CN113116500A - Stoma system - Google Patents

Abstract

Translated fromChinese

本申请公开一种造口系统，包括手柄、鞘管组件及电极支架，所述鞘管组件包括所述鞘管及活动穿装于所述鞘管的推送件，所述电极支架固定于所述推送件的远端并收容于所述鞘管内，所述电极支架通过扩张和消融作用在造口处组织建立分流通道，所述手柄包括输送装置，所述输送装置包括鞘管接头结构、推杆接头结构及传动结构，所述鞘管接头结构与所述鞘管的近端固定连接，所述推杆接头结构与所述推送件的近端固定连接，所述推杆接头结构通过所述传动结构与所述鞘管接头结构连接；所述鞘管接头结构带动所述鞘管沿轴向方向运动，所述传动结构带动所述推杆接头结构推动所述推送件向所述鞘管运动方向相反的方向运动，从而释放或回收所述电极支架。

The present application discloses an ostomy system, including a handle, a sheath tube assembly and an electrode support, the sheath tube assembly includes the sheath tube and a pusher movably threaded through the sheath tube, and the electrode support is fixed to the sheath tube. The distal end of the pusher is accommodated in the sheath, the electrode support establishes a shunt channel in the tissue at the stoma through expansion and ablation, the handle includes a delivery device, and the delivery device includes a sheath joint structure, a push rod Joint structure and transmission structure, the sheath tube joint structure is fixedly connected with the proximal end of the sheath tube, the push rod joint structure is fixedly connected with the proximal end of the pusher, and the push rod joint structure is connected through the transmission The structure is connected with the sheath tube joint structure; the sheath tube joint structure drives the sheath tube to move in the axial direction, and the transmission structure drives the push rod joint structure to push the pusher to the sheath tube movement direction Movement in the opposite direction releases or retracts the electrode holder.

Description

Stoma system

Technical Field

The present application relates to the field of medical devices, and more particularly to a stoma system.

Background

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

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

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

On the other hand, pulmonary hypertension is a group of diseases characterized by progressive increase of pulmonary arterial system circulatory resistance, and its pathological changes include pulmonary vasoconstriction and remodeling, abnormal proliferation of pulmonary vascular smooth muscle and endothelial cells, in-situ thrombosis, etc., which ultimately leads to death by exhaustion of right heart function. At present, with the intensive research on the pathogenesis of pulmonary hypertension, the treatment methods are more and more. The treatment scheme of the pulmonary hypertension is characterized by individuation and systematization, and can not be treated by a single drug, and the treatment mode comprises the following steps: general therapy, non-specific drug therapy, targeted drug therapy, NO inhalation therapy, gene therapy, intervention and surgical therapy. In the later stage of the disease of the pulmonary hypertension patient, after the comprehensive treatment, the effect is not obvious, the survival rate is low, and the prognosis is very poor, at the moment, surgical treatment methods such as interatrial septum fistulization, lung transplantation, heart-lung combined transplantation and the like can be tried, so that the life of the patient is saved, but the treatment methods have a plurality of factors such as high operation risk, donor deficiency, transplantation rejection, high subsequent treatment cost and the like.

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

Conventional interatrial septum ostomy methods, such as balloon interatrial septum ostomy, have a tendency for the myocardial tissue to recoil after the stoma and over time the stoma may shrink or even close completely. In order to solve the problem of the reduction and even the closure of the stoma, the prior art provides an ostomy support, which can respectively disclose an implant for atrial shunt, and is characterized in that after percutaneous interatrial puncture, a shunt device is implanted at the interatrial puncture position by delivering an implant percutaneously so as to keep the opening of the shunt unobstructed, however, the implantation of the shunt device can easily cause thrombosis or the device falls off to form embolism. In addition, the passage is closed and the shunting action is lost, as endothelial attachment can cause the instrument opening to be blocked.

Disclosure of Invention

To address the foregoing problems, the present application provides an ostomy system.

A stoma system comprises a handle, a sheath tube assembly and an electrode support, wherein the sheath tube assembly comprises a sheath tube and a pushing member movably sleeved on the sheath tube, the electrode support is fixed at the far end of the pushing member and contained in the sheath tube, the electrode support is contained at the far end of the sheath tube assembly, the electrode support is used for establishing a shunt channel at a stoma tissue through expansion and ablation, the handle comprises a conveying device, the conveying device comprises a sheath tube joint structure, a push rod joint structure and a transmission structure, the sheath tube joint structure is fixedly connected with the near end of the sheath tube, the push rod joint structure is fixedly connected with the near end of the pushing member, and the push rod joint structure is connected with the sheath tube joint structure through the transmission structure; the sheath pipe joint structure drives the sheath pipe to move along the axial direction, and the transmission structure drives the push rod joint structure to push the pushing piece to move in the direction opposite to the movement direction of the sheath pipe, so that the electrode support is released or recovered.

The stoma system that provides in this application, connect the sheath pipe through the sheath pipe joint design among conveyor, push rod joint structural connection propelling part, the sheath pipe joint design passes through the motion of transmission structure drive push rod joint design, and the motion direction of sheath pipe joint design and push rod joint design is opposite, the motion direction of sheath pipe and propelling part is opposite promptly, electrode holder's release and recovery speed have been improved, and be favorable to radially compressing electrode holder's near-end through the sheath pipe in recovery process, make electrode holder's radial dimension diminish, the axial dimension grow, electrode holder retrieves more smoothly.

Drawings

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

Figure 1 is a schematic perspective view of an ostomy system according to a first embodiment of the present application;

FIG. 2 is an exploded perspective view of the ostomy system of FIG. 1;

FIG. 3 is a perspective view of an electrode holder;

FIG. 4 is a cross-sectional view of the sheath assembly;

FIG. 5 is a perspective view of a portion of the structure of the ostomy system;

FIG. 6 is a cross-sectional view taken along line A-A shown in FIG. 5;

FIG. 7 is a cross-sectional view taken along line B-B shown in FIG. 5;

FIG. 8 is a perspective view of the sizing rack;

FIG. 9 is a perspective view of a diameter adjusting gear set;

FIG. 10 is a perspective view of the sheath fitting;

FIG. 11 is a perspective view of a drive rack from a perspective;

FIG. 12 is a perspective view of another perspective of the driving rack;

FIG. 13 is a perspective view of the sheath joint engaged with the driving rack;

FIG. 14 is a cross-sectional view taken along line X-X of FIG. 13;

FIG. 15 is a perspective view of the spindle;

FIG. 16 is a cross-sectional view of a portion of the ostomy system with the hook moved proximally of the receiving chamber;

FIG. 17 is an enlarged view of region I in FIG. 16

FIG. 18 is a perspective view of a push rod joint structure;

FIG. 19 is a perspective view of another embodiment of a putter joint structure;

FIG. 20 is an exploded perspective view of the main shaft and locking member of the ostomy system;

figures 21-23 are exploded isometric views of a stoma system provided in accordance with a second embodiment of the present application from different perspectives;

fig. 24 is a perspective view of a sheath joint structure according to a second embodiment of the present application;

FIG. 25 is a schematic view of a portion of the ostomy system with the driving rack spacing transmission arrangement set;

FIG. 26 is a cross-sectional view taken along line C-C of FIG. 25;

figure 27 is a partial schematic view of the ostomy system with the driving rack engaging the drive structure.

