CN111166462A

CN111166462A - Interatrial septum stoma device and interatrial septum stoma system with improved ablation effect

Info

Publication number: CN111166462A
Application number: CN201811336604.8A
Authority: CN
Inventors: 王永胜; 吴俊飞; 董元博; 王坤
Original assignee: Hangzhou Nuosheng Medical Technology Co ltd
Current assignee: Hangzhou Nuosheng Medical Technology Co ltd
Priority date: 2018-11-09
Filing date: 2018-11-09
Publication date: 2020-05-19

Abstract

The present invention provides an atrial septostomy system with improved ablation effect, which comprises an atrial septostomy device, a stoma device control mechanism for controlling the atrial septostomy device, and a radio frequency power supply, the radio frequency power supply passing through the stoma device The control mechanism is electrically connected to the ablation piece of the atrial septostomy device, the atrial septostomy device includes a support frame for propping up the perforation on the atrial septum, the support frame is provided with at least one ablation piece, the An ablation member contacts the atrial septum and is used to ablate the atrial septum, and the device cannot ablate blood or tissue other than the ablation member. The present invention also relates to an atrial septostomy device of the atrial septostomy system.

Description

Interatrial septum stoma device and interatrial septum stoma system with improved ablation effect

Technical Field

The invention relates to the technical field of interventional medical instruments, in particular to an interatrial septum ostomy device for improving ablation effect through percutaneous intervention and an interatrial septum ostomy system provided with the interatrial septum ostomy device.

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 reconstruction 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, is expensive and difficult to obtain, and is not marketed in China. Heart transplantation is the final solution, but the source of donors is very limited and expensive.

On the other hand, pulmonary hypertension is a group of diseases characterized by progressive increase of pulmonary arterial system circulatory resistance, and its pathological changes include pulmonary vasoconstriction and remodeling, abnormal proliferation of pulmonary vascular smooth muscle and endothelial cells, in-situ thrombosis, etc., which ultimately leads to death by exhaustion of right heart function. At present, with the research on the pathogenesis of pulmonary hypertension, the treatment method is more and more. The treatment scheme of the pulmonary hypertension is characterized by individuation and systematization, and never can be treated by a single drug, and the treatment mode comprises the following steps: general therapy, non-specific drug therapy, targeted drug therapy, NO inhalation therapy, gene therapy, intervention and surgical therapy. In the later stage of the disease of the pulmonary hypertension patient, after the comprehensive treatment, the effect is not obvious, the survival rate is low, and the prognosis is very poor, at the moment, surgical treatment methods such as interatrial septum fistulization, lung transplantation, cardiopulmonary combination transplantation and the like can be tried, so that the life of the patient is saved, but the treatment methods have a plurality of factors such as high operation risk, donor deficiency, transplantation rejection, high subsequent treatment cost and the like.

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 of stoma shrinkage and even closing, the prior art provides an ostomy support, and respectively discloses 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.

Disclosure of Invention

An object of the present invention is to provide an interatrial septum ostomy device in which an ostomy is not easily blocked and an ablation effect is improved, and an interatrial septum ostomy system provided with the interatrial septum ostomy device.

In order to solve the technical problem, the invention provides an interatrial septum ostomy device for improving ablation effect, which comprises a supporting framework for expanding perforation on the interatrial septum, wherein at least one ablation piece is arranged on the supporting framework, the ablation piece is contacted with the interatrial septum and is used for ablating the interatrial septum, and blood or tissue can not be ablated on the device except the ablation piece.

The invention also provides an interatrial septum stoma system, which comprises an interatrial septum stoma device, an ostomy device control mechanism for controlling the interatrial septum stoma device and a radio frequency power supply, wherein the radio frequency power supply is electrically connected with an ablation piece of the interatrial septum stoma device through the ostomy device control mechanism, the interatrial septum stoma device comprises a supporting framework for opening a perforation on the interatrial septum, at least one ablation piece is arranged on the supporting framework, the ablation piece is contacted with the interatrial septum and is used for ablating the interatrial septum, and blood or tissues can not be ablated on the device except the ablation piece.

The interatrial septum ostomy device of the interatrial septum ostomy system comprises a supporting framework for expanding perforation on the interatrial septum and an ablation piece arranged on the supporting framework, wherein the ablation piece is used for ablating interatrial septum tissues near the stoma, and blood or tissues cannot be ablated on the device except the ablation piece. Therefore, the supporting framework can prop up the perforation on the interatrial septum to form the stoma, and the interatrial septum tissue around the stoma is ablated through the ablation piece, the shape of the stoma after being processed by the interatrial septum stoma device is more regular and is not easy to block, the smoothness of the stoma can be kept, and the blood shunting of the left and right atrium rooms 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 representation of the structure of a first embodiment of a compartmental ostomy system according to the first embodiment of the invention;

FIG. 2 is an enlarged view of the septal ostomy device of the septal ostomy system of FIG. 1;

FIG. 3 is an expanded schematic view of the wire assembly of the interatrial septum ostomy device of FIG. 2;

FIG. 4 is a cross-sectional view of one of the leads of the lead assembly of FIG. 3;

fig. 5 is an enlarged schematic view of portion V in fig. 1.

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

FIG. 7 is a cross-sectional view taken along line VII-VII of FIG. 5;

figures 8 to 11 are schematic views illustrating the operation of the septal stoma system in use according to the first embodiment of the present invention.

FIG. 12 is a schematic view of an ablation occluding device of a interatrial septum stoma system according to a second embodiment of the present invention;

FIG. 13 is a front partial cross-sectional view of the ablation occluding device of FIG. 12;

FIG. 14 is a schematic view of an ablation occluding device of a interatrial septum stoma system according to a third embodiment of the present invention;

FIG. 15 is a schematic view of an ablation occluding device of a interatrial septum stoma system according to a fourth embodiment of the present invention;

FIG. 16 is a schematic view of an ablation occluding device of a interatrial septum stoma system according to a fifth embodiment of the present invention;

FIG. 17 is a schematic representation of the construction of a septal stoma system according to a sixth embodiment of the present invention;

FIG. 18 is a schematic view of the ablation occluding device of the interatrial septum ostomy system of FIG. 17 with the insulating film removed;

FIG. 19 is a schematic representation of the construction of a septal stoma system according to a seventh embodiment of the present invention;

FIG. 20 is a schematic view of a septal stoma system provided in accordance with an eighth embodiment of the present invention;

FIG. 21 is a schematic view of a septal stoma system according to a ninth embodiment of the present invention;

FIG. 22 is a schematic view of the ablation occluding device of the interatrial septum stoma system of FIG. 21 with the insulating film removed;

FIG. 23 is a sectional view taken along line XXIII-XXIII in FIG. 21;

fig. 24 is an enlarged view of the XXIV portion in fig. 23;

FIG. 25 is a schematic representation of the construction of a septal stoma system according to a tenth embodiment of the present invention;

FIG. 26 is a schematic view of the ablation occluding device of the interatrial septum ostomy system of FIG. 25 with the insulating film removed;

figure 27 is a schematic view of a compartmental ostomy system according to an eleventh embodiment of the invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying 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 derived by a person skilled in the art from the embodiments given herein without any inventive step, 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 referring to the end of the interatrial septum location that is closer to the heart, and the "distal" end referring to the end of the interatrial septum location that is further from the heart. Axial refers to the direction of the 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 and 2, fig. 1 is a schematic structural view of a first embodiment of a interatrial septum ostomy system according to a first embodiment of the invention; fig. 2 is an enlarged view of the interatrial septum ostomy device of the interatrial septum ostomy system of fig. 1. The present invention provides a interatrial septum ostomy system 100 comprising an interatrial septum ostomy device 20 and an ostomy device control mechanism 50 for controlling the interatrial septum ostomy device 20. The interatrial septum stoma device 20 includes a support framework 21 for distracting the perforation in the interatrial septum to distract the perforation to form the stoma. The support frame 21 is provided with at least one ablating member 210, and the ablating member 210 contacts the atrial septum tissue adjacent to the perforation on the atrial septum and is used for ablating the atrial septum tissue, i.e. the atrial septum ostomy device 20 cannot ablate blood or tissue except for the ablating member 210.

In this embodiment, the ablation member 210 includes at least one electrode for ablation, at least one of the electrodes may be an external electrode, or an electrode directly disposed on the supporting frame 21, at least one of the electrodes is electrically connected to the rf power source, and at least one of the electrodes receives energy of the rf power source and is used for ablating atrial septal tissue around the stoma.

The interatrial septum ostomy device 20 of the interatrial septum ostomy system 100 comprises a supporting framework 21 for expanding perforation holes on the interatrial septum and an ablation piece 210 arranged on the supporting framework 21, wherein the ablation piece 210 is used for ablating the interatrial septum tissues around the stoma, and the supporting framework 21 is subjected to insulation treatment in the area corresponding to the ablation piece 210. Therefore, the supporting framework 21 can prop open the perforation on the interatrial septum to form the stoma, and is right through the ablation piece 210 the interatrial septum tissue around the stoma is ablated, so the shape of the stoma after the interatrial septum ostomy device 20 is processed is more regular, and is not easy to block, the smoothness of the stoma can be kept, and then the blood shunting in the left and right atrium is smooth.

An insulating film 27 is disposed between the supporting framework 21 and the ablating member 210, and the insulating film 27 may be, but is not limited to, a teflon film, a polyurethane film, a polyimide film, or the like. Because the supporting framework 21 and the ablating part 210 are isolated by the insulating film 27, the insulating film 27 can not only isolate the heat conduction between the ablating part 210 and the supporting framework 21, i.e. prevent the energy from being transferred to the supporting framework 21, thereby concentrating the heat on the ablating part 210 to ablate the interatrial septum tissue and improving the energy utilization rate; and the insulating film 27 can also form an insulating barrier on the blood-facing side of the ablating member 210, thereby reducing the current density through the blood, reducing the heating of the blood by the ablating member 210, and reducing the risk of thrombosis.

In this embodiment, the insulation film 27 is disposed on the outer wall surface of the support frame 21 corresponding to the ablation member 210. Specifically, the insulating film 27 is connected to the outer wall surface of the supporting frame 21 by sewing or gluing.

In other embodiments, the insulating film 27 may also be disposed on a surface of the ablation member 210 corresponding to the support frame 21, specifically, the insulating film 27 is adhered to an outer surface of the ablation member 210 facing the support frame 21 by an adhesive.

