CN114052897A

CN114052897A - Atrial shunt apparatus and ostomy apparatus

Info

Publication number: CN114052897A
Application number: CN202210011826.2A
Authority: CN
Inventors: 唐玉华
Original assignee: Shenzhen Baite Micro Medical Technology Co ltd
Current assignee: Shenzhen Baite Micro Medical Technology Co ltd
Priority date: 2022-01-07
Filing date: 2022-01-07
Publication date: 2022-02-18
Anticipated expiration: 2042-01-07
Also published as: CN114052897B

Abstract

The present invention relates to an atrial shunt and ostomy device. The atrium shunting device comprises a traction piece, a cutting piece, a sheath tube and a control handle, wherein the traction piece, the cutting piece and the sheath tube are all connected with the control handle; the traction piece is movably accommodated in the sheath tube and is used for drawing the tissue to be cut into the sheath tube; the control handle comprises a traction piece control assembly and a limiting piece, the traction piece control assembly controls the traction piece to be movably accommodated in the sheath tube, and the limiting piece is used for locking the relative position of the traction piece and the sheath tube; the cutting member includes a cutting portion; the cutting portion is connected with the radio frequency power connector, so that when the cutting portion is electrified, the cutting portion is electrified to perform electric cutting. The atrium shunting device is used for carrying out ostomy shunting, a bracket is not required to be implanted, and the opening can be prevented from being closed.

Description

Atrial shunt apparatus and ostomy apparatus

Technical Field

The invention relates to the technical field of medical instruments, in particular to an atrium shunting instrument and an ostomy instrument.

Background

This section provides background information related to the present disclosure only and is not necessarily prior art.

Heart failure is a complex group of clinical syndromes with impaired ventricular filling or ejection capacity due to structural or functional abnormalities of the heart, with major clinical manifestations of dyspnea and weakness (limited exercise tolerance), and fluid retention (pulmonary congestion and peripheral edema). Heart failure is a severe and terminal stage of various heart diseases, has a very high incidence and has become the most important cardiovascular disorder worldwide. With the advent of the aging era, the incidence of heart failure is on an increasing trend, and patients have poor activity tolerance, low survival rate, repeated hospitalization and low quality of life.

Heart failure can be divided into diastolic heart failure and systolic heart failure. Diastolic heart failure refers to a condition in which ventricular relaxation and compliance are reduced, resulting in reduced ventricular filling and increased filling pressure, under normal ventricular contraction, resulting in pulmonary and systemic congestion syndrome. Diastolic heart failure can result in elevated pressures in the left atrium and pulmonary veins, preventing the normal flow of oxygenated blood. At present, the treatment of diastolic heart failure is mainly based on drug therapy, and the curative effect of the drug therapy is limited.

In the blood circulation system of the human body, the left atrium and the right atrium are completely isolated from each other by the interatrial septum under normal conditions, and blood cannot intercommunicate. Clinical data show that a small hole is formed in the interatrial septum of a patient with diastolic heart failure by using an interventional instrument, so that blood in the left atrium and the right atrium can be communicated with each other to form left-to-right shunting, thereby being beneficial to reducing the pressure of the left atrium of the patient with diastolic heart failure, increasing blood oxygen saturation, relieving pulmonary congestion, improving the heart failure symptoms such as exercise tolerance and the like of the patient.

At present, a mode of forming a small hole on an interatrial septum through an interventional instrument is mainly to use a balloon or a stent to expand a puncture part after puncturing the interatrial septum so as to form the small hole. However, tissue recoil often occurs when the balloon is withdrawn, resulting in a reduction in the opening or even a closure. The stent is an implant and can be endothelialized, and the opening of the interatrial septum is easily covered and blocked by the endothelial membrane. And the occurrence probability of channel embolism and thrombus formation is correspondingly increased after the stent is implanted. Also, the presence of the stent makes it difficult to re-administer the stoma after the blockage has occurred.

Therefore, whether balloon expansion or stent expansion is used, there is a risk of the opening closing, resulting in poor patient prognosis.

Disclosure of Invention

In view of this, there is a need for an atrial shunt device that does not require an implanted stent and avoids closure of the opening.

There is also a need to provide an ostomy appliance that does not require the implantation of a stent and avoids the closure of the opening.

An atrial shunt device comprising: the traction part, the cutting part, the sheath tube and the control handle are all connected with the control handle;

the traction piece is movably accommodated in the sheath tube and is used for drawing the tissue to be cut into the sheath tube;

the control handle comprises a traction piece control assembly and a limiting piece, the traction piece control assembly controls the traction piece to be movably accommodated in the sheath tube, and the limiting piece is used for locking the relative position of the traction piece and the sheath tube;

the cutting member includes a cutting portion; the cutting portion is connected with the radio frequency power connector, so that when the cutting portion is electrified, the cutting portion is electrified to perform electric cutting.

In one embodiment, the pulling member includes a pulling portion and a connecting portion connected to the pulling portion, one end of the connecting portion, which is far away from the pulling portion, is connected to the pulling member control assembly, the limiting member is connected to the pulling member control assembly, and the limiting member locks the position of the pulling member control assembly, so as to lock the relative position of the pulling member and the sheath.

In one embodiment, the control assembly of the pulling element comprises a fixing element of the pulling element, the control handle further comprises a shell and a sliding element, the sliding element is sleeved on the shell and can axially slide relative to the shell, the fixing element of the pulling element is connected with the connecting part, the fixing element of the pulling element is partially contained in the shell, partially extends out of the shell and is connected with the sliding element, and the sliding element slides along the axial direction of the shell to drive the connecting part to axially slide.

In one embodiment, the limiting member includes a pressing portion and a limiting portion connected to the pressing portion, the housing has a limiting hole or a limiting groove, the pressing portion is connected to the sliding member, and the limiting portion extends into the housing from the sliding member and is detachably engaged with the limiting hole or the limiting groove.

In one embodiment, the control handle further comprises a cutting member control assembly, the cutting member control assembly comprises a cutting member connecting member, the cutting member further comprises a stretching portion connected with the cutting portion, the cutting member connecting member is connected with one end of the stretching portion far away from the cutting portion, and the cutting member connecting member can drive the stretching portion to axially slide so as to enable the cutting portion to be deformed to perform cutting.

In one embodiment, the extension portion extends proximally through the cutting element coupling member and is coupled to the rf power connector, and the extension portion is covered with an insulating layer.

In one embodiment, the cutting element further comprises a stretching part connected with the cutting part, an axially extending first channel is arranged on the inner wall of the sheath, and the stretching part penetrates through the first channel and is connected with the radio frequency power connector, so that the cutting part is electrified to perform electric cutting when electrified.

In one embodiment, an axially extending second channel is further disposed on the inner portion of the sheath, the second channel is radially opposite to the first channel, and the cutting element further includes an adjusting portion, one end of the adjusting portion is connected to the cutting portion, and the other end of the adjusting portion extends into the second channel.

In one embodiment, the adjusting part comprises a first adjusting wire and a second adjusting wire, the cutting part, the stretching part and the first adjusting wire are of an integrated structure, and the second adjusting wire is lapped on the first adjusting wire.

In one embodiment, the cutting element control assembly further comprises a slide rail, and the cutting element connecting element is sleeved on the slide rail and can axially slide relative to the slide rail;

or at least part of the cutting connecting piece is accommodated in the sliding rail and can axially slide relative to the sliding rail.

In one embodiment, the cutting element control assembly further comprises a damping element, the damping element is sleeved on the slide rail or arranged in the slide rail, and the cutting element connecting element extrudes the damping element when sliding axially relative to the slide rail.