Detailed Description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments obtained by a person of ordinary skill in the art without any inventive work based on the embodiments in the present application are within the scope of protection of the present application.

In the field of interventional medical device technology, a position close to the operator is generally defined as proximal and a position far from the operator as distal; the direction of the rotation center axis of an object such as a cylinder or a pipe is defined as an axial direction, and the direction perpendicular to the axial direction is defined as a radial direction. The definitions are for convenience only and do not limit the present application.

First embodiment

Referring to fig. 1 and 2, fig. 1 is a perspective view of an ostomy system according to a first embodiment of the present application, and fig. 2 is an exploded perspective view of the ostomy system shown in fig. 1. theostomy system 100 includes anelectrode holder 10, asheath assembly 20 and ahandle 30. Theelectrode stent 10 is accommodated at the distal end of thesheath assembly 20, and theelectrode stent 10 establishes a shunt channel at the tissue at the stoma by the action of expansion and ablation.

Referring to fig. 3, fig. 3 is a perspective view of an electrode holder. Theelectrode stent 10 is released at the puncture site to the tissue at the stoma of the patient, and an artificial "defect" is formed in the tissue at the stoma of the patient by radio frequency ablation. Theelectrode holder 10 includes aproximal end portion 11, awaist portion 13, and adistal end portion 15 fixedly connected in this order. Theproximal portion 11 is received in the distal end of thesheath assembly 20. In this embodiment, the diameter of thewaist 13 is the smallest, i.e. theelectrode holder 10 is thick at both ends, thin in the middle, and waist-drum shaped, and thewaist 13 is conductive for establishing a shunt channel at the tissue at the stoma by the action of dilation and ablation. Since the shunt passage is established to the tissue at the stoma by the expanding and ablating action using theelectrode stent 10, the shunt passage does not close in a short time. It will be appreciated that thewaist 13 is not limited to being electrically conductive, but may be electrically conductive in other areas of theelectrode holder 10, such as thedistal end portion 15.

Referring to fig. 4, fig. 4 is a cross-sectional view of the sheath assembly. Thesheath assembly 20 includes asheath 21, apusher 23, a firstinner sheath core 24 and a secondinner sheath core 25. The pushingcomponent 23 is movably arranged in thesheath tube 21. Theproximal portion 11 of theelectrode holder 10 is fixed to the distal end of the pushingmember 23 and is accommodated in thesheath 21, and after theelectrode holder 10 is released from thesheath assembly 20, theelectrode holder 10 is located at the distal end of thesheath assembly 20 and extends out of the sheath 21 (fig. 2). The proximal end of thesheath 21 and the proximal end of thepusher 23 are connected to thehandle 30. The firstinner sheath core 24 and the secondinner sheath core 25 are threaded into the pushingmember 23. The outer wall of the pushingpart 23 has a gap with the inner wall of thesheath 21, and the pushingpart 23 and thesheath 21 can move relatively. In this embodiment, the pushingmember 23 is a multi-lumen tube, the pushingmember 23 includes afirst lumen 231 and a second lumen 233 which are arranged at intervals, the firstinner sheath core 24 and the secondinner sheath core 25 are inserted into the samefirst lumen 231, and the firstinner sheath core 24 and the secondinner sheath core 25 are hollow lumens. The secondinner sheath core 25 is used for threading a guide wire (not shown), and thesheath assembly 20 is used for running along the guide wire in a blood vessel to a stoma.

Theostomy system 100 further comprises acable 40, thecable 40 being threaded into the second lumen 233, the distal end of thecable 40 being adapted to be connected to theelectrode holder 10. Specifically, the distal end of thecable 40 is connected with theproximal end portion 11 of theelectrode holder 10, the outer layers of theproximal end portion 11 and thedistal end portion 15 are provided with insulating coatings, and the portions wrapped in the insulating coatings of theproximal end portion 11 and thedistal end portion 15 are electrically connected with thewaist portion 13. The proximal end of thecable 40 is adapted to be connected to a radio frequency power source for theelectrode holder 10 to expand and ablate tissue at the stoma. In this embodiment, the number of the second channels 233 is two, the number of thecables 40 is two, eachcable 40 is inserted into one second channel 233, and the twocables 40 are used for transmitting the bipolar radio frequency signal to theelectrode holder 10, in the modified embodiment, thecables 40 are omitted from one second channel 233, that is, theelectrode holder 10 is electrically connected to onecable 40, so as to transmit the unipolar radio frequency signal.

The plurality of cavities are arranged in the pushingmember 23 at intervals, so that interference among structures (such as thecable 40, the guide wire and the like) penetrating in the pushingmember 23 is reduced, and the accuracy of the ostomy operation is improved.

In a modified embodiment, theelectrode holder 10 ablates the ostomy tissue by one or any combination of heat, cold, light, electricity, gas, mechanical waves, electromagnetic waves, radioactive particles, chemical agents, and accordingly, the second channel 233 of thepusher 23 for receiving thecable 40 can also be used for receiving a medium for transmitting the above-mentioned substances.

It is understood that the pushingmember 23 may also be a single lumen tube, and thecable 40, inner sheath core, etc. may be threaded into the pushingmember 23.

Referring to fig. 2, 5 and 6, the handle 30 (fig. 1) includes amain shaft 31, adiameter adjusting device 33 and a conveyingdevice 35. Thediameter adjusting device 33 is disposed at the proximal end of themain shaft 31 compared with the conveyingdevice 35, and is used for adjusting the diameter of theelectrode stent 10 released from thesheath 21, so as to meet the requirements of different patients. Themain shaft 31 is provided with aguide groove 311 in the axial direction. Thedelivery device 35 is accommodated in theguide groove 311, and is used for delivering theelectrode stent 10 to the tissue at the stoma.

Thediameter adjusting device 33 includes adiameter adjusting structure 331, adiameter adjusting line 333 and ascale assembly 335. The proximal end of the diameter-adjustingwire 333 is fixedly connected with the diameter-adjustingstructure 331, and the distal end of the diameter-adjustingwire 333 is wound around thewaist 13 of theelectrode holder 10. Thediameter adjusting structure 331 controls thediameter adjusting line 333 to adjust thewaist 13, and drives thescale assembly 335 to display the diameter or the diameter change information of thewaist 13 of theelectrode holder 10.

