CN116407254A

CN116407254A - Ostomy device and ostomy system

Info

Publication number: CN116407254A
Application number: CN202111679739.6A
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 a ostomy device, it includes that the ostomy piece is connected to the sheath pipe assembly of ostomy piece, the ostomy piece includes the ostomy main part that can radially expand and connects to the first setting element of ostomy main part, first setting element is the bending state or the flattening state for the ostomy main part, the sheath pipe assembly includes sheath core and along the axle movable cover locate the receipts sheath combination of sheath core, the ostomy main part cover locate the sheath core and one end fixedly connected to the sheath core, receipts sheath combination is connected to first setting element, receipts sheath combination is along axial displacement in order to adjust first setting element changes between the bending state with the flattening state for the 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

Ostomy device and ostomy system

Technical Field

The application relates to the technical field of interventional medical instruments, in particular to an ostomy device and a ostomy system provided with the 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 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 above technical problem, the present application provides a ostomy device, it includes the ostomy member that is used for forming the stoma on the tissue, ostomy device still including connect in the sheath pipe assembly of ostomy member, ostomy member include can radial expansion the ostomy main part and connect in the first setting element of ostomy main part, first setting element for the ostomy main part is the bending state or the flattening state, sheath pipe assembly includes sheath core and along the movable cover of axial locate the receipts sheath combination of sheath core, ostomy main part cover is located sheath core and one end fixed connection in the sheath core, receipts sheath combination connect in first setting element, receipts sheath combination for the sheath core is along axial displacement in order to adjust first setting element changes between the bending state with the flattening state.

The transvaginal combination of the ostomy device of the present application is axially movable relative to the sheath core to adjust the first positioning to a flattened 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.

The utility model provides a system of making mouth, it includes making mouth device, controller and ablation energy ware, the controller is used for controlling make mouth device makes the mouth to the tissue, ablation energy ware is used for make mouth device provides ablation energy, make mouth device still including connect in make the sheath pipe assembly of mouth piece, make the mouth piece including can radial expansion make mouth main part and connect in the first setting element of making mouth main part, first setting element for making mouth main part be the state of buckling or flattening state, sheath pipe assembly includes the sheath core and along axial activity cover locate the receipts sheath combination of sheath core, make mouth main part cover locate sheath core and one end fixed connection in the sheath core, receive the sheath combination connect in first setting element, receive the sheath combination for the sheath core moves in order to adjust first setting element is in buckling state with the flattening state is transformed.

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 an exploded view of the ostomy member and sheath core of FIG. 2;

FIG. 6 is a schematic cross-sectional structural view of a housing and a regulatory assembly of the regulatory mechanism of FIG. 1;

Fig. 7-10 are schematic views of the ostomy device of fig. 1 during a ostomy procedure;

fig. 11 is a schematic structural view of an ostomy device provided in a second embodiment of the present application;

FIG. 12 is a schematic view of the structure of the ostomy member and sheath assembly of the adjustment mechanism of FIG. 11;

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

FIG. 14 is a schematic elevational structural view of the ostomy member of FIG. 13;

fig. 15 is a schematic perspective view of a ostomy member of a ostomy device provided in a third embodiment of the application;

FIG. 16 is a schematic elevational view of the ostomy member of FIG. 15;

fig. 17 is a schematic perspective view of a ostomy member of a ostomy device provided in a fourth embodiment of the application;

FIG. 18 is a schematic elevational view of the ostomy member of FIG. 17;

fig. 19 is a schematic perspective view of a ostomy member of a ostomy device provided in a fifth embodiment of the application;

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

fig. 21 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.

In the description of the present application, the tissue between the left atrium and the right atrium of the present application is referred to as the atrial septum, the "proximal" end being the end proximal to the delivery device connection location and the "distal" end being the end distal to the delivery device connection 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 the definition is only for convenience of description and is not to be construed as limiting the application.

It should be noted that: the ostomy device and ostomy system of the present application include, but are not limited to, use with an interatrial septum stoma, but may be used with 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 radially telescopic bracket, and the ostomy member 20 comprises a ostomy main body 22 capable of being radially expanded 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 assembly 45 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 stoma main body is fixedly connected to the sheath core 41, the sheath retracting assembly 45 is connected to the first positioning piece 24, and the sheath retracting assembly 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 combination 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 retracting the ostomy member 20 to the outer sheath, the sheath retracting assembly 45 adjusts the first positioning member 24 to be in a flattened state, i.e. the first positioning member 24 is parallel to the ostomy main body 22, so that the blockage 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 ostomy member retracting device is convenient to use and simple to operate.

