CN116407255A

CN116407255A - Adjustable interatrial septum ostomy device

Info

Publication number: CN116407255A
Application number: CN202111679926.4A
Authority: CN
Inventors: 高国庆; 潘晓彤; 王永胜
Original assignee: Hangzhou Nuosheng Medical Technology Co ltd
Current assignee: Hangzhou Nuosheng Medical Technology Co ltd
Priority date: 2021-12-31
Filing date: 2021-12-31
Publication date: 2023-07-11

Abstract

The utility model provides an ostomy device, it includes ostomy piece and connect in the sheath pipe subassembly of ostomy piece, ostomy piece include can radial expansion ostomy main part and connect in the first locating piece of ostomy main part, first locating piece is the bending state or the flattening state for ostomy main part, sheath pipe subassembly includes sheath core and along the receipts sheath pull rod of axial activity cover locating sheath core, ostomy main part cover is located sheath core and distal end fixed connection in sheath core, receipts sheath pull rod connect in the tip that first locating piece kept away from ostomy main part, receipts sheath pull rod is along axial displacement in order to adjust first locating piece conversion between bending state and flattening state for sheath core; when the ostomy member is retracted to the outer sheath, the sheath retraction combination adjusts the first positioning member to be in a flattened state, so that the first positioning member is prevented from being blocked, and the ostomy member can be conveniently and smoothly retracted to the sheath. The present application also provides an ostomy system provided with the ostomy device.

Description

Adjustable interatrial septum ostomy device

Technical Field

The application relates to the technical field of interventional medical instruments, in particular to an adjustable atrial septum ostomy device.

Background

Heart failure (abbreviated heart failure) is a complex set of clinical syndromes of impaired ventricular filling or ejection capacity due to any structural or functional abnormality of the heart, which are mainly manifested clinically by dyspnea and hypodynamia (activity tolerance), and fluid retention (pulmonary congestion and peripheral oedema). According to the left ventricular ejection fraction, heart failure with reduced ejection fraction, heart failure with retained ejection fraction, and heart failure with intermediate ejection fraction are classified. According to the time and speed of heart failure, it is classified into chronic heart failure and acute heart failure. Most acute heart failure patients are subjected to hospitalization, and symptoms are partially relieved, and the patients are transferred into chronic heart failure; patients with chronic heart failure often need hospitalization due to various acute exacerbations. Heart failure is a serious and terminal stage of various heart diseases, and has high incidence rate, which is one of the most important cardiovascular diseases at present. The sites where heart failure occurs can be classified into left heart, right heart and full heart failure.

Heart failure is a serious disease with high incidence and mortality. The incidence rate of heart failure in China is 2-3%, which is over 1200 ten thousand. The causes of heart failure mainly include hypertension, coronary heart disease, myocardial infarction, heart valve diseases, atrial fibrillation, cardiomyopathy and the like. Cardiovascular disease causes left ventricular injury, resulting in pathological remodeling of the left ventricle, leading to hypocardiac function. Each time a patient with myocardial infarction is successfully treated, a potential heart failure patient is brought.

Heart failure patients with preserved ejection fraction are clinically characterized by labored dyspnea, and there are many mechanisms that can lead to reduced exercise tolerance in heart failure patients with preserved ejection fraction. Left ventricular relaxation disorder and stiffness increase in heart failure patients with ejection fraction retention, and prevent end diastole left ventricular volume increase during exercise, thereby raising Pulmonary Capillary Wedge Pressure (PCWP) and Left Atrial Pressure (LAP), resulting in increased pulmonary congestion and poorer prognosis.

In the aspect of treatment, at present, medicaments such as cardiotonic medicaments, diuretic medicaments, vasodilator medicaments and the like are adopted for heart failure with reduced ejection fraction, so that the progress of the type of heart failure exacerbation can be effectively slowed down. However, no drug or device has been available to date that significantly reduces mortality or hospitalization risk in HFpEF patients. Cardiac Resynchronization Therapy (CRT) is not suitable for all heart failure patients, and there are 20% -30% patients who do not respond to cardiac resynchronization therapy. Left Ventricular Assist Device (LVAD) surgery requires extracorporeal circulation, which is highly invasive, has a high incidence of complications, and is expensive to equipment and difficult to obtain. Heart transplantation is the final solution, but the source of donors is very limited.

The atrial shunt instrument is implanted into the atrial septum by a medical instrument to form an artificial defect in the atrial septum. The left atrium is shunted to the right atrium, thereby reducing left atrial pressure. After the left atrium pressure is reduced, the pulmonary artery pressure and the pulmonary capillary wedge pressure are reduced, so that the symptoms of dyspnea, fatigue and the like of a patient are relieved.

Existing ostomy appliances comprise a ostomy member for forming a stoma in a room space, the ostomy member comprising an ablation portion and positioning portions arranged on opposite sides of the ablation portion, the positioning portions being adapted to grip the room space for positioning the ostomy member in the room space. However, the positioning portion may prevent the ostomy member from being retracted into the sheath.

Disclosure of Invention

An object of the present application is to provide an ostomy device with a smoothly retrievable ostomy member; the present application also provides an ostomy system provided with the ostomy device.

In order to solve the technical problem, the application provides a stoma device, it includes the ostomy piece that is used for forming the ostomy on the tissue and connect in the sheath pipe assembly of ostomy piece, ostomy piece include can radial expansion ostomy main part and connect in the first setting element of ostomy main part, first setting element for the ostomy main part is bending state or flattening state, sheath pipe assembly includes sheath core and along the cover of axial activity locate the receipts sheath pull rod of sheath core, ostomy main part cover is located sheath core and distal end fixed connection in the sheath core, receive the sheath pull rod connect in first setting element keep away from the tip of ostomy main part, receive the sheath pull rod for the sheath core is along axial displacement in order to adjust first setting element is in the bending state with flattening state changes.

The sheath retracting pull rod of the ostomy device can adjust the first positioning piece to be in a flattened state or a bent state relative to the sheath core in the axial movement. When the ostomy member is retracted to the outer sheath, the sheath retracting pull rod is used for adjusting the first positioning member to be in a flattening state, so that the obstruction formed by the first positioning member is avoided, the ostomy member can be conveniently and smoothly retracted to the outer sheath, and the operation is convenient.

The present application also provides an ostomy system comprising a ostomy device, a controller for controlling the ostomy device to ostomy tissue, and an ablative energy source for providing ablative energy to the ostomy device; the ostomy device comprises a ostomy member for forming a stoma on tissues and a sheath tube assembly connected to the ostomy member, the ostomy member comprises a ostomy main body capable of being radially expanded and a first positioning member connected to the ostomy main body, the first positioning member is in a bending state or a flattening state relative to the ostomy main body, the sheath tube assembly comprises a sheath core and a sheath retracting pull rod movably sleeved on the sheath core along the axial direction, the ostomy main body is sleeved on the sheath core, the distal end of the sheath retracting pull rod is fixedly connected to the sheath core, the sheath retracting pull rod is connected to the end, far away from the ostomy main body, of the first positioning member, and the sheath retracting pull rod moves relative to the sheath core along the axial direction to adjust the first positioning member to change between the bending state and the flattening state.

The first positioning of the ostomy device of the ostomy system of the present application can be adjusted to a flattened or folded state. When retrieving the ostomy member to outer sheath pipe, receive sheath combination regulation first setting element and be the exhibition state, avoid the hindrance of first setting element can conveniently retrieve the ostomy member to the sheath pipe smoothly, convenient to use, easy operation.

Drawings

In order to more clearly illustrate the technical solutions of the examples of the present application, the drawings that are needed 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 application, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

Fig. 1 is a schematic structural view of an ostomy device provided in a first embodiment of the present application;

FIG. 2 is a schematic view of the structure of the ostomy member and sheath assembly of the adjustment mechanism of FIG. 1;

FIG. 3 is a schematic perspective view of the ostomy member of FIG. 2;

FIG. 4 is a schematic elevational view of the ostomy member of FIG. 3;

FIG. 5 is a schematic cross-sectional structural view of the housing and the regulatory assembly of the regulatory mechanism of FIG. 1;

fig. 6-9 are schematic views of the ostomy device of fig. 1 during a ostomy procedure;

Fig. 10 is a schematic structural view of an ostomy device provided in a second embodiment of the present application;

FIG. 11 is a schematic structural view of the ostomy member and sheath assembly of the adjustment mechanism of FIG. 10;

fig. 12 is a schematic perspective view of a ostomy member of a ostomy device according to a third embodiment of the invention;

FIG. 13 is a schematic elevational structural view of the ostomy member of FIG. 12;

fig. 14 is a schematic perspective view of a ostomy member of a ostomy device provided in a fourth embodiment of the application;

fig. 15 is a schematic elevational structural view of the ostomy member of fig. 14;

fig. 16 is a schematic perspective view of a ostomy member of a ostomy device provided in a fifth embodiment of the application;

FIG. 17 is a schematic elevational view of the ostomy member of FIG. 16;

fig. 18 is a schematic structural view of a ostomy member and sheath tube assembly of a ostomy device provided in a sixth embodiment of the application;

FIG. 19 is a schematic perspective view of the ostomy member of FIG. 18;

FIG. 20 is a schematic elevational structural view of the ostomy member of FIG. 19;

fig. 21 is a schematic structural view of a ostomy member of a ostomy device provided in a seventh embodiment of the application;

fig. 22 is a schematic structural view of an ostomy system provided in one embodiment of the present application.