More specifically, thediameter adjusting structure 331 includes adiameter adjusting member 3311 and adiameter adjusting knob 3313. The diameter-adjustingmember 3311 is movably accommodated in theguide groove 311. Thediameter adjusting knob 3313 is screwed to thediameter adjusting member 3311, and thediameter adjusting knob 3313 is adapted to drive thediameter adjusting member 3311 to move axially in theguide slot 311 when rotated. In this embodiment, the sizingknob 3313 is disposed near the proximal end of themain shaft 31. The diameter-adjustingwire 333 includes adrawing wire 3331 and a diameter-adjusting wire 3332 (shown in fig. 3). The proximal end of thepull wire 3331 is fixedly connected to the diameter-adjustingmember 3311. Thewire 3331 is inserted into thedelivery device 35 and the first inner sheath core 24 (see fig. 4).

The proximal end of the diameter-adjusting wire 3332 is fixedly connected to the distal end of thewire 3331, and the distal end of the diameter-adjusting wire 3332 is wound around thewaist 13 of the electrode holder 10 (as shown in fig. 3). In this embodiment, the drawnwire 3331 is a wire made of a material with high rigidity, such as a metal wire, so that the drawnwire 3331 can move back and forth in the firstinner sheath core 24 without bending and winding, and is convenient to control; the diameter-adjusting wire 3332 is a wire made of a material with high flexibility, such as a thin polymer suture, so as to have high flexibility and facilitate winding and adjusting the diameter of thewaist 13. It is understood that the material of the drawnwire 3331 is not limited, and the material of the diameter-adjusting wire 3332 is not limited. In a modified embodiment, thesizing wire 333 is made of a material, such as a wire or suture, and the diameter of thesizing wire 333 tapers from a proximal end to a distal end.

Thescale assembly 335 includes apointer plate 3351 and a dial 3353 stacked on each other. Thepointer plate 3351 is provided on themain shaft 31 and covers the opening of theguide groove 311. Thepointer plate 3351 is connected to thediameter adjusting member 3311. Dial 3353 is fixed tospindle 311 by cover 36 (shown in fig. 2). In other words, thecover 36 is stationary relative to themain shaft 311, and thecover 36 is used to carry the dial 3353. The dial 3353 may be carried by providing a recess in thecover 36. Thepointer plate 3351 is located between the dial 3353 and the diameter-adjustingmember 3311. A side of thepointer plate 3351 facing the dial 3353 is provided with a pointer (not shown), such as a vertical line. In the present embodiment, dial 3353 has a transparent structure, and dial 3353 is provided with scales (not shown). The diameter-adjustingmember 3311 moves in theguide slot 311 to drive thepointer plate 3351 to move synchronously, so that the pointer points to the corresponding scale on the dial 3353. It should be understood that the position and connection relationship of thescale assembly 335 on thespindle 31 are not limited, and for example, thepointer plate 3351 may be accommodated in theguide groove 311, the dial 3353 may be directly fixed to thespindle 31, and thepointer plate 3351 may move along with thediameter adjuster 3311 to indicate the scale corresponding to the dial 3353.

More specifically, referring to fig. 7 and 8, the diameter-adjustingmember 3311 includes a diameter-adjusting joint 3321 and a diameter-adjusting rack 3323. The diameter adjustment joint 3321 is threadedly coupled to a diameter adjustment knob 3313 (fig. 2). The diameter-adjusting joint 3321 is fixedly connected with the near end of the diameter-adjusting rack 3323. Thepointer plate 3351 is provided with a plate rack (not shown), and thediameter adjusting device 33 further comprises a diameter adjusting gear set 337 rotatably accommodated in theguide slot 311, wherein the plate rack faces the diameter adjusting gear set 337 and is meshed with the diameteradjusting gear set 337. Referring to fig. 9, the diameter adjusting gear set 337 includes afirst gear 3371 and asecond gear 3373 which are concentrically disposed, the diameter of thefirst gear 3371 is smaller than the diameter of thesecond gear 3373, thefirst gear 3371 is engaged with thediameter adjusting rack 3323, and thesecond gear 3373 is engaged with the plate rack, so that the minor displacement change of thediameter adjusting line 333 along the axial direction is displayed on the scale 3353 in an enlarged manner, which is convenient for an operator to obtain the diameter or diameter change information of thewaist portion 13 of theelectrode holder 10.

Theostomy system 100 provided by the application can be applied to ostomy operations such as cardiac atrial septal group weaving port, gastrointestinal tract ostomy, arteriovenous fistulation and the like. When theelectrode holder 10 is pre-assembled in thesheath 20 without release, the diameter of thewaist 13 of theelectrode holder 10 is adjusted to a minimum for easy delivery and release. Thewaist 13 is used to deliver the tissue to the puncture site at the stoma, theproximal portion 11 and the distal portion 15 (fig. 3) are located at the openings on both sides of the puncture site, a predetermined stoma diameter can be calculated according to the patient's condition, and then the diameter of thewaist 13 is adjusted to be equal to or close to (e.g., within 5%) the predetermined stoma diameter.

Specifically, the diameter of thewaist 13 of theelectrode holder 10 is increased, the diameter-adjustingknob 3313 is used to drive the diameter-adjusting rack 3323 to move distally, so as to drive thewire 3331 and the diameter-adjusting wire 3332 to move distally, the diameter-adjusting wire 3332 wound around thewaist 13 becomes loose, the diameter of thewaist 13 of theelectrode holder 10 is increased, and the diameters of theproximal portion 11 and thedistal portion 15 are increased; accordingly, thediameter adjusting rack 3323 drives the pointer on thepointer plate 3351 to move relative to the dial 3353 through the diameter adjusting gear set 337 and indicates to a larger size on the dial 3353.

When the size of thewaist portion 13 is adjusted too large to exceed the preset stoma diameter, the diameter of thewaist portion 13 of theelectrode holder 10 needs to be reduced. Specifically, the diameter-adjustingknob 3313 is used to drive the diameter-adjusting rack 3323 to move proximally, so as to drive thewire 3331 and the diameter-adjusting wire 3332 to move proximally, the diameter of thewaist 13 of theelectrode holder 10 is reduced, and the diameters of theproximal portion 11 and thedistal portion 15 are reduced; accordingly, thediameter adjusting rack 3323 drives the pointer on thepointer plate 3351 to move relative to the dial 3353 and indicate to the smaller size on the dial 3353.

Thescale assembly 335 can accurately indicate the diameter of thewaist 13 of theelectrode holder 10, thereby facilitating operator control of the size of the shunt passage required to be established. Specifically, the diameter adjusting size range is 4.0-16.0 mm. It is understood that the range of the diameter-adjusting size is not limited to 4.0-16.0mm, and the diameter-adjusting wire 3332 wound on thewaist 13 can be adjusted according to the determined size of thewaist 13 according to the actual condition of the patient.

