CN212346703U - Adjustable interatrial septum ostomy device - Google Patents

Abstract

The utility model provides an adjustable interatrial septum stoma device, which comprises a stoma piece for forming a stoma on an interatrial septum, wherein the stoma piece comprises a stoma main body capable of radially expanding and an ablation part arranged on the stoma main body and used for ablating tissues around the stoma, the adjustable interatrial septum stoma device further comprises an adjusting mechanism connected with the stoma main body and a control piece controlling the near end of the stoma main body, and the adjusting mechanism is matched with the control piece to adjust the radial dimension of the ablation part arranged on the stoma main body so as to adjust the stoma to a proper size; the ablation part contacts the interatrial septum tissue near the stoma, the ablation part receives radio frequency energy to the interatrial septum in the tissue at the stoma is ablated to make the interatrial septum tissue near the stoma lose activity, prevent to climb to cover the stoma to be blocked because of the repair endothelium of the tissue, and pass through behind the stoma of the adjustable interatrial septum ostomy device, the shape behind the stoma can be fixed.

Description

Adjustable interatrial septum ostomy device

Technical Field

The utility model relates to an intervene medical instrument technical field, especially relate to an adjustable interatrial septum ostomy device of percutaneous intervention.

Background

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

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

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

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

Conventional interatrial septum ostomy methods such as balloon interatrial septum ostomy, interatrial septum cutting, grasping devices, atrial shunt implantation devices, and the like; however, there is a tendency for the myocardial tissue to rebound after the stoma, which can cause problems with stoma shrinkage and even closure; interatrial septum cutting and grasping devices that may loosen during the grasping device procedure or cause the cut tissue to fall off and form emboli during retrieval; the atrial shunt implantation device is easy to cause thrombosis or appliance falling off to form embolism and the like. In order to solve the problem of stoma reduction and even closure, the prior art provides an ostomy support which is characterized in that after percutaneous interatrial puncture, a shunt device is implanted at the interatrial puncture position by delivering an implant percutaneously so as to keep the shunt opening unobstructed.

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, the stoma diameter of the stoma stent cannot be adjusted, as it cannot.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide a make mouthful be difficult for the shutoff and can adjust the interatrial septum of making mouthful device with adjustable in aperture.

In order to solve the technical problem, the utility model provides an interatrial septum ostomy device with adjustable, it is including being used for forming the ostomy piece of the mouth that makes on the interatrial septum, make mouthful piece including can radial expansion make mouthful main part and set up in it is used for melting to make mouthful main part make the portion of melting of tissue around the mouth, adjustable interatrial septum ostomy device still including connect in make the adjustment mechanism and the control of mouthful main part distal end make the control of mouthful main part near-end, the adjustment mechanism cooperation the control is adjusted make mouthful main part be provided with melt the radial dimension of portion department.

Preferably, the adjusting mechanism comprises a traction piece inserted into the stoma body in an axial sliding manner, and an adjusting piece arranged between the traction piece and the stoma body, and the traction piece slides in the axial direction to drive the adjusting piece to adjust the radial size of the stoma body.

Preferably, the stoma body comprises at least a stoma portion having a cylindrical structure, the ablation portion is located at an outer peripheral wall of the stoma portion, and the adjustment member is connected between the stoma portion and the traction member, and is used for adjusting a radial dimension of the stoma portion.

Preferably, the adjusting member comprises a plurality of connecting rods, one end of each connecting rod is connected to the stoma portion, the other opposite end is connected to the traction member, and the plurality of connecting rods are arranged in a circle along the circumferential direction of the stoma portion.

Preferably, a plurality of the connecting rods are evenly arranged at intervals in a circle, and one end of each connecting rod, which is far away from the traction piece, is connected to the middle or the far end of the stoma part.

Preferably, the connecting rod is made of a rigid material, the connecting rod transmitting a pushing force expanding the radial dimension of the stoma portion or a pulling force contracting the radial dimension of the stoma portion.

Preferably, the adjusting part further comprises a converging part arranged on the traction part, and one ends of the connecting rods, which are far away from the stoma part, are respectively connected to the converging part.

Preferably, the converging part is a cutting pipe head or a steel sleeve, the converging part is fixedly connected to the far end of the traction part, and the far ends of the connecting rods are fixedly connected to the cutting pipe head or the steel sleeve.

Preferably, the traction piece moves towards the near end along the axial direction to drive the connecting rod to push the stoma portion, so that the stoma portion is radially expanded; the traction piece moves towards the far end along the axial direction to drive the connecting rod to pull the stoma part, so that the stoma part is contracted in the radial direction.

Preferably, the stoma portion is located at a distal or central portion of the stoma body.

Preferably, the proximal end of the stoma body is provided with a recovery portion, the control member being connected to the recovery portion.

Preferably, the stoma body further comprises a distal end positioning portion and a proximal end positioning portion, the distal end positioning portion is disposed at the distal end of the stoma portion, the proximal end positioning portion is disposed at the proximal end of the stoma portion, and the distal end positioning portion and the proximal end positioning portion are attached to the interatrial space on two opposite side surfaces of the stoma.

Preferably, the distal positioning part and the proximal positioning part are disc-shaped structures and/or spherical structures; the maximum diameter of the distal positioning portion and/or the proximal positioning portion is larger than the diameter of the stoma portion.

Preferably, the ablation part is arranged on one of the stoma part, the distal positioning part and the proximal positioning part; or the ablation part is respectively arranged on the stoma part, the distal end positioning part and the proximal end positioning part; or the ablation part is respectively arranged on the stoma part, the distal end positioning part and the proximal end positioning part.

Preferably, at least one circle of developing points or developing wires is arranged on one of the stoma part, the distal end positioning part and the proximal end positioning part; or at least one circle of developing points or developing wires are respectively arranged on the stoma part, the far-end positioning part and the near-end positioning part; or at least one circle of developing points or developing wires are respectively arranged on the stoma part, the far-end positioning part and the near-end positioning part.

Preferably, the stoma body is a supporting framework made of a conductive material, the ablation part is a part of the supporting framework which is not subjected to insulation treatment, and the outer surfaces of the supporting framework except the ablation part are coated with an insulation coating or fixed insulation sleeves.

Preferably, the ablation part is a ring-shaped electrode which is arranged at least one continuous or discontinuous circle along the circumferential direction of the outer wall surface of the stoma body; or the ablation part is a plurality of point-like electrodes or strip-like electrodes, and the plurality of point-like electrodes or strip-like electrodes are arranged at least one circle along the circumferential direction of the outer wall surface of the ostomy piece.

The utility model discloses a interatrial septum is made mouthful device with adjustable is including forming interatrial septum on the ostomy piece and connect in the adjustment mechanism of making an oral cavity distal end and the control of near-end, make an oral cavity piece including can radial expansion and radial contraction make the oral cavity main part and set up in it is used for melting the portion of melting of making the tissue around the oral cavity to make the oral cavity main part. Adjusting the radial dimension of the stoma body to adjust the stoma to a suitable size by cooperation of the adjustment mechanism and the control member; the ablation part contacts the interatrial septum tissue near the stoma, the ablation part receives a radio frequency power supply to the interatrial septum in the tissue at the stoma is ablated to make the interatrial septum tissue near the stoma lose activity, prevent to climb to cover the stoma to be blocked because of the repaired endothelium of the tissue, and pass through after the stoma of the adjustable interatrial septum ostomy device, the shape after the stoma can be fixed. Therefore, the stoma shape processed by the adjustable interatrial septum stoma device is more regular and is not easy to block, the smoothness of the stoma can be kept, and the blood shunting in the left and right atrium rooms is smooth.