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 the middle thereof, a first support portion 223 provided at the proximal end of the stoma portion 221, and a second support portion 225 provided at the distal end of the stoma portion 221; specifically, the first support portion 223 is connected to the stoma portion 221 and the pushrod connection 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 distal end of each secondary support rod 2250 is connected to the sheath-core connection 28 and the proximal end of each secondary support rod 2250 is connected to a corresponding ablation blade 2210. The stoma body 22 is radially expandable or contractible, and in the expanded state, the stoma body 22 is spaced between each adjacent two of the plurality of ablation tabs 2210, at which time 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; when the stoma body 22 is radially contracted to a minimum diameter with no or little spacing between each adjacent two of the ablation tabs 2210, the stoma 221 has a radial dimension that is equal to or slightly greater than the proximal end of the first support 223 and 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 connection portion 28 of the ostomy member 20 is connected to the sheath core 41 and the push rod connection portion 27 of the ostomy member 20 is connected to the push rod 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 assembly 45 includes a sheath receiving connector 451 and a sheath receiving adjuster 453, the sheath receiving connector 451 is connected between the first positioning member 24 and the sheath receiving adjuster 453, and the sheath receiving adjuster 453 moves axially relative to the sheath core 41 to drive the sheath receiving connector 451 to adjust the first positioning member 24, so that the first positioning member 24 is in a bent state or a flattened state. Specifically, the sheath adjusting member 453 is slidably sleeved outside the sheath core 41 in the axial direction, and the pushrod 43 is slidably sleeved outside the sheath adjusting member 453 in the axial direction, that is, the sheath adjusting member 453 is axially slidable relative to the pushrod 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 sheath receiving connecting piece 451 comprises a plurality of sheath receiving wires 4510, a plurality of sheath receiving wires 4510 are in one-to-one correspondence with a plurality of first positioning rods 241, one end of each sheath receiving wire 4510 is connected to the end part of the corresponding first positioning rod 241 far away from the ostomy main body 22, and the other end of each sheath receiving wire 4510 is connected to the sheath receiving adjusting piece 453. When the sheath adjusting member 453 is slid proximally in the axial direction with respect to the sheath core 41 to tighten the sheath wires 4510, each sheath wire 4510 pulls the corresponding first positioning rod 241 from the folded state to the flattened state, and the first positioning rod 241 is elastically deformed. When the sheath adjusting member 453 is slid axially and distally relative to the sheath core 41 to relax the sheath wire 4510, the first positioning rod 241 is elastically restored from the flattened state to the folded state.

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, the plurality of first positioning rods 241 are in one-to-one correspondence with the plurality of ablation sheets 2210 of the stoma part 221, and the plurality of second positioning rods 261 are in one-to-one correspondence with the plurality of 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 pieces 24 are in a bent state with respect to the stoma body 22, each first positioning rod 241 extends away from the stoma portion 221 such that the tip of the first positioning rod 241 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. 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 parallel to the corresponding first support rod 2230 of the first support 223; 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, specifically, each second positioning lever 261 is parallel to the corresponding second support lever 2250 of the second support 225.

As shown in fig. 2-4, 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 the first positioning portion 2412 away from the ostomy main body 22, and the sheath wire 4510 is connected to the corresponding connecting portion 2416. That is, one end of the first positioning portion 2412 of each first positioning rod 241 is connected to the corresponding ablation sheet 2210, and the connection portion 2416 is connected to the other end of the first positioning portion 2412. When the first positioning members 24 are in a bent state, the first positioning portion 2412 of each first positioning rod 241 extends obliquely from the stoma main body 22 in the direction of the sheath tube assembly 40, i.e., the first positioning portion 2412 extends obliquely from the stoma 221 in the direction of the push rod connecting portion 27; 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. The second positioning rod 261 includes a second positioning portion 2612 connected to the ostomy main body 22 and an extending portion 2614 connected to the second positioning portion 2612 and far away from the ostomy main body 22, and an arc surface is provided on an end surface of the extending portion 2614 far away from the second positioning portion 2612, and the arc surface can prevent the end of the second positioning rod 261 from scratching tissues. In this embodiment, the end of the extending portion 2614 away from the second positioning portion 2612 is provided with a circular piece. In other embodiments, the end of the extension 2614 may be provided with, but is not limited to, a sphere or the like. One end of the second positioning portion 2612 of each second positioning rod 261 is connected to the corresponding ablation sheet 2210, and the extension portion 2614 is connected to the other end of the second positioning portion 2612. 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 surface of the first positioning portion 2412 that is attached to the tissue may be, but is not limited to, an umbrella surface, a conical surface, or a cambered surface; that is, the first positioning portion 2412 of the first positioning member 24 and the tissue-adhering surface enclose an umbrella surface, a conical surface, an arc surface, or the like. The surface of the second positioning portion 2612 contacting the tissue may be, but is not limited to, an umbrella surface, a conical surface or a cambered surface; that is, the second positioning portion 2612 of the second positioning member 26 and the tissue-contacting surface enclose an umbrella surface, a conical surface, an arc surface, or the like.

