CN112754651A

CN112754651A - Heart interatrial septum shunt system

Info

Publication number: CN112754651A
Application number: CN201911079534.7A
Authority: CN
Inventors: 王永胜; 董元博; 王坤
Original assignee: Hangzhou Nuosheng Medical Technology Co ltd
Current assignee: Hangzhou Nuosheng Medical Technology Co ltd
Priority date: 2019-11-06
Filing date: 2019-11-06
Publication date: 2021-05-07

Abstract

The invention provides a cardiac interatrial septum shunt system comprising an ostomy member for forming an ostomy opening in an interatrial septum, the cardiac interatrial septum shunt system further comprising an expansion member arranged in the space inside the ostomy member, the expansion member being fillable with a fluid, the ostomy member comprising an electrically conductive portion for ablating tissue surrounding the ostomy opening. The augment varying the size of the diameter of the stoma by the amount of inflation fluid to adjust the stoma to a suitable size; the conductive part contacts the interatrial septum tissue near the stoma, and the conductive part receives the radio frequency power supply in order to the interatrial septum in the tissue of stoma department melts to make the interatrial septum tissue near the stoma lose activity, prevent to climb to cover because of the prosthetic endothelium of tissue and block up the stoma, and after the stoma is made to the interatrial septum system, can fix the form behind the stoma.

Description

Heart interatrial septum shunt system

Technical Field

The invention relates to the technical field of interventional medical instruments, in particular to a percutaneous interventional heart interatrial septum shunt system.

Background

Heart failure (abbreviated as heart failure) is a complex group of clinical syndromes in which the filling of the ventricles or the ability to eject blood is impaired due to any structural or functional abnormality of the heart, and its main clinical manifestations are dyspnea and fatigue (limited movement tolerance), and fluid retention (pulmonary congestion and peripheral edema). Heart failure is the severe and terminal stage of various heart diseases, has high morbidity and is one of the most important cardiovascular diseases at present. There are left heart, right heart and whole heart failure according to the occurrence of heart failure.

Heart failure is a serious disease with high incidence and mortality. The incidence rate of heart failure in China is 2-3%, and is over 1200 ten thousand. The causes of heart failure include hypertension, coronary heart disease, myocardial infarction, valvular heart disease, atrial fibrillation, cardiomyopathy, etc. Cardiovascular diseases cause damage to the left ventricle, leading to pathological remodeling of the left ventricle and resulting in reduced cardiac function. Each time a myocardial infarction patient is successfully treated, a potential heart failure patient is brought about.

In terms of treatment, after optimizing drug treatment, the symptoms of patients still recur, and the current drug treatment almost only has better curative effect on patients with reduced ejection fraction, and the curative effect on patients with retained ejection fraction is not ideal. Cardiac resynchronization therapy is not suitable for all heart failure patients, and over 20% of patients do not have effective cardiac resynchronization pacing. The left ventricle auxiliary device operation needs extracorporeal circulation trauma, has high complication incidence rate and is expensive and difficult to obtain. Heart transplantation is the final solution, but the source of donors is very limited and expensive.

An interatrial ostomy is a stoma at the patient's interatrial septum, creating a shunt in the left and right heart rooms, which can be used to treat pulmonary hypertension (right-to-left shunt) or left heart failure (left-to-right shunt), and has proven clinically effective.

Conventional interatrial septum ostomy methods, such as balloon interatrial septum ostomy, have a tendency for the myocardial tissue to recoil after the stoma and over time the stoma may shrink or even close completely. In order to solve the problem that the stoma is reduced or even closed, the prior art provides an ostomy bracket, which can respectively disclose an implant for atrial shunt.

Another ostomy appliance comprises a cutting device and a grabbing device, wherein when the appliance performs ostomy on tissues, the grabbing device firstly positions and grabs partial tissues to be cut; then, the cutting part of the tissue grabbed by the grabbing device is cut by the cutting part of the cutting device, and the cut part of the tissue is taken out of the body by the grabbing device, so that the stoma is formed.

The above-mentioned techniques have the following drawbacks: implants for atrial shunts leave the device in place at the stoma, which can easily lead to thrombosis, or the device falling off, forming an embolism. In addition, the passage is closed and the shunting action is lost, as endothelial attachment can cause the instrument opening to be blocked. In addition, there is a high risk of cutting the endocardial tissue during the procedure by means of a mechanical or high frequency electrotome, which may lead to the cut tissue falling out and forming emboli, for example, during the operation of the intraoperative grasping device, or during retrieval. Furthermore, loosening of the grasping device can easily result in damage to other myocardial tissue if it is cut during the cutting process.

Disclosure of Invention

The invention aims to provide a heart interatrial septum shunt system which is not easy to close a stoma and can not cause damage to other myocardial tissues.

In order to solve the above technical problem, the present invention provides a cardiac interatrial septum shunt system comprising an ostomy member for forming an ostomy on an interatrial septum, the cardiac interatrial septum shunt system further comprising an expansion member arranged in the space inside the ostomy member, the expansion member being inflatable with a fluid, the ostomy member comprising an electrically conductive portion for ablating tissue surrounding the ostomy.

The cardiac interatrial septum shunting system of the interatrial septum stoma system of the present invention comprises an ostomy member radially distracting a stoma on the interatrial septum, an expansion member disposed within an inner cavity of the ostomy member for adjusting a diameter of the ostomy member, and a conductive portion disposed on the ostomy member. The expansion member varying the size of the diameter of the stoma by the amount of filling fluid to adjust the stoma to a suitable size; the conductive part contacts the interatrial septum tissue near the stoma, and the conductive part receives the radio frequency power supply in order to the interatrial septum in the tissue of stoma department melts to make the interatrial septum tissue near the stoma lose activity, prevent to climb to cover because of the prosthetic endothelium of tissue and block up the stoma, and after the stoma is made to the interatrial septum system, can fix the form behind the stoma. Therefore, the shape of the stoma after being processed by the atrial septal shunt system is regular and is not easy to be blocked, and the stoma can be kept smooth, so that the blood shunt in the left and right ventricles is smooth.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

FIG. 1 is a schematic view of a septal stoma system according to a first embodiment of the present invention;

FIG. 2 is a schematic illustration of the construction of an ostomy member of the atrial septal shunt system of FIG. 1;

FIG. 3 is a schematic view of an augment of the compartmental ostomy system of FIG. 1;

FIG. 4 is a cross-sectional view of the extender of FIG. 3 taken along line III-III;

FIG. 5 is a schematic view of an extender for a compartmental ostomy system according to a second embodiment of the invention;

FIG. 6 is a cross-sectional view of the extender of FIG. 5 taken along line VI-VI;

FIG. 7 is a schematic view of a septum ostomy system according to a third embodiment of the invention;

FIG. 8 is a schematic view of the extension of the compartmental ostomy system of FIG. 7;

FIG. 9 is a schematic view of a septum ostomy system according to a fourth embodiment of the invention;

FIG. 10 is a schematic view of the extension of the compartmental ostomy system of FIG. 9;

FIG. 11 is a schematic view of an extender for a compartmental ostomy system according to a fifth embodiment of the invention;

FIG. 12 is a schematic view of an extender for a compartmental ostomy system according to a sixth embodiment of the invention;

FIG. 13 is a schematic view of an extender for a compartmental ostomy system according to a seventh embodiment of the invention;

FIG. 14 is a schematic view of an extender for a compartmental ostomy system according to an eighth embodiment of the invention;

FIG. 15 is a schematic view of the construction of an ostomy member of a compartmental ostomy system according to a ninth embodiment of the invention;

FIG. 16 is a schematic view of the construction of an ostomy member of a compartmental ostomy system according to a tenth embodiment of the invention;

FIG. 17 is a schematic view of a construction of an ostomy member of a compartmental ostomy system according to an eleventh embodiment of the invention;

FIG. 18 is a schematic view of the construction of an ostomy member of a compartmental ostomy system according to a twelfth embodiment of the invention;

FIG. 19 is a schematic view of the construction of an ostomy member of a compartmental ostomy system according to a thirteenth embodiment of the invention;

FIG. 20 is a schematic view of a construction of an ostomy member of a compartmental ostomy system according to a fourteenth embodiment of the invention;

figure 21 is a schematic view of a construction of an ostomy member of a compartmental ostomy system according to a fifteenth embodiment of the invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without inventive effort based on the embodiments of the present invention, are within the scope of the present invention.

In the description of the present invention, the tissue between the left atrium and the right atrium of the present invention is referred to as the interatrial septum, the "proximal" end being the end proximal to the delivery device attachment site, and the "distal" end being the end distal to the delivery device attachment site. Axial refers to the direction of the central axis of the device, and radial is the direction perpendicular to the central axis, and this definition is for convenience only and should not be construed as limiting the invention.

Referring to fig. 1, fig. 1 is a schematic structural view of a septal ostomy system according to a first embodiment of the present invention. The present invention provides an interatrial septum ostomy system 100 comprising a cardiac interatrial septum shunt system 20 and an ostomy device delivery mechanism 50 for delivering the cardiac interatrial septum shunt system 20. The cardiac atrial septal shunt system 20 includes an ostomy member 21 for forming an ostium in the atrial septum and a augment 22 disposed within a lumen of the ostomy member 21, the augment 22 being inflatable with a fluid such that radial expansion of the augment 22 serves to expand and adjust a diameter of the ostomy member 21, the ostomy member 21 including an electrically conductive portion 60 for isolating tissue surrounding the ostium. The extender 22 is used to adjust the diameter of the ostomy 21 to expand the stoma to a suitable size; the conductive part 60 is attached to the atrial septum tissue at the stoma, the conductive part 60 is electrically connected to the radio frequency power supply, and the conductive part 60 receives energy output by the radio frequency power supply to ablate the tissue around the stoma at the atrial septum for ablating the tissue around the stoma.

In this embodiment, the fluid filling the expansion member 22 may be a gas or a liquid, and in the present invention, the fluid is saline; the conductive portion 60 is an ablation electrode.

The cardiac interatrial septum shunting system 20 of the interatrial septum stoma system 100 of the present invention comprises an ostomy member 21 forming the stoma in the interatrial septum, an extender 22 arranged in the lumen of the ostomy member 21, and a conductive portion 60 arranged on the ostomy member 21. The expansion member 22 on the one hand changes the size of the diameter of the stoma 21 by the amount of filling fluid in order to adjust the stoma to the desired size; on the other hand, the fluid-filled expansion member 22 is able to provide a greater radial support force, while imparting support force to the ostomy member 21 and simultaneously expanding the perforation in the atrial septum, expanding the perforation, because of the radial support effect of the expansion member 22, the ostomy member 21 can be used only as a conductive part carrier, rather than simultaneously as a force imparting structure for radial expansion, providing more room for the choice of the material and structure of the ostomy member 21, and allowing the choice of metals or non-metallic materials with better biocompatibility; furthermore, because of the expansion member 22, the ostomy member 22 may be selected from a balloon-type material and need not be limited to a self-expanding material. The conductive part 60 contacts the interatrial septum tissue near the stoma, and the conductive part 60 receives a radio frequency power supply to melt the interatrial septum tissue at the stoma to inactivate the interatrial septum tissue near the stoma, prevent the stomal blockage caused by the repair endothelium climbing of the tissue, and fix the shape after the stoma is made by the interatrial septum stoma system 100. Therefore, the shape of the stoma after being treated by the atrial septal shunt system 20 is regular and not easy to be blocked, and the stoma can be kept smooth, so that the blood in the left and right ventricles can be shunted smoothly.