Drawings

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

FIG. 1 is a schematic view of an adjustable interatrial septum ostomy device according to a first embodiment of the present invention;

FIG. 2 is a schematic view of a portion of the pulling member and converging member of the adjustable interatrial septum ostomy device of FIG. 1;

FIGS. 3 to 5 are schematic views illustrating the operation of the adjustable interatrial septum ostomy device according to the first embodiment of the present invention;

FIG. 6 is a schematic view of an adjustable interatrial septum ostomy device according to a second embodiment of the present invention;

FIG. 7 is a schematic view of an adjustable interatrial septum ostomy device according to a third embodiment of the present invention;

FIG. 8 is a schematic view of an adjustable interatrial septum ostomy device according to a fourth embodiment of the present invention;

FIG. 9 is a schematic view of an adjustable interatrial septum ostomy device according to a fifth embodiment of the present invention;

FIG. 10 is a schematic view of an adjustable interatrial septum ostomy device according to a sixth embodiment of the present invention;

FIG. 11 is a schematic view of an adjustable interatrial septum ostomy device according to a seventh embodiment of the present invention;

FIG. 12 is a schematic view of an adjustable interatrial septum ostomy device according to an eighth embodiment of the present invention;

Detailed Description

The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without any creative effort belong to the protection 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 near the conveyor attachment location, and the "distal end" refers to the end away from the conveyor attachment location. The axial direction refers to the direction of the central axis of the device, and the radial direction is the direction perpendicular to the central axis, and this definition is only for the convenience of expression and can not be understood as the limitation of the present invention.

Referring to fig. 1, fig. 1 is a schematic structural view of an adjustable interatrial septum ostomy device 100 according to a first embodiment of the invention. The utility model provides an adjustable interatrial septum ostomy device 100, which comprises an ostomy piece 20 for forming an ostomy on the interatrial septum, an adjusting mechanism 50 connected to the far end of the ostomy piece 20 and a control piece 30 connected to the near end; the ostomy member 20 comprises an ostomy body 21 capable of radial expansion and radial contraction and an ablation portion 23 arranged on the ostomy body 21 for ablating the tissue surrounding the stoma, the proximal end of the ostomy body 21 comprises a recovery portion 215, and the proximal end of the recovery portion is connected with the control member 30. The adjustment mechanism 50 and the control member 30 are moved relatively to adjust the radial dimension of the stoma body 21 where the ablation portion 23 is provided, to adjust the stoma to a suitable size; the ablation part 23 is attached to the interatrial septum tissue at the stoma, the ablation part 23 is electrically connected to the radio frequency power supply, and the ablation part 23 receives energy output by the radio frequency power supply to ablate the tissue around the stoma at the interatrial septum and is used for ablating the tissue around the stoma.

The utility model discloses an interatrial septum ostomy device 100 with adjustable includes the ostomy piece 20 that forms the stoma on the interatrial septum and connects in the adjustment mechanism 50 of the ostomy piece 20 distal end and the control 30 of near-end, and ostomy piece 20 includes the stoma main part 21 that can radial expansion and radial contraction and sets up in the department of melting 23 that stoma main part 21 is used for melting the peristomal tissue. The proximal end of the stoma body 21 includes a reclamation portion 215 that is proximally connected to the control member 30. The control member 30 stabilizes the stoma body 21 against displacement of the stoma 20 when the adjustment mechanism 50 adjusts the radial dimension of the stoma body 21 to adjust the stoma to a suitable size; ablation portion 23 contacts interatrial septum tissue near the stoma, ablation portion 23 to interatrial septum in the tissue of stoma department melts, so that interatrial septum tissue near the stoma loses activity, prevents to climb to cover because of the repair endothelium of tissue and will make the stoma to block up, and after making the mouth through adjustable interatrial septum ostomy device 100, can fix the form after making the mouth. Therefore, the stoma shape processed by the adjustable interatrial septum stoma device 100 is more regular and not easy to be blocked, and the smoothness of the stoma can be kept, so that the blood in the left and right atrium can be smoothly shunted.

The ostomy body 21 is a radially expandable and contractible ostomy device, and in particular, the ostomy body 21 may be an elastic metal supporting framework or an elastic non-metal supporting framework. In this embodiment, the stoma body 21 is a nickel alloy stent and the proximal control member 30 is a tubular structure connecting the stoma body 21 and the delivery device. When the adjustable interatrial septum ostomy device 100 is delivered through a sheath, the diameter of the ostomy body 21 may be contracted to a smaller state for delivery in the sheath; when the adjustable interatrial septum ostomy device 100 is released in the heart, the ostomy body 21 may automatically expand and adjust the radial dimension of the ostomy portion 210 to the desired stoma inner diameter dimension via the adjustment mechanism 50 so that the ostomy body 21 can distract the perforation in the interatrial septum to form the stoma. The adjustment mechanism 50 exerts a radial pushing force on the stoma body 21 so that the stoma body 21 exerts a radial supporting effect on the inner wall of the perforation within said perforation, thereby obtaining a stoma of suitable size. At this time, the ablation part 23 of the stoma body 21 is attached to the interatrial septum tissue near the perforation, and the ablation part 23 receives radio frequency energy to ablate the tissue at the perforation, so that the interatrial septum tissue near the perforation is inactivated, thereby preventing the stoma from being blocked by the repair endothelium covering of the tissue, and fixing the shape after the stoma is made by the adjustable interatrial septum ostomy device 100.

The stoma body 21 can be cut by a nickel alloy tube, and the stoma body 21 is of a cylindrical frame structure after being released in the heart so as to keep the atrial septal passage smooth; the stoma body 21 may also be woven from nickel alloy wire or may be machined by local weaving combined with local tube cutting, and the different parts may be welded or fixed to each other by connectors. The material of the tube is stainless steel, cobalt-chromium alloy or memory metal material or biocompatible non-metal material, such as nickel-titanium alloy material. The overall shape of the stoma body 21 may be any suitable shape such as a straight cylinder, a disk, a cone, etc., and is not limited thereto. The control member 30 is made of a polymer material or a metal material, such as stainless steel, and when the control member 30 is made of a conductive metal material, the proximal end thereof is connected to the radio frequency energy source.

The stoma body 21 is a support skeleton made of a conductive material, and the outer wall surface and the inner wall surface of the support skeleton can be subjected to insulation treatment. In this embodiment, the control member 30 is connected to the rf source, and is configured to transmit the rf energy to the supporting framework of the stoma body 21, and the portions of the outer wall surface and the inner wall surface of the stoma body 21, except for the ablation portion 23, are coated with insulating parylene, which may be, but is not limited to parylene, teflon, polyurethane, or polyimide, etc. The ablation part 23 is a part of the supporting framework which is not subjected to insulation treatment on the outer wall surface of the supporting framework, namely a circle of electrical exposed area of the outer wall surface of the stoma body 21.

In other embodiments, the nickel alloy rod of the stoma body 21 may also be sheathed with an insulating sleeve in addition to the ablation portion 23.

