CN112754651A - Heart interatrial septum shunt system - Google Patents

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 interatrialseptum ostomy system 100 comprising a cardiac interatrialseptum shunt system 20 and an ostomydevice delivery mechanism 50 for delivering the cardiac interatrialseptum shunt system 20. The cardiac atrialseptal shunt system 20 includes anostomy member 21 for forming an ostium in the atrial septum and aaugment 22 disposed within a lumen of theostomy member 21, theaugment 22 being inflatable with a fluid such that radial expansion of theaugment 22 serves to expand and adjust a diameter of theostomy member 21, theostomy member 21 including an electricallyconductive portion 60 for isolating tissue surrounding the ostium. Theextender 22 is used to adjust the diameter of theostomy 21 to expand the stoma to a suitable size; theconductive part 60 is attached to the atrial septum tissue at the stoma, theconductive part 60 is electrically connected to the radio frequency power supply, and theconductive 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 theexpansion member 22 may be a gas or a liquid, and in the present invention, the fluid is saline; theconductive portion 60 is an ablation electrode.

The cardiac interatrialseptum shunting system 20 of the interatrialseptum stoma system 100 of the present invention comprises anostomy member 21 forming the stoma in the interatrial septum, anextender 22 arranged in the lumen of theostomy member 21, and aconductive portion 60 arranged on theostomy member 21. Theexpansion member 22 on the one hand changes the size of the diameter of thestoma 21 by the amount of filling fluid in order to adjust the stoma to the desired size; on the other hand, the fluid-filledexpansion member 22 is able to provide a greater radial support force, while imparting support force to theostomy member 21 and simultaneously expanding the perforation in the atrial septum, expanding the perforation, because of the radial support effect of theexpansion member 22, theostomy 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 theostomy member 21, and allowing the choice of metals or non-metallic materials with better biocompatibility; furthermore, because of theexpansion member 22, theostomy member 22 may be selected from a balloon-type material and need not be limited to a self-expanding material. Theconductive part 60 contacts the interatrial septum tissue near the stoma, and theconductive 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 interatrialseptum stoma system 100. Therefore, the shape of the stoma after being treated by the atrialseptal 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 atrialseptal shunt system 20, theostomy member 21 includes anostomy portion 23 having alumen 230, theostomy portion 23 being capable of radial contraction and expansion, and theexpansion member 22 is disposed in thelumen 230 of theostomy portion 23 and on both the proximal and distal sides thereof. When theextender 22 is inflated with fluid, theextender 22 can expand radially against the inner circumferential wall of thelumen 230 of thestoma portion 23 to adjust the diameter of the outer circumferential wall of thestoma portion 23 while giving thestoma 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. Theostomy member 21 is an expandable ostomy device and theostomy 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, theostomy member 21 is a metal stent having elasticity, and further, theostomy member 21 is a nickel titanium alloy stent. When atrialseptal shunt system 20 is delivered through the sheath, the diameter of theostomy 21 can be contracted to a smaller state for delivery in the sheath; when the atrialseptal shunt system 20 is released from the heart, theostomy member 21 is automatically expanded to form theinner lumen 230, and then filled with a fluid, such as saline, to expand and adjust the diameter of theinner lumen 230 of theostomy member 21 so that theostomy member 21 can open the perforations in the atrial septum to form the stoma, i.e., theexpansion member 22 exerts a radial pushing force against the inner circumferential wall of theostomy member 21 in theinner lumen 230 of theostomy member 21, and theostomy portion 23 of theostomy member 21 and theexpansion 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, theconductive part 60 of theostomy member 21 is attached to the interatrial septum tissue near the perforation, and theconductive 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 interatrialseptum stoma system 100.

Theostomy 21 can also be cut from a tube, and theostomy 21 is a cylindrical frame structure after being released in vivo to keep the passageway of the interatrial space open; theostomy 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 theostomy 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 atrialseptal shunt system 20 is completely released,stoma portion 23 ofstoma 21 has a generally cylindrical shape, andlumen 230 ofstoma portion 23 has a circular hole. In the fully released state of the cardiac interatrialseptum shunt system 20, theostomy member 21 further comprises anextension portion 25 disposed at the distal end of theostomy portion 23 and acoupling portion 27 disposed at the proximal end of theostomy portion 23, theextension portion 25 and thecoupling portion 27 being adapted to position theostomy member 21 over the interatrial septum. Specifically, when theostomy member 21 is implanted in the interatrial septum, theostomy portion 23 is inserted in the perforation of the interatrial septum, theextension portion 25 is positioned in the left atrium and abuts the interatrial septum tissue surrounding the perforation, and theconnection portion 27 is positioned in the right atrium and abuts the interatrial septum tissue surrounding the perforation.

Theextension portion 25 includes afirst locator 251 attached to the distal end of thestoma portion 23, and the connectingportion 27 includes asecond locator 271 attached to the proximal end of thestoma portion 23, thefirst locator 251 and thesecond locator 271 being positioned on opposite sides of the atrial septum when thestoma portion 23 is positioned in the perforation of the atrial septum. The diameter of thefirst positioning portion 251 is larger than that of thestoma portion 23, and thefirst positioning portion 251 is provided with a positioning surface, a positioning line, or a positioning point contacting the atrial septum. Specifically, one side of thefirst positioning portion 251 facing thestoma 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 atrialseptal shunt system 20 from moving towards the proximal end; theconductive portion 60 may be provided on the positioning point, the positioning line, or the positioning surface of thefirst positioning portion 251.

The diameter of thesecond positioning portion 271 is larger than that of thestoma portion 23, and thesecond 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 thesecond positioning portion 271 facing thestoma 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 atrialseptal shunt system 20 from moving to the distal end, thereby positioning the cardiac atrialseptal shunt system 20 on the atrial septum. Theconductive portion 60 may be provided on the positioning point, the positioning line, or the positioning surface of thesecond positioning portion 271.

In other embodiments, theconductive portions 60 may be disposed on the positioning surfaces, the positioning lines, or the positioning points of thefirst positioning portions 251 and thesecond positioning portions 271, respectively.

In this embodiment, thestoma portion 23 is a plurality of supportingsheets 232 arranged circumferentially, specifically, the plurality of supportingsheets 232 are arranged in a circle along the axial line of thestoma portion 23, each supportingsheet 232 extends along the axial line direction of thestoma portion 23, and the middle portion of each supportingsheet 232 is recessed towards the axial line direction of thestoma portion 23 to form an arc. Thestoma 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 mountinghole 2320 is formed in the middle of each supportingpiece 232, developing points are arranged in the mountingholes 2320, and the developing points in the mountingholes 2320 form a circle, so that thestoma 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 theostomy portion 23 facing away from the axial lead of theostomy member 21 is provided with aconductive part 60, specifically, the side of each supportingsheet 232 facing away from the axial lead of theostomy member 21 is provided with aconductive part 60, and theconductive parts 60 enclose a circle along the circumferential direction of theostomy portion 23. When theostomy member 21 is released in the perforation in the atrial septum tissue, theexpansion member 22 is filled with fluid to expand and adjust the diameter of theostomy member 21, theostomy member 21 and theexpansion member 22 are used for expanding the perforation to a proper size to form a stoma of a proper size, theconductive part 60 is connected with a radio frequency power supply, and then radio frequency energy is transmitted to theconductive 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.

Thefirst positioning portion 251 includes twofirst positioning bars 2510 bent and radiated from the distal end of each supportingpiece 232 of thestoma portion 23 to the direction away from the axial center line of thestoma 21 along both sides, and the distal ends of the twofirst positioning bars 2510 adjacent to each other on the two adjacent supportingpieces 232 are joined to form a connectingpiece 2511. Eachcoupling piece 2511 is inclined to a distal end, and the distal end of eachcoupling piece 2511 is rounded. Specifically, the outer peripheral surface of the distal end of theconnection piece 2511 is configured as an arc surface or a rounded angle, or the distal end of theconnection piece 2511 is configured as a circular piece, a spherical structure or a similar spherical structure. In this embodiment, the distal end of eachcoupling tab 2511 is rounded. The distal end of each connectingpiece 2511 is smoothed to prevent the connectingpiece 2511 as a free end from scratching the cardiac tissue when the atrialseptal shunt system 20 enters the cardiac tissue, thereby improving safety.