It can be understood that the structure of the diameter-adjusting gear set 337 is not limited, the diameter-adjusting gear set 337 is meshed with the diameter-adjusting rack 3323, the diameter-adjusting gear set 337 is meshed with thepointer plate 3351, and the diameter-adjusting gear set 337 can drive thepointer plate 3351 to move.

It can be understood that the diameter-adjusting gear set 337 can be omitted, and the diameter-adjustingmember 3311 directly drives thepointer plate 3351 to move; thescale assembly 335 may be omitted, i.e. theostomy system 100 does not have the function of displaying information on the diameter or the change in diameter of the electrode-stent 10.

Referring again to fig. 2, 5 and 7, the conveyingdevice 35 includes arotating cylinder 351, asheath connector 353, apush rod connector 355 and atransmission structure 356. Therotating cylinder 351 is sleeved outside themain shaft 31 and used for driving the sheath joint 353, the push rod joint 355 and thetransmission structure 356 to move. The sheathjoint structure 353, the push rodjoint structure 355, and thetransmission structure 356 are accommodated in theguide groove 311 of themain shaft 31. The sheathjoint structure 353 is engaged with the inner surface of thebarrel 351.Sheath connector structure 353 is fixedly connected to the proximal end ofsheath 21, and pushrod connector structure 355 is fixedly connected to the proximal end ofpusher 23. Thepushrod connector structure 355 is connected to thesheath connector structure 353 through thetransmission structure 356.

The sheathjoint structure 353 drives thesheath 21 to move along the axial direction, and thetransmission structure 356 drives the push rodjoint structure 355 to push the pushingmember 23 to move towards the direction opposite to the moving direction of thesheath 21, i.e. the pushingmember 23 moves in the direction opposite to the moving direction of thesheath 21, so as to release or recover theelectrode holder 10.

When therotary cylinder 351 rotates relative to themain shaft 31 along the first direction, the sheathjoint structure 353 drives thesheath 21 to move from the distal end to the proximal end along the axial direction of themain shaft 31, and thetransmission structure 356 can drive the push rodjoint structure 355 to push the pushingmember 23 to move from the proximal end to the distal end along the axial direction of themain shaft 31, so as to release theelectrode holder 10 accommodated in thesheath 21, that is, theelectrode holder 10 exposes out of the distal end of thesheath 21.

When therotary cylinder 351 rotates relative to themain shaft 31 along the second direction, the sheathjoint structure 353 drives thesheath 21 to move from the proximal end to the distal end along the axial direction of themain shaft 31, and thetransmission structure 356 can drive the push rodjoint structure 355 to push the pushingmember 23 to move from the distal end to the proximal end along the axial direction of themain shaft 31, so that theelectrode holder 10 retracts and is accommodated in thesheath 21.

The sheath tubejoint structure 353 and the push rodjoint structure 355 can be driven to do opposite linear motion on the main shaft 312 by rotating therotary cylinder 351, namely, the conveyingdevice 35 is a linkage device, so that the control is convenient, the conveying step of theelectrode support 10 is simplified, and the efficiency of the ostomy operation is improved.

In this embodiment, thetransmission structure 356 is a transmission gear set. The sheathjoint structure 353 includes a sheath joint 3531 and adriving rack 3532 provided at intervals in the axial direction of themain shaft 31. In addition, referring to fig. 7 again, in the present embodiment, thesheath assembly 20 is further provided with apush rod 27, and thepush rod 27 is inserted into thefirst channel 231 and interposed between the pushingelement 23 and thesheath 21, so as to prevent the pushingelement 23 from rubbing against the sheath joint 3531 in the main shaft, thereby increasing the mechanical and electrical protection for the inner sheath core.

Referring to fig. 10, thesheath tube connector 3531 includes aconnector 3533 and an engagingmember 3534 protruding from a proximal end of theconnector 3533. The bottom surface of thejoint member 3533 facing away from theguide groove 311 is provided with afirst screw thread 3535. The inner surface of therotary cylinder 351 is provided with a second thread 3511 (as shown in fig. 2), and thefirst thread 3535 is engaged with thesecond thread 3511, so that therotary cylinder 351 can drive thesheath connector 3531 to move in the axial direction in theguide groove 311. Thecatch 3534 includes agroove 3536 and ahook 3537 connected, wherein thehook 3537 is located at a proximal end of thecatch 3534 distal from theconnector 3533. Thegroove 3536 is used for clamping connection with thedriving rack 3532.

Theactive rack 3532 is located between the sheath joint 3531 and thetransmission structure 356. Thedrive rack 3532 is engaged with thedrive structure 356. Referring to fig. 11, thedriving rack 3532 includes amain body 3541, a firstelastic member 3542 and a secondelastic member 3543, and themain body 3541 is accommodated in theguide slot 311 of themain shaft 31. The proximal end of thebody 3541 is provided with a plurality of teeth that engage thedrive structure 356. The distal end of themain body 3541 is provided with a receiving groove 3545 (as shown in fig. 12) along the axial direction for inserting the engagingmember 3534. Themain body 3541 is provided with a throughhole 3546 communicating with theaccommodating groove 3545.

The firstelastic member 3542 is provided on a side of themain body 3541 facing away from the bottom surface of theguide groove 311. In the present embodiment, the firstelastic member 3542 extends in the axial direction.

The secondelastic member 3543 is movably clamped between the firstelastic member 3542 and themain body 3541. Thesheath connector 3531 can be engaged with thedriving rack 3532 when moving from the distal end to the proximal end. Referring to fig. 13 and 14, fig. 13 is a perspective view illustrating the sheath joint and the driving rack in a locked connection state; fig. 14 is a sectional view taken along line X-X shown in fig. 13.

The secondelastic member 3543 has a substantially "n" shape. The secondelastic member 3543 includes a connectingportion 3547 and abending portion 3548 formed by bending and extending an end portion of the connectingportion 3547, and the connectingportion 3547 extends into the accommodating groove 3545 (fig. 12) through the throughhole 3546. The connectingportion 3547 is interposed between the firstelastic member 3542 and themain body 3541. When the engagingmember 3534 is inserted into theaccommodating groove 3545, the connectingportion 3547 is accommodated in thegroove 3536, so that thedriving rack 3532 is engaged with thesheath tube connector 3531. When the engagingmember 3534 is inserted into the receivinggroove 3545, thehook portion 3537 pushes up the connectingportion 3547 to enter the nearest end of the receivinggroove 3545, and the connectingportion 3547 is received in thegroove 3536.

