 22a includes an inner wall 222 sleeved on the support tube 24 and an outer wall 221 connected to the proximal and distal ends of the inner wall 222. The inner wall 222 and the outer wall 221 form an expansion cavity 223. The inner wall 222 has an injection hole 2220, and the support tube 24 has an infusion hole 242 communicating with the injection hole 2220. Specifically, the inner wall 222 is a positioning tube sleeved on the support tube 24. The positioning tube is elastic, and its diameter is smaller than that of the support tube 24, thereby allowing the inner wall 222 to be firmly positioned on the support tube 24. The distal end of the outer wall 221 is sealed to the distal end of the inner wall 222, and the proximal end of the outer wall 221 is sealed to the proximal end of the inner wall 222, so that the outer wall 221 and the inner wall 222 form a sealed expansion cavity 223. The saline from the external saline source is delivered into the expansion cavity 223 through the inner cavity of the support tube 24, via the injection hole 2220 and the irrigation hole 242, causing the expansion cavity 223 to expand and radially push against the inner peripheral wall of the inner cavity 230 of the stoma 23, thereby increasing the diameter of the stoma 23. The fluid in the expansion cavity 223 can flow through the irrigation hole 242 and the injection hole 2220 into the inner cavity of the support tube 24 and outward, which can cause the expansion cavity 223 to contract radially, thereby reducing the diameter of the stoma 23.

[0073] The connection and positional relationship between the expansion member 22a and the stoma member 21 in the second embodiment are the same as those in the first embodiment, and will not be repeated here.

[0074] The room-septal stoma system in the second embodiment needs to be used in conjunction with a support tube, a conductive pusher, an ablation power supply and power connection cable, and a neutral electrode plate. The specific usage procedure and method are the same as in the first embodiment, and will not be repeated here.

[0075] Please refer to the following: Figure 7 and Figure 8 , Figure 7 This is a schematic diagram of the room partition stoma system provided in the third embodiment of the present invention; Figure 8 yes Figure 7 A schematic diagram of the structure of the expansion member of the atrial septum shunt system in the present invention. The structure of the cardiac atrial septum shunt system provided in the third embodiment of the present invention is similar to that of the first embodiment, except that: in the third embodiment, the expansion member 22b has a plurality of spray holes 2210 near the stoma portion 23, and the plurality of spray holes 2210 are used to spray the fluid onto the atrial septum adjacent to the conductive portion 60. Specifically, at least one ring of spray holes 2210 is circumferentially formed at the middle position of the outer wall 221, and these spray holes 2210 can be opened by heating a large-hole needle or by laser cutting.

[0076] In this embodiment, two rings of spray holes 2210 are circumferentially formed at the center of the outer wall 221, and the two rings of spray holes 2210 are set at the perforation positions of the outer wall 221 corresponding to the compartments. The positions of one ring of spray holes 2210 and the other ring of spray holes 2210 can be staggered or not staggered. The staggered position means that each spray hole 2210 in one ring of spray holes 2210 is located between two adjacent spray holes 2210 in the other ring of spray holes 2210; the non-staggered position means that one ring of spray holes 2210 and the other ring of spray holes 2210 correspond to each other.

[0077] Preferably, the number of spray holes 2210 is 10-50, and these spray holes 2210 are distributed in 2-4 rings at intervals or arranged in a spiral.

[0078] Each spray hole 2210 has a diameter of less than 0.2 mm to prevent insufficient pressure from the expansion member 22b, which would prevent it from radially pushing the stoma member 21 to open the atrial septum.

[0079] The room-septal stoma system provided in the third embodiment of the present invention needs to be used in conjunction with a support tube, a conductive pusher, an ablation power supply and power connection wire, and a neutral electrode plate. The method of use is as follows:

[0080] 1. After atrial septal puncture, the guidewire is inserted into the left superior pulmonary vein, and the puncture kit is removed. The support tube is pushed along the guidewire into the left atrium, and the guidewire is removed.

[0081] 2. Select an appropriately sized atrial septal shunt system 20, push the pusher 56 forward to deliver the stoma 21 to the atrial septum, observe and ensure the imaging point is located in the atrial septal tissue. Then slowly push the pusher 56 or withdraw the outer tube 54, ensuring the imaging point is located in the atrial septal tissue during the process, so that the stoma 23 of the stoma 21 is fully opened.

[0082] 3. Fluid such as saline is filled into the expansion cavity 223 of the expansion member 22b through the infusion channel 550 of the inner tube 55, the inner cavity of the support tube 24 and the irrigation hole 242. The expansion stoma member 21 expands the interstitial septum tissue at the stoma to form a shunt channel of a specific size (determined by ultrasound or DSC).

[0083] 4. After confirming that the tissue at the stoma site is completely attached to the stoma portion 23, the expansion member 22b sprays cold saline solution onto the interatrial septum tissue near the stoma portion 23 through the spray hole 2210 to pre-cool the interatrial septum tissue outside the expected ablation range near the conductive part 60. Connect the proximal end of the pusher to the radio frequency power supply and set the heating parameters (e.g., power 50W, duration 30S). Then start heating so that during the heating process, the expansion member 22b continuously sprays cold saline solution onto the interatrial septum tissue near the stoma portion 23 through the spray hole 2210.

[0084] 5. After heating stops, the cold saline in the expansion cavity 223 is discharged through the irrigation hole 242, the inner cavity of the support tube 24 and the infusion channel 550 of the inner tube 55. Then, the expansion component 22b and the stoma component 21 are recycled into the outer tube 54 and removed from the body. The stoma diameter is then measured to see if it has reached the expected value.

[0085] In this embodiment, the stoma component 21 of the interatrial septum stoma system 100 is inserted into the perforation of the interatrial septum. By injecting cold saline into the expansion cavity 223 of the expansion component 22b, the outer wall of the expansion component 22b pushes against the inner peripheral wall of the inner cavity 230 of the stoma portion 23, thereby adjusting the diameter of the outer peripheral wall of the stoma portion 23 so that the stoma portion 23 can open the perforation on the interatrial septum to form a stoma of appropriate diameter. The expansion component 22b sprays cold saline into the interatrial septum tissue outside the expected ablation range near the conductive part 60 through the spray hole 2210 to pre-cool the interatrial septum tissue near the conductive part 60 and reduce the heat-affected zone. The conductive part 60 contacts the interatrial septum tissue near the stoma. The conductive part 60 receives radio frequency power to ablate the tissue of the interatrial septum at the stoma, thereby deactivating the interatrial septum tissue near the stoma, preventing the stoma from being blocked by the endothelial regeneration of the tissue, and fixing the shape of the stoma after stoma formation by the interatrial septum stoma system 100. During the ablation of the atrial septum tissue by the conductive part 60, the expansion part 22b continuously sprays cold saline into the atrial septum tissue near the stoma 23 through the spray hole 2210. This can increase the flow of blood around the ablated atrial septum tissue, making it less susceptible to heating. At the same time, it can directly cool the blood, avoiding the formation of thrombi. This reduces the damage and risks of ablation while forming an effective ablation stoma.