In other embodiments, the surface of the supporting frame 21 corresponding to the ablating member 210 is coated with an insulating coating, or the surface of the ablating member 210 corresponding to the supporting frame 21 is coated with an insulating coating, which may be, but is not limited to, a parylene coating, a teflon coating, a polyurethane coating, or a polyimide coating. Because the support framework 21 and the ablation piece 210 are insulated by the insulating coating, the energy of the ablation piece 210 is not easy to be conducted to the support framework 21, the energy is concentrated on the ablation piece 210 to ablate the interatrial septum, and the energy utilization rate is improved.

As shown in fig. 2, the support frame 21 is a self-expanding ostomy device, and the support frame 21 may be a resilient metal stent or a resilient non-metal stent. In this embodiment, the supporting framework 21 is a nickel alloy stent, and when the interatrial septum ostomy device 20 is delivered through the sheath, the diameter of the supporting framework 21 can be contracted to a smaller state so as to be delivered in the sheath; when the interatrial septum ostomy device 20 is released in the heart, the support skeleton 21 may automatically expand to the desired shape and size, so that the support skeleton 21 may prop open the stoma at the interatrial septum, i.e. the part of the support skeleton 21 in the stoma exerts a radial support effect on the tissue of the stoma.

The supporting framework 21 can be formed by cutting a nickel alloy pipe or weaving a nickel alloy wire. The density of the net structure of the supporting frame 21 is set as required. In this embodiment, the rhombic structure units are continuously and circumferentially arranged in a circle to form the supporting framework 21, and the overall shape of the supporting framework may be various applicable shapes such as a straight cylinder shape, a disk shape, a cone shape, and the like, which is not limited herein.

The outer wall surface and the inner wall surface of the supporting framework 21 are coated with insulating coatings, and the insulating coatings can be, but are not limited to, polytetrafluoroethylene coatings, polyurethane coatings, polyimide coatings, or the like. In this embodiment, the outer wall surface and the inner wall surface of the supporting framework 21 are coated with polytetrafluoroethylene coatings.

In other embodiments, the nickel alloy wire of the supporting framework 21 may also be sleeved with an insulating sleeve.

In the state where the interatrial septum ostomy device 20 is completely released, the supporting framework 21 comprises a cylindrical opening portion 211, a first positioning portion 213 disposed at one end of the opening portion 211, an extending portion 214 disposed at one end of the opening portion 211 opposite to the first positioning portion 213, and a recovery portion 215 disposed at one end of the extending portion 214 away from the opening portion 211. The opening part 211 is used for opening the perforation on the atrial septum to form a stoma; the first positioning portion 213 is used for positioning the support frame 21 into the atrial septum stoma; the extension 214 can prevent the distraction of the distraction portion 211 from the stoma when the distraction portion 211 extends distally, which would result in failure to dilate the tissue at that location, so that the extension 214 can compensate for the adverse effect of the distraction portion 211 deviating from the stoma.

In this embodiment, when the supporting frame 21 is completely released, the expanding portion 211 can radially expand after being released, so as to uniformly expand the perforation on the atrial septum, and expand the perforation on the atrial septum to form a hole. Specifically, the expanding portion 211 is a ring-shaped structure with a wave shape arranged circumferentially continuously, the proximal end of the first positioning portion 213 is connected to the expanding portion 211, that is, the first positioning portion 213 is connected to a wave peak of the ring-shaped structure, and the distal end of the first positioning portion 213 extends radially to form a conical surface or a circular surface. The proximal end of the extension 214 is connected with the expanding part 211, namely, the extension 214 is connected with the wave trough of the wave-shaped structure, and the distal end of the extension 214 extends axially; the proximal end of the recovery portion 215 is connected to the extension portion 214, and the distal end of the recovery portion 215 extends axially and merges.

In other embodiments, the distracting portion 211 may be a mesh stent, a rod stent, a multi-layered wave stent, or a combination thereof forming a tubular or ring structure. The reticular stent has an obvious warp-weft staggered structure or a repeated unit lattice structure, can adopt a weaving mode or a cutting mode, and the warp-weft staggered parts can slide relative to each other or be fixed with each other; the wave-shaped support is provided with a multi-ring wave-shaped structure which comprises wave crests, wave troughs and wave rods, wherein the wave rods adjacent in the circumferential direction are connected at the near end to form the wave crests, and the wave rods at the far end are connected to form the wave troughs; tubular structures are understood to extend axially a distance, for example, an axial dimension greater than or equal to the outer diameter of the tubular structure, and an axial dimension of the annular structure is slightly smaller relative to the tubular structure, typically less than the outer diameter of the annular structure; two axially adjacent circles of wave structures can be connected through the film, or a plurality of circles of film can be fixedly connected on the tubular film; the rod-shaped support is provided with a plurality of axially extending support rods, the support rods surround to form a tubular structure, and the support rods can be connected with each other through a film of a high polymer or fixedly connected to the tubular film.

The shape of the expanding portion 211 can be various, for example, the expanding portion 211 can be a curved surface with a concave or/and convex outer side wall, a cylinder, an elliptical cylinder or a combination thereof. The curved surface shape is a closed curved surface structure formed in the circumferential direction, the positions of the outer protrusion and the inner recess can be set as required, the outer protrusion structure or the inner recess structure can be formed independently, and the outer protrusion structure or the inner recess structure can be combined to be arranged on the same opening part 211. The convex structure is as follows: disc, table shape etc., concave structure is as follows: the waist drum shape, which adopts a cylindrical structure in the embodiment, forms an integral cylindrical structure with the straight cylindrical smooth transition of the supporting framework 21. The axial length of the expanding portion 211 is set according to actual needs, and generally matches with the thickness of the atrial septum.

The retrieving portion 215 is conical, the proximal end of which is connected to the extension 214, the distal end of the retrieving portion 215 is joined to a connecting member 2152, and the connecting member 2152 is used for connecting the ostomy device control mechanism 50. Specifically, the recycling part 215 includes a plurality of extension pieces 2151 connected between the extension part 214 and the connection part 2152, and the connection part 2152. The connector 2152 is a tubular structure having a released outer diameter that is less than the released outer diameter of the extension 214. The connecting ring 2152 is provided with a plurality of fixing holes 2154 along the circumferential direction, and the fixing holes 2154 are used for fixing the connecting ring 2152 to the ostomy device control mechanism 50. In this embodiment, the ablation part 210 is disposed on the expansion part 211, specifically, the ablation part 210 is disposed on the outer wall surface of the expansion part 211, the insulating film 27 is disposed between the ablation part 210 and the outer wall surface of the expansion part 211, and the region of the ablation part 210 projected onto the insulating film 27 is located in the insulating film 27, that is, the area of the projection of the ablation part 210 on the insulating film 27 is smaller than or equal to the area of the insulating film 27.

In this embodiment, the ablation member 210 is an external electrode, specifically, the ablation member 210 is a monopole electrode, the monopole electrode is connected with the radio frequency source, and is used in cooperation with an additional neutral electrode plate to ablate the atrial septal tissue. The external electrode refers to an electrode that is attached to the support frame 21 by means of gluing, sewing, or the like, independently from the electrode of the support frame 21.

Referring to fig. 2-4, the ablating member 210 includes a plurality of flexible wires 2102, an ablating portion 2104 disposed at a proximal end of each of the wires 2102, and a connecting portion 2105 disposed at a distal end of each of the wires 2102. Each of the wires 2102 is sewn to the outer wall surface of the support frame 21 by gluing or sewing. The ablation part 2104 of each wire 2102 is located on the outer wall surface of the distraction part 211, and the ablation parts 2104 are arranged at least one turn along the circumferential direction of the distraction part 211; the connecting portion 2105 of each wire 2102 extends axially out of the connector 2152 and is electrically connected to an rf source.

As shown in fig. 4, in this embodiment, the conductive wires 2102 include a flexible metal layer 2106, an insulating layer 2107 covering the metal layer 2106, and an adhesive layer 2108 adhered to the insulating layer 2107 of the conductive wires 2102 for adhering the conductive wires 2102 to the supporting frame 21. The ablation portion 2104 has the proximal end of the wire 2102 removed from the insulation layer 2107 on the side facing away from the adhesive layer 2108; the connecting portion 2105 is formed by removing the insulating layer 2107 and the adhesive layer 2108 from the distal end of the wire 2102.

The insulating film 27 is further arranged between the ablation part 2104 and the stretching part 21, specifically, the insulating film 27 is an annular structure covering a circle of the outer wall surface of the stretching part 211, and the insulating film 27 is sewn on the outer wall surface of the stretching part 211 through a seam for a circle so that the ablation part 2104 and the stretching part 211 are insulated from each other.

Referring to figures 1, 5 and 6, the ostomy device control mechanism 50 includes a pusher 52, an outer sheath assembly 54, and a control handle 56. The pushing member and the interatrial septum ostomy device can be detachably connected or fixedly connected as a whole, in this embodiment, the pushing member 52 and the interatrial septum ostomy device 20 are fixedly connected as a whole, a wire 521 is arranged in the pushing member 52, and the wire 521 is electrically connected with a wire 2105 of the interatrial septum ostomy device 20.

The pushing element 52 includes a double lumen tube 520 and a connecting sleeve 523 disposed over the outer wall of the proximal end of the double lumen tube 520. Specifically, an accommodating opening 5202 is circumferentially formed in the outer wall surface of the proximal end of the double-lumen tube 520, the connecting sleeve 523 is sleeved on the double-lumen tube 520 and is accommodated in the accommodating opening 5202, and at this time, the outer surface of the connecting sleeve 523 is aligned with the outer surface of the double-lumen tube 520. The dual lumen tube 520 is made of polyethylene, and the dual lumen tube 520 includes a first cavity 5201 and a second cavity 2503 extending axially. The first cavity 5201 is used for placing a sheath core, and the second cavity 2503 is used for accommodating a lead 521. The proximal end of the pusher 52 is mechanically connected to the connector 2152 at the distal end of the septal ostomy device 20. Specifically, the connecting sleeve 523 is a tube body made of conductive metal, the proximal end of the connecting sleeve 523 is sleeved on the distal end of the connecting member 2152, the proximal end of the wire 521 inside the pushing member 52 passes through the wall of the double lumen tube 520 and then is welded on the connecting sleeve 523, and the distal end of the wire 521 extends along the second cavity 2503 until being connected to the radio frequency power supply. The connection portion 2105 of the flexible wire 2102 of the ablation member 210 is welded to the outer wall surface of the connection sleeve 523.