Thesecond positioning portion 271 includes a plurality of positioning elements, the positioning elements correspond to thesupport pieces 232 one by one, and the distal end of each positioning element is connected to the proximal end of thecorresponding support piece 232. Each positioning element comprises twosecond positioning rods 2710 which are formed by diverging from the proximal ends of the corresponding supportingpieces 232 to the direction far away from the axial lead of theostomy piece 21, the proximal ends of the two adjacentsecond 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 theostomy piece 21 than the proximal ends of the corresponding supportingpieces 232.

At least one circle of developing points or developing wires is arranged on one of the mouth-makingpart 23, thefirst positioning part 251 and thesecond positioning part 271; that is, thestoma portion 23 is provided with at least one turn of developing dots or developing wires, thefirst positioning portion 251 is provided with at least one turn of developing dots or developing wires, or thesecond positioning portion 271 is provided with at least one turn of developing dots or developing wires.

In other embodiments, theconductive portion 60 is an ablation electrode disposed on one of thestoma portion 23, thefirst positioning portion 251 and thesecond positioning portion 271. Specifically, theconductive part 60 may also be at least one circle of ablation electrodes arranged on the side surface of thefirst positioning part 251 facing thesecond positioning part 271, and preferably, at least one circle of ablation electrodes is arranged on the side surface of thefirst positioning rods 2510 facing away from the axial line of thestoma piece 21; alternatively, theconductive portion 60 may be at least one turn of an ablation electrode provided on the side surface of thesecond positioning portion 271 facing thefirst 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 theostomy member 21. When theostomy member 21 is released in the perforation in the atrial septum tissue, theextender 22 is filled with fluid to expand and adjust the diameter of theostomy member 21, theostomy member 21 struts the perforation to a suitable size to form the stoma, theconductive portion 60 is connected to a radio frequency power supply, and then radio frequency energy is transmitted to theconductive 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, theconductive portion 60 may be two upper ablation electrodes respectively disposed on thestoma portion 23, thefirst positioning portion 251 and thesecond positioning portion 271; that is, at least one circle of ablation electrodes is arranged on the side of thestoma portion 23 departing from the axis thereof and at least one circle of ablation electrodes is arranged on the side of thefirst positioning portion 251 facing thesecond positioning portion 271, or at least one circle of ablation electrodes is arranged on the side of thestoma portion 23 departing from the axis thereof and at least one circle of ablation electrodes is arranged on the side of thesecond positioning portion 271 facing thefirst positioning portion 251, or at least one circle of ablation electrodes is arranged on the side of thefirst positioning portion 251 facing thesecond positioning portion 271 and at least one circle of ablation electrodes is arranged on the side of thesecond positioning portion 271 facing thefirst positioning portion 251. Specifically, at least one circle of ablation electrodes is arranged on the side of the plurality of supportingpieces 232 departing from the axial lead of theostomy piece 21, at least one circle of ablation electrodes is arranged on the side of the plurality offirst positioning rods 2510 departing from the axial lead of theostomy piece 21, at least one circle of ablation electrodes is arranged on the side of the plurality of supportingpieces 232 departing from the axial lead of theostomy piece 21, at least one circle of ablation electrodes is arranged on the side of the plurality ofsecond positioning rods 2710 departing from the axial lead of theostomy piece 21, at least one circle of ablation electrodes is arranged on the side of the plurality offirst positioning rods 2510 departing from the axial lead of theostomy piece 21, and at least one circle of ablation electrodes is arranged on the side of the plurality ofsecond positioning rods 2710 departing from the axial lead of theostomy piece 21. When theostomy member 21 is released in the perforation in the atrial septum tissue, theexpansion member 22 is filled with fluid to expand and adjust the diameter of theostomy member 21 to prop open the perforation to a suitable size to form the stoma, both loops of theconductive portion 60 are connected to the radio frequency power supply to transmit radio frequency energy to theconductive 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, theconductive part 60 may also be an ablation electrode respectively disposed on thestoma portion 23, thefirst positioning portion 251 and thesecond positioning portion 271, that is, at least one circle of ablation electrode is disposed on the side of thestoma portion 23 away from the axis thereof, at least one circle of ablation electrode is disposed on the side of thefirst positioning portion 251 facing thesecond positioning portion 271, and at least one circle of ablation electrode is disposed on the side of thesecond positioning portion 271 facing thefirst positioning portion 251. Specifically, at least one circle of ablation electrodes is arranged on the side of the supportingsheet 232 departing from the axial lead of theostomy piece 21, at least one circle of ablation electrodes is arranged on the side of thefirst positioning rods 2510 departing from the axial lead of theostomy piece 21, and at least one circle of ablation electrodes is arranged on the side of thesecond positioning rods 2710 departing from the axial lead of theostomy piece 21. When theostomy member 21 is released in the perforation in the atrial septum tissue, theexpansion member 22 is filled with fluid to expand and adjust the diameter of theostomy member 21 to open the perforation to a suitable size to form the stoma, the three turns of theconductive portion 60 are all connected to the radio frequency power supply, and then the radio frequency energy is transmitted to theconductive 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-makingportion 23, thefirst positioning portion 251 and thesecond positioning portion 271; that is, at least one circle of developing dots or developing wires is provided on the mouth-makingportion 23 and thefirst positioning portion 251, or at least one circle of developing dots or developing wires is provided on the mouth-makingportion 23 and thesecond positioning portion 271, or at least one circle of developing dots or developing wires is provided on thefirst positioning portion 251 and thesecond positioning portion 271.

In other embodiments, at least one circle of developing dots or developing wires is disposed on thestoma portion 23, thefirst positioning portion 251 and thesecond positioning portion 271.

Further, the developing points or the developing wires are arranged at the position of theconductive 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 connectingportion 27 further includes a plurality of connectingrods 272 connected to the proximal end of thesecond positioning portion 271, a supportingmember 273 disposed at the proximal end of each connectingrod 272, an extendingrod 276 disposed at the proximal end of each supportingmember 273, and a connectinghead 278 disposed at the proximal end of the extendingrod 276. The connectingrods 272 are respectively connected to the intersecting portions of the proximal ends of thesecond positioning portions 271, the connectingrods 272 are arranged along the circumferential direction of thesecond positioning portions 271, the distal end of each connectingrod 272 is connected to the corresponding intersecting portion, the proximal ends of the connectingrods 272 are connected to the distal ends of the corresponding supportingmembers 273, and the middle portion of each connectingrod 272 protrudes in the direction away from the axial line of thestoma 21 to form an arc rod. Each supportingmember 273 includes two supportingbranch bars 2730 radiating bent from the proximal end of the corresponding connectingbar 272 toward the axis line of theostomy member 21 along both sides, and the proximal ends of the adjacent two supportingbranch bars 2730 of each adjacent two supportingmembers 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 connectingbar 272; the proximal end of each intersection continues to extend proximally to form theextension rod 276, and the proximal end of theextension rod 276 converges with theconnector 278 to form a generally lantern-shaped structure. Theconnector 278 is a cylindrical or elliptical cylindrical structure, the axial length of theconnector 278 is about 1-3 mm, the edge is smooth and has no sharp corner, and theconnector 278 can be fixedly or detachably connected with the ostomydevice conveying mechanism 50.

Referring to fig. 1, 3 and 4, theexpansion 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 thestoma portion 23, and the diameter of the perforation inserted with thestoma portion 23 is convenient to adjust.

The atrialseptal shunt system 20 further includes asupport tube 24, thesupport tube 24 is axially inserted into thelumen 230 of thestoma portion 23, theexpansion member 22 is disposed on thesupport tube 24, and theexpansion member 22 is disposed between thesupport tube 24 and thestoma portion 23. In this embodiment, the axis of thesupport tube 24 coincides with the axis of theostomy member 21, and theextension member 22 surrounds thesupport 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 ofsupport tube 24 and enlarge the diameter of the lumen ofsupport tube 24, andsupport tube 24 is used to convey saline from an external saline source intoextension 22.