In the fully released state of the atrial septal shunt system 20, the ostomy member 21 includes an ostomy portion 23 having a lumen 230, the ostomy portion 23 being capable of radial contraction and expansion, and the expansion member 22 is disposed in the lumen 230 of the ostomy portion 23 and on both the proximal and distal sides thereof. When the extender 22 is inflated with fluid, the extender 22 can expand radially against the inner circumferential wall of the lumen 230 of the stoma portion 23 to adjust the diameter of the outer circumferential wall of the stoma portion 23 while giving the stoma portion 23 radial support to expand the septal perforation.

Referring to fig. 1 and 2 together, fig. 2 is a schematic view of the structure of an ostomy member of the atrial septal shunt system of fig. 1. The ostomy member 21 is an expandable ostomy device and the ostomy member 21 may be a ball-expanding (e.g. made of stainless steel or cobalt chrome, etc.) or a self-expanding (e.g. shape memory alloy such as nickel alloy) metal or non-metal supporting frame. In this embodiment, the ostomy member 21 is a metal stent having elasticity, and further, the ostomy member 21 is a nickel titanium alloy stent. When atrial septal shunt system 20 is delivered through the sheath, the diameter of the ostomy 21 can be contracted to a smaller state for delivery in the sheath; when the atrial septal shunt system 20 is released from the heart, the ostomy member 21 is automatically expanded to form the inner lumen 230, and then filled with a fluid, such as saline, to expand and adjust the diameter of the inner lumen 230 of the ostomy member 21 so that the ostomy member 21 can open the perforations in the atrial septum to form the stoma, i.e., the expansion member 22 exerts a radial pushing force against the inner circumferential wall of the ostomy member 21 in the inner lumen 230 of the ostomy member 21, and the ostomy portion 23 of the ostomy member 21 and the expansion member 22 exert a radial supporting effect against the inner wall of the perforation in the perforation, thereby obtaining a stoma of suitable size. At this time, the conductive part 60 of the ostomy member 21 is attached to the interatrial septum tissue near the perforation, and the conductive part 60 receives the radio frequency power to ablate the tissue at the perforation of the interatrial septum, so that the interatrial septum tissue near the perforation is inactivated to prevent the stomal blockage by the repair endothelium covering of the tissue, and the shape after the stoma can be fixed after the stoma is made by the interatrial septum stoma system 100.

The ostomy 21 can also be cut from a tube, and the ostomy 21 is a cylindrical frame structure after being released in vivo to keep the passageway of the interatrial space open; the ostomy member 21 may also be braided from wire or processed by local braiding in combination with local tube cutting, and the different parts may be welded or fixed to each other by connectors. The material of the tube is stainless steel, cobalt-chromium alloy or memory metal material or biocompatible non-metal material, such as nickel-titanium alloy material. The overall shape of the ostomy member 21 may be any suitable shape such as a cylinder, a disc, a cone, etc., and is not limited herein.

In the present embodiment, as shown in fig. 2, in the state where atrial septal shunt system 20 is completely released, stoma portion 23 of stoma 21 has a generally cylindrical shape, and lumen 230 of stoma portion 23 has a circular hole. In the fully released state of the cardiac interatrial septum shunt system 20, the ostomy member 21 further comprises an extension portion 25 disposed at the distal end of the ostomy portion 23 and a coupling portion 27 disposed at the proximal end of the ostomy portion 23, the extension portion 25 and the coupling portion 27 being adapted to position the ostomy member 21 over the interatrial septum. Specifically, when the ostomy member 21 is implanted in the interatrial septum, the ostomy portion 23 is inserted in the perforation of the interatrial septum, the extension portion 25 is positioned in the left atrium and abuts the interatrial septum tissue surrounding the perforation, and the connection portion 27 is positioned in the right atrium and abuts the interatrial septum tissue surrounding the perforation.

The extension portion 25 includes a first locator 251 attached to the distal end of the stoma portion 23, and the connecting portion 27 includes a second locator 271 attached to the proximal end of the stoma portion 23, the first locator 251 and the second locator 271 being positioned on opposite sides of the atrial septum when the stoma portion 23 is positioned in the perforation of the atrial septum. The diameter of the first positioning portion 251 is larger than that of the stoma portion 23, and the first positioning portion 251 is provided with a positioning surface, a positioning line, or a positioning point contacting the atrial septum. Specifically, one side of the first positioning portion 251 facing the stoma portion 23 is provided with a positioning surface, a positioning line or a positioning point which can press the atrial septal tissue, and the positioning surface, the positioning line or the positioning point is abutted against the atrial septal tissue to prevent the cardiac atrial septal shunt system 20 from moving towards the proximal end; the conductive portion 60 may be provided on the positioning point, the positioning line, or the positioning surface of the first positioning portion 251.

The diameter of the second positioning portion 271 is larger than that of the stoma portion 23, and the second positioning portion 271 is provided with a positioning surface, a positioning line, or a positioning point that contacts the atrial septum. Specifically, one side of the second positioning portion 271 facing the stoma portion 23 is provided with a positioning surface, a positioning line or a positioning point, which can abut against the atrial septal tissue, so as to prevent the cardiac atrial septal shunt system 20 from moving to the distal end, thereby positioning the cardiac atrial septal shunt system 20 on the atrial septum. The conductive portion 60 may be provided on the positioning point, the positioning line, or the positioning surface of the second positioning portion 271.

In other embodiments, the conductive portions 60 may be disposed on the positioning surfaces, the positioning lines, or the positioning points of the first positioning portions 251 and the second positioning portions 271, respectively.

In this embodiment, the stoma portion 23 is a plurality of supporting sheets 232 arranged circumferentially, specifically, the plurality of supporting sheets 232 are arranged in a circle along the axial line of the stoma portion 23, each supporting sheet 232 extends along the axial line direction of the stoma portion 23, and the middle portion of each supporting sheet 232 is recessed towards the axial line direction of the stoma portion 23 to form an arc. The stoma portion 23 is provided with a developing point or a developing wire, and the developing point or the developing wire is fixed by means of inlaying and hot pressing. Specifically, a mounting hole 2320 is formed in the middle of each supporting piece 232, developing points are arranged in the mounting holes 2320, and the developing points in the mounting holes 2320 form a circle, so that the stoma portion 23 can be conveniently positioned in the through hole of the room partition. The developing point or the developing wire can be made of gold, platinum, tantalum and other materials.

The side of the ostomy portion 23 facing away from the axial lead of the ostomy member 21 is provided with a conductive part 60, specifically, the side of each supporting sheet 232 facing away from the axial lead of the ostomy member 21 is provided with a conductive part 60, and the conductive parts 60 enclose a circle along the circumferential direction of the ostomy portion 23. When the ostomy member 21 is released in the perforation in the atrial septum tissue, the expansion member 22 is filled with fluid to expand and adjust the diameter of the ostomy member 21, the ostomy member 21 and the expansion member 22 are used for expanding the perforation to a proper size to form a stoma of a proper size, the conductive part 60 is connected with a radio frequency power supply, and then radio frequency energy is transmitted to the conductive part 60 at the perforation to ablate the tissue at the stoma, so that the tissue at the stoma is prevented from rebounding, and the stoma shape can be better maintained.

The first positioning portion 251 includes two first positioning bars 2510 bent and radiated from the distal end of each supporting piece 232 of the stoma portion 23 to the direction away from the axial center line of the stoma 21 along both sides, and the distal ends of the two first positioning bars 2510 adjacent to each other on the two adjacent supporting pieces 232 are joined to form a connecting piece 2511. Each coupling piece 2511 is inclined to a distal end, and the distal end of each coupling piece 2511 is rounded. Specifically, the outer peripheral surface of the distal end of the connection piece 2511 is configured as an arc surface or a rounded angle, or the distal end of the connection piece 2511 is configured as a circular piece, a spherical structure or a similar spherical structure. In this embodiment, the distal end of each coupling tab 2511 is rounded. The distal end of each connecting piece 2511 is smoothed to prevent the connecting piece 2511 as a free end from scratching the cardiac tissue when the atrial septal shunt system 20 enters the cardiac tissue, thereby improving safety.

The second positioning portion 271 includes a plurality of positioning elements, the positioning elements correspond to the support pieces 232 one by one, and the distal end of each positioning element is connected to the proximal end of the corresponding support piece 232. Each positioning element comprises two second positioning rods 2710 which are formed by diverging from the proximal ends of the corresponding supporting pieces 232 to the direction far away from the axial lead of the ostomy piece 21, the proximal ends of the two adjacent second positioning rods 2710 of the two adjacent positioning elements are converged to form an intersection part, and the proximal end of the intersection part is farther away from the axial lead of the ostomy piece 21 than the proximal ends of the corresponding supporting pieces 232.

At least one circle of developing points or developing wires is arranged on one of the mouth-making part 23, the first positioning part 251 and the second positioning part 271; that is, the stoma portion 23 is provided with at least one turn of developing dots or developing wires, the first positioning portion 251 is provided with at least one turn of developing dots or developing wires, or the second positioning portion 271 is provided with at least one turn of developing dots or developing wires.

In other embodiments, the conductive portion 60 is an ablation electrode disposed on one of the stoma portion 23, the first positioning portion 251 and the second positioning portion 271. Specifically, the conductive part 60 may also be at least one circle of ablation electrodes arranged on the side surface of the first positioning part 251 facing the second positioning part 271, and preferably, at least one circle of ablation electrodes is arranged on the side surface of the first positioning rods 2510 facing away from the axial line of the stoma piece 21; alternatively, the conductive portion 60 may be at least one turn of an ablation electrode provided on the side surface of the second positioning portion 271 facing the first positioning portion 251; preferably, at least one turn of the ablation electrode is disposed on a side of the second positioning stems 2710 facing away from the axis of the ostomy member 21. When the ostomy member 21 is released in the perforation in the atrial septum tissue, the extender 22 is filled with fluid to expand and adjust the diameter of the ostomy member 21, the ostomy member 21 struts the perforation to a suitable size to form the stoma, the conductive portion 60 is connected to a radio frequency power supply, and then radio frequency energy is transmitted to the conductive portion 60 at the stoma to ablate the tissue at the stoma, preventing the tissue at the stoma from springing back, enabling better maintenance of the stoma shape.

In other embodiments, the conductive portion 60 may be two upper ablation electrodes respectively disposed on the stoma portion 23, the first positioning portion 251 and the second positioning portion 271; that is, at least one circle of ablation electrodes is arranged on the side of the stoma portion 23 departing from the axis thereof and at least one circle of ablation electrodes is arranged on the side of the first positioning portion 251 facing the second positioning portion 271, or at least one circle of ablation electrodes is arranged on the side of the stoma portion 23 departing from the axis thereof and at least one circle of ablation electrodes is arranged on the side of the second positioning portion 271 facing the first positioning portion 251, or at least one circle of ablation electrodes is arranged on the side of the first positioning portion 251 facing the second positioning portion 271 and at least one circle of ablation electrodes is arranged on the side of the second positioning portion 271 facing the first positioning portion 251. Specifically, at least one circle of ablation electrodes is arranged on the side of the plurality of supporting pieces 232 departing from the axial lead of the ostomy piece 21, at least one circle of ablation electrodes is arranged on the side of the plurality of first positioning rods 2510 departing from the axial lead of the ostomy piece 21, at least one circle of ablation electrodes is arranged on the side of the plurality of supporting pieces 232 departing from the axial lead of the ostomy piece 21, at least one circle of ablation electrodes is arranged on the side of the plurality of second positioning rods 2710 departing from the axial lead of the ostomy piece 21, at least one circle of ablation electrodes is arranged on the side of the plurality of first positioning rods 2510 departing from the axial lead of the ostomy piece 21, and at least one circle of ablation electrodes is arranged on the side of the plurality of second positioning rods 2710 departing from the axial lead of the ostomy piece 21. When the ostomy member 21 is released in the perforation in the atrial septum tissue, the expansion member 22 is filled with fluid to expand and adjust the diameter of the ostomy member 21 to prop open the perforation to a suitable size to form the stoma, both loops of the conductive portion 60 are connected to the radio frequency power supply to transmit radio frequency energy to the conductive portion 60 to ablate the tissue at the stoma, preventing the tissue at the stoma from rebounding and better maintaining the stoma shape.

