CN111166463A

CN111166463A - Interatrial septum ostomy device with improved ablation mode and interatrial septum ostomy system

Info

Publication number: CN111166463A
Application number: CN201811336798.1A
Authority: CN
Inventors: 吴俊飞; 王永胜; 王坤; 董元博
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 invention provides an interatrial septum stoma system with an improved ablation mode, which comprises an interatrial septum stoma device, an ostomy device control mechanism for controlling the interatrial septum ostomy device, a radio frequency power supply and an ablation piece, wherein the interatrial septum ostomy device comprises a supporting framework for opening a perforation on an interatrial septum, the interatrial septum ostomy device also comprises the ablation piece arranged on the supporting framework, the radio frequency power supply is electrically connected with the interatrial septum ostomy device through the ostomy device control mechanism, the ablation piece comprises a first electrode and a second electrode, one of the first electrode and the second electrode is electrically connected with the output end of the radio frequency power supply, and the other electrode is connected with the input end of the radio frequency power supply so as to form a current loop for receiving the energy of the radio frequency power supply to ablate the interatrial septum. The invention also relates to a compartmental ostomy device of said system.

Description

Interatrial septum ostomy device with improved ablation mode and interatrial septum ostomy system

Technical Field

The invention relates to the technical field of interventional medical instruments, in particular to an interatrial septum ostomy device for improving an ablation mode 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 remodeling of the left ventricle and resulting in reduced cardiac function. Each time a myocardial infarction patient is successfully treated, a potential heart failure patient is brought about.

In terms of treatment, after optimizing drug treatment, the symptoms of patients still recur, and the current drug treatment almost only has better curative effect on patients with reduced ejection fraction, and the curative effect on patients with retained ejection fraction is not ideal. Cardiac resynchronization therapy is not suitable for all heart failure patients, and over 20% of patients do not have effective cardiac resynchronization pacing. The left ventricle auxiliary device operation needs extracorporeal circulation trauma, has high complication incidence rate, 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 intensive research on the pathogenesis of pulmonary hypertension, the treatment methods are more and more. The treatment scheme of the pulmonary hypertension is characterized by individuation and systematization, and can not 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, heart-lung combined 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 that the stoma is reduced or even closed, the prior art provides an ostomy bracket, which can respectively disclose an implant for atrial shunt.

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

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

Disclosure of Invention

It is an object of the present invention to provide an interatrial septum ostomy device with an improved ablation pattern in which the stoma is not easily blocked, 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 with an improved ablation mode, which comprises a supporting framework for expanding a perforation on an interatrial septum, and further comprises an ablation piece arranged on the supporting framework, wherein the ablation piece comprises a first electrode and a second electrode, one of the first electrode and the second electrode is electrically connected to a radio frequency power supply, and the other electrode is connected with the input end of the radio frequency power supply so as to form a current loop for receiving the energy of the radio frequency power supply to ablate the interatrial septum.

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 interatrial septum stoma device comprises a supporting framework for opening a perforation on an interatrial septum, the interatrial septum stoma device further comprises an ablation piece arranged on the supporting framework, the radio frequency power supply is electrically connected with the interatrial septum stoma device through the ostomy device control mechanism, the ablation piece comprises a first electrode and a second electrode, one of the first electrode and the second electrode is electrically connected with the output end of the radio frequency power supply, and the other electrode is connected with the input end of the radio frequency power supply so as to form a current loop for receiving the energy of the radio frequency power supply to ablate the interatrial septum.

The interatrial septum stoma system comprises a supporting framework for expanding a perforation on an interatrial septum and an ablation piece arranged on the supporting framework, wherein one electrode is electrically connected to the output end of a radio frequency power supply, and the other electrode is connected with the input end of the radio frequency power supply, so that a current loop is formed by the first electrode and the second electrode to receive the energy of the radio frequency power supply to ablate the interatrial septum, the interatrial septum tissue near the perforation loses activity, the perforation is prevented from being blocked due to the climbing of the repaired endothelium of the tissue, and the shape of the perforation after stoma can be fixed after the interatrial septum stoma system performs stoma, the stoma is not easy to be blocked, and the smoothness of the stoma can be kept; in addition, the first electrode and the second electrode are both arranged on the supporting framework, so that the distribution of the current of the ablation piece is easily controlled, the current can be concentrated on the interatrial space and released between the first electrode and the second electrode, namely, the energy is easily gathered and can cause continuous damage, the loss of radio frequency energy on the electrodes is prevented, the ablation efficiency is improved, and the damage to other tissues of the body is prevented.

Drawings

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

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

FIG. 2 is 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 schematic view of an ablation occluding device of a interatrial septum stoma system according to a third embodiment of the present invention;

FIG. 14 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. 15 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. 16 is a schematic view of an ablation occluding device of a interatrial septum stoma system according to a sixth embodiment of the present invention;

FIG. 17 is a schematic view of an ablation occluding device of a interatrial septum stoma system according to a seventh embodiment of the present invention;

FIG. 18 is a schematic view of a septal stoma system according to an eighth embodiment of the present invention;

FIG. 19 is a schematic view of the ablation occluding device of the interatrial septum stoma system of FIG. 18 with the addition of an insulating membrane;

FIG. 20 is a schematic view of a septal ostomy system provided in accordance with a ninth embodiment of the present invention;

FIG. 21 is a schematic representation of the construction of a septal stoma system according to a tenth embodiment of the present invention;

FIG. 22 is a schematic representation of the construction of a compartmental ostomy system according to an eleventh embodiment of the invention;

FIG. 23 is a schematic view of the ablation occluding device of the interatrial septum stoma system of FIG. 22 with the addition of an insulating membrane;

FIG. 24 is a cross-sectional view taken along line XXIV-XXIV in FIG. 23;

fig. 25 is an enlarged view of the XXV portion in fig. 24;

FIG. 26 is a schematic representation of the construction of a interatrial septum stoma system according to a twelfth embodiment of the invention;

FIG. 27 is a schematic view of the ablation occluding device of the interatrial septum stoma system of FIG. 26 with the addition of an insulating membrane;

figure 28 is a schematic view of a septal ostomy system according to a thirteenth embodiment of the invention.

Detailed Description

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

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

Referring to fig. 1 and 2, fig. 1 is a schematic structural view of a first embodiment of an improved ablation 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 ostomy device 20 comprises a support frame 21 for distracting the perforations in the interatrial septum, the support frame 21 being adapted to distract the perforations to form the stoma. The supporting framework 21 is provided with an ablation part 23, the ablation part 23 comprises a first electrode 231 and a second electrode 233, both the first electrode 231 and the second electrode 233 are in contact with the atrial septum, one of the first electrode 231 and the second electrode 233 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, namely, when the first electrode 231 is electrically connected to the output end of the radio frequency power supply, the second electrode 233 is connected to the input end of the radio frequency power supply; or when the second electrode 233 is electrically connected to the rf power output terminal, the first electrode 231 is connected to the rf power input terminal. The first electrode 231 and the second electrode 233 form a current loop to receive energy from the rf power output to ablate the atrial septum.

In this embodiment, the first electrode 231 is used as an electrode for ablation, and the second electrode 233 is used as an electrode for connecting to an input end of a radio frequency power supply.

The interatrial septum ostomy device 20 of the interatrial septum ostomy system 100 comprises a support framework 21 for expanding perforation on the interatrial septum and an ablation piece 23 arranged on the support framework 21, wherein the first electrode 231 and the second electrode 233 both contact the interatrial septum tissue near the perforation, one electrode is electrically connected to the output end of a radio frequency power supply, the other electrode is connected with the input end of the radio frequency power supply, the first electrode 231 and the second electrode 233 form a current loop for receiving the energy of the radio frequency power supply to ablate the interatrial septum, so that the interatrial septum tissue near the perforation loses activity, the perforation is prevented from being blocked by the repair endothelium of the tissue in an creeping manner, and the perforation shape after the ostomy can be fixed after the interatrial septum ostomy system 100 is subjected to the ostomy. Therefore, the shape of the stoma after being processed by the interatrial septum stoma device 20 is regular and is not easy to be blocked, and the smoothness of the stoma can be kept, so that the blood in the left and right ventricles can be smoothly shunted; in addition, because the first electrode 231 and the second electrode 233 are both located on the supporting framework 21, the distance between the first electrode 231 and the second electrode 233 is short, so that the distribution of the current of the ablation member 23 is easy to control, the current can be concentrated between the first electrode 231 and the second electrode 233 for release, i.e., the energy is easy to gather and can cause continuous damage, the loss of the radio frequency energy on the electrodes is prevented, the ablation efficiency is improved, and the damage of other tissues of the body is prevented.

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 support frame or a resilient non-metal support frame. 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 frame 21 may automatically expand to the desired shape and size, so that the support frame 21 may distract the perforation in the interatrial septum to form the stoma, i.e. the part of the support frame 21 in the perforation exerts a radial support effect on the inner wall of the perforation.