In one embodiment, a stabilizing tube is arranged inside the sheath tube, the stabilizing tube is connected with the inner wall of the sheath tube, the distal end of the stabilizing tube is closer to the control handle than the distal end of the sheath tube, and the connecting part is controlled by the traction piece control assembly to be movably accommodated in the stabilizing tube.

In one embodiment, the atrium shunt device further comprises a puncture piece and a puncture tube, wherein the puncture piece is arranged at the distal end of the pulling piece, the puncture tube is movably accommodated in the stabilizing tube, and the pulling piece control assembly controls the pulling piece to be movably accommodated in the puncture tube.

In one embodiment, the control handle further comprises a puncture tube control assembly, the puncture tube control assembly comprises a puncture tube fixing member, the control handle further comprises a shell and a sliding member, the sliding member is sleeved on the shell and can axially slide relative to the shell, the puncture tube fixing member is partially contained in the shell, a part of the puncture tube fixing member extends out of the shell and is connected with the sliding member, and the sliding member slides along the axial direction of the shell to drive the puncture tube to axially slide.

In one embodiment, the puncture tube control assembly further includes a puncture tube driving member, the puncture tube driving member is sleeved on the sliding member, a portion of the puncture tube fixing member extending from the housing extends from the sliding member and is connected to the puncture tube driving member, and the puncture tube driving member is driven by the rotation of the puncture tube driving member to axially slide.

In one embodiment, the pulling member further comprises a pulling wire, and the pulling wire penetrates through the connecting part and is connected with the distal end of the pulling part.

In one embodiment, the control handle further comprises a wire pulling control assembly, the wire pulling control assembly comprises a wire pulling fixing piece, the control handle further comprises a shell and a sliding piece, the sliding piece is sleeved on the shell and can axially slide relative to the shell, the wire pulling fixing piece is partially contained in the shell, part of the wire pulling fixing piece extends out of the shell and is connected with the sliding piece, and the sliding piece slides along the axial direction of the shell to drive the wire pulling fixing piece to axially slide.

In one embodiment, the wire pulling control assembly further comprises a wire pulling driving member, the wire pulling driving member is sleeved on the sliding member, a portion of the wire pulling fixing member, which extends out of the housing, extends out of the sliding member and is connected with the wire pulling driving member, and the rotation of the wire pulling driving member drives the wire pulling fixing member to axially slide.

In one embodiment, the method comprises the following steps: the traction part, the cutting part, the sheath tube and the control handle are all connected with the control handle;

According to the atrial shunt instrument provided by the embodiment, when atrial shunt is performed, after the tissue to be cut is pulled into the sheath tube by the pulling part, the relative position of the pulling part and the sheath tube is locked by the limiting part, so that the tissue to be cut is reliably contained in the sheath tube, and irregular cutting appearance or incomplete cutting caused by unstable position of the tissue to be cut can be avoided. And, carry out the electricity cutting, can cut off the tissue when, can kill the histiocyte at the opening edge, be favorable to avoiding the opening to close.

The atrium shunting device that above-mentioned embodiment provided avoids opening closed two aspects to cooperate through stable tissue and electric current cutting, need not to implant the support and struts the puncture hole and can form stable opening on the interatrial septum.

The ostomy appliance provided by the embodiment avoids the two aspects of opening closure to be matched through stabilizing tissues and cutting current, and can form a stable opening on the tissues without implanting a bracket to prop open a puncture.

Drawings

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

Wherein:

FIG. 1 is a schematic structural view of an atrial shunt device according to one embodiment;

FIG. 2 is a partial schematic structural view of an atrial shunt apparatus according to one embodiment;

FIG. 3 is a schematic view of an embodiment of a cutting element;

FIG. 4 is a schematic view of an embodiment of a connection between a cutting element and a sheath;

FIG. 5 is a cross-sectional view of a sheath according to an embodiment;

FIG. 6 is a schematic structural view of a pull member according to one embodiment;

FIG. 7 is a schematic structural view of a pull member according to another embodiment;

FIG. 8 is an enlarged view of a portion of FIG. 3;

FIG. 9 is a schematic view of another embodiment of a connection between a cutting element and a sheath;

FIG. 10 is a schematic structural diagram of a housing according to an embodiment;

FIG. 11 is a schematic view of the housing of FIG. 10 at another angle;

FIG. 12 is a schematic structural view of a slider according to an embodiment;

FIG. 13 is a schematic view of an embodiment of a retractor fastener;

FIG. 14 is a schematic structural view of an enclosure according to an embodiment;

FIG. 15 is a schematic structural diagram of a position limiting element according to an embodiment;

FIG. 16 is an enlarged view of a portion of FIG. 2;

FIG. 17 is a partial schematic view of one embodiment of a control handle;

FIG. 18 is a schematic structural view of a fixing member of the puncture tube fixing member according to an embodiment;

FIG. 19 is a schematic structural view of a puncture tube driver according to an embodiment;

FIG. 20 is a schematic diagram of an embodiment of a pull string fastener;

FIG. 21 is a schematic structural view of a pull wire drive member according to an embodiment;

FIG. 22 is a schematic view of an embodiment of a cutter control assembly;

figure 23 is a schematic structural view of an ostomy appliance according to an embodiment.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

In the description of the embodiments of the present invention, it should be noted that the orientations or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", and the like are based on the orientations or positional relationships shown in the drawings, and are only for convenience in describing the embodiments of the present invention and simplifying the description, but do not indicate or imply that the referred devices or elements must have a specific orientation, be configured in a specific orientation, and operate, and thus, should not be construed as limiting the embodiments of the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the embodiments of the present invention, it should be noted that, unless otherwise explicitly stated or limited, the terms "mounted," "connected" and "connected" should be interpreted broadly, and may be, for example, fixedly connected, interchangeably connected, or integrally connected, mechanically connected, electrically connected, directly connected, indirectly connected through an intermediate medium, or communicated between two elements. Specific meanings of the above terms in the embodiments of the present invention can be understood in specific cases by those of ordinary skill in the art.

In the field of interventional medical devices, the end of a medical device implanted in a human or animal body closer to an operator is generally referred to as the "proximal end", the end farther from the operator is referred to as the "distal end", and the "proximal end" and the "distal end" of any component of the medical device are defined according to this principle. "axial" generally refers to the length of the medical device as it is being delivered, and "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction, and defines both "axial" and "radial" directions for any component of the medical device in accordance with this principle.

Referring to fig. 1, one embodiment of an atrial shunt device 100 includes a retractor 10, a cutting element 20, a sheath 30, and a control handle 40. The pulling element 10, the cutting element 20 and the sheath 30 are all connected with a control handle 40.

The pulling member 10 is movably accommodated in the sheath tube 30, and is used for pulling the tissue to be cut into the sheath tube 30, so that after cutting, the cut tissue is accommodated in the sheath tube 30 and is transported out of the body through the sheath tube 30, thereby preventing the cut tissue from falling into the blood circulation system to cause embolism.

Referring to fig. 2, the control handle 40 includes a pull member control assembly 410 and a limiting member 420. The pulling element control assembly 410 controls the pulling element 10 to be movably accommodated in the sheath 30, and the limiting element 420 is used for locking the relative position of the pulling element 10 and the sheath 30. The stopper 420 locks the relative position of the pulling member 10 and the sheath 30 by restricting the axial displacement of the pulling control member 410.

Referring to fig. 3, the cutting member 20 includes a cutting portion 210 and a stretching portion 220 connected to the cutting portion 210. Referring to fig. 4, in a natural state (the natural state refers to an unused state after the atrial shunt device 100 is assembled, or a state without external force, and the natural state is the same as that described below and will not be described), the cutting portion 210 is located outside the sheath 30. Referring also to fig. 5, the projection of the cutting portion 210 on a plane perpendicular to the axial center axis V-V of the sheath 30 surrounds the projection of the sheath 30 on the plane or substantially surrounds the projection of the sheath 30 on the plane.