[0086] Please refer to the following: Figure 9 and Figure 10 , Figure 9 This is a schematic diagram of the room partition stoma system provided in the fourth embodiment of the present invention; Figure 10 yes Figure 9A schematic diagram of the structure of the expansion component of the atrial septal shunt system. The structure of the cardiac atrial septal shunt system provided in the fourth embodiment of the present invention is similar to that of the first embodiment, except that: in the fourth embodiment, the stoma component 21a is made of woven silk. In the fully released state, the stoma component 21a includes a concave, curved stoma portion 23a, an extension portion 25a disposed at the distal end of the stoma portion 23a, and a connecting portion 27a disposed at the proximal end of the stoma portion 23a. A first positioning portion 251a is disposed on the side of the extension portion 25a facing the stoma portion 23a, and a second positioning portion 271a is disposed on the side of the connecting portion 27a facing the stoma portion 23a. The proximal end of the first positioning part 251a is connected to the distal end of the stoma part 23a, and the distal end of the first positioning part 251a extends radially. The distal end of the second positioning part 271a is connected to the proximal end of the stoma part 23a, and the proximal end of the second positioning part 271a extends axially along the stoma part 23a and merges with it. The stoma part 23a has an inner cavity, and an expansion member 22c is disposed in the inner cavity of the stoma part 23a. When fluid is filled into the expansion member 22c, the radial dimension of the expansion member 22c increases, causing the expansion member 22c to push against the stoma part 23a to open the perforation of the atrial septum to a suitable size to form a stoma. A conductive part is also provided on the stoma member 21a. The conductive part is attached to the atrial septum tissue near the stoma, and the conductive part is electrically connected to a radio frequency power supply. The conductive part receives energy output from the radio frequency power supply to ablate the tissue around the stoma of the atrial septum.

[0087] In this embodiment, the stoma component 21a is a woven mesh nickel-titanium alloy stent, the first positioning part 251a is a single-layer woven mesh structure, and the second positioning part 271a is a double-layer woven mesh structure. The first positioning part 251a includes a conical or circular positioning surface extending radially from the distal edge of the stoma part 23a, and a curved frame bending distally from the outer edge of the positioning surface. The curved frame smoothly transitions distally to avoid damage to atrial tissue. The second positioning part 271a includes a conical or circular positioning surface extending radially outward from the proximal edge of the stoma part 23a, and a conical thrombus trapping cage connected to the outer edge of the positioning surface and extending toward the end away from the stoma part 23a. The proximal end of the thrombus trapping cage closes and merges.

[0088] An ablation electrode is provided on one of the following three surfaces: the side of the stoma portion 23a facing away from the axis of the stoma component 21a, the positioning surface of the first positioning part 251a, and the positioning surface of the second positioning part 271a; or an ablation electrode is provided on two of the following three surfaces: the side of the stoma portion 23a facing away from the axis of the stoma component 21a, the positioning surface of the first positioning part 251a, and the positioning surface of the second positioning part 271a; or an ablation electrode is provided on the side of the stoma portion 23a facing away from the axis of the stoma component 21a, the positioning surface of the first positioning part 251a, and the positioning surface of the second positioning part 271a.

[0089] At least one ring of developing dots or developing wires is provided on one of the three stoma sections 23a, the first positioning section 251a and the second positioning section 271a; or at least one ring of developing dots or developing wires is provided on two of the three stoma sections 23a, the first positioning section 251a and the second positioning section 271a; or at least one ring of developing dots or developing wires is provided on each of the three stoma sections 23a, the first positioning section 251a and the second positioning section 271a.

[0090] In this embodiment, the atrial septal shunt system has two or more branch tubes 244 at the stoma 23a corresponding to the support tube 24a. These branch tubes 244 are arranged in a ring along the axis of the support tube 24a. The expansion member 22c includes expansion support members 226 respectively disposed on each branch tube 244, with each expansion support member 226 located between the corresponding branch tube 244 and the stoma 23a. In this embodiment, there are four branch tubes 244, arranged in a ring along the axis of the support tube 24a. Each branch tube 244 has one expansion support member 226 disposed on the side opposite to the axis of the support tube 24a.

[0091] like Figure 10 As shown, each branch pipe 244 is connected to the support pipe 24a. Specifically, the proximal and distal ends of each branch pipe 244 are connected to the inner cavity of the support pipe 24a, meaning that fluid in the support pipe 24a can flow into each branch pipe 244. Each expansion support 226 is a balloon structure, made of a polymer material. Preferably, the polymer material may include, but is not limited to, polyethylene (PE), polyethylene terephthalate (PET), nylon, and polyurethane. Each expansion support 226 has an expansion cavity for containing fluid, meaning that each branch pipe 244 can fill the expansion cavity of the corresponding expansion support 226 with fluid to increase the radial dimension of the expansion support 226.

[0092] In this embodiment, each expansion support 226 is connected to the corresponding branch tube 244 via a snap fastener 227. The snap fastener 227 has an injection hole communicating with the expansion cavity of the corresponding expansion support 226, and the outer wall of the branch tube 244 has an infusion hole communicating with the injection hole. External fluid, such as saline, is injected into the expansion cavity of each expansion support 226 through the infusion channel 550, the inner cavity of the support tube 24a, the branch tube 244 and its infusion hole, and the injection hole of the corresponding snap fastener 227. Alternatively, fluid, such as saline, within the expansion cavity of each expansion support 226 is discharged through the injection hole, the infusion hole of the branch tube 244, the branch tube 244, the inner cavity of the support tube 24a, and the infusion channel 550. The snap fastener 227 can be made of a radiopaque material, which not only fixes the expansion support 226 to the corresponding branch tube 244, but also makes it easier for the operator to observe the position of the ablation electrode.

[0093] The interstitial spacer system in the fourth embodiment of the present invention needs to be used in conjunction with a support tube, a conductive pusher, an ablation power supply and power connection cable, and a neutral electrode plate. The method of use is as follows:

[0094] 1. After atrial septal puncture, the guidewire is inserted into the left superior pulmonary vein, and the puncture kit is removed. The support tube is pushed along the guidewire into the left atrium, and the guidewire is removed.

[0095] 2. Select a suitable-sized stoma piece 21a, push the pusher 56 forward to deliver the stoma piece 21a to the atrial septum, observe and ensure that the imaging point is located in the atrial septum tissue. Then slowly push the pusher 56 or withdraw the outer tube 54, ensuring that the imaging point is located in the atrial septum tissue during the process, so that the stoma portion 23a of the stoma piece 21a is fully opened.

[0096] 3. Fluid is filled into the expansion cavity of each expansion support 226 through the infusion channel 550 of the inner tube 55, the inner cavity of the support tube 24a, the branch tube 244 and the irrigation hole of the branch tube and the injection hole of the corresponding buckle 227, so as to expand the stoma expansion component 21 at the stoma to form a shunt channel of a specific size (determined by ultrasound or DSC).

[0097] 4. After confirming that the tissue at the stoma site is completely in contact with the stoma, connect the proximal end of the pusher to the radio frequency power supply, and set the heating parameters (e.g., power 50W, duration 30S), and then start heating.

[0098] 5. After heating stops, the fluid in the expansion cavity of each expansion support 226 is discharged through the injection hole of the buckle 227, the injection hole 242 of the branch pipe, the branch pipe 244, the inner cavity of the support pipe 24a and the infusion channel 550. Then, the expansion support 22c and the stoma support 21a are recycled into the outer tube 54 and removed from the body. The stoma diameter is then measured to see if it has reached the expected value.