In other embodiments, the conductive part 60 may also be an ablation electrode respectively disposed on the stoma portion 23, the first positioning portion 251 and the second positioning portion 271, that is, at least one circle of ablation electrode is disposed on the side of the stoma portion 23 away from the axis thereof, at least one circle of ablation electrode is disposed on the side of the first positioning portion 251 facing the second positioning portion 271, and at least one circle of ablation electrode is disposed on the side of the second positioning portion 271 facing the first positioning portion 251. Specifically, at least one circle of ablation electrodes is arranged on the side of the supporting sheet 232 departing from the axial lead of the ostomy piece 21, at least one circle of ablation electrodes is arranged on the side of the first positioning rods 2510 departing from the axial lead of the ostomy piece 21, and at least one circle of ablation electrodes is arranged on the side of the second positioning rods 2710 departing from the axial lead of the ostomy piece 21. When the ostomy member 21 is released in the perforation in the atrial septum tissue, the expansion member 22 is filled with fluid to expand and adjust the diameter of the ostomy member 21 to open the perforation to a suitable size to form the stoma, the three turns of the conductive portion 60 are all connected to the radio frequency power supply, and then the radio frequency energy is transmitted to the conductive portion 60 to ablate the tissue at the stoma, preventing the tissue at the stoma from rebounding, and better maintaining the stoma shape.

In other embodiments, at least one circle of developing points or developing wires is respectively arranged on two of the mouth-making portion 23, the first positioning portion 251 and the second positioning portion 271; that is, at least one circle of developing dots or developing wires is provided on the mouth-making portion 23 and the first positioning portion 251, or at least one circle of developing dots or developing wires is provided on the mouth-making portion 23 and the second positioning portion 271, or at least one circle of developing dots or developing wires is provided on the first positioning portion 251 and the second positioning portion 271.

In other embodiments, at least one circle of developing dots or developing wires is disposed on the stoma portion 23, the first positioning portion 251 and the second positioning portion 271.

Further, the developing points or the developing wires are arranged at the position of the conductive part 60 or on the surrounding structure thereof, and are used for marking the position of the conductive part and accurately positioning the ablation region.

As shown in fig. 2, the connecting portion 27 further includes a plurality of connecting rods 272 connected to the proximal end of the second positioning portion 271, a supporting member 273 disposed at the proximal end of each connecting rod 272, an extending rod 276 disposed at the proximal end of each supporting member 273, and a connecting head 278 disposed at the proximal end of the extending rod 276. The connecting rods 272 are respectively connected to the intersecting portions of the proximal ends of the second positioning portions 271, the connecting rods 272 are arranged along the circumferential direction of the second positioning portions 271, the distal end of each connecting rod 272 is connected to the corresponding intersecting portion, the proximal ends of the connecting rods 272 are connected to the distal ends of the corresponding supporting members 273, and the middle portion of each connecting rod 272 protrudes in the direction away from the axial line of the stoma 21 to form an arc rod. Each supporting member 273 includes two supporting branch bars 2730 radiating bent from the proximal end of the corresponding connecting bar 272 toward the axis line of the ostomy member 21 along both sides, and the proximal ends of the adjacent two supporting branch bars 2730 of each adjacent two supporting members 273 meet to form an intersection. The proximal end of the intersection is closer to the axis of the ostomy 21a than the proximal end of the connecting bar 272; the proximal end of each intersection continues to extend proximally to form the extension rod 276, and the proximal end of the extension rod 276 converges with the connector 278 to form a generally lantern-shaped structure. The connector 278 is a cylindrical or elliptical cylindrical structure, the axial length of the connector 278 is about 1-3 mm, the edge is smooth and has no sharp corner, and the connector 278 can be fixedly or detachably connected with the ostomy device conveying mechanism 50.

Referring to fig. 1, 3 and 4, the expansion member 22 is made of a balloon structure made of a polymer material and having elasticity, and the diameter of the balloon structure changes with the filling of the fluid. Preferably, the polymer material may include, but is not limited to, Polyethylene (PE), polyethylene terephthalate (PET), nylon, polyurethane, and the like. When the balloon structure is filled with fluid, such as saline, the volume of the balloon structure expands along with the increase of the filled fluid, so that the outer peripheral wall of the balloon structure is pushed against the inner peripheral wall of the inner cavity of the stoma portion 23, and the diameter of the perforation inserted with the stoma portion 23 is convenient to adjust.

The atrial septal shunt system 20 further includes a support tube 24, the support tube 24 is axially inserted into the lumen 230 of the stoma portion 23, the expansion member 22 is disposed on the support tube 24, and the expansion member 22 is disposed between the support tube 24 and the stoma portion 23. In this embodiment, the axis of the support tube 24 coincides with the axis of the ostomy member 21, and the extension member 22 surrounds the support tube 24. Support tube 24 may be made of a thin-walled tube material of polyimide or the like, so as to reduce the space occupied by the wall of support tube 24 and enlarge the diameter of the lumen of support tube 24, and support tube 24 is used to convey saline from an external saline source into extension 22.

In this embodiment, the extension member 22 includes an outer wall 221 surrounding the support tube 24, the proximal end and the distal end of the outer wall 221 are respectively connected to the support tube 24 in a sealing manner, the outer wall 221 and the outer peripheral wall of the support tube 24 define an extension cavity 223, and the outer wall of the support tube 24 is provided with a filling hole 242 communicating with the extension cavity 223. Saline from the external saline source is delivered into the expansion chamber 223 through the lumen of the support tube 24 to the infusion port 242, so that the expansion of the expansion chamber 223 radially pushes against the inner circumferential wall of the lumen 230 of the stoma portion 23 to increase the diameter of the stoma portion 23; when the saline in the expansion chamber 223 is discharged outwardly through the lumen of the support tube 24, the expansion chamber 223 contracts radially to reduce the diameter of the stoma portion 23.

The outer wall 221 of the extension 22 is made of a polymer material such as Polyethylene (PE), polyethylene terephthalate (PET), nylon, and polyurethane, and the proximal end and the distal end of the outer wall 221 can be hermetically connected to the support tube 24 by heat pressing, adhesive bonding, and the like.

When the ostomy member 21 is made of a conductive material, a part of the ostomy member 21 can be directly used as the ablation electrode 60, and the ablation electrode can be arranged at a position where the ostomy member 23, the first positioning part 24 or the second positioning part 26 is in contact with the tissues around the perforation, because the ostomy member 21 itself is made of a conductive material, the outer surface of the ostomy member 21 except for the position as the ablation electrode 60 needs to be insulated to prevent the rest of the outer surface from being in contact with blood and conducting electricity, so that the impedance is reduced, and the ablation of the atrial septal tissues at the specific position cannot be completed. The insulation treatment can be to coat an insulation coating on the outer surface of the supporting framework or to sleeve an insulation sleeve on the supporting framework. Since the ostomy 21 itself is electrically conductive, the radio frequency power may be switched on directly through the connection head 278 via the ostomy device delivery mechanism 50, thereby transferring the radio frequency energy to the electrically conductive part 60. To further concentrate the energy on the septal tissue of the stoma portion 23, the outer surface of the stoma 21 at the remaining site in pressing contact with the septal tissue may be coated with an insulating coating. Further, the insulating coating is plated with a parylene insulating coating.

As shown in FIG. 1, the ostomy device delivery mechanism 50 includes a loader, a support tube, an electrically conductive pusher 56, an ablation power source, and the like. The support tube comprises a push tube 52, an outer tube 54 sleeved outside the push tube 52, and an inner tube 55 arranged inside the push tube 52. The distal end of the push tube 52 is fixedly attached or removably attached to the connector 278; the far end of the inner tube 55 is axially connected to the support tube 24, and the inner tube 55 is axially provided with a transfusion channel 550 communicated with the inner cavity of the support tube 24, and the external saline is poured into the expansion cavity 223 through the transfusion channel 550, the inner cavity of the support tube 24 and the pouring hole 242, or the saline in the expansion cavity 223 is discharged through the pouring hole 242, the inner cavity of the support tube 24 and the transfusion channel 550. A lead is arranged in the push tube 52, and one end of the lead is electrically connected with the conductive part 60 of the heart interatrial septum shunt system 20; the other end of the lead is electrically connected with the ablation power supply.

The interatrial septum ostomy system 100 of the present invention, when used, needs to be used in conjunction with a support tube, a conductive pusher, an ablation power supply and power supply connection, a neutral electrode plate, and the like. The using method comprises the following steps:

1. after the interatrial septum is punctured, the guide wire is sent into the left upper pulmonary vein, and the puncture suite is removed. And pushing the supporting tube into the left atrium along the guide wire, and removing the guide wire.

2. With the atrial septal shunt system 20 of the appropriate size selected, the pusher 56 is advanced to deliver the ostomy member 21 to the interatrial septum site and the visualization site is visualized and located in the interatrial septum tissue. The pusher 56 is then slowly advanced or the outer tube 54 is withdrawn, while the site of visualization is guaranteed to be in the interatrial septum tissue, allowing the stoma portion 23 of the stoma 21 to fully open.

3. The fluid is filled in the expansion cavity 223 of the expansion piece 22 through the infusion channel 550 of the inner tube 55, the inner cavity of the support tube 24 and the perfusion hole 242, and the atrial septal tissue of the expansion ostomy piece 21 at the stoma is expanded to form a shunt channel with a specific size (determined by ultrasound or DSC).

4. After confirming that the tissue at the stoma is completely attached to the stoma, the proximal end of the pusher is connected to a radio frequency power supply, and heating parameters (e.g., power 50W, duration 30S) are set, and then the conductive portion 60 is activated to heat.

5. After the heating is stopped, the fluid in the expansion chamber 223 is discharged through the perfusion hole 242, the lumen of the support tube 24 and the infusion channel 550 of the inner tube 55, the expansion member 22 and the ostomy member 21 are withdrawn into the outer tube 54 and removed from the body, and it is measured whether the stoma diameter is as expected.

The ostomy member 21 of the interatrial septum ostomy system 100 in this embodiment is inserted into the through hole of the interatrial septum, and the outer wall 221 of the extender 22 is pushed against the inner circumferential wall of the inner cavity 230 of the ostomy portion 23 by filling the extender cavity 223 of the extender 22 with fluid to adjust the diameter of the outer circumferential wall of the ostomy portion 23, so that the ostomy portion 23 can prop open the through hole on the interatrial septum to form an ostomy with a proper diameter; the conductive part 60 contacts the interatrial septum tissue near the stoma, and the conductive part 60 receives a radio frequency power supply to melt the interatrial septum tissue at the stoma to inactivate the interatrial septum tissue near the stoma, prevent the repair endothelium from climbing to cover and blocking the stoma, and can fix the shape of the stoma after the stoma is made by the interatrial septum stoma system 100. Therefore, the shape of the stoma after being treated by the atrial septal shunt system 20 is regular and not easy to be blocked, and the stoma can be kept smooth, so that the blood in the left and right ventricles can be shunted smoothly.