The connecting sleeve 523 and the connecting piece 2152 are further sleeved with a protective tube 527, the protective tube 527 is made of insulating materials such as polytetrafluoroethylene, polyurethane or polyimide, the near end of the protective tube 527 is sleeved on the outer wall surfaces of the connecting sleeve 523 and the connecting piece 2152, and the far end of the protective tube 527 extends backwards from the near end of the pushing piece 52 until the rear part of the connecting sleeve 523 is covered by a certain length. At this time, the connection portion 2105 of each wire 2102 of the ablation member 210 is located between the connection sleeve 523 and the protection tube 527. All materials at the connecting sleeve 523 are also fused together, and the welding part is completely fused inside the materials, so that the safety and reliability of the electrical connection are ensured.

As shown in fig. 1, the outer sheath assembly 54 includes a sheath 540 having a sheath lumen 541, and a sheath core 543. The pushing member 52 is located in the sheath lumen 541, and the sheath core 543 is located in the first cavity 5201 of the pushing member 52. The sheath core 543 comprises a PEEK tube 5432 with a cavity, and a tip 5434 disposed at the front end of the PEEK tube 5432 and matching with the sheath tube 540. The PEEK tube 5432 is received in the first cavity 5201 of the pusher 52, and the plug 5434 serves as a guide when the atrial septal ostomy device 20 is inserted into the perforation of the atrial septum.

The rear ends of the pushing piece 52, the sheath tube 540 and the sheath core 543 are respectively connected with the control handle 56. The distal end to which the control handle 56 is connected is provided with a connector 562 for connection to a radio frequency power source. The distal end of the lead 521 of the pushing member 52 is electrically connected to the connector 562. The control handle 56 is provided with independent moving mechanisms, so that the pushing member 52, the sheath tube 540 and the sheath core 543 can move independently.

Referring to fig. 1, fig. 2 and fig. 8 to fig. 11, in the embodiment, the interatrial septum ostomy device 20, the pushing member 52, the sheath core 543, the sheath tube 540 and the control handle 56 are a complete system, and the operation flow of the interatrial septum ostomy system of the embodiment is as follows:

puncturing the atrial septum 601 by using a puncturing mechanism, delivering a guide wire into the left superior pulmonary vein 605 after puncturing, and withdrawing a puncturing kit;

connect the connector 562 at the proximal end of the handle to a radio frequency power source (rf power source) and push the interatrial ostomy device 20 pre-loaded in the sheath 540 along the guide wire into the body with the sheath's front end in the left atrium 606;

the sheath 540 is withdrawn to completely sheath the first positioning portion 213 of the interatrial septum ostomy device 20, and the first positioning portion 213 is completely opened, and whether the first positioning portion 213 is completely opened is determined by ultrasound or DSC. The distal end of the sheath 540 must be maintained within the left atrium during the procedure. Then keeping the instruments from moving relatively and pulling the sheath 540 backwards to make the first positioning part 213 cling to the surface of the atrial septum 601 facing the left atrium;

withdrawing the sheath 540 to fully sheath the dilating portion 211 of the interatrial septum stoma device 20, and dilating the interatrial septum 601 by a small hole as determined by ultrasound or DSC, i.e. forming the stoma 603 on the interatrial septum 601;

the ablating member 210 is observed and brought into good contact with the tissue of the atrial septum 601, then the heating parameters are set (e.g., power 30W, duration 120S), and then heating is initiated.

After the heating is stopped, the sheath 540 is pushed forward, the retracting portion 215 and the extending portion 214 are retracted to a smaller size and accommodated in the sheath 540, and the sheath 540 is pushed forward, so that the expanding portion 211 and the first positioning portion 213 are retracted to the sheath completely and are retracted integrally. The stoma 603 is then measured by ultrasound or DSC for clinical requirements.

The opening part 211 of the atrial septum ostomy device 20 of the atrial septum ostomy system 100 in the embodiment opens the through hole on the atrial septum to form the stoma, and the ablation piece 210 on the opening part 211 can eliminate the tissue on the inner wall surface of the stoma, so that the endothelial near the stoma can be prevented from climbing to block the stoma, and the smoothness of the stoma can be kept; secondly, the insulating film 27 can form an insulating barrier between the ablation part 210 and the side facing the blood, so that the current density passing through the blood is reduced, the heating of the blood by the current is reduced, and the risk of thrombus formation is reduced; in addition, the interatrial septum ostomy device 20 can be retrieved after the stoma is completed, i.e. the interatrial septum ostomy device 20 need not remain on the interatrial septum, thereby avoiding the formation of emboli due to the falling off of the instrument.

Referring to fig. 12 and 13 together, fig. 12 is a schematic structural view of an ablation occlusion device of an interatrial septum ostomy system according to a second embodiment of the invention; figure 13 is a front partial cross-sectional view of the ablation occluding device of figure 12. The second embodiment of the present invention provides an ablation occlusion device having a structure similar to that of the first embodiment, except that: in the second embodiment, the supporting frame 21 of the atrial septal ostomy device 20a is also a self-expanding nickel alloy stent, and the atrial septal ostomy device 20a also includes a cylindrical distracting portion 211, a first positioning portion 213, an extending portion 214, and a recovery portion 215 in a completely released state, wherein the first positioning portion 213 is located at one end of the distracting portion 211, and the extending portion 214 is located at one end of the distracting portion 211 away from the first positioning portion 213.

The proximal end of the recycling portion 215 is connected to the end of the extending portion 214 away from the opening portion 211, and the distal end of the recycling portion 215 is contracted to the connecting member 2152. The connecting piece 2152 is cylindrical, a positioning piece 2155 is arranged in the connecting piece 2152, and the positioning piece 2155 is glued, clamped or screwed into the connecting piece 2152. In this embodiment, the positioning member 2155 is a metal conductive member, specifically, the positioning member 2155 is a metal nut, an internal thread is disposed on an inner surface of the connecting member 2152, and the positioning member 2155 is screwed into the connecting member 2152. The middle part of the positioning member 2155 is axially provided with a screw hole 2157, and the screw hole 2157 is used for connecting the pushing member 52. The positioning member 2155 and the connecting member 2152 are insulated from each other.

In other embodiments, the positioning member 2155 may be in interference fit with the connecting member 2152, so that the positioning member 2155 is clamped in the connecting member 2152; the positioning member 2155 may also be adhesively attached within the connector 2152.

In this embodiment, one end of the flexible wire 2102 of the supporting framework 21 is electrically connected to the ablation element 210a, and the other end of the flexible wire 2102 is electrically connected to the positioning element 2155. Specifically, the flexible wire 2102 is located in the supporting framework 21, one end of the flexible wire 2102 passes through the supporting framework 21 and is welded to the ablation part 210a, the other end of the flexible wire 2102 is welded to the positioning part 2155, and the positioning part 2155 is electrically connected to a radio frequency power source through a wire in the pushing member 52.

In other embodiments, the positioning member 2155 may also be made of a non-conductive material, the positioning member 2155 is axially provided with a threading hole, and one end of the flexible lead 2102 of the support frame 21, which is far away from the ablation member 210a, passes through the threading hole and then is directly electrically connected to the rf power supply.

The opening portion 211 is provided with a plurality of through holes 2112, and the through holes 2112 are arranged one turn in the circumferential direction of the opening portion 211. One end of the flexible wire 2102 is electrically connected to the ablation member 210a after passing through one of the through holes 2112. The other through holes 2112 are provided with visualization marks 2114, that is, these visualization marks 2114 surround the distracting portion 211 once to facilitate the implantation and positioning of the supporting framework 21. The development marks 2114 are provided in the corresponding through-holes 2112 by mechanical, welding, or adhesion. The material of the development mark 2114 may be selected from, but is not limited to: gold, platinum-tungsten, palladium, platinum-iridium, rhodium, tantalum, or alloys or composites of these metals.

The first positioning portion 213 is a disk-shaped structure formed by radiating radially from a connection point connecting the end edges of the expanding portion 211, and the diameter of the disk-shaped structure is larger than that of the expanding portion 211. In this embodiment, the first positioning portion 213 is a circular single-layer planar structure, which can be used as a positioning structure for fixing the position of the stretching portion 211. When the opening part 211 is inserted into the stoma of the interatrial septum, the first positioning part 213 faces the outer surface of the opening part 211 and abuts against the outer circumferential surface of the interatrial septum, so as to prevent the opening part 211 from deviating from the stoma position of the interatrial septum.

Further, the first positioning portion 213 further includes an outer edge tilting structure, and the outer edge tilting structure is a smooth transition bending from the outer edge portion of the first positioning portion 213 to the side away from the stretching portion 211, so as to avoid damaging the atrial tissue.

The planar structure of the first positioning portion 213 is at least partially conformed to the surface of the interatrial septum facing the left atrium, and the ablating member 210a is positioned between the first positioning portion 213 and the surface of the interatrial septum facing the left atrium such that the ablating member 210a contacts the surface of the interatrial septum facing the left atrium. The ablating member 210a is at least one ring of connected or spaced ring electrodes arranged along the circumference of the opening portion 211, and the ring electrodes are external electrodes. In this embodiment, the ablating member 210a is a ring-shaped electrode disposed around the opening portion 211, and the radial distance between the ring-shaped electrode and the opening portion 211 can be set to 0-5 mm, preferably 3 mm.

In particular, the ablating member 210a is a continuous loop of flexible, highly elastic metal wire. Such as a nickel titanium multi-strand wire or a nickel titanium multi-strand wire wrapped by a gold spring. The ablating member 210a may be attached to the first positioning portion 213 by stitching and/or binding. One end of the conductive wire 2102 is soldered to the ring electrode, and the other end is electrically connected to the positioning member 2155.

The inner and outer surfaces of the supporting frame 21 are coated with an insulating layer, such as parylene insulating coating, so that the ablation member 210a and the supporting frame 21 are insulated from each other. Further, an insulating film 27a is provided between the ablating member 210a and the first positioning portion 213. Specifically, the insulating film 27a is provided in a ring-shaped structure, and the insulating film 27a includes a first ring-shaped insulating film 271 covering one circumference of the first positioning portion 213 adjacent to the spreader portion 211, and a second ring-shaped insulating film 273 covering one circumference of the spreader portion 211 adjacent to the first positioning portion 213. The ablation piece 210a and the first positioning part 213 can be isolated by using the insulating film 27a, so that not only can the heat conduction between the first positioning part 213 and the supporting framework 21 be isolated, and the energy is prevented from being transmitted to the supporting framework 21, so that the energy is concentrated on the ablation piece 210a, the tissues on the surface of the interatrial septum facing the left atrium and around the stoma are ablated, and the energy utilization rate is improved; and the insulating film 27a can form an insulating barrier on the side of the ablating member 210a facing blood, so that the density of current passing through the blood is reduced, the heating of the blood by the current is reduced, and the risk of thrombus formation is reduced.