[0099] In other embodiments, each expansion support 226 includes an outer wall surrounding the corresponding branch pipe 244. The proximal and distal ends of the outer wall are respectively sealed to the branch pipe 244. The outer wall of the expansion support 226 and the outer peripheral wall of the branch pipe 244 form the expansion cavity. The outer peripheral wall of the branch pipe 244 has an injection hole communicating with the expansion cavity of the expansion support 226. The outer wall of the expansion support 226 is made of polymer materials such as polyethylene (PE), polyethylene terephthalate (PET), nylon, and polyurethane. The proximal and distal ends of the outer wall of the expansion support 226 can be sealed to the branch pipe 244 by means of hot pressing, adhesive bonding, etc.

[0100] In other embodiments, each expansion support 226 includes an inner wall sleeved on the outer peripheral wall of the corresponding branch pipe 244 and an outer wall sealed to the proximal and distal ends of the inner wall. The inner wall and outer wall of the expansion support 226 form an expansion cavity. An injection hole is provided in the inner wall, and an injection hole communicating with the injection hole is provided in the outer wall of the branch pipe 244.

[0101] In other embodiments, each expansion support 226 can also be fixed to the corresponding branch pipe 244 by adhesive bonding, and the outer wall of the branch pipe 244 is provided with an injection hole that communicates with the expansion cavity of the expansion support 226.

[0102] Please see Figure 11 , Figure 11 This is a schematic diagram of the structure of the expansion component of the atrial septum shunt system provided in the fifth embodiment of the present invention. The structure of the cardiac atrial septum shunt system provided in the fifth embodiment of the present invention is similar to that of the fourth embodiment, except that in the fifth embodiment, each expansion support 226 has a plurality of spray holes 2210 near the stoma portion 23a, and the plurality of spray holes 2210 are used to spray the fluid onto the atrial septum adjacent to the conductive portion. Specifically, each expansion support 226 has at least one ring of spray holes 2210 circumferentially formed at the middle position on the side opposite to the axis of the stoma component 21a. These spray holes 2210 can be opened by heating a large-hole needle or by laser cutting.

[0103] In this embodiment, two rings of spray holes 2210 are circumferentially opened at the middle position of the expanded support member 226, and the two rings of spray holes 2210 are set on the outer wall of the expanded support member 226 corresponding to the perforation position of the room partition.

[0104] Each spray hole 2210 has a diameter of less than 0.2 mm to prevent insufficient pressure from the expansion support 226, which would prevent it from radially pushing the stoma 21a to open the atrial septum.

[0105] The room-septal stoma system provided in the fifth embodiment of this invention needs to be used in conjunction with a support tube, a conductive pusher, an ablation power supply and power connection wire, and a neutral electrode plate. The method of use is as follows:

[0106] 1. After atrial septal puncture, the guidewire is inserted into the left superior pulmonary vein, and the puncture kit is removed. The support tube is pushed along the guidewire into the left atrium, and the guidewire is removed.

[0107] 2. Select a suitable-sized stoma piece 21a, push the pusher 56 forward to deliver the stoma piece 21a to the atrial septum, observe and ensure that the imaging point is located in the atrial septum tissue. Then slowly push the pusher 56 or withdraw the outer tube 54, ensuring that the imaging point is located in the atrial septum tissue during the process, so that the stoma portion 23a of the stoma piece 21a is fully opened.

[0108] 3. Cold saline is filled into the expansion cavity of each expansion member 226 through the infusion channel 550 of the inner tube 55, the inner cavity of the support tube 24a, the branch tube 244 and the irrigation hole of the branch tube and the injection hole of the corresponding buckle 227, so as to adjust the stoma member 21a to expand the interatrial septum tissue at the stoma to form a shunt channel of a specific size (determined by ultrasound or DSC).

[0109] 4. After confirming that the tissue at the stoma site is completely in contact with the stoma portion 23a, each expansion support 226 sprays cold saline solution onto the atrial septum tissue near the stoma portion 23a through the spray hole 2210 to pre-cool the atrial septum tissue outside the expected ablation range near the conductive part 60. Connect the proximal end of the pusher to the radio frequency power supply and set the heating parameters (e.g., power 50W, duration 30S). Then start heating so that during the heating process, each expansion support 226 continuously sprays cold saline solution onto the atrial septum tissue near the stoma portion 23a through the spray hole 2210.

[0110] 5. After heating stops, the cold saline in the expansion chamber of each expansion support 226 is discharged through the injection hole of the injection buckle 227, the injection hole of the branch tube, the inner cavity of the branch tube 244, the support tube 24a and the infusion channel 550. Then the expansion support 22c and the stoma support 21a are recycled into the outer tube 54 and removed from the body. The stoma diameter is then measured to see if it has reached the expected value.

[0111] In this embodiment, the stoma component 21a of the interatrial septum stoma system is inserted into the perforation of the interatrial septum. By filling the expansion cavity of each expansion support 226 with fluid such as cold saline, the outer wall of the expansion support 226 pushes against the inner peripheral wall of the stoma portion 23a, thereby adjusting the diameter of the outer peripheral wall of the stoma portion 23a so that the stoma portion 23a can open the perforation on the interatrial septum to form a stoma of appropriate diameter. Each expansion support 226 sprays cold saline into the interatrial septum tissue near the stoma portion 23a through the spray hole 2210 to pre-cool the interatrial septum tissue near the ablation electrode, reducing the heat-affected zone. The ablation electrode contacts the interatrial septum tissue near the stoma and receives radio frequency power to ablate the tissue of the interatrial septum at the stoma, thereby deactivating the interatrial septum tissue near the stoma, preventing the stoma from being blocked by the endothelial regeneration of the tissue, and fixing the shape of the stoma after stoma formation by the interatrial septum stoma system. During the ablation of the atrial septum tissue by the ablation electrode, each expansion support 226 continuously sprays cold saline into the atrial septum tissue near the stoma 23a through the spray hole 2210. This increases the flow of blood around the ablated atrial septum tissue, making it less susceptible to heating. It also directly cools the blood, preventing thrombus formation. This reduces ablation damage and risks while creating an effective ablation stoma.

[0112] Please see Figure 12 , Figure 12 This is a schematic diagram of the structure of the expansion component of the atrial septum shunt system provided in the sixth embodiment of the present invention. The structure of the atrial septum shunt system provided in the sixth embodiment of the present invention is similar to that of the third embodiment, except that the shape and position of the spray holes of the expansion component 22d in the sixth embodiment are different from those in the third embodiment. In the sixth embodiment, at least one ring of spray holes 2212 is provided near the proximal and distal ends of the expansion component 22d, that is, at least one ring of spray holes 2212 is provided near the proximal and distal ends of the stoma portion 23. The diameter of each spray hole 2212 is less than 0.2 mm to prevent insufficient pressure of the expansion component 22d from radially pushing the stoma component 21 to open the atrial septum tissue. The plurality of spray holes 2212 are used to spray the fluid, such as cold saline, onto the atrial septum near the stoma portion 23 to reduce the temperature of the atrial septum tissue outside the expected ablation range near the conductive part 60 and the temperature of the blood near the conductive part 60, avoiding thrombus formation, and reducing ablation damage and risks while forming an effective ablation stoma.