Referring back to fig. 1, in one embodiment, the distal end of the sheath 30 is curved to facilitate passage through a curved lumen structure in a living body. When the distal end of the sheath 30 is curved, the above-mentioned axial central axis V-V means the axial central axis of the curved section.

The stretching portion 220 has one end connected to the cutting portion 210 and the other end extending axially inside the sheath 330, and the proximal end of the stretching portion 220 is connected to the rf power connector 430. The cutting part 210 and the stretching part 220 are made of an electrically conductive material. During surgery, the RF power connector 430 is connected to an external RF power source to energize the cutting section 210 for electrical cutting when energized.

In the atrial shunt device 100 provided in the above embodiment, when the atrial shunt is performed, after the tissue to be cut is pulled into the sheath 30 by the pulling member 10, the relative position between the pulling member 10 and the sheath 30 is locked by the limiting member 420, so that the tissue to be cut is reliably accommodated in the sheath 30, which is beneficial to avoiding irregular cutting appearance or incomplete cutting due to unstable position of the tissue to be cut. And, carry out the electricity cutting, can cut off the tissue when, can kill the histiocyte at the opening edge, be favorable to avoiding the opening to close.

The atrial shunt device 100 provided by the above embodiment can form a stable opening on the interatrial septum without implanting a stent to prop open the puncture opening by cooperating two aspects of tissue stabilization and current cutting to avoid opening healing.

And, the cutting part 210 of the cutting member 20 is located outside the sheath 30, and the projection of the cutting part 210 on the plane perpendicular to the axial central axis V-V of the sheath 30 surrounds or substantially surrounds the projection of the sheath 30 on the plane, so that after the retractor 10 pulls the tissue to be cut into the sheath 30, the cutting part 210 surrounds the tissue to be cut, and the cutting part 210 is located at the distal end of the tissue to be cut, which facilitates cutting more tissue to form a larger opening.

The stopper 420 locks the relative position of the retractor 10 and the sheath 30 by restricting the axial displacement of the retraction control unit 410, and when the restriction of the stopper 420 is not released, the retractor 10 stably retracts the tissue to be cut into the sheath 30, so that the tissue can be stabilized and a hole with a good shape can be cut compared to the negative pressure suction method.

Referring to fig. 6, in an embodiment, the pulling member 10 includes a pulling portion 110 and a connecting portion 120. In a natural state, the pulling portion 110 has a substantially cage-like structure. Referring to fig. 7, the pulling part 110 includes a plurality of elastic rods 111 and two sleeves 112, and two ends of the plurality of elastic rods 111 respectively converge on the two sleeves 112 to form a cage-shaped structure. The proximal end of each elastic rod 111 forms an abutment surface 1111, and the abutment surfaces 1111 of the plurality of elastic rods 111 form the abutment portions of the retractor 10.

The connecting portion 120 is an elongated rod, and the distal end of the connecting portion 120 is fixedly connected to the proximal sleeve 112. And, the proximal end of the connecting portion 120 (i.e. the end far away from the pulling portion 110) is connected to the pulling member control assembly 410, and the pulling member control assembly 410 is operated to make the connecting portion 120 axially slide along the inner cavity of the sheath 30, so that the pulling member 10 can be movably accommodated in the sheath 30. Therefore, the retractor 10 can be pushed out of the sheath 30, the tissue to be cut can be pulled into the sheath 30 by sliding the retractor 10 proximally in the axial direction of the sheath 30 after the abutment portion of the retractor 10 abuts the tissue to be cut.

In one embodiment, the connecting portion 120 extends into the pulling portion 110 and is fixedly connected to the proximal sleeve 112, and a distal end surface of the connecting portion 120 forms a gap with a proximal end surface of the distal sleeve 112.

In one embodiment, the pulling portion 110 includes a plurality of anchors 113, one end of each anchor 113 is connected to the elastic rod 111, and the other end is a free end, and the free end is of a spike structure and faces the proximal end surface of the elastic rod 111. When the abutment portion of the pulling portion 110 abuts against the tissue, the anchor 113 pierces the tissue, which is advantageous in preventing the pulling portion 110 from directly penetrating the puncture hole to cause a failure in pulling the tissue in the process of pulling the pulling portion 110 proximally to pull the tissue into the sheath 30.

In one embodiment, the number of the anchoring elements 113 corresponds to the number of the elastic rods 111, i.e., one anchoring element 113 is disposed on each elastic rod 111. Alternatively, the number of the anchors 113 is smaller than the number of the elastic bars 111, that is, the anchors 112 are not provided on some of the elastic bars 111.

In one embodiment, the flexible rod 111, the sleeve 112 and the anchor 113 are a one-piece structure formed by cutting and shaping a flexible hollow tube. Alternatively, the elastic rod 111 and the anchor 113 are an integral structure, the anchor 113 is formed by cutting the body of the elastic rod 111, and then the two ends of the elastic rod 111 are gathered and fixed to the two sleeves 112 respectively.

In any of the above-described methods, the pulling member 10 has a self-expanding structure in the pulling portion 110, and when the radial constraint applied to the pulling portion 110 is removed, the pulling portion 110 automatically returns to the natural state.

With continued reference to fig. 7, in one embodiment, the pulling element 10 further includes a pulling wire 130. The connecting portion 120 is a hollow elongated tube having an inner cavity with two open ends. The pulling wire 130 extends through the connecting portion 120 and into the pulling portion 110, and the distal end of the pulling wire 130 is connected to the pulling portion 210, such as to the distal sleeve 112. When the pulling wire 130 is pulled to the proximal end, compared with the shape in the natural state, the elastic rod 111 can deform to increase the radial size of the pulling part 110 and increase the length of the abutting surface 1111 in the radial direction, so that the area of the abutting part of the pulling part 110 is increased, more tissues can be pulled, and a hole with a larger hole diameter can be formed after cutting, so that the clinical requirement can be met, the hole is not easy to close, and the existence of the hole can be maintained for a long time.

In one embodiment, atrial shunt instrument 100 further includes a penetrating member 50 and a penetrating tube 60. The penetrating member 50 is attached to the cannula 112 at the distal end of the retractor 10. The puncture tube 60 is movably received in the sheath 30 and the pull 10 is movably received in the puncture tube 60.

Referring to fig. 3 and 8, in one embodiment, cutting element 20 includes a cutting portion 210, a stretching portion 220, and an adjustment portion 230. The cutting portion 210, the stretching portion 220, and the regulating portion 230 are all made of electrically conductive filamentary material. In one embodiment, the cutting part 210 includes two C-shaped coils 211, and the open ends of the two C-shaped coils 211 are connected to form a closed coil-shaped structure. The two connection ends 212 of the two C-shaped coils 211 are recessed with respect to the other portions of the coil-like structure. Since the two connection ends 212 are recessed with respect to the other portions of the coil structure, the above-described projection of the cutting portion 210 on the plane perpendicular to the axial central axis of the sheath 30 substantially surrounds the projection of the sheath 30 on the plane, which is the case where the projection of the cutting portion 210 does not surround the projection of the sheath 30 at the recessed portion.

Stretching portion 220 is a rod-like structure. One end of the stretching portion 220 is connected to one of the connection ends 212, and the other end is freely extended. In a natural state, the stretching part 220 is not on the same plane as the cutting part 210. In one embodiment, in a natural state, the stretching portion 220 is perpendicular or substantially perpendicular to the cutting portion 210.

In one embodiment, the adjustment part 230 includes a first adjustment wire 231 and a second adjustment wire 232, the first adjustment wire 231 is connected to the connection end 212 of the cutting part 210, and the second adjustment wire 232 is connected to the first adjustment wire 231.