Thebent portion 3548 is received in themain body 3541 and partially exposed out of themain body 3541. Referring to fig. 15, the side wall of theguide slot 311 is provided with an inclined portion 313 (see also fig. 6) extending in the axial direction. In the distal-to-proximal direction, the angle between theinclined portion 313 and the axial parallel direction of themain shaft 31 is an acute angle, in other words, the proximal end of theinclined portion 313 is close to the axial parallel direction, and the distal end of theinclined portion 313 is far away from the axial parallel direction. The portion of thebent portion 3548 exposed from themain body 3541 is in contact with theinclined portion 313.

When the sheath joint 3531 is separated from theactive rack 3532, thebent portion 3548 is located at the distal end of theinclined portion 313. Under the driving of therotary drum 351, thesheath connector 3531 moves from the distal end to the proximal end, that is, thesheath connector 3531 moves towards thedriving rack 3532, thesheath connector 3531 is inserted into theaccommodating groove 3545 of thedriving rack 3532, thehook portion 3537 contacts the connectingportion 3547 of the secondelastic member 3543 in theaccommodating groove 3545, and as thesheath connector 3531 gradually moves towards the proximal end, thehook portion 3537 jacks up the connectingportion 3547 in the accommodating groove 3545 (as shown in fig. 7), and is inserted into the farthest end of theaccommodating groove 3545 through the connecting portion 3547 (as shown in fig. 16), so that thesheath connector 3531 is clamped and connected with thedriving rack 3532; thesheath tube connector 3531 drives the driving rack 3232 to move from the far end to the near end, the bendingportion 3548 moves from the far end to the near end along theinclined portion 313, and the near end of the driving rack 3232 can drive thetransmission structure 356 to move.

Under the condition that thesheath tube connector 3531 is connected with thedriving rack 3532, if thedriving rack 3532 moves from the proximal end to the distal end, thebending part 3548 moves along theinclined part 313, the bottom wall of theinclined part 313 of thespindle 31 is inclined, the secondelastic element 3543 is lifted until thehook part 3537 and the bottom of the connectingpart 3547 do not overlap in the axial direction, the bottom of the connectingpart 3547 cannot block thehook part 3537, thehook part 3537 of theclamping element 3534 is separated from theaccommodating groove 3545, and thesheath tube connector 3531 is separated from thedriving rack 3532. By the guiding effect of theinclined portion 313 on the movement of thebent portion 3548, the sheath joint 3531 and thedriving rack 3532 are automatically unlocked, and the efficiency of thestoma system 100 is improved. In the present embodiment, theinclined portion 313 has a groove structure, and an end wall of theinclined portion 313 can abut against thebent portion 3548, thereby limiting the movement displacement of thedriving rack 3532.

Referring to fig. 16, 18 and 19, thepusher connector structure 355 includes apusher connector 3551 and a drivenrack 3553 fixedly connected to a distal end of thepusher connector 3551, wherein thepusher connector 3551 is fixedly connected to a proximal end of the pushingelement 23. Thewire drawing 3331 is arranged through the sheath tube joint 3531 and the push rod joint 3551. The drivenrack 3553 is engaged with thedrive structure 356.

Referring to fig. 16 and 20, thedelivery device 35 further includes a lockingmember 357. The bottom of theguide groove 311 is penetrated by a receivinghole 315, and the receivinghole 315 includes afirst receiving hole 3151 and asecond receiving hole 3153 spaced apart from each other at the bottom of theguide groove 311. The lockingmember 357 includes a connectingportion 3571, a holdingportion 3573 and alocking portion 3575 connected in sequence. The distal end of the connectingportion 3571 is pivotally connected to the distal end of the firstaccommodating hole 3151. The connectingportion 3571 and the abuttingportion 3573 can be accommodated in the firstaccommodating hole 3151. The abuttingportion 3573 is a boss formed by bending and extending the proximal end of the connectingportion 3571 toward the side of themain shaft 31. The proximal end of the lockingportion 3575 can be received in thesecond receiving hole 3153. The proximal end of thelatch 3575 is provided with afirst locking tooth 3576 on the side toward themain shaft 31, and the side of thepusher block 3551 toward themain shaft 31 is provided with asecond locking tooth 3554 for engaging with thefirst locking tooth 3576. It is to be understood that the abuttingportion 3573 is not limited to a boss, and may be another structure capable of abutting against the sheath joint 3531.

When thefirst locking tooth 3576 is received in thesecond receiving hole 3153 and is engaged with thesecond locking tooth 3554, the push rodjoint structure 355 is positioned by thelocking component 357 and cannot move, i.e. thelocking component 357 is in the locking position.

When thefirst locking tooth 3576 is not engaged with thesecond locking tooth 3554, that is, when thefirst locking tooth 3576 is disengaged from thesecond locking tooth 3554, the push rodjoint structure 355 is not positioned by the lockingmember 357, and the push rodjoint structure 355 can move axially under the driving of the transmission gear set 357.

In this embodiment, thedriving rack 3532 is always engaged with thetransmission joint 356, and the drivenrack 3553 is always engaged with thetransmission joint 356. When thedriving rack 3532 is not engaged with thesheath connector 3531, thesheath connector 3531 is separated from thedriving rack 3532, thedriving rack 3532 does not move synchronously with thesheath connector 3531, and the lockingmember 357 is located at the locking position. During the process that therotating cylinder 351 drives thesheath connector 3531 to move from the distal end to the proximal end in theguide slot 311, after the part with the largest diameter of theproximal portion 11 of theelectrode holder 10 is released from thesheath 21, thesheath connector 3531 pushes the abuttingportion 3573, the locking portion 3575 (proximal end) of the lockingmember 357 rotates in the direction away from themain shaft 31, and thedriving rack 3532 disengages from the pushrod connector structure 355 before pushing the transmission gear set to rotate, so as to unlock the pushrod connector structure 355.

In the process that therotating cylinder 351 drives thesheath connector 3531 to move from the proximal end to the distal end in theguide groove 311, thesheath connector 3531 continues to push the abuttingportion 3573, and before theproximal portion 11 of theelectrode holder 10 with the largest diameter is retracted or retracted into thesheath 21, thesheath connector 3531 is far away from the abuttingportion 3573 after thedriving rack 3532 is disengaged from thetransmission structure 356, and the lockingmember 357 is engaged with the pushrod connector structure 355, so that the pushrod connector structure 355 is positioned.

The conveyingdevice 35 further comprises anelastic member 358, and one end of theelastic member 358 is fixed to a side of the lockingportion 3575 facing away from themain shaft 31 through welding. Thehandle 30 also includes a housing 37 (shown in FIG. 2) and a grip 38 (shown in FIG. 2). Thehousing 37 is fitted over the proximal end of themain shaft 31. Theelastic member 358 is located between the lockingportion 3575 and the inner wall of thehousing 37, and is used for resetting the lockingmember 357 when thesheath connector 3531 is away from (not contacting) the abuttingportion 3573, and pushing the lockingportion 3575 to rotate toward the direction adjacent to themain shaft 31, so that the proximal end of the lockingmember 357 is locked with the pushrod connector structure 355, i.e. thefirst locking tooth 3576 is engaged with thesecond locking tooth 3554. Thehandle 38 is sleeved on the distal end of themain shaft 31, and therotary cylinder 351 is located between thehandle 38 and thehousing 37. Thehousing 37, thegrip 38 and thebarrel 351 together form an outer shell of thehandle 30.