[0113] Specifically, the expansion member 22d also includes an expansion cavity 223 formed by the outer wall 221 surrounding the support pipe 24 and the outer peripheral wall of the support pipe 24 and the outer wall 221. A ring of spray holes 2212 is formed near the distal and proximal ends of the outer wall 221. A water pipe 2213 protrudes outward from the outer surface of the outer wall 221 around each spray hole 2212, meaning the spray hole 2212 connects to the corresponding water pipe 2213. Each water pipe 2213 near the distal end of the outer wall 221 extends inclined towards the proximal end, and each water pipe 2213 near the proximal end of the outer wall 221 extends inclined towards the distal end. Specifically, the angle between each water pipe 2213 and the axial direction of the support pipe 24 is less than 90 degrees. In this embodiment, there are six sprinkler pipes 2213 in each ring, and the two rings of sprinkler pipes 2213 are staggered, that is, each sprinkler pipe 2213 in one ring is located between two adjacent sprinkler pipes 2213 in the other ring.

[0114] In this embodiment, since the opening of each spray pipe 2213 faces the stoma 23, the fluid, such as cold saline, flows more smoothly to the atrial septum tissue outside the expected ablation range, thereby increasing the fluidity of the blood around the ablated atrial septum tissue, making it less susceptible to heating, and also directly cooling the blood to avoid thrombosis; directly cooling the atrial septum tissue outside the expected ablation range reduces the heat-affected zone, thus reducing ablation damage and risks while forming an effective ablation stoma.

[0115] The room-septal stoma system in this embodiment needs to be used in conjunction with a loader, sheath, sheath core, conductive pusher, radio frequency power supply, and power connection cable. The specific usage process and method are the same as in the third embodiment, and will not be repeated here.

[0116] In other embodiments, a ring of spray holes 2212 may be provided only at the proximal or distal end of the expansion member 22d near the stoma portion 23, and a water spray pipe 2213 may be obliquely protruding from the outer surface of the outer wall 221 toward the stoma portion 23 around each spray hole 2212, with each water spray pipe 2213 connected to the corresponding spray hole 2212.

[0117] Please see Figure 13 , Figure 13This is a schematic diagram of the structure of the expansion component of the atrial septum shunt system provided in the seventh embodiment of the present invention. The structure of the cardiac atrial septum shunt system provided in the seventh embodiment of the present invention is similar to that of the third embodiment, except that the shape and position of the spray holes of the expansion component 22d in the seventh embodiment are different from those in the third embodiment. In the seventh embodiment, the expansion component 22e has several spray holes 2210 in the middle and a ring of spray holes 2212 near the proximal end. A water spray pipe 2213 is provided obliquely around each spray hole 2212 towards the stoma 23, and each water spray pipe 2213 is connected to the corresponding spray hole 2212. The spray holes 2210 and 2212 are used to spray fluid such as cold saline onto the atrial septum near the stoma 23 to reduce the temperature of the atrial septum tissue outside the expected ablation range and the temperature of the blood near the conductive part 60, avoiding thrombus formation, and reducing ablation damage and risks while forming an effective ablation stoma. Specifically, at least one ring of spray holes 2210 is opened on the outer wall 221 corresponding to the stoma 23. These spray holes 2210 can be opened by heating a large-hole needle or by laser cutting process, and the diameter of each spray hole 2210 is less than 0.2mm.

[0118] Specifically, the expansion member 22e also includes an expansion cavity 223 formed by the outer wall 221 surrounding the support tube 24 and the outer peripheral wall of the support tube 24 and the outer wall 221. Two rings of spray holes 2210 are formed on the outer wall 221 corresponding to the stoma portion 23. The two rings of spray holes 2210 can be staggered, or a ring of spray holes 2212 can be formed near the proximal end of the outer wall 221. A water spray pipe 2213 protrudes obliquely from the outer surface of the outer wall 221 towards the stoma portion 23 around each spray hole 2212, and the water spray pipe 2213 connects to the corresponding spray hole 2212. Specifically, the angle between each water spray pipe 2213 and the axial direction of the support tube 24 is less than 90 degrees. In this embodiment, there are six water spray pipes 2213 in each ring, arranged in a circular array along the axis of the stoma portion 23.

[0119] In this embodiment, since the expansion member 22e has a spray hole 2212 corresponding to the stoma 23, and a water spray pipe 2213 is provided near the proximal end of the expansion member 22e facing the stoma 23, fluid such as cold saline is sprayed from the spray hole 2212 and the water spray pipe 2213 to the atrial septum tissue outside the expected ablation range. This increases the fluidity of the blood around the ablated atrial septum tissue, making it less susceptible to heating. At the same time, it can directly cool the blood and avoid thrombus formation. Directly cooling the atrial septum tissue outside the expected ablation range reduces the heat-affected zone, thus reducing ablation damage and risks while forming an effective ablation stoma.

[0120] The room-septal stoma system in this embodiment needs to be used in conjunction with a loader, sheath, sheath core, conductive pusher, radio frequency power supply, and power connection cable. The specific usage process and method are the same as in the third embodiment, and will not be repeated here.

[0121] Please see Figure 14 , Figure 14 This is a schematic diagram of the structure of the expansion component of the atrial septum shunt system provided in the eighth embodiment of the present invention. The structure of the cardiac atrial septum shunt system provided in the eighth embodiment of the present invention is similar to that of the third embodiment, except that the shape and position of the spray holes of the expansion component 22f in the eighth embodiment are different from those in the third embodiment. In the eighth embodiment, a plurality of spray holes 2210 are formed in the middle of the expansion component 22f and a ring of spray holes 2212 is formed near the distal end. A water spray pipe 2213 is provided obliquely around each spray hole 2212 towards the stoma 23, and each water spray pipe 2213 is connected to the corresponding spray hole 2212. The spray holes 2210 and 2212 are used to spray fluid such as cold saline onto the atrial septum near the stoma 23 to reduce the temperature of the atrial septum tissue outside the expected ablation range and the temperature of the blood near the conductive part 60, thereby avoiding thrombus formation and reducing ablation damage and risks while forming an effective ablation stoma. Specifically, at least one ring of spray holes 2210 is opened on the outer wall 221 corresponding to the stoma 23.

[0122] Specifically, the expansion member 22f also includes an expansion cavity 223 formed by the outer wall 221 surrounding the support tube 24 and the outer peripheral wall of the support tube 24 and the outer wall 221. Two rings of spray holes 2210 are formed at the stoma portion 23 on the outer wall 221, and a ring of spray holes 2212 is formed near the distal end of the outer wall 221. A water spray pipe 2213 protrudes obliquely towards the stoma portion 23 around each spray hole 2212 on the outer surface of the outer wall 221, and the water spray pipe 2213 connects to the corresponding spray hole 2212. Specifically, the angle between each water spray pipe 2213 and the axial direction of the support tube 24 is less than 90 degrees. In this embodiment, there are six water spray pipes 2213 in each ring, arranged in a circular array along the axis of the stoma portion 23.