In one embodiment, the cutting portion 210, the stretching portion 220, and the first adjusting wire 231 are a unitary structure, and the second adjusting wire 232 is overlapped on the first adjusting wire 231.

In one embodiment, the cutting portion 210, the stretching portion 220, and the first adjusting wire 231 are formed by bending and shaping a conductive wire. As shown in fig. 8, the stretching portion 220 includes two parallel stretching line segments 221, and one end of the stretching line segment 221 away from the cutting portion 210 is a free end. The first adjusting wire 231 comprises two parallel line segments 2311, and one ends of the two line segments 2311 away from the cutting part 21 are connected, namely, one end of the first adjusting wire 231 away from the cutting part 210 is a closed end. The second adjustment wire 232 is overlapped at the closed ends of the two line segments 2311.

Referring to fig. 9, in an embodiment, an axially extending first channel 310 and an axially extending second channel 320 are disposed on an inner wall of the sheath 30, and the first channel 310 and the second channel 320 are opposite to each other in a radial direction. Stretching portion 220 of cutting member 20 extends into first channel 310 and regulating portion 230 extends into second channel 320.

In one embodiment, the sheath 30 is provided with a stabilizer tube 330 inside, and the stabilizer tube 330 is connected to the inner wall of the sheath 30. In one embodiment, the sheath 30 and the stabilization tube 330 are a unitary structure. The stabilization tube 330 extends within the lumen of the sheath 30, with the proximal ends of the stabilization tube 330 and the sheath 30 both being connected to the control handle 40, and the distal end of the stabilization tube 330 being closer to the control handle 40 than the distal end of the sheath 30.

In one embodiment, the control handle 40 further includes a housing 430 (shown in fig. 10 and 11) and a slider 440 (shown in fig. 12).

Referring to fig. 10, the housing 430 includes an upper shell 431 and a lower shell 432, and the upper shell 431 and the lower shell 432 are detachably connected to form a first receiving portion 430A and a second receiving portion 430B.

Referring to fig. 11, the housing 430 further includes a first locking cap 433 and a second locking cap 434, and the inner walls of the first locking cap 433 and the second locking cap 434 are both provided with threads. Both ends of the upper case 431 are formed with threads, and both ends of the lower case 432 are formed with threads. The first locking cap 433 is fitted over the upper and

lower cases

431 and 432, and the second locking cap 434 is fitted over the upper and

lower cases

431 and 432, so that the upper and

lower cases

431 and 432 are detachably coupled by a screw coupling.

The first receiving portion 430A has a first receiving cavity (not shown) and a first operating window 4301, and the first operating window 4301 is communicated with the first receiving cavity. In one embodiment, there are two first operating windows 4301, and the two first operating windows 4301 are disposed symmetrically with respect to the axial central axis of the housing 430 and are opposite to each other in the radial direction.

The second receiving portion 430B has a second receiving cavity (not shown), a second operating window 4302 and a third operating window 4303, and the second operating window 4302 and the third operating window 4303 are both communicated with the second receiving cavity. In one embodiment, there are two second operating windows 4302, and the two second operating windows 4302 are disposed symmetrically with respect to the axial central axis of the housing 430 and are opposite to each other in the radial direction. The number of the third operating windows 4303 is two, and the two third operating windows 4303 are arranged symmetrically with respect to the axial center axis of the housing 430 as a symmetry axis and are opposite to each other in the radial direction. The second operating window 4302 is located at the distal end of the third operating window 4303.

Referring to fig. 10, in an embodiment, the upper shell 431 is formed with a plurality of limiting holes 4311, and the plurality of limiting holes 4311 are located in the second receiving portion 430B. The plurality of limit holes 4311 are axially spaced apart. Each limiting hole 4311 is communicated with the second accommodating cavity.

In one embodiment, the number of the limiting holes 4311 is 2 to 20, so as to limit at a plurality of positions. In another embodiment, the number of the limiting holes 4311 is 3 to 10, so as to limit at a plurality of positions and take into account the length of the second receiving portion 430B.

Referring to fig. 12, the sliding member 440 has an inner cavity with two open ends, so that the sliding member 440 can be sleeved on the housing 430 and can slide along the axial direction of the housing 430.

Specifically, the sliding member 440 is sleeved on the second receiving portion 430B of the housing 430 and is axially slidable along the second receiving portion 430B. Referring back to fig. 11, the proximal end surface of the first receiving portion 430A and the distal end surface of the second locking cap 434 form two abutting portions, respectively, and when the sliding member 440 slides distally or proximally, the two abutting portions abut against the sliding member 440, so as to prevent the sliding member 440 from slipping off when sliding axially.

Referring to fig. 12, two engaging holes 441 are formed on the sliding member 440, and the two engaging holes 441 are respectively located at two opposite sides of the sliding member 440 in the radial direction.

The sliding member 440 further has a through hole 442, two mounting grooves 443 are formed on both sides of the through hole 442, and a receiving groove 444 is formed at a proximal end of the through hole 442. A fixing column 445 is arranged at the bottom of the accommodating groove 444.

A boss 446 is formed at the middle of the slider 440. The sliding member 440 is formed with 4 bar-shaped holes 447, which are distributed on the left and right sides of the protrusion 446 two by two. Wherein the two strip-shaped apertures 447 on each side are diametrically opposite.

Two stoppers 448 are also formed at both sides of the sliding member 440, respectively.

In one embodiment, the slider 440 includes a first slider 449 and a second slider 4410, the first slider 449 and the second slider 4410 being removably coupled. A through hole 442, a mounting groove 443, an accommodating groove 444, and a fixing post 445 are formed on the first slide plate 449. The first sliding piece 449 and the second sliding piece 4410 are provided with notches, so that the first sliding piece 449 and the second sliding piece 4410 are connected to form the engaging hole 441 and the strip-shaped hole 447.

The slider 440 is formed by detachably coupling the first and

second sliders

449 and 4410 so as to facilitate assembly of the control handle 40.

Referring back to fig. 2, in one embodiment, the retractor control assembly 410 includes a retractor mount 411 and two mounting members 412 coupled to the retractor mount 411. Referring also to fig. 13, the mounting elements 412 are connected to the pull member fixing element 411, and the two mounting elements 412 are located at two sides of the pull member fixing element 411. In one embodiment, the pull member securing member 411 and the two mounting members 412 are integrally formed.

The pull member fixing member 411 is formed with a fixing hole 4111, and one end of the connecting portion 120 of the pull member 10 far away from the pull portion 110 extends into the fixing hole 4111 and is fixedly connected to the pull member fixing member 411. In an embodiment, an end of the connecting portion 120 away from the pulling portion 110 extends into the fixing hole 411 and is fixed in the fixing hole 4111 by an adhesive.

In another embodiment, the pulling member control assembly 410 further comprises a locking member received and embedded in the fixing hole 4111, and an end of the connecting portion 120 away from the pulling portion 110 extends into the locking member and is clamped by the locking member.

Referring back to fig. 2, the retractor control assembly 410 further includes an enclosure 414. Referring also to fig. 14, the enclosure 414 is an open-ended cavity. In one embodiment, the enclosure 414 includes a first enclosure portion 4141 and a second enclosure portion 4142, the first enclosure portion 4141 and the second enclosure portion 4142 being removably connected.

The first surrounding portion 4141 has an inner wall formed with a receiving hole 4143. Two mounting grooves (not shown) are formed on an inner wall of the first enclosing part 4141, and the two mounting grooves are located at both sides of the accommodating hole 4143.

The pulling piece fixing piece 411 is received in the second receiving portion 430B of the housing 310, and the two mounting pieces 412 respectively extend from the two third operating windows 4303, radially extend into the sliding piece 440, and are embedded in the two engaging holes 441 of the sliding piece 440.