In this embodiment, theextension member 22 includes anouter wall 221 surrounding thesupport tube 24, the proximal end and the distal end of theouter wall 221 are respectively connected to thesupport tube 24 in a sealing manner, theouter wall 221 and the outer peripheral wall of thesupport tube 24 define anextension cavity 223, and the outer wall of thesupport tube 24 is provided with a fillinghole 242 communicating with theextension cavity 223. Saline from the external saline source is delivered into theexpansion chamber 223 through the lumen of thesupport tube 24 to theinfusion port 242, so that the expansion of theexpansion chamber 223 radially pushes against the inner circumferential wall of thelumen 230 of thestoma portion 23 to increase the diameter of thestoma portion 23; when the saline in theexpansion chamber 223 is discharged outwardly through the lumen of thesupport tube 24, theexpansion chamber 223 contracts radially to reduce the diameter of thestoma portion 23.

Theouter wall 221 of theextension 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 theouter wall 221 can be hermetically connected to thesupport tube 24 by heat pressing, adhesive bonding, and the like.

When theostomy member 21 is made of a conductive material, a part of theostomy member 21 can be directly used as theablation electrode 60, and the ablation electrode can be arranged at a position where theostomy member 23, thefirst positioning part 24 or the second positioning part 26 is in contact with the tissues around the perforation, because theostomy member 21 itself is made of a conductive material, the outer surface of theostomy member 21 except for the position as theablation 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 theostomy 21 itself is electrically conductive, the radio frequency power may be switched on directly through theconnection head 278 via the ostomydevice delivery mechanism 50, thereby transferring the radio frequency energy to the electricallyconductive part 60. To further concentrate the energy on the septal tissue of thestoma portion 23, the outer surface of thestoma 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 ostomydevice delivery mechanism 50 includes a loader, a support tube, an electricallyconductive pusher 56, an ablation power source, and the like. The support tube comprises apush tube 52, anouter tube 54 sleeved outside thepush tube 52, and aninner tube 55 arranged inside thepush tube 52. The distal end of thepush tube 52 is fixedly attached or removably attached to theconnector 278; the far end of theinner tube 55 is axially connected to thesupport tube 24, and theinner tube 55 is axially provided with atransfusion channel 550 communicated with the inner cavity of thesupport tube 24, and the external saline is poured into theexpansion cavity 223 through thetransfusion channel 550, the inner cavity of thesupport tube 24 and the pouringhole 242, or the saline in theexpansion cavity 223 is discharged through the pouringhole 242, the inner cavity of thesupport tube 24 and thetransfusion channel 550. A lead is arranged in thepush tube 52, and one end of the lead is electrically connected with theconductive part 60 of the heart interatrialseptum shunt system 20; the other end of the lead is electrically connected with the ablation power supply.

The interatrialseptum 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 atrialseptal shunt system 20 of the appropriate size selected, thepusher 56 is advanced to deliver theostomy member 21 to the interatrial septum site and the visualization site is visualized and located in the interatrial septum tissue. Thepusher 56 is then slowly advanced or theouter tube 54 is withdrawn, while the site of visualization is guaranteed to be in the interatrial septum tissue, allowing thestoma portion 23 of thestoma 21 to fully open.

3. The fluid is filled in theexpansion cavity 223 of theexpansion piece 22 through theinfusion channel 550 of theinner tube 55, the inner cavity of thesupport tube 24 and theperfusion hole 242, and the atrial septal tissue of theexpansion 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 theconductive portion 60 is activated to heat.

5. After the heating is stopped, the fluid in theexpansion chamber 223 is discharged through theperfusion hole 242, the lumen of thesupport tube 24 and theinfusion channel 550 of theinner tube 55, theexpansion member 22 and theostomy member 21 are withdrawn into theouter tube 54 and removed from the body, and it is measured whether the stoma diameter is as expected.

Theostomy member 21 of the interatrialseptum ostomy system 100 in this embodiment is inserted into the through hole of the interatrial septum, and theouter wall 221 of theextender 22 is pushed against the inner circumferential wall of theinner cavity 230 of theostomy portion 23 by filling theextender cavity 223 of theextender 22 with fluid to adjust the diameter of the outer circumferential wall of theostomy portion 23, so that theostomy portion 23 can prop open the through hole on the interatrial septum to form an ostomy with a proper diameter; theconductive part 60 contacts the interatrial septum tissue near the stoma, and theconductive 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 interatrialseptum stoma system 100. Therefore, the shape of the stoma after being treated by the atrialseptal 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, theinner tube 55 and thesupport 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 aninner wall 222 sleeved on thesupport tube 24 and anouter wall 221 connected to the proximal end and the distal end of theinner wall 222, theinner wall 222 and theouter wall 221 define anexpansion cavity 223, theinner wall 222 defines aninjection hole 2220, and thesupport tube 24 defines aninjection hole 242 communicating with theinjection hole 2220. Specifically, theinner wall 222 is a positioning tube sleeved on thesupport tube 24, the positioning tube has elasticity, and the diameter of the positioning tube is smaller than that of thesupport tube 24, so that theinner wall 222 can be firmly positioned on thesupport tube 24. The distal end of theouter wall 221 is sealingly connected to the distal end of theinner wall 222, and the proximal end of theouter wall 221 is sealingly connected to the proximal end of theinner wall 222, such that theouter wall 221 and theinner wall 222 enclose a sealedexpansion chamber 223. Saline from the external saline source passes through the inner cavity of thesupport tube 24 and is delivered into theexpansion cavity 223 through theinjection hole 2220 and theinjection hole 242, so that theexpansion cavity 223 expands to radially push against the inner circumferential wall of theinner cavity 230 of thestoma portion 23, thereby increasing the diameter of thestoma portion 23; fluid in theexpansion chamber 223 can flow through the perfusion holes 242 and 2220 to the interior of thesupport tube 24 and be expelled outwardly, allowing theexpansion chamber 223 to contract radially to reduce the diameter of thestoma portion 23.

The connection and position of the extension 22a and theostomy 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, theextension 22b is provided with a plurality ofspray holes 2210 near thestoma portion 23, the plurality ofspray holes 2210 being used for spraying the fluid onto the atrial septum adjacent to theconductive portion 60. Specifically, at least one circle of sprayingholes 2210 is circumferentially opened at a middle position of theouter 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 sprayingholes 2210 are formed in the middle of theouter wall 221 in the circumferential direction, and the two circles of sprayingholes 2210 are formed in the perforated position of theouter wall 221 corresponding to the room space. The positions of one circle ofspray holes 2210 may or may not be staggered from the other circle ofspray holes 2210, the staggering being that eachspray hole 2210 of one circle ofspray holes 2210 is located between twoadjacent spray holes 2210 of the other circle ofspray 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 thespray holes 2210 are distributed or spirally arranged in 2 to 4 turns at intervals.

The diameter of eachspray hole 2210 is smaller than 0.2mm in order to avoid that the pressure of theexpansion piece 22b is insufficient and cannot radially push against the ostomymember 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:

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 atrialseptal shunt system 20 of the appropriate size selected, thepusher 56 is advanced to deliver theostomy member 21 to the interatrial septum site and the visualization site is visualized and located in the interatrial septum tissue. Thepusher 56 is then slowly advanced or theouter tube 54 is withdrawn, while the site of visualization is guaranteed to be in the interatrial septum tissue, allowing thestoma portion 23 of thestoma 21 to fully open.

3. Theexpandable cavity 223 of theexpandable member 22b is filled with a fluid, such as saline, through theinfusion channel 550 of theinner tube 55, the lumen of thesupport tube 24 and theinfusion orifice 242, and the atrial septal tissue of theexpandable 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 thestoma 23, theextender 22b sprays cold saline to the interatrial septum tissue near thestoma 23 through thespray holes 2210 to lower the interatrial septum tissue outside the desired ablation range near theconductive 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 theextender 22b sprays cold saline all the way to the interatrial septum tissue near thestoma 23 through thespray holes 2210 during the heating process.