The following is a brief description of theostomy system 100 establishing a shunt channel for the interatrial septum of the heart, where the ostium is the interatrial septum between the left atrium and the right atrium of the heart, i.e., theostomy system 100 is used to establish a shunt channel for the interatrial septum of the heart.

Firstly, puncturing the interatrial septum by using a puncturing mechanism, feeding a guide wire into the left upper pulmonary vein after puncturing, and removing a puncturing kit. The dilator andsheath assembly 20 is advanced over the guidewire of the secondinner sheath core 25 into the left atrium, and the guidewire and dilator are removed. Theelectrode stent 10 is advanced over the guidewire through the lumen of the secondinner sheath core 25 into the left atrium.

Assuming the state of theostomy system 100 when theelectrode holder 10 is not released as an initial state: at the distal end of theostomy system 100, the opening of the pushingmember 23 is retracted inside the opening of thesheath 21, the diameter of thewaist 13 is reduced to a smaller extent by thesizing wire 3332, and thewaist 13 is fixed to the distal end of the pushingmember 23 by thesizing wire 3332, so that theelectrode holder 10 cannot move back and forth in the axial direction. Theelectrode holder 10 is axially elongated so as to be radially compressed and fully received in the opening of thesheath 21, without thedistal end portion 15 of theelectrode holder 10 protruding from the distal end of thesheath 21. The sheath tube joint 3531 and thedriving rack 3532 are arranged at intervals and do not contact with each other, the connectingportion 3536 of the secondelastic piece 3543 is contained in the containingcavity 3545, the position of the connecting portion is an initial position, thedriving rack 3532 is meshed with thetransmission structure 356, and the drivenrack 3553 is meshed with thetransmission structure 356. Thesheath connector 3531 is away from the abuttingportion 3573 of the lockingmember 357. Theresilient member 358 abuts the inner wall of thehousing 37 and the lockingmember 357 is in the locked position, i.e., thefirst locking tooth 3576 engages thesecond locking tooth 3554.

The process of releasing theelectrode stent 10 includes:

a first period: thedistal part 15 of theelectrode holder 10 is released in the left atrium, thewaist 13 in the atrial septum perforation site and a part of theproximal part 11 in the right atrium, in particular where the diameter of theproximal part 11 is largest.

Specifically, by holding thehandle 38 and rotating therotating barrel 351 in a first direction (e.g., clockwise when viewed from the proximal end to the distal end of the ostomy system 100), therotating barrel 351 drives thesheath connector 3531 to move proximally in the axial direction, thesheath connector 3531 drives thesheath 21 to move proximally, thesheath connector 3531 gradually approaches theactive rack 3532, and theelectrode holder 10 is gradually released from thesheath 21.

After the maximum diameter portion of theproximal portion 11 of theelectrode holder 10 is released from thesheath 21, thehook portion 3537 contacts the connectingportion 3547 of the secondelastic member 3543 in theaccommodating groove 3545, and as thesheath connector 3531 gradually moves proximally, thehook portion 3537 lifts the connectingportion 3547 in the accommodating groove 3545 (as shown in fig. 7), and is inserted into the farthest end of theaccommodating groove 3545 through the connecting portion 3547 (as shown in fig. 14 and 16), while thegroove 3536 faces the connectingportion 3547, and the connectingportion 3547 drops to the initial position; at the same time, or before this moment, the bottom of thesheath connector 3531 abuts against the abuttingportion 3573 of the lockingmember 357, and pushes the abuttingportion 3573 to drive the locking portion 3575 (the proximal end of the locking member 357) of the lockingmember 357 to rotate in a direction away from themain shaft 31, so that the abuttingmember 357 is converted from the locking position to the unlocking position, and thus, thepush rod connector 3551 can drive the pushingmember 23 to slide in theguide slot 311 of themain shaft 31 along the axial direction.

A second period of time: theproximal part 11 is further released in the right atrium until theelectrode holder 10 is completely released.

Specifically, as shown in fig. 2, therotary cylinder 351 continues to rotate in the first direction, the sheath joint 3531 drives thedriving rack 3532 to move towards the proximal end in the axial direction, and thesheath 21 moves towards the proximal end; the plurality of teeth at the proximal end of thedriving rack 3532 are engaged with thetransmission structure 356 and drive thetransmission structure 356 to rotate, the drivenrack 3553 engaged with thetransmission structure 356 is driven by thetransmission structure 356 to move towards the distal end, thepush rod connector 3551 drives the pushingelement 23 to move towards the distal end until the distal end of the pushingelement 23 extends out of thesheath tube 21, theelectrode stent 10 is completely released from thesheath tube 21, and after the complete release, the inner wall of thesheath tube 21 does not compress theelectrode stent 10 any more, so that the diameter of theproximal part 11 of theelectrode stent 10 is enlarged relative to the diameter before the complete release, and theproximal part 11 is more easily attached to an atrial anatomical structure. In the second time period, thesheath 21 moves towards the proximal end, the pushingmember 23 moves towards the distal end, that is, thesheath 21 and the pushingmember 23 are linked, and in the releasing process of theelectrode support 10, as thesheath 21 and the pushingmember 23 are linked, that is, thesheath 21 moves towards the proximal end, and the pushingmember 23 moves towards the distal end, under the condition that thewaist 13 is fixed, the diameter of theproximal portion 11 is further enlarged, the diaphragm between the left atrium and the right atrium can be better attached, and thewaist 13 is tightened by thediameter adjusting wire 3332 so as to be accurately fixed at the puncture position, thereby accurately positioning the subsequent position which needs to be ablated.

The diameter adjusting process comprises the following steps: after a second period of time, the appropriate size may be selected for burning according to the patient's specific condition, and the diameter of thewaist 13 of theelectrode holder 10 may be adjusted to establish an appropriate interatrial septum shunting channel.

A pulse ablation process: after confirming that the tissue at the stoma is properly apposed to theelectrode holder 10, the proximal end of thecable 40 is connected to a radio frequency power source (ablation power source, not shown), and heating parameters (e.g., power 20-80W, duration 10-50S) are set, and then heating is initiated. After the heating is stopped, theelectrode stent 10 may be recovered to thesheath 21 and removed from the body, and whether the stoma diameter is as expected or not may be measured.