In the present embodiment, as shown in fig. 1, in a state where the interatrial septum ostomy device 20 is completely released, the stoma body 21 includes a cylindrical stoma portion 210 and a recovery portion 215 provided at the proximal end of the stoma portion 210. The stoma portion 210 may be located at the distal or middle portion of the stoma body 21, in this embodiment the stoma portion 210 is located at the distal end of the stoma body 21. Specifically, the stoma portion 210 is formed by a plurality of rhombic structure units which are continuously and circumferentially arranged in a circle, and the stoma portion 210 is in a straight cylinder shape. The stoma portion 210 includes a plurality of support sheets 211 extending along an axial direction, a first extension sheet 213 having a wave-shaped structure and disposed at a distal end of the plurality of support sheets 211, and a second extension sheet 214 having a wave-shaped structure and disposed at a proximal end of the plurality of support sheets 211, wherein each wave trough of the first extension sheet 213 is connected to a distal end of the corresponding support sheet 211, and each wave crest of the second extension sheet 214 is connected to a proximal end of the corresponding support sheet 211. The plurality of supporting pieces 211 are arranged in a circle at uniform intervals along the circumference of the stoma body 21, and the first extending piece 213 and the second extending piece 214 also enclose a circle along the circumference of the stoma body 21. The first extension piece 213 is rounded at each peak to avoid damaging the atrial tissue.

In other embodiments, the stoma body 21 may also be a mesh stent, a rod stent, a multi-layered wave stent, or a combination thereof forming a tubular or ring structure. The reticular stent has an obvious warp-weft staggered structure or a repeated unit lattice structure, and can adopt a weaving mode or a cutting mode; 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 troughs, and the wave rods which are adjacent in the circumferential direction are connected at the far end to form the wave crests; 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 stoma portion 210 may be various, for example, the stoma portion 210 may be a curved shape, a cylindrical shape, an elliptical cylindrical shape, or a combination thereof, with an outer sidewall being concave or/and convex. The curved surface shape is a closed curved surface structure formed in the circumferential direction, the convex and concave positions can be set as required, and the convex structure or the concave structure can be formed independently. The convex structure is as follows: disc, table shape etc., concave structure is as follows: the waist drum shape, which is a cylindrical structure in this embodiment, forms an integral cylindrical structure with the straight cylindrical smooth transition of the stoma portion 210. The axial length of the stoma portion 210 is set according to actual needs, generally matching the thickness of the atrial septum.

The stoma portion 210 includes a support sheet 211, a first extension sheet 213 at the distal end of the support sheet 211, and a second extension sheet 214 at the proximal end. The supporting sheet 211 is provided with a positioning surface, a positioning line or a positioning point contacting with the atrial septum, specifically, the outer wall of the supporting sheet 211 is provided with a positioning surface, a positioning line or a positioning point capable of pressing the tissue of the atrial septum, and the ablation part 23 may be disposed on the positioning point, the positioning line or the positioning surface of the first extending sheet 213.

In this embodiment, the outer wall of the supporting sheet 211 is provided with a positioning surface for pressing the atrial septal tissue, and the ablation portion 23 is disposed on the positioning surface of the supporting sheet 211. The first extension piece 213 may also be provided with a positioning surface, a positioning line or a positioning point contacting the atrial septum, specifically, the outer wall of the first extension piece 213 is provided with a positioning surface, a positioning line or a positioning point capable of abutting the atrial septum tissue, and the positioning surface, the positioning line or the positioning point abuts the atrial septum tissue to prevent the adjustable atrial septum ostomy device 100 from moving to the proximal end; the ablation part 23 may be disposed on the location point, location line or location plane of the first extension piece 213. The second extending piece 214 may also be provided with a positioning surface, a positioning line or a positioning point which contacts the atrial septum, specifically, the outer wall of the second extending piece 214 is provided with a positioning surface, a positioning line or a positioning point which can press the atrial septum tissue, and the positioning surface, the positioning line or the positioning point is abutted against the atrial septum tissue to prevent the adjustable atrial septum ostomy device 100 from moving to the far end; the ablation part 23 may be provided on the positioning point, the positioning line, or the positioning plane of the second extension piece 214.

In other embodiments, the ablation portions 23 may be respectively disposed on one of the support sheet 211, the first extension sheet 213 and the second extension sheet 214; the ablation portion 23 may be disposed on two of the support sheet 211, the first extension sheet 213, and the second extension sheet 214; alternatively, the support sheet 211, the first extension sheet 213, and the second extension sheet 214 may be provided with the ablation portion 23. The recovery part 215 is conical and comprises a plurality of extension pieces 216 arranged at the far end and a connecting head 218 arranged at the near end, the plurality of extension pieces 216 are connected between the second extension piece 214 and the connecting head 218, the control member 30 is arranged at the near end of the connecting head 218 and is used for connecting the stoma body 21 and the conveying device, and meanwhile, when the radial dimension of the stoma portion 210 is adjusted, the control member 30 can fix the near end of the stoma body 21 or control the near end of the stoma body 21 and the adjusting mechanism 50 to move towards each other, so that the change of the radial dimension of the stoma portion 210 is controlled. The proximal end of the control member 30 is made of a polymer material or a metal material such as stainless steel, and when the control member 30 is made of a conductive metal material, the outer surface or the contact position with the connector 218 is insulated.

Specifically, the distal end of each extension piece 216 is connected to the corresponding trough of the second extension piece 214, and the proximal end of each extension piece 216 is connected to the connector 218. The connector 218 is a tubular structure having a released outer diameter that is less than the released outer diameter of the second extension piece 214.

As shown in fig. 1, in the present embodiment, a plurality of supporting sheets 211 are annularly arrayed one turn along the axis of the stoma portion 210, each supporting sheet 211 extends along the axis of the stoma portion 210, the side of each supporting sheet 211 facing away from the axis of the stoma portion 210 is provided with an ablation portion 23, and the ablation portions 23 form one turn along the circumference of the stoma portion 210. When the stoma body 21 is released in the through hole at the interatrial septum tissue, the adjusting mechanism 50 adjusts the diameter of the stoma portion 210, so that the stoma portion 210 and the adjusting mechanism 50 prop open the through hole to a proper size to form a stoma with a proper size, the ablation portion 23 is connected with a radio frequency power supply, and the ablation portion 23 further transmits radio frequency energy to the ablation portion 23 at the through hole to ablate the stoma tissue, so as to prevent the stoma tissue from rebounding, and better maintain the stoma shape.

The stoma portion 210 is provided with a developing point or a developing wire, and the developing point or the developing wire is fixed by means of inlaying and hot pressing. Specifically, each supporting piece 211 is provided with a mounting hole 2110, a plurality of developing points are arranged in the mounting holes 2110, and the developing points in the mounting holes 2110 surround a circle, so that the positioning from the stoma part 210 to the through hole of the room space is facilitated. The developing point or the developing wire can be made of gold, platinum, tantalum and other materials.

In other embodiments, at least one circle of developing dots or developing filaments is disposed on one of the supporting sheet 211, the first extending sheet 213 and the second extending sheet 214; that is, the supporting sheet 211 is provided with at least one turn of developing dots or developing wires, the first extending sheet 213 is provided with at least one turn of developing dots or developing wires, or the second extending sheet 214 is provided with at least one turn of developing dots or developing wires.