Preferably, the end of the connecting portion 2416 remote from the first positioning portion 2412 is provided as an arc surface capable of avoiding the tip of the first positioning rod 24 from scratching tissue. The intersection of the first positioning portion 2413 and the connecting portion 2416 is rounded to avoid scratching tissue. The intersection of the second positioning portion 2612 and the extending portion 2614 is arc-shaped to avoid scratching tissue.

In this embodiment, the first positioning portion 2412 has a strip-shaped structure, the first positioning portion 2412 includes a positioning segment 2413 connected to the ostomy main body 22 and an extension segment 2414 connected to one end of the positioning segment 2413 far away from the ostomy main body 22, the connecting portion 2416 is connected to the end of the extension segment 2414, the end of the connecting portion 2416 is provided with a circular sheet, and the sheath winding line 4510 is connected to the circular sheet. When the first positioning member 24 is in a bent state with respect to the stoma main body 22, the positioning segment 2413 extends obliquely in a direction approaching the push rod connecting portion 27, and the extension segment 2414 extends from the positioning segment 2413 in a direction approaching the push rod connecting portion 27; preferably, the junction of the positioning segment 2413 and the extension segment 2414 is rounded to avoid scratching tissue. The connecting portion 2416 is a circular piece connected to an end of the extension segment 2414 remote from the positioning segment 2413. Preferably, the connecting portion 2416 is provided with a connecting hole 2417, and the sheath winding wire 4510 is connected to the connecting hole 2417.

Preferably, the hosel wires 4510 are connected to the connection portion 2416, and in particular, one end of each hosel wire 4510 remote from the hosel adjustment member 453 is connected to the connection portion 2416 of the corresponding first positioning rod 241. In this embodiment, an end of the sheath retracting wire 4510 away from the sheath retracting adjustment member 453 is connected to the circular piece, specifically, an end of the sheath retracting wire 4510 away from the sheath retracting adjustment member 453 is connected to the wire hole 2417 of the connection portion 2416.

As shown in fig. 2, the sheath-retracting adjusting member 453 includes a sheath-retracting pull rod 4532, the sheath-retracting pull rod 4532 is axially slidably sleeved on the sheath core 41, and one end of the plurality of sheath-retracting wires 4510, which is far away from the first positioning rod 241, is connected to the sheath-retracting pull rod 4532. When the sheath drawing tie bars 4532 slide axially and proximally relative to the sheath core 41 to tighten the sheath drawing wires 4510, each sheath drawing wire 4510 pulls the corresponding first positioning bar 241 from the bent state to the flattened state, and the first positioning bar 241 is elastically deformed; when the sheath stay 4532 is slid axially and distally relative to the sheath core 41 to release the sheath wire 4510, the primary positioning rod 241 is elastically restored from the flattened state to the folded state.

Preferably, the sheath adjusting member 453 further includes a sheath receiving connecting cylinder 4534 axially sleeved on the sheath core 41, the sheath receiving connecting cylinder 4534 is connected to the sheath pulling rod 4532, and one end of the plurality of sheath wires 4510, which is far from the first positioning rod 241, is connected to the sheath receiving connecting cylinder 4534. Specifically, the hosel connection cartridge 4534 is fixedly attached to the distal end of the hosel pull rod 4532.