Referring to fig. 15, the position-limiting member 420 includes a pressing portion 421, a position-limiting portion 422, and a connecting portion 423. The spacing portion 422 is connected with the pressing portion 421, the spacing portion 422 extends from the bottom surface of the pressing portion 421, and one end of the spacing portion 422 away from the pressing portion 421 is a free end. The engaging portions 423 are two, both the engaging portions 423 are connected to the pressing portion 421, and the two engaging portions 423 are located on both sides of the pressing portion 421.

The position-limiting member 420 further includes an elastic member (not shown), which may be a spring or an elastic sleeve. One end of the elastic member is connected to the bottom of the pressing portion 421.

Referring to fig. 2, 12 and 16, an end of the elastic member of the position-limiting member 420 away from the pressing portion 421 is sleeved on the fixing column 445 of the sliding member 440 and is fixedly connected to the bottom of the accommodating groove 444. The two engagement portions 423 of the stopper 420 are partially received in the mounting grooves 443, respectively. The limiting portion 422 of the limiting member 420 extends into the through hole 442 and extends toward the housing 430.

The surrounding member 414 is covered on the protrusion 446 of the sliding member 440, and the pressing portion 421 of the limiting member 420 protrudes from the receiving hole 4143, as shown in fig. 17. The portion of the engagement portion 423 of the stopper 420 that is not received in the receiving groove 443 is received in the receiving groove of the surrounding member 414. That is, the engagement portion 423 of the stopper 420 is received in the receiving portion composed of the mounting groove 443 of the slider 440 and the mounting groove of the surrounding member 414. The engaging portion 423 is clamped by the sliding member 440 and the enclosing member 414, so that the limiting member 420 is movably installed between the sliding member 440 and the enclosing member 414, and the limiting portion 421 movably extends to the casing 430.

In a natural state, the elastic component of the limiting member 420 is in an uncompressed state or a partially compressed state, the pressing portion 421 is in a horizontal state or a substantially horizontal state, the limiting portion 423 extends into the limiting hole 4311 of the housing 430, and in the limiting state, the sliding member 440 cannot slide axially along the housing 430.

When the proximal end of the pressing portion 421 is pressed, the elastic member is compressed or further compressed, so that the distal end of the pressing portion 421 tilts, the limiting portion 422 is bounced to leave the limiting hole 4311, and the limiting is released.

Referring back to FIG. 2, in one embodiment, the control handle 40 further includes a puncture control assembly 450. In one embodiment, the puncture control assembly 450 includes a puncture mount 451. The puncture tube 60 is connected to a puncture tube mount 451. The puncture tube holder 451 is partially received in the housing 430, partially protrudes from the second operation window 4302 of the housing 430, and is connected to the sliding member 440, and the sliding member 440 slides axially along the housing 430 to axially slide the puncture tube 60.

In one embodiment, the puncture tube control assembly 450 further includes a puncture tube driver 452. The puncture tube driving member 452 is sleeved on the sliding member 440 (as shown in fig. 17), the portion of the puncture tube fixing member 451 extending from the housing 430 extends from the sliding member 440 and is connected to the puncture tube driving member 452, and the puncture tube fixing member 451 is axially slid by the rotation of the puncture tube driving member 452. The axial sliding of the puncture tube mount 451 causes the puncture tube 60 to slide axially.

With continued reference to fig. 2, in one embodiment, the puncture tube mount 451 includes a locking feature 4511 and a mounting feature 4512. Referring to fig. 18, the fixing member 4512 is provided with a through hole 4513 extending in an axial direction, the puncture tube 60 passes through the through hole 4513, and then the locking member 4511 is fitted over the puncture tube 60 and the fixing member 4512 and locked to connect the puncture tube 60 and the puncture tube fixing member 451.

In one embodiment, two clamping slots 4514 are respectively disposed on two sides of the fixing component 4512.

Referring to FIG. 19, in one embodiment, the puncture tube driving member 452 is a generally open-ended sleeve structure. The puncture tube driver 452 has an inner cavity with both ends open, and a spiral groove 4521 is formed on the inner wall of the puncture tube driver 452. The catching groove 4514 of the fixing member 4512 is engaged with the spiral groove 4521 so that when the puncture tube driving member 452 rotates, the fixing member 4512 moves along the spiral groove 4521 to slide the puncture tube fixing member 451 in the axial direction.

In one embodiment, puncture tube driver 452 includes a first driver 4522 and a second driver 4523, wherein first driver 4522 and second driver 4523 are removably coupled to form a open-ended sleeve configuration. For example, first driver 4522 and second driver 4523 are removably coupled via a snap-fit connection. Clamping grooves are formed in the first driving part 4522 and the second driving part 4523, and when the first driving part 4522 is connected with the second driving part 4523, the clamping grooves in the first driving part 4522 and the second driving part 4523 are combined to form a spiral groove 4521.

Referring back to fig. 2, in one embodiment, the control handle 40 further includes a pull wire control assembly 460. In one embodiment, the pull wire control assembly 460 includes a pull wire mount 461. The pull wire 130 is connected to a pull wire mount 461. The wire-pulling fixing element 461 is partially accommodated in the housing 460, partially extends out of the housing 430 and is connected to the sliding element 440, and the sliding element 440 slides axially along the housing 430 to drive the wire-pulling fixing element 461 to slide axially, thereby driving the wire 130 to slide axially.

In one embodiment, the pull wire control assembly 460 further includes a pull wire drive 462. The pulling wire driving member 462 is sleeved on the sliding member 440 (as shown in fig. 17), a portion of the pulling wire fixing member 461 extending from the housing 430 extends radially to the sliding member 440, extends from the sliding member 440, and is connected to the pulling wire driving member 462, and the rotation of the pulling wire driving member 462 drives the pulling wire fixing member 461 to slide axially. The axial sliding of the wire-pulling fastener 461 drives the wire-pulling 130 to axially slide.

In an embodiment, the wire fixing element 461 is provided with a through hole (not shown) extending axially, and the wire fixing element 461 is further provided with a fixing hole 4611 (shown in fig. 20) extending radially from the surface to the through hole, wherein the fixing hole 4611 is communicated with the through hole. The pulling wire 130 passes through the through hole, and the fixing member (not shown) passes through the fixing hole 4611 to tightly press against the pulling wire 130, so that the pulling wire 130 is connected with the pulling wire fixing member 461. For example, the fastener is threaded into the securing hole 4611 to tighten the pull wire 130.

Two clamping grooves 4612 are respectively arranged on two sides of the wire pulling fixing element 461.

Referring to fig. 21, in one embodiment, the pull wire driving member 462 is a sleeve structure with two open ends. The pull wire driving member 462 has an inner cavity with both ends open, and a spiral groove 4621 is formed on the inner wall of the pull wire driving member 462. The slot 4612 of the pull wire mount 461 cooperates with the helical slot 4621 such that when the pull wire drive 462 is rotated, the pull wire mount 461 moves along the helical slot 4621 to axially slide the pull wire mount 461.

In one embodiment, the pull wire driving member 462 includes a first pull wire driving portion 4622 and a second pull wire driving portion 4623, and the first pull wire driving portion 4622 and the second pull wire driving portion 4623 are detachably connected to form a sleeve structure with two open ends. For example, the first pull wire drive 4622 and the second pull wire drive 4623 are removably connected by a snap. The first wire-pulling driving part 4622 and the second wire-pulling driving part 4623 are provided with a slot, and when the first wire-pulling driving part 4622 is connected with the second wire-pulling driving part 4623, the slots on the first wire-pulling driving part 4622 and the second wire-pulling driving part 4623 are combined to form a spiral groove 4621.