Detailed Description

The following description of the embodiments of the present application will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all, of the embodiments of the present application. All other embodiments, which can be made by one of ordinary skill in the art based on the embodiments herein without undue burden, are within the scope of the present application.

For clarity of description, the end closer to the operator will be referred to as the "proximal end" and the end farther from the operator will be referred to as the "distal end" in the following ostomy procedure; 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; the tissue between the left atrium and the right atrium of the present application is referred to as the "atrial septum"; the foregoing definitions are provided for convenience of description and are not to be construed as limiting the present application.

It should be noted that: the ostomy device and ostomy system of the present invention may be used for, but is not limited to, interatrial septum ostomy and may be used for other tissues requiring a stoma. In this context, the use of the ostomy device for room space will be described and illustrated as an example.

Referring to fig. 1 and 2, the present application provides an ostomy device 100 comprising a ostomy member 20 for forming a stoma in tissue and an adjustment mechanism 30 connected to the ostomy member 20. The ostomy member 20 is a support with elastic expansion, the ostomy member 20 comprises a ostomy main body 22 capable of radial expansion and a first positioning member 24 connected to the ostomy main body 22; the first positioning member 24 is in a folded or flattened state relative to the ostomy body 22. The adjusting mechanism 30 comprises a sheath assembly 40, a housing 50, a diameter adjusting assembly 60, a sheath receiving adjusting assembly 70 and an outer sheath adjusting assembly 80; the sheath tube assembly 40 is connected to the ostomy member 20, and the diameter control assembly 60, the sheath control assembly 70 and the sheath control assembly 80 are disposed in the housing 50, respectively. The sheath tube assembly 40 comprises a sheath core 41 and a sheath retracting pull rod 45 which is movably sleeved on the sheath core 41 along the axial direction, the stoma main body 22 is sleeved on the sheath core 41, one end of the sheath retracting pull rod 45 is fixedly connected with the sheath core 41, the sheath retracting pull rod 45 is connected with the end part of the first positioning piece 24 far away from the stoma main body 22, and the sheath retracting pull rod 45 moves along the axial direction relative to the sheath core 41 so as to adjust the first positioning piece 24 to change between the bending state and the flattening state. Specifically, when the first positioning member 24 is in the folded state, the first positioning member 24 is used to position the stoma body 22 in the stoma; when the first positioning member 24 is in its flattened state, the first positioning member 24 is parallel to the stoma body 22, i.e. the first positioning member 24 does not hinder retraction of the stoma 20 into the outer sheath.

The sheath stay 45 of the ostomy device 100 of the present application is axially movable relative to the sheath core 41 to adjust the first positioning member 24 to a flattened state. When the ostomy member 20 is retracted to the outer sheath, the sheath retracting pull rod 45 adjusts the first positioning member 24 to be in a flattened state, so that the obstruction formed by the first positioning member 24 is avoided, the ostomy member 20 can be conveniently and smoothly retracted to the outer sheath, and the operation is convenient and simple.

As shown in fig. 2-4, the ostomy member 20 further comprises a push rod connection portion 27 provided at the proximal end of the ostomy body 22 and a sheath core connection portion 28 provided at the distal end of the ostomy body 22. The stoma body 22 includes a stoma portion 221 in a central portion thereof, a first support portion 223 provided at a proximal end of the stoma portion 221, and a second support portion 225 provided at a distal end of the stoma portion 221. Specifically, the first support portion 223 is connected between the stoma portion 221 and the pushrod connecting portion 27; the second support portion 225 is connected between the stoma portion 221 and the sheath-core connection portion 28. The stoma 221 is connected to an ablative energy source which provides ablative energy to the stoma 221 so that the stoma 221 ablates tissue of the inner peripheral wall of the stoma. The ablation energy source is not limited to a radio frequency energy source, but may also be: pulsed energy, laser energy, ultrasonic energy, microwave energy, cryogenic energy, or thermal energy, among others. The stoma 221 may be an ablation electrode provided to the stoma body 22, the ablation electrode being connected to an ablation energy source. In this embodiment, the stoma 221 includes a plurality of ablation sheets 2210, each of the ablation sheets 2210 is electrically connected to an ablation energy source through a wire, the ablation sheets 2210 are used for ablating an inner circumferential surface of the stoma, and the plurality of ablation sheets 2210 are circumferentially surrounded by a circle along the stoma body 22.

The ostomy member 20 may be cut from a nickel alloy tube, and the ostomy main body 22 is a cylindrical frame structure after release to keep the room septum channel clear; the ostomy member 20 may also be woven from nickel alloy wires or may be manufactured by means of local weaving in combination with local cutting of the tube, the different parts being welded or fastened to each other by means of a connecting piece. The material of the pipe is stainless steel, cobalt-chromium alloy or memory metal material or biocompatible nonmetallic material, such as nickel-titanium alloy material. The overall shape of the ostomy body 22 may be any of a variety of suitable shapes including, but not limited to, straight cylindrical, tapered, etc.

In other embodiments, the stoma 20 is a conductive metal frame made of a conductive material, the stoma 221 is an electrically bare conductive portion provided in the stoma body 22, and the stoma 20 is electrically connected to an ablative energy source. Specifically, the ostomy member 20 is partially or completely insulated on the outer surface except for the conductive part on the stoma part 221. Preferably, the ostomy member 20 is insulated from all outer surfaces except the outer peripheral surface of the ostomy portion 221, i.e. a circle of electrically exposed areas of the outer wall surface of the ostomy body 22. The insulation treatment can be, but is not limited to, coating an insulation coating or sleeving an insulation sleeve, etc., and the insulation coating can be, but is not limited to, parylene, polytetrafluoroethylene coating, polyurethane coating, polyimide coating, etc.

In other embodiments, the nickel alloy stem of the stoma body 21 may also be sleeved with an insulating sleeve in addition to the stoma 221.

The first supporting portion 223 includes a plurality of first supporting rods 2230, and the plurality of first supporting rods 2230 are in one-to-one correspondence with the plurality of ablation sheets 2210; the proximal end of each first support rod 2230 is connected to the push rod connection portion 27, and the distal end of each first support rod 2230 is connected to the corresponding ablation sheet 2210. The second supporting portion 225 includes a plurality of second supporting rods 2250, and the plurality of second supporting rods 2250 are in one-to-one correspondence with the plurality of ablation sheets 2210; the stoma body 22 is radially expandable or contractible, and in the expanded state of the stoma body 22, the stoma 221 has a radial dimension that is greater than the proximal end of the first support 223 and the distal end of the second support 255, for each adjacent two of the ablation tabs 2210; the stoma body 22 is in the inflated condition with no or little spacing between each adjacent two of the ablation tabs 2210, at which time the stoma 221 has a radial dimension that is equal to or slightly greater than the radial dimension of the proximal end of the first support 223 and the radial dimension of the distal end of the second support 255. The value of the outer radial dimension of the stoma 221 determines the value of the inner diameter of the stoma, the value of the radial dimension of the stoma 221 being adjustable, and thus the stoma 20 being able to form stomas of different inner diameter values.

In this embodiment, the stoma 221 includes 10 ablation sheets 2210, the 10 ablation sheets 2210 are enclosed into a circle, and the push rod connecting portion 27 and the sheath core connecting portion 28 are both cylinders; the plurality of ablation sheets 2210 are uniformly arranged at intervals along the circumferential direction of the stoma 221, the plurality of first support bars 2230 are uniformly connected to the pushrod connection 27 along the circumferential direction of the pushrod connection 27, and the plurality of second support bars 2250 are uniformly connected to the sheath core connection 28 along the circumferential direction of the sheath core connection 28. In other embodiments, the number of ablation sheets 2210 may be set as desired, as the stoma 221 may include, but is not limited to, 8, 9, 10, 11, or 12 sheets, etc.; the plurality of ablation sheets 2210 may also enclose, but are not limited to, an oval, a polygon, etc.