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 or polyimide coatings. 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 supporting framework 21 into the through hole of the atrial septum; the extension 214 can prevent the distraction portion 211 from deviating from the perforation of the atrial septum when extending distally, which results in the inability to dilate the tissue, and therefore, the extension 214 can compensate for the adverse effect of the distraction portion 211 deviating from the perforation.

In this embodiment, when the supporting framework 21 is completely released into the through hole of the atrial septum, the expanding portion 211 can radially expand after being released, so as to uniformly expand the through hole on the atrial septum, and to expand the through hole on the atrial septum to form a hole. Specifically, the opening portion 211 is a ring-shaped structure with a wave shape continuously arranged circumferentially, the proximal end of the first positioning portion 213 is connected to the opening portion 211, that is, the first positioning portion 213 is connected to the wave peak of the ring-shaped structure, and the distal end of the first positioning portion 213 radially extends to form a conical or circular positioning surface 2132. First positioning portion 213 includes still that the outer fringe turns over and sticks up the structure, the outer fringe turns over and sticks up the structure for from the outer fringe portion of positioning portion 213 to keeping away from the one side rounding off bending of strutting portion 211, avoids haring the atrium tissue. 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 support frame 21 may be a mesh stent, a rod stent, a multi-layered wave stent, or a tubular or ring structure formed by a combination thereof. 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 annular wave-shaped structure and comprises wave crests, wave troughs and wave rods, the wave rods which are adjacent in the circumferential direction are connected at the near end to form the wave crests, and the wave rods which are adjacent in the circumferential direction are connected at the far end 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 elliptic 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 recovery part 215 is conical and comprises a plurality of extension pieces 2151 arranged at the proximal end and a connecting member 2152 arranged at the distal end, wherein the plurality of extension pieces 2151 are connected between the extension part 214 and the connecting member 2152, and the connecting member 2152 is used for connecting the ostomy device control mechanism 50. The connector 2152 is a tubular structure having a released outer diameter that is less than the released outer diameter of the extension 214. A plurality of fixing holes 2154 are formed in the connecting member 2152 along the circumferential direction, and the fixing holes 2154 are used for fixing the connecting member 2152 to the ostomy device control mechanism 50.

In this embodiment, the first electrode 231 of the ablation member 23 is disposed on the expansion portion 211, and the second electrode 233 is disposed on the first positioning portion 213. Specifically, the first electrode 231 is disposed on the outer wall surface of the distracting part 211, the second electrode 233 is disposed on the positioning surface 2132 of the first positioning part 213, and both the outer wall surface of the distracting part 211 and the positioning surface 2132 of the first positioning part 213 contact the atrial septum. Therefore, the first electrode 231 and the second electrode 233 both contact the interatrial septum, and a current loop is formed between the first electrode 231 and the second electrode 233, that is, current only flows through the tissue of the interatrial septum between the first electrode 233 and the second electrode 233, so as to prevent the current from damaging other tissues of the human body, and the radio frequency energy can be concentrated on the first electrode 233 for ablation, thereby achieving better ablation effect.

Referring to fig. 2 to 4, in the present embodiment, the ablation member 23 includes a plurality of first flexible wires 235 and a plurality of second flexible wires 236, and the first flexible wires 235 have the same structure as the second flexible wires 236 and have different lengths. The first flexible wire 235 is spaced apart from and disposed alongside the second flexible wire 236. The proximal end of each first flexible wire 235 is provided with an ablation portion, which is the first electrode 231, and the distal end of the first flexible wire 235 is provided with a connecting portion 237. Each first flexible wire 235 is sewn to the outer wall surface of the support frame 21 by gluing or sewing. The first electrodes 231 of each first flexible wire 235 are located on the outer wall surface of the expansion portion 211, and specifically, the first electrodes 231 are arranged at least one turn along the circumferential direction of the expansion portion 211; the connecting portion 237 of each first flexible wire 235 axially extends out of the connecting member 2152 and is electrically connected to an rf source. The proximal end of each second flexible lead 236 is provided with an ablation portion, which is the second electrode 233, the distal end of the second flexible lead 236 is provided with a connecting portion 237, the second electrode 233 of each second flexible lead 236 is located on the positioning surface 2132 of the first positioning portion 213, and specifically, the second electrodes 233 are arranged at least once along the circumferential direction of the distraction portion 211. The connecting portion 237 of each second flexible wire 236 extends axially out of the connecting member 2152 and is connected to the rf power input.

As shown in fig. 4, in the present embodiment, each of the first flexible conducting wire 235 and the second flexible conducting wire 236 includes a flexible metal layer 2351, an insulating layer 2353 sleeved outside the metal layer 2351, and an adhesive layer 2355 adhered outside the insulating layer 2353 and adhered to the supporting frame 21. The first electrode 231 and the second electrode 233 are formed by removing the insulating layer 2353 on the side opposite to the adhesive layer 2355 at the proximal ends of the first flexible lead 235 and the second flexible lead 236, respectively; the connection portions 237 are formed by removing the insulating layer 2353 and the adhesive layer 2355 from the distal ends of the first flexible wire 235 and the second flexible wire 236, respectively.

Referring to figures 1, 5 and 6, the ostomy device control mechanism 50 comprises a pusher 52, an outer sheath assembly 54, and a control handle 56. The pushing member 52 is detachably connected or integrally and fixedly connected with the interatrial septum ostomy device 20, a wire 521 is arranged in the pushing member 52, and the wire 521 is electrically connected with the first flexible wire 235 and the second flexible wire 236 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 connection sleeve 523 is a tube body made of conductive metal, the proximal end of the connection sleeve 523 is sleeved on the distal end of the connection member 2152, the proximal end of one of the wires 521 in the push member 52 passes through the wall of the double lumen tube 520 and then is welded to the connection sleeve 523, and the distal end of the wire 521 extends along the second cavity 2503 until being connected to the output end of the radio frequency power supply. The connecting part 237 of the first flexible wire 235 of the ablation piece 23 is welded on the outer wall surface of the connecting sleeve 523; the connecting portion 237 of the second flexible conductive wire 236 is directly electrically connected to another conductive wire 521 inside the pushing member 52, and the another conductive wire 521 is connected to an input end of a radio frequency power source. At this time, the first electrode 231 serves as an ablation electrode, and the second electrode 233 serves as an input electrode for connecting a radio frequency power source.

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 covering a section of length behind the connecting sleeve 523. At this time, the connecting portion 237 of each of the first flexible conducting wire 235 and the second flexible conducting wire 236 of the ablation member 23 is located between the connecting sleeve 523 and the protective tube 527, and the first flexible conducting wire 235 and the second flexible conducting wire 236 are insulated. 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 plug 5434 disposed at the front end of the PEEK tube 5432 and matching with the sheath 540. The PEEK tube 5432 is received in the first cavity 5201 of the pusher 52, and the tip 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 of the control handle 56 is provided with a connector 562 for connection to a radio frequency power source. The distal end of the wire 521 of the pusher 52 is electrically connected to the connector 562, so that the first electrode 231 is connected to the ablation power source, and the second electrode is connected to the rf power input terminal. 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;

connecting a connector 562 at the proximal end of the handle to a radio frequency power source and advancing the interatrial ostomy device 20 pre-loaded in the sheath 540 along the guide wire into the body with the sheath's forward 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 backward to make the first positioning part 213 cling to the surface of the interatrial septum 601 facing the left atrium, observe and make the second electrode 233 contact with the tissues of the interatrial septum 601 well;

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 23 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 system 100 in the embodiment opens the perforation on the atrial septum to form the stoma, and the ablation piece 23 on the supporting framework 21 can eliminate the tissue of the atrial septum near the perforation, thereby preventing the endothelium near the perforation from attaching and blocking the stoma and keeping the stoma open; secondly, because the first electrode 231 and the second electrode 233 are both located on the supporting framework 21, the distance between the first electrode 231 and the second electrode 233 is short, and the distribution of the current of the ablation piece 23 is easy to control, i.e. the current only passes through the interatrial tissue between the first electrode 231 and the second electrode 233, so that the radio frequency energy can be concentrated between the interatrial tissue and the first electrode 231 and the second electrode 233 for release, i.e. the energy is easy to gather and can cause continuous damage, thereby preventing the radio frequency energy on the electrodes from losing, improving the ablation efficiency, and preventing the damage of other tissues of the body; in addition, the interatrial septum ostomy device 20 can be retrieved after completion of the stoma, i.e. the interatrial septum ostomy device 20 need not remain on the interatrial septum, thereby avoiding the formation of emboli due to the dropping of the instrument.

In an embodiment, the first electrode 231 may be disposed on the positioning surface 2132 of the first positioning portion 213, and the second electrode 233 may be disposed on the outer wall surface of the stretching portion 211; the first electrode 231 and the second electrode 233 may be disposed on the positioning surface 2132 of the first positioning portion 213 or the outer wall surface of the stretching portion 211 at intervals; the second electrode 233 may be provided on the outer wall surface of the extension portion 214, and the first electrode 231 may be provided on the positioning surface 2132 of the first positioning portion 213 and the outer wall surface of the stretcher portion 211.