In other embodiments, the insulating film 27a may include only the first annular insulating film 271 covering one circumference of the first positioning portion 213 adjacent to the spreader portion 211, that is, the insulating film 27a may omit the second annular insulating film 273. The first annular insulating film 271 is used to isolate the ablating member 210a from the first positioning portion 213.

The securing member 2155 is attached to the pusher member, i.e., the proximal end of the pusher member may be threaded onto the securing member 2155, i.e., the securing member 2155 is attached to the pusher member through the threaded hole 2157 of the securing member 2155. The wire in the pusher is electrically connected to the positioning member 2155, such that the ablating member 210a is electrically connected to the rf power source through the flexible wire 2102, the positioning member 2155, and the wire in the pusher.

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

The opening part 211 of the atrial septum ostomy device 20a of the atrial septum ostomy system in the embodiment can open the perforation on the atrial septum to form the stoma, and the ablation part 210a on the first positioning part 213 can eliminate the tissue around the stoma of the atrial septum, so that the endothelial tract near the stoma can be prevented from attaching to block the stoma, the stoma can be prevented from being blocked, and the stoma can be kept smooth; secondly, the insulation film 27 can also form an insulation barrier on the side of the ablation member 210a facing blood, so as to reduce the current density passing through blood, reduce the heating of the ablation member 210a to blood, and reduce the risk of thrombus formation; in addition, the interatrial septum ostomy device 20a can be retrieved after the stoma is completed, i.e. the interatrial septum ostomy device 20a need not remain on the interatrial septum, thereby avoiding the instrument falling out and forming an embolism.

In other embodiments, the ablation member 210a may be at least one ring-shaped electrode disposed on the outer wall surface of the expansion portion 211 around the expansion portion 211, and an insulating film 27a is disposed between the ablation member 210a and the outer wall surface of the expansion portion 211.

In another embodiment, the ablating member 210a may be at least one turn of a wave-shaped ring electrode disposed on the outer wall surfaces of the distracting part 211 and the first positioning part 213 around the distracting part 211, that is, a part of the wave-shaped ring electrode is disposed on the outer wall surface of the distracting part 211, another part of the wave-shaped ring electrode is disposed on the outer wall surface of the first positioning part 213, and the insulating film 27a is disposed between the ablating member 210a and the outer wall surfaces of the distracting part 211 and the first positioning part 213.

Referring to fig. 14, fig. 14 is a schematic structural view of an ablation occlusion device of an interatrial septum ostomy system according to a third embodiment of the invention. The third embodiment of the present invention provides an ablation occlusion device having a structure similar to that of the first embodiment, except that: the structure of the ablating member in the third embodiment is different from that in the first embodiment, the ablating member 210b of the ablation occluding device 20b comprises a plurality of spaced point-like electrodes which are external electrodes and are arranged at least one turn in the circumferential direction of the outer wall surface of the supporting framework 21. Specifically, the plurality of spot-like electrodes are arranged in a circle along the circumferential direction of the outer wall surface of the opening portion 211, and the ablating member 210b is insulated from the supporting framework 21. The insulation treatment is performed by coating an insulation coating on the outer wall surface of the support frame 21 contacting the spot-like electrode, or inserting an insulation sleeve on the wire contacting the support frame 21 and the spot-like electrode, the insulation sleeve wrapping the outer wall surface of the wire of the support frame 12, and an insulation film 27 being provided between the ablation member 210b and the support frame 21. The insulating coating or sleeve material may be selected from FEP/ETFE/PFA, and the insulating film 27 may be, but is not limited to, a teflon film, a polyurethane film, a polyimide film, or the like.

The point electrodes are used as ablation electrodes, the point electrodes are electrically connected with the flexible lead 2102 after being connected in series through a lead, and the flexible lead 2102 is electrically connected with a radio frequency power supply through the connecting piece 2152, the connecting sleeve 523 and the lead arranged in the pushing piece.

The opening part 211 of the atrial septum ostomy device 20b of the atrial septum ostomy system in the embodiment opens the perforation on the atrial septum to form the stoma, and the ablation part 210b on the opening part 211 can eliminate the tissue on the inner wall of the stoma, thereby preventing the endothelium near the stoma from attaching to block the stoma, preventing the stoma from being blocked and keeping the stoma open; secondly, the insulating film 27 can also form an insulating barrier on the side of the ablation part 210b facing blood, so as to reduce the current density passing through the blood, reduce the heating of the ablation part 210b to the blood, and reduce the risk of thrombus formation; in addition, the interatrial septum ostomy device 20b can be retrieved after the stoma is completed, i.e. the interatrial septum ostomy device 20b need not remain on the interatrial septum, thereby avoiding the instrument falling out and forming an embolism.

In other embodiments, at least one circle of dot-shaped electrodes may be disposed on the outer wall surface of the first positioning portion 213 facing the stretching portion 211, and the insulating film 27 is disposed between the at least one circle of dot-shaped electrodes and the first positioning portion 213.

Referring to fig. 15, fig. 15 is a schematic structural view of an ablation occlusion device of an interatrial septum ostomy system according to a fourth embodiment of the invention. The fourth embodiment of the present invention provides an ablation occlusion device having a structure similar to that of the first embodiment, except that: the structure of the ablating member in the fourth embodiment is different from that in the first embodiment, the ablating member 210c of the ablation occlusion device 20c is a single-turn intermittent ring-shaped electrode disposed on the outer wall circumference of the supporting skeleton 21, the ring-shaped electrode is an external electrode, and the ring-shaped electrode and the supporting skeleton 21 are insulated from each other. Specifically, a single-turn discontinuous ring electrode is provided on the outer wall surface of the expansion portion 211, and an insulating film 27 is provided between the ring electrode and the expansion portion 211. The ring electrodes are electrically connected to a lead 2102 by a lead in series, and the lead 2102 is connected to a radio frequency power source.

The distraction part 211 of the interatrial septum ostomy device 20c of the interatrial septum ostomy system in the embodiment can distract the perforation on the interatrial septum to form the stoma, and the ablation piece 210c on the distraction part 211 can disassemble the tissue on the inner wall of the stoma, thereby preventing the endothelium near the stoma from attaching to block the stoma, preventing the stoma from being blocked and keeping the stoma unobstructed; secondly, the insulation film 27 can also form an insulation barrier on the side of the ablation member 210c facing blood, so as to reduce the current density passing through the blood, reduce the heating of the ablation member 210c to the blood, and reduce the risk of thrombus formation; in addition, the interatrial septum ostomy device 20c can be recycled after the stoma is completed, i.e. the interatrial septum ostomy device 20c need not remain on the interatrial septum, thereby avoiding the formation of emboli due to the detachment of the instrument.

In other embodiments, a single turn of the discontinuous ring-shaped electrode may be disposed on the outer wall surface of the first positioning portion 213 facing the stretching portion 211, and the insulating film 27 is disposed between the single turn of the discontinuous ring-shaped electrode and the first positioning portion 213.

Referring to fig. 16, fig. 16 is a schematic structural diagram of an ablation occlusion device of an interatrial septum ostomy system according to a fifth embodiment of the invention. The fifth embodiment of the present invention provides an ablation occlusion device having a structure similar to that of the second embodiment, except that: the structure of the ablation member in the fifth embodiment is different from that in the second embodiment, in the fifth embodiment, the ablation member 210d of the ablation occlusion device 20d includes a plurality of spaced rod-shaped electrodes, each rod-shaped electrode is an external electrode and extends in the axial direction of the supporting skeleton 21, and the rod-shaped electrodes are arranged at least one turn in the circumferential direction of the external wall surface of the supporting skeleton 21. Specifically, the rod-shaped electrodes are arranged at least once along the outer wall surface of the expanding portion 211, and the ablation member 210d and the support frame 21 are insulated from each other. The insulation treatment is performed by coating an insulation coating on the outer wall surface of the support frame 21 in contact with the rod-shaped electrode, or inserting an insulation sleeve on the wire in contact with the rod-shaped electrode in the support frame 21, wherein the insulation sleeve is wrapped on the outer wall surface of the wire of the support frame 21, and an insulation film 27a is provided between the ablation piece 210d and the support frame 21. The insulating coating or sleeve material may be selected from FEP/ETFE/PFA, and the insulating film 27 may be a teflon film, a polyurethane film, a polyimide film, or the like.

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

The opening part 211 of the atrial septum ostomy device 20d of the atrial septum ostomy system in the embodiment can open the perforation on the atrial septum to form the stoma, and the ablation piece 210d on the opening part 211 can eliminate the tissue on the inner wall of the stoma, so that the endothelial attachment near the stoma can be prevented from blocking the stoma, the stoma is prevented from being blocked, and the smoothness of the stoma can be kept; secondly, the insulation film 27a can also form an insulation barrier on the side of the ablation part 210d facing blood, so as to reduce the current density passing through the blood, reduce the heating of the ablation part 210d to the blood, and reduce the risk of thrombus formation; in addition, the interatrial septum ostomy device 20d can be retrieved after the stoma is completed, i.e. the interatrial septum ostomy device 20d need not remain on the interatrial septum, thereby avoiding the formation of emboli due to the dropping of instruments.

In other embodiments, at least one turn of rod-shaped electrodes may be disposed on the outer wall surface of the first positioning portion 213 facing the stretching portion 211, and the insulating film 27a is disposed between the at least one turn of rod-shaped electrodes and the first positioning portion 213.

Referring to fig. 17 and 18, fig. 17 is a schematic structural view of a septal stoma system according to a sixth embodiment of the present invention; figure 18 is a schematic view of the interatrial septum ostomy system of figure 17 with the insulating film removed. The sixth embodiment of the present invention provides a compartmental ostomy system having a structure similar to that of the first embodiment except that: in the sixth embodiment, in a state where the interatrial septum stoma device 20e is completely released, the support framework 21a includes a cylindrical distracting portion 211, a first positioning portion 213a provided at one end of the distracting portion 211, and a second positioning portion 217 provided at the other end opposite to the distracting portion 211; the proximal end of the first positioning portion 213a is connected to the expanding portion 211, and the distal end extends axially and converges; the proximal end of the second positioning portion 217 is connected with the expanding portion 211, and the distal end extends axially and converges.