As shown in fig. 2, the sheath assembly 40 further includes a push rod 43 movably sleeved on the sheath core 41 along the axial direction, and opposite ends of the ostomy member 20 are respectively connected to the sheath core 41 and the push rod 43; the pushrod 43 is connected to the pushrod connection portion 27, and an end portion of the stoma body 22 remote from the pushrod connection portion 27 is connected to the sheath core 41, and the pushrod 43 moves axially with respect to the sheath core 41 to adjust the radial size of the stoma 221. The sheath core connecting portion 28 is connected to the sheath core 41, and the pushrod connecting portion 27 is connected to the pushrod 43. In this embodiment, the sheath core connecting portion 28 is fixedly connected to the distal end of the sheath core 41, and the pushrod connecting portion 27 is fixedly connected to the distal end of the pushrod 43. Specifically, the sheath-core coupling portion 28 is fixedly coupled to the distal end of the sheath core 41 by a tapered head 283, which facilitates insertion of the ostomy member 20 into the stoma.

As shown in fig. 2, the sheath-retracting tie 45 is a pull tube axially slidably sleeved on the sheath core 41, and the pull tube moves axially relative to the sheath core 41 to adjust the first positioning member 24 so as to make the first positioning member 24 in a bent state or a flattened state. Specifically, the sheath-receiving pull rod 45 is slidably sleeved outside the sheath core 41 in the axial direction, and the push rod 43 is slidably sleeved outside the sheath-receiving pull rod 45 in the axial direction, that is, the sheath-receiving pull rod 45 can slide in the axial direction relative to the push rod 43. Further, the sheath assembly 40 further includes an outer sheath 47 axially slidably disposed over the pushrod 43, and the first positioning member 24 is retractable into the outer sheath 47 in the flattened state.

As shown in fig. 3 and 4, the first positioning member 24 includes a plurality of first positioning rods 241, one end of each first positioning rod 241 is connected to the ostomy main body 22, and the plurality of first positioning rods 241 are arranged one round along the circumference of the ostomy main body 22. The proximal end of each primary positioning rod 241 is connected to the telescoping pull rod 45, i.e., directly to the proximal end of the primary positioning rod 241 via the distal end of the telescoping pull rod 45. The sheath pulling rod 45 slides axially relative to the sheath core 41 to adjust the first positioning rod 241 to a bent or flattened state. The first positioning pieces 24 are bent in a state of being bent, the middle of each first positioning rod 241 is bent away from the stoma main body 22; each first positioning rod 241 is parallel to the ostomy body 22 in the flattened state of the first positioning member 24.

The first positioning rod 241 includes a first positioning portion 2412 connected to the ostomy main body 22 and a connecting portion 2416 connected to a proximal end of the first positioning portion 2412, the connecting portion 2416 being connected to the sheath pulling rod 45. The distal end of the first positioning portion 2412 is connected to the ostomy main body 22, and the end of the connecting portion 2416 remote from the first positioning portion 2412 is connected to the sheath pull rod 45. The connecting portion 2416 is inserted into the push rod connecting portion 27, and an end of the connecting portion 2416 remote from the first positioning portion 2412 is connected to a distal end of the sheath stay 45.

The first positioning portion 2412 includes a positioning segment 2413 and a supporting segment 2414, the positioning segment 2413 extends obliquely from the stoma main body 22 in a direction away from the stoma main body 22, the supporting segment 2414 bends from a distal end of the positioning segment 2413 toward the stoma main body 22 and extends obliquely to gather at the connecting portion 2416, and the positioning segment 2413 is adapted to abut against the tissue. Optionally, the surfaces of the positioning sections 2413 of the first positioning rods 241, which are attached to the tissues of the septum, are umbrella surfaces, conical surfaces, cambered surfaces or the like. The connecting part 2416 is inserted into the push rod connecting part 27, and the end of the connecting part 2416 far away from the first positioning part 2412 is connected to the sheath-retracting pull rod 45; specifically, the positioning segment 2413 is a V-shaped structure, the supporting segment 2414 is an arc-shaped rod, the distal end of the arc-shaped rod is connected to the tip of the V-shaped structure, the proximal end of the arc-shaped rod is bent towards the first supporting portion 223 and extends obliquely to gather at the connecting portion 2416, the end of the V-shaped structure far away from the supporting segment 2414 is connected to the stoma main body 22, and specifically, the two ends of the V-shaped structure far away from the supporting segment 2414 are respectively connected to two adjacent ablation sheets 2210. Specifically, the connection portion 2416 is a bar-shaped rod, the distal end of which is connected to the proximal end of the corresponding support segment 2414, and the proximal end of which passes through the push rod connection portion 27 and is then connected to the sheath-pulling rod 45. The first positioning member 24, in the folded state, the first positioning portion 2412 is for abutting against tissue in the vicinity of the stoma, specifically, the first positioning portion 2412 is for abutting against tissue around one side of the stoma.

In other embodiments, the connecting portion 2416 of the first positioning rod 241 is omitted, the push rod connecting portion 27 is a connecting tube, the supporting sections 2414 are in a bar-shaped structure, the proximal ends of the supporting sections 2414 of the plurality of first positioning rods 241 gather toward the push rod connecting portion 27 and pass through the first supporting portion 223, and then pass through the inner cavity of the push rod connecting portion 27 to form a connecting portion, and the connecting portion is fixedly connected to the sheath-receiving pull rod 45.

Preferably, the positioning segment 2413 of the first positioning portion 2412 transitions from the connecting piece arc of the support segment 2414 to avoid damaging tissue during use of the ostomy member 20. The intersection of the first positioning portion 2412 and the connecting portion 2416 is in arc transition, so that bending and flattening of the first positioning member 24 are smoother.

The first supporting portion 223 is provided with a position avoiding groove corresponding to the first positioning rod 241, and when the first positioning member 241 is in the flattened state, the first positioning rod 241 is accommodated in the position avoiding groove. Specifically, a first avoidance groove 2231 is formed between every two adjacent first support rods 2230, and the first positioning rod 241 is accommodated in the first avoidance groove 2231 when the first positioning member 24 is in the unfolded state. Preferably, the middle of the proximal end of each ablation sheet 2210 is connected to the distal end of the corresponding first support rod 2230, and the proximal end of each ablation sheet 2210 is connected to the first positioning portion 2412 at two opposite sides of the first support rod 2230.

The ostomy member 20 further comprises a second positioning member 26, the first positioning member 24 and the second positioning member 26 being connected to the ostomy body 22, respectively. The first positioning member 24 and the second positioning member 26 can be respectively in a bending state or a flattening state relative to the ostomy main body 22; when both the first positioning member 24 and the second positioning member 26 are in a flattened state relative to the ostomy body 22, so as to accommodate the ostomy member 20 to the outer sheath; when both the first positioning member 24 and the second positioning member 26 are in a flexed state relative to the stoma body 22, to facilitate positioning of the stoma 20 into the stoma.

The second positioning member 26 includes a plurality of second positioning rods 261, one end of each second positioning rod 261 is connected to the ostomy main body 22, and the plurality of second positioning rods 261 are arranged one round along the circumference of the ostomy main body 22. In this embodiment, two second positioning rods 261 are provided on each ablation sheet 2210 of the stoma part 221, and the second positioning parts 2612 of two adjacent second positioning rods 261 on each adjacent two ablation sheets 2210 are close to each other and contact with each other at the end far from the stoma part 221, and the extending part 2614 of each second positioning rod 261 is bent and extended from the end of the second positioning part 2612 in the direction far from the stoma part 221. The second support rods 2250 are bar-shaped, with a proximal end of each second support rod 2250 being connected to a corresponding ablation plate 2210, and a distal end of the second support rod 2250 being connected to the sheath-core connection 28. A second avoidance groove 2251 is formed between every two adjacent second support bars 2250, and when the second positioning member 26 is in the unfolded state, the second positioning bar 261 is accommodated in the corresponding second avoidance groove 2231. Preferably, a second supporting rod 2250 is disposed at the middle of the distal end of each ablation sheet 2210, and second positioning portions 2612 are respectively connected to two opposite sides of the distal end of each ablation sheet 2210 opposite to the second supporting rod 2250.

Preferably, the connection between the second positioning portion 2612 and the extending portion 2614 of each second positioning rod 261 is in arc transition, and the second positioning portion 2612 is in arc transition with the connecting piece of the ablation plate 2210, so as to avoid the second positioning rod 261 from scratching tissues.

In other embodiments, the end of the extension 2614 may be provided with, but is not limited to, a sphere or the like. When the second positioning members 26 are in a bent state, the second positioning portion 2612 of each second positioning rod 261 extends obliquely from the stoma portion 221 in a direction away from the sheath assembly 40, that is, the second positioning portion 2612 extends obliquely from the stoma portion 221 in a direction toward the sheath-core connecting portion 28; at this time, the second positioning portion 2612 is used to abut against the tissue around the other side of the stoma.

The first positioning rods 241 are in one-to-one correspondence with the ablation sheets 2210 of the stoma part 221, and the second positioning rods 261 are in one-to-one correspondence with the ablation sheets 2210 of the stoma part 221; specifically, the number of the first positioning rods 241 and the second positioning rods 261 is 10.