In other embodiments, the distal end of the first positioning portion 213 extends radially to form a plurality of positioning rods, which may be tapered or rounded. The first electrode 231 and/or the second electrode 233 are disposed on the positioning rod such that the first electrode 231 and/or the second electrode 233 contact the atrial septum.

In other embodiments, the distal end of the first positioning portion 213 radially extends to form a plurality of positioning rods, the plurality of positioning rods surround to form a cone or a circle, and the plurality of positioning rods are provided with a plurality of positioning points. The first electrodes 231 and/or the second electrodes 233 are disposed on a plurality of the positioning points, such that the first electrodes 231 and/or the second electrodes 233 contact the atrial septum.

In other embodiments, the distal end of the first positioning portion 213 radially extends to form a positioning surface, the positioning surface is provided with a plurality of positioning points, and the first electrode 231 and/or the second electrode 233 are/is disposed on the positioning points, such that the first electrode 231 and/or the second electrode 233 contact the atrial septum.

Referring to fig. 12, fig. 12 is a schematic structural view of an ablation occluding device of an interatrial septum ostomy system according to a second embodiment of the invention. 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 framework 21 is a metal supporting framework, specifically, the supporting framework 21 is a nickel alloy supporting framework, and the supporting framework 21 serves as an input end of the ablation member 23 connected to the radio frequency power supply. Specifically, the positioning surface 2132 of the first positioning portion 213 is provided with an electrical exposed region, the outer surface of the supporting framework 21 is coated with an insulating coating except the electrical exposed region, and the electrical exposed region serves as the second electrode 233 of the ablation member 23. The electrical exposed area may be disposed on at least one position of the positioning surface 2132. The connecting member 2152 of the supporting frame 21 passes through the pushing member 52 via a wire to connect to the rf power input end, so that the electrically exposed region is connected to the rf power input end, i.e. the second electrode 233 is connected to the rf power input end.

The proximal end of each lead 235 is provided with a first electrode 231, the first electrodes 231 are adhered to the outer wall surface of the expansion part 211, and the first electrodes 231 are arranged at least one connected or discontinuous circle along the circumferential direction of the outer wall surface of the expansion part 211. The distal end of each wire 235 is electrically connected to the connecting sleeve, and then electrically connected to the rf power source through the wire 521 of the pushing member 52 and the connector 562. The first electrode 231 is used as an ablation electrode, and the second electrode 233 is used as an input electrode connected with a radio frequency power supply.

When the ablation occlusion device is used, the distraction portion 211 is supported in the perforation of the interatrial septum, so that the first electrode 231 contacts the interatrial septum; the first positioning portion 213 is located in the left atrium and the positioning surface 2132 contacts the interatrial septum, such that the second electrode 233 contacts the interatrial septum; the first electrode 231 and the second electrode 233 form a current loop, current only flows through the tissue of the interatrial septum between the first electrode 233 and the second electrode 233, and the first electrode 231 receives energy at the output end of the radio frequency power supply to ablate the interatrial septum, so that the tissue of the interatrial septum near the perforation loses activity, and the perforation is prevented from being blocked by repairing endothelium covering of the tissue.

In other embodiments, the electrically exposed area on the positioning surface 2132 of the first positioning portion 213 is at least one connected or discontinuous circle along the circumference of the stretching portion 211, and the supporting frame 21 is electrically connected to the rf power output end through the conducting wire 521 in the pushing member 52, that is, the second electrode 233 is electrically connected to the rf power output end; the first electrode 231 may be connected to the rf power input through a wire in the pusher 52, i.e., the electrically exposed region serves as an ablation electrode for the atrial septum. At this time, the second electrode 233 is an ablation electrode, and the first electrode 231 serves as an input electrode for connecting to a radio frequency power source.

In other embodiments, at least one circle of electrical exposed regions that are connected or disconnected are arranged on the outer wall surface of the stretching portion 211 along the circumferential direction thereof, and the electrical exposed regions are connected to the input end of the radio frequency power source or the output end of the radio frequency power source through the wires in the supporting framework 21 and the pushing member 52, that is, the electrical exposed regions can be used as the ablation electrodes or the electrodes connected to the input end of the radio frequency power source.

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

Referring to fig. 13, fig. 13 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: in the third embodiment, an insulating film 27 is provided between the support skeleton 21 and the ablating member 23. Further, the insulating film 27 is located between the first electrode 231 of the ablating member 23 and the supporting skeleton 21. The insulating film 27 may be, but is not limited to, a teflon film, a polyurethane film, a polyimide film, or the like. The first electrode 231 is an ablation electrode, the second electrode 233 is an input electrode connected with a radio frequency power supply, and the first electrode 231 is used for ablating atrial septal tissue. Since the supporting framework 21 and the first electrode 231 are isolated by the insulating film 27, the insulating film 27 can not only isolate the heat conduction between the ablation electrode and the supporting framework 21, i.e. prevent the energy from being transmitted to the supporting framework 21, so that the heat can be concentrated on the first electrode 231 to ablate the interatrial septum tissue, thereby improving the energy utilization rate; and the insulating film 27 can also form an insulating barrier on the side of the first electrode 231 facing blood, so as to reduce the current density passing through the blood, reduce the heating of the blood by the ablating member 23, and reduce the risk of thrombus formation.

In this embodiment, the insulation film 27 is disposed on the outer wall surface of the supporting framework 21 corresponding to the ablation member 23. 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 23 corresponding to the support frame 21, specifically, the insulating film 27 is adhered to an outer surface of the ablation member 23 facing the support frame 21 by gluing.

The area of the ablation member 23 projected onto the insulation film 27 is located within the insulation film 27, i.e. the projected area of the ablation member 23 on the insulation film 27 is smaller than or equal to the area of the insulation film 27, thereby isolating the heat conduction between the first electrode 231 and the support skeleton 21. .

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

Referring to fig. 14, fig. 14 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 ablation occlusion device provided by the fourth embodiment of the invention has a structure similar to that of the third embodiment, except that: the structure of the ablating member in the fourth embodiment is different from that in the third embodiment, and in the fourth embodiment, the first electrode 231a of the ablating member 23 of the ablation occlusion device 20 includes a plurality of spaced dot-shaped electrodes which are arranged at least one turn in the circumferential direction of the outer wall surface of the support skeleton 21. Specifically, the dot-shaped electrodes are arranged in a circle along the circumferential direction of the outer wall surface of the opening portion 211, and the first electrode 231a is insulated from the support frame 21. The insulation treatment is performed by coating an insulation coating on the outer wall surface of the support frame 21 in contact with the spot-like electrode, or inserting an insulation sleeve on the metal wire in contact with the spot-like electrode and the support frame 21, wherein the insulation sleeve is wrapped on the outer wall surface of the metal wire of the support frame 12, and an insulation film 27 is arranged between the ablation piece 23 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.

In this embodiment, the point-like electrodes are used as ablation electrodes, and are electrically connected to the flexible wire 235 through a wire after being connected in series, and the flexible wire 235 is electrically connected to the radio frequency power source through the connecting member 2152, the connecting sleeve 523, and the wire inside the pushing member.

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

The expanding part 211 of the atrial septum ostomy device 20 in the embodiment expands the perforation on the atrial septum to form the stoma, and the first electrode 231a of the ablation piece 23 on the expanding part 211 can eliminate the tissue on the inner wall of the perforation, so that the endothelium near the perforation can be prevented from attaching to block the perforation, the perforation can be prevented from being blocked, and the smoothness of the perforation can be kept; secondly, the insulation film 27 can also form an insulation barrier on the side of the first electrode 231a of the ablation part 23 facing blood, so as to reduce the current density passing through the blood, reduce the heating of the first electrode 231a to the blood, and reduce the risk of thrombus formation; in addition, the interatrial septum ostomy device 20 can be retrieved after the ostomy is completed, i.e. the interatrial septum ostomy device 20 does not need to remain on the interatrial septum, thereby avoiding the formation of emboli due to the falling off of the instrument; in addition, the current of the ablation member 23 only flows through the interatrial space between the first electrode 231a and the second electrode 233, so that the loss of the radio frequency energy on the electrodes is prevented, the ablation efficiency is improved, and the damage to other tissues of the body is prevented.

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 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 third embodiment, except that: the structure of the ablation member in the fifth embodiment is different from that in the third embodiment, and in the fifth embodiment, the first electrode 231b of the ablation member 23 of the ablation occlusion device 20 is a single-turn intermittent ring-shaped electrode disposed on the outer wall circumference of the support frame 21, and the ring-shaped electrode is insulated from the support frame 21. 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 annular electrode is electrically connected to the lead 235 after being connected in series through a lead, and the lead 235 is connected to the output end of the radio frequency power supply through a connecting sleeve 523 and a lead 521 in the pushing member 52.

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.

In other embodiments, the first electrode 231c of the ablating member 23 can be a single uninterrupted loop electrode disposed on the outer wall of the support framework 21, and the loop electrode is connected to the rf power output via a wire.