[0123] In this embodiment, since the expansion member 22f has a spray hole 2212 corresponding to the stoma 23, and a water spray pipe 2213 is provided near the proximal end of the expansion member 22f facing the stoma 23, fluid such as cold saline is sprayed from the spray hole 2212 and the water spray pipe 2213 to the atrial septum tissue outside the expected ablation range. This increases the fluidity of the blood around the ablated atrial septum tissue, making it less susceptible to heating. At the same time, it can directly cool the blood and avoid thrombosis. Directly cooling the atrial septum tissue outside the expected ablation range reduces the heat-affected zone, thus reducing the damage and risk of ablation while forming an effective ablation stoma.

[0124] The interstitial ostomy system in this embodiment can be used in conjunction with a sheath, sheath core, conductive pusher, radio frequency power supply, and power connection cable. The specific usage process and method are the same as in the third embodiment, and will not be repeated here.

[0125] Please see Figure 15 , Figure 15 This is a schematic diagram of the structure of the expansion component of the atrial septal shunt system provided in the ninth embodiment of the present invention. The structure of the atrial septal shunt system provided in the ninth embodiment of the present invention is similar to that of the first embodiment, except that the structure of the stoma portion 23b and the extension portion 25b of the stoma component 21b in the ninth embodiment is different from that in the first embodiment. In the ninth embodiment, the stoma component 21b also includes a stoma portion 23b for opening the stoma, an extension portion 25b connected to the distal end of the stoma portion 23b, and a connecting portion 27 connected to the proximal end of the stoma portion 23b. The distal end of the extension portion 25b has a closing portion 250 extending in the direction of the axis of the stoma component 21b. A conductive portion 60 is provided on the stoma component 21b. The stoma device delivery mechanism is used to deliver the atrial septal shunt system to the perforation in the atrial septum. The conductive portion 60 is attached to the tissue at the perforation and is electrically connected to a radio frequency power supply. The conductive portion 60 receives energy output from the radio frequency power supply to ablate the tissue around the perforation in the atrial septum. In addition, since the distal end of the extension 25b has a closing portion 250 extending toward the axis of the stoma 21a, the extension 25, as a free end, can prevent damage to myocardial tissue when it enters the heart tissue through the atrial septal shunt system, thereby improving safety.

[0126] The stoma component 21b is a self-expanding stoma device. The stoma component 21b can be an elastic metal support frame or an elastic non-metallic support frame. In this embodiment, the stoma component 21b is a nickel-titanium alloy stent. When the atrial septal shunt system is delivered through a sheath, the diameter of the stoma component 21b can shrink to a smaller state for delivery within the sheath. When the atrial septal shunt system is released within the heart, the stoma component 21b can automatically expand. The expander 22 can be filled with fluid to expand and adjust the diameter of the stoma component 21b, so that the stoma component 21b can open the perforation on the atrial septum to form a stoma. The conductive part 60 is attached to the atrial septal tissue at the stoma site and is electrically connected to a radio frequency power supply. The conductive part 60 receives energy output from the radio frequency power supply to ablate the tissue around the stoma in the atrial septum.

[0127] With the atrial septal shunt system fully deployed, the stoma 23b is cylindrical, connected to the extension 25b via a first positioning part 24; the stoma 23b is connected to the connecting part 27 via a second positioning part 271b. When the atrial septal shunt system is implanted into the perforation in the atrial septum, the stoma 23b supports the inner wall of the perforation, and the first positioning part 24 and the second positioning part 271b are respectively positioned on opposite sides of the atrial septum. The diameter of the first positioning part 24 is larger than the diameter of the stoma 23b, and the first positioning part 24 is provided with a positioning surface, positioning line, or positioning point that contacts the atrial septum. Specifically, the side of the first positioning part 24 facing the stoma 23b is provided with a positioning surface, positioning line, or positioning point that can press against the atrial septal tissue. The positioning surface, positioning line, or positioning point abuts against the atrial septal tissue to prevent the atrial septal shunt system from moving proximally; the conductive part 60 can be provided on the positioning point, positioning line, or positioning surface.

[0128] The diameter of the second positioning part 271b is larger than the diameter of the stoma part 23b. The second positioning part 271b is provided with a positioning surface, positioning line, or positioning point that contacts the atrial septum. Specifically, the side of the second positioning part 271b facing the stoma part 23b is provided with a positioning surface, positioning line, or positioning point that can press against the atrial septum tissue. The positioning surface, positioning line, or positioning point abuts against the atrial septum tissue to prevent the atrial septal shunt system from moving distally, thereby positioning the atrial septal shunt system on the atrial septum. The conductive part 60 may be provided on the positioning point, positioning line, or positioning surface.

[0129] In other embodiments, the conductive part 60 may be disposed on the positioning surface, positioning line or positioning point of the first positioning part 24 and the second positioning part 271b respectively.

[0130] In this embodiment, the stoma portion 23b is a wave-shaped annular structure with at least one continuous circumferential arrangement. A first positioning part 24 is connected to the crest of the wave-shaped annular structure, and a second positioning part 271b is connected to the trough of the wave-shaped annular structure. Specifically, the stoma portion 23b is formed by a plurality of V-shaped support rods arranged end-to-end to form the wave-shaped annular structure. The wave-shaped annular structure includes crests 231, troughs 233, and wave rods 235. Circumferentially adjacent wave rods 235 are connected at their distal ends to form crests 231, and circumferentially adjacent wave rods 235 are connected at their proximal ends to form troughs 233. The middle portion of each wave rod 235 is concave and arc-shaped towards the axis of the stoma component 21a. The proximal end of the first positioning part 24 is connected to a plurality of crests 231, and the distal end of the second positioning part 271b is connected to a plurality of troughs 233. The stoma portion 23b is generally required to facilitate radial compression while maintaining necessary strength.

[0131] The stoma 23b is provided with imaging points, which are fixed by embedding and hot pressing. Specifically, imaging points are provided on one of the peaks 231, troughs 233, and spurs 235 of the stoma 23b, forming a ring of imaging points on the stoma 23b; or imaging points are provided on two of the peaks 231, troughs 233, and spurs 235, forming two rings of imaging points spaced apart on the stoma 23b; or imaging points are provided on all three peaks 231, troughs 233, and spurs 235, forming three rings of imaging points spaced apart on the stoma 23b, thereby facilitating the positioning of the stoma 23b within the perforation of the interatrial septum. The imaging points can be made of materials such as gold, platinum, or tantalum.

[0132] The extension 25b includes a plurality of first connecting rods 252 disposed at the distal end of the first positioning part 24, and an extension member 253 disposed at the distal end of each first connecting rod 252. The plurality of first connecting rods 252 are arranged in a circle around the circumference of the first positioning part 24. The proximal end of each first connecting rod 252 is connected to the first positioning part 24, and the distal end of the first connecting rod 252 is connected to the extension member 253. The middle part of the first connecting rod 252 protrudes in a direction away from the axis of the stoma member 21a to form an arc rod. The plurality of extension members 253 form the closing part 250.

[0133] Each extension 253 extends obliquely from the distal end of the corresponding first connecting rod 252 toward the axis of the stoma 21b, and a plurality of the extensions 253 are arranged in a ring around the axis of the stoma 21b to form the closing portion 250.