In other embodiments, the inner tube 55 and the support tube 24 may be integrally formed together.

Referring to fig. 5 and 6 together, fig. 5 is a schematic structural view of an extension of a septal stoma system according to a second embodiment of the present invention; fig. 6 is a cross-sectional view of the extender of fig. 5 taken along line VI-VI. The second embodiment of the invention provides a compartmental ostomy system similar in construction to that of the first embodiment, except that: in the second embodiment, the expansion piece 22a includes an inner wall 222 sleeved on the support tube 24 and an outer wall 221 connected to the proximal end and the distal end of the inner wall 222, the inner wall 222 and the outer wall 221 define an expansion cavity 223, the inner wall 222 defines an injection hole 2220, and the support tube 24 defines an injection 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 has elasticity, and the diameter of the positioning tube is smaller than that of the support tube 24, so that the inner wall 222 can be firmly positioned on the support tube 24. The distal end of the outer wall 221 is sealingly connected to the distal end of the inner wall 222, and the proximal end of the outer wall 221 is sealingly connected to the proximal end of the inner wall 222, such that the outer wall 221 and the inner wall 222 enclose a sealed expansion chamber 223. Saline from the external saline source passes through the inner cavity of the support tube 24 and is delivered into the expansion cavity 223 through the injection hole 2220 and the injection hole 242, so that the expansion cavity 223 expands to radially push against the inner circumferential wall of the inner cavity 230 of the stoma portion 23, thereby increasing the diameter of the stoma portion 23; fluid in the expansion chamber 223 can flow through the perfusion holes 242 and 2220 to the interior of the support tube 24 and be expelled outwardly, allowing the expansion chamber 223 to contract radially to reduce the diameter of the stoma portion 23.

The connection and position of the extension 22a and the ostomy member 21 in the second embodiment are the same as those in the first embodiment, and are not described herein again.

The interatrial septum ostomy system of the second embodiment is used in conjunction with a support tube, an electrically conductive pusher, an ablation power supply and power supply connection, a neutral electrode plate, and the like. The specific application process and method are the same as those of the first embodiment, and are not described herein again.

Referring to fig. 7 and 8 together, fig. 7 is a schematic structural view of a septal stoma system according to a third embodiment of the present invention; figure 8 is a schematic view of the extension of the compartmental ostomy system of figure 7. The third embodiment of the present invention provides a cardiac interatrial septum shunt system having a structure similar to that of the first embodiment, except that: in the third embodiment, the extension 22b is provided with a plurality of spray holes 2210 near the stoma portion 23, the plurality of spray holes 2210 being used for spraying the fluid onto the atrial septum adjacent to the conductive portion 60. Specifically, at least one circle of spraying holes 2210 is circumferentially opened at a middle position of the outer wall 221, and the spraying holes 2210 may be opened by heating a large-hole needle or through a laser cutting process.

In this embodiment, two circles of spraying holes 2210 are formed in the middle of the outer wall 221 in the circumferential direction, and the two circles of spraying holes 2210 are formed in the perforated position of the outer wall 221 corresponding to the room space. The positions of one circle of spray holes 2210 may or may not be staggered from the other circle of spray holes 2210, the staggering being that each spray hole 2210 of one circle of spray holes 2210 is located between two adjacent spray holes 2210 of the other circle of spray holes 2210; the non-offset means that one circle of the spray holes 2210 corresponds to the other circle of the spray holes 2210, respectively.

Preferably, the number of the spray holes 2210 is 10 to 50, and the spray holes 2210 are distributed or spirally arranged in 2 to 4 turns at intervals.

The diameter of each spray hole 2210 is smaller than 0.2mm in order to avoid that the pressure of the expansion piece 22b is insufficient and cannot radially push against the ostomy member 21 to distract the atrial septum tissue.

In use, the interatrial septum ostomy system of the third embodiment of the invention is used in conjunction with a support tube, an electrically conductive pusher, an ablation power supply and power supply connection, a neutral electrode plate, and the like. The using method comprises the following steps:

3. The expandable cavity 223 of the expandable member 22b is filled with a fluid, such as saline, through the infusion channel 550 of the inner tube 55, the lumen of the support tube 24 and the infusion orifice 242, and the atrial septal tissue of the expandable ostomy member 21 at the stoma is dilated to form a shunt channel of a specific size (as determined by ultrasound or DSC).

4. After confirming that the tissue at the stoma is completely attached to the stoma 23, the extender 22b sprays cold saline to the interatrial septum tissue near the stoma 23 through the spray holes 2210 to lower the interatrial septum tissue outside the desired ablation range near the conductive portion 60 in advance, connects the proximal end of the pusher to the radio frequency power source, sets heating parameters (e.g., power 50W, duration 30S), and then starts heating so that the extender 22b sprays cold saline all the way to the interatrial septum tissue near the stoma 23 through the spray holes 2210 during the heating process.

5. After the heating is stopped, the cold saline in the expansion chamber 223 is discharged through the perfusion hole 242, the lumen of the support tube 24 and the transfusion channel 550 of the inner tube 55, and the expansion piece 22b and the stoma 21 are recovered into the outer tube 54 and removed, and whether the stoma diameter is as expected or not is measured.

The ostomy member 21 of the interatrial septum ostomy system 100 in this embodiment is inserted into the through hole of the interatrial septum, and the outer wall of the expansion member 22b is pushed against the inner circumferential wall of the inner cavity 230 of the ostomy member 23 by filling cold saline into the expansion cavity 223 of the expansion member 22b to adjust the diameter of the outer circumferential wall of the ostomy member 23, so that the ostomy member 23 can expand the through hole on the interatrial septum to form an ostomy with a proper diameter; the extender 22b sprays cold saline to the atrial septum tissue outside the intended ablation range near the conductive part 60 through the spray holes 2210 to lower the temperature of the atrial septum tissue near the conductive part 60 in advance to reduce the heat affected zone, the conductive part 60 contacting the atrial septum tissue near the stoma; the conductive portion 60 receives radio frequency power to ablate the interatrial septum tissue at the stoma to inactivate the interatrial septum tissue near the stoma, preventing the stoma from being blocked by the climbing of the repaired endothelium of the tissue, and being able to fix the shape of the stoma after it has been made by the interatrial septum stoma system 100. In the process that the conducting part 60 ablates the interatrial septum tissue, the expansion part 22b sprays cold saline to the interatrial septum tissue near the mouth-making part 23 through the spraying holes 2210, so that the fluidity of blood around the ablated interatrial septum tissue can be increased, the tissue is not easy to be heated and heated, meanwhile, the blood can be directly cooled, the formation of thrombus is avoided, and the injury and the risk of ablation are reduced while the effective ablation mouth-making is formed.

Referring to fig. 9 and 10 together, fig. 9 is a schematic structural view of a septal stoma system according to a fourth embodiment of the present invention; figure 10 is a schematic view of the extension of the compartmental ostomy system of figure 9. The fourth embodiment of the present invention provides a cardiac interatrial septum shunt system having a structure similar to that of the first embodiment, except that: in the fourth embodiment, the ostomy member 21a is knitted from a wire material, and in a state where the atrial septal shunt system is completely released, the ostomy member 21a includes an ostomy portion 23a of an inner concave surface of revolution, an extension portion 25a provided at a distal end of the ostomy portion 23a, and a connecting portion 27a provided at a proximal end of the ostomy portion 23 a. The extending portion 25a is provided with a first positioning portion 251a on the side facing the stoma portion 23a, and the connecting portion 27a is provided with a second positioning portion 271a on the side facing the stoma portion 23 a. The proximal end of the first retainer 251a is connected to the distal end of the stoma portion 23a, and the distal end of the first retainer 251a extends radially; the distal end of the second positioning portion 271a is connected to the proximal end of the stoma portion 23a, and the proximal end of the second positioning portion 271a extends in the axial direction of the stoma portion 23a and merges. The stoma portion 23a has an inner cavity, and the expansion piece 22c is disposed in the inner cavity of the stoma portion 23a, and when the expansion piece 22c is filled with fluid, the radial dimension of the expansion piece 22c is increased, so that the expansion piece 22c pushes against the stoma portion 23a to expand the perforation of the atrial septum to a proper size to form the stoma. The ostomy component 21a is also provided with a conductive part, the conductive part is attached to the atrial septum tissue near the stoma, the conductive part is electrically connected to the radio frequency power supply, and the conductive part receives the energy output by the radio frequency power supply to ablate the tissue around the stoma of the atrial septum and is used for ablating the tissue around the stoma.

In this embodiment, the stoma 21a is a braided net-shaped nitinol stent, the first positioning portion 251a is a single-layer braided net structure, and the second positioning portion 271a is a double-layer braided net structure. The first retainer 251a includes a positioning surface radially extending from the distal edge of the stoma portion 23a in a conical or circular shape, and a curved rim curving distally from the outer edge of the positioning surface, the curved rim curving smoothly toward the distal end to avoid damaging atrial tissue. The second positioning portion 271a includes a positioning face radially outwardly extending from the proximal end edge of the stoma portion 23a to form a cone or a circle, and a cone-shaped thrombus-capturing cage connected at the outer edge of the positioning face and extending toward the end away from the stoma portion 23a, the proximal ends of which close and merge.

An ablation electrode on one of the side of the stoma portion 23a facing away from the axis of the stoma 21a, the positioning surface of the first positioning portion 251a, and the positioning surface of the second positioning portion 271 a; or on the side of the stoma portion 23a facing away from the axial line of the stoma 21a, on both the positioning surface of the first positioning portion 251a and the positioning surface of the second positioning portion 271 a; or the side of the stoma portion 23a departing from the axis of the stoma 21a, the positioning surface of the first positioning portion 251a and the positioning surface of the second positioning portion 271a are provided with ablation electrodes.

At least one circle of developing points or developing wires is arranged on one of the mouth-making part 23a, the first positioning part 251a and the second positioning part 271 a; or at least one circle of developing points or developing wires are respectively arranged on two of the mouth-making part 23a, the first positioning part 251a and the second positioning part 271 a; or at least one circle of developing dots or developing wires is provided on the mouth-forming portion 23a, the first positioning portion 251a, and the second positioning portion 271a, respectively.

In the atrial septal shunt system of the present embodiment, two or more branch tubes 244 are provided at the support tube 24a corresponding to the stoma 23a, and the two or more branch tubes 244 are annularly arrayed along the axial center line of the support tube 24 a. The expanding member 22c includes expanding branch members 226 respectively disposed on each branch pipe 244, and each expanding branch member 226 is located between the corresponding branch pipe 244 and the stoma portion 23 a. In this embodiment, the number of the branch pipes 244 is four, four branch pipes 244 are annularly arrayed along the axial line of the support tube 24a, and one branch expansion member 226 is disposed on a side of each branch pipe 244 away from the axial line of the support tube 24 a.