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 sixth embodiment of the invention. The ablation occlusion device provided by the sixth embodiment of the invention has a structure similar to that of the third embodiment, except that: the structure of the ablation member in the sixth embodiment is different from that in the third embodiment, in the sixth embodiment, the first electrode 231c of the ablation member 23 includes a plurality of spaced rod-shaped electrodes each extending in the axial direction of the support frame 21, and the rod-shaped electrodes are arranged at least one turn in the circumferential direction of the outer wall surface of the support frame 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 23 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 metal wire in contact with the rod-shaped electrode and the support frame 21, wherein the insulation sleeve is wrapped on the outer wall surface of the metal wire of the support frame 21, and an insulation film 27 is arranged between the ablation piece 23 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.

Referring to fig. 17, fig. 17 is a schematic structural view of an ablation occlusion device of an interatrial septum ostomy system according to a seventh embodiment of the invention. The structure of the ablation occlusion device provided by the seventh embodiment of the invention is similar to that of the first embodiment, except that: in the seventh embodiment, the supporting frame 21 is a metal supporting frame, specifically, the supporting frame 21 is a self-expanding nickel alloy stent, and when the atrial septal ostomy device 20 is in a completely released state, the atrial septal ostomy device 20 also includes a cylindrical opening portion 211, a first positioning portion 213, an extension portion 214, and a recovery portion 215, wherein the first positioning portion 213 is located at one end of the opening portion 211, and the extension portion 214 is located at one end of the opening 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.

The first electrode 231d of the ablation member 23 in this embodiment is an annular electrode disposed on the positioning surface 2132 of the first positioning portion 213, the annular electrode surrounds the distraction portion 211 in a circle along the circumferential direction, a gap is disposed between the annular electrode and the distraction portion 211 in the radial direction, specifically, the radial distance between the annular electrode and the distraction portion 211 may be set to 0-5 mm, and is preferably set to 3 mm; the second electrode 233a is a ring-shaped electrode that surrounds the strut 211 along its outer wall surface by at least one turn. The first electrode 231d is electrically connected to the positioning member 2155 through the flexible wire 238. Specifically, the flexible lead 238 is located in the support frame 21, one end of the flexible lead 238 passes through the support frame 21 and is then welded to the first electrode 231d, the other end of the flexible lead 238 is welded to the positioning element 2155, and the positioning element 2155 is electrically connected to the rf power output end through a lead in the push element 52. The second electrode 233a is connected to the rf power input via another flexible wire 238.

In this embodiment, the first electrode 231d and the second electrode 233a are both a continuous ring-shaped, highly elastic, and flexible metal wire. Such as a nickel-titanium multi-strand wire or a nickel-titanium multi-strand wire wrapped by a gold spring. The first electrode 231d and the second electrode 233a may be attached to the support frame 21 by sewing and/or binding with sutures.

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 wire 238, which is far away from the ablation member 23, passes through the threading hole and then is directly electrically connected to the rf power output terminal or the rf power input terminal.

At least one circle of developing marks 2114 is circumferentially arranged on the outer wall surface of the supporting frame 21 in the expanding portion 211. Specifically, a plurality of through holes 2112 are formed in the expanding portion 211 adjacent to the ablation member 23, and the through holes 2112 are arranged in a circle along the circumference of the expanding portion 211. The proximal ends of the two flexible wires 23 are electrically connected to the first electrode 231d and the second electrode 233a after passing through the two through holes 2112, respectively. Development marks 2114 are provided in the other through holes 2112, that is, these development marks 2114 surround the expanding portion 211 once, so as to facilitate implantation and positioning of the supporting frame 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 radially formed 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 configured as a circular single-layer planar structure, and the side of the circular single-layer planar structure facing the stretching portion 211 is the positioning surface 2132. When the opening part 211 is inserted into the stoma of the interatrial septum, the positioning surface 2132 of the first positioning part 213 contacts the outer peripheral surface of the interatrial septum to prevent the opening part 211 from deviating from the stoma position.

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

The inner and outer surfaces of the supporting frame 21 are coated with an insulating layer, such as parylene insulating coating, so that the first electrode 231d and the second electrode 233a are insulated from the supporting frame 21. Further, an insulating film 27 is provided between the ablating member 23 and the supporting skeleton 21. Specifically, the insulating film 27 is provided in a ring-shaped structure, and the insulating film 27 includes a first ring-shaped insulating film covering one circumference of the first positioning portion 213 adjacent to the spreader portion 211, and a second ring-shaped insulating film covering one circumference of the spreader portion 211 adjacent to the first positioning portion 213. The ablation piece 23 and the support framework 21 can be isolated by using the insulating film 27, so that not only can the heat conduction between the ablation piece 23 and the support framework 21 be isolated, and the energy is prevented from being transmitted to the support framework 21, so that the energy is concentrated on the first electrode 231d, the tissues of the surface of the interatrial septum facing the left atrium and near the perforation are ablated, and the energy utilization rate is improved; the insulation film 27 can form an insulation barrier on one side of the ablation part 23 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 addition, the current of the ablation member 23 only flows through the interatrial space between the first electrode 231d and the second electrode 233a, thereby preventing the loss of the radio frequency energy on the electrodes, improving the ablation efficiency, and preventing the damage of other tissues of the body.

In other embodiments, the insulating film 27 may include only the first annular insulating film covering one circumference of the first positioning portion 213 adjacent to the strut portion 211, that is, the second annular insulating film may be omitted from the insulating film 27. The first ring-shaped insulating film is used to isolate the first electrode 231d from the first positioning portion 213.

The retainer 2155 is attached to the pusher, i.e., the proximal end of the pusher can be threaded onto the retainer 2155, and in particular, the retainer 2155 can be attached to the pusher through the threaded hole 2157. The conductive wire in the pushing element is electrically connected to the positioning element 2155, so that the first electrode 231d is electrically connected to the rf power output end through the flexible conductive wire 238, the positioning element 2155 and the conductive wire in the pushing element; the flexible lead 238 connected to the second electrode 233a is connected to the rf power input via the pusher.

In another embodiment, the first electrode 231d may be at least one ring-shaped electrode disposed on the outer wall surface of the strut 211 around the strut 211, and the insulating film 27 is disposed between the first electrode 231d and the outer wall surface of the strut 211.

In another embodiment, the first electrode 231d may be a wave-shaped ring electrode that is provided around the strut 211 on at least one turn of the outer wall surface of the strut 211 and the positioning surface 2132 of the first positioning portion 213, that is, a part of the wave-shaped ring electrode is positioned on the outer wall surface of the strut 211, another part of the wave-shaped ring electrode is positioned on the positioning surface 2132 of the first positioning portion 213, and the insulating film 27 is provided between the first electrode 231d and the outer wall surfaces of the strut 211 and the first positioning portion 213.

Referring to fig. 18 and 19, fig. 18 is a schematic structural view of a septal stoma system according to an eighth embodiment of the present invention; fig. 19 is a schematic view of the ablation occluding device of the interatrial septum ostomy system of fig. 18 with the addition of an insulating membrane. The atrial septal ostomy system of the eighth embodiment of the present invention is similar in structure to the first embodiment except that: in the eighth embodiment, in a state where the interatrial septum ostomy device 20 is completely released, the supporting frame 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 opposite end of 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 and converges in the axial direction of the expanding portion 211; the proximal end of the second positioning portion 217 is connected to the expanding portion 211, and the distal end extends and converges in the axial direction of the expanding portion 211. In this embodiment, the support frame 21a is a metal support frame, and specifically, the support frame 21a is a self-expandable nickel alloy stent.

In this embodiment, the supporting frame 21a is a braided mesh-like nitinol stent, and when the interatrial septum ostomy device 20 is delivered through a sheath, the diameter of the supporting frame 21a can 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 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 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 on a push rod 2136. When the atrial septal ostomy device 20 is used, the first positioning portion 213a is positioned in the left atrium and the positioning surface 2132 is in abutment with the atrial septum, and the outer surface of the first thrombus trapping cage 2133 is not in abutment with the atrial septum. The ejector pin 2136 is used to smoothly penetrate the perforation in the atrial septum when the atrial septum ostomy device 20 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 extending toward an end away from the distracting portion 211. The distal end of the second thrombus capture cage 2173 closes off to form a second closing-off surface 2175, the second closing-off surface 2175 is a conical surface, and the distal end of the second closing-off surface 2175 merges with a conical tip 2176. When the atrial septum ostomy device 20 is in use, the second locator portion 217 is in the right atrium and the locating surface 2172 is in abutment with the atrial septum, the outer surface of the second thrombus capture cage 2173 is not in abutment with the atrial septum and the conical tip 2176 is adapted to engage the proximal end of the pusher 52 a.