In other embodiments, two of the support sheet 211, the first extension sheet 213 and the second extension sheet 214 are respectively provided with at least one circle of developing points or developing wires; that is, the supporting sheet 211 and the first extending sheet 213 are respectively provided with at least one circle of developing dots or developing wires, or the supporting sheet 211 and the second extending sheet 214 are respectively provided with at least one circle of developing dots or developing wires.

In other embodiments, the supporting sheet 211, the first extending sheet 213 and the second extending sheet 214 are respectively provided with at least one circle of developing dots or developing wires.

Further, the developing points or the developing wires are arranged at the position of the ablation part 23 or on the surrounding structure thereof and used for marking the position of the ablation part and accurately positioning the ablation area.

Referring to fig. 1 and 2, the adjustment mechanism 50 includes a pulling member 52 axially slidably inserted in the stoma body 21, an adjustment member 53 disposed between the pulling member 52 and the stoma body 21, and a converging member 55 disposed at a distal end of the pulling member 52. The pulling member 52 axially penetrates the control member 30, and the pulling member 52 axially slides relative to the control member 30 to drive the adjusting member 53 to adjust the radial dimension of the stoma body 21. In this embodiment, the pulling member 52 is a pulling rod slidably inserted in the axial direction into the stoma body 21, and the merging member 55 is fixed to a distal end of the pulling rod; an adjustment member 53 is connected between the stoma portion 210 and the pulling member 52, the adjustment member 53 being used to adjust the radial dimension of the stoma portion 210.

The regulating member 53 comprises two or more connecting rods 532, and the connecting rods 532 are arranged in one turn in the circumferential direction of the stoma portion 210; one end of each connecting rod 532 is connected to the stoma portion 210 and the opposite end of each connecting rod 532 is connected to the junction 55. In this embodiment, the number of the connecting rods 532 is the same as the number of the supporting sheets 211, the connecting rods 532 are arranged at intervals along the circumference of the stoma portion 210, the proximal end of each connecting rod 532 is connected to the distal end of the corresponding supporting sheet 211, i.e. the proximal end of each connecting rod 532 is connected to the corresponding trough of the first extending sheet 213. The connecting rods 532 are evenly arranged in a circle at intervals along the circumferential direction of the stoma portion 210, so that the stress of the stoma portion 210 is even, and the radial size of the stoma portion 210 can be adjusted more conveniently.

In this embodiment, when the adjustable interatrial septum ostomy device 100 is in an expanded state, the converging part 55 is located at the distal end of the ostomy portion 210, and the included angle between each connecting rod 532 and the axial lead of the ostomy portion 210 is less than 90 degrees, i.e. the proximal end and the distal end of each connecting rod 532 form a certain angle with respect to the horizontal plane, and the size of the angle can be set according to actual needs. The connecting rod 532 is made of a rigid material and is fixed to the stoma portion 210 by metal welding, and the connecting rod 532 transmits a pushing force for expanding the radial dimension of the stoma portion 210 or a pulling force for contracting the radial dimension of the stoma portion 210, thereby facilitating adjustment of the radial dimension of the stoma portion 210.

The distal ends of the connecting rods 532 are respectively connected to the merging members 55, and specifically, the distal ends of the connecting rods 532 are gathered in the merging members 55 by laser welding. In the embodiment, as shown in fig. 2, the junction element 55 includes an inner steel sleeve 552 and an outer steel sleeve 554, the inner steel sleeve 552 is fixedly sleeved on the distal end of the towing element 52, the inner diameter of the outer steel sleeve 554 is larger than the outer diameter of the inner steel sleeve 552, and when the outer steel sleeve 554 is sleeved on the inner steel sleeve 552, a positioning groove for fixedly connecting the distal end of the connecting rod 532 is defined between the outer steel sleeve 554 and the inner steel sleeve 552. The inner steel sleeve 552 is insulated from the pulling member 52 by an insulating material, preventing the electrical connection between the two from losing ablation energy. Preferably, after the distal end of the connecting rod 532 is inserted into a positioning groove surrounded by the outer steel sleeve 554 and the inner steel sleeve 552, laser welding is performed on the outer wall of the outer steel sleeve 554, so that the outer steel sleeve 554, the connecting rod 532 and the inner steel sleeve 552 are fused into a whole, and the connection is firmer.

In this embodiment, the inner wall surfaces and the outer wall surfaces of the adjusting member 53 and the converging member 55 are subjected to insulation treatment, and an insulating coating is applied or sleeved on the insulating sleeve, wherein the insulating coating may be, but is not limited to, parylene, teflon, polyurethane, polyimide, or the like.

In other embodiments, merging component 55 is a cutting tip, pulling component 52 is fixedly inserted into the cutting tip, and the pulling component 52 is isolated from the cutting tip by an insulating material, and the distal ends of connecting rods 532 are respectively fixedly connected to the cutting tip.

In other embodiments, the junction element 55 may be a unitary structure, with the distal end of the connecting rod 532 being welded directly to the junction element 55; the junction element 55 may also be made of other rigid materials, and the connecting rod 532 and the junction element 55 may also be fixedly connected by clamping or bonding.

In other embodiments, the pulling member 52 and the converging member 55 may also be coupled by bonding or threading. The screw connection is provided with an insulating film to prevent the junction element 55 from being electrically connected to the pulling member 52, or the pulling member 52 is made of a rigid material which is not electrically conductive. Specifically, the converging part 55 is provided with a screw hole along the axial direction, the outer wall of the far end of the traction part 52 is provided with an external thread corresponding to the screw hole, or the far end of the traction part 52 is provided with a stud corresponding to the screw hole; or the far end surface of the traction element 52 is provided with a screw hole along the axial direction, and the near end of the converging element 55 is convexly provided with a stud corresponding to the screw hole.

Referring to fig. 1-5, the adjustable interatrial septum ostomy device 100 of the present invention is used in conjunction with the sheath of the delivery device, the ablation power source, and the power connection. The using method comprises the following steps:

1. the atrial septum 601 is punctured with a puncture mechanism, after puncturing, a guidewire is fed into the inferior vena cava 605, and the puncture kit is removed. The outer sheath 300 is advanced over the guidewire into the left atrium 606, which is removed.

2. The adjustable interatrial septum ostomy device 100 is selected and the outer sheath 300 is pushed forward, so that the adjustable interatrial septum ostomy device 100 is conveyed to the interatrial septum position, and the visualization point is observed and positioned in the interatrial septum tissue. The control member 30 is then slowly advanced or the sheath 300 is withdrawn, while the site of visualization is ensured in the interatrial septum tissue, causing the stoma body 21 of the stoma 20 to expand.

3. Pulling the pulling member 52 proximally, the control member 30 remains stationary or moves in the opposite direction relative to the pulling member 52, and the pulling member 52 drives the junction 55 to move proximally, so that the connecting rod 532 pushes the stoma portion 210 to expand radially, thereby adjusting the radial dimension of the stoma portion 210, and causing the interatrial septum tissue of the stoma portion 210 at the stoma 603 to open and form a shunt channel of a specific size (as determined by ultrasound or DSC).

4. After confirming that the tissue at the stoma 603 is completely attached to the stoma portion 210, the RF power source at the proximal end of the control member 30 is connected, and the heating parameters (e.g., power 50W, duration 30S) are set, and then the ablation portion 23 is activated to heat.