[0134] The distal end of each extension 253 is closer to the axis of the stoma 21b than the corresponding first connecting rod 252. The distal end of the extension 253 is rounded. Specifically, the outer peripheral surface of the distal end of the extension 253 is set as an arc surface or a rounded corner, or the distal end of the extension 253 is set as a circular piece, a spherical structure or a similar spherical structure.

[0135] In this embodiment, each extension 253 includes two branch rods 2530 that bend and radiate from the distal end of the first connecting rod 252 toward the axis of the stoma 21b. The distal ends of the two adjacent branch rods 2530 of each pair of adjacent extensions 253 intersect to form an intersection portion 2532. The distal end of the intersection portion 2532 is closer to the axis of the stoma 21a than the distal end of the first connecting rod 252.

[0136] The distal end of each intersecting portion 2532 is rounded. Specifically, the distal outer peripheral surface of the intersecting portion 2532 is set as an arc surface or a rounded corner, or the intersecting portion 2532 is a circular structure or a spherical structure.

[0137] The rounded distal end of the extension 253 prevents the free end of the extension 253 from scratching the myocardial tissue when it enters the cardiac tissue via the atrial septal shunt system 20, thus improving safety.

[0138] The first positioning part 24 includes two first positioning rods 240 that radiate outwards from each peak 231 of the stoma portion 23b along both sides in a direction away from the axis of the stoma member 21a. The distal ends of two adjacent first positioning rods 240 on two adjacent peaks 231 meet. A plurality of first connecting rods 252 correspond one-to-one with a plurality of distal ends meeting at the first positioning part 24, that is, the proximal end of each first connecting rod 252 is connected to the corresponding distal end meeting point of the first positioning part 24.

[0139] In other embodiments, at least one ring of developing dots is provided on the first positioning part 24, and the developing dots are fixed by embedding or hot pressing. Specifically, developing dots are embedded or hot-pressed on each of the first positioning rods 240 of the first positioning part 24. At least one ring of flexible developing wire may also be provided on the first positioning part 24, and the flexible developing wire is fixed by embedding or hot pressing.

[0140] The second positioning part 271b is a second positioning rod that extends from each trough 233 of the stoma 23 toward the axis away from the stoma member 21. Specifically, the distal end of each second positioning rod is connected to the corresponding trough 233, and the proximal end extends toward the axis away from the stoma member 21b and tilts proximally.

[0141] The connecting part provided in the ninth embodiment of the present invention is the same as that in the first embodiment, and will not be described again here.

[0142] In this embodiment, the stoma portion 23b is provided with a conductive portion 60. Specifically, each wave rod 235 has a conductive portion 60 on its side facing away from the axis of the stoma member 21b, and these conductive portions 60 form a circle around the circumference of the stoma portion 23b. In other embodiments, conductive portions 60 are provided on the side of the spaced wave rods 235 facing away from the axis of the stoma member 21b, and these conductive portions 60 form a circle around the circumference of the stoma portion 23a.

[0143] In this embodiment, the radio frequency power supply is connected via connector 278, thereby transmitting radio frequency energy to the conductive portion 60 at the perforation. To further concentrate energy on the atrial septum tissue of the stoma portion 23b, an insulating coating can be applied to the outer surface of the remaining positions of the stoma component 21b that are in contact with the atrial septum tissue. Furthermore, the insulating coating used is a perylene-coated insulating coating.

[0144] The room-septal stoma system in the ninth embodiment needs to be used in conjunction with a support tube, a conductive pusher, an ablation power supply and power connection cable, and a neutral electrode plate. The specific usage procedure and method are the same as in the first embodiment, and will not be repeated here.

[0145] Please see Figure 16 , Figure 16 This is a schematic diagram of the structure of the expansion component of the atrial septal shunt system provided in the tenth embodiment of the present invention. The structure of the cardiac atrial septal shunt system provided in the tenth embodiment of the present invention is similar to that of the ninth embodiment, except that: in the tenth embodiment, an insulating film 28 is provided between the stoma component 21b and the conductive part 60. Further, the insulating film 28 is located between the conductive part 60 and the stoma component 23b. The insulating film 28 may be, but is not limited to, a polytetrafluoroethylene film, a polyurethane film, or a polyimide film. Since the stoma component 23b and the conductive part 60 are isolated by the insulating film 28, the insulating film 28 can not only isolate the heat conduction between the conductive part 60 and the stoma component 21b, i.e., prevent energy from being transferred to the stoma component 21b, thereby concentrating heat on the conductive part 60 to ablate the atrial septal tissue and improve energy utilization; but the insulating film 28 can also form an insulating barrier on the side of the conductive part 60 facing the blood, thereby reducing the current density passing through the blood, reducing the heating of the blood by the conductive part 60, and reducing the risk of thrombus formation.

[0146] In this embodiment, the insulating film 28 is disposed on the outer wall surface of the stoma portion 23b facing the conductive portion 60. Specifically, the insulating film 28 is connected to the outer wall surface of the stoma portion 23b by means of suture or adhesive.

[0147] The area of ​​the conductive part 60 projected onto the insulating film 28 is located within the insulating film 28, that is, the area of ​​the conductive part 60 projected onto the insulating film 28 is less than or equal to the area of ​​the insulating film 28.

[0148] Please see Figure 17 , Figure 17 This is a schematic diagram of the atrial septal shunt system provided in the eleventh embodiment of the present invention. The structure of the atrial septal shunt system provided in the eleventh embodiment is similar to that of the tenth embodiment, except that in the eleventh embodiment, the conductive part 60a is at least one annular electrode disposed on the outer wall of the stoma portion 23b, and the at least one annular electrode surrounds the stoma portion 23b circumferentially. The at least one annular electrode is electrically connected to a radio frequency power supply via a flexible wire located within the stoma component 21b. The annular electrode is a continuous, highly elastic, and flexible metal wire, such as a nickel-titanium multi-strand wire or a nickel-titanium multi-strand wire wrapped with a gold spring. The annular electrode can be attached to the stoma component 21b by sutures and / or binding.

[0149] In this embodiment, two spaced-apart annular electrodes are provided on the outer wall of the stoma 23b.

[0150] An insulating film 28 is provided between the stoma portion 23b and the conductive portion 60a to isolate the stoma portion 23b from the conductive portion 60a. The insulating film 28 may be, but is not limited to, a polytetrafluoroethylene film, a polyurethane film, or a polyimide film.

[0151] In other embodiments, the side of the stoma portion 23b facing the conductive portion 60a is coated with an insulating layer, such as a pyrene insulating coating, thereby insulating the conductive portion 60a from the stoma portion 21b.

[0152] Please see Figure 18 , Figure 18 This is a schematic diagram of the atrial septal shunt system provided in the twelfth embodiment of the present invention. The structure of the atrial septal shunt system provided in the twelfth embodiment is similar to that of the tenth embodiment, except that in the twelfth embodiment, the conductive part 60b includes a plurality of spaced point electrodes, which are arranged in at least one ring around the outer wall surface of the stoma member 21b. Specifically, these point electrodes are arranged in at least one ring around the outer wall surface of the stoma part 23b, and the conductive part 60b and the stoma member 21b are insulated. The insulation treatment is achieved by coating an insulating coating on the outer wall surface of the stoma member 21b that contacts the point electrodes, or by providing an insulating film 28 between the conductive part 60b and the stoma member 21b. The insulating coating may be, but is not limited to, FEP / ETFE / PFA, etc., and the insulating film 28 may be, but is not limited to, a polytetrafluoroethylene film, a polyurethane film, or a polyimide film, etc.