In this embodiment, the supporting frame 21a is a braided mesh-like nitinol stent, and when the interatrial septum ostomy device 20e is delivered through a sheath, the diameter of the supporting frame 21a may be contracted to a smaller state for delivery in the sheath; when released in the heart, it expands automatically to the desired shape and size, and the expansion part 211 can exert a certain radial supporting effect on the inner wall tissue of the perforation on the interatrial septum in contact with it and can expand the perforation to form the stoma; the first positioning portion 213a is located in the left atrium and at least partially attached to the surface of the interatrial septum facing the left atrium, and the second positioning portion 217 is located in the right atrium and at least partially attached to the surface of the interatrial septum facing away from the left atrium, so that the strut 211 can be positioned in the ostium of the interatrial septum.

The first positioning portion 213a includes a positioning surface 2132 radially extending from an end edge of the distracting portion 211 to form a planar or approximately planar conical surface or an arc surface, and a conical first thrombus capture cage 2133 connected to an outer edge of the positioning surface 2132 and extending toward an end away from the distracting portion 211. The distal end of the first thrombus capture cage 2133 is closed to form a first closing surface 2135, the first closing surface 2135 is a conical surface, and the distal end of the first closing surface 2135 is converged at a vertex 2136. The outer surface of the first thrombus capture cage 2133 does not abut the atrial septum and the apex 2136 is adapted to allow the apex 2136 to pass smoothly through the puncture in the atrial septum when the atrial septum ostomy device 20e is implanted.

The second positioning portion 217 includes a positioning surface 2172 radially extending from the end edge of the distracting portion 211 to form a planar or approximately planar conical surface or arc surface, and a second thrombus capture cage 2173 connected to an outer edge of the positioning surface 2172 and having a conical shape extending toward an end away from the distracting portion 211. The distal end of the second thrombus capture cage 2173 is tapered to form a second converging surface 2175, the second converging surface 2175 is a conical cone, and the distal end of the second converging surface 2175 converges on a conical tip 2176. The outer surface of the second thrombus capture cage 2173 does not abut the atrial septum and the conical tip 2176 is adapted to engage the proximal end of the pusher member 52 a.

In this embodiment, two ablation elements 210e are provided, wherein one ablation element 210e is at least one ring of connected or spaced ring-shaped electrodes arranged along the circumferential direction of the strutting portion 211, the other ablation element 210e is at least one ring of connected or spaced ring-shaped electrodes arranged on the positioning surface 2172 of the second positioning portion 217 and arranged along the circumferential direction of the strutting portion 211, and both ring-shaped electrodes are external electrodes. Specifically, the ablating part 210e on the opening part 211 is a continuous ring of annular electrodes; the ablating member 210e on the positioning surface 2172 of the second positioning portion 217 is also a ring-shaped electrode which is continuous, and the radial distance between the ring-shaped electrode and the stretching portion 211 can be set to be 0-5 mm, preferably 3 mm. Each ring electrode is made of a highly elastic and flexible metal wire or sheet, such as a nickel-titanium multi-strand wire or a gold spring-wrapped nickel-titanium multi-strand wire. Each ablating member 210e is sewn or glued to the supporting skeleton 21a by sutures.

Each ablating member 210e is insulated from the supporting framework 21 a. Specifically, the inner and outer surfaces of the supporting frame 21a are coated with an insulating layer, such as parylene insulating coating, so that the ablation member 210e and the supporting frame 21a are insulated from each other. Further, an insulating film 27 is provided between the outer wall surface of the strut portion 211 and the corresponding ablation member 210e, and an insulating film 27 is also provided between the outer wall surface of the second positioning portion 217 and the corresponding ablation member 210 e; the insulating film 27 on the strut member 211 covers the outer wall surface of the strut member 211 by one turn, and the insulating film 27 on the outer wall surface of the second positioner 217 covers the outer wall surface of the second positioner 217 by one turn and extends to the second thrombus-capturing cage 2173. The insulating film 27 on the strut members 211 and the insulating film 27 on the outer wall surface of the second positioning portion 217 may be two separate insulating films or may be a single insulating film. The ablation piece 210e and the supporting framework 21a can be isolated by using the insulating film 27, so that heat conduction between the ablation piece 210e and the supporting framework 21a can be isolated, energy is prevented from being transmitted to the supporting framework 21a, the energy is concentrated on the ablation piece 210e, tissues on the inner surface of the stoma at the atrial interval and tissues on the periphery of the stoma facing away from the surface of the left atrium are ablated, and the energy utilization rate is improved; and the insulating film 27 can form an insulating barrier on the side of the electrode facing blood, reduce the current density passing through the blood, reduce the heating of the blood by the current and reduce the risk of thrombus formation.

Each ablation member 210e is electrically connected to the rf power source through the conducting wire 521, and the outer surface of the conducting wire 521 is insulated. Specifically, one end of the wire 521 is connected to the corresponding ablating member 210e by welding, and the other end of the wire 521 is connected to the rf power source via the second thrombus capture cage 2173, the apex 2176, and the pusher member 52 a.

The polarity of the ablating member 210e on the opening part 211 and the ablating member 210e on the second positioning part 217 is selected from the following three schemes:

1. the ablation part 210e on the opening part 211 and the ablation part 210e on the second positioning part 217 are both connected to the same radio frequency output port through a lead 521, and the neutral electrode plate is connected to the input end of the radio frequency power supply.

2. The ablation part 210e on the opening part 211 is connected with the radio frequency output port through a lead 521, and the ablation part 210e on the second positioning part 217 is connected with the radio frequency power supply input end through a lead 521, and has no neutral electrode plate.

3. The ablation part 210e on the second positioning part 217 is connected with the radio frequency output port through a lead 521, and the ablation part 210e on the opening part 211 is connected with the radio frequency power supply input end through a lead without a neutral electrode plate.

In use of the interatrial septum ostomy device 20e in this embodiment, the expansion portion 211 expands the perforations in the interatrial septum to form an stoma; the first thrombus capture cage 2133 is deployed in the left atrium, and the positioning surface 2132 of the first positioning portion 213a is attached to the interatrial septum, the second thrombus capture cage 2173 is deployed in the right atrium, and the positioning surface 2172 of the second positioning portion 217 is attached to the interatrial septum to cover the three-dimensional space region near the heating region of the interatrial septum, thereby preventing emboli formed by heating of blood from entering the circulatory system and preventing embolism.

In this embodiment, the pusher 52a is a solid structure, the pusher body is made of an insulating polymer material, and the apex 2176 of the second positioning portion 217 of the atrial septal ostomy device 20e is attached to the proximal end of the pusher body by heat fusion or adhesive. The wire 521 extends to the tail end through the inside of the pushing element 52a and is electrically connected to a tail end connector 562, and the connector 562 is electrically connected to a radio frequency power source.

In this embodiment, the interatrial septum ostomy device 20e is used in conjunction with a loader, a sheath core, a radio frequency power supply, a power connection wire, a neutral electrode plate, etc. The using method comprises the following steps:

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 sheath core and the sheath tube into the left atrium along the guide wire, and removing the guide wire and the sheath core.

The atrial septal ostomy device 20e of the appropriate size is selected. The pusher is passed proximally through the loader and the distal end of the interatrial septum ostomy device 20e is attached to the proximal end of the pusher. The push-back device receives the interatrial septum ostomy device 20e into the loader.

The distal end of the loader is connected to the proximal end of the sheath and the pusher is pushed forward to deliver the interatrial ostomy device 20e to the front end of the sheath. The pusher or the withdrawn sheath is then slowly advanced to fully open the first thrombus capture cage 2133 of the interatrial septum ostomy device 20e (as judged by ultrasound or DSA). Then, the instrument is kept from relative movement, the sheath is pulled backwards to enable the expanding portion 211 to be contained in the perforation of the interatrial septum, the expanding portion 211 is completely expanded to expand the perforation to form the stoma, and the positioning surface 2132 on the first thrombus capture cage 2133 is tightly attached to the surface of the interatrial septum. The septum ostomy device 20 and pusher member are then held in place and the sheath tube is withdrawn, leaving the second thrombus capture cage 2173 of the second positioning portion 217 fully open, with the second thrombus capture cage 2173 in the right atrium and the locating surface 2172 on the second thrombus capture cage 2173 abutting the surface of the septum facing away from the left atrium.

After confirming that the distraction part 211 and the ablation part 210e on the second positioning part 217 are completely attached to the atrial septum, connecting the distal end of the pusher to a radio frequency power supply, setting heating parameters (such as power 50W and duration 30S), and then starting heating.

After the heating is stopped, the interatrial septum ostomy device 20e may be withdrawn into the sheath and removed from the body, and a measurement may be made as to whether the stoma diameter is as desired.

In other embodiments, the distal end of the first positioning portion 213a extends radially to form a plurality of positioning rods, the plurality of positioning rods surrounding a cone or circle, and the ablating member 210e disposed on the plurality of positioning rods such that the ablating member 210e contacts the atrial septum.

In other embodiments, the positioning surface 2132 has a plurality of positioning points, and the ablating member 210e is disposed at the positioning points, such that the ablating member 210e contacts the atrial septum.

In other embodiments, the positioning surface 2132 is provided with positioning rods, and the ablation element 210e is disposed on the positioning rods, such that the ablation element 210e contacts the atrial septum.

Referring to fig. 19, fig. 19 is a schematic structural view of a septal ostomy system according to a seventh embodiment of the invention. The seventh embodiment of the present invention provides a compartmental ostomy system having a structure similar to that of the sixth embodiment except that: in the seventh embodiment, at least one ring of the connected or spaced ring electrodes 210e is provided on the positioning surface 2132 of the first positioning portion 213a of the atrial septal ostomy device 20f in the circumferential direction of the strut portion 211, and at least one ring of the connected or spaced ring electrodes 210e is provided in the circumferential direction of the strut portion 211, and the ring electrodes are external electrodes. Specifically, the ablating part 210e on the opening part 211 is a continuous ring-shaped electrode; the ablating member 210e on the positioning surface 2132 of the first positioning portion 213a is a continuous ring of ring-shaped electrodes, and the radial distance between the ring-shaped electrodes and the opening portion 211 can be set to 0-5 mm, preferably 3 mm. Each ring electrode is made of a highly elastic and flexible metal wire or sheet, such as a nickel-titanium multi-strand wire or a gold spring-wrapped nickel-titanium multi-strand wire. Each ablating member 210e is sewn or glued to the supporting skeleton 21a by sutures.