Further, the peripheral wall of the sheath receiving connecting cylinder 4534 is provided with a plurality of fixing holes 4535, the plurality of fixing holes 4535 are arranged in a circle along the circumferential direction of the sheath receiving connecting cylinder 4534, and the plurality of sheath receiving wires 4510 are respectively connected to the plurality of fixing holes 4535. Specifically, one ends of the plurality of sheath wires 4510, which are far from the first positioning rod 241, are respectively connected to the plurality of fixing holes 4535. The fixing holes 4535 are in one-to-one correspondence with the sheath collecting wires 4510, in this embodiment, the number of the sheath collecting wires 4510 is ten, the number of the fixing holes 4535 is ten, and the ten fixing holes 4535 are uniformly arranged at intervals along the circumferential direction of the sheath core 41.

Referring to fig. 2 and 5, a through slot 412 is formed in the sheath core 41 along the axial direction, a plurality of penetrating holes 413 are formed in the sheath core 41 near the first positioning rod 241 and are communicated with the through slot 412, a plurality of penetrating holes 415 are formed in the sheath core 41 near the sheath retracting adjusting member 453 and are communicated with the through slot 412, and the sheath retracting wire 4510 is connected to the sheath retracting adjusting member 453 after penetrating through the penetrating holes 413, the through slot 412 and the penetrating holes 415. Specifically, one end of each sheath receiving wire 4510, which is far away from the first positioning rod 241, sequentially passes through the penetrating hole 413, the through-slot 412 and the penetrating hole 415 and then is connected to the fixing hole 4535 corresponding to the sheath receiving adjusting member 453.

The plurality of penetrating holes 413 are in one-to-one correspondence with the plurality of first positioning rods 241, and the plurality of penetrating holes 413 are arranged in a circle along the circumferential direction of the sheath core 41; the plurality of penetrating holes 415 are in one-to-one correspondence with the plurality of sheath collecting wires 4510, and the plurality of penetrating holes 415 are arranged in a circle along the circumferential direction of the sheath core 41. In the present embodiment, the number of the penetration holes 413 is 10, and 10 penetration holes 413 are uniformly arranged at intervals in the circumferential direction of the sheath core 41; the number of the penetration holes 415 is 10, and 10 penetration holes 415 are arranged one turn in the circumferential direction of the sheath core 41.

Preferably, the extending directions of the penetrating hole 413 and the penetrating hole 415 are inclined to the axial direction, so that the sheath wire 4510 can slide smoothly in the penetrating hole 413 and the penetrating hole 415. Further, the edge of the opening of the penetrating hole 413 is provided with an arc surface, and the edge of the opening of the penetrating hole 415 is provided with an arc surface, so that the sliding resistance of the sheath winding wire 4510 is reduced, the abrasion of the sheath winding wire 4510 is reduced, and the service life of the sheath winding wire 4510 is prolonged.

In other embodiments, the number of the penetrating holes 413 may not correspond to the number of the first positioning rods 241, for example, one penetrating hole 413 corresponds to two first positioning rods 241, and two sheath wires 4510 connected to two first positioning rods 241 penetrate through one penetrating hole 413.

Preferably, the ostomy member 20 is a radially stretchable and elastically stretchable scaffold, in particular the ostomy member 20 may be an elastic metal support skeleton or an elastic non-metal support 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. 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 from 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 5mm, 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.

As shown in fig. 2 and 5, the sheath core 41 is provided with a plurality of second marks 314 axially arranged along the sheath core, 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, and different radial dimension values of the ostomy main body 22 are obtained. 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.

As shown in fig. 2, the push rod 43 is provided with a threading groove in the axial direction, and a wire 432 is provided in the threading groove, the wire 432 being electrically connected between the ablation energy source and the stoma 221.

Referring to fig. 1, 2 and 6, 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 timing assembly 70 is connected to the sheath timing lever 4532, and the diameter adjusting assembly 60 is configured to control the movement of the sheath timing lever 4532 relative to the sheath core 41 to adjust the first positioning member 24 to a flattened or folded 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 4532 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 4532 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 4532 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 4532 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 4532 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 telescoping pull rod 4532 remote from the ostomy 20 is fixedly attached 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 4532 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. 9, 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.

As shown in fig. 2, the ostomy device 100 further comprises a temperature sensor 224 provided to the ostomy body 22, the temperature sensor 224 being electrically connected to the ablation power control system, the temperature sensor 224 being in contact with the ostomy inner peripheral surface of the tissue for sensing the temperature of said tissue. In the present embodiment, the temperature sensor 224 is provided near the stoma part 221.