The ablation member 23 in this embodiment includes a first electrode 231f provided on the expansion portion 211, and a second electrode 233b provided on the second positioning portion 217. Specifically, the first electrode 231f is a ring electrode provided with at least one turn of connection or spacing along the circumferential direction of the stretching portion 211, and the second electrode 233b is a ring electrode provided with at least one turn of connection or spacing along the circumferential direction of the stretching portion 211 and provided on the positioning surface 2172 of the second positioning portion 217. Specifically, the first electrode 231f on the opening portion 211 is a continuous ring-shaped electrode; the second electrode 233b is also a continuous ring-shaped electrode, and a gap is provided between the ring-shaped electrode and the spreading portion 211 in the radial direction, specifically, the radial distance between the second electrode 233b and the spreading portion 211 may be set to 0-5 mm, and 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. The first electrode 231f and the second electrode 233b are each sewn or glued to the support skeleton 21 by stitches.

Each ablating member 23 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 23 and the supporting frame 21a are insulated from each other.

In other embodiments, the proximal end of the second positioning portion 217 extends radially to form a plurality of positioning rods, and the plurality of positioning rods surround to form a cone or a circle. The first electrode 231f and/or the second electrode 233b are disposed on the positioning rod such that the first electrode 231f and/or the second electrode 233b contact the atrial septum.

In other embodiments, the proximal end of the second positioning portion 217 radially extends to form a plurality of positioning rods, the plurality of positioning rods surround to form a cone or a circle, and the plurality of positioning points are disposed on the positioning rods. The first electrode 231f and/or the second electrode 233b are disposed on a plurality of the positioning points, such that the first electrode 231f and/or the second electrode 233b contact the atrial septum.

In other embodiments, the proximal end of the second positioning portion 217 radially extends to form a positioning surface, the positioning surface is provided with a plurality of positioning points, and the first electrode 231f and/or the second electrode 233b are/is disposed on the positioning points, so that the first electrode 231f and/or the second electrode 233b contact the atrial septum.

As shown in fig. 19, an insulating film 27 is provided between the outer wall surface of the spacer 211 and the first electrode 231f, and an insulating film 27 is also provided between the positioning surface 2172 of the second positioning portion 217 and the second electrode 233 b; 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 positioning surface 2172 of the second positioner 217 covers the positioning surface 2172 of the second positioner 217 by one turn and extends to the second thrombus capture 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 23 and the supporting framework 21a can be isolated by the insulating film 27, so that heat conduction between the ablation piece 23 and the supporting framework 21a can be isolated, energy is prevented from being transmitted to the supporting framework 21a, energy is concentrated on the ablation piece 23, and tissues on the inner surface of the stoma of the interatrial septum or tissues near the stoma facing away from the surface of the left atrium are ablated, and the energy utilization rate is improved; the insulating film 27 can form an insulating barrier on one 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 addition, the distance between the first electrode 231f and the second electrode 233b is short, so that the distribution of the current of the ablation member 23 is easily controlled, that is, the current only flows through the tissue of the interatrial space between the first electrode 231f and the second electrode 233b, the current can be prevented from damaging other tissues of the human body, and the radio frequency energy can be concentrated on the first electrode 233f for ablation, thereby achieving a better ablation effect.

The first electrode 231f and the second electrode 233b are electrically connected to the rf power output terminal or the rf power input terminal through a wire 521, and the outer surface of the wire 521 is subjected to insulation treatment. Specifically, one end of the wire 521 is connected to the first electrode 231f or the second electrode 233b by welding, and the other end of the wire 521 is connected to the output end of the rf power supply or the input end of the rf power supply through the second thrombus capture cage 2173, the conical tip 2176, and the pushing member 52 a.

The polarity of the first electrode 231f and the second electrode 233b can be selected from, but not limited to, the following two schemes:

1. the first electrode 231f is connected to the rf output port through a wire 521, and the second electrode 233b is connected to the rf power input terminal through a wire 521, without a neutral electrode plate. At this time, the first electrode 231f serves as an ablation electrode, and the second electrode 233b serves as an input electrode for connecting to a radio frequency power source (the input electrode for connecting to the radio frequency power source may also be referred to as a ground electrode).

2. The second electrode 233b is connected to the rf output port via a wire 521, and the first electrode 231f is connected to the rf power input terminal via a wire 521, without a neutral electrode plate. At this time, the second electrode 233b serves as an ablation electrode, and the first electrode 231f serves as an input electrode for connecting a radio frequency power source.

In use of the interatrial septum ostomy device 20 of this embodiment, the distracting portion 211 distracts the perforation 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 is attached to the atrial septum; the second thrombus capture cage 2173 is deployed in the right atrium, and the positioning surface 2172 is attached to the interatrial septum to cover the three-dimensional space region near the heating region of the interatrial septum, preventing emboli formed by blood heating from entering the circulatory system and preventing emboli.

The pusher 52a in this embodiment is made of an insulating polymeric material and the apex 2176 of the second locator portion 217 of the atrial septum ostomy device 20 is attached to the proximal end of the pusher body by heat fusion or adhesive. The inside axial of propelling part 52a has seted up the through wires hole, wire 521 extends to the tail end and with tail end connector 562 electric connection through the inside through wires hole of propelling part 52a, connector 562 is used for electric connection radio frequency power supply.

The interatrial septum ostomy device 20 of this embodiment, when in use, needs to be used in conjunction with a loader, a sheath core, a radio frequency power supply, a power supply connection wire, and the like. 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 20 of the appropriate size is selected. The pusher is passed proximally through the loader and the distal end of the interatrial septum ostomy device 20 is attached to the proximal end of the pusher. The push-back device receives the interatrial septum ostomy device 20 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 20 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 20 (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 are then held in place and the sheath 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 positioning surface 2172 against the surface of the septum facing away from the left atrium.

After confirming that the first electrode 231f on the spreading portion 211 and the second electrode 233b on the second positioning portion 217 are completely attached to the atrial septum, the distal end of the pusher is connected to the rf power source, and the heating parameters (such as power 50W, duration 30S) are set, and then the heating is started.

After the heating is stopped, the interatrial septum ostomy device 20 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.

Referring to fig. 20, fig. 20 is a schematic structural view of a septal ostomy system according to a ninth embodiment of the invention. The ninth embodiment of the present invention provides a compartmental ostomy system having a structure similar to that of the eighth embodiment except that: in the ninth embodiment, the first electrode 231f of the atrial septal ostomy device 20 is disposed on the first positioning portion 213a, and the second electrode 233b is disposed on the distracting portion 211. Specifically, the first electrodes 231f are ring electrodes connected to each other by at least one turn or spaced apart from each other in the circumferential direction of the strut 211 on the positioning surface 2132 of the first positioning portion 213a, and the second electrodes 233b are ring electrodes connected to each other by at least one turn or spaced apart from each other in the circumferential direction of the strut 211.

In this embodiment, the first electrode 231f is a continuous ring of ring electrodes disposed on the positioning surface 2132, a gap is disposed between the ring electrodes and the stretching portion 211 in a radial direction, specifically, a radial distance between the ring electrodes and the stretching portion 211 may be set to 0-5 mm, and is preferably set to 3 mm; the second electrode 233b is a ring-shaped electrode provided on the opening portion 211 in one continuous turn; 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. The first electrode 231f and the second electrode 233b are each sewn or glued to the support skeleton 21a by stitches.

The first electrode 231f can be electrically connected to the rf power output end through a wire 521, and the second electrode 233b is connected to the rf power input end through a wire 521, at this time, the first electrode 231f is used as an ablation electrode, and the second electrode 233b is used as an electrode connected to the rf power input end; or the second electrode 233b can be electrically connected to the rf power output end through the wire 521, the first electrode 231f is connected to the rf power input end through the wire 421, the second electrode 233b serves as an ablation electrode, and the first electrode 231f serves as an electrode connected to the rf power input end. The insulating film 27 is provided between the outer wall surface of the strut 211 and the corresponding second electrode 233b, and the insulating film 27 is also provided between the positioning surface 2132 of the first positioning portion 213a and the corresponding first electrode 231 f. The insulating film 27 on the outer wall surface of the first positioning portion 213a covers the positioning surface 2132 for one circumference and extends to the first thrombus capture cage 2133. The insulating film 27 on the strut members 211 and the insulating film 27 on the positioning surfaces 2132 of the first positioning portions 213a may be two separate insulating films or may be a single insulating film. By using the insulating film 27 to isolate the ablation part 23 and the supporting framework 21a, not only can the heat conduction between the ablation part 23 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 part 23, the tissue on the inner surface of the stoma of the interatrial septum or the tissue facing the left atrium and near the stoma is ablated, and the energy utilization rate is improved; the insulating film 27 can form an insulating barrier on one 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 addition, the distance between the first electrode 231f and the second electrode 233b is short, so that the distribution of the current of the ablating member 23 can be easily controlled, that is, the current flows only through the tissue of the interatrial space between the first electrode 231f and the second electrode 233b, and the current can be prevented from damaging other tissues of the human body.