As shown in fig. 10, each branch pipe 244 is in communication with the support tube 24a, and specifically, the proximal end and the distal end of each branch pipe 244 are in communication with the lumen of the support tube 24a, respectively, i.e., fluid in the support tube 24a can flow into each branch pipe 244. Each of the expandable struts 226 is of a balloon structure, and the expandable struts 226 are made of a polymer material, which may preferably include, but is not limited to, Polyethylene (PE), polyethylene terephthalate (PET), nylon, polyurethane, and the like. Each of the expandable branches 226 has an expansion chamber for receiving fluid, i.e., each branch pipe 244 is capable of filling the expansion chamber of the corresponding expandable branch 226 with fluid to increase the radial dimension of the expandable branch 226.

In this embodiment, each of the sufficient expansion branch members 226 is connected to the corresponding branch pipe 244 by a fastener 227, the fastener 227 opens an injection hole communicating with the expansion cavity of the corresponding expansion branch member 226, and the outer wall of the branch pipe 244 opens a filling hole communicating with the injection hole. An external fluid such as saline is injected into the expansion cavity of each of the expandable branch members 226 through the infusion channel 550, the lumen of the support tube 24a, the injection holes of the branch tube 244 and the branch tube, and the injection hole of the corresponding buckle 227, or the fluid such as saline in the expansion cavity of each of the expandable branch members 226 is discharged through the injection hole, the injection hole of the branch tube 244, the lumen of the support tube 24a, and the infusion channel 550. The snaps 227 can be made of a visualization material that not only secures the expandable legs 226 to the corresponding legs 244, but the snaps 227 allow the operator to more easily view the position of the ablation electrode.

The atrial septal ostomy system of the fourth embodiment of the invention, when in use, needs to be used in combination with a support tube, an electrically conductive pusher, an ablation power supply and power supply connection wires, a neutral electrode plate, etc. The using method comprises the following steps:

2. The appropriately sized ostomy member 21a is selected and the pusher 56 is advanced to deliver the ostomy member 21a to the interatrial septum site and view and locate the visualization site in the interatrial septum tissue. The pusher 56 is then slowly advanced or the outer tube 54 is withdrawn, while the site of visualization is guaranteed to be in the interatrial septum tissue, allowing the stoma portion 23a of the stoma 21a to fully open.

3. The fluid is filled into the expansion cavity of each expandable branch 226 through the infusion channel 550 of the inner tube 55, the lumen of the support tube 24a, the branch tube 244, the infusion hole of the branch tube and the corresponding injection hole of the buckle 227, so as to expand the atrial septum tissue of the expandable stoma 21 to form a shunt channel (determined by ultrasound or DSC) with a specific size.

4. After confirming that the tissue at the stoma is completely attached to the stoma, the proximal end of the pusher is connected to a radio frequency power supply, and heating parameters (e.g., power 50W, duration 30S) are set, and then heating is initiated.

5. After the heating is stopped, the fluid in the expansion chamber of each expandable support 226 is discharged through the injection hole of the clip 227, the injection hole 242 of the branch pipe, the branch pipe 244, the inner chamber of the support tube 24a and the infusion channel 550, and the expansion 22c and the stoma 21a are withdrawn into the outer tube 54 and removed, and the stoma diameter is measured to determine whether the stoma diameter is as desired.

In other embodiments, each of the expandable branches 226 includes an outer wall surrounding the corresponding branch tube 244, the proximal end and the distal end of the outer wall are respectively and hermetically connected to the branch tube 244, the outer wall of the expandable branch 226 and the outer peripheral wall of the branch tube 244 define the expansion cavity, and the outer peripheral wall of the branch tube 244 defines an infusion hole communicating with the expansion cavity of the expandable branch 226. The outer wall of the expandable support 226 is made of a polymer material such as Polyethylene (PE), polyethylene terephthalate (PET), nylon, polyurethane, etc., and the proximal and distal ends of the outer wall of the expandable support 226 can be hermetically connected to the branch tube 244 by heat pressing, glue bonding, etc.

In other embodiments, each expandable branch 226 includes an inner wall sleeved on the outer peripheral wall of the corresponding branch 244 and an outer wall hermetically connected to the proximal end and the distal end of the inner wall, the inner wall and the outer wall of the expandable branch 226 form an expandable cavity, the inner wall defines an injection hole, and the outer wall of the branch 244 defines an injection hole communicated with the injection hole.

In other embodiments, each of the expandable branch members 226 may also be fixed to the corresponding branch pipe 244 by gluing, and the outer wall of the branch pipe 244 is provided with a perfusion hole communicating with the expansion cavity of the expandable branch member 226.

Referring to fig. 11, fig. 11 is a schematic structural view of an expansion member of a septal ostomy system according to a fifth embodiment of the invention. The fifth embodiment of the present invention provides a cardiac interatrial septum shunt system having a structure similar to that of the fourth embodiment, except that: in the fifth embodiment, each enlarged branch 226 is opened with a plurality of spray holes 2210 near the stoma portion 23a, the plurality of spray holes 2210 being used for spraying the fluid onto the atrial septum adjacent to the conductive portion. Specifically, at least one circle of spray holes 2210 is circumferentially opened in the middle position of the side of each of the enlarged full legs 226 facing away from the axial line of the ostomy member 21a, the spray holes 2210 being bored by heating a large-bore needle or by a laser cutting process.

In this embodiment, two circles of spraying holes 2210 are formed in the middle of the extended branch member 226 in the circumferential direction, and the two circles of spraying holes 2210 are disposed at the perforated positions of the outer wall of the extended branch member 226 corresponding to the atrial septum.

The diameter of each spray hole 2210 is smaller than 0.2mm in order to avoid under-pressure of the expandable support 226 being unable to radially push against the ostomy member 21a to distract the atrial septum tissue.

In use, the interatrial septum ostomy system of the fifth embodiment of the invention is used in conjunction with a support tube, an electrically conductive pusher, an ablation power supply and power supply connection, a neutral electrode plate, and the like. The using method comprises the following steps:

3. The expandable cavity of each expandable branch 226 is filled with cold saline through the infusion channel 550 of the inner tube 55, the lumen of the support tube 24a, the branch tube 244, the infusion hole of the branch tube and the corresponding infusion hole of the buckle 227, so as to adjust the expansion of the interatrial septum tissue of the ostomy member 21a at the ostomy to form a shunt channel of a specific size (determined by ultrasound or DSC).

4. After confirming that the tissue at the stoma is completely attached to the stoma 23a, each of the expandable legs 226 sprays cold saline to the interatrial septum tissue near the stoma 23a through the spray holes 2210 to lower the interatrial septum tissue outside the expected ablation range near the conductive portion 60 in advance, connects the proximal end of the pusher to the RF power source, sets the heating parameters (e.g., power 50W, duration 30S), and then starts heating so that each of the expandable legs 226 sprays cold saline all the way to the interatrial septum tissue near the stoma 23a through the spray holes 2210 during the heating process.

5. After the heating is stopped, the cold saline in the expansion chamber of each of the sufficient expansion legs 226 is discharged through the injection hole of the filling clip 227, the filling hole of the branch tube, the branch tube 244, the inner chamber of the support tube 24a and the infusion channel 550, and the expansion member 22c and the stoma 21a are recovered into the outer tube 54 and removed, and whether the stoma diameter is expected or not is measured.

The ostomy member 21a of the interatrial septum ostomy system of this embodiment is inserted into the through-hole of the interatrial septum, and the outer wall of each expandable branch 226 is pushed against the inner circumferential wall of the inner cavity of the ostomy portion 23a by filling the expansion cavity of each expandable branch 226 with a fluid such as cold saline to adjust the diameter of the outer circumferential wall of the ostomy portion 23a so that the ostomy portion 23a can expand the through-hole in the interatrial septum to form an ostomy with a suitable diameter; each of the dilatant branches 226 sprays cold saline to the interatrial septum tissue near the stoma portion 23a through the spray holes 2210 to lower the interatrial septum tissue near the ablation electrode in advance; reduce the heat affected zone, the electrode contact of ablating the electrode the interatrial septum tissue near the stoma, the electrode receiving radio frequency power supply in order to interatrial septum in the tissue of stoma melts to make the interatrial septum tissue near the stoma lose the activity, prevent to climb to cover because of the repair endothelium of tissue and to make mouthful jam, and behind the interatrial septum stoma system stoma, can fix the form of making a mouthful back of making a mouthful. In the process of ablating interatrial tissues by the ablation electrode, cold saline is sprayed on the interatrial tissues near the mouth-making part 23a by each full branch piece 226 through the spraying holes 2210, so that the fluidity of blood around the ablated interatrial tissues can be increased, the blood is not easy to be heated and heated, meanwhile, the blood can be directly cooled, the formation of thrombus is avoided, and the injury and the risk of ablation are reduced while forming an effective ablation mouth.

Referring to fig. 12, fig. 12 is a schematic structural view of an expansion member of a septal ostomy system according to a sixth embodiment of the invention. The sixth embodiment of the present invention provides a cardiac atrial septal shunt system having a structure similar to that of the third embodiment, except that the shape and position of the spray holes of the expansion members 22d of the sixth embodiment are different from those of the third embodiment. In the sixth embodiment, the extension 22d is provided with at least one ring of spraying holes 2212 near its proximal end and distal end, respectively, i.e. the extension 22d is provided with at least one ring of spraying holes 2212 near the proximal end and distal end of the stoma portion 23, respectively. The diameter of each spray orifice 2212 is less than 0.2mm to avoid the insufficient pressure of the expansion piece 22d from radially pushing against the stoma 21 to distract the atrial septum tissue. The plurality of spray holes 2212 are used to spray the fluid, such as cold saline, onto the atrial septum adjacent to the stoma portion 23 to lower the temperature of the atrial septum tissue outside the intended ablation range adjacent to the conductive portion 60 and the temperature of the blood adjacent to the conductive portion 60 to avoid thrombus formation and reduce the damage and risk of ablation while forming an effective ablation stoma.

Specifically, the extension 22d also includes an outer wall 221 surrounding the support tube 24, and an extension cavity 223 surrounded by the outer wall 221 and the outer peripheral wall of the support tube 24. The outer wall 221 is provided with a ring of spraying holes 2212 near the distal end and the proximal end, respectively, and the outer surface of the outer wall 221 is provided with a spraying tube 2213 protruding outward around each spraying hole 2212, that is, the spraying holes 2212 are communicated with the corresponding spraying tubes 2213. Each of the water spray tubes 2213 of outer wall 221 near the distal end extends obliquely towards the proximal end, and each of the water spray tubes 2213 of outer wall 221 near the proximal end extends obliquely towards the distal end. Specifically, the included angle between each sprinkler tube 2213 and the support tube 24 in the axial direction is less than 90 degrees. In this embodiment, each ring of spray tubes 2213 is six, and two rings of spray tubes 2213 are staggered, i.e., each spray tube 2213 of one ring is located between two adjacent spray tubes 2213 of another ring of spray tubes 2213.

In this embodiment, the opening of each sprinkler 2213 faces the stoma 23, so that the fluid, such as cold saline, flows more smoothly to the interatrial space tissue outside the expected ablation range, so as to increase the fluidity of the blood around the ablated interatrial space tissue, so that the blood is not easily heated and heated, and meanwhile, the blood can be directly cooled, thereby avoiding the formation of thrombus; direct cooling of the atrial septum tissue outside the intended ablation range reduces the heat affected zone, reducing the trauma and risk of ablation while creating an effective ablation stoma.

In this embodiment, the interatrial septum ostomy system is used in combination with a loader, a sheath core, a conductive pusher, a radio frequency power source, a power source connection wire, etc. The specific use flow and method are the same as those in the third embodiment, and are not described herein again.