5. After the heating is stopped, the pulling member 52 is pushed to the distal end, the control member 30 is kept still or moves reversely relative to the pulling member 52, the pulling member 52 drives the converging member 55 to move towards the distal end, so as to pull the connecting rod 532 to move and make the stoma portion 210 contract radially, the adjustable interatrial septum ostomy device 100 is recovered into the outer tube and removed from the body, and whether the stoma diameter is expected or not is measured.

The ostomy body 21 of the adjustable interatrial septum ostomy device 100 in this embodiment is inserted into the perforation of the interatrial septum, and the radial dimension of the ostomy portion 210 is adjusted by controlling the traction member 52 to slide axially relative to the control member 30 by the conveyor. Specifically, the pulling member 52 is pulled proximally, the control member 30 is kept still or moves reversely relative to the pulling member 52, so that the connecting rod 532 of the adjusting member 53 is pushed against the stoma portion 210 to adjust the diameter of the peripheral wall of the stoma portion 210, so that the stoma portion 210 can open the perforation on the interatrial septum to form a stoma with a proper diameter, and the supporting force of the stoma portion 210 is larger and more stable, thereby the adjustment of the ablation aperture of the interatrial septum becomes more accurate and controllable; in this embodiment, the control member 30 is further connected to a radio frequency energy source to transmit radio frequency electricity to the ostomy member 21, the ablation portion 23 serves as the only electrical exposed area of the ostomy member 21, the radio frequency power source is concentrated on the ostomy body 21 to contact the interatrial tissue near the stoma, so as to ablate the tissue of the interatrial septum at the stoma, so that the interatrial tissue near the stoma is inactivated, prevent the stoma from being blocked due to the repair endothelium covering of the tissue, and fix the shape of the stoma after the stoma is made by the adjustable interatrial ostomy device 100. Therefore, the stoma shape processed by the adjustable interatrial septum stoma device 10 is regular and is not easy to block, and the stoma can be kept smooth, so that the blood in the left and right atrium can be smoothly shunted.

Referring to fig. 6, fig. 6 is a schematic structural view of an adjustable interatrial septum ostomy device 100a according to a second embodiment of the invention. The utility model discloses the structure of the adjustable interatrial septum ostomy device 100a that the second embodiment provided is similar to the structure of the first embodiment, and the difference lies in: in the second embodiment, the proximal end of each connecting rod 532 of the adjusting mechanism 50 is connected to the middle of the corresponding supporting plate 211, and specifically, the proximal end of each connecting rod 532 is connected to the middle of the side of the corresponding supporting plate 211 facing the traction element 52.

The adjustable interatrial septum ostomy device 100a of the second embodiment, when in use, needs to be used in conjunction with the sheath of the delivery device, the ablation power supply, and the power supply connection wires. 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 proximal end of each connecting bar 532 of the adjustment mechanism 50 is attached to the proximal end of the corresponding support tab 211.

Referring to fig. 7, fig. 7 is a schematic structural view of an adjustable interatrial septum ostomy device 100b according to a third embodiment of the invention. The utility model discloses the structure of the adjustable interatrial septum ostomy device 100b that the third embodiment provided is similar to the structure of the first embodiment, and the difference lies in: in the third embodiment, the distal end of the ostomy portion 210 is provided with the distal positioning portion 217, and when the adjustable interatrial septum ostomy device 100b is used for ablating the interatrial septum, the distal positioning portion 217 is abutted against the interatrial septum, so that the adjustable interatrial septum ostomy device 100b is not easy to slip and is more stable, and the adjustment of the aperture for ablation of the interatrial septum becomes more accurate and controllable.

The distal positioning portion 217 in this embodiment is formed by bending the distal end of the first extending piece 213 of the first embodiment in the direction away from the axial line of the stoma body 21, and each peak of the first extending piece 213 is inclined toward the distal end, that is, the middle and the distal end of the first extending piece 213 are folded and deformed toward the proximal end, so that the first extending piece 213 forms a circle of plane, arc or cone. Preferably, the distal positioning portion 217 is a flange-shaped plane, is located at the distal end of the supporting sheet 211, and forms an included angle of 90-100 degrees with the ablation portion 23, and the distal positioning portion 217 can be flatly attached to the left atrial surface of the interatrial septum when the interatrial septum is ablated and made. Each peak of the first extension piece 213 is rounded, and specifically, the outer circumferential surface of each peak of the first extension piece 213 is configured to be a circular arc surface or a rounded corner.

In other embodiments, each peak of the first extension piece 213 is configured as a circular piece, a sphere structure or a sphere-like structure. In this embodiment, each peak of the first extension piece 213 is rounded to prevent the peak as a free end from scratching the myocardial tissue when the adjustable atrial septal ostomy device 100 enters the cardiac tissue, thereby improving the safety.

The distal end of the distal positioning portion 217 extends radially to form a conical or rounded positioning surface 2172 which, when the stoma body 21 of the ostomy member 20 opens the perforation of the interatrial septum, the positioning surface 2172 lies against the left atrial surface of the interatrial septum to position the ostomy member 20. The distal positioning portion 217 provides a supporting point for the adjustable atrial septal ostomy device 100 on the left atrial surface of the atrial septum, enhancing the stability and controllability of the adjustable atrial septal ostomy device 100.

In other embodiments, the positioning surface 2172 of the distal positioning portion 217 is also provided with an ablation portion 23, so that the ablation portion 23 on the support sheet 211 of the adjustable interatrial septum ostomy device 100 and the ablation portion 23 on the distal positioning portion 217 together ablate the tissue of the interatrial septum at the stoma, so that the interatrial septum tissue near the stoma is inactivated to achieve better ablation effect.

In other embodiments, the positioning surface 2172 of the distal positioning portion 217 may also be provided with a developing spot or a developing wire, which is fixed by means of inlay or thermocompression.

The adjustable interatrial septum ostomy device 100b of the third embodiment, when in use, needs to be used in combination with the sheath of the delivery device, the ablation power supply, the power supply 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. 8, fig. 8 is a schematic structural view of an adjustable interatrial septum ostomy device 100c according to a fourth embodiment of the invention. The utility model discloses the structure of the adjustable interatrial septum ostomy device 100c that the fourth embodiment provided is similar to the structure of the third embodiment, and the difference lies in: in the fourth embodiment, an insulating film 232 is provided between the stoma portion 210 and the ablation portion 23. Further, the insulating film 232 is located between the ablation portion 23 and the support sheet 211. The insulating film 232 may be, but is not limited to, a parylene film, a teflon film, a polyurethane film, a polyimide film, or the like. Since the stoma portion 210 and the ablation portion 23 are isolated by the insulation film 232, the insulation film 232 can not only isolate the heat conduction between the ablation electrode and the stoma body 21, i.e. prevent the energy from being transferred to the stoma body 21, thereby concentrating the heat on the ablation portion 23 to ablate the interatrial septum tissue and improving the energy utilization rate; and the insulating film 232 can also form an insulating barrier on the side of the ablation part 23 facing blood, so that the current density passing through the blood is reduced, the heating of the ablation part 23 to the blood is reduced, and the risk of thrombus formation is reduced.

In this embodiment, the insulating film 232 is provided on the outer wall surface of the stoma portion 210 corresponding to the ablation portion 23. The insulating film 232 may be attached to the outer wall surface of the stoma body 21 by sewing or gluing with a suture.