With continued reference to fig. 2, in one embodiment, control handle 40 further includes a cutter control member 470. Cutter control member 470 is used to control the cutting of cutter 20.

Referring to fig. 22, in one embodiment, cutting member control member 470 includes a cutting member connector 471, a first locking member 472, a second locking member 473, a slide rail 474, a first mounting member 475, a second mounting member 476, a damping member 477, and a slide block 478.

The cutting member coupler 471 includes a body 4711, and two channels 4712 are formed on the body 4711 to allow the cutting member coupler 471 to be sleeved on the slide rail 474.

The body 4711 is provided with an accommodating groove 4713, and the first locking member 472 is embedded in the accommodating groove 4713. The bottom of the accommodating groove 4713 is provided with an opening. The first locking member 472 has a receiving groove, and the second locking member 473 is received in the receiving groove of the first locking member 472. Both the first locking member 472 and the second locking member 473 have openings therein. The stretching portion 220 of the cutting member 20 passes through the opening of the receiving groove 4713, the opening of the first locking member 472, and the opening of the second locking member 473 in this order, and the second locking member 473 is rotated to fit the second locking member 473 into the first locking member 472, thereby connecting the stretching portion 220 to the cutting member connecting member 471.

In one embodiment, the cutting member connectors 471 also include two connecting tabs 4714, the two connecting tabs 4714 being connected to the body 4711, the two connecting tabs 4714 being located on either side of the body 4711. The number of the sliding blocks 478 is two, and the two sliding blocks 478 are detachably connected to the two connecting pieces 4714, respectively. The two connecting plates 4714 are respectively extended from the two first operating windows 4301 of the first receiving portion 430A, and then are respectively connected to the two sliding blocks 478.

In one embodiment, the slide rail 474 is fixedly coupled at one end to the first mounting member 475 and removably coupled at the other end to the second mounting member 476 to facilitate installation. In one embodiment, the slide rail 474 and the first mount 475 are a one-piece structure. In one embodiment, the slide rail 474 and the first mount 475 are removably coupled.

Referring to fig. 2, 10 and 22, the slide rail 474 is mounted in the first receiving portion 430A of the housing 430 by a first mounting member 475 and a second mounting member 476.

As shown in fig. 2, the cutter coupler 471 is sleeved on the slide rail 474 and axially slidable along the slide rail 474 to tighten or loosen the pull wire 130.

Damping member 477 is an elastomeric member, for example, damping member 477 may be a spring or an elastomeric sleeve.

In one embodiment, the damping member 477 is disposed on the slide rail 474, the damping member 477 is disposed at the proximal end of the cutter coupler 471, and the cutter coupler 471 needs to compress the damping member 477 to axially slide proximally, i.e., the damping member 477 needs to overcome the blocking effect to axially slide proximally. Damping member 477 is provided to help avoid erroneous operation.

In another embodiment, the slide track 474 includes a first slide 4741 and a second slide 4742, the first and

second slides

4741 and 4742 being diametrically opposed, a proximal end of the first slide 4741 and a proximal end of the second slide 4742 each being coupled to the first mounting member 475. A gap is formed between the first sliding portion 4741 and the second sliding portion 4742.

In one embodiment, the damping member 477 is received in a gap between the first 4741 and second 4742 slides and compresses the damping member 477 as the cutter link 471 slides axially along the slide track 474.

In one embodiment, the cutter connectors 471 are at least partially disposed in the gaps of the slide rails 474, and the two attachment tabs 4714 of the cutter connectors 471 extend out of the gaps of the slide rails 474. In this embodiment, the damping member 477 may be disposed on the slide rail 474 or disposed in the gap of the slide rail 474. Also, in such embodiments, the shape of the body 4711 needs to be adjusted so that the extension portion 220 of the cutting member 20 can pass through the cutting member coupler 471 and couple with the cutting member coupler 471. For example, the stretching portion 220 is connected to the cutting member connector 471 through the receiving groove 4713, the first locking member 472 and the second locking member 473, but the opening direction of the receiving groove 4713, the first locking member 472 and the second locking member 473 is different from the opening direction of the embodiment in which the cutting member connector 471 is sleeved on the sliding rail 474.

Referring back to fig. 3, when the cutter coupler 471 axially slides along the slide rail 474 toward the proximal end, the stretching part 220 is pulled, and accordingly, the stretching part 220 pulls the cutting part 210, so that the two C-shaped coils 211 of the cutting part 210 are deformed into a substantially straight line for cutting.

In operation, the retractor 10 is first accommodated in the puncture tube 60, the puncture element 50 is positioned outside the puncture tube 60, and both the puncture element 50 and the puncture tube 60 are accommodated in the sheath tube 30. In this positional relationship, atrial shunt device 100 is advanced to the interatrial septum. The slider 440 is then slid distally along the housing 430 to push the lancet 50, retractor 10 and puncture tube 60 as a whole out of the sheath 30. With the retractor 10 received in the penetration tube 60 and the lancet 50 outside the penetration tube 60, the slider 440 continues to slide distally along the housing 430 so that the lancet 50, retractor 10 and puncture tube 60 are entirely threaded through the atrial septum. Then, the puncture tube driving member 452 is rotated to withdraw the puncture tube 60 into the sheath 30 and further into the stabilization tube 330. Further, the pull wire driving member 462 is rotated to retract the pull wire 130 to shorten the distance between the distal end and the proximal end of the pull member 10, thereby increasing the area of the contact surface 1111. Further, sliding the slider 440 proximally along the housing 430 draws the retractor 10 back into abutment with the interatrial septum tissue, and then continuing to slide the slider 440 proximally, causing the retractor 10 to draw the tissue into the sheath 310. At this time, the cutting part 210 of the cutting member 20 surrounds the pulling member 10 and the tissue to be cut. Cutting portion 210 is deformed to perform a cut by operating slider 478 to slide cutter link 471 axially proximally along slide rail 474.

It will be appreciated that during lancing, the lancet 50 is connected to an external power source. During the cutting process, the rf power connector 430 is connected to an external power source.

The stretching portion 220 is made of a filament, and the length of the stretching portion 220 is large, generally greater than 1 meter. The stretching part 220 extends in the first channel 310 of the sheath 30, and the first channel 310 can stabilize the position of the stretching part 220, so that when the stretching part 220 is stretched, the force can be stably transmitted to the cutting part 210, and the cutting is smooth. Further, since the first channel 310 is provided by charging the stretching portion 220 at the time of cutting, the portion of the stretching portion 220 in the sheath 30 can be isolated from other components in the sheath 30, and the first channel 310 can also function as an insulator.

In one embodiment, the stretching portion 220 is coated with an insulating layer to improve safety and stability.

In one embodiment, the insulating layer covers the entire surface of the stretching portion 220. In another embodiment, the insulating layer covers a portion of the surface of the stretching portion 220, and the surface of the portion of the stretching portion 220 located in the first channel 310 is not covered by the insulating layer.

When the cutting element 20 further comprises the adjusting portion 230, the sheath 30 further comprises a second channel 320, and the adjusting portion 230 extends into the second channel 320, which facilitates the cutting portion 210 to be stressed stably when the stretching portion 220 is stretched. When the stretching portion 220 is stretched in advance due to an erroneous operation, at least a portion of the adjusting portion 230 is still accommodated in the second channel 320, so that the pulled portion of the adjusting portion 230 can be easily inserted into the second channel 320 to adjust the position or shape of the cutting portion 210 for cutting.

It should be noted that in other embodiments, the adjustment portion 230 may be omitted, and the adjustment portion 230 may be omitted to achieve normal cutting. Accordingly, when the adjustment part 230 is omitted, the second passage 320 may be omitted.