5. After the heating is stopped, the cold saline in theexpansion chamber 223 is discharged through theperfusion hole 242, the lumen of thesupport tube 24 and thetransfusion channel 550 of theinner tube 55, and theexpansion piece 22b and thestoma 21 are recovered into theouter tube 54 and removed, and whether the stoma diameter is as expected or not is measured.

Theostomy member 21 of the interatrialseptum ostomy system 100 in this embodiment is inserted into the through hole of the interatrial septum, and the outer wall of theexpansion member 22b is pushed against the inner circumferential wall of theinner cavity 230 of theostomy member 23 by filling cold saline into theexpansion cavity 223 of theexpansion member 22b to adjust the diameter of the outer circumferential wall of theostomy member 23, so that theostomy member 23 can expand the through hole on the interatrial septum to form an ostomy with a proper diameter; theextender 22b sprays cold saline to the atrial septum tissue outside the intended ablation range near theconductive part 60 through thespray holes 2210 to lower the temperature of the atrial septum tissue near theconductive part 60 in advance to reduce the heat affected zone, theconductive part 60 contacting the atrial septum tissue near the stoma; theconductive 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 interatrialseptum stoma system 100. In the process that the conductingpart 60 ablates the interatrial septum tissue, theexpansion part 22b sprays cold saline to the interatrial septum tissue near the mouth-makingpart 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, anextension portion 25a provided at a distal end of the ostomy portion 23a, and a connectingportion 27a provided at a proximal end of the ostomy portion 23 a. The extendingportion 25a is provided with afirst positioning portion 251a on the side facing the stoma portion 23a, and the connectingportion 27a is provided with asecond positioning portion 271a on the side facing the stoma portion 23 a. The proximal end of thefirst retainer 251a is connected to the distal end of the stoma portion 23a, and the distal end of thefirst retainer 251a extends radially; the distal end of thesecond positioning portion 271a is connected to the proximal end of the stoma portion 23a, and the proximal end of thesecond positioning portion 271a extends in the axial direction of the stoma portion 23a and merges. The stoma portion 23a has an inner cavity, and theexpansion piece 22c is disposed in the inner cavity of the stoma portion 23a, and when theexpansion piece 22c is filled with fluid, the radial dimension of theexpansion piece 22c is increased, so that theexpansion 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, thefirst positioning portion 251a is a single-layer braided net structure, and thesecond positioning portion 271a is a double-layer braided net structure. Thefirst 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. Thesecond 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 thefirst positioning portion 251a, and the positioning surface of thesecond 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 thefirst positioning portion 251a and the positioning surface of thesecond positioning portion 271 a; or the side of the stoma portion 23a departing from the axis of the stoma 21a, the positioning surface of thefirst positioning portion 251a and the positioning surface of thesecond 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, thefirst positioning part 251a and thesecond 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, thefirst positioning part 251a and thesecond positioning part 271 a; or at least one circle of developing dots or developing wires is provided on the mouth-forming portion 23a, thefirst positioning portion 251a, and thesecond positioning portion 271a, respectively.

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

As shown in fig. 10, eachbranch pipe 244 is in communication with thesupport tube 24a, and specifically, the proximal end and the distal end of eachbranch pipe 244 are in communication with the lumen of thesupport tube 24a, respectively, i.e., fluid in thesupport tube 24a can flow into eachbranch 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 theexpandable branches 226 has an expansion chamber for receiving fluid, i.e., eachbranch pipe 244 is capable of filling the expansion chamber of the correspondingexpandable branch 226 with fluid to increase the radial dimension of theexpandable branch 226.

In this embodiment, each of the sufficientexpansion branch members 226 is connected to thecorresponding branch pipe 244 by afastener 227, thefastener 227 opens an injection hole communicating with the expansion cavity of the correspondingexpansion branch member 226, and the outer wall of thebranch 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 theexpandable branch members 226 through theinfusion channel 550, the lumen of thesupport tube 24a, the injection holes of thebranch tube 244 and the branch tube, and the injection hole of thecorresponding buckle 227, or the fluid such as saline in the expansion cavity of each of theexpandable branch members 226 is discharged through the injection hole, the injection hole of thebranch tube 244, the lumen of thesupport tube 24a, and theinfusion channel 550. Thesnaps 227 can be made of a visualization material that not only secures theexpandable legs 226 to the correspondinglegs 244, but thesnaps 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:

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. The appropriately sized ostomy member 21a is selected and thepusher 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. Thepusher 56 is then slowly advanced or theouter 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 eachexpandable branch 226 through theinfusion channel 550 of theinner tube 55, the lumen of thesupport tube 24a, thebranch tube 244, the infusion hole of the branch tube and the corresponding injection hole of thebuckle 227, so as to expand the atrial septum tissue of theexpandable 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 eachexpandable support 226 is discharged through the injection hole of theclip 227, theinjection hole 242 of the branch pipe, thebranch pipe 244, the inner chamber of thesupport tube 24a and theinfusion channel 550, and theexpansion 22c and the stoma 21a are withdrawn into theouter tube 54 and removed, and the stoma diameter is measured to determine whether the stoma diameter is as desired.

In other embodiments, each of theexpandable branches 226 includes an outer wall surrounding the correspondingbranch tube 244, the proximal end and the distal end of the outer wall are respectively and hermetically connected to thebranch tube 244, the outer wall of theexpandable branch 226 and the outer peripheral wall of thebranch tube 244 define the expansion cavity, and the outer peripheral wall of thebranch tube 244 defines an infusion hole communicating with the expansion cavity of theexpandable branch 226. The outer wall of theexpandable 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 theexpandable support 226 can be hermetically connected to thebranch tube 244 by heat pressing, glue bonding, etc.

In other embodiments, eachexpandable branch 226 includes an inner wall sleeved on the outer peripheral wall of thecorresponding 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 theexpandable branch 226 form an expandable cavity, the inner wall defines an injection hole, and the outer wall of thebranch 244 defines an injection hole communicated with the injection hole.

In other embodiments, each of theexpandable branch members 226 may also be fixed to thecorresponding branch pipe 244 by gluing, and the outer wall of thebranch pipe 244 is provided with a perfusion hole communicating with the expansion cavity of theexpandable 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, eachenlarged branch 226 is opened with a plurality ofspray holes 2210 near the stoma portion 23a, the plurality ofspray holes 2210 being used for spraying the fluid onto the atrial septum adjacent to the conductive portion. Specifically, at least one circle ofspray holes 2210 is circumferentially opened in the middle position of the side of each of the enlargedfull legs 226 facing away from the axial line of the ostomy member 21a, thespray holes 2210 being bored by heating a large-bore needle or by a laser cutting process.

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

The diameter of eachspray hole 2210 is smaller than 0.2mm in order to avoid under-pressure of theexpandable 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:

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. The appropriately sized ostomy member 21a is selected and thepusher 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. Thepusher 56 is then slowly advanced or theouter 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 expandable cavity of eachexpandable branch 226 is filled with cold saline through theinfusion channel 550 of theinner tube 55, the lumen of thesupport tube 24a, thebranch tube 244, the infusion hole of the branch tube and the corresponding infusion hole of thebuckle 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 theexpandable legs 226 sprays cold saline to the interatrial septum tissue near the stoma 23a through thespray holes 2210 to lower the interatrial septum tissue outside the expected ablation range near theconductive 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 theexpandable legs 226 sprays cold saline all the way to the interatrial septum tissue near the stoma 23a through thespray holes 2210 during the heating process.