The ablation part 23 is a plurality of electrode plates which surround the outer wall surface of the stoma main body 21 for one circle, the electrode plates are connected to the insulating film 232 in a sewing or gluing mode through sutures, and the projection area of the ablation part 23 on the insulating film 232 is smaller than or equal to the area of the insulating film 232, so that the insulating film 232 can isolate heat conduction between the ablation part 23 and the stoma main body 21. Each electrode plate is connected with a power supply connecting wire with an insulated outer surface, and is arranged inside the adjustable interatrial septum ostomy device 100c, and the near end is connected with an ablation power supply, which is not shown in the figure.

The adjustable interatrial septum ostomy device 100c of the fourth embodiment is used in conjunction with the sheath of the delivery device, the ablation power source, and the power source connection wires. The specific application process and method are the same as those of the first embodiment, and are not described herein again.

Referring to fig. 9, fig. 9 is a schematic structural view of an adjustable interatrial septum ostomy device 100d according to a fifth embodiment of the invention. The utility model discloses the structure of the adjustable interatrial septum ostomy device 100d that the fifth embodiment provided is similar to the structure of the fourth embodiment, and the difference lies in: the structure of the ablation portion 23a in the fifth embodiment is different from that in the fourth embodiment, and in the fifth embodiment, the ablation portion 23a of the adjustable atrial septal ostomy device 100d comprises a plurality of spaced point-like electrodes which are connected into a whole by wire electrodes and are arranged at least one turn in the circumferential direction of the outer wall surface of the ostomy main body 21. Specifically, the spot-like electrodes are provided in a single turn along the circumferential direction of the outer wall surface of the stoma portion 210, and the ablation portion 23a and the stoma body 21 are insulated from each other.

In this embodiment, the point-like electrodes are used as ablation electrodes, and the point-like electrodes are electrically connected to the radio frequency power supply through a power wire which is connected in series and then extends out of a power supply connecting wire.

The adjustable interatrial septum ostomy device 100d of the fifth embodiment, when in use, needs to be used in conjunction with the sheath of the delivery device, the ablation power supply, the power supply 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. 10, fig. 10 is a schematic structural view of an adjustable interatrial septum ostomy device 100e according to a sixth embodiment of the invention. The utility model discloses the structure of the adjustable interatrial septum ostomy device 100e that the sixth embodiment provided is similar to the structure of the fourth embodiment, and the difference lies in: the structure of the ablation portion 23b is different from the fourth embodiment in the sixth embodiment in which the ablation portion 23b is a single-turn intermittent ring-shaped electrode provided in the circumferential direction of the outer wall of the stoma body 21, which is insulated from the stoma body 21. Specifically, a single-turn discontinuous ring electrode is provided on the outer wall surface of the stoma portion 210, and an insulating film 232 is provided between the ring electrode and the stoma portion 210. The annular electrodes are electrically connected with the radio frequency power supply after being connected in series through a lead.

The adjustable interatrial septum ostomy device 100e of the sixth embodiment, when in use, needs to be used in conjunction with the sheath of the delivery device, the ablation power supply, the power supply 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.

In other embodiments, the outer wall surface of the stoma portion 210 is provided with two or more circles of ablation portions 23b, or the outer wall surface of the stoma portion 210 is provided with a single uninterrupted circle of ring-shaped electrodes, and the ring-shaped electrodes are connected with the rf power output end through wires.

Referring to fig. 11, fig. 11 is a schematic structural view of an adjustable atrial septal ostomy device 100f according to a seventh embodiment of the present invention. The utility model discloses the supporting structure and the ablation electrode arrangement form of the adjustable interatrial septum ostomy device 100f that the seventh embodiment provided are similar to the structure of the first embodiment, and the difference lies in: in the seventh embodiment, the proximal end of the ostomy portion 210 is provided with the proximal end positioning portion 219, and when the adjustable interatrial septum ostomy device 100f is used for ablating the interatrial septum, the proximal end positioning portion 219 abuts against the interatrial septum, so that the adjustable interatrial septum ostomy device 100f is not easy to slip and is more stable, and the adjustment of the aperture for ablation of the interatrial septum becomes more accurate and controllable.

Specifically, the proximal end positioning portion 219 is a spherical, disc-shaped or other protruding structure provided at the proximal end of the stoma portion 210. The proximal end positioning portion 219 in this embodiment is the proximal end positioning portion 219 in which the middle portion of the second extending piece 214 of the first embodiment is convex outward away from the axial center line of the stoma main body 21 to form a spherical shape.

The side of the peripheral wall of the proximal positioning portion 219 adjacent to the support piece 211 forms a tapered or rounded positioning surface 2192, which positioning surface 2192 lies against the right atrial surface of the interatrial septum when the stoma body 21 opens the perforation of the interatrial septum to position the ostomy 20. The proximal positioning portion 219 provides a support point for the adjustable interatrial septum ostomy device 100f on the right atrial surface of the interatrial septum, enhancing the stability and controllability of the adjustable interatrial septum ostomy device 100 f.

The adjustable interatrial septum ostomy device 100f of the seventh embodiment, when in use, needs to be used in conjunction with the sheath of the delivery device, the ablation power supply, the power supply 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.

In other embodiments, the positioning surface 2192 of the proximal positioning portion 219 is also provided with an ablation portion 23, so that the ablation portion 23 on the support sheet 211 of the adjustable atrial septal ostomy device 100f and the ablation portion 23 on the proximal positioning portion 219 can ablate the tissue of the atrial septum at the stoma together, so that the tissue of the atrial septum near the stoma is inactivated to achieve better ablation effect.

In other embodiments, the positioning surface 2192 of the proximal positioning portion 219 may also be provided with a developing spot or a developing wire, which is fixed by means of insert or hot pressing.

Referring to fig. 12, fig. 12 is a schematic structural view of an adjustable interatrial septum ostomy device 100g according to an eighth embodiment of the invention. The utility model discloses the supporting structure and the ablation electrode arrangement form of 100g of interatrial septum ostomy device with adjustable that the eighth embodiment provided are similar with the structure of first embodiment, and the difference lies in: the stent structure of the stoma body 21a in the eighth embodiment differs from that in the first embodiment as follows:

the stoma body 21a also includes a stoma portion 210a for expanding a stoma and a recovery portion 215a connected to the proximal end of the stoma portion 210 a. The stoma portion 210a includes a support piece 211a of a ring-shaped wave-shaped ring structure, a first extension piece 213 of a ring-shaped wave-shaped ring structure disposed at a distal end of the support piece 211a, and a second extension piece 214 of a ring-shaped wave-shaped ring structure disposed at a proximal end of the support piece 211a, which are continuously and circumferentially arranged; the distal end of the first extending piece 213 is bent first in the direction away from the axis of the stoma main body 21a and then in the direction close to the axis of the stoma main body 21a to form a distal end positioning portion 217 a; the proximal end of the second extending piece 214 extends obliquely in a direction away from the axis of the stoma main body 21a to form a proximal end positioning portion 219 a. The proximal end of the distal locating portion 217a extends radially to form a tapered or rounded locating surface 2172; a tapered or circular positioning surface 2192 is formed on a side of the outer peripheral wall of the proximal end positioning portion 219a adjacent to the support piece 211 a. When the stoma portion 210a of the stoma body 21a opens the perforation of the interatrial septum, the positioning surface 2172 lies flat against the left atrial surface of the interatrial septum, so that the distal end positioning portion 217a provides a supporting point for the adjustable interatrial septum ostomy device 100g on the left atrial surface of the interatrial septum, and the positioning surface 2192 lies flat against the right atrial surface of the interatrial septum, so that the proximal end positioning portion 219a provides another supporting point for the adjustable interatrial septum ostomy device 100g on the right atrial surface of the interatrial septum, thereby enhancing the stability and controllability of the adjustable interatrial septum ostomy device 100g, and the adjustable interatrial septum ostomy device 100b is not easy to slip off and is more stable, so that the adjustment of the ablation aperture of the interatrial septum becomes more accurate and controllable.