Alternatively, temperature sensor 224 may be, but is not limited to, a thermocouple or thermistor.

The temperature sensor 224 may be fixedly attached to the stoma body 22 adjacent to the stoma 221 by, but not limited to, using a medical adhesive or welding.

Referring to fig. 1-2 and 7-10, 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 bring the sheath adjusting member 453 to move distally in the axial direction, and the sheath adjusting member 453 releases the sheath connecting member 451 to release the first positioning member 24 slowly. 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 224 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 adversely affect 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. Then, the pull rod operating member 72 is adjusted to bring the sheath adjusting member 453 to axially move proximally, and the sheath adjusting member 453 tightens the sheath connector 451 to retract the adjustment first positioning member 24 parallel to the stoma body 22 to prevent the retrieval of the stoma member 20 into 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 100 is withdrawn from the body, resulting in a stoma 905 of defined stoma diameter.

The ostomy body 22 of the ostomy device 100 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 by the alignment of the first mark 312 with the second mark 314, an accurate radial dimension value of the stoma 221 is determined. In addition, the pull rod driving member 71 is moved in the axial direction by rotating the pull rod operating member 72 to adjust the first positioning member 24 to be in a flattened state, so that the first positioning member 24 is parallel to the ostomy main body 22, thereby facilitating the retraction of the ostomy member 20 into the outer sheath 47.

Referring to fig. 11-14, the structure of the ostomy device 100a according to the second embodiment of the present application is similar to that of the first embodiment, except that: in the second embodiment, the structure of the stoma 20a is slightly different from that of the stoma 20 in the first embodiment, specifically: the first supporting portion 223 is provided with a first avoiding groove 2231 corresponding to the first positioning rod 241, and when the first positioning piece 24 is in a flattened state relative to the ostomy main body 22, the first positioning rod 241 is accommodated in the first avoiding groove 2231; the second supporting portion 225 is provided with a second position-avoiding groove 2251 corresponding to the second positioning rod 261, and when the second positioning member 26 is in the flattened state, the second positioning rod 261 is accommodated in the second position-avoiding groove 2251, so as to facilitate the recovery of the ostomy member 20a into the outer sheath 47.

As shown in fig. 13 and 14, each first support rod 2230 of the first support portion 223 is provided with a first avoidance groove 2231, the first avoidance groove 2231 extends along the length direction of the first support rod 2230, and the width of the first avoidance groove 2231 is greater than the width of the first positioning rod 241; the distal end of the first positioning rod 241 is connected to the corresponding ablation sheet 2210, and the first positioning rod 241 corresponds to the first avoidance groove 2231. Preferably, the first avoidance groove 2231 is provided at the middle of the first support rod 2230, the distal end of the first avoidance groove 2231 extends to the stoma part 221, and the proximal end of the first avoidance groove 2231 extends to the pushrod connecting part 27. Each second support rod 2250 of the second support part 225 is provided with a second position-avoiding groove 2251, the second position-avoiding groove 2251 extends along the length direction of the second support rod 2250, and the width of the second position-avoiding groove 2251 is greater than the width of the second positioning rod 261; the proximal end of the second positioning rod 261 is connected to the corresponding ablation sheet 2210, and the second positioning rod 261 corresponds to the second clearance groove 2251. Preferably, a second clearance groove 2251 is provided in the middle of the second support rod 2250, a proximal end of the second clearance groove 2251 extending to the stoma part 221, and a distal end of the second clearance groove 2251 extending to the sheath-core connection part 28.

Each first support rod 2230 of the first support portion 223 of the ostomy member 20a in the present embodiment is provided with a first avoidance groove 2231, each second support rod 2250 of the second support portion 225 is provided with a second avoidance groove 2251, and when the first positioning member 24 and the second positioning member 26 of the ostomy member 20a are in the unfolded state, the first positioning rod 241 is accommodated in the first avoidance groove 2231, and the second positioning rod 261 is accommodated in the corresponding second avoidance groove 2231, so as to facilitate recycling of the ostomy member 20a.

Preferably, the connection of each first positioning rod 241 with the corresponding ablation sheet 2210 is in circular arc transition, and the connection of the positioning segment 2413 of the first positioning rod 241 with the extension segment 2414 is in circular arc transition. The connection of each second positioning rod 261 and the corresponding ablation sheet 2210 is in arc transition, and the connection of the second positioning portion 2612 of the second positioning rod 261 and the extension portion 2614 is in arc transition. The above-described rounded transitions in the ostomy member 20a of the present embodiment facilitate implantation of the ostomy device 100a and avoid damaging tissue of the ostomy member 20a during use.