The first positioning member 24 can be in a folded or flattened state relative to the ostomy body 22 and the second positioning member 26 can be in a folded or flattened state relative to the ostomy body 22. Specifically, when the first positioning member 24 is in a bent state with respect to the stoma body 22, the middle portion of each first positioning rod 241 is bent away from the stoma portion 221 such that the middle portion of the first positioning rod 241 is away from the stoma portion 221 in the radial direction of the stoma body 22, i.e. the junction of the positioning segment 2413 and the support segment 2414 is away from the stoma portion 221 in the radial direction of the stoma body 22; when the second positioning members 26 are in a bent state with respect to the stoma body 22, each second positioning rod 261 extends away from the stoma 221 such that the distal end of the second positioning rod 261 is remote from the stoma 221 in the radial direction of the stoma body 22, i.e. the extension 2614 is remote from the stoma 221 in the radial direction of the stoma body 22. When the first positioning member 24 is in a flattened state with respect to the stoma main body 22, the first positioning member 24 is parallel to the first support 223, specifically each first positioning lever 241 is accommodated in the first avoiding groove 2231; when the second positioning member 26 is in a flattened state with respect to the ostomy main body 22, the second positioning member 26 is parallel to the second supporting portion 225, in particular the second positioning rod 261 is accommodated in the corresponding second avoidance groove 2231.

Preferably, the ostomy member 20 is a radially stretchable and elastic scaffold, in particular the ostomy member 20 may be an elastic metal or non-metal supporting skeleton. In this embodiment, the ostomy member 20 is a nitinol stent, and when the ostomy device 100 is delivered through the sheath, the diameter of the ostomy member 20 may be contracted to a smaller state for delivery in the sheath; when the ostomy device 100 is released, the ostomy member 20 may be automatically inflated, bringing the push rod connection part 27 by means of the sheath assembly 40 to move axially in relation to the stoma part 221 to adjust the outer diameter dimension of the stoma part 221 so that the stoma part 221 can prop open the stoma on the atrial septum to form a stoma of a suitable diameter.

Preferably, the stoma body 22 is provided with a positioning developing member 226, the stoma body 22 being positioned in the stoma by the positioning developing member 226; specifically, the positioning developing member 226 is provided on the stoma 221, and the positioning developing member 226 surrounds at least one turn along the circumference of the stoma 221. Preferably, the positioning developing member 226 encloses one turn at the middle position of the stoma 221. The positioning developer 226 may be, but is not limited to, a developer ring, a developer wire, or a number of developer dots, etc.

Preferably, the surface of the ostomy member 21 is coated with a heparin coating, which has an anticoagulant effect, which reduces the adhesion of platelets, which has a protective effect on the platelets, and which better improves the blood compatibility of the ostomy device 100.

As shown in fig. 1 and 2, the ostomy member 20 and the adjusting mechanism 30 are provided with a combination of marks, the adjusting mechanism 30 being used for adjusting the radial dimension value of the ostomy body 22, the radial dimension value of the ostomy body 22 being determined on the basis of said combination of marks. Alternatively, the combination of markers may be provided only on the adjustment mechanism 30. The adjustment mechanism 30 of the ostomy device 100 of the present application is capable of adjusting the radial dimension value of the ostomy body 22 and the radial dimension value of the ostomy body 22 is determinable from the combination of the markers. Thus, the diameter value of the stoma formed by the stoma body 22 of the stoma device 100 of the present application can be accurately adjusted to meet the needs of different patients.

In this embodiment, the mark assembly 310 is disposed on the ostomy member 20 and the sheath assembly 40, and specifically, the mark assembly 310 includes a first mark disposed on the push rod connecting portion 27 and a second mark 314 disposed on the sheath core 41. The second marker 314 is adjacent the stoma body 22 and the push rod 43 is moved axially relative to the sheath core 41 to bring the first marker 312 into alignment with the second marker 314.

The first mark 312 on the push rod connection portion 27 may be, but is not limited to, a developing ring, a developing wire, or a number of developing points; preferably, the developing ring surrounds at least one circle along the circumference of the push rod connecting portion 27, the developing wire surrounds at least one circle along the circumference of the push rod connecting portion 27, or a plurality of developing points surround at least one circle along the circumference of the push rod connecting portion 27.

In other embodiments, the marker combination 310 may also be disposed on the sheath assembly 40, i.e., the first marker 312 is disposed on the push rod 43 and the second marker 314 is disposed on the sheath core 41; specifically, the first mark 312 is located on the push rod 43 near the push rod connection portion 27, and the push rod 43 moves axially relative to the sheath core 41 to bring the first mark into alignment with the second mark.

When the first mark 312 is aligned with the second mark 314, the outer diameter dimension of the stoma 221 has a value of a, which may be any number; alternatively, the A may range from, but is not limited to, any one of 5mm to 15mm, e.g., A may be 6mm, 7mm, 8mm, 9mm, 10mm, etc.

Preferably, the first mark 312 is at least one first developing member disposed on the push rod connecting portion 27 or the push rod 43, and the second mark 314 is at least one second developing member disposed on the sheath core 41. The first developing member may be, but is not limited to, a developing ring, a developing wire, or a number of developing points; preferably, the developing ring surrounds at least one circle along the circumference of the push rod connecting portion 27 or the push rod 43, the developing wire surrounds at least one circle along the circumference of the push rod connecting portion 27 or the push rod 43, or the plurality of developing points surround at least one circle along the circumference of the push rod connecting portion 27 or the push rod 43. The second developing member may be, but is not limited to, a developing ring, a developing wire, or a number of developing points; preferably, the developing ring surrounds at least one circle along the circumference of the sheath core 41, the developing wire surrounds at least one circle along the circumference of the sheath core 41, or a plurality of developing points surround at least one circle along the circumference of the sheath core 41. The developing ring, the developing wire or the developing point can be made of gold, platinum, tantalum and other materials.

The sheath core 41 is axially provided with a plurality of second marks 314, and the push rod 43 drives the push rod connecting part 27 to axially move, so that the first marks 312 are respectively aligned with one of the plurality of second marks 314 to obtain different radial dimension values of the ostomy main body 22. Specifically, the plurality of second marks 314 are arranged at intervals along the sheath core 41, the push rod connecting portion 27 is provided with a first mark 312, and during the axial movement of the push rod 43 relative to the sheath core 41, the push rod 43 drives the first mark 312 on the push rod connecting portion 27 to be aligned with one of the plurality of second marks 314, so as to obtain different external diameter dimension values of the stoma 221.

Alternatively, the first indicia 312 are each aligned with one of the plurality of second indicia 314 during proximal to distal movement, and the radial dimension of the stoma body 22 increases gradually, i.e. the outer diameter dimension of the stoma 221 increases gradually; the first marks 312 are each aligned with one of the second marks 314 during distal-to-proximal movement, and the radial dimension of the stoma body 22, i.e. the outer diameter of the stoma 221, is progressively reduced.

The number of second marks 314 on the sheath core 41 may be set as desired, such as 2, 3, 4, 5, or other numbers of second marks 314 may be provided. The stoma 221 has an outside diameter dimension value of B when the first indicium 312 is aligned with the most proximal second indicium 314 and C when the first indicium 312 is aligned with the most distal second indicium 314, wherein C is greater than B. The outer diameter dimension of the stoma 221 may be any range of values from B to C, alternatively, from B to C may be, but is not limited to, 5mm to 15mm. In this embodiment, four second marks 314 are provided on the sheath core 41, and when the first marks 312 are aligned with one of the four second marks 314, the outer diameter dimension values of the stoma 221 may be, but are not limited to, 5mm, 7mm, 9mm, 11mm, respectively. One ostomy member 20 in this embodiment can form stomas with different inner diameter values accurately, and is convenient to use and can meet the requirements of different patients.

Referring to fig. 1, 2 and 5, the housing 50 includes a first strip-shaped housing 51 and a second strip-shaped housing 53, and the first housing 51 and the second housing 53 are detachably connected together. When the first housing 51 is connected with the second housing 53, a tubular structure is enclosed. The diameter control assembly 60, the sheath control assembly 70 and the sheath control assembly 80 are disposed in the tubular structure; a diameter adjustment assembly 60 is connected to the push rod 43, the diameter adjustment assembly 60 being used to control the movement of the push rod 43 relative to the sheath core 41 to adjust the radial dimension value of the stoma body 22. The sheath adjusting and controlling assembly 70 is connected to the sheath pulling rod 45, and the diameter adjusting and controlling assembly 60 is used for controlling the sheath pulling rod 45 to move relative to the sheath core 41 so as to adjust the first positioning member 24 to be in a flattened state or a bent state. The outer sheath regulatory assembly 80 is connected to the outer sheath 47, the outer sheath regulatory assembly 80 being used to control movement of the outer sheath 47 relative to the sheath core 41 to allow removal or retraction of the ostomy member 20 to the outer sheath 47.