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

Referring to fig. 21, fig. 21 is a schematic structural view of a atrial septal ostomy system according to a tenth embodiment of the present invention. The construction of a septal ostomy system provided by a tenth embodiment of the invention is similar to that of the eighth embodiment, except that: in the tenth embodiment, the first electrode 231f of the ablating member 23 of the atrial septal ostomy device 20 is disposed on the first positioning portion 213a, and the second electrode 233b is disposed on the second positioning portion 217. Specifically, the first electrodes 231f are ring electrodes connected in at least one turn or spaced apart from each other in the circumferential direction of the spacer 211 on the positioning surface 2132 of the first positioning portion 213a, and the second electrodes 233b are ring electrodes connected in at least one turn or spaced apart from each other in the circumferential direction of the spacer 211 on the positioning surface 2172 of the second positioning portion 217.

In this embodiment, the first electrode 231f is a ring-shaped electrode that is provided on the positioning surface 2132 of the first positioning portion 213a and that is circumferentially continuous around the strut 211 by one turn, and the ring-shaped electrode and the strut 211 are provided with a gap in the radial direction, specifically, the radial distance between the ring-shaped electrode and the strut 211 may be set to 0 to 5mm, and preferably 3 mm. The second electrode 233b is an annular electrode that is disposed on the positioning surface 2172 of the second positioning portion 217 and continuously surrounds the spreading portion 211 in one circle in the circumferential direction, and the annular electrode and the spreading portion 211 are provided with a gap in the radial direction, specifically, the radial distance between the annular electrode and the spreading portion 211 may be set to 0 to 5mm, and 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. The first electrode 231f and the second electrode 233b are each sewn or glued to the support skeleton 21a by stitches.

The first electrode 231f is electrically connected to the radio frequency power supply output end through a lead, the second electrode 233b is connected to the radio frequency power supply input end through a lead, the first electrode 231f is used as an ablation electrode, and the second electrode 233b is used as an electrode connected to the radio frequency power supply input end; or the second electrode 233b is electrically connected to the rf power output end through a wire, the first electrode 231f is connected to the rf power input end through a wire, the second electrode 233b is used as an ablation electrode, and the first electrode 231f is used as an electrode connected to the rf power input end.

Further, an insulating film 27 is provided between the positioning surface 2132 of the first positioning portion 213a and the first electrode 231 f; an insulating film 27 is also provided between the positioning surface 2172 of the second positioning portion 217 and the second electrode 233 b. The ablation piece 23 and the supporting framework 21a can be isolated by using the insulating film 27, so that not only can heat conduction between the ablation piece 23 and the supporting framework 21a be isolated, and energy is prevented from being transmitted to the supporting framework 21a, so that the energy is concentrated on the ablation piece 23, and tissues near a stoma on the surface of the interatrial septum facing the left atrium or tissues near the stoma on the surface back facing the left atrium are ablated, and the energy utilization rate is improved; the insulating film 27 can form an insulating barrier on one 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 addition, the distance between the first electrode 231f and the second electrode 233b is short, so that the distribution of the current of the ablation member 23 is easily controlled, that is, the current only flows through the tissue of the interatrial space between the first electrode 231f and the second electrode 233b, the current can be prevented from damaging other tissues of the human body, the radio frequency energy can be intensively used for the ablation member 23, and a better ablation effect is achieved.

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. 22-25, fig. 22 is a schematic structural view of a septal stoma system according to an eleventh embodiment of the present invention; FIG. 23 is a schematic view of the ablation occluding device of the interatrial septum stoma system of FIG. 22 with the addition of an insulating membrane; FIG. 24 is a cross-sectional view taken along line XXIV-XXIV in FIG. 23; fig. 25 is an enlarged view of the XXV portion in fig. 24. The compartmental ostomy system according to the eleventh embodiment of the present invention is similar in structure to the eighth embodiment except that: in the eleventh embodiment, in a state where the interatrial septum ostomy device 20 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 and converges in the axial direction of the expanding portion 211. In this embodiment, the support frame 21b is a metal support frame, and specifically, the support frame 21b is a self-expandable nickel alloy stent.

In this embodiment, the supporting frame 21b is a braided nickel-titanium alloy stent, the first positioning portion 213b is a single-layer braided mesh structure, and the second positioning portion 217a is a double-layer braided mesh structure. When the interatrial septum ostomy device 20 is delivered through the sheath, the diameter of the support skeleton 21b may be contracted to a smaller state for delivery in the sheath; when released in the heart, the artificial cardiac implant 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 artificial cardiac implant and can strut the perforation of the interatrial septum to form a stoma; the first positioning portion 213b is located in the left atrium and 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 213b 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 shape or a circular shape radially extending outward from the end edge of the expanded portion 211 to form a cone shape, and a second thrombus capture cage 2173 of a conical shape connected to an outer edge of the positioning surface 2172 and extending toward an end away from the expanded portion 211. The distal end of the second thrombus capture cage 2173 closes off and merges with a conical tip 2176. The conical tip 2176 is adapted to engage the proximal end of the pusher member 52 a.

The ablation member 23 in this embodiment includes a first electrode 231f provided on the positioning surface 2172 of the second positioning portion 217a, and a second electrode 233b provided on the positioning surface 2132 of the first positioning portion 213 b. Specifically, the first electrode 231f is an annular electrode which is arranged at least one circle of connected or spaced ring-shaped electrodes along the circumferential direction of the stretching portion 211, a gap is arranged between the annular electrode and the stretching portion 211 in the radial direction, specifically, the radial distance between the annular electrode and the stretching portion 211 can be set to be 0-5 mm, and preferably 3 mm. The first electrode 231f is a flexible metal wire or sheet with high elasticity, such as a nickel-titanium multi-strand wire or a gold spring-wrapped nickel-titanium multi-strand wire. The first electrode 231f is sewn or glued to the positioning surface 2172 of the second positioning portion 217a by a stitch.

The second electrode 233b is an electrically exposed region disposed on the positioning surface 2132, that is, the region of the nickel-titanium alloy of the supporting framework 21b corresponding to the second electrode 233b on the positioning surface 2132 is not coated with an insulating coating, and the electrically exposed nickel-titanium alloy region on the positioning surface 2132 may be at least one circle of region disposed and connected or spaced along the circumferential direction of the stretching portion 211. In this embodiment, the second electrode 233b is a ring of electrically exposed annular nitinol region connected along the circumferential direction of the distraction portion 211, the annular nitinol region and the distraction portion 211 are provided with a gap in the radial direction, and specifically, the radial distance between the annular nitinol region and the distraction portion 211 can be set to 0-5 mm, preferably 3 mm.

The first electrode 231f is electrically connected to the output end of the rf power source through a wire 521, and the outer surface of the wire 521 is insulated. Specifically, one end of the wire 521 is connected to the first electrode 231f by welding, and the other end of the wire 521 passes through the second positioning portion 217a, the conical tip 2176, the pushing member 52a and the connector 562 and is connected to the output end of the rf power supply. The second electrode 233b is connected to the input terminal of the radio frequency power source through a wire 521. Specifically, one end of the 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 input end of the rf power source through the pushing element 52a and the connector 562. At this time, the first electrode 231f serves as an ablation electrode, and the second electrode 233b serves as an input electrode for connecting a radio frequency power source.

In other embodiments, the first electrode 231f is connected to the rf power input terminal through a wire 521, and the second electrode 233b is electrically connected to the rf power output terminal through a wire 521. Specifically, the outer surface of the wire 521 is subjected to insulation treatment, one end of the wire 521 is connected to the first electrode 231f by welding, and the other end of the wire 521 is connected to the input end of the radio frequency power supply through the second positioning portion 217a, the conical top 2176, the pushing member 52a and the connector 562; one end of the other wire 521 is welded to the conical top 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 521 is connected to the output end of the rf power supply through the pushing element 52a and the connector 562. At this time, the second electrode 233b serves as an ablation electrode, and the first electrode 231f serves as an input electrode for connecting to a radio frequency power source.

In other embodiments, the positioning surface 2132 has a plurality of positioning points, and the positioning points are electrically exposed regions.

In other embodiments, the proximal end of the first positioning portion 213b extends radially to form a plurality of positioning rods, and the plurality of positioning rods surround a cone or a circle. The surfaces of the positioning rods contacting the room partition are provided with electric exposed areas.

In other embodiments, the proximal end of the first positioning portion 213b extends radially to form a plurality of positioning rods, and the positioning rods have a plurality of positioning points disposed thereon, and the positioning points are disposed as electrically exposed regions.

As shown in fig. 23, the ablating member 23 and the supporting framework 21b are insulated from each other, and specifically, the supporting framework 21b is coated with an insulating coating, such as a parylene insulating coating, on all surfaces except the surface provided with the second electrode 233b, so as to insulate the ablating member 23 and the supporting framework 21b from each other. Further, the outer wall surface of the second positioning portion 217a is entirely covered with an insulating film 27, and the insulating film 27 insulates the first electrode 231f from the support frame 21 b. The side of the first positioning portion 213b facing away from the spreading portion 211 corresponding to the second electrode 233b 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. The first electrode 231f and the supporting framework 21b can be isolated by using the insulating film 27, so that not only can the heat conduction between the ablation piece 23 and the supporting framework 21b be isolated, and the energy is prevented from being transmitted to the supporting framework 21b, so that the energy is concentrated on the ablation piece 23, and the tissues of the atrial septum facing the surface of the left atrium and the tissues of the left atrium facing away from the surface of the left atrium and the tissues of the atrial septum in the vicinity of the stoma are ablated, thereby improving the energy utilization rate; the insulating film 27 and the insulating coating can form an insulating barrier on one 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 addition, the current only flows through the tissue of the atrial septum between the first electrode 231f and the second electrode 233b, which can prevent the current from damaging other tissues of the human body, and can concentrate the radio frequency energy for the ablation member 23, thereby achieving better ablation effect.