5. After the heating is stopped, the cold saline in the expansion chamber of each of thesufficient expansion legs 226 is discharged through the injection hole of the fillingclip 227, the filling hole of the branch tube, thebranch tube 244, the inner chamber of thesupport tube 24a and theinfusion channel 550, and theexpansion member 22c and the stoma 21a are recovered into theouter 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 eachexpandable branch 226 is pushed against the inner circumferential wall of the inner cavity of the ostomy portion 23a by filling the expansion cavity of eachexpandable 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 thedilatant branches 226 sprays cold saline to the interatrial septum tissue near the stoma portion 23a through thespray 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 eachfull 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 theexpansion members 22d of the sixth embodiment are different from those of the third embodiment. In the sixth embodiment, theextension 22d is provided with at least one ring of sprayingholes 2212 near its proximal end and distal end, respectively, i.e. theextension 22d is provided with at least one ring of sprayingholes 2212 near the proximal end and distal end of thestoma portion 23, respectively. The diameter of eachspray orifice 2212 is less than 0.2mm to avoid the insufficient pressure of theexpansion piece 22d from radially pushing against thestoma 21 to distract the atrial septum tissue. The plurality ofspray holes 2212 are used to spray the fluid, such as cold saline, onto the atrial septum adjacent to thestoma portion 23 to lower the temperature of the atrial septum tissue outside the intended ablation range adjacent to theconductive portion 60 and the temperature of the blood adjacent to theconductive portion 60 to avoid thrombus formation and reduce the damage and risk of ablation while forming an effective ablation stoma.

Specifically, theextension 22d also includes anouter wall 221 surrounding thesupport tube 24, and anextension cavity 223 surrounded by theouter wall 221 and the outer peripheral wall of thesupport tube 24. Theouter wall 221 is provided with a ring of sprayingholes 2212 near the distal end and the proximal end, respectively, and the outer surface of theouter wall 221 is provided with aspraying tube 2213 protruding outward around eachspraying hole 2212, that is, the sprayingholes 2212 are communicated with thecorresponding spraying tubes 2213. Each of thewater spray tubes 2213 ofouter wall 221 near the distal end extends obliquely towards the proximal end, and each of thewater spray tubes 2213 ofouter wall 221 near the proximal end extends obliquely towards the distal end. Specifically, the included angle between eachsprinkler tube 2213 and thesupport tube 24 in the axial direction is less than 90 degrees. In this embodiment, each ring ofspray tubes 2213 is six, and two rings ofspray tubes 2213 are staggered, i.e., eachspray tube 2213 of one ring is located between twoadjacent spray tubes 2213 of another ring ofspray tubes 2213.

In this embodiment, the opening of eachsprinkler 2213 faces thestoma 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 sprayingholes 2212 may be provided only on the proximal end or the distal end of theexpansion piece 22d near thestoma portion 23, the outer surface of theouter wall 221 is provided with aspraying tube 2213 protruding obliquely to thestoma portion 23 around eachspraying hole 2212, and each sprayingtube 2213 is communicated with thecorresponding 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 theexpansion members 22d of the seventh embodiment are different from those of the third embodiment. In the seventh embodiment, the middle of theextension 22e is opened withseveral spray holes 2210 and a circle ofspray holes 2212 near the proximal end, theextension 22e is provided withspray tubes 2213 around eachspray hole 2212 and obliquely toward thestoma portion 23, and eachspray tube 2213 is communicated with the correspondingspray hole 2212. The spray holes 2210, 2212 are used to spray a fluid, such as cold saline, onto the atrial septum adjacent to thestoma portion 23 to lower the temperature of the atrial septum tissue outside the intended ablation range and the temperature of the blood adjacent theconductive portion 60, avoiding the formation of thrombi, and reducing the damage and risk of ablation while forming an effective ablation stoma. Specifically, theouter wall 221 is provided with at least one circle of sprayingholes 2210 corresponding to thestoma portion 23, the sprayingholes 2210 may be formed by heating a large-hole needle or by a laser cutting process, and the diameter of eachspraying hole 2210 is less than 0.2 mm.

Specifically, theextension 22e also includes anouter wall 221 surrounding thesupport tube 24, and anextension cavity 223 surrounded by theouter wall 221 and the outer peripheral wall of thesupport tube 24. Two circles of sprayingholes 2210 are formed in theouter wall 221 corresponding to thestoma portion 23, the two circles of sprayingholes 2210 can be arranged in a staggered manner, or a circle of sprayingholes 2212 are formed in theouter wall 221 corresponding to the near end. The outer surface of theouter wall 221 is provided with awater spray tube 2213 protruding obliquely to thestoma portion 23 around eachspray hole 2212, and thewater spray tube 2213 is communicated with the correspondingspray hole 2212. Specifically, the included angle between eachsprinkler tube 2213 and thesupport tube 24 in the axial direction is less than 90 degrees. In this embodiment, the number ofspray tubes 2213 in each ring is six, and sixspray tubes 2213 are annularly arrayed along the axial center line of thestoma portion 23.

In this embodiment, since theexpansion piece 22e is provided with thespraying hole 2212 corresponding to thestoma portion 23, and theexpansion piece 22e is provided with thewater spraying tube 2213 facing thestoma portion 23 near the proximal end, fluid such as cold saline is sprayed from thespraying hole 2212 and thewater 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.

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.

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 theexpansion members 22f in the eighth embodiment are different from those in the third embodiment. In the eighth embodiment, the middle of theextension 22f is opened with a plurality ofspray holes 2210 and a circle ofspray holes 2212 near the distal end, theextension 22f is provided withspray tubes 2213 around eachspray hole 2212 and inclined toward thestoma portion 23, and eachspray tube 2213 is communicated with the correspondingspray hole 2212. The spray holes 2210, 2212 are used to spray a fluid, such as cold saline, onto the atrial septum adjacent to thestoma portion 23 to lower the temperature of the atrial septum tissue outside the intended ablation range and the temperature of the blood adjacent theconductive 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 sprayingholes 2210 are formed in theouter wall 221 corresponding to thestoma portion 23.

Specifically, theextension 22f also includes anouter wall 221 surrounding thesupport tube 24, and anextension cavity 223 surrounded by theouter wall 221 and the outer peripheral wall of thesupport tube 24. Two circles of sprayingholes 2210 and one circle of sprayingholes 2212 arranged at the far end of theouter wall 221 are arranged at the position of theouter wall 221 corresponding to thestoma part 23. The outer surface of theouter wall 221 is provided with awater spray tube 2213 protruding obliquely to thestoma portion 23 around eachspray hole 2212, and thewater spray tube 2213 is communicated with the correspondingspray hole 2212. Specifically, the included angle between eachsprinkler tube 2213 and thesupport tube 24 in the axial direction is less than 90 degrees. In this embodiment, the number ofspray tubes 2213 in each ring is six, and sixspray tubes 2213 are annularly arrayed along the axial center line of thestoma portion 23.

In this embodiment, since theexpansion piece 22f is provided with thespraying hole 2212 corresponding to thestoma portion 23, and theexpansion piece 22f is provided with thewater spraying tube 2213 facing thestoma portion 23 near the proximal end, fluid such as cold saline is sprayed from thespraying hole 2212 and thewater 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 thestoma portion 23b and theextension portion 25b of thestoma 21b in the ninth embodiment are different in structure from those of the first embodiment. In the ninth embodiment, theostomy member 21b also comprises astoma portion 23b for distracting the stoma, anextension portion 25b attached to the distal end of thestoma portion 23b, and a connectingportion 27 attached to the proximal end of thestoma portion 23 b. The distal end of the extendingportion 25b has a necked-inportion 250 extending in the axial direction of thestoma 21 b. Theostomy piece 21b is provided with aconductive part 60, the ostomy device delivery mechanism is used for delivering the heart interatrial septum shunt system to the perforation on the interatrial septum, theconductive part 60 is attached to the tissue at the perforation, theconductive part 60 is electrically connected to the radio frequency power supply, and theconductive 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 extendingportion 25b has the closingportion 250 extending in the axial direction of the stoma 21a, the extendingportion 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.