The diameter regulating assembly 60 comprises a push rod driving member 61 connected to the push rod 43 and a push rod operating member 62 connected to the push rod driving member 61, wherein the push rod operating member 62 can drive the push rod driving member 61 to move axially so as to drive the push rod 43 to move axially relative to the sheath core 41, thereby realizing the adjustment of the radial dimension value of the stoma main body 22. Specifically, the proximal end of the push rod 43 is connected to the push rod driving member 61, the push rod operating member 62 is rotatably connected to the housing 50, the rotation axis of the push rod operating member 62 is collinear with the axis of the sheath core 41, the push rod driving member 61 is in threaded engagement with the push rod operating member 62, and rotation of the push rod operating member 62 relative to the housing 50 can drive the push rod driving member 61 to move axially to drive the push rod 43 to move axially.

In this embodiment, the push rod operating member 62 is a first knob rotationally sleeved on the housing 50, an inner wall of the first knob is provided with an internal thread, the push rod driving member 62 is a first push rod sliding block arranged in an inner cavity of the first knob, and an outer wall of the first push rod sliding block is provided with an external thread matched with the internal thread; the end of the push rod 43 remote from the stoma 20 is fixedly connected to the first push rod slide. The first knob is rotated to drive the first push rod sliding block to axially move relative to the sheath core 41, and the first push rod sliding block drives the push rod 43 to axially slide so as to adjust the radial dimension value of the stoma main body 22.

Preferably, the inner wall of the housing 50 is provided with a first spacing portion 54 and a second spacing portion 55 at intervals, the first spacing portion 54 is located at the distal end of the push rod driver 61, and the second spacing portion 55 is located at the proximal end of the push rod driver 61; the axial distance between the first limiting portion 54 and the second limiting portion 55 is the axial movement stroke of the push rod driver 61. That is, the push rod driver 61 can be stopped at the first and second limiting

portions

54 and 55 during the axial movement. Specifically, the first limiting portion 54 and the second limiting portion 55 are limiting blocks protruding from an inner wall of the housing 50. Further, the first limiting portion 54 and the second limiting portion 55 are annular blocks protruding from an inner wall of the housing 50, the push rod 43 is axially slidably inserted into the distal annular block, and the sheath-receiving pull rod 45 is axially slidably inserted into the proximal annular block.

The sheath retraction adjusting and controlling assembly 70 is located at the proximal end of the diameter adjusting and controlling assembly 60, and the sheath retraction adjusting and controlling assembly 70 includes a pull rod driving member 71 connected to the sheath retraction pull rod 45 and a pull rod operating member 72 connected to the pull rod driving member 71, wherein the pull rod operating member 72 can drive the pull rod driving member 71 to move axially so as to drive the sheath retraction pull rod 45 to move axially relative to the sheath core 41, thereby realizing adjustment of the first positioning member 24 in a flattened state or a bent state. Specifically, the proximal end of the sheath-retracting lever 45 is connected to the lever driving member 71, the lever operating member 72 is rotatably connected to the housing 50, the rotation axis of the lever operating member 72 is collinear with the axis of the sheath core 41, the lever driving member 71 is in threaded engagement with the lever operating member 72, and rotation of the lever operating member 72 relative to the housing 50 drives the lever driving member 71 to move axially to drive the sheath-retracting lever 45 to move axially.

In this embodiment, the pull rod operating member 72 is a second knob rotationally sleeved on the housing 50, an inner wall of the second knob is provided with an internal thread, the push rod driving member 62 is a second push rod sliding block arranged in an inner cavity of the second knob, and an outer wall of the second push rod sliding block is provided with an external thread matched with the internal thread; the end of the sheath stay 45 remote from the ostomy member 20 is fixedly connected to the second push rod slide. The second knob is rotated to drive the second push rod sliding block to axially move relative to the sheath core 41, and the second push rod sliding block drives the push rod 43 to axially slide, so as to adjust the first positioning member 24 to be in the flattened state or the bent state.

Preferably, the inner wall of the housing 50 is provided with a third spacing portion 56 and a fourth spacing portion 57 which are spaced apart, the third spacing portion 56 is positioned at the distal end of the pull rod driving member 71, and the fourth spacing portion 57 is positioned at the proximal end of the pull rod driving member 71; the axial distance between the third limit portion 56 and the fourth limit portion 57 is the axial movement stroke of the pull rod driving member 71. That is, the pull rod driving member 71 can be stopped at the third and fourth limiting

portions

56 and 57 during the axial movement. Specifically, the third limiting portion 56 and the fourth limiting portion 57 are limiting blocks protruding from the inner wall of the housing 50. Further, the third limiting portion 56 and the fourth limiting portion 57 are annular blocks protruding from the inner wall of the housing 50, the sheath-receiving pull rod 45 is axially slidably inserted into the distal annular block, and the sheath core 41 is axially slidably inserted into the proximal annular block.

Preferably, the proximal end of the sheath core 41 passes through the fourth limiting portion 57, and the sheath core 41 is provided with a connection block 413 for connecting an external device, the connection block 413 being capable of stopping against the fourth limiting portion 57.

The outer sheath regulating assembly 80 is located at the distal end of the diameter regulating assembly 60, and the outer sheath regulating assembly 80 includes a sheath driving member 81 connected to the outer sheath 47 and a sheath operating member 82 connected to the sheath driving member 81, wherein the sheath operating member 82 can drive the sheath driving member 81 to move axially so as to drive the outer sheath 47 to move axially relative to the sheath core 41, thereby enabling the ostomy member 20 to be moved out of or retracted into the outer sheath 47. Specifically, the proximal end of the outer sheath 47 is connected to the sheath driving member 81, the sheath operating member 82 is rotatably connected to the housing 50, the rotation axis of the sheath operating member 82 is collinear with the axis of the sheath core 41, the sheath driving member 81 is in threaded engagement with the sheath operating member 82, and rotation of the sheath operating member 82 relative to the housing 50 can drive the sheath driving member 81 to move axially to drive the outer sheath 47 to move axially.

In this embodiment, the sheath operating member 82 is a third knob rotationally sleeved on the housing 50, an inner wall of the third knob is provided with an internal thread, the sheath driving member 81 is a third push rod sliding block disposed in an inner cavity of the third knob, and an outer wall of the third push rod sliding block is provided with an external thread matched with the internal thread; the end of the outer sheath 47 remote from the ostomy member 20 is fixedly connected to said third push rod slide. The third knob is rotated to drive the third push rod sliding block to axially move relative to the sheath core 41, and the third push rod sliding block drives the outer sheath 47 to axially slide so as to adjust the movement of the ostomy member 20 out of or back into the outer sheath 47.

Preferably, the inner wall of the housing 50 is provided with a fifth limiting portion 58, and the fifth limiting portion 58 is located at the distal end of the sheath driving member 81; the sheath driving member 81 is located between the first limiting portion 54 and the fifth limiting portion 58, and the axial distance between the first limiting portion 54 and the fifth limiting portion 58 is the axial movement stroke of the sheath driving member 81. That is, the sheath driving member 81 can be stopped at the first and fifth limiting

portions

54 and 58 during the axial movement. Specifically, the first limiting portion 54 and the fifth limiting portion 58 are limiting blocks protruding from an inner wall of the housing 50. Further, the first limiting portion 54 and the fifth limiting portion 58 are annular blocks protruding from the inner wall of the housing 50, and the outer sheath 47 is axially slidably inserted into the distal annular block.

As shown in fig. 5, in the present embodiment, the first housing 51 and the second housing 53 are connected by a positioning pin and a screw. In other embodiments, the first housing 51 and the second housing 53 may be, but are not limited to, snap fit, glue joint, etc. The housing 50 has a sliding groove axially formed therein, in which the proximal end of the sheath assembly 40, the push rod driver 61, the pull rod driver 71, and the sheath driver 81 are axially slidably received.

The ostomy device 100 further comprises a temperature sensor (not shown) provided in the ostomy body 22, the temperature sensor being electrically connected to the ablation power control system, the temperature sensor being in contact with the ostomy inner peripheral surface of the tissue for sensing the temperature of said tissue. In this embodiment, the temperature sensor is provided near the stoma 221.

Alternatively, the temperature sensor may be, but is not limited to, a thermocouple or thermistor.

The temperature sensor may be attached to the stoma body 22 proximate the stoma 221 by, but not limited to, medical adhesive or welding.