[0153] In this embodiment, these point electrodes are connected in series by a flexible wire and then wrapped around the outer wall surface of the stoma 23b twice. The flexible wire is electrically connected to a radio frequency power supply.

[0154] The room-septal stoma system in this embodiment needs to be used in conjunction with a loader, sheath, sheath core, conductive pusher, radio frequency power supply, and power connection cable. The specific usage process and method are the same as in the first embodiment, and will not be repeated here.

[0155] Please see Figure 19 , Figure 19This is a schematic diagram of the atrial septal shunt system provided in the thirteenth embodiment of the present invention. The structure of the atrial septal shunt system provided in the thirteenth embodiment is similar to that of the tenth embodiment, except that in the thirteenth embodiment, the ablation electrode 60c is a double-ringed, intermittent annular electrode disposed on the circumferential surface of the outer wall of the stoma 21b, and the intermittent annular electrode is insulated from the stoma 21b. Specifically, the double-ringed, intermittent annular electrode is disposed on the outer wall surface of the stoma 23b, and an insulating film 28 is disposed between the annular electrode and the stoma 23b. The intermittent annular electrode is electrically connected to a radio frequency power supply via a flexible wire in series.

[0156] In other embodiments, the ablation electrode 60c can be a single-turn intermittent annular electrode disposed on the circumferential direction of the outer wall of the stoma 23b, and the single-turn intermittent annular electrode is connected to the radio frequency power output terminal through a flexible wire.

[0157] Please see Figure 20 , Figure 20 This is a schematic diagram of the atrial septal shunt system provided in the fourteenth embodiment of the present invention. The structure of the atrial septal shunt system provided in the fourteenth embodiment is similar to that of the tenth embodiment, except that in the fourteenth embodiment, the ablation electrode 60d includes a plurality of spaced rod-shaped electrodes, which are arranged in at least one ring around the outer wall surface of the stoma 21b. Specifically, these rod-shaped electrodes are arranged in at least one ring around the outer wall surface of the stoma 23b, and the ablation electrode 60d and the stoma 21b are insulated. The insulation treatment is achieved by coating an insulating coating on the outer wall surface of the stoma 23b that contacts the rod-shaped electrodes, or by providing an insulating film 28 between the ablation electrode 60d and the stoma 23b. The insulating coating may be, but is not limited to, FEP / ETFE / PFA, etc., and the insulating film 28 may be, but is not limited to, a polytetrafluoroethylene film, a polyurethane film, or a polyimide film, etc.

[0158] In this embodiment, these rod-shaped electrodes are connected in series by a flexible wire and then wrapped around the outer wall surface of the stoma 23b twice. The flexible wire is electrically connected to the output terminal of the radio frequency power supply.

[0159] In other embodiments, the stoma device is a support frame made of conductive material, and the ablation electrode is the uninsulated portion of the support frame. All outer surfaces of the support frame, except for the ablation electrode, are coated with an insulating coating or have fixed insulating sleeves. Preferably, the surface of the ablation electrode is plated with a gold or platinum layer, which not only serves as a imaging marker, making it easier for the operator to observe the location of the ablation electrode, but also improves the conductivity of the ablation electrode.

[0160] Please see Figure 21 , Figure 21 This is a schematic diagram of the atrial septal shunt system provided in the fifteenth embodiment of the present invention. The structure of the atrial septal shunt system provided in the fifteenth embodiment is similar to that of the ninth embodiment, except that the first connecting rod 251 and the second connecting rod 272 are omitted from the atrial septal shunt system provided in the ninth embodiment. The specific structure is as follows:

[0161] The atrial septal shunt system provided in the fifteenth embodiment also includes a stoma 23b, an extension 25c disposed at the distal end of the stoma 23b, and a connecting portion 27 disposed at the proximal end of the stoma 23b. The extension 25c is connected to the stoma 23b via a first positioning portion 24a, and the connecting portion 27 is connected to the stoma 23b via a second positioning portion 26a. The structure of the stoma 23b and the connecting portion 27 is the same as that in the ninth embodiment, and will not be described again here.

[0162] The first positioning part 24a includes a plurality of first positioning rods 240a, each corresponding to a plurality of peaks 231. The proximal end of each first positioning rod 240a is connected to the corresponding peak 231, and the distal end of each first positioning rod 240a extends distally at an angle away from the axis of the stoma piece 21c. The extension part 25c includes a plurality of extension members 253 disposed at the distal end of the first positioning part 24a, each corresponding to a plurality of first positioning rods 240a. The proximal end of each extension member 253 is connected to the distal end of the corresponding first positioning rod 240a. The plurality of extension members 253 are arranged circumferentially along the support frame 21 to form the extension part 25c. Each extension 253 includes two branch rods 2530 branching out radially from the outermost end of the corresponding first positioning rod 240a. The two branch rods 2530 are inclined and bent in a direction away from the stoma portion 23b. The distal ends of the two adjacent branch rods 2530 of two adjacent extensions 253 meet to form an intersection portion 2532. Several intersection portions 2532 extend towards the axis of the stoma portion 21c to form a closing portion 250. The distal end of each intersection portion 2532 is rounded; specifically, the distal end of each intersection portion 2532 is set as a circular plate. Because the closing portion 250 extends towards the axis of the stoma portion 21c, and the distal end of each intersection portion 2532 is set as a circular plate, the atrial septal shunt system is less likely to damage important myocardial tissue during surgery, making it safe and reliable.

[0163] The distal end of the extension 253 of the extension portion 25c is provided with at least one ring of radiopaque dots. Specifically, the distal end of the extension 253 of the extension portion 25c is inlaid or hot-pressed with at least one ring of radiopaque dots around the axis of the stoma member 21c to facilitate implantation into the atrial septal shunt system. In this embodiment, the intersecting portion 2532 has mounting holes 2535, and each mounting hole 2535 is provided with a radiopaque dot. Specifically, each mounting hole 2535 is inlaid with a radiopaque dot, and the radiopaque dots on several intersecting portions 2532 form a ring. The radiopaque dots can be made of materials such as gold, platinum, or tantalum.

[0164] In other embodiments, at least one loop of flexible developing wire is provided at the distal end of the extension 253 of the extension portion 25c, and the developing wire is fixed by embedding and hot pressing.