In other embodiments, a circle of spraying holes 2212 may be provided only on the proximal end or the distal end of the expansion piece 22d near the stoma portion 23, the outer surface of the outer wall 221 is provided with a spraying tube 2213 protruding obliquely to the stoma portion 23 around each spraying hole 2212, and each spraying tube 2213 is communicated with the corresponding spraying hole 2212.

Referring to fig. 13, fig. 13 is a schematic view of an expansion member of a septal ostomy system according to a seventh embodiment of the invention. The seventh embodiment of the present invention provides a cardiac atrial septal shunt system having a structure similar to that of the third embodiment, except that the shape and position of the spray holes of the expansion members 22d of the seventh embodiment are different from those of the third embodiment. In the seventh embodiment, the middle of the extension 22e is opened with several spray holes 2210 and a circle of spray holes 2212 near the proximal end, the extension 22e is provided with spray tubes 2213 around each spray hole 2212 and obliquely toward the stoma portion 23, and each spray tube 2213 is communicated with the corresponding spray hole 2212. The spray holes 2210, 2212 are used to spray a fluid, such as cold saline, onto the atrial septum adjacent to the stoma portion 23 to lower the temperature of the atrial septum tissue outside the intended ablation range and the temperature of the blood adjacent the conductive portion 60, avoiding the formation of thrombi, and reducing the damage and risk of ablation while forming an effective ablation stoma. Specifically, the outer wall 221 is provided with at least one circle of spraying holes 2210 corresponding to the stoma portion 23, the spraying holes 2210 may be formed by heating a large-hole needle or by a laser cutting process, and the diameter of each spraying hole 2210 is less than 0.2 mm.

Specifically, the extension 22e also includes an outer wall 221 surrounding the support tube 24, and an extension cavity 223 surrounded by the outer wall 221 and the outer peripheral wall of the support tube 24. Two circles of spraying holes 2210 are formed in the outer wall 221 corresponding to the stoma portion 23, the two circles of spraying holes 2210 can be arranged in a staggered manner, or a circle of spraying holes 2212 are formed in the outer wall 221 corresponding to the near end. The outer surface of the outer wall 221 is provided with a water spray tube 2213 protruding obliquely to the stoma portion 23 around each spray hole 2212, and the water spray tube 2213 is communicated with the corresponding spray hole 2212. Specifically, the included angle between each sprinkler tube 2213 and the support tube 24 in the axial direction is less than 90 degrees. In this embodiment, the number of spray tubes 2213 in each ring is six, and six spray tubes 2213 are annularly arrayed along the axial center line of the stoma portion 23.

In this embodiment, since the expansion piece 22e is provided with the spraying hole 2212 corresponding to the stoma portion 23, and the expansion piece 22e is provided with the water spraying tube 2213 facing the stoma portion 23 near the proximal end, fluid such as cold saline is sprayed from the spraying hole 2212 and the water spraying tube 2213 to the interatrial septum tissue outside the expected ablation range, so as to increase the fluidity of blood around the ablated interatrial tissue, so that the tissue is not easily heated and warmed, and at the same time, the blood can be directly cooled, thereby preventing the formation of thrombus; direct cooling of the atrial septum tissue outside the intended ablation range reduces the heat affected zone, reducing the trauma and risk of ablation while creating an effective ablation stoma.

Referring to fig. 14, fig. 14 is a schematic structural view of an extender of a septal ostomy system according to an eighth embodiment of the invention. The eighth embodiment of the present invention provides a cardiac atrial septal shunt system having a structure similar to that of the third embodiment, except that the shape and position of the spray holes of the expansion members 22f in the eighth embodiment are different from those in the third embodiment. In the eighth embodiment, the middle of the extension 22f is opened with a plurality of spray holes 2210 and a circle of spray holes 2212 near the distal end, the extension 22f is provided with spray tubes 2213 around each spray hole 2212 and inclined toward the stoma portion 23, and each spray tube 2213 is communicated with the corresponding spray hole 2212. The spray holes 2210, 2212 are used to spray a fluid, such as cold saline, onto the atrial septum adjacent to the stoma portion 23 to lower the temperature of the atrial septum tissue outside the intended ablation range and the temperature of the blood adjacent the conductive portion 60, avoiding the formation of thrombi, and reducing the damage and risk of ablation while forming an effective ablation stoma. Specifically, at least one circle of spraying holes 2210 are formed in the outer wall 221 corresponding to the stoma portion 23.

Specifically, the extension 22f also includes an outer wall 221 surrounding the support tube 24, and an extension cavity 223 surrounded by the outer wall 221 and the outer peripheral wall of the support tube 24. Two circles of spraying holes 2210 and one circle of spraying holes 2212 arranged at the far end of the outer wall 221 are arranged at the position of the outer wall 221 corresponding to the stoma part 23. The outer surface of the outer wall 221 is provided with a water spray tube 2213 protruding obliquely to the stoma portion 23 around each spray hole 2212, and the water spray tube 2213 is communicated with the corresponding spray hole 2212. Specifically, the included angle between each sprinkler tube 2213 and the support tube 24 in the axial direction is less than 90 degrees. In this embodiment, the number of spray tubes 2213 in each ring is six, and six spray tubes 2213 are annularly arrayed along the axial center line of the stoma portion 23.

In this embodiment, since the expansion piece 22f is provided with the spraying hole 2212 corresponding to the stoma portion 23, and the expansion piece 22f is provided with the water spraying tube 2213 facing the stoma portion 23 near the proximal end, fluid such as cold saline is sprayed from the spraying hole 2212 and the water spraying tube 2213 to the interatrial septum tissue outside the expected ablation range, so as to increase the fluidity of blood around the ablated interatrial tissue, so that the tissue is not easily heated and warmed, and at the same time, the blood can be directly cooled, thereby preventing the formation of thrombus; direct cooling of the atrial septum tissue outside the intended ablation range reduces the heat affected zone, reducing the trauma and risk of ablation while creating an effective ablation stoma.

The interatrial septum ostomy system of this embodiment may be used in conjunction with a sheath, a sheath core, a conductive pusher, a radio frequency power source, a power source connection, and the like. The specific use flow and method are the same as those in the third embodiment, and are not described herein again.

Referring to fig. 15, fig. 15 is a schematic structural view of an expansion member of a septal ostomy system according to a ninth embodiment of the invention. The ninth embodiment of the present invention provides a cardiac interatrial septum shunt system having a structure similar to that of the first embodiment, except that the stoma portion 23b and the extension portion 25b of the stoma 21b in the ninth embodiment are different in structure from those of the first embodiment. In the ninth embodiment, the ostomy member 21b also comprises a stoma portion 23b for distracting the stoma, an extension portion 25b attached to the distal end of the stoma portion 23b, and a connecting portion 27 attached to the proximal end of the stoma portion 23 b. The distal end of the extending portion 25b has a necked-in portion 250 extending in the axial direction of the stoma 21 b. The ostomy piece 21b is provided with a conductive part 60, the ostomy device delivery mechanism is used for delivering the heart interatrial septum shunt system to the perforation on the interatrial septum, the conductive part 60 is attached to the tissue at the perforation, the conductive part 60 is electrically connected to the radio frequency power supply, and the conductive part 60 receives the energy output by the radio frequency power supply to melt the tissue around the perforation of the interatrial septum. In addition, since the distal end of the extending portion 25b has the closing portion 250 extending in the axial direction of the stoma 21a, the extending portion 25 as the free end can be prevented from damaging the myocardial tissue when the atrial septal shunt system enters the cardiac tissue, and safety can be improved.

The ostomy 21b is a self-expanding ostomy device, and the ostomy 21b may be a resilient metal support frame or a resilient non-metal support frame. In this embodiment, the ostomy member 21b is a nitinol stent, and when the atrial septal shunt system is delivered through the sheath, the diameter of the ostomy member 21b can be contracted to a smaller state for delivery in the sheath; when the atrial septal shunt system of the heart is released in the heart, the ostomy member 21b can be automatically expanded, the expansion member 22 can be internally filled with fluid to expand and adjust the diameter of the ostomy member 21b, so that the ostomy member 21b can expand the perforation on the atrial septal to form the stoma, the conductive part 60 is attached to the atrial septal tissue at the stoma, the conductive part 60 is electrically connected to the radio frequency power supply, and the conductive part 60 receives the energy output by the radio frequency power supply to ablate the tissue around the stoma of the atrial septal for ablating the tissue around the stoma.

In the state where the atrial septal shunt system is completely released, the stoma portion 23b has a cylindrical shape, and the stoma portion 23b and the extension portion 25b are connected by the first positioning portion 24; the mouth portion 23b and the connecting portion 27 are connected by the second positioning portion 271 b. When the atrial septal shunt system is implanted in the perforation on the atrial septum, the stoma portion 23b supports the inner wall of the perforation, and the first positioning portion 24 and the second positioning portion 271b are positioned on the opposite two side surfaces of the atrial septum, respectively. The diameter of the first positioning portion 24 is larger than that of the stoma portion 23b, and the first positioning portion 24 is provided with a positioning surface, a positioning line, or a positioning point that contacts the atrial septum. Specifically, one side of the first positioning portion 24 facing the stoma portion 23b is provided with a positioning surface, a positioning line or a positioning point which can press the atrial septal tissue, and the positioning surface, the positioning line or the positioning point is abutted against the atrial septal tissue to prevent the cardiac atrial septal shunt system from moving to the proximal end; the conductive portion 60 may be provided on the positioning point, the positioning line, or the positioning face.

The diameter of the second positioning portion 271b is greater than that of the stoma portion 23b, the second positioning portion 271b is provided with a positioning surface, a positioning line or a positioning point which is in contact with the interatrial septum, specifically, one side of the surface of the second positioning portion 271b facing the stoma portion 23n is provided with a positioning surface, a positioning line or a positioning point which can support and press the interatrial septum tissue, and the positioning surface, the positioning line or the positioning point is abutted to the interatrial septum tissue to prevent the heart interatrial septum shunt system from moving towards the far end, so that the heart interatrial septum shunt system is positioned on the interatrial septum. The conductive portion 60 may be provided on the positioning point, the positioning line, or the positioning face.

In other embodiments, the conductive portions 60 may be disposed on the positioning surfaces, the positioning lines, or the positioning points of the first positioning portions 24 and the second positioning portions 271b, respectively.

In this embodiment, the mouth-making portion 23b is a wave-shaped ring structure arranged at least one turn circumferentially continuously, the first positioning portion 24 is connected to the wave crest of the wave-shaped ring structure, and the second positioning portion 271b is connected to the wave trough of the wave-shaped ring structure. Specifically, the stoma portion 23b is formed by sequentially arranging and connecting a plurality of V-shaped support rods end to enclose a wave-shaped annular structure, the wave-shaped annular structure comprises wave crests 231, wave troughs 233 and wave rods 235, the circumferentially adjacent wave rods 235 are connected at the distal end to form the wave crests 231, and the circumferentially adjacent wave rods 235 are connected at the proximal end to form the wave troughs 233; the middle of each wave bar 235 is concave in an arc shape toward the axis of the ostomy member 21 a. The proximal end of the first positioning portion 24 is connected to the plurality of wave crests 231, and the distal end of the second positioning portion 271b is connected to the plurality of wave troughs 233. The stoma portion 23b is generally required to facilitate radial compression and to maintain necessary strength.