The usage of the ostomy device 100a of the second embodiment is the same as that of the first embodiment, and will not be described here again.

Referring to fig. 15 and 16, the structure of the ostomy device according to the third embodiment of the present invention is similar to that of the first 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 first example; 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 distal end of each first positioning rod 241 is connected to the corresponding ablation sheet 2210, the first positioning rod 241 is located between the two second rod bodies 2234 of the ablation sheet 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.

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 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, the proximal end of the first bar 2252 being connected to a tip of the second bar 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 proximal end of each second positioning rod 261 is connected to a corresponding ablation plate 2210, the second positioning rods 261 are located between two second rod bodies 2254 of the ablation plate 2210, and the second positioning rods 261 face the second avoidance grooves 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.

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. 17 and 18, the structure of the ostomy device according to the fourth embodiment of the present invention is similar to that of 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 first embodiment; specifically:

in the fourth embodiment, each of the first positioning portions 2412 of the first positioning rod 241 has a V-shaped structure, the connecting portion 2416 is connected to the tip of the V-shaped structure, and the end of the V-shaped structure remote from the connecting portion 2416 is connected to the stoma main body 22. Specifically, each connecting portion 2416 is a circular plate, the circular plate is connected to the tip of the V-shaped structure, two ends of the V-shaped structure away from the connecting portion 2416 are connected to two opposite sides of the proximal end of the corresponding ablation plate 2210, and the connecting hole 2417 is formed in the circular plate. The first supporting portion 223 includes a plurality of strip-shaped first supporting bars 2230, two first supporting bars 2230 are disposed on each of the ablation sheets 2210, the proximal ends of the ablation sheets 2210 are connected to the distal ends of the two first supporting bars 2230, and the proximal ends of the two adjacent first supporting bars 2230 of each adjacent two of the ablation sheets 2210 are close to each other and fixedly connected to the push rod connecting portion 27. In this embodiment, the ends of the V-shaped structures of each first positioning rod 241 on each ablation sheet 2210 away from the connection portion 2416 respectively correspond to the distal ends of two first support rods 2230 on each ablation sheet 2210.

In other embodiments, the end of the V-shaped structure of each first positioning rod 241 on each ablation sheet 2210 away from the connection portion 2416 is respectively offset from the distal ends of the two first support rods 2230 on the ablation sheet 2210, specifically, the end of the V-shaped structure of each first positioning rod 241 on each ablation sheet 2210 away from the connection portion 2416 is located between the distal ends of the two first support rods 2230 on the ablation sheet 2210. When the first positioning member 24 is in the flattened state, the first positioning rod 241 is accommodated in the gap between the corresponding two first supporting rods 2230.

Each of the ablation sheets 2210 of the stoma 221 is provided with two second positioning rods 261 spaced apart from each other, and the extending portions 2614 of the two second positioning rods 261 are connected at the end portions remote from the second positioning portions 2612. The second supporting portion 223 includes a plurality of strip-shaped second supporting bars 2250, two second supporting bars 2250 are disposed on each of the ablation sheets 2210, distal ends of the ablation sheets 2210 are connected to proximal ends of the two second supporting bars 2250, and distal ends of two adjacent second supporting bars 2250 of each adjacent two of the ablation sheets 2210 are close to each other and fixedly connected to the sheath-core connecting portion 28. In this embodiment, the ends of the two second positioning rods 261 on each ablation sheet 2210 far from the extension 2614 respectively correspond to the proximal ends of the two second support rods 2250 on each ablation sheet 2210.

In other embodiments, the ends of the two second positioning rods 261 on each of the ablation sheets 2210 distal from the extensions 2614 are offset from the proximal ends of the two second support rods 2250 on each of the ablation sheets 2210. Specifically, the ends of the two second positioning rods 261 on each of the ablation sheets 2210 distal from the extensions 2614 are located between the distal ends of the two second support rods 2250 on the ablation sheets 2210; when the second positioning member 26 is in the flattened state, the second positioning rod 261 is accommodated in the gap between the corresponding two second support rods 2250.