Referring to fig. 1-2 and 6-9, the ostomy device 100 may be used in combination with an ablation power source and power connection wire of the delivery device. The using method is as follows:

The septum 901 is pierced with a piercing mechanism, after which a guidewire is fed into the inferior vena cava 903 and the piercing fitment is removed. Pushing the outer sheath 47 along the guidewire into the left atrium 906 and puncturing the septum 901 to the left atrium 906 with the tapered head 283; allowing delivery of ostomy member 20 to the atrial septum 901 location and viewing and positioning visualization member 226 in the atrial septum 901 tissue. Rotating the sheath operating member 82 on the housing 50 causes the outer sheath 47 to be proximally withdrawn to release the second positioning member 26 of the ostomy member 20; continued rotation of the sheath operating member 82 withdraws the outer sheath 47 into the right atrium to release the entire ostomy member 20.

When the stoma member 20 is released entirely, the pull rod operating member 72 is rotated to move the sheath pull rod 45 axially distally, the sheath pull rod 45 adjusting the first positioning member 24 for slow release. At this time, the room space 901 will be confined between the first positioning piece 24 and the second positioning piece 26. The position of the stoma 221 on the room septum 901 may be adjusted by positioning the developer 226 on the stoma 221.

When the stoma part 221 of the stoma part 20 is adjusted to a suitable position, the push rod operating member 62 is rotated to adjust the outer diameter dimension value of the stoma part 221. At this time, the specific position of advancement of the pushrod 43 and the corresponding outer diameter dimension value of the stoma 221 may be determined by the first mark 312 on the pushrod connection 27 or pushrod 43 and the second mark 314 on the sheath core 41. When the outer diameter size of the stoma 221 is adjusted to an accurate value, the ablation energy source may be released, ablating the stoma 905 of the septum 901. At this time, the temperature sensor located near the stoma 221 will detect the ablation temperature, and the detected ablation temperature is fed back to the external control module, and the control module controls the output of the ablation energy device to prevent the ablation temperature from being too high, which would cause adverse effects on the patient.

When ablation is completed, the push rod operator 62 is adjusted to adjust the outer diameter dimension of the stoma 221 to a minimum. The pull rod operator 72 is then adjusted to move the sheath pull rod 45 axially proximally, the sheath pull rod 45 adjusting the primary positioning member 24 to retract parallel to the stoma body 22 to prevent impeding retraction of the stoma member 20 to the outer sheath 47.

When both steps are completed, the sheath operating member 82 is adjusted to advance the outer sheath 47 forward (i.e., distally) until it reaches the junction of the ostomy body 22 and the conical head 283. At this point the ostomy member 20 will be fully retracted into the outer sheath 47 and the ostomy device 100e is withdrawn from the body, resulting in a stoma 905 of a defined stoma diameter.

The ostomy body 22 of the ostomy device 100e of the present embodiment is inserted into the stoma of the septum 901, and the radial dimension of the stoma 221 of the ostomy body 22 is adjusted by controlling the sliding of the push rod 43 relative to the sheath core 41 by means of the diameter regulating assembly 60; and determining the exact radial dimension value of the stoma 221 by the alignment of the first marking 312 and the second marking 314 so that the stoma 221 can open the stoma on the atrial septum to form a stoma 905 of the exact diameter value; in addition, the pull rod operating member 72 is rotated to drive the pull rod driving member 71 to move axially, so as to drive the sheath receiving pull rod 45 to slide axially, and directly adjust the first positioning member 24 to be in a flattened state, so that the ostomy member 20 is conveniently retracted into the outer sheath 47. Because the first positioning member 24 is directly connected to the sheath receiving pull rod 45, compared with the first embodiment, the ostomy device 100e of the sixth embodiment omits the sheath receiving connecting cylinder 4534 and the sheath receiving connecting member 451, thereby saving material cost, avoiding connection and penetration of the sheath receiving, reducing manufacturing process and greatly reducing manufacturing cost; in addition, the direct connection of the primary positioning member 24 to the telescoping pull rod 45 can increase the useful life of the ostomy device 100 e.

Referring to fig. 10 and 11, the structure of the ostomy device according to the second embodiment of the present application is similar to that of the first embodiment, except that: the structure of the ostomy member 20a in the second embodiment is slightly different from that of the ostomy member 20 in the sixth embodiment; specifically, the push rod attachment portion 27 includes a plurality of attachment pieces 272, and the attachment pieces 272 are arranged one turn in the circumferential direction of the ostomy member 20a, that is, the attachment pieces 272 are arranged one turn each other in the circumferential direction of the sheath core; the support segments 2414 of the plurality of first positioning rods 241 are gathered proximally toward the push rod connection 223 and pass through the push rod connection 223 to form a connection 2416.

Specifically, the plurality of connection pieces 272 are in one-to-one correspondence with the plurality of ablation pieces 2210 of the stoma 221, a first support rod 2230 is connected between each connection piece 272 and the corresponding ablation piece 2210, and a connection portion 2416 of each first positioning rod 241 is located between two adjacent connection pieces 272. Preferably, the distal end of the first support rod 2230 is connected to a middle portion of the proximal end of the corresponding ablation sheet 2210, and the proximal end of the first support rod 2230 is connected to a middle portion of the distal end of the corresponding connection sheet 272.

In this embodiment, each of the connection pieces 272 is a circular arc piece, and the circular arc pieces are arranged in a circular ring structure along the circumferential direction of the stoma body 22.

In other embodiments, each of the connection tabs 272 may also be, but not limited to, rectangular, circular, oval, polygonal, etc.

In this embodiment, each two adjacent connecting pieces 272 in the push rod connecting portion 27 form a gap, and when the ostomy member 20a is assembled to the sheath assembly 40, the supporting section 2414 is conveniently inserted into the push rod connecting portion 27 from the gap and then connected to the sheath retracting pull rod 45; so that the first positioning rod 241 is more conveniently and simply connected with the push rod connecting part 27, and the efficiency is improved.

The usage of the ostomy device of the second embodiment is the same as that of the first embodiment, and will not be repeated here.

Referring to fig. 12-13, the third embodiment of the present application provides an ostomy device similar to the sixth embodiment except that: the structure of the ostomy member 20b in the third embodiment is slightly different from that of the ostomy member 20 in the first embodiment; that is, the shape of each first support rod 2230 of the first support portion 223 and the shape of each second support rod 2250 of the second support portion 225 of the ostomy member 20b in the third embodiment are different from those of the sixth embodiment; and the structure of the first positioning lever 241 and the structure of the second positioning lever 261 in the third embodiment are different from those in the first embodiment. Specifically:

In the third embodiment, each first supporting rod 2230 of the first supporting portion 223 is Y-shaped, the first supporting rod 2230 includes a strip-shaped first rod 2232 at a proximal end thereof and a V-shaped second rod 2234 at a distal end of the first rod 2232, and one end of the first rod 2232 is connected to a tip of the second rod 2234. One end of the first rod body 2232 of the first support rod 2230, which is far away from the second rod body 2234, is connected to the push rod connecting portion 27, and two ends of the second rod body 2234 of the first support rod 2230, which are far away from the first rod body 2232, are respectively connected to two adjacent ablation sheets 2210. Every two adjacent second rod bodies 2234 are connected to the corresponding ablation sheet 2210 at intervals, and the two second rod bodies 2234 enclose a first avoidance groove 2231; the positioning segment 2413 and the supporting segment 2414 of each first positioning rod 241 are bar-shaped rods, the end of the positioning segment 2413 far away from the supporting segment 2414 is connected to the corresponding ablation sheet 2210, and the end of the supporting segment 2414 far away from the positioning segment 2413 passes through the push rod connecting portion 27 to form a connecting portion 2416. The first positioning rod 241 is located between the two second rod bodies 2234 of the ablation plate 2210, and the first positioning rod 241 faces the first avoidance groove 2231. When the first positioning member 24 is in the flattened state, the first positioning rod 241 is accommodated in the first avoidance groove 2231. The connecting portion 2416 is a tube inserted into the inner cavity of the push rod connecting portion 27.

Each of the second support rods 2250 of the second support part 225 has an inverted Y shape, and the second support rod 2250 includes a bar-shaped first rod 2252 at a distal end thereof and an inverted V-shaped second rod 2254 at a proximal end of the first rod 2252, the proximal end of the first rod 2252 being connected to a tip of the second rod 2234. One end of the first rod body 2252 of the second support rod 2250, which is far away from the second rod body 2254, is connected to the sheath core connecting part 28, two ends of the second rod body 2254 of the second support rod 2250, which is far away from the first rod body 2252, are respectively connected to two adjacent ablation sheets 2210, each two adjacent second rod bodies 2254 are mutually connected to the corresponding ablation sheets 2210 at intervals, and the two second rod bodies 2254 enclose a second avoidance groove 2251; the second positioning portion 2612 and the extending portion 2614 of each second positioning rod 261 are bar-shaped rods, the proximal end of the extending portion 2614 is connected to the corresponding ablation plate 2210, the second positioning rod 261 is located between the two second rod bodies 2254 of the ablation plate 2210, and the second positioning rod 261 is opposite to the second avoidance groove 2251. When the second positioning member 26 is in the flattened state, the second positioning lever 261 is accommodated in the second escape groove 2251.