A process for recovering anelectrode stent 10, comprising:

a third period: rotating therotator barrel 351 in a second direction (e.g., counterclockwise when viewed from the proximal end to the distal end of the ostomy system 100), therotator barrel 351 causes thesheath connector 3531 to move axially towards the distal end, and thesheath connector 3531 causes thesheath 21 to move distally. Thesheath 21 gradually accommodates the proximal end of theelectrode holder 10 therein; meanwhile, thehook 3537 of thedriving rack 3532 pulls the bottom of themain body 3541 to drive thedriving rack 3532 to move towards the far end, and thedriving rack 3532 drives the drivenrack 3553, the push rod joint 3551 and the pushingelement 23 to move towards the near end through thetransmission structure 356.

In the third time period, the maximum diameter of theproximal portion 11 of theelectrode holder 10 is located outside thesheath 21, a part of theproximal portion 11 is accommodated in thesheath 21, the radial dimension of theelectrode holder 10 is compressed by the inner wall of thesheath 21 under the action of pulling thepush rod connector 3551 towards the proximal end, the axial length is lengthened, and theelectrode holder 10 is further recovered into thesheath 21, because the radial dimension of theelectrode holder 10 can be compressed in the recovery process, theelectrode holder 10 is recovered smoothly, the diameter of theproximal portion 11 of theelectrode holder 10 can be designed to be larger, so that theproximal portion 11 can better fit the diaphragm between the left atrium and the right atrium, and the accuracy of positioning the ablation part is improved.

The sheath tube joint 3531 drives thesheath tube 21 to move towards the far end, and the near end of thedriving rack 3532 is limited (cannot be lifted) by thehook portion 3537 in the direction perpendicular to the axial direction. Since the connectingportion 3547 is disposed on the top surface of themain body 3541 away from the bottom of theguide slot 311, the twobent portions 3548 are connected to one end of themain body 3541 and extend to two opposite sides of themain body 3541, that is, thebent portions 3548 are exposed out of themain body 3541. The bottom wall of theinclined portion 313 of themain shaft 31 is inclined and abuts against the bottom of thebent portion 3548. During the process that thedriving rack 3532 moves distally along theinclined portion 313, before the maximum diameter of theproximal portion 11 is retracted into thesheath 21, the secondelastic member 3543 is lifted until thehook portion 3537 and the bottom of the connectingportion 3547 do not overlap in the axial direction, the bottom of the connectingportion 3547 cannot block thehook portion 3537, so that thehook portion 3537 is disengaged from theaccommodating groove 3545, and thesheath connector 3531 is separated from thedriving rack 3532. At this time, or after this time, thesheath connector 3531 and the abuttingportion 3573 of the lockingmember 357 are disengaged from each other and slide distally, and theelastic member 358 abuts against the inner wall of thehousing 37, so that the proximal end of the lockingmember 357 abuts against themain shaft 31, and the lockingmember 357 is shifted from the unlocking position to the locking position.

In the third time period, the sheath joint 3531 drives thesheath 21 to move towards the distal end, and the pushingmember 23 moves towards the proximal end, that is, thesheath 21 and the pushingmember 23 are linked. At the end of the third period, theproximal portion 11 of theelectrode stent 10 is positioned outside thesheath 21 where the diameter is the largest. And in the first period, thebent portion 3548 is also jacked up by theinclined portion 313 in the process that theconnection portion 3547 of the secondelastic member 3543 is jacked up by thehook portion 3537.

And a fourth time period: the rotatingcylinder 351 continues to rotate in the second direction, therotating cylinder 351 drives thesheath tube connector 3531 to move along the axial distal end, thesheath tube connector 3531 drives thesheath tube 21 to move towards the distal end, and thedriving rack 3532 and the pushingelement 23 are fixed relative to themain shaft 31. Thesheath 21 retrieves the remaining portion of theelectrode stent 10 therein.

In the fourth time period, after theproximal portion 11 is completely retracted into thesheath 21, and before the distal portion is retracted into thesheath 21, that is, when thewaist portion 13 is located at the distal opening position of thesheath 21, the diameter-adjustingwires 3332 around thewaist portion 13 are tightened, so as to avoid the situation that after thewaist portion 13 is tightened before, the operator rotates the components on thehandle 30 to retract theelectrode holder 10, which causes theelectrode holder 10 to move back and forth between the left atrium and the right atrium, and damages the heart tissue.

It is to be understood that theostomy system 100 may also be used in ostomy procedures such as gastrointestinal ostomy, arteriovenous fistulation, and the like.

Second embodiment

Referring to fig. 21-23, fig. 21 is an exploded perspective view of astoma system 200 according to a second embodiment of the present application, thestoma system 200 according to the second embodiment of the present application having a configuration substantially similar to thestoma system 100 according to the first embodiment. With reference to fig. 24, thesheath adapter 653 includes asheath adapter 6531 and adriving rack 6532, which are fixedly connected, and thedriving rack 6532 is disposed at an interval of the transmission structure 656 (as shown in fig. 25 and 26). In an initial state without releasing theelectrode holder 201, thedriving rack 6532 is disposed at an interval from thetransmission structure 656, the connectingportion 6571 of the lockingmember 657 is pivotally connected to thespindle 611, and the lockingportion 6575 of the lockingmember 657 is locked with the bottom of the push rodjoint structure 655.

The sheath joint 6531 and thedriving rack 6532 are always connected to one body. Before thedriving rack 6532 pushes thetransmission structure 356 to rotate, the lockingmember 657 needs to be disengaged from the push rodjoint structure 655 to prevent the push rodjoint structure 655 from being locked.

It is understood that the sheath joint 6531 and thedriving rack 6532 are not limited to be fixedly connected, and the sheath joint 6531 and thedriving rack 6532 may move synchronously. The sheathjoint structure 353 does not include a locking member, a first elastic member, a second elastic member, and an accommodating groove.

The main differences between the process of releasing and retrieving theelectrode holder 201 and the first embodiment include:

a first period: thesheath coupling structure 653 slides proximally as a whole, thedriving rack 6532 does not contact thetransmission structure 656 at the distal end (as shown in fig. 25 and 26), and when thesheath coupling structure 653 moves from the distal end to the proximal end until thedriving rack 6532 engages the transmission structure 656 (as shown in fig. 27), and at the same time or before this time, the bottom of thesheath coupling structure 653 abuts against the abuttingportion 6573 of the lockingmember 657 and pushes the abuttingportion 6573 to rotate the proximal end of the lockingmember 657 away from themain shaft 611, the lockingmember 657 is shifted from the locking position to the unlocking position, so that the pushrod coupling structure 655 can drive the pushingmember 623 to slide in themain shaft 611 along the axial direction.

A second period of time: the sheathfitting structure 653 slides proximally as a unit.

A third period: the sheathfitting structure 653 slides distally as a unit until thedriving rack 6532 disengages from thedrive structure 656 and thelocking element 657 shifts to the locked state.

And a fourth time period: the rotary cylinder 651 drives the sheathfitting structure 653 to move distally in the axial direction as a whole.