Each ablation sheet 2210 in the embodiment is connected with two first support rods 2230 and two second support rods 2250, each first positioning rod 241 has a V-shaped structure, each ablation sheet 2210 is provided with two second positioning rods 261 spaced from each other, and distal ends of the two second positioning rods 261 are connected; making the construction of the stoma 20c more rigid and facilitating the support of the stoma by the stoma 20 c.

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. 19 and 20, the structure of the ostomy device according to the fifth embodiment is similar to that of 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; specifically:

In the fifth embodiment, each first positioning portion 2412 of the first positioning rod 241 has a V-shaped structure, each connecting portion 2416 is a connecting ring, and the sheath winding wire 4510 is connected to the connecting ring. The tip of the V-shaped structure extends obliquely towards the proximal end, the connecting ring is connected to the tip of the V-shaped structure, and two ends of the V-shaped structure away from the connecting portion 2416 are respectively connected to two adjacent ablation sheets 2210. The first support portion 223 includes a plurality of first support rods 2230 in a bar shape, a distal end of each first support rod 2230 is connected to a corresponding ablation sheet 2210, and a proximal end of the first support rod 2230 is connected to the push rod connection portion 27. A first avoidance groove 2231 is formed between every two adjacent first support rods 2230, and when the first positioning member 24 is in the unfolded state, the first positioning rod 241 is accommodated in the first avoidance groove 2231. Preferably, a first supporting rod 2230 is disposed in the middle of the proximal end of each ablation sheet 2210, and first positioning portions 2412 are respectively connected to two opposite sides of the proximal end of each ablation sheet 2210. Preferably, the arc transition of the connection part of the first positioning portion 2412 of each first positioning rod 241 and the connection ring is that the arc transition of the first positioning portion 2412 and the connection piece of the ablation sheet 2210 is that the first positioning rod 241 scratches the tissue.

Two second positioning rods 261 spaced from each other are provided on each of the ablation sheets 2210 of the stoma 221, and the extending portions 2614 of the two adjacent second positioning rods 261 on each adjacent two of the ablation sheets 2210 are connected at the end portions remote from the second positioning portions 2612. The second support portion 225 includes a plurality of second support rods 2250 in the form of a bar, a proximal end of each second support rod 2250 being connected to a corresponding ablation sheet 2210, and a distal end of the second support rod 2250 being connected to the sheath-core connection portion 28. A second avoidance groove 2251 is formed between every two adjacent second support rods 2250, and when the second positioning member 26 is in the unfolded state, the second positioning rod 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.

When the first positioning member 24 and the second positioning member 26 of the ostomy member 20d are in the unfolded state, the first positioning rod 241 is accommodated in the first avoidance groove 2231, and the second positioning rod 261 is accommodated in the corresponding second avoidance groove 2231, so as to facilitate recycling of the ostomy member 20d.

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. 1-21, 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 ostomy 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 first positioning of the ostomy device of the ostomy system of the present application can be adjusted to a flattened or folded state. When the ostomy member 20 is retracted to the outer sheath 41, the sheath retracting assembly 45 adjusts the first positioning member 24 to be in a flattened state, so that the obstruction of the first positioning member 24 is avoided, the ostomy member 20 can be conveniently and smoothly retracted to the outer sheath 41, and the ostomy member is convenient to use and easy to operate.

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. The utility model provides a ostomy device, its includes the ostomy piece that is used for forming the stoma on the tissue, its characterized in that, ostomy device still includes connect in ostomy piece's sheath pipe assembly, ostomy piece include can radial expansion the ostomy main part and connect in ostomy main part's first setting element, first setting element is bending state or flattening state for ostomy main part, sheath pipe assembly includes sheath core and along the movable cover in the receipts sheath combination of sheath core, ostomy main part cover is located sheath core and one end fixed connection in the sheath core, receive sheath combination connect in first setting element, receive sheath combination for the sheath core moves in the axial direction in order to adjust first setting element changes between bending state and flattening state.

2. The ostomy device of claim 1, wherein the sheath assembly comprises a sheath connector and a sheath adjuster, the sheath connector being connected between the first positioning member and the sheath adjuster, the sheath adjuster moving axially relative to the sheath core to drive the sheath connector to adjust the first positioning member.