In the present embodiment, since each first support rod 2230 of the first support portion 223 is of a Y-shape and each second support rod 2250 of the second support portion 225 is of an inverted Y-shape, the structure of the stoma body 22 is stabilized and the stoma at the atrial septum can be better opened.

Preferably, the connection of the positioning segment 2413 and the supporting segment 2414 of each first positioning rod 241 is in arc transition; the joint of each first positioning rod 241 and the ablation sheet 2210 is in arc transition; the connection part of the second positioning part 2612 and the extension part 2614 of each second positioning rod 261 is in arc transition; the joint of each second positioning rod 261 and the ablation sheet 2210 is in arc transition; to avoid the ostomy member 20b scratching tissue.

The usage method of the ostomy device of the third embodiment is the same as that of the first embodiment, and will not be repeated here.

Referring to fig. 15 to 16, the fourth embodiment of the present application provides an ostomy device similar to the first embodiment except that: the structure of the ostomy member 20c in the fourth embodiment is slightly different from that of the ostomy member 20 in the sixth embodiment; that is, the shape of each first support rod 2230 of the first support portion 223 and the shape of each second support rod 2250 of the second support portion 225 of the ostomy member 20c in the fourth embodiment are different from those of the sixth embodiment; and the structure of the first positioning lever 241 and the structure of the second positioning lever 261 in the fourth embodiment are different from those in the first embodiment. Specifically:

in the fourth embodiment, each first supporting rod 2230 of the first supporting portion 223 has a Y-shape, the first supporting rod 2230 includes a strip-shaped first rod 2232 at a proximal end thereof and a V-shaped second rod 2234 at a distal end of the first rod 2232, and one end of the first rod 2232 is connected to a tip of the second rod 2234. One end of the first rod body 2232 of the first support rod 2230, which is far away from the second rod body 2234, is connected to the push rod connecting portion 27, and two ends of the second rod body 2234 of the first support rod 2230, which are far away from the first rod body 2232, are respectively connected to two adjacent ablation sheets 2210. Each adjacent two of the second rod bodies 2234 are connected to the corresponding ablation sheet 2210 at intervals. The positioning section 2413 of each first positioning rod 241 is in a V-shaped structure, the supporting section 2414 of the first positioning rod 241 is a bar-shaped rod, the bar-shaped rod is connected to the tip of the V-shaped structure, two ends of the positioning section 2413 far away from the supporting section 2414 are respectively connected to two adjacent ablation sheets 2210, so that the positioning section 2413 corresponds to the corresponding second rod body 2234; the end of the support segment 2414 away from the positioning segment 2413 extends from the inner cavity of the pushrod connection 27 after passing through the corresponding first rod body 2232 near the pushrod connection 27. When the first positioning rod 24 is in the flattened state, the positioning segment 2413 is attached to the corresponding second rod body 2234, and the supporting segment 2414 is attached to the corresponding first rod body 2232.

Each of the first support rods 2230 of the second support part 225 has an inverted Y shape, and the first support rod 2230 includes a first bar 2252 having a bar shape at a distal end thereof and a second bar 2254 having an inverted V shape at a proximal end of the first bar 2252, and one end of the first bar 2252 is connected to a tip of the second bar 2254. One end of the first rod 2252 of the first support rod 2230, which is far away from the second rod 2254, is connected to the sheath-core connection portion 28, and two ends of the second rod 2254 of the first support rod 2230, which are far away from the first rod 2232, are respectively connected to two adjacent ablation sheets 2210. Each adjacent two of the second rod bodies 2234 are connected to the corresponding ablation sheet 2210 at intervals. The second positioning portion 2612 of each second positioning rod 261 is in an inverted Y-shaped structure, the second positioning portion 2612 of the second positioning rod 261 is a bar-shaped rod, two ends of the second positioning portion 2612 far away from the extending portion 2614 are respectively connected to two adjacent ablation plates 2210, so that the second positioning portion 2612 corresponds to the corresponding second rod body 2254; the end of the extending portion 2614 away from the second positioning portion 2612 extends in a direction away from the stoma portion 221. When the second positioning rod 261 is in the flattened state, the second positioning portion 2612 is attached to the corresponding second rod body 2234, and the extension portion 2614 is attached to the corresponding first rod body 2232.

In the present embodiment, since each of the first support rods 2230 of the first support portion 223 is of a Y-shape, each of the second support rods 2250 of the second support portion 225 is of an inverted Y-shape, the positioning segments 2413 are of a Y-shape, and the second positioning portions 2612 are of an inverted Y-shape, the structure of the stoma body 22 is more stable, and the stoma on the atrial septum can be better stretched.

Preferably, the junction of the positioning segment 2413 and the support segment 2414 of each first positioning rod 241 is rounded to avoid the ostomy 20b scoring tissue.

The method of using the ostomy device of the fourth embodiment is the same as that of the first embodiment, and will not be described here again.

Referring to fig. 16-17, a fifth embodiment of the present application provides an ostomy device similar to the first embodiment except that: the structure of the ostomy member 20d in the fifth embodiment is slightly different from that of the ostomy member 20 in the first embodiment; that is, the shape of each first support rod 2230 of the first support portion 223 and the shape of each second support rod 2250 of the second support portion 225 of the ostomy member 20d in the fifth embodiment are different from those of the first embodiment; and the structure of the first positioning lever 241 and the structure of the second positioning lever 261 in the fifth embodiment are different from those in the sixth embodiment. Specifically:

In the fifth embodiment, the first supporting portion 223 includes a plurality of first supporting rods 2230, each ablation sheet 2210 is connected with two first supporting rods 2230, specifically, distal ends of the two first supporting rods 2230 are connected to two opposite sides of proximal ends of the corresponding ablation sheet 2210, and proximal ends of the two first supporting rods 2230 are connected to the push rod connecting portion 27 after being close to each other; a first avoidance groove 2231 is formed between the two first support bars 2230. The first positioning portion 2412 includes a strip-shaped positioning segment 2413 and a strip-shaped supporting segment 2414, wherein an end of the positioning segment 2413 far from the supporting segment 2414 is connected to the corresponding ablation sheet 2210, and an end of the supporting segment 2414 far from the positioning segment 2413 is bent toward the first supporting portion 223 and passes through a proximal end of the corresponding first avoidance groove 2231 to be connected to the connecting portion 2416. In this embodiment, the push rod connecting portion 27 is a connecting cylinder, the positioning segment 2413 and the supporting segment 2414 are both in a bar-shaped structure, the connecting portion 2416 is a cylinder body movably penetrating through the inner cavity of the push rod connecting portion 27 along the axial direction, the proximal ends of the supporting segments 2414 of the plurality of first positioning rods 241 are gathered into the cylinder body, that is, the distal ends of the supporting segments 2414 are connected to the distal ends of the cylinder body; the proximal end of the barrel is connected to the distal end of the telescoping pull rod 45. When the first positioning rod 241 is in the unfolded state, the first positioning rod 241 is accommodated in the first avoidance groove 2231.

The second supporting portion 225 includes a plurality of second supporting rods 2250, each of the ablation plates 2210 is connected to two of the second supporting rods 2250, proximal ends of the two second supporting rods 2250 are connected to opposite sides of distal ends of the corresponding ablation plates 2210, and distal ends of the two second supporting rods 2250 are connected to the push rod connecting portion 27 after being close to each other; a second clearance groove 2251 is formed between the two second support bars 2250. The second positioning rod 261 includes a strip-shaped second positioning portion 2612 and a strip-shaped extension portion 2614, and an end portion of the second positioning portion 2612 remote from the extension portion 2614 is connected to the corresponding ablation sheet 2210. The extension 2614 is provided with a circular plate at its end. When the second positioning piece 26 is in the unfolded state, the second positioning rod 261 is accommodated in the corresponding second avoidance groove 2231.

In this embodiment, since the proximal end of each ablation sheet 2210 is connected to two first support rods 2230, the distal end of each ablation sheet 2210 is connected to two second support rods 2250, and the support segment 2414 of each first positioning portion 2412 passes through the corresponding first avoidance slot 2231 and then is connected to the connecting portion 2416, the structure of the stoma piece 20d is more stable, and the stoma on the atrial septum can be better stretched.

The method of using the ostomy device of the fifth embodiment is the same as that of the first embodiment, and will not be described here again.