The outer peripheral wall of the supporting sheet 211a is provided with an ablation part 23, the ostomy device conveying mechanism is used for conveying the adjustable atrial septal ostomy device 100g to the perforation on the atrial septal, the ablation part 23 is attached to the tissue at the perforation, the ablation part 23 is electrically connected to the radio frequency power supply, and the ablation part 23 receives the energy output by the radio frequency power supply to ablate the tissue around the perforation of the atrial septal.

The ostomy body 21a is a self-expanding ostomy device, and the ostomy body 21a may be a resilient metal support frame or a resilient non-metal support frame. In this embodiment, the stoma body 21a is a nitinol stent, and when the adjustable interatrial septum ostomy device 100g is delivered through a sheath, the stoma body 21a may be contracted to a smaller diameter for delivery in the sheath; when the adjustable atrial septal ostomy device 100g is released in the heart, the adjustable atrial septal ostomy device 100g can be automatically expanded, the traction piece 52 is pulled towards the proximal end to enable the connecting rod 532 of the adjusting piece 53 to be propped against the ostomy portion 210a so as to adjust the diameter of the outer peripheral wall of the supporting piece 211a, the supporting piece 211a can prop open the perforation on the atrial septal to form an ostomy with a proper diameter, the ablation portion 23 is attached to the atrial septal tissue at the ostomy, the ablation portion 23 is electrically connected to the radio-frequency power supply, and the ablation portion 23 receives the energy output by the radio-frequency power supply to ablate the tissue around the ostomy of the atrial septal for ablating the tissue around the ostomy.

In a state where the adjustable interatrial septum ostomy device 100g is completely released, the support piece 211a has a diameter smaller than the diameters of the distal positioning portion 217a and the proximal positioning portion 219 a. When the adjustable atrial septal ostomy device 100g is implanted into the perforation on the atrial septum, the supporting sheet 211a supports the inner wall of the perforation, and the distal end positioning part 217a and the proximal end positioning part 219a are respectively positioned at two opposite side surfaces of the atrial septum. The distal positioning portion 217a is provided with a positioning surface, a positioning line, or a positioning point that contacts the atrial septum. Specifically, one side of the distal positioning portion 217a facing the support sheet 211a is provided with a positioning surface, a positioning line or a positioning point which can press the atrial septum tissue, and the positioning surface, the positioning line or the positioning point abuts against the atrial septum tissue to prevent the adjustable atrial septum ostomy device 100g from moving to the proximal end; the ablation portion 23 may be provided at the location point, location line or location plane.

The proximal positioning part 219a is provided with a positioning surface, a positioning line or a positioning point which is in contact with the atrial septum, specifically, one side of the proximal positioning part 219a facing the support sheet 211a is provided with a positioning surface, a positioning line or a positioning point which can abut against the atrial septum tissue to prevent the cardiac atrial septum shunt system from moving to the distal end, so that the adjustable atrial septum ostomy device 100g is positioned on the atrial septum. The ablation portion 23 may be provided at the location point, location line or location plane.

In this embodiment, the support piece 211a is a wave-shaped annular structure that is continuously arranged circumferentially for at least one turn, the distal end positioning portion 217a is connected to a wave crest of the wave-shaped annular structure, and the proximal end positioning portion 219a is connected to a wave trough of the wave-shaped annular structure. Specifically, the supporting sheet 211a is formed by sequentially arranging and connecting a plurality of V-shaped supporting rods end to enclose the wavy annular structure, the wavy annular structure comprises wave crests, wave troughs and wave rods, circumferentially adjacent wave rods are connected at the distal end to form the wave crests, and circumferentially adjacent wave rods are connected at the proximal end to form the wave troughs; the middle portion of each wave bar is concave in an arc shape toward the axial line direction of the stoma portion 210 a. The wave troughs of the proximal end of the distal end positioning portion 217a are respectively connected to the plurality of wave crests of the support piece 211a, and the wave crests of the distal end of the proximal end positioning portion 219a are respectively connected to the plurality of wave troughs of the support piece 211 a.

The support piece 211a is provided with a developing point, and the developing point is fixed in a manner of inlaying and hot pressing. Specifically, one of the wave crest, the wave trough and the wave bar of the supporting sheet 211a is provided with a developing point, and a circle of developing points is formed on the supporting sheet 211 a; or two development points are arranged on the wave crest, the wave trough and the wave rod of the supporting sheet 211a, and two circles of development points are surrounded on the supporting sheet 211 a; or the wave crests, wave troughs and wave bars of the supporting sheet 211a are all provided with developing points, and three circles of spaced developing points are surrounded on the supporting sheet 211a, so that the supporting sheet 211a can be conveniently positioned in the through holes of the room space. The developing point can be made of gold, platinum, tantalum and other materials.

In this embodiment, the proximal ends of the connecting bars 532 of the adjusting member 53 are connected to the intersections of the wave crests of the supporting piece 211a and the wave troughs of the first extending piece 213, respectively.

In other embodiments, distal positioning portion 217a and/or proximal positioning portion 219a are provided with developing spots, and the developing spots are fixed by means of insert molding or hot pressing.

The circular piece 2174 is provided for each wave crest of the distal end positioning portion 217a, and the circular piece 2174 can prevent the distal end positioning portion 217a as a free end from scratching the myocardial tissue when the adjustable interatrial septum ostomy device 100g is introduced into the cardiac tissue, improving safety.

In other embodiments, a spherical structure or a similar spherical structure may be provided on each peak of the distal end positioning portion 217 a.

The recycling portion 215a further includes a plurality of connecting rods 2160 connected to the proximal end of the proximal positioning portion 219a, a support member 2161 disposed at the proximal end of each connecting rod 2160, an extension rod 2165 disposed at the proximal end of each support member 2161, and a connector 218 disposed at the proximal end of the extension rod 2165. The connecting rods 2160 are respectively connected to the troughs at the proximal end of the proximal end positioning part 219a, the connecting rods 2160 are arranged along the circumference of the proximal end positioning part 219a, the distal end of each connecting rod 2160 is connected to the corresponding trough of the proximal end positioning part 219a, the proximal end of each connecting rod 2160 is connected to the distal end of the corresponding support member 2161, and the middle part of each connecting rod 2160 protrudes towards the direction far away from the axial lead of the stoma body 21 to form an arc rod. Each of the supporters 2161 includes two supporting branch bars 2163 radiating from the proximal end of the corresponding connecting rod 2160 to the axial line direction of the stoma body 21 while being bent in both sides, and the proximal ends of the adjacent two supporting branch bars 2163 of each adjacent two supporters 2161 meet to form an intersection. The proximal end of the intersection is closer to the axial center line of the stoma body 21a than the proximal end of the connecting rod 2160; the proximal end of each intersection continues to extend proximally to form the extension rod 2165, and the proximal ends of the extension rods 2165 converge on the connector 218 to form a generally lantern-shaped structure. The connector 218 is of a cylindrical or elliptical cylindrical configuration, and the distal end of the connector 218 is fixedly connected to the ostomy device delivery mechanism via the control 30.