In theostomy system 200 according to the second embodiment, thesheath adapter 6531 of thesheath adapter structure 653 and thedriving rack 6532 are an integral component, thereby reducing the number of parts of theostomy system 200 and simplifying the structure of theostomy system 200.

It should be noted that the specific technical solutions in the above embodiments can be mutually applied without departing from the technical principle of the present invention.

The above disclosure is only for the purpose of illustrating the preferred embodiments of the present application and is not to be construed as limiting the scope of the present application, so that the present application is not limited thereto, and all equivalent variations and modifications can be made to the present application.

Claims (18)

Translated fromChinese

1.一种造口系统，其特征在于，包括手柄、鞘管组件及电极支架，所述鞘管组件包括所述鞘管及活动穿装于所述鞘管的推送件，所述电极支架固定于所述推送件的远端并收容于所述鞘管内，所述电极支架通过扩张和消融作用在造口处组织建立分流通道，所述手柄包括输送装置，所述输送装置包括鞘管接头结构、推杆接头结构及传动结构，所述鞘管接头结构与所述鞘管的近端固定连接，所述推杆接头结构与所述推送件的近端固定连接，所述推杆接头结构通过所述传动结构与所述鞘管接头结构连接；所述鞘管接头结构带动所述鞘管沿轴向方向运动，所述传动结构带动所述推杆接头结构推动所述推送件向所述鞘管运动方向相反的方向运动，从而释放或回收所述电极支架。1. an ostomy system, is characterized in that, comprises handle, sheath tube assembly and electrode support, described sheath tube assembly comprises described sheath tube and the pusher that is movably worn in described sheath tube, and described electrode support is fixed At the distal end of the pusher and accommodated in the sheath, the electrode support establishes a shunt channel in the tissue at the stoma through expansion and ablation, the handle includes a delivery device, and the delivery device includes a sheath joint structure , Push rod joint structure and transmission structure, the sheath tube joint structure is fixedly connected with the proximal end of the sheath tube, the push rod joint structure is fixedly connected with the proximal end of the push piece, and the push rod joint structure is connected by The transmission structure is connected with the sheath joint structure; the sheath joint structure drives the sheath to move in the axial direction, and the transmission structure drives the push rod joint structure to push the pusher toward the sheath The tube moves in the opposite direction to release or retract the electrode holder.2.如权利要求1所述的造口系统，其特征在于，所述手柄包括主轴，所述主轴沿轴向设有导向槽，所述鞘管接头结构、所述推杆接头结构及所述传动结构均收容于所述主轴的导向槽内。2 . The ostomy system according to claim 1 , wherein the handle comprises a main shaft, the main shaft is provided with a guide groove along the axial direction, the sheath joint structure, the push rod joint structure and the The transmission structures are all accommodated in the guide grooves of the main shaft.3.如权利要求2所述的造口系统，其特征在于，所述鞘管接头结构带动所述鞘管沿所述主轴沿轴向由远端向近端方向运动时，所述传动结构能够带动所述推杆接头结构推动所述推送件沿所述主轴沿轴向由近端向远端方向运动，以释放收容于所述鞘管内的所述电极支架；3 . The ostomy system according to claim 2 , wherein when the sheath tube joint structure drives the sheath tube to move from the distal end to the proximal end in the axial direction along the main shaft, the transmission structure can 3 . driving the push rod joint structure to push the push piece to move from the proximal end to the distal end along the main shaft in the axial direction, so as to release the electrode holder accommodated in the sheath tube;所述鞘管接头结构带动所述鞘管沿所述主轴沿轴向由近端向远端方向运动时，所述传动结构能够带动所述推杆接头结构推动所述推送件沿所述主轴的轴向由远端向近端方向运动，以回收所述电极支架至所述鞘管内。When the sheath tube joint structure drives the sheath tube to move in the axial direction from the proximal end to the distal end along the main shaft, the transmission structure can drive the push rod joint structure to push the pushing member along the main shaft. The axial direction is moved from the distal end to the proximal end to recover the electrode holder into the sheath tube.4.如权利要求3所述的造口系统，其特征在于，所述输送装置还包括旋筒，所述旋筒套设于所述主轴外，所述鞘管接头结构与所述旋筒的内表面啮合，所述旋筒转动时能够带动所述鞘管接头结构沿所述主轴的轴向运动。4. The ostomy system according to claim 3, wherein the delivery device further comprises a rotating cylinder, the rotating cylinder is sleeved outside the main shaft, and the sheath joint structure is connected to the rotating cylinder. The inner surfaces are engaged, and the rotating cylinder can drive the sheath joint structure to move along the axial direction of the main shaft.5.如权利要求4所述的造口系统，其特征在于，所述传动结构包括传动齿轮组，所述鞘管接头结构包括沿所述主轴的轴向设置的鞘管接头及主动齿条，所述鞘管接头与所述旋筒的内表面啮合，所述主动齿条位于所述鞘管接头与所述传动齿轮组之间用于与所述传动齿轮组啮合，所述传动齿轮组与所述推杆接头结构啮合，所述鞘管接头能够在所述旋筒的驱动下，带动所述主动齿条与所述传动齿轮组运动，使所述推杆接头结构沿所述主轴轴向运动。5. The ostomy system according to claim 4, wherein the transmission structure comprises a transmission gear set, and the sheath joint structure comprises a sheath joint and a driving rack arranged along the axial direction of the main shaft, The sheath joint is engaged with the inner surface of the rotary cylinder, and the driving rack is located between the sheath joint and the transmission gear set for meshing with the transmission gear set, and the transmission gear set is connected to the transmission gear set. The push rod joint structure is engaged, and the sheath tube joint can drive the driving rack and the transmission gear set to move under the driving of the rotary cylinder, so that the push rod joint structure is axially along the main shaft. sports.6.如权利要求5所述的造口系统，其特征在于，所述鞘管接头与所述主动齿条间隔设置，所述鞘管接头包括接头件及凸设于所述接头件近端的卡合件，所述接头件与所述旋筒的内表面啮合，所述旋筒的转动能够驱动所述鞘管接头沿所述主轴轴向由远端向近端方向运动，所述卡合件朝向所述主动齿条运动并最终与所述主动齿条卡合相接，进而带动所述主动齿条随同所述接头件作同向运动。6 . The ostomy system according to claim 5 , wherein the sheath joint and the driving rack are arranged at intervals, and the sheath joint comprises a joint piece and a protruding joint at the proximal end of the joint piece. 7 . an engaging piece, the joint piece is engaged with the inner surface of the rotating cylinder, the rotation of the rotating cylinder can drive the sheath tube joint to move from the distal end to the proximal end along the axial direction of the main shaft, the engaging The connecting piece moves toward the driving rack and finally engages with the driving rack, thereby driving the driving rack to