In other embodiments, the side of the first positioning portion 213b facing away from the supporting portion 211 corresponding to the area of the second electrode 233b is provided with an insulating film, and the insulating film is sewn or glued on the supporting frame by sewing.

The polarity of the first electrode 231f and the second electrode 233b in this embodiment is selected to include, but not limited to, the following two schemes:

1. the first electrode 231f is connected to the rf output port through a wire 521, and the second electrode 233b is connected to the rf power input terminal through a wire 521, without a neutral electrode plate. At this time, the first electrode 231f serves as an ablation electrode, and the second electrode 233b serves as an input electrode for connecting a radio frequency power source.

2. The second electrode 233b is connected to the rf output port via a wire 521, and the first electrode 231f is connected to the rf power input terminal via a wire, without a neutral electrode plate. At this time, the second electrode 233b serves as an ablation electrode, and the first electrode 231f serves as an input electrode for connecting to a radio frequency power source.

In this embodiment, the interatrial septum ostomy system is used in combination with a loader, a sheath core, a conductive pusher, a radio frequency power output, a power connection wire, 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. 26 and 27, fig. 26 is a schematic structural view of a interatrial septum ostomy system according to a twelfth embodiment of the invention; fig. 27 is a schematic view of the ablation occluding device of the interatrial septum stoma system of fig. 26 with the addition of an insulating membrane. The construction of a interatrial septum stoma system according to a twelfth embodiment of the invention is similar to that of the eighth embodiment, except that: in a state where the interatrial septum ostomy device 20 is completely released, the support frame 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 and converges along the axial direction of the expanding portion 211; the proximal end of the second positioning portion 217 is connected to the expanding portion 211, and the distal end extends and converges along the axial direction of the expanding portion 211. The first positioning portion 213c and the second positioning portion 217b are both formed in a double-layer woven mesh structure.

In this embodiment, the supporting frame 21c is a braided mesh-like nitinol stent, and when the interatrial septum ostomy device 20 is delivered through the 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.

The first positioning portion 213c includes a positioning surface 2132 radially extending outward from the end edge of the strut 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 strut 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 is closed and fits over a post 2136. the post 2136 is configured to allow the post 2136 to pass smoothly through the perforation 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 conical second thrombus capture cage 2173 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 surface or a conical surface or an arc surface with an approximate plane, and the outer surface of the second positioning portion 217b does not abut against the atrial septum. The distal end of the second thrombus capture cage 2173 closes off and merges with a conical tip 2176, which is adapted to engage the proximal end of the pusher member 52 a.

In this embodiment, the ablation member 23 includes two first electrodes 231f and one second electrode 233b, the two first electrodes 231f are respectively disposed on the positioning surface 2132 of the first positioning portion 213c and the positioning surface 2172 of the second positioning portion 217b, and the second electrode 233b is disposed on the outer wall surface of the opening portion 211. Specifically, the first electrode 231f on the positioning surface 2132 of the first positioning portion 213c is an electrical exposed area disposed on the positioning surface 2132 of the support frame 21c, that is, the outer surface of the support frame 21c is coated with an insulating coating except for the electrical exposed area, and the electrical exposed area on the positioning surface 2132 is circumferentially connected or disposed at least one turn at intervals along the stretching portion 211. In this embodiment, the first electrode 231f on the first positioning portion 213c is disposed in one circle along the circumferential direction of the spreading portion 211, and the radial distance between the first electrode 231f and the spreading portion 211 may be set to 0 to 5mm, preferably 3 mm. The first electrode 231f on the positioning surface 2172 of the second positioning portion 217b is an electrically exposed region disposed on the positioning surface 2172 of the support frame 21c, that is, the outer surface of the support frame 21c is coated with an insulating coating except for the electrically exposed region, and the electrically exposed region on the positioning surface 2172 is circumferentially connected or disposed at intervals for at least one turn along the spreading portion 211. In this embodiment, the first electrode 231f on the second positioning portion 217b is disposed in one circle along the circumferential direction of the spreading portion 211, and the radial distance between the first electrode 231f and the spreading portion 211 may be set to 0-5 mm, preferably 3 mm.

The second electrode 233b of the opening portion 211 is an annular electrode that is arranged along the circumferential direction of the opening portion 211 and is connected in at least one circle or spaced, specifically, the second electrode 233b is an annular electrode of a continuous circle, and the annular electrode is a metal wire or a metal sheet with high elasticity and flexibility, such as a nickel-titanium multi-strand wire or a nickel-titanium multi-strand wire wrapped by a gold spring. The second electrode 233b is sewn or glued to the support skeleton 21c by means of a suture.

The two first electrodes 231f are electrically connected to the rf power output end through the wire 521, specifically, one end of the wire 521 is welded to the conical top 2176 of the supporting frame 21c, so that the supporting frame 21c is electrically connected to the wire 521, and the other end of the wire 521 is connected to the rf power output end through the pushing member 52. The second electrode 233b is connected to the rf power input through another wire 521, specifically, one end of the wire 521 is connected to the second electrode 233b by welding, and the other end of the wire 521 is connected to the rf power input through the second thrombus capture cage 2173, the conical tip 2176, the pusher 52a, and the connector 562. At this time, the two first electrodes 231f are ablation electrodes, and the second electrode 233b is an input electrode connected to a radio frequency power supply.

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

In other embodiments, the two first electrodes 231f are connected to the input end of the rf power source through the wires 521, specifically, one end of the wire 521 is welded to the vertex 2176 of the supporting frame 21c, so that the supporting frame 21c is electrically connected to the wires 521, and the other end of the wire is connected to the input end of the rf power source through the pushing member 52. The second electrode 233b is connected to the output end of the rf power source through another wire 521, specifically, one end of the wire 521 is connected to the second electrode 233b by welding, and the other end of the wire 521 is connected to the output end of the rf power source through the second thrombus capture cage 2173, the conical tip 2176, the pushing member 52a, and the connector 562. At this time, the two first electrodes 231f are both connected to the input end of the rf power source, and the second electrode 233b is an ablation electrode.

In other embodiments, the positioning surface 2172 is provided with a plurality of positioning points, which are configured as electrically exposed areas.

In other embodiments, the proximal end of the second positioning portion 217b extends radially to form a plurality of positioning rods, and the plurality of positioning rods surround to form a cone or a circle. The surfaces of the positioning rods contacting the room partition are provided with electric exposed areas.

In other embodiments, the proximal end of the second positioning portion 217b radially extends to form a plurality of positioning rods, and the positioning rods are provided with a plurality of positioning points, which are electrically exposed regions.

As shown in fig. 27, an insulating film 27 is provided between the strut 211 and the second electrode 233b, that is, the insulating film 27 covers the outer wall surface of the strut 211 around, so that the insulating film 27 insulates the second electrode 233b from the supporting frame 21 c. The inner and outer surfaces of the first positioning portion 213c and the second positioning portion 217b except for the area of the first electrode 231f 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.

Referring to fig. 28, fig. 28 is a schematic structural view of a interatrial septum ostomy system according to a thirteenth embodiment of the invention. The construction of a interatrial septum stoma system in accordance with a thirteenth embodiment of the invention is similar to that of the eighth embodiment, except that: in the thirteenth embodiment, three electrodes are provided, and the three electrodes may include two first electrodes 231f and one second electrode 233b, or two second electrodes 233b and one first electrode 231 f. The first electrode 231f and the second electrode 233b may be provided on one of the outer wall surface of the expansion portion 211, the positioning surface 2132 of the first positioning portion 213a, and the positioning surface 2172 of the second positioning portion 217; the first electrode 231f and the second electrode 233b may be respectively disposed on two of the outer wall surface of the opening portion 211, the positioning surface 2132 of the first positioning portion 213a, and the positioning surface 2172 of the second positioning portion 217; the three electrodes may be provided on the outer wall surface of the opening portion 211, the positioning surface 2132 of the first positioning portion 213a, and the positioning surface 2172 of the second positioning portion 217, respectively.

In this embodiment, the ablating member 23 includes two first electrodes 231f and one second electrode 233b, the two first electrodes 231f are respectively disposed on the positioning surfaces 2132 of the first positioning portions 213a and the outer wall surface of the supporting portion 211, and the second electrode 233b is disposed on the positioning surface 2172 of the second positioning portion 217. Specifically, the first electrodes 231f on the positioning surfaces 2132 of the first positioning portions 213a are annular electrodes that are arranged on the positioning surfaces 2132 and are connected in at least one turn or spaced apart from each other along the circumferential direction of the spreader portion 211; the first electrode 231f on the strut 211 is an annular electrode which is arranged at least one circle of connection or interval along the circumferential direction of the strut 211; the second electrode 233b of the positioning surface 2172 of the second positioning portion 217 is an annular electrode that is provided on the positioning surface 2172 and is provided with at least one turn of connection or spacing along the circumferential direction of the expanding portion 211. 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 ring-shaped electrode is sewn or glued to the supporting skeleton 21a by means of stitches.