3. The ostomy device of claim 2, wherein the first positioning member comprises a plurality of first positioning rods, one end of each first positioning rod is connected to the ostomy main body, the plurality of first positioning rods are arranged in a circle along the circumferential direction of the ostomy main body, the sheath-collecting connecting member comprises a plurality of sheath-collecting wires, the plurality of sheath-collecting wires are in one-to-one correspondence with the plurality of first positioning rods, one end of each sheath-collecting wire is connected to the end of the corresponding first positioning rod, which is far away from the ostomy main body, and the other end of each sheath-collecting wire is connected to the sheath-collecting adjusting member.

4. A ostomy device according to claim 3, wherein the first positioning rod comprises a first positioning part connected to the ostomy body and a connecting part connected to the first positioning part remote from the ostomy body, the sheath wire being connected to the connecting part.

5. The ostomy device of claim 4, wherein the first positioning portion extends obliquely from the ostomy body in the direction of the transvaginal adjustment member, the first positioning portion being adapted to abut the tissue in the folded state.

6. The ostomy device of claim 5, wherein the surface of the first positioning portion that engages the tissue is an umbrella surface, a conical surface, or a cambered surface.

7. The ostomy device of claim 4, wherein an end of the connecting portion remote from the first positioning portion is provided as an arc surface.

8. 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.

9. The ostomy device of claim 4, wherein the first positioning portion has a bar-shaped structure, the first positioning portion comprises a positioning section connected to the ostomy main body and an extension section connected to one end of the positioning section away from the ostomy main body, the connecting portion is connected to the tail end of the extension section, a circular sheet is arranged at the tail end of the connecting portion, and the sheath winding wire is connected to the circular sheet.

10. The ostomy device of claim 9, wherein the circular piece is provided with a connecting hole, and wherein the sheath wire is connected to the connecting hole.

11. The ostomy device of claim 4, wherein the first positioning portion is a V-shaped structure, the connecting portion being connected to a tip of the V-shaped structure, an end of the V-shaped structure remote from the connecting portion being connected to the ostomy body.

12. The ostomy device of claim 11, wherein the connection portion is a connection ring to which the sheath wire is connected.

13. The ostomy device of claim 12, wherein the connection of the connection ring and the first positioning portion transitions in a circular arc.

14. A ostomy device according to claim 3, wherein the sheath adjusting member comprises a sheath stay, the sheath stay is axially slidably sleeved on the sheath core, and a plurality of sheath wires are connected to the sheath stay.

15. The ostomy device of claim 14, wherein the sheath adjustment member further comprises a sheath coupling barrel axially sleeved on the sheath core, the sheath coupling barrel coupled to the sheath tie rod, a plurality of sheath wires coupled to the sheath coupling barrel.

16. The ostomy device of claim 15, wherein the peripheral wall of the sheath tube is provided with a plurality of fixing holes, the plurality of fixing holes are arranged in a circle along the circumferential direction of the sheath tube, and the plurality of sheath wires are respectively connected to the plurality of fixing holes.

17. A ostomy device as claimed in claim 3 wherein the sheath core is provided with a through slot in the axial direction, the sheath core is provided with a plurality of penetration holes communicating with the through slot near the first positioning rod, the sheath core is provided with a plurality of penetration holes communicating with the through slot near the sheath receiving adjusting member, and the sheath receiving wire is connected to the sheath receiving adjusting member after penetrating through the penetration holes, the through slot and the penetration holes.

18. The ostomy device of claim 17, wherein a plurality of the penetration holes are in one-to-one correspondence with a plurality of the first positioning rods, and the plurality of penetration holes are arranged in a circle along the circumferential direction of the sheath core; the plurality of penetrating holes are in one-to-one correspondence with the plurality of sheath collecting wires, and the plurality of penetrating holes are arranged in a circle along the circumferential direction of the sheath core.

19. A ostomy device according to claim 3, 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, a number of the first positioning rods being connected to the stoma part, the first support part being provided with a clearance groove, the first positioning rods being accommodated in the clearance groove when the first positioning member is in a flattened state in relation to the ostomy body.

20. The ostomy device of claim 19, wherein the sheath assembly further comprises a pushrod axially movably sleeved to the receiving sheath assembly, the pushrod being connected to the pushrod connection, an end of the ostomy body remote from the pushrod connection being connected to the sheath core, the pushrod being axially movable relative to the sheath core to adjust the radial size of the stoma.

21. The ostomy device of claim 20, 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.

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

23. An ostomy system, characterized in that: comprising an ostomy device according to any of claims 1-22, a controller for controlling the ostomy device to ostomy tissue and an ablative energy source for providing ablative energy to the ostomy device.