The adjustable interatrial septum ostomy device of the eighth embodiment is used in combination with the sheath of the delivery device, the ablation power supply, the power supply connecting wire and the like. The specific application process and method are the same as those of the first embodiment, and are not described herein again.

In other embodiments, ablation portions 23 may be disposed on the positioning surfaces, the positioning lines, or the positioning points of distal positioning portion 217a and proximal positioning portion 219a, respectively. Specifically, the ablation part 23 is an ablation electrode or an electrical exposed area disposed on one of the support sheet 211a, the distal positioning part 217a and the proximal positioning part 219 a; the ablation portion 23 may also be at least one turn of ablation electrode or electrically exposed region disposed on the positioning surface 2172 of the distal positioning portion 217 a; or the ablation part 23 may also be at least one circle of ablation electrodes or an electrical exposed area arranged on the positioning surface 2192 of the proximal positioning part 219 a; when the stoma body 21 is released in the through hole at the atrial septal tissue, the radial dimension of the support sheet 211 is adjusted to the inner diameter dimension of the stoma by the adjusting mechanism 50, so that the stoma body 21 can prop open the through hole on the atrial septal tissue to form the stoma, the ablation part 23 is connected with the radio frequency power supply, and then the radio frequency energy is transmitted to the ablation part 23 at the stoma to ablate the tissue at the stoma, thereby preventing the tissue at the stoma from rebounding and better maintaining the shape of the stoma.

In other embodiments, the ablation portion 23 is an ablation electrode or an electrical exposed area disposed on two of the support sheet 211a, the distal positioning portion 217a and the proximal positioning portion 219 a; alternatively, the ablation part 23 may be an ablation electrode or an electrical exposure region respectively disposed on the support sheet 211a, the distal positioning part 217a and the proximal positioning part 219 a.

The above is an implementation manner of the embodiments of the present invention, and it should be noted that, for those skilled in the art, a plurality of improvements and decorations can be made without departing from the principles of the embodiments of the present invention, and these improvements and decorations are also considered as the protection scope of the present invention.

Claims (17)

1. The utility model provides an interatrial septum ostomy device with adjustable, its is including being used for forming the ostomy piece of the stoma on the interatrial septum, its characterized in that, ostomy piece including can radial expansion make mouthful main part and set up in it is used for melting to make mouthful main part make the department that melts of tissue around the mouth, interatrial septum ostomy device with adjustable still including connect in make mouthful main part's adjustment mechanism and control make the control of mouthful main part near-end, adjustment mechanism cooperation the control is adjusted make mouthful main part be provided with melt the radial dimension of portion department.

2. The adjustable atrial septal ostomy device of claim 1, wherein the adjustment mechanism comprises a traction member axially slidably inserted into the ostomy body, and an adjustment member disposed between the traction member and the ostomy body, the traction member axially sliding to drive the adjustment member to adjust the radial dimension of the ostomy body.

3. The adjustable atrial septal ostomy device of claim 2, wherein the ostomy body comprises at least a stoma portion of a cylindrical structure, the ablation portion is located at a peripheral wall of the stoma portion, and the adjustment member is connected between the stoma portion and the traction member for adjusting a radial dimension of the stoma portion.

4. The adjustable atrial septal ostomy device of claim 3, wherein the adjustment member comprises a plurality of connecting rods, each connecting rod having one end connected to the ostomy portion and the opposite end connected to the traction member, the plurality of connecting rods being arranged in a circle along the circumference of the ostomy portion.

5. The adjustable atrial septal ostomy device of claim 4, wherein a plurality of the connecting rods are arranged at intervals in a circle, and one end of each connecting rod, which is far away from the traction member, is connected to the middle or the far end of the ostomy portion.

6. The adjustable atrial septal ostomy device of claim 4, wherein the connecting rod is made of a rigid material, the connecting rod transmitting a pushing force expanding the radial dimension of the stoma portion or a pulling force contracting the radial dimension of the stoma portion.

7. The adjustable atrial septal ostomy device of claim 4, wherein the adjusting member further comprises a junction member disposed on the traction member, and one ends of the connecting rods, which are far away from the ostomy portion, are respectively connected to the junction member.

8. The adjustable atrial septal ostomy device of claim 7, wherein the converging member is a cutting tip or a steel sleeve, the converging member is fixedly connected to the distal end of the traction member, and the distal ends of the plurality of connecting rods are fixedly connected to the cutting tip or the steel sleeve.

9. The adjustable atrial septal ostomy device of claim 4, wherein the pulling member moves axially towards the proximal end to drive the connecting rod to push against the ostomy portion, so as to radially expand the ostomy portion; the traction piece moves towards the far end along the axial direction to drive the connecting rod to pull the stoma part, so that the stoma part is contracted in the radial direction.

10. The adjustable atrial septal ostomy device of claim 3, wherein the stoma portion is located at a distal or central portion of the stoma body.

11. The adjustable atrial septal ostomy device of claim 3, wherein the proximal end of the ostomy body is provided with a recovery portion, and the control member is connected with the recovery portion.

12. The adjustable atrial septum ostomy device according to claim 3, wherein the ostomy main body further comprises a distal positioning portion and a proximal positioning portion, the distal positioning portion is disposed at the distal end of the ostomy portion, the proximal positioning portion is disposed at the proximal end of the ostomy portion, and the distal positioning portion and the proximal positioning portion are attached to the atrial septum on opposite sides of the ostomy.

13. The adjustable atrial septal ostomy device of claim 12, wherein the distal positioning portion and the proximal positioning portion are disc-shaped structures and/or spherical structures; the maximum diameter of the distal positioning portion and/or the proximal positioning portion is larger than the diameter of the stoma portion.

14. The adjustable atrial septal ostomy device of claim 12, wherein the ablation portion is disposed on one of the ostomy portion, the distal positioning portion and the proximal positioning portion; or the ablation part is respectively arranged on the stoma part, the distal end positioning part and the proximal end positioning part; or the ablation part is respectively arranged on the stoma part, the distal end positioning part and the proximal end positioning part.

15. The adjustable atrial septal ostomy device of claim 12, wherein at least one circle of developing points or developing wires is arranged on one of the ostomy portion, the distal positioning portion and the proximal positioning portion; or at least one circle of developing points or developing wires are respectively arranged on the stoma part, the far-end positioning part and the near-end positioning part; or at least one circle of developing points or developing wires are respectively arranged on the stoma part, the far-end positioning part and the near-end positioning part.

16. The adjustable atrial septal ostomy device of claim 1, wherein the ostomy main body is a supporting framework made of conductive material, the ablation part is a part of the supporting framework which is not subjected to insulation treatment, and all the outer surfaces of the supporting framework except the ablation part are coated with an insulation coating or fixed insulation sleeves.

17. The adjustable atrial septal ostomy device of claim 1, wherein the ablation portion is a ring-shaped electrode circumferentially disposed at least one continuous or intermittent turn along the outer wall surface of the ostomy body; or the ablation part is a plurality of point-like electrodes or strip-like electrodes, and the plurality of point-like electrodes or strip-like electrodes are arranged at least one circle along the circumferential direction of the outer wall surface of the ostomy piece.

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