The cutting part 210, the stretching part 220, and the first adjusting wire 231 are an integrated structure, and the second adjusting wire 232 is overlapped on the first adjusting wire 231. Since the cutting member 20 is made of a conductive wire having a small wire diameter, for example, less than 0.5 mm, in order to prevent the wire from being easily broken due to a weak portion caused by connection, the cutting portion 210, the stretching portion 220, and the first adjusting wire 231 are formed in an integrated structure, and are formed by bending and shaping one wire. Moreover, one end, far away from the cutting part 210, of the first adjusting wire 231 is of a closed structure, so that the second adjusting wire 232 can be connected to the first adjusting wire 231 in a lap joint mode, connection is convenient, connection is not required to be achieved in modes such as welding, and the silk thread breakage is avoided.

When tensioning portion 220 to effect cutting, sufficient tensioning occurs to bring cutting element 20 into abutment with tissue to effect cutting. Since the cutting portion 210, the stretching portion 220 and the first adjusting wire 231 are of an integral structure, and the first adjusting wire 231 includes two parallel line segments 2311, there is no fixed connection point between the cutting portion 210 and the first adjusting wire 231. Cutting is only achieved when the cutting section 210 and the first adjusting wire 231 are simultaneously deformed until the closed end of the first adjusting wire 231 abuts the tissue. Therefore, the stroke of the axial sliding of the stretching portion 220 is the sum of the stroke of the deformation of the cutting portion 210 and the stroke of the deformation of the first adjusting wire 231 until the first adjusting wire 231 abuts against the tissue, which inevitably requires a larger stroke of the axial sliding of the sliding member 440 to achieve the abutment of the closed end of the first adjusting wire 231 against the tissue, and thus requires a correspondingly larger length of the sliding rail 474. Accordingly, the length of the housing 310 is inevitably large, and the housing is not only not easy to transport and store, but also inconvenient and long in operation time.

Therefore, the second adjusting wire 232 is added, and the second adjusting wire 232 is overlapped on the first adjusting wire 231, and the second adjusting wire 232 does not increase the stroke of the axial sliding of the stretching part 220. The length of the first adjusting wire 231 may be short to overlap the second adjusting wire 232, so as to shorten the stroke of the axial sliding of the cutter holder 471. The length of the second adjusting wire 232 does not affect the axial sliding stroke of the cutter holder 471, and the second adjusting wire 232 can be set long enough to adjust the cutting portion 210 to be deformed or dislocated in advance, so as to continue cutting.

Cutting portion 210, tensile portion 220 and first regulation silk 231 formula structure as an organic whole promptly, the setting mode of second regulation silk 232 overlap joint on first regulation silk 231 can compromise the intensity of cutting member 20, avoid the silk thread fracture, can adjust when taking place the dislocation, the holistic volume of apparatus is less, convenient operation and save advantages such as operating time.

It should be further noted that in other embodiments, the two C-shaped coils 211 of the cutting portion 210 may have other shapes, and are not limited to a C shape. For example, the cutting portion 210 may be formed by connecting two semicircular coils. The cutting portion 210 may be a circular coil as a whole. However, referring back to fig. 8, the cutting portion 210 includes two C-shaped coils 211, the two connecting ends 212 are recessed, the two connecting ends 212 are respectively connected to the stretching portion 220 and the adjusting portion 230, and when the stretching portion 220 and the adjusting portion 230 respectively extend into the first channel 310 and the second channel 320, the cutting portion 210 can be stably located outside the sheath 30, which is beneficial to avoiding deformation or dislocation of the cutting portion 210 and cutting a small hole with a desired aperture and shape.

The sheath tube 30 is provided with a stabilization tube 330, and the puncture tube 30 is movably accommodated in the stabilization tube 330. Because the puncture tube 60 is long (generally greater than 1 meter or close to 1 meter) and thin, the stabilizing tube 330 is arranged to support the puncture tube 60 to a certain extent and prevent the puncture tube 60 from being broken.

It is understood that in other embodiments, the stability tube 330 may be omitted. The strength of the puncture tube 60 may be increased in other ways, such as by increasing the wall thickness of the puncture tube 60.

Returning to fig. 17, in other embodiments, the enclosure 414 may be omitted. When the surrounding element 414 is omitted, the limiting element 420 and the sliding element 440 are connected properly, so that the limiting portion 422 can be engaged with the limiting hole 4311 of the housing 430 in a natural state. When the proximal end of the pressing portion 421 is pressed, the distal end of the pressing portion 421 may be tilted to release the engagement between the stopper portion 422 and the stopper hole 4311. For example, the two engagement portions 423 of the limiting member 420 are received in the mounting groove 443 and are connected to the sliding member 440 by two fixing members, respectively, so as to prevent the two engagement portions 423 from falling off from the mounting groove 443, but not affect the tilting or resetting of the pressing portion 421.

However, as shown in FIG. 17, enclosure 414 is provided and enclosure 414, puncture tube drive 452 and pull wire drive 462 collectively fit over slider 440 to form a smooth surface to facilitate sliding axial movement of slider 440 along housing 430 as a whole. And, the enclosure 414, the puncture tube driving member 452, the pulling wire driving member 462 and the two stoppers 448 of the sliding member 440 are engaged, so that the enclosure 414, the puncture tube driving member 452 and the pulling wire driving member 462 can be stably sleeved on the sliding member 440.

The two mounting members 412 of the pulling member control assembly 410 are embedded in the engaging holes 441 of the sliding member 440, the puncture tube fixing member 451 is connected to the puncture tube driving member 452, and the puncture tube driving member 452 is sleeved on the sliding member 440. Furthermore, the wire pulling fixing element 461 is connected to the wire pulling driving element 462, and the wire pulling driving element 462 is sleeved on the sliding element 440, as shown in fig. 17. Thus, the sliding member 440 slides in the axial direction of the housing 430, and can simultaneously drive the retractor fixing member 411, the puncture tube fixing member 451, and the retractor fixing member 461 to simultaneously slide in the axial direction. During lancing, the relative positional relationship of the lancet 50, retractor 10, puncture tube 60 and pull wire 130 is maintained as the slider 440 is slid axially along the housing 310 so that the lancet 50, retractor 10 and puncture tube 60 pass through tissue as a whole. The pulling part 110 is self-expandable and cannot smoothly pass through the tissue when it is located outside the puncture tube 60. Also, the pull wire 130 cannot be tightened before the pull portion 110 passes through the tissue to avoid prematurely expanding the pull portion 110. Therefore, the puncture needle is reasonably arranged in the above mode, is convenient to operate, and is favorable for ensuring that the puncture is smoothly carried out. Also, due to the connection described above, rotating puncture tube driver 452 enables the puncture tube 60 to be withdrawn individually to release the retractor 10 and to leave a containment space for the retractor 10 and tissue. Rotating the pull wire drive 462 can individually move the pull wires 130 to individually adjust the radial dimension of the pull 110 to avoid causing undesirable linkage of other components.

Therefore, according to the connection mode and connection relationship, the puncture piece 50, the pulling piece 10 and the puncture tube 60 can be integrally linked, the puncture tube 60 can be axially slid alone and the pulling wire 130 can be axially slid alone, the single axial sliding of the puncture tube 60 and the axial sliding of the pulling wire 130 do not need to additionally prolong the length of the shell 310, and the shell 310 is prevented from being too long, so that the transportation and the operation are convenient.

In addition, the pulling wire driving member 462 is rotated to axially slide the pulling wire fixing member 461, which is beneficial to controlling the moving speed of the pulling wire 130 and avoiding the elastic rod 111 of the pulling member 10 from being broken due to over-tensioning of the pulling wire 130.