An insulating film 27 is provided between the outer wall surface of the strut portion 211 and the corresponding ablation member 210e, and an insulating film 27 is also provided between the outer wall surface of the first positioning portion 213a and the corresponding ablation member 210 e. The insulating film 27 on the strut members 211 covers the outer wall surfaces of the strut members 211 by one turn, and the insulating film 27 on the outer wall surfaces of the first positioning portions 213a covers the outer wall surfaces of the positioning surfaces 2132 by one turn and extends to the first thrombus-capturing cage 2133. The insulating film 27 on the opening portions 211 and the insulating film 27 on the outer wall surface of the first positioning portion 213a may be two separate insulating films or may be a single insulating film in combination. The ablation piece 210e and the supporting framework 21a can be isolated by using the insulating film 27, so that not only can the heat conduction between the ablation piece 210e and the supporting framework 21a be isolated, and the energy is prevented from being transmitted to the supporting framework 21a, so that the energy is concentrated on the ablation piece 210e, and the tissues on the inner surface of the stoma of the interatrial septum and the tissues facing the left atrium and near the stoma are ablated, and the energy utilization rate is improved; and the insulating film 27 can form an insulating barrier on the side of the electrode facing blood, reduce the current density passing through the blood, reduce the heating of the blood by the current and reduce the risk of thrombus formation.

In this embodiment, the interatrial septum ostomy system is used in conjunction with a loader, a sheath core, a conductive pusher, a radio frequency power supply and power supply connection, a neutral electrode plate, etc. The specific use flow and method are the same as those in the sixth embodiment, and are not described herein again.

Referring to fig. 20, fig. 20 is a schematic structural view of a septal ostomy system according to an eighth embodiment of the invention. The atrial septal ostomy system of the eighth embodiment of the present invention is similar in structure to the sixth embodiment except that: in the eighth embodiment, at least one ring of the connected or spaced ring electrodes 210e is provided on the positioning surface 2132 of the first positioning portion 213a of the atrial septal ostomy device 20g in the circumferential direction of the distracting portion 211, and at least one ring of the connected or spaced ring electrodes 210e is provided on the positioning surface 2172 of the second positioning portion 217 in the circumferential direction of the distracting portion 211, the ring electrodes being external electrodes. Specifically, the ablating member 210e on the positioning surface 2132 of the first positioning portion 213a is a continuous ring-shaped electrode, and the radial distance between the ring-shaped electrode and the stretching portion 211 may be set to 0-5 mm, preferably 3 mm. The ablating member 210e on the positioning surface 2172 of the second positioning portion 217 is a ring-shaped electrode with a continuous circle, and the radial distance between the ring-shaped electrode and the opening portion 211 can be set to be 0-5 mm, preferably 3 mm. Each ring electrode is made of a highly elastic and flexible metal wire or sheet, such as a nickel-titanium multi-strand wire or a gold spring-wrapped nickel-titanium multi-strand wire. Each ablating member 210e is sewn or glued to the supporting skeleton 21a by sutures.

An insulating film 27 is provided between the outer wall surface of the first positioning portion 213a and the corresponding ablation member 210 e; an insulating film 27 is also provided between the outer wall surface of the second positioning portion 217 and the corresponding ablating member 210 e. The insulating film 27 on the outer wall surface of the first positioning portion 213a covers the outer wall surface of the positioning surface 2132 for one circumference and extends to the first thrombus capture cage 2133; the insulating film 27 on the outer wall surface of the second positioning portion 217 covers the outer wall surface of the positioning surface 2172 for one circle and extends onto the second thrombus capture cage 2173. The ablation piece 210e and the supporting framework 21a can be isolated by using the insulating film 27, so that not only can the heat conduction between the ablation piece 210e and the supporting framework 21a be isolated, and the energy is prevented from being transmitted to the supporting framework 21a, so that the energy is concentrated on the ablation piece 210e, and the tissues of the atrial septum, facing the surface of the left atrium and the surface of the left atrium, facing away from the left atrium and the tissues of the atrial septum, near the stoma are ablated, and the energy utilization rate is improved; and the insulating film 27 can form an insulating barrier on the side of the annular electrode facing blood, so that the current density passing through the blood is reduced, the heating of the blood by the current is reduced, and the risk of thrombus formation is reduced.

In another embodiment, the outer wall surface of the stretching portion 211 may be covered with a peripheral insulating film, and the insulating films on the stretching portion 211, the first positioning portion 213a, and the second positioning portion 217 may be formed as an integral structure.

Referring to fig. 21-24, fig. 21 is a schematic view of a septal stoma system according to a ninth embodiment of the present invention; FIG. 22 is a schematic view of the ablation occluding device of the interatrial septum stoma system of FIG. 21 with the insulating film removed; FIG. 23 is a sectional view taken along line XXIII-XXIII in FIG. 21; fig. 24 is an enlarged view of the XXIV portion in fig. 22. The ninth embodiment of the present invention provides a compartmental ostomy system having a structure similar to that of the sixth embodiment except that: in the ninth embodiment, in a state where the interatrial septum ostomy device 20h is completely released, the supporting frame 21b includes a distracting portion 211 of an inwardly concave surface of revolution, a first positioning portion 213b provided at one end of the distracting portion 211, and a second positioning portion 217a provided at the opposite end of the distracting portion 211. The proximal end of the first positioning part 213b is connected to the expanding part 211, and the distal end extends radially; the proximal end of the second positioning portion 217a is connected to the expanding portion 211, and the distal end extends axially and converges.

In this embodiment, the supporting frame 21b is a braided net-shaped nitinol stent, the first positioning portion 213b is a single-layer braided net structure, and when the atrial septum ostomy device 20h is delivered through the sheath, the diameter of the supporting frame 21b can be contracted to a smaller state for delivery through the sheath; when released in the heart, the stent can automatically expand to the required shape and size, and the strutting part 211 can generate certain radial support effect on the inner wall tissue of the perforation of the interatrial septum contacted with the stent and can strut the perforation of the interatrial septum to form the stoma; the first positioning portion 213b is attached to the surface of the interatrial septum facing the left atrium, and the second positioning portion 217a is located in the right atrium and attached to the surface of the interatrial septum facing away from the left atrium, thereby positioning the opening 211 in the ostium of the interatrial septum.

The first positioning portion 213a includes a conical or circular positioning surface 2132 radially extending from the end edge of the opening portion 211, and a bending frame 2134 bending from the outer edge of the positioning surface 2132 to the distal end, wherein the bending frame 2134 is smoothly bent towards the distal end to avoid damaging atrial tissue.

The second positioning portion 217a includes a positioning surface 2172 of a conical or circular shape radially extending outward from the end edge of the expanded portion 211 in the radial direction, and a second thrombus-capturing cage 2173 of a conical shape connected to the outer edge of the positioning surface 2172 and extending toward the end away from the expanded portion 211. The distal end of the second thrombus capture cage 2173 closes to meet a conical tip 2176. The conical tip 2176 is adapted to engage the proximal end of the pusher member 52 a.

In this embodiment, ablation elements 210e are disposed on locating surface 2172 of second locator portion 217a and ablation elements 210f are disposed on locating surface 2132 of first locator portion 213 a. The ablation part 210e is at least one ring of connected or spaced ring electrodes arranged along the circumferential direction of the distraction part 211, and the ring electrodes are external electrodes. Specifically, the ablation part 210e is a continuous ring of ring electrodes, and the radial distance between the ring electrodes and the opening part 211 can be set to 0-5 mm, preferably 3 mm. The ablation member 210e is a flexible metal wire or sheet with high elasticity, such as a nickel-titanium multi-strand wire or a nickel-titanium multi-strand wire wrapped by a gold spring. The ablating member 210e is stitched or glued by stitches to the positioning surface 2172 of the second positioning portion 217 a. The ablation piece 210f is a part of electrically exposed metal wires on the positioning surface 2132 of the first positioning portion 213a, a part of electrically exposed area is directly used as an electrode, that is, the metal wires of the supporting framework 21b are not coated with an insulating coating on the area of the positioning surface 2132 corresponding to the ablation piece 210f, and the electrically exposed metal wire area on the positioning surface 2132 is at least one circle of metal wires which are arranged and connected or spaced along the circumferential direction of the stretching portion 211. In this embodiment, the ablation piece 210f is a circle of exposed metal wires connected along the circumferential direction of the distraction part 211, and the radial distance between the ablation piece 210f and the distraction part 211 can be set to 0-5 mm, preferably 3 mm. The bare metal wire may be selected from a memory alloy or stainless steel, preferably a memory alloy, preferably nitinol.

As shown in fig. 21, the ablating member 210e and the positioning surface 2172 of the second positioning portion 217a are insulated from each other, and specifically, the supporting framework 21a is coated with an insulating coating, such as parylene insulating coating, on all surfaces except the surface provided with the ablating member 210f, so as to insulate the ablating member 210e and the supporting framework 21a from each other. Further, the outer wall surface of the second positioning portion 217a is entirely covered with an insulating film 27, and the ablation member 210e is insulated from the support frame 21b by the insulating film 27. The side of the first positioning portion 213a facing away from the opening portion 211 is coated with an insulating coating corresponding to the ablating member 210f, and the insulating coating may be, but is not limited to, a parylene coating, a teflon coating, a polyurethane coating, or a polyimide coating. The ablation piece 210e and the supporting framework 21b can be isolated by using the insulating film 27, the inner and outer surfaces of the first positioning part 213a except the ablation piece 210f are coated with the insulating material to isolate the ablation piece 210f and the supporting framework 21b, so that not only can the heat conduction between the

ablation pieces

210e and 210f and the supporting framework 21b be isolated, but also the energy can be prevented from being transmitted to the supporting framework 21b, and therefore, the energy is concentrated on the

ablation pieces

210e and 210f, so that the tissues of the atrial septum facing the left atrium near the stoma and the tissues of the atrial septum back facing the left atrium near the stoma can be ablated, and the energy utilization rate is improved; and the insulating film 27 and the insulating coating can form an insulating barrier on the side of the electrode facing blood, so that the current density passing through the blood is reduced, the heating of the blood by the current is reduced, and the risk of thrombus formation is reduced.

In other embodiments, the first positioning portion 213a is covered with an insulating sleeve except for the ablation element 210 f.

In other embodiments, the side of the first positioning portion 213a facing away from the opening portion 211 corresponding to the area of the ablation element 210f is provided with an insulating film, and the insulating film is sewn or glued on the supporting framework by stitches.

The ablating member 210e is electrically connected to the radio frequency power source through the conducting wire 521, and the outer surface of the conducting wire 521 is insulated. Specifically, one end of the wire 521 is connected to the ablating member 210e by welding, and the other end of the wire 521 is connected to the rf power source through the second positioning portion 217a, the conical tip 2176, the pushing member 52a and the connector 562. The ablating member 210f is electrically connected to the rf power source through another wire 521, and specifically, one end of the another wire 521 is welded to the conical tip 2176 of the supporting frame 21b, so that the supporting frame 21b is electrically connected to the wire 521, and the other end of the wire is connected to the rf power source through the pushing member 52a and the connector 562.