The stoma portion 23b is provided with a developing point, and the developing point is fixed in a manner of inlaying and hot pressing. Specifically, one of the wave crest 231, the wave trough 233 and the wave bar 235 of the mouth-making part 23b is provided with a developing point, and a circle of developing points is enclosed on the mouth-making part 23 b; or two of the wave crest 231, the wave trough 233 and the wave bar 235 are provided with developing points, and two circles of spaced developing points are surrounded on the stoma part 23 b; or the wave crest 231, the wave trough 233 and the wave rod 235 are all provided with developing points, and three circles of spaced developing points are enclosed on the stoma portion 23b, so that the positioning stoma portion 23b is conveniently positioned in the through hole of the room space. The developing point can be made of gold, platinum, tantalum and other materials.

The extending portion 25b includes a plurality of first connecting rods 252 disposed at the distal end of the first positioning portion 24, and an extending member 253 disposed at the distal end of each first connecting rod 252, wherein the plurality of first connecting rods 252 are arranged along the circumference of the first positioning portion 24 to form a circle, the proximal end of each first connecting rod 252 is connected to the first positioning portion 24, the distal end of each first connecting rod 252 is connected to the extending member 253, the middle portion of each first connecting rod 252 protrudes in the direction away from the axial line of the ostomy member 21a to form an arc rod, and the plurality of extending members 253 forms the closing portion 250.

Each of the extending members 253 extends obliquely from the distal end of the corresponding first connecting rod 252 toward the axis of the ostomy member 21b, and the extending members 253 are arranged in a circular array around the axis of the ostomy member 21b to enclose the mouth portion 250.

The distal end of each of the extension members 253 is positioned closer to the axial center line of the ostomy member 21b than the corresponding first connecting rod 252, and the distal end of the extension member 253 is rounded, specifically, the outer peripheral surface of the distal end of the extension member 253 is provided with a circular arc surface or a rounded corner, or the distal end of the extension member 253 is provided with a circular plate, a spherical structure or a similar spherical structure.

In this embodiment, each extension 253 includes two branch struts 2530 that are bent and radiated from the distal end of the first connecting rod 252 toward the axis of the ostomy member 21b along both sides, and the distal ends of the adjacent two branch struts 2530 of each adjacent two extension 253 meet to form an intersection 2532. The distal end of the intersection 2532 is closer to the axis of the ostomy 21a than the distal end of the first connecting rod 252.

The distal end of each intersection 2532 is rounded, and specifically, the outer peripheral surface of the distal end of each intersection 2532 is provided with a circular arc surface or a rounded corner, or each intersection 2532 is a circular structure or a sphere-like structure.

The distal end of the extension 253 is smoothly processed, so that the extension 253 as a free end can be prevented from scratching myocardial tissue when the atrial septal shunt system 20 enters the cardiac tissue, and safety is improved.

The first positioning portion 24 includes two first positioning bars 240 bent and radiating from each peak 231 of the stoma portion 23b in the direction away from the axial center line of the stoma 21a, and the distal ends of the two adjacent first positioning bars 240 on the two adjacent peaks 231 meet. The first connecting rods 252 are connected to the distal intersections of the first positioning portions 24, i.e., the proximal end of each first connecting rod 252 is connected to the corresponding distal intersection of the first positioning portion 24.

In other embodiments, at least one circle of developing dots is disposed on the first positioning portion 24, and the developing dots are fixed by means of embedding or hot pressing. Specifically, each first positioning rod 240 of the first positioning portion 24 is inlaid with or hot-pressed with a developing spot. At least one flexible developing wire can be arranged on the first positioning portion 24, and the flexible developing wire is fixed in an embedding and hot-pressing mode.

The second positioning portion 271b is a second positioning rod extending from each of the valleys 233 of the stoma portion 23 in a direction away from the axial center line of the stoma 21. Specifically, each second positioning rod is connected at its distal end to a corresponding trough 233 and extends proximally and obliquely away from the axis of the ostomy member 21 b.

The connection portion provided in the ninth embodiment of the present invention is the same as the first embodiment, and is not described herein again.

In the present embodiment, the stoma portion 23b is provided with the conductive portions 60, and specifically, the conductive portions 60 are provided on the side of each wave bar 235 away from the axis of the stoma member 21b, and the conductive portions 60 enclose a circle along the circumferential direction of the stoma portion 23 b. In other embodiments, the spaced wave bars 235 are provided with electrically conductive portions 60 on the side facing away from the axis of the ostomy member 21b, the electrically conductive portions 60 enclosing a circle in the circumferential direction of the ostomy portion 23 a.

In this embodiment, the connector 278 is used to connect to a radio frequency power source, so as to transmit radio frequency energy to the conductive part 60 at the perforation, and in order to further concentrate the energy on the atrial septal tissue of the stoma portion 23b, an insulating coating may be coated on the outer surface of the remaining portion of the stoma component 21b that is in pressing contact with the atrial septal tissue. Further, the insulating coating is plated with a parylene insulating coating.

The atrial septal ostomy system of the ninth embodiment, when in use, needs to be used in conjunction with a support tube, an electrically conductive pusher, an ablation power supply and power supply connection, a neutral electrode plate, and the like. The specific application process and method are the same as those of the first embodiment, and are not described herein again.

Referring to fig. 16, fig. 16 is a schematic structural view of an expansion member of a compartmental ostomy system according to a tenth embodiment of the invention. The tenth embodiment of the present invention provides a cardiac interatrial septum shunt system having a structure similar to that of the ninth embodiment, except that: in the tenth embodiment, an insulating film 28 is provided between the ostomy member 21b and the conductive part 60. Further, the insulating film 28 is located between the conductive portion 60 and the stoma portion 23 b. The insulating film 28 may be, but is not limited to, a teflon film, a polyurethane film, a polyimide film, or the like. Since the ostomy portion 23b is isolated from the conductive portion 60 by the insulating film 28, the insulating film 28 not only isolates heat conduction between the conductive portion 60 and the ostomy member 21b, i.e. prevents energy from being transferred to the ostomy member 21b, thereby concentrating heat on the conductive portion 60 to ablate interatrial septum tissue and improving energy efficiency; and the insulating film 28 can also form an insulating barrier on the side of the conductive part 60 facing the blood, so that the current density passing through the blood is reduced, the heating of the conductive part 60 to the blood is reduced, and the risk of thrombus formation is reduced.

In this embodiment, the insulating film 28 is provided on the outer wall surface of the stoma portion 23b facing the conductive portion 60. Specifically, the insulating film 28 is attached to the outer wall surface of the stoma portion 23b by sewing or gluing with a sewing thread.

The area of the conductive portion 60 orthographically projected onto the insulating film 28 is located within the insulating film 28, that is, the area of the orthographically projected area of the conductive portion 60 on the insulating film 28 is smaller than or equal to the area of the insulating film 28.

Referring to fig. 17, fig. 17 is a schematic structural diagram of a cardiac atrial septal shunt system according to an eleventh embodiment of the present invention. The structure of the atrial septal shunt system provided by the eleventh embodiment of the present invention is similar to that of the tenth embodiment, except that: in the eleventh embodiment, the conductive portion 60a is at least one ring-shaped electrode provided on the outer wall of the stoma portion 23b, the at least one ring-shaped electrode being wound around one turn in the circumferential direction of the stoma portion 23 b. At least one of the ring electrodes is electrically connected to a radio frequency power source by a flexible wire, which is located within the ostomy member 21 b. The annular electrode is a continuous annular, high-elasticity and flexible metal wire. Such as a nickel-titanium multi-strand wire or a nickel-titanium multi-strand wire wrapped by a gold spring. The ring-shaped electrode may be attached to the ostomy member 21b by stitching and/or binding.

In this embodiment, the outer wall of the stoma portion 23b is provided with two annular electrodes spaced from each other.

An insulating film 28 is provided between the opening portion 23b and the conductive portion 60a, and the opening portion 23b and the conductive portion 60a are isolated from each other by the insulating film 28. The insulating film 28 may be, but is not limited to, a teflon film, a polyurethane film, a polyimide film, or the like.

In other embodiments, the side of the ostomy portion 23b facing the conductive portion 60a is coated with an insulating layer, such as parylene, to insulate the conductive portion 60a and the ostomy member 21b from each other.

Referring to fig. 18, fig. 18 is a schematic structural diagram of a cardiac atrial septal shunt system according to a twelfth embodiment of the present invention. The structure of the atrial septal shunt system provided by the twelfth embodiment of the present invention is similar to that of the tenth embodiment, except that: in the twelfth embodiment, the conductive portion 60b comprises a number of spaced point-like electrodes arranged at least one turn in the circumferential direction of the outer wall surface of the ostomy member 21 b. Specifically, the spot-like electrodes are provided at least once in the circumferential direction along the outer wall surface of the stoma portion 23b, and the conductive portion 60b and the stoma member 21b are insulated from each other. The insulation treatment is performed by applying an insulating coating to the outer wall surface of the mouthpiece 21b in contact with the spot-like electrode, or by providing an insulating film 28 between the conductive portion 60b and the mouthpiece 21 b. 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 teflon film, a polyurethane film, a polyimide film, etc.

In this embodiment, the dot-shaped electrodes are connected in series by a flexible wire and then wound around the outer wall surface of the stoma portion 23b for two turns, and the flexible wire is electrically connected to a radio frequency power source.

In this embodiment, the interatrial septum ostomy system is used in combination with a loader, a sheath core, a conductive pusher, a radio frequency power source, a power source connection wire, etc. The specific application process and method are the same as those of the first embodiment, and are not described herein again.

Referring to fig. 19, fig. 19 is a schematic structural diagram of a cardiac atrial septal shunt system according to a thirteenth embodiment of the present invention. The thirteenth embodiment of the present invention provides a cardiac interatrial septum shunt system having a structure similar to that of the tenth embodiment, except that: in the thirteenth embodiment, the ablation electrode 60c is a double turn interrupted ring electrode disposed circumferentially around the outer wall of the ostomy member 21b, which is insulated from the ostomy member 21 b. Specifically, a double-turn intermittent ring electrode is provided on the outer wall surface of the stoma portion 23b, and an insulating film 28 is provided between the ring electrode and the stoma portion 23 b. The discontinuous annular electrodes are electrically connected with the radio frequency power supply after being connected in series through a flexible lead.

In other embodiments, the ablation electrode 60c may be a single turn of intermittent ring-shaped electrode disposed circumferentially around the outer wall of the stoma portion 23b, the single turn of intermittent ring-shaped electrode being connected to the rf power output by a flexible wire.

Referring to fig. 20, fig. 20 is a schematic structural diagram of a cardiac atrial septal shunt system according to a fourteenth embodiment of the present invention. The fourteenth embodiment of the present invention provides a cardiac interatrial septum shunt system having a structure similar to that of the tenth embodiment, except that: in the fourteenth embodiment, the ablation electrode 60d comprises a plurality of spaced rod-shaped electrodes arranged at least one turn in the circumferential direction of the outer wall surface of the ostomy member 21 b. Specifically, these rod-like electrodes are provided at least once circumferentially along the outer wall surface of the stoma portion 23b, and the ablation electrode 60d is insulated from the stoma member 21 b. The insulation treatment is performed by applying an insulating coating to the outer wall surface of the stoma portion 23b in contact with the rod-shaped electrode, or by providing an insulating film 28 between the ablation electrode 60d and the stoma portion 23 b. 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 teflon film, a polyurethane film, a polyimide film, etc.

In this embodiment, the rod-shaped electrodes are connected in series by a flexible wire, and then are wound around the outer wall surface of the stoma portion 23b for two turns, and the flexible wire is electrically connected to the output end of the rf power supply.