Theostomy 21b is a self-expanding ostomy device, and theostomy 21b may be a resilient metal support frame or a resilient non-metal support frame. In this embodiment, theostomy member 21b is a nitinol stent, and when the atrial septal shunt system is delivered through the sheath, the diameter of theostomy 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, theostomy member 21b can be automatically expanded, theexpansion member 22 can be internally filled with fluid to expand and adjust the diameter of theostomy member 21b, so that theostomy member 21b can expand the perforation on the atrial septal to form the stoma, theconductive part 60 is attached to the atrial septal tissue at the stoma, theconductive part 60 is electrically connected to the radio frequency power supply, and theconductive 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, thestoma portion 23b has a cylindrical shape, and thestoma portion 23b and theextension portion 25b are connected by thefirst positioning portion 24; themouth portion 23b and the connectingportion 27 are connected by thesecond positioning portion 271 b. When the atrial septal shunt system is implanted in the perforation on the atrial septum, thestoma portion 23b supports the inner wall of the perforation, and thefirst positioning portion 24 and thesecond positioning portion 271b are positioned on the opposite two side surfaces of the atrial septum, respectively. The diameter of thefirst positioning portion 24 is larger than that of thestoma portion 23b, and thefirst 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 thefirst positioning portion 24 facing thestoma 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; theconductive portion 60 may be provided on the positioning point, the positioning line, or the positioning face.

The diameter of thesecond positioning portion 271b is greater than that of thestoma portion 23b, thesecond 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 thesecond 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. Theconductive portion 60 may be provided on the positioning point, the positioning line, or the positioning face.

In other embodiments, theconductive portions 60 may be disposed on the positioning surfaces, the positioning lines, or the positioning points of thefirst positioning portions 24 and thesecond positioning portions 271b, respectively.

In this embodiment, the mouth-makingportion 23b is a wave-shaped ring structure arranged at least one turn circumferentially continuously, thefirst positioning portion 24 is connected to the wave crest of the wave-shaped ring structure, and thesecond positioning portion 271b is connected to the wave trough of the wave-shaped ring structure. Specifically, thestoma 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, wavetroughs 233 andwave rods 235, the circumferentiallyadjacent wave rods 235 are connected at the distal end to form the wave crests 231, and the circumferentiallyadjacent wave rods 235 are connected at the proximal end to form thewave troughs 233; the middle of eachwave bar 235 is concave in an arc shape toward the axis of the ostomy member 21 a. The proximal end of thefirst positioning portion 24 is connected to the plurality of wave crests 231, and the distal end of thesecond positioning portion 271b is connected to the plurality ofwave troughs 233. Thestoma portion 23b is generally required to facilitate radial compression and to maintain necessary strength.

Thestoma 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 thewave crest 231, thewave trough 233 and thewave bar 235 of the mouth-makingpart 23b is provided with a developing point, and a circle of developing points is enclosed on the mouth-makingpart 23 b; or two of thewave crest 231, thewave trough 233 and thewave bar 235 are provided with developing points, and two circles of spaced developing points are surrounded on thestoma part 23 b; or thewave crest 231, thewave trough 233 and thewave rod 235 are all provided with developing points, and three circles of spaced developing points are enclosed on thestoma portion 23b, so that thepositioning 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 extendingportion 25b includes a plurality of first connectingrods 252 disposed at the distal end of thefirst positioning portion 24, and an extendingmember 253 disposed at the distal end of each first connectingrod 252, wherein the plurality of first connectingrods 252 are arranged along the circumference of thefirst positioning portion 24 to form a circle, the proximal end of each first connectingrod 252 is connected to thefirst positioning portion 24, the distal end of each first connectingrod 252 is connected to the extendingmember 253, the middle portion of each first connectingrod 252 protrudes in the direction away from the axial line of the ostomy member 21a to form an arc rod, and the plurality of extendingmembers 253 forms the closingportion 250.

Each of the extendingmembers 253 extends obliquely from the distal end of the corresponding first connectingrod 252 toward the axis of theostomy member 21b, and the extendingmembers 253 are arranged in a circular array around the axis of theostomy member 21b to enclose themouth portion 250.

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

In this embodiment, eachextension 253 includes twobranch struts 2530 that are bent and radiated from the distal end of the first connectingrod 252 toward the axis of theostomy member 21b along both sides, and the distal ends of the adjacent twobranch struts 2530 of each adjacent twoextension 253 meet to form anintersection 2532. The distal end of theintersection 2532 is closer to the axis of the ostomy 21a than the distal end of the first connectingrod 252.

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

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

Thefirst positioning portion 24 includes two first positioning bars 240 bent and radiating from eachpeak 231 of thestoma 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 twoadjacent peaks 231 meet. The first connectingrods 252 are connected to the distal intersections of thefirst positioning portions 24, i.e., the proximal end of each first connectingrod 252 is connected to the corresponding distal intersection of thefirst positioning portion 24.

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

Thesecond positioning portion 271b is a second positioning rod extending from each of thevalleys 233 of thestoma portion 23 in a direction away from the axial center line of thestoma 21. Specifically, each second positioning rod is connected at its distal end to acorresponding trough 233 and extends proximally and obliquely away from the axis of theostomy 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, thestoma portion 23b is provided with theconductive portions 60, and specifically, theconductive portions 60 are provided on the side of eachwave bar 235 away from the axis of thestoma member 21b, and theconductive portions 60 enclose a circle along the circumferential direction of thestoma portion 23 b. In other embodiments, the spaced wave bars 235 are provided with electricallyconductive portions 60 on the side facing away from the axis of theostomy member 21b, the electricallyconductive portions 60 enclosing a circle in the circumferential direction of the ostomy portion 23 a.

In this embodiment, theconnector 278 is used to connect to a radio frequency power source, so as to transmit radio frequency energy to theconductive part 60 at the perforation, and in order to further concentrate the energy on the atrial septal tissue of thestoma portion 23b, an insulating coating may be coated on the outer surface of the remaining portion of thestoma 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 insulatingfilm 28 is provided between theostomy member 21b and theconductive part 60. Further, the insulatingfilm 28 is located between theconductive portion 60 and thestoma portion 23 b. The insulatingfilm 28 may be, but is not limited to, a teflon film, a polyurethane film, a polyimide film, or the like. Since theostomy portion 23b is isolated from theconductive portion 60 by the insulatingfilm 28, the insulatingfilm 28 not only isolates heat conduction between theconductive portion 60 and theostomy member 21b, i.e. prevents energy from being transferred to theostomy member 21b, thereby concentrating heat on theconductive portion 60 to ablate interatrial septum tissue and improving energy efficiency; and the insulatingfilm 28 can also form an insulating barrier on the side of theconductive part 60 facing the blood, so that the current density passing through the blood is reduced, the heating of theconductive part 60 to the blood is reduced, and the risk of thrombus formation is reduced.

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

The area of theconductive portion 60 orthographically projected onto the insulatingfilm 28 is located within the insulatingfilm 28, that is, the area of the orthographically projected area of theconductive portion 60 on the insulatingfilm 28 is smaller than or equal to the area of the insulatingfilm 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, theconductive portion 60a is at least one ring-shaped electrode provided on the outer wall of thestoma portion 23b, the at least one ring-shaped electrode being wound around one turn in the circumferential direction of thestoma 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 theostomy 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 theostomy member 21b by stitching and/or binding.