Referring back to fig. 7, the distal end of the connecting portion 120 extends into the pulling portion 110, and a gap is formed between the distal end of the connecting portion 120 and the distal end of the pulling portion 110, so that when the pulling wire 130 is pulled to a certain extent, the pulling portion 110 abuts against the distal end surface of the connecting portion 120 and cannot be pulled again, which is beneficial to preventing the pulling wire 130 from being excessively pulled to cause excessive deformation of the pulling portion 120, and thus, beneficial to preventing the elastic rod 111 from being broken.

Referring to fig. 23, one embodiment of an ostomy appliance 500 includes a pull member 510, a cutting member 520, a sheath 530 and a control handle 540. The pulling element 510, cutting element 520, and sheath 530 are all connected to a control handle 540.

The structure of the pulling element 510, the cutting element 520, the sheath 530 and the control handle 540 is the same as that of the pulling element 10, the cutting element 20, the sheath 30 and the control handle 40, respectively, and the description thereof is omitted.

The control handle 540 includes a retractor control assembly 541 and a stop 542. The pulling element control assembly 541 controls the pulling element 510 to be movably accommodated in the sheath tube 530, and the limiting member 542 is used for locking the relative position of the pulling element 510 and the sheath tube 530. The stretching portion of the cutting element 520 is connected to the rf power connection 543. The rf power source 543 is located outside the control handle 540.

The ostomy appliance 500 provided by the above embodiment locks the relative position of the pulling member 510 and the sheath tube 530 through the limiting member 542 after the pulling member 510 pulls the tissue to be cut into the sheath tube 530 when the tissue is assembled, so that the tissue to be cut is reliably contained in the sheath tube 530, which is beneficial to avoiding irregular cutting morphology or incomplete cutting caused by unstable position of the tissue to be cut. And, carry out the electricity cutting, can cut off the tissue when, can kill the histiocyte at the edge of opening, be favorable to avoiding the opening healing.

Thus, the ostomy appliance 500 can form a large opening in tissue and a stable opening in tissue without the need for an implanted stent.

The ostomy appliance 500 is suitable for performing an ostomy operation on the atrial septum of the heart, a site of the stomach, the colon, or the like.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above disclosure is only for the purpose of illustrating the preferred embodiments of the present invention, and it is therefore to be understood that the invention is not limited by the scope of the appended claims.

Claims

1. An atrial shunt apparatus, comprising: the traction part, the cutting part, the sheath tube and the control handle are all connected with the control handle;

2. The atrial shunt device of claim 1, wherein the pulling member comprises a pulling portion and a connecting portion connected to the pulling portion, wherein an end of the connecting portion remote from the pulling portion is connected to the pulling member control assembly, and wherein the stopper locks the position of the pulling member control assembly to lock the relative position of the pulling member and the sheath.

3. The atrial shunt device of claim 2, wherein said puller control assembly comprises a puller mount, said control handle further comprising a housing and a slider, said slider being slidably axially mounted in said housing, said puller mount being coupled to said coupling portion, said puller mount being partially received in said housing and partially extending from said housing and coupled to said slider, axial sliding of said slider along said housing causing axial sliding of said coupling portion.

4. The atrial shunt apparatus according to claim 3, wherein the limiting member comprises a pressing portion and a limiting portion connected to the pressing portion, the housing has a limiting hole or a limiting groove, the pressing portion is connected to the sliding member, and the limiting portion extends from the sliding member into the housing and is detachably engaged with the limiting hole or the limiting groove.

5. The atrial shunt device of claim 1, wherein the control handle further comprises a cutting member control assembly, the cutting member control assembly comprising a cutting member coupling member, the cutting member further comprising a stretching portion coupled to the cutting portion, the cutting member coupling member coupled to an end of the stretching portion distal from the cutting portion, the cutting member coupling member configured to axially slide the stretching portion to deform the cutting portion for cutting.

6. The atrial shunt device of claim 5, wherein said tensioning portion extends proximally through said cutting element connector and is connected to said RF power connector, and wherein said tensioning portion is coated with an insulating layer.

7. The atrial shunt device of claim 1, wherein the cutting member further comprises a stretching portion connected to the cutting portion, wherein an axially extending first channel is formed on an inner wall of the sheath, and the stretching portion penetrates through the first channel and is connected to the radio frequency power connector, so that the cutting portion is electrically charged to perform electrical cutting when the sheath is powered on.

8. The atrial shunt device of claim 7, wherein said sheath further defines an axially extending second channel on an interior thereof, said second channel being diametrically opposed to said first channel, said cutting member further comprising an adjustment portion, said adjustment portion having one end connected to said cutting portion and another end extending into said second channel.

9. The atrial shunt device of claim 8, wherein the adjustment portion comprises a first adjustment wire and a second adjustment wire, the cutting portion, the stretching portion, and the first adjustment wire being a unitary structure, the second adjustment wire overlapping the first adjustment wire.

10. The atrial shunt instrument of claim 5, wherein the cutting member control assembly further comprises a slide rail, the cutting member connector being disposed on the slide rail and axially slidable relative to the slide rail;

or, the cutting element connecting element is at least partially accommodated in the slide rail and can axially slide relative to the slide rail.

11. The atrial shunt apparatus of claim 10, wherein the cutting element control assembly further comprises a damping element disposed on or within the rail, wherein the cutting element connector compresses the damping element as the cutting element connector slides axially relative to the rail.

12. The atrium shunt device according to claim 2, wherein said sheath has a stabilizing tube disposed therein, said stabilizing tube is connected to an inner wall of said sheath, and a distal end of said stabilizing tube is closer to said control handle than a distal end of said sheath, said pulling member control assembly controls said connecting portion to be movably received in said stabilizing tube.

13. The atrial shunt device according to claim 12, further comprising a puncture member and a puncture tube, wherein the puncture member is disposed at a distal end of the pull member, the puncture tube is movably received in the stability tube, and the pull member control assembly controls the pull member to be movably received in the puncture tube.

14. The atrial shunt device of claim 13, wherein the control handle further comprises a puncture tube control assembly, wherein the puncture tube control assembly comprises a puncture tube holder, wherein the control handle further comprises a housing and a sliding member, wherein the sliding member is sleeved on the housing and is axially slidable relative to the housing, the puncture tube holder is partially received in the housing, partially extends out of the housing and is connected to the sliding member, and the sliding member slides axially along the housing to drive the puncture tube to axially slide.

15. The atrial shunt device according to claim 14, wherein the puncture tube control assembly further comprises a puncture tube driving member, the puncture tube driving member is sleeved on the sliding member, the portion of the puncture tube fixing member extending from the housing extends from the sliding member and is connected to the puncture tube driving member, and the rotation of the puncture tube driving member drives the puncture tube fixing member to axially slide.

16. The atrial shunt device of claim 2, wherein said pulling member further comprises a pulling wire disposed through said connecting portion and connected to a distal end of said pulling portion.

17. The atrial shunt device of claim 16, wherein the control handle further comprises a pull wire control assembly, wherein the pull wire control assembly comprises a pull wire fixing member, wherein the control handle further comprises a housing and a sliding member, wherein the sliding member is sleeved on the housing and is axially slidable relative to the housing, the pull wire fixing member is partially accommodated in the housing, partially extends out of the housing and is connected to the sliding member, and the sliding member slides axially along the housing to drive the pull wire fixing member to axially slide.

18. The atrial shunt device of claim 17, wherein the pull wire control assembly further comprises a pull wire driving member, the pull wire driving member is sleeved on the sliding member, a portion of the pull wire fixing member extending from the housing extends from the sliding member and is connected to the pull wire driving member, and rotation of the pull wire driving member drives the pull wire fixing member to axially slide.

19. An ostomy appliance, comprising: the traction part, the cutting part, the sheath tube and the control handle are all connected with the control handle;