In other embodiments, the ostomy member is a supporting framework made of a conductive material, the ablation electrode is a part of the supporting framework which is not subjected to insulation treatment, and the outer surfaces of the supporting framework except the ablation electrode are coated with an insulation coating or fixed with an insulation sleeve. Preferably, the surface of the ablation electrode is provided with a gold-plated layer or a platinum-plated layer, and the gold-plated layer or the platinum-plated layer can be used as a development mark, so that an operator can observe the position of the ablation electrode more easily; and can improve the conductivity of the ablation electrode.

Referring to fig. 21, fig. 21 is a schematic structural diagram of a cardiac atrial septal shunt system according to a fifteenth embodiment of the present invention. The structure of the atrial septal shunt system provided by the fifteenth embodiment of the present invention is similar to that of the ninth embodiment, except that: the heart interatrial septum shunt system provided by the fifteenth embodiment omits the first connecting rod 251 and the second connecting rod 272 on the basis of the heart interatrial septum shunt system provided by the ninth embodiment, and has the following specific structure:

the atrial septal shunt system of the fifteenth embodiment also includes a stoma portion 23b, an extension portion 25c disposed at the distal end of the stoma portion 23b, and a connection portion 27 disposed at the proximal end of the stoma portion 23b, wherein the extension portion 25c is connected to the stoma portion 23b by a first positioning portion 24a, and the connection portion 27 is connected to the stoma portion 23b by a second positioning portion 26 a. The structures of the mouth-making portion 23b and the connecting portion 27 are the same as those in the ninth embodiment, and are not described again.

The first positioning portion 24a includes a plurality of first positioning rods 240a, the plurality of first positioning rods 240a correspond to the plurality of peaks 231 one by one, the proximal end of each first positioning rod 240a is connected to the corresponding peak 231, and the distal end of the first positioning rod 240a extends toward the distal end in a direction away from the axial line of the stoma member 21 c. The extending portion 25c includes a plurality of extending members 253 disposed at the distal end of the first positioning portion 24a, the plurality of extending members 253 correspond to the plurality of first positioning rods 240a one-to-one, the proximal end of each extending member 253 is connected to the distal end of the corresponding first positioning rod 240a, and the plurality of extending members 253 are arranged along the circumference of the supporting framework 21 to form the extending portion 25 c. Each of the extending members 253 includes two branch bars 2530 branched from the radially outermost position of the corresponding first positioning bar 240a, the two branch bars 2530 are bent obliquely in a direction away from the stoma portion 23b, distal ends of two adjacent branch bars 2530 of two adjacent extending members 253 meet to form an intersection portion 2532, and a plurality of intersection portions 2532 extend in a direction of an axis of the stoma 21c to form the mouth portion 250. The distal end of each intersection 2532 is rounded, and in particular, the distal end of each intersection 2532 is configured as a circular piece. Since the closing-up portion 250 extends toward the axial line of the ostomy member 21c and the distal end of each intersection portion 2532 is configured as a circular piece, the heart interatrial septum shunt system is not easy to damage important myocardial tissues during the operation, and is safe and reliable.

The distal end of the extension 253 of the extension 25c is provided with at least one circle of visualization points, and specifically, the distal end of the extension 253 of the extension 25c is inlaid or hot-pressed with the axis of the axial lead of the ostomy member 21c for at least one circle of visualization points, so as to facilitate implantation of the atrial septal shunt system. In this embodiment, the intersection portions 2532 are provided with mounting holes 2535, each mounting hole 2535 is provided with a developing point, specifically, each mounting hole 2535 is embedded with a developing point, and the developing points on the plurality of intersection portions 2532 form a circle. The developing point can be made of gold, platinum, tantalum and other materials.

In other embodiments, at least one circle of flexible developing wire is disposed at the distal end of the extension 253 of the extension 25c, and the developing wire is fixed by means of embedding and hot pressing.

The second positioning portions 26a are a plurality of second positioning rods 260a connected to the plurality of wave troughs 233, the plurality of second positioning rods 260a correspond to the plurality of wave troughs 233 one to one, the distal end of each second positioning rod 260a is connected to the corresponding wave trough 233, and the proximal end of the second positioning rod 260a extends toward the proximal end obliquely in the direction away from the axial line of the stoma 21 c. The connecting portion 27 includes a plurality of supporting members 273 disposed at the proximal end of the second positioning portion 260a, an extending rod 276 disposed at the proximal end of each supporting member 273, and a connecting head 278 disposed at the proximal end of the extending rod 276. The supporting members 273 correspond to the second positioning rods 260a one-to-one, the distal end of each supporting member 273 is connected to the proximal end of the corresponding second positioning rod, and the supporting members 273 are arranged along the circumferential direction of the second positioning portion 271 a. Each supporting member 273 includes two supporting branch bars 2730 formed by branching from the radial outermost end of the corresponding second positioning bar, the two supporting branch bars 2730 are bent obliquely along the direction back to the stoma portion 23, the proximal ends of two adjacent second positioning bars of two adjacent supporting members 273 are joined to form an intersection, and the proximal end of the intersection is closer to the axis of the stoma 21c than the radial outermost end of the corresponding supporting branch bar 2730; the proximal end of each intersection continues to extend proximally to form the extension rod 276, and the proximal end of the extension rod 276 converges with the connector 278 to form a generally lantern-shaped structure. The connector 278 is a cylindrical or elliptical cylindrical structure, the axial length of the connector 278 is about 1-3 mm, the edge is smooth and has no sharp corner, and the connector 278 can be fixedly or detachably connected with the ostomy device conveying mechanism.

The foregoing is illustrative of embodiments of the present invention, and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the embodiments of the present invention and are intended to be within the scope of the present invention.

Claims

1. A cardiac interatrial septum shunt system comprising an ostomy member for forming an ostomy in an interatrial septum, wherein the cardiac interatrial septum shunt system further comprises an extender arranged in an inner space of the ostomy member, the extender being fillable with fluid, the ostomy member comprising an electrically conductive portion for ablating tissue surrounding the ostomy.

2. The atrial septal shunt system of claim 1, wherein the ostomy member comprises a stoma portion having a lumen when deployed, the stoma portion being radially collapsible and expandable, the expansion member being disposed within the lumen of the stoma portion, the expansion member being radially expandable to push against an inner peripheral wall of the stoma portion to adjust the diameter of the outer peripheral wall of the stoma portion when the expansion member is inflated with fluid.

3. The atrial septal shunt system of claim 2, wherein the expandable member comprises a resilient balloon structure made of a polymeric material, the balloon structure having a diameter that varies with the inflation of the fluid.

4. The atrial septal shunt system of claim 2, further comprising a support tube disposed axially within the lumen of the stoma portion, wherein the augment is disposed on the support tube, and wherein the augment is positioned between the support tube and the stoma portion.

5. The atrial septal shunt system of claim 4, wherein the extension member includes an outer wall surrounding the support tube, the outer wall has a proximal end and a distal end sealingly connected to the support tube, the outer wall and the outer peripheral wall of the support tube define an extension chamber, and the support tube defines an infusion hole communicating with the extension chamber of the extension member.

6. The atrial septal shunt system of claim 4, wherein the expansion member comprises an inner wall sleeved on the support tube and outer walls connected to the proximal end and the distal end of the inner wall, the inner wall and the outer walls define an expansion chamber, the inner wall is provided with an injection hole, and the support tube is provided with an injection hole communicated with the injection hole.

7. The system according to claim 2, further comprising a support tube, wherein a plurality of branch tubes are disposed at the support tube corresponding to the stoma portion, the branch tubes are circumferentially disposed around the support tube, the expanding member comprises a sufficient expanding member disposed at each branch tube, and each sufficient expanding member is disposed between the corresponding branch tube and the stoma portion.

8. The atrial septal shunt system of claim 7, wherein each expandable support comprises an outer wall surrounding the corresponding branch tube, the proximal end and the distal end of the outer wall are respectively and sealingly connected to the branch tube, the outer wall and the outer peripheral wall of the branch tube define an expansion chamber, and the outer peripheral wall of the support tube is provided with an infusion hole communicating with the expansion chamber of the expandable support.

9. The atrial septal shunt system of claim 7, wherein each expandable branch member comprises an inner wall sleeved on the outer peripheral wall of the corresponding branch pipe and outer walls connected to the proximal end and the distal end of the inner wall, the inner wall and the outer walls define an expansion chamber, the inner wall defines an injection hole, and the outer peripheral wall of the branch pipe defines a perfusion hole communicated with the injection hole.

10. The atrial septal shunt system of claim 2, wherein the stoma component further comprises a connecting portion disposed proximal to the stoma portion and an extension portion disposed distal to the stoma portion, the connecting portion and/or the extension portion having a maximum diameter greater than the stoma portion diameter.

11. The system of claim 10, wherein the extension portion includes a first locator portion coupled to a distal end of the stoma portion, and the coupling portion includes a second locator portion coupled to a proximal end of the stoma portion, the first locator portion and the second locator portion being positioned on opposite sides of the atrial septum when the stoma portion is positioned within the septal puncture.

12. The atrial septal shunt system of claim 11, wherein the distal end of the extension portion is provided with a constriction extending in a direction of an axis of the stoma, the constriction further comprising a plurality of extension members, the plurality of extension members being arranged in a circle along a circumference of the first positioning portion, a distal end of each extension member being inclined toward the axis of the stoma.

13. The atrial septal shunt system of claim 12, wherein the distal peripheral surface of each elongate member is configured as a radius or rounded corner, or the distal ends of the elongate members are configured as a circular piece or sphere.

14. The atrial septal shunt system of claim 11, wherein said conductive portion is an ablation electrode disposed on one of said ostomy portion, said first positioning portion, and said second positioning portion; or the conductive parts are two upper ablation electrodes respectively arranged on the stoma part, the first positioning part and the second positioning part; or the conductive part is an ablation electrode provided on the stoma part, the first positioning part and the second positioning part, respectively.

15. The atrial septal shunt system of claim 14, wherein the ostomy member is a supporting framework made of an electrically conductive material, the ablation electrode is a part of the supporting framework which is not insulated, and the supporting framework is coated with an insulating coating or fixed insulating sleeve on all the outer surfaces except the ablation electrode.

16. The atrial septal shunt system of claim 15, wherein the ablation electrode is a ring electrode circumferentially disposed at least one contiguous or intermittent turn along the outer wall surface of the ostomy member; or the ablation electrode is a plurality of point-like electrodes or strip-like electrodes, and the plurality of point-like electrodes or strip-like electrodes are arranged at least one circle along the circumferential direction of the outer wall surface of the ostomy piece.

17. The atrial septal shunt system of claim 16, wherein an insulating membrane is disposed between said ablation electrode and said ostomy member; or the outer surface of the ostomy piece is coated with an insulating coating corresponding to the ablation electrode.

18. The system according to claim 16, wherein at least one ring of visualization points or visualization wires is disposed on one of the stoma portion, the first positioning portion and the second positioning portion; or at least one circle of developing points or developing wires are respectively arranged on two of the stoma part, the first positioning part and the second positioning part; or at least one circle of developing points or developing wires are respectively arranged on the stoma part, the first positioning part and the second positioning part.

19. The atrial septal shunt system of claim 2, wherein said augment defines a plurality of spray holes adjacent to said conductive portion, said plurality of spray holes for spraying said fluid substance onto blood or tissue adjacent to the periphery of said conductive portion.