[0165] The second positioning part 26a consists of a plurality of second positioning rods 260a connected to a plurality of troughs 233. Each second positioning rod 260a corresponds one-to-one with a plurality of troughs 233. The distal end of each second positioning rod 260a is connected to the corresponding trough 233, and the proximal end of the second positioning rod 260a extends proximally away from the axis of the stoma unit 21c. The connecting part 27 includes a plurality of support members 273 disposed at the proximal end of the second positioning part 260a, an extension rod 276 disposed at the proximal end of each support member 273, and a connector 278 disposed at the proximal end of the extension rod 276. Each support member 273 corresponds one-to-one with a plurality of second positioning rods 260a, and the distal end of each support member 273 is connected to the proximal end of the corresponding second positioning rod. The plurality of support members 273 are arranged circumferentially along the second positioning part 271a. Each support member 273 includes two supporting branch rods 2730 branching from the outermost radial end of the corresponding second positioning rod. The two supporting branch rods 2730 are inclined and bent in a direction away from the stoma portion 23. The proximal ends of the two adjacent second positioning rods of two adjacent support members 273 meet to form an intersection portion. The proximal end of the intersection portion is closer to the axis of the stoma portion 21c than the outermost radial end of the corresponding supporting branch rod 2730. The proximal end of each intersection portion continues to extend proximally to form an extension rod 276. The proximal ends of the extension rods 276 converge to the connector 278 to form a roughly lantern-shaped structure. The connector 278 is a cylindrical or elliptical cylindrical structure with an axial length of approximately 1-3 mm and smooth edges without sharp corners. The connector 278 can be fixedly or detachably connected to the stoma device delivery mechanism.

[0166] The room-septal stoma system in this embodiment needs to be used in conjunction with a loader, sheath, sheath core, conductive pusher, radio frequency power supply, and power connection cable. The specific usage process and method are the same as in the first embodiment, and will not be repeated here.

[0167] The above are the embodiments of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the embodiments of the present invention, and these improvements and modifications are also considered to be within the protection scope of the present invention.

Claims

1. A cardiac atrial septal shunt system comprising a stoma component for forming a stoma on the atrial septum, characterized in that, The cardiac atrial septal shunt system also includes an expansion member disposed in the inner space of the stoma, the expansion member being capable of being filled with fluid, and the stoma including a conductive portion for ablating the tissue surrounding the stoma. The stoma includes a stoma portion having an inner cavity after unfolding, a connecting portion disposed at the proximal end of the stoma portion, and an extension portion disposed at the distal end of the stoma portion. The stoma portion is capable of radial contraction and expansion, and the maximum diameter of the connecting portion and / or the extension portion is greater than the diameter of the stoma portion. The extension portion includes a first positioning portion connected to the distal end of the stoma portion, and the connecting portion includes a second positioning portion connected to the proximal end of the stoma portion. When the stoma portion is located within the perforation of the atrial septum, the first positioning portion and the second positioning portion are respectively positioned on opposite sides of the atrial septum. The stoma fitting can automatically expand to form an inner cavity, and the expander is used to fill the inner cavity of the stoma fitting with fluid after the stoma fitting automatically expands to adjust the diameter of the inner cavity of the stoma fitting.

2. The atrial septal shunt system according to claim 1, characterized in that, The expander is disposed in the inner cavity of the stoma. When fluid is filled into the expander, the expander can expand radially and push against the inner peripheral wall of the stoma to adjust the diameter of the outer peripheral wall of the stoma.

3. The atrial septal shunt system according to claim 2, characterized in that, The expander includes an elastic balloon structure made of a polymer material, the diameter of which changes as fluid is introduced.

4. The atrial septal shunt system according to claim 2, characterized in that, The atrial septal shunt system further includes a support tube axially disposed within the cavity of the stoma, and an expansion member disposed on the support tube, the expansion member being located between the support tube and the stoma.

5. The atrial septal shunt system according to claim 4, characterized in that, The expansion member includes an outer wall surrounding the support tube, with the proximal and distal ends of the outer wall respectively sealed to the support tube. The outer wall and the outer peripheral wall of the support tube form an expansion cavity, and the support tube has an injection hole communicating with the expansion cavity of the expansion member.

6. The atrial septal shunt system according to claim 4, characterized in that, The expansion member includes an inner wall sleeved on the support tube and an outer wall connected to the proximal and distal ends of the inner wall. The inner wall and the outer wall form an expansion cavity. An injection hole is provided in the inner wall, and an injection hole communicating with the injection hole is provided in the support tube.

7. The atrial septal shunt system according to claim 2, characterized in that, The cardiac atrial septal shunt system also includes a support tube, which has several branch tubes arranged at the stoma. The branch tubes are arranged circumferentially around the support tube as the axis. The expansion member includes expansion support members respectively arranged at each branch tube. Each expansion support member is located between the corresponding branch tube and the stoma.

8. The atrial septal shunt system according to claim 7, characterized in that, Each expansion support includes an outer wall surrounding the corresponding branch pipe, with the proximal and distal ends of the outer wall respectively sealed to the branch pipe. The outer wall and the outer peripheral wall of the branch pipe form an expansion cavity. An injection hole communicating with the expansion cavity of the expansion support is opened on the outer peripheral wall of the support pipe.

9. The atrial septal shunt system according to claim 7, characterized in that, Each expansion support includes an inner wall sleeved on the outer peripheral wall of the corresponding branch pipe and an outer wall connected to the proximal and distal ends of the inner wall. The inner wall and the outer wall form an expansion cavity. An injection hole is provided on the inner wall, and a filling hole communicating with the injection hole is provided on the outer peripheral wall of the branch pipe.

10. The atrial septal shunt system according to claim 1, characterized in that, The distal end of the extension is provided with a closing portion extending toward the axis of the stoma. The closing portion also includes a plurality of extension members, which are arranged in a circle around the first positioning portion. The distal end of each extension member is inclined toward the axis of the stoma.

11. The cardiac atrial septal shunt system according to claim 10, characterized in that, The distal outer circumferential surface of each extension is set as an arc surface or a rounded corner, or the distal end of the extension is set as a circular piece or a spherical structure.

12. The atrial septal shunt system according to claim 1, characterized in that, The conductive part is an ablation electrode disposed on one of the stoma, the first positioning part, and the second positioning part; or the conductive part is an ablation electrode disposed on two of the stoma, the first positioning part, and the second positioning part; or the conductive part is an ablation electrode disposed on the stoma, the first positioning part, and the second positioning part.

13. The cardiac atrial septal shunt system according to claim 12, characterized in that, The stoma device is a support frame made of conductive material. The ablation electrode is the part of the support frame that is not insulated. Except for the ablation electrode, all other outer surfaces of the support frame are coated with an insulating coating or fixed with an insulating sleeve.

14. The cardiac atrial septal shunt system according to claim 13, characterized in that, The ablation electrode is a ring electrode, and the ring electrode is arranged in at least one ring, either connected or discontinuous, along the outer wall surface of the stoma; or the ablation electrode is a plurality of point electrodes or strip electrodes, and the plurality of point electrodes or strip electrodes are arranged in at least one ring along the outer wall surface of the stoma.

15. The cardiac atrial septal shunt system according to claim 14, characterized in that, An insulating film is provided between the ablation electrode and the stoma; or an insulating coating is applied to the outer surface of the stoma corresponding to the ablation electrode.

16. The cardiac atrial septal shunt system according to claim 14, characterized in that, At least one ring of developing dots or developing wires is provided on one of the three parts: the stoma, the first positioning part, and the second positioning part; or at least one ring of developing dots or developing wires is provided on two of the three parts: the stoma, the first positioning part, and the second positioning part; or at least one ring of developing dots or developing wires is provided on the stoma, the first positioning part, and the second positioning part.

17. The atrial septal shunt system according to claim 2, characterized in that, The expansion member has a plurality of spray holes near the conductive part, and the plurality of spray holes are used to spray the fluid onto the blood or tissue surrounding the conductive part.

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