The polarity of the

ablating members

210e, 210f in this embodiment can be selected from, but is not limited to, the following three schemes:

1 the ablation part 210e and the ablation part 210f are both connected to the same radio frequency output port through a lead 521, and the neutral electrode plate is connected to the input end of the radio frequency power supply.

2. The ablating member 210e is connected with the radio frequency output port through a lead 521, and the ablating member 210f is connected with the radio frequency power supply input end through a lead 521, and has no neutral electrode plate.

3. The ablation part 210f is connected with the radio frequency output port through a lead 521, and the ablation part 210e is connected with the radio frequency power supply input end through a lead without a neutral electrode plate.

Referring to fig. 25 and 26, fig. 25 is a schematic structural view of a septal stoma system according to a tenth embodiment of the present invention; fig. 26 is a schematic view of the ablation occluding device of the interatrial septum ostomy system of fig. 25 with the insulating film removed. The tenth embodiment of the present invention provides a compartmental ostomy system having a structure similar to that of the sixth embodiment except that: in a state where the interatrial septum stoma device 20i is completely released, the support skeleton 21c includes a cylindrical distracting portion 211, a first positioning portion 213c provided at one end of the distracting portion 211, and a second positioning portion 217b provided at the opposite end of the distracting portion 211; the proximal end of the first positioning portion 213c is connected to the expanding portion 211, and the distal end extends axially and converges; the proximal end of the second positioning portion 217 is connected with the expanding portion 211, and the distal end extends axially and converges. The first positioning portion 213c and the second positioning portion 217b are both of a double-layer woven mesh structure.

In this embodiment, the supporting frame 21c is a braided mesh nitinol stent, and when the interatrial septum ostomy device 20i is delivered through a sheath, the diameter of the supporting frame 21c may be contracted to a smaller state for delivery in the sheath; when released in the heart, it expands automatically to the desired shape and size, and the expansion part 211 can exert a certain radial supporting effect on the inner wall tissue of the perforation of the interatrial septum in contact with the expansion part and can expand the perforation of the interatrial septum to form the stoma; the first positioning portion 213c is located in the left atrium and attached to the surface of the interatrial septum facing the left atrium, and the second positioning portion 217b is located in the right atrium and attached to the surface of the interatrial septum facing away from the left atrium, thereby positioning the opening 211 in the ostium of the interatrial septum.

As shown in fig. 26, the first positioning portion 213c includes a positioning surface 2132 radially extending outward from the end edge of the expanded portion 211, and a first thrombus-capturing cage 2133 having a conical shape connected to the outer edge of the positioning surface 2132 and extending toward the end away from the expanded portion 211. The positioning surface 2132 may be a planar surface or a conical surface or an arc surface which is approximately planar, and the outer surface of the first thrombus capture cage 2133 is not abutted against the atrial septum. The distal end of the first thrombus capture cage 2133 converges to an apex 2136, the apex 2136 being configured to facilitate the smooth passage of the apex 2136 through the puncture in the atrial septum when the atrial septum ostomy device 20 is implanted.

The second positioning portion 217b includes a positioning surface 2172 formed by radially extending outward from the end edge of the strut 211, and a second thrombus-capturing cage 2173 of a conical shape connected to the outer edge of the positioning surface 2172 and extending toward the end away from the strut 211. The positioning surface 2172 may be a plane or a conical surface or an arc surface with an approximate plane, and the outer surface of the second positioning portion 217b is not abutted against the atrial septum. The distal end of the second thrombus capture cage 2173 closes off and merges into a conical tip 2176, which is adapted to engage the proximal end of the pusher member 52 a.

In this embodiment, three ablation elements are provided, which are an ablation element 210e disposed on the outer wall surface of the opening portion 211, an ablation element 210f disposed on the positioning surface 2132 of the first positioning portion 213c, and an ablation element 210f disposed on the positioning surface 2172 of the second positioning portion 217 b. The ablation piece 210e on the opening part 211 is along the opening part 211 circumference sets up at least one round of connected or spaced ring electrode, the ring electrode is external electrode, and is concrete, the ablation piece 210e on the opening part 211 is the ring electrode of continuous round, the ring electrode is for having higher elasticity, flexible metal wire or sheetmetal, such as nickel titanium stranded wire, or the nickel titanium stranded wire of gold spring parcel isotructure. The ablating member 210e is sewn or glued to the support frame 21a by sutures.

The ablation piece 210f on the positioning surface 2132 of the first positioning portion 213c is a partially electrically exposed metal wire on the positioning surface 2132 of the supporting framework 21c, that is, the metal wire of the supporting framework 21c is not coated with an insulating coating on the region where the ablation piece 210f is arranged, and the partially electrically exposed metal wire directly serves as an electrode of the ablation piece 210 f. The exposed metal wire areas on the positioning surface 2132 are circumferentially arranged at least one turn along the expanding portion 211. In this embodiment, the ablation pieces 210f on the first positioning portion 213c are arranged in one circle along the circumferential direction of the expanding portion 211, and the radial distance between the ablation pieces 210f and the expanding portion 211 may be set to 0-5 mm, preferably 3 mm. The ablation pieces 210f on the positioning surface 2172 of the second positioning portion 217b are partially electrically exposed metal wires on the positioning surface 2172 of the supporting framework 21c, that is, the metal wires of the supporting framework 21c are not coated with an insulating coating on the region of the positioning surface 2172 where the ablation pieces 210f are arranged, and the exposed metal wire region on the positioning surface 2172 is at least one turn of connected or spaced along the circumferential direction of the spreading portion 211. In this embodiment, the ablation pieces 210f on the second positioning portion 217b are arranged in a circle along the circumferential direction of the expanding portion 211, and the radial distance between the ablation pieces 210f and the expanding portion 211 can be set to 0-5 mm, preferably 3 mm. The bare metal wire may be selected from the group consisting of memory alloys or stainless steels, preferably memory alloys, preferably nitinol.

As shown in fig. 25, the ablation member 210e and the expanding portion 211 are insulated from each other. Specifically, the inner and outer surfaces of the supporting frame 21c except for the ablation pieces 210f are all plated with parylene insulating coatings, so that the

ablation pieces

210e and 210f are insulated from the supporting frame 21 a. Furthermore, an insulating film 27 is provided between the expanding portion 211 and the ablation member 210e, that is, the insulating film 27 covers the outer wall surface of the expanding portion 211 for one circle, so that the ablation member 210e is insulated from the supporting frame 21c by the insulating film 27. The inner and outer surfaces of the first positioning portion 213c and the second positioning portion 217b except for the area of the ablation member 210f are coated with an insulating coating, which may be, but not limited to, a parylene coating, a teflon coating, a polyurethane coating, or a polyimide coating. The

ablation pieces

210e and 210f and the supporting framework 21b can be isolated by using the insulating film 27 and the insulating coating, so that not only can the heat conduction between the

ablation pieces

210e and 210f and the supporting framework 21c be isolated, the energy is prevented from being transmitted to the supporting framework 21c, and the energy is concentrated on the

ablation pieces

210e and 210f, so that the inner surface of the stoma of the interatrial septum, the tissue of the surface of the interatrial septum facing the left atrium at the vicinity of the stoma and the tissue of the surface of the interatrial septum facing away from the left atrium at the vicinity of the stoma are ablated, and the energy utilization rate is improved; and the insulating film 27 and the insulating coating can form an insulating barrier on the side of the electrode facing blood, so that the current density passing through the blood is reduced, the heating of the blood by the current is reduced, and the risk of thrombus formation is reduced.

The ablating member 210e is electrically connected to the radio frequency power source through the conducting wire 521, and the outer surface of the conducting wire 521 is insulated. Specifically, one end of the wire 521 is connected to the corresponding ablating member 210e by welding, and the other end of the wire 521 is connected to the rf power source via the second thrombus capture cage 2173, the tip 2176, the pusher member 52a, and the connector 562. The two ablating members 210f are electrically connected to the rf power source through another wire 521, and specifically, one end of the another wire 521 is welded to the vertex 2176 of the supporting framework 21c, so that the supporting framework 21c is electrically connected to the wire 521, and the other end of the wire is connected to the rf power source through the pushing member 52.

The polarity of the ablating member 210e on the opening portion 211 and the ablating member 210f on the second positioning portion 217b and the first positioning portion 213c can be selected from the following three schemes:

1. the ablation part 210e on the opening part 211, the ablation part 210f on the proximal second positioning part 217b and the first positioning part 213c are connected to the same radio frequency output port through the lead 521, and the neutral electrode plate is connected to the radio frequency power input end.

2. The ablation part 210e on the opening part 211 is connected to the rf output port through a wire 521, and the ablation parts 210f on the second positioning part 217b and the first positioning part 213c are connected to the rf power input end through a wire 521, without a neutral electrode plate.

3. The ablation elements 210f on the second positioning portion 217b and the first positioning portion 213c are connected to the rf output port through a lead 521, and the ablation elements 210e on the spreading portion 211 are connected to the rf power input end through a lead without a neutral electrode plate.

Referring to fig. 27, fig. 27 is a schematic structural view of a septal ostomy system according to an eleventh embodiment of the invention. The eleventh embodiment of the present invention provides a compartmental ostomy system having a structure similar to that of the sixth embodiment except that: in the eleventh embodiment, three ablating members 210e are provided, wherein one ablating member 210e is at least one ring of connected or spaced ring-shaped electrodes arranged along the circumference of the opening portion 211; the other ablating member 210e is a ring-shaped electrode which is arranged on the positioning surface 2132 of the first positioning part 213a and is connected or spaced at least once along the circumferential direction of the expanding part 211; the ablation member 210e is a ring-shaped electrode which is arranged on the positioning surface 2172 of the second positioning portion 217 and is connected or spaced at least once along the circumferential direction of the expanding portion 211. Specifically, the ablating part 210e on the opening part 211 is a continuous ring of annular electrodes; the ablating member 210e on the positioning surfaces 2132, 2172 of the first positioning portion 213a and the second positioning portion 217 are continuous ring electrodes, and the radial distance between the ring electrodes and the spreading portion 211 can be set to 0-5 mm, preferably 3 mm. Each annular electrode is a flexible metal wire or sheet with high elasticity, such as a nickel-titanium multi-strand wire or a nickel-titanium multi-strand wire wrapped by a gold spring. Each ablating member 210e is sewn or glued to the supporting skeleton 21a by sutures.