The ablators 23 are insulated from the supporting frame 21a, and specifically, an insulating film 27 is provided between the outer wall surface of the expansion portion 211 and the corresponding first electrode 231f, an insulating film 27 is also provided between the outer wall surface of the first positioning portion 213a and the corresponding first electrode 231f, and an insulating film 27 is also provided between the outer wall surface of the second positioning portion 217 and the second electrode 233 b. 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. By using the insulating film 27, the ablation part 23 and the supporting framework 21a can be isolated, so that not only can heat conduction between the ablation part 23 and the supporting framework 21a be isolated, and energy is prevented from being transmitted to the supporting framework 21a, so that the energy is concentrated on the ablation part 23, and tissues on the inner surface of the stoma of the interatrial septum and tissues on the vicinity of the stoma facing the left atrium can be ablated, and the energy utilization rate is improved; the insulating film 27 can form an insulating barrier on one 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 current only flows through the tissue of the interatrial space between the first electrode 231f and the second electrode 233b, which can prevent the current from damaging other tissues of the human body, and can concentrate the radio frequency energy for the ablation member 23, achieving better ablation effect.

The polarity of the two first electrodes 231f and the second electrodes 233b on the supporting skeleton 21a can be selected from the following four schemes:

1. the two first electrodes 231f are electrically connected to the rf output port through the wires 521, and the second electrode 233b is connected to the rf power input port through the wires 521.

2. The second electrode 233b is electrically connected to the rf output port through a wire 521, and the two first electrodes 231f are connected to the rf power input terminal through a wire 521.

3. One of the first electrodes 231f and the second electrode 233b is connected to the rf output port through a wire 521, and the other first electrode 231f is connected to the rf power input terminal through a wire 521.

4. The two first electrodes 231f and the second electrodes 233B are respectively connected with the phase-A, phase-B and phase-C output ports of the three-phase voltage source, the three ports output three paths of sinusoidal alternating currents 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 source.

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. The utility model provides an improve interatrial septum ostomy device that melts mode, its is including being used for strutting the fenestrate support chassis on the interatrial septum, its characterized in that, interatrial septum ostomy device still including set up in ablation piece on the support chassis, ablation piece includes first electrode and second electrode, one of them electrode electric connection in first electrode and the second electrode is in radio frequency power supply output, and radio frequency power supply input is connected to another electrode to the energy that forms the electric current return circuit and receive radio frequency power supply melts the interatrial septum.

2. The atrial septal ostomy device of claim 1, wherein the supporting framework comprises a distraction portion for distracting the perforation, and a positioning portion provided at an end of the distraction portion, the first electrode and the second electrode being provided at one of the distraction portion and the positioning portion; or the first electrode and the second electrode are respectively arranged on the opening part and the positioning part.

3. The interatrial septum ostomy device according to claim 2, wherein when the distraction portion is received in the perforation, the distraction portion exerts a radial supporting effect on an inner wall of the perforation, the positioning portion is located in the left atrium, the positioning portion is provided with a positioning surface, a positioning line or a positioning point contacting the interatrial septum, and the first electrode and/or the second electrode is/are provided on the positioning surface, the positioning line or the positioning point.

4. The atrial septal ostomy device of claim 2, wherein the supporting framework is a metal supporting framework, an electrical exposed region contacting the atrial septal is arranged on the supporting framework, and the supporting framework is electrically connected to the radio frequency power output end or the radio frequency power input end, so that the electrical exposed region forms the first electrode or the second electrode of the ablation member.

5. The atrial septal ostomy device of claim 4, wherein the outer surface of the support framework is coated with an insulating coating except for the electrically exposed region.

6. The atrial septal ostomy device of claim 4, wherein the electrical exposed area is provided on the outer wall surface of the distraction portion, and the electrical exposed area is provided with at least one connected or discontinuous circle along the circumferential direction of the outer wall surface of the distraction portion.

7. The atrial septal ostomy device of claim 4, wherein the positioning portion comprises a positioning surface, a positioning line or a positioning point contacting the atrial septum, the positioning surface, the positioning line or the positioning point is provided with the electrical exposed region, and the electrical exposed region is provided with at least one connected or discontinuous circle along the circumferential direction of the distraction portion.

8. The atrial septal ostomy device of claim 2, wherein the first electrode and/or the second electrode is a ring-shaped electrode disposed on the outer wall surface of the distracting portion and/or the positioning portion, the ring-shaped electrode being disposed at least one continuous or intermittent turn along the circumferential direction of the outer wall surface of the distracting portion.

9. The atrial septal ostomy device of claim 2, wherein the first electrode and/or the second electrode is a plurality of point-like electrodes or strip-like electrodes disposed on the opening portion or the positioning portion, the plurality of point-like electrodes or strip-like electrodes encircle the supporting framework for one circle, and the plurality of point-like electrodes or strip-like electrodes are connected in series through a lead and then connected to an input end or an output end of a radio frequency power supply.

10. The atrial septal ostomy device of claim 8 or 9, wherein the ablating member is insulated from the supporting framework.

11. The atrial septal ostomy device of claim 10, wherein an outer surface of the support skeleton is coated with an insulating coating.

12. The atrial septal ostomy device of claim 10, wherein an insulating film is disposed between the first electrode or the second electrode electrically connected to the rf power source and the support frame.

13. The atrial septal ostomy device of claim 10, wherein an insulating coating is disposed between the first electrode or the second electrode electrically connected to the rf power source and the support frame.

14. The interatrial septum ostomy device of claim 1, wherein at least one circle of developing marks is circumferentially disposed on the outer wall surface of the distraction portion on the supporting skeleton.

15. The atrial septal ostomy device of claim 1, wherein the supporting framework comprises a distraction portion for distracting the perforation, a first positioning portion at one end of the distraction portion, and a second positioning portion at the opposite end of the distraction portion, the first and second electrodes being disposed together on one of the distraction portion, the first positioning portion, and the second positioning portion; or the first electrode and the second electrode are respectively arranged on two of the opening part, the first positioning part and the second positioning part.

16. The atrial septal ostomy device of claim 15, wherein the first electrode and the second electrode are ring-shaped electrodes that are connected or interrupted by at least one turn along the outer wall surface of the distraction portion.

17. The atrial septal ostomy device of claim 15, wherein the first positioning portion and the second positioning portion are each provided with a positioning surface, a positioning line or a positioning point contacting the atrial septum, and the first electrode and the second electrode are together provided on the positioning surface, the positioning line or the positioning point of the first positioning portion or the positioning surface, the positioning line or the positioning point of the second positioning portion; or the first electrode and the second electrode are respectively arranged on the positioning surfaces, the positioning lines or the positioning points of the first positioning part and the second positioning part.

18. The atrial septal ostomy device of claim 17, wherein the first electrode or the second electrode is a ring-shaped electrode that is connected or interrupted by at least one turn disposed circumferentially of the distracting portion.

19. The atrial septal ostomy device of claim 17, wherein the supporting framework is a metal supporting framework, an electrical exposed region is disposed on one of an outer wall surface of the distraction portion of the metal supporting framework, a positioning surface, a positioning line or a positioning point of the first positioning portion, a positioning surface, a positioning line or a positioning point of the second positioning portion, and the supporting framework is electrically connected to the output end of the radio frequency power supply or the input end of the radio frequency power supply, so that the electrical exposed region forms the first electrode or the second electrode of the ablation member.

20. The atrial septal ostomy device of claim 17, wherein the supporting framework is a metal supporting framework, two of the outer wall surface of the distraction portion of the metal supporting framework, the positioning surface, the positioning line or the positioning point of the first positioning portion, the positioning surface, the positioning line or the positioning point of the second positioning portion are respectively provided with an electrical exposed area, and the supporting framework is electrically connected to the output end of the radio frequency power supply or the input end of the radio frequency power supply, so that the two electrical exposed areas together form the first electrode or the second electrode of the ablation member.

21. The atrial septal ostomy device of claim 19 or 20, wherein the electrically exposed region is provided in at least one contiguous or intermittent turn around the circumference of the distracting portion.

22. The atrial septal ostomy device of claim 21, wherein a gap exists between the electrically exposed region and a radial direction of the distracting portion.

23. The atrial septal ostomy device of claim 17, wherein the first locator further comprises a first thrombus capture device attached to an outer edge of the locating surface of the first locator and/or the second locator.

24. A compartmental ostomy system comprising a compartmental ostomy device according to any of claims 1-23, ostomy device control means for controlling the compartmental ostomy device and a radio frequency power source electrically connected to the compartmental ostomy device via the ostomy device control means.