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

An insulatingfilm 28 is provided between the openingportion 23b and theconductive portion 60a, and theopening portion 23b and theconductive portion 60a are isolated from each other by the insulatingfilm 28. The insulatingfilm 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 theostomy portion 23b facing theconductive portion 60a is coated with an insulating layer, such as parylene, to insulate theconductive portion 60a and theostomy 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, theconductive 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 theostomy member 21 b. Specifically, the spot-like electrodes are provided at least once in the circumferential direction along the outer wall surface of thestoma portion 23b, and theconductive portion 60b and thestoma member 21b are insulated from each other. The insulation treatment is performed by applying an insulating coating to the outer wall surface of themouthpiece 21b in contact with the spot-like electrode, or by providing an insulatingfilm 28 between theconductive portion 60b and themouthpiece 21 b. The insulating coating may be, but is not limited to, FEP/ETFE/PFA, etc., and the insulatingfilm 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 thestoma 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, theablation electrode 60c is a double turn interrupted ring electrode disposed circumferentially around the outer wall of theostomy member 21b, which is insulated from theostomy member 21 b. Specifically, a double-turn intermittent ring electrode is provided on the outer wall surface of thestoma portion 23b, and an insulatingfilm 28 is provided between the ring electrode and thestoma 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, theablation electrode 60c may be a single turn of intermittent ring-shaped electrode disposed circumferentially around the outer wall of thestoma 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, theablation 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 theostomy member 21 b. Specifically, these rod-like electrodes are provided at least once circumferentially along the outer wall surface of thestoma portion 23b, and theablation electrode 60d is insulated from thestoma member 21 b. The insulation treatment is performed by applying an insulating coating to the outer wall surface of thestoma portion 23b in contact with the rod-shaped electrode, or by providing an insulatingfilm 28 between theablation electrode 60d and thestoma portion 23 b. The insulating coating may be, but is not limited to, FEP/ETFE/PFA, etc., and the insulatingfilm 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 thestoma 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 connectingrod 251 and the second connectingrod 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 astoma portion 23b, anextension portion 25c disposed at the distal end of thestoma portion 23b, and aconnection portion 27 disposed at the proximal end of thestoma portion 23b, wherein theextension portion 25c is connected to thestoma portion 23b by afirst positioning portion 24a, and theconnection portion 27 is connected to thestoma portion 23b by asecond positioning portion 26 a. The structures of the mouth-makingportion 23b and the connectingportion 27 are the same as those in the ninth embodiment, and are not described again.

Thefirst positioning portion 24a includes a plurality of first positioning rods 240a, the plurality of first positioning rods 240a correspond to the plurality ofpeaks 231 one by one, the proximal end of each first positioning rod 240a is connected to thecorresponding 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 thestoma member 21 c. The extendingportion 25c includes a plurality of extendingmembers 253 disposed at the distal end of thefirst positioning portion 24a, the plurality of extendingmembers 253 correspond to the plurality of first positioning rods 240a one-to-one, the proximal end of each extendingmember 253 is connected to the distal end of the corresponding first positioning rod 240a, and the plurality of extendingmembers 253 are arranged along the circumference of the supportingframework 21 to form the extendingportion 25 c. Each of the extendingmembers 253 includes twobranch bars 2530 branched from the radially outermost position of the corresponding first positioning bar 240a, the twobranch bars 2530 are bent obliquely in a direction away from thestoma portion 23b, distal ends of twoadjacent branch bars 2530 of two adjacent extendingmembers 253 meet to form anintersection portion 2532, and a plurality ofintersection portions 2532 extend in a direction of an axis of thestoma 21c to form themouth portion 250. The distal end of eachintersection 2532 is rounded, and in particular, the distal end of eachintersection 2532 is configured as a circular piece. Since the closing-upportion 250 extends toward the axial line of theostomy member 21c and the distal end of eachintersection 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 theextension 253 of theextension 25c is provided with at least one circle of visualization points, and specifically, the distal end of theextension 253 of theextension 25c is inlaid or hot-pressed with the axis of the axial lead of theostomy member 21c for at least one circle of visualization points, so as to facilitate implantation of the atrial septal shunt system. In this embodiment, theintersection portions 2532 are provided with mountingholes 2535, each mountinghole 2535 is provided with a developing point, specifically, each mountinghole 2535 is embedded with a developing point, and the developing points on the plurality ofintersection 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 theextension 253 of theextension 25c, and the developing wire is fixed by means of embedding and hot pressing.

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

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.

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 (19)