Referring to fig. 18 to 20, a sixth embodiment of the present application provides an ostomy device similar to the first embodiment except that: the structure of the ostomy member 20e and the structure of the sheath assembly 40a in the sixth embodiment are slightly different from those of the ostomy member 20 and the sheath assembly 40 in the first embodiment; specifically: the push rod attachment portion 27 comprises a number of attachment tabs 272, which attachment tabs 272 are arranged one turn in the circumferential direction of the stoma 20e, i.e. the attachment tabs 272 are arranged one turn apart from each other in the circumferential direction of the sheath core. The connecting portion 2416 is disposed around the push rod connecting portion 27, and an end portion of the connecting portion 2416 remote from the first positioning portion 2413 is connected to the sheath-pulling rod 45. Specifically, the support segments 2414 of the plurality of first positioning rods 241 are gathered proximally toward the push rod connection portion 223 near the outer peripheral surface of the push rod connection portion 27 to form a connection portion 2416. That is, the connecting portion 2416 of the first positioning member 24 is sleeved outside the push rod connecting portion 27.

Preferably, the positioning segments 2413 and the supporting segments 2413 are each in a strip-shaped structure, and the supporting segments 2414 of the plurality of first positioning rods 241 are gathered toward the push rod connecting portion 27 at the proximal end thereof to form a connecting portion 2416 at the outer periphery of the push rod connecting portion 27.

Specifically, the plurality of connection pieces 272 are in one-to-one correspondence with the plurality of ablation pieces 2210 of the stoma 221, a first support rod 2230 is connected between each connection piece 272 and the corresponding ablation piece 2210, and a connection portion 2416 of each first positioning rod 241 is located between two adjacent connection pieces 272. Preferably, the distal ends of the first support rods 2230 are connected to the middle of the proximal ends of the corresponding ablation sheets 2210, and the proximal ends of the first support rods 2230 are connected to the middle of the distal ends of the corresponding connection sheets 272.

As shown in fig. 18, the sheath tube assembly 40a includes a sheath core 41, a push rod 43 axially slidably sleeved on the sheath core 41, a sheath retracting lever 45 axially slidably sleeved on the push rod 43, and an outer sheath 305 axially slidably sleeved on the sheath retracting lever 45; the sheath-core connection 28 of the ostomy member 20e is fixedly connected to the distal end of the sheath core 41, the pushrod connection 27 of the ostomy member 20e is fixedly connected to the distal end of the pushrod 43, and the connection 2416 is fixedly connected to the distal end of the sheath-receiving rod 45.

The method of using the ostomy device of the sixth embodiment is the same as that of the first embodiment, and will not be described here again.

Referring to fig. 21, a seventh embodiment of the present application provides an ostomy device having a similar structure to the sixth embodiment, except that: the push rod connecting portion 27 of the ostomy member 20f in the seventh embodiment is a cylindrical body, and the connecting portions 2416 of the plurality of first positioning rods 241 of the first positioning member 24 are provided around the outer periphery of the push rod connecting portion 27.

The method of using the ostomy device of the seventh embodiment is the same as that of the sixth embodiment and will not be described here again.

Referring to fig. 22, the present application further provides an ostomy system comprising a ostomy device according to any of the above embodiments, a controller 110, and an ablative energy source 120, the controller 110 being adapted to control the ostomy device to perform a ostomy on tissue, the ablative energy source 120 being adapted to provide ablative energy to the ostomy device. In this embodiment, the ablation applicator 120 is a radio frequency power source electrically connected to the leads 432 of the ostomy device via the controller 110 such that the stoma 221 is electrically connected to the radio frequency power source, the stoma 221 contacting the atrial septum and ablating the stoma.

The foregoing is a description of embodiments of the present application, and it should be noted that, for those skilled in the art, several improvements and modifications can be made without departing from the principles of the embodiments of the present application, and these improvements and modifications are also considered as the protection scope of the present application.

Claims

1. An ostomy device comprising a ostomy member for forming a stoma in tissue, the ostomy device further comprising a sheath tube assembly connected to the ostomy member, the ostomy member comprising a ostomy body capable of radially expanding and a first positioning member connected to the ostomy body, the first positioning member being in a bent state or a flattened state relative to the ostomy body, the sheath tube assembly comprising a sheath core and a sheath receiving pull rod movably sleeved on the sheath core in an axial direction, the ostomy body being sleeved on the sheath core and being fixedly connected to the sheath core at a distal end thereof, the sheath receiving pull rod being connected to an end of the first positioning member remote from the ostomy body, the sheath receiving pull rod being axially movable relative to the sheath core to adjust the first positioning member to switch between the bent state and the flattened state.

2. The ostomy device of claim 1, wherein the first positioning member comprises a plurality of first positioning rods, a distal end of each first positioning rod being connected to the ostomy body, the plurality of first positioning rods being arranged in a circle along a circumference of the ostomy body, a proximal end of each first positioning rod being connected to the sheath-receiving drawbar, a middle portion of each first positioning rod being bent away from the ostomy body in a bent state; each first positioning rod is parallel to the ostomy body in the flattened state of the first positioning member.

3. The ostomy device of claim 2, wherein the first positioning rod comprises a first positioning portion connected to the ostomy body and a connecting portion connected to a proximal end of the first positioning portion, the connecting portion being connected to the sheath pull rod.

4. A stoma device according to claim 3, wherein the first positioning portion comprises a positioning section extending obliquely from the stoma body in a direction away from the stoma body, and a support section bent from a distal end of the positioning section towards the stoma body and gathering in the connection portion extending obliquely, the positioning section being adapted to rest against the tissue.

5. The ostomy device of claim 4, wherein the surfaces of the positioning segments of the first positioning rods, which are attached to the tissue, are umbrella surfaces, conical surfaces or cambered surfaces.

6. The ostomy device of claim 4, wherein the junction of the positioning section and the supporting section of the first positioning portion is rounded.

7. The ostomy device of claim 4, wherein the intersection of the first positioning portion and the connecting portion transitions through an arc of a circle.

8. The ostomy device of claim 4, wherein the ostomy body comprises a stoma part for abutting against an inner wall of the stoma, a push rod connection part, and a first support part connected between the stoma part and the push rod connection part, the connection part being interposed in the push rod connection part, an end of the connection part remote from the first positioning part being connected to the telescoping pull rod.

9. The ostomy device of claim 8, wherein the pushrod connecting portion is a connecting barrel, the positioning segments and the supporting segments are each in a bar-shaped structure, and the supporting segments of the plurality of first positioning rods are gathered toward the connecting barrel and pass through the connecting barrel to form the connecting portion.

10. The ostomy device of claim 9, wherein the first support portion is provided with a clearance groove corresponding to the first positioning rod, and wherein the first positioning rod is received in the clearance groove when the first positioning member is in the flattened state.

11. The ostomy device of claim 8, wherein the push rod connecting portion is a connecting cylinder, the positioning section and the supporting section are both in a strip-shaped structure, the connecting portion is a cylinder body penetrating through the connecting cylinder in an axial movable mode, and the proximal ends of the supporting sections of the first positioning rods gather the cylinder body.

12. The ostomy device of claim 8, wherein the positioning section is a V-shaped structure, the distal end of the support section being connected to the tip of the V-shaped structure, the end of the V-shaped structure remote from the support section being connected to the ostomy body.

13. The ostomy device of claim 12, wherein the support section is in a strip-like configuration, and wherein the proximal end of the support section gathers toward the push rod connection and passes through the first support section before exiting the lumen of the push rod connection to form the connection.

14. The ostomy device of claim 8, wherein the push rod connection comprises a plurality of connection tabs arranged one around the circumference of the sheath core, the support sections of the plurality of first positioning rods gathering proximally towards and through the push rod connection to form the connection.

15. The ostomy device of claim 8, wherein the sheath assembly further comprises a push rod axially movably sleeved on the receiving rod, the push rod being connected to the push rod connection, the push rod being axially movable relative to the sheath core to adjust the radial size of the ostomy body.

16. The ostomy device of claim 4, wherein the ostomy body comprises a stoma part for abutting against an inner peripheral surface of the stoma, a push rod connecting part, and a first support part connected between the stoma part and the push rod connecting part, the connecting part surrounding the push rod connecting part, an end of the connecting part remote from the first positioning part being connected to the sheath pull rod.

17. The ostomy device of claim 16, wherein the positioning segments and the support segments are each in a bar-like configuration, and wherein the support segments of the plurality of first positioning bars are gathered proximally toward the pushrod connection to form the connection at the outer periphery of the pushrod connection.

18. The ostomy device of claim 15, wherein a first marker is provided on the sheath core and a second marker is provided on the push rod connection or on the push rod, the second marker being moved axially with the push rod relative to the sheath core into alignment with the first marker to yield a radial dimension value of the ostomy body.

19. The ostomy device of claim 8, wherein the ostomy portion is provided with a positioning developing member along its circumference.

20. An ostomy system, characterized in that: comprising a controller for controlling the ostomy device to ostomy tissue, an ablative energy source for providing ablative energy to the ostomy device, and a ostomy device according to any of claims 1-19.