Each ablation piece 210e is insulated from the supporting framework 21a, and specifically, the outer surface of the supporting framework 21a is plated with a parylene insulating coating, so that the ablation piece 210e is insulated from the supporting framework 21 a. Further, an insulating film 27 is provided between the outer wall surface of the strut portion 211 and the corresponding ablation member 210e, an insulating film 27 is also provided between the outer wall surface of the first positioning portion 213a and the corresponding ablation member 210e, and an insulating film 27 is also provided between the outer wall surface of the second positioning portion 217 and the corresponding ablation member 210 e. Specifically, the insulating film 27 on the expansion part 211 covers the outer wall surface of the expansion part 211 for one circle; the insulating film 27 on the outer wall surface of the first positioning portion 213a covers the positioning surface 2132 of the second positioning portion 213a and extends to the first thrombus capture cage 2133; the insulating film 27 on the outer wall surface of the second positioning portion 217 covers the positioning surface 2172 of the second positioning portion 217 and extends onto the second thrombus capture cage 2173. The three insulating films 27 may be three separate insulating films or may be combined into one insulating film. The three ablating parts 210e and the supporting framework 21a can be isolated by the insulating film 27, so that not only can the heat conduction between the ablating parts 210e and the supporting framework 21a be isolated, the energy is prevented from being transmitted to the supporting framework 21a, and the energy is concentrated on the ablating parts 210e, so as to ablate the tissues on the inner surface of the stoma of the interatrial septum, the tissues on the vicinity of the stoma facing the surface of the left atrium and the tissues on the vicinity of the stoma facing away from the surface of the left atrium, and the energy utilization rate is improved; and the insulating film 27 can form an insulating barrier on the side of the electrode facing blood, so that the current density passing through the blood is reduced, the heating of the blood by the current is reduced, and the risk of thrombus formation is reduced.

Each ablation member 210e is electrically connected to the rf power source through the conducting wire 521, and the outer surface of the conducting wire 521 is insulated. Specifically, one end of each wire 521 is connected to the corresponding ablating member 210e by welding, and the other end of the wire 521 is connected to the rf power source through the supporting framework 21a and the pushing member 52 a.

The polarity of the three ablation elements 210e on the support frame 21a can be selected from, but not limited to, the following six options:

1. the ablation piece 210e on the opening part 211, the ablation piece 210e of the first positioning part 213a and the ablation piece 210e of the second positioning part 217 are all connected with the same radio frequency output port, and the neutral electrode plate is connected with the radio frequency power supply input end.

2. The ablation part 210e of the second positioning portion 217 and the ablation part 210e of the first positioning portion 213a are connected to the rf output port, and the ablation part 210e of the opening portion 211 is connected to the rf power input terminal without a neutral electrode plate.

3. The ablation part 210e on the opening part 211 is connected with the radio frequency output port, the ablation part 210e of the second positioning part 217 and the ablation part 210e of the first positioning part 213a are connected with the input end of the radio frequency power supply, and no neutral electrode plate is arranged.

4. The ablation part 210e of the second positioning portion 217 and the ablation part 210e of the opening portion 211 are connected to the rf output port, and the ablation part 210e of the first positioning portion 213a is connected to the rf power input port without a neutral electrode plate.

5. The ablation piece 210e of the second positioning part 217, the ablation piece 210e of the first positioning part 213a and the ablation piece 210e on the spreading part 211 are respectively connected with three-phase voltage source phase A, phase B and phase C output ports, three ports output three paths of sine alternating current with equal amplitude, same frequency and phase angle which are sequentially different by 120 degrees, and the neutral electrode plate is connected with the input end of the radio frequency power supply.

6. The ablation piece 210e of the second positioning part 217, the ablation piece 210e of the first positioning part 213a and the ablation piece 210e on the opening part 211 are respectively connected with three-phase voltage source phase-A, phase-B and phase-C output ports, three ports output three paths of sine alternating currents with equal amplitude, same frequency and phase angle which are sequentially different by 120 degrees, and no neutral electrode plate is arranged.

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

Claims

1. An atrial septostomy device for improving ablation effect, comprising a support frame for propping up a perforation on the atrial septum, wherein the support frame is provided with at least one ablation piece, and the ablation piece contacts the The atrial septum is used to ablate the atrial septum, and the device cannot ablate blood or tissue except for the ablation element.

2 . The atrial septostomy device according to claim 1 , wherein the ablation element is an external electrode disposed on the support frame. 3 .

3 . The atrial septostomy device according to claim 2 , wherein the external electrodes are sutured or glued to the support frame by sutures. 4 .

4 . The atrial septostomy device according to claim 2 , wherein the ablation element is a plurality of point electrodes or rod electrodes arranged on the support skeleton, and a plurality of the point electrodes or rod electrodes The electrodes are arranged along the support frame at least once.

5 . The atrial septostomy device according to claim 2 , wherein the ablation element is a ring-shaped electrode disposed in the circumferential direction of the outer wall of the support frame. 6 .

6 . The atrial septostomy device according to claim 2 , wherein the outer surface of the support frame that is in contact with the tissue at least in the region corresponding to the ablation element is insulated. 7 .

7 . The atrial septostomy device according to claim 6 , wherein an insulating film is provided between the support frame and the ablation member. 8 .

8 . The atrial septostomy device according to claim 7 , wherein the insulating film is disposed on the surface of the support frame corresponding to the ablation member, or is attached to the support frame corresponding to the ablation member. 9 . s surface.

9 . The atrial septostomy device according to claim 7 , wherein the insulating film is sutured or glued to the outer wall surface of the support skeleton. 10 .

10 . The atrial septostomy device according to claim 6 , wherein the support frame is coated with an insulating coating corresponding to the surface of the ablation member, or the ablation member is coated corresponding to the surface of the support frame. 11 . insulating coating.

11 . The atrial septostomy device according to claim 1 , wherein the support frame is a metal stent, and the ablation member is provided with at least a A ring of connected or intermittent electrically exposed areas.

12 . The atrial septostomy device according to claim 11 , wherein the support frame is insulated except for the region corresponding to the ablation member. 13 .

13 . The atrial septostomy device according to claim 11 , wherein at least the outer surface of the support frame in contact with tissue or blood is coated with an insulating coating. 14 .

14. The interatrial septum ostomy device according to any one of claims 1 to 13, wherein the support frame comprises a spreading portion for spreading the perforation on the interatrial septum, and is provided in the spreading portion. A first positioning portion at one end of the opening portion, and a second positioning portion disposed at the opposite end of the opening portion, the ablation member is disposed on the outer wall surface of the opening portion, the outer wall surface of the first positioning portion, or On the outer wall surface of the second positioning portion, an insulating film or an insulating coating is provided between the ablation member and the expanding portion, the first positioning portion, or the second positioning portion.

15 . The atrial septostomy device according to claim 14 , wherein the ablation member can be arranged on the expansion part, the first positioning part or the second positioning part to contact the atrial septum. 16 . s position.

16 . The atrial septostomy device according to claim 14 , wherein the ablation member is provided at least one circle along the outer wall surface of the expanding portion. 17 .

17 . The atrial septostomy device according to claim 15 , wherein the first positioning portion is located in the left atrium and at least partially abuts the atrial septum, and the ablation member is stretched around the atrial septum. 18 . At least one ring of connected or discontinuous annular electrodes is provided on the first positioning portion, and the insulating film or the insulating coating is located between the annular electrode and the first positioning portion.

18. The atrial septostomy device according to claim 17, wherein the first positioning portion comprises a positioning surface radially extending from an end edge of the opening portion to form, the positioning surface at least Partly attached to the interatrial septum, the annular electrode is arranged on the positioning surface, and the insulating film or the insulating coating is located between the annular electrode and the positioning surface.

19. The atrial septostomy device according to claim 17, wherein the first positioning portion further comprises a thrombus capturing device connected to the outer edge of the positioning surface.

20 . The atrial septostomy device according to claim 14 , wherein the second positioning portion is located in the right atrium and is abutted against the atrial septum, and the ablation member is at least around the opening portion. 21 . A circle of connected or discontinuous annular electrodes is disposed on the second positioning portion, and the insulating film or the insulating coating is located between the annular electrodes and the positioning frame.

21. The atrial septostomy device according to claim 19, wherein the second positioning portion comprises a positioning surface radially extending from an end edge of the stretched portion to form, the positioning surface at least Partly attached to the interatrial septum, the annular electrode is arranged on the positioning surface, and the insulating film or the insulating coating is located between the annular electrode and the positioning surface.

22. The septostomy device of claim 14, wherein the distraction portion is radially expandable to distract a perforation in the atrial septum to form a stoma.

23. The atrial septostomy device of claim 14, wherein the radial dimension of the distraction is adjustable.

24 . The atrial septostomy device according to claim 14 , wherein the ablation member comprises two electrodes, and the two electrodes are simultaneously disposed on the expansion part, the first positioning part, and the other electrodes. 25 . one of the three second positioning parts; two of the electrodes are respectively arranged on two of the three of the opening part, the first positioning part and the second positioning part.

25. The atrial septostomy device according to claim 24, wherein the two electrodes are both electrically connected to the output end of the radio frequency power supply.

26. The interatrial septostomy device according to claim 24, wherein one electrode is electrically connected to the output end of the radio frequency power supply, and the other electrode is connected to the input end of the radio frequency power supply.

27 . The atrial septostomy device according to claim 14 , wherein the ablation member comprises three electrodes, and the three electrodes are simultaneously disposed on the expansion part, the first positioning part, and all the electrodes. 28 . one of the three second positioning parts; three of the electrodes are respectively arranged on two of the three of the opening part, the first positioning part, and the second positioning part; or three of the electrodes The electrodes are respectively arranged on the opening portion, the first positioning portion and the second positioning portion.

28. The atrial septostomy device according to claim 27, wherein the three electrodes are all electrically connected to a radio frequency power supply.

29. The interatrial septostomy device according to claim 27, wherein two of the electrodes are electrically connected to a radio frequency power supply, and the other electrode is connected to an input end of the radio frequency power supply; or one of the electrodes is electrically connected to a radio frequency power supply. On the RF power supply, the other electrode is connected to the input terminal of the RF power supply.

30. The atrial septostomy device according to claim 27, wherein the three electrodes are respectively connected to a three-phase power supply.

31. An interatrial septostomy system, comprising the interatrial septostomy device according to any one of claims 1-30, a stoma device control mechanism for controlling the interatrial septostomy device, and a radio frequency power supply, the radio frequency power supply The ablation element of the atrial septostomy device is electrically connected through the ostomy device control mechanism.