Translated fromChinese

1.一种心脏房间隔分流系统，其包括用于形成房间隔上的造口的造口件，其特征在于，所述心脏房间隔分流系统还包括设置于所述造口件的内侧空间的扩充件，所述扩充件内能充盈流体，所述造口件包括用于消融所述造口周围组织的导电部。1. A cardiac atrial septal shunt system, comprising a stoma member for forming a stoma on the atrial septum, wherein the cardiac atrial septal shunt system further comprises a stoma provided in the inner space of the stoma member. The expansion piece can be filled with fluid, and the stoma piece includes a conductive part for ablating the tissue around the stoma.2.根据权利要求1所述的心脏房间隔分流系统，其特征在于，所述造口件包括展开后具有内腔的造口部，所述造口部能径向收缩及膨胀，所述扩充件设置于所述造口部的内腔，当向所述扩充件充盈流体时，所述扩充件能径向膨胀而抵推所述造口部的内周壁，以调节所述造口部的外周壁的直径。2 . The cardiac atrial septal shunt system according to claim 1 , wherein the stoma member comprises a stoma portion having an inner cavity after deployment, the stoma portion can be radially contracted and expanded, and the expansion The stoma is arranged in the inner cavity of the stoma, and when the expansion piece is filled with fluid, the expansion piece can be radially expanded to push against the inner peripheral wall of the stoma, so as to adjust the diameter of the stoma. The diameter of the peripheral wall.3.根据权利要求2所述的心脏房间隔分流系统，其特征在于，所述扩充件包括由高分子材料制成的具有弹性的球囊结构，所述球囊结构的直径大小随着流体的充入而改变。3 . The cardiac atrial septal shunt system according to claim 2 , wherein the expansion piece comprises an elastic balloon structure made of polymer material, and the diameter of the balloon structure varies with the fluid flow. 4 . change by charging.4.根据权利要求2所述的心脏房间隔分流系统，其特征在于，所述心脏房间隔分流系统还包括支撑管，所述支撑管轴向设置于所述造口部的内腔，所述扩充件设置于所述支撑管上，所述扩充件位于所述支撑管与所述造口部之间。4 . The cardiac atrial septal shunt system according to claim 2 , wherein the cardiac atrial septal shunt system further comprises a support tube, the support tube is axially arranged in the lumen of the stoma, and the The expansion piece is arranged on the support tube, and the expansion piece is located between the support tube and the stoma.5.根据权利要求4所述的心脏房间隔分流系统，其特征在于，所述扩充件包括围设于所述支撑管的外壁，所述外壁的近端及远端分别密封连接于所述支撑管，所述外壁与所述支撑管的外周壁围成扩充腔，所述支撑管开设连通所述扩充件的扩充腔的灌注孔。5 . The cardiac atrial septal shunt system according to claim 4 , wherein the expansion piece comprises an outer wall surrounding the support tube, and the proximal end and the distal end of the outer wall are respectively sealed and connected to the support tube. 6 . The outer wall and the outer peripheral wall of the support tube form an expansion cavity, and the support tube defines a perfusion hole that communicates with the expansion cavity of the expansion piece.6.根据权利要求4所述的心脏房间隔分流系统，其特征在于，所述扩充件包括套接于所述支撑管的内壁及连接于所述内壁的近端和远端的外壁，所述内壁与所述外壁围成扩充腔，所述内壁开设注入孔，所述支撑管开设连通所述注入孔的灌注孔。6 . The cardiac atrial septal shunt system according to claim 4 , wherein the expansion piece comprises an inner wall sleeved on the support tube and an outer wall connected to the proximal end and the distal end of the inner wall, and the The inner wall and the outer wall form an expansion cavity, the inner wall is provided with an injection hole, and the support pipe is provided with an injection hole that communicates with the injection hole.7.根据权利要求2所述的心脏房间隔分流系统，其特征在于，所述心脏房间隔分流系统还包括支撑管，所述支撑管对应所述造口部处设置若干分支管，所述分支管以所述支撑管为轴心周向设置，所述扩充件包括分别设置于每一分支管的扩充分支件，每一扩充分支件位于对应的分支管与所述造口部之间。7 . The cardiac atrial septal shunt system according to claim 2 , wherein the cardiac atrial septal shunt system further comprises a support tube, the support tube is provided with a plurality of branch tubes corresponding to the stoma, and the branch tubes The tube is circumferentially arranged with the support tube as the axis, and the expansion piece includes expansion branch pieces respectively arranged on each branch tube, and each expansion branch piece is located between the corresponding branch tube and the stoma.8.根据权利要求7所述的心脏房间隔分流系统，其特征在于，每一扩充分支件包括围设于对应的分支管的外壁，所述外壁的近端及远端分别密封连接于所述分支管，所述外壁与所述分支管的外周壁围成扩充腔，所述支撑管的外周壁上开设连通所述扩充分支件的扩充腔的灌注孔。8 . The cardiac atrial septal shunt system according to claim 7 , wherein each expansion branch comprises an outer wall surrounding the corresponding branch tube, and the proximal end and the distal end of the outer wall are respectively sealed and connected to the outer wall. 9 . A branch pipe, wherein the outer wall and the outer peripheral wall of the branch pipe form an expansion cavity, and the outer peripheral wall of the support pipe is provided with a perfusion hole that communicates with the expansion cavity of the expansion branch piece.9.根据权利要求7所述的心脏房间隔分流系统，其特征在于，每一扩充分支件包括套接于对应的分支管的外周壁的内壁及连接于所述内壁的近端和远端的外壁，所述内壁与所述外壁围成扩充腔，所述内壁开设注入孔，所述分支管的外周壁开设连通所述注入孔的灌注孔。9 . The cardiac atrial septal shunt system according to claim 7 , wherein each expansion branch comprises an inner wall sleeved on the peripheral wall of the corresponding branch tube and a proximal end and a distal end connected to the inner wall. 10 . An outer wall, the inner wall and the outer wall enclose an expansion cavity, the inner wall is provided with an injection hole, and the outer peripheral wall of the branch pipe is provided with an injection hole that communicates with the injection hole.10.根据权利要求2所述的心脏房间隔分流系统，其特征在于，所述造口件还包括设置于所述造口部近端的连接部及设置于所述造口部远端的延伸部，所述连接部和/或所述延伸部的最大直径大于所述造口部直径。10 . The cardiac atrial septal shunt system according to claim 2 , wherein the stoma member further comprises a connecting portion disposed at the proximal end of the stoma portion and an extension disposed at the distal end of the stoma portion. 11 . the maximum diameter of the connecting part and/or the extension part is larger than the diameter of the stoma.11.根据权利要求10所述的心脏房间隔分流系统，其特征在于，所述延伸部包括连接于所述造口部的远端的第一定位部，所述连接部包括连接于所述造口部的近端的第二定位部，当所述造口部位于所述房间隔的穿孔内时，所述第一定位部及所述第二定位部分别定位于所述房间隔相对的两侧面。11. The cardiac atrial septal shunt system of claim 10, wherein the extension portion comprises a first positioning portion connected to the distal end of the stoma portion, the connecting portion comprising a first positioning portion connected to the stoma portion The second positioning portion at the proximal end of the mouth portion, when the stoma portion is located in the perforation of the interatrial septum, the first positioning portion and the second positioning portion are respectively positioned at two opposite sides of the interatrial septum. side.12.根据权利要求11所述的心脏房间隔分流系统，其特征在于，所述延伸部的远端设置有向所述造口件的轴心线方向延伸的收口部，所述收口部还包括若干延伸件，若干延伸件沿所述第一定位部的周向排列一圈，每一延伸件的远端朝所述造口件的轴心线倾斜。12 . The cardiac atrial septal shunt system according to claim 11 , wherein the distal end of the extension portion is provided with a cuff portion extending in the direction of the axis line of the stoma member, and the cuff portion further comprises: 13 . A plurality of extension pieces are arranged in a circle along the circumference of the first positioning portion, and the distal end of each extension piece is inclined toward the axis line of the stoma piece.13.根据权利要求12所述的心脏房间隔分流系统，其特征在于，每一延伸件的远端外周面设置成圆弧面或倒圆角，或者延伸件的远端设置成圆形片或球体结构。13. The cardiac atrial septal shunt system according to claim 12, wherein the outer peripheral surface of the distal end of each extension piece is set as a circular arc surface or a rounded corner, or the distal end of the extension piece is set as a circular sheet or sphere structure.14.根据权利要求11所述的心脏房间隔分流系统，其特征在于，所述导电部是设置于所述造口部、所述第一定位部及所述第二定位部的三者之一上的消融电极；或者所述导电部是分别设置于所述造口部、所述第一定位部及所述第二定位部的三者之二上消融电极；或者所述导电部是分别设置于所述造口部、所述第一定位部及所述第二定位部上消融电极。14 . The cardiac atrial septal shunt system according to claim 11 , wherein the conductive portion is provided on one of the stoma portion, the first positioning portion and the second positioning portion. 15 . or the conductive parts are respectively provided on the ablation electrodes on two of the stoma part, the first positioning part and the second positioning part; or the conductive parts are respectively provided Electrodes are ablated on the stoma portion, the first positioning portion and the second positioning portion.15.根据权利要求14所述的心脏房间隔分流系统，其特征在于，所述造口件是由导电材料制成的支撑骨架，所述消融电极为所述支撑骨架上未做绝缘处理的部分支撑骨架，所述支撑骨架上除消融电极外其余所有的外表面涂设绝缘涂层或者固定绝缘套管。15 . The cardiac atrial septal shunt system according to claim 14 , wherein the stoma is a support frame made of conductive material, and the ablation electrode is a part of the support frame without insulation treatment. 16 . A support skeleton, on which all other outer surfaces except the ablation electrode are coated with an insulating coating or fixed with an insulating sleeve.16.根据权利要求15所述的心脏房间隔分流系统，其特征在于，所述消融电极为环状电极，所述环状电极沿所述造口件的外壁面周向设置连接的或间断的至少一圈；或者所述消融电极是若干点状电极或者条状电极，若干所述若干点状电极或者条状电极沿所述造口件的外壁面周向设置至少一圈。16 . The cardiac atrial septal shunt system according to claim 15 , wherein the ablation electrode is a ring-shaped electrode, and the ring-shaped electrode is provided with connected or discontinuous electrodes along the circumference of the outer wall surface of the stoma member. 17 . At least one circle; or the ablation electrodes are several point electrodes or strip electrodes, and the several point electrodes or strip electrodes are arranged at least one circle along the circumference of the outer wall surface of the stoma.17.根据权利要求16所述的心脏房间隔分流系统，其特征在于，所述消融电极与所述造口件之间设置绝缘膜；或者所述造口件的外表面对应所述消融电极涂设绝缘涂层。17 . The cardiac atrial septal shunt system according to claim 16 , wherein an insulating film is provided between the ablation electrode and the stoma member; or an outer surface of the stoma member is coated corresponding to the ablation electrode. 18 . Provide insulating coating.18.根据权利要求16所述的心脏房间隔分流系统，其特征在于，所述造口部、所述第一定位部及所述第二定位部的三者之一上设置有至少一圈显影点或显影丝；或者所述造口部、所述第一定位部及所述第二定位部的三者之二上分别设置有至少一圈显影点或显影丝；或者所述造口部、所述第一定位部及所述第二定位部上分别设置有至少一圈显影点或显影丝。18 . The cardiac atrial septal shunt system according to claim 16 , wherein at least one circle of imaging is provided on one of the stoma portion, the first positioning portion and the second positioning portion. 19 . dots or developing wires; or at least one circle of developing dots or developing wires are respectively set on two of the stoma portion, the first positioning portion and the second positioning portion; or the stoma portion, The first positioning portion and the second positioning portion are respectively provided with at least one circle of developing points or developing wires.19.根据权利要求2所述的心脏房间隔分流系统，其特征在于，所述扩充件于靠近所述导电部处开设若干喷洒孔，若干所述喷洒孔用于将所述流体物喷洒到邻近所述导电部周围的血液或组织。19 . The cardiac atrial septal shunt system according to claim 2 , wherein the expansion member is provided with a plurality of spray holes near the conductive portion, and the plurality of spray holes are used to spray the fluid to adjacent areas. 20 . blood or tissue around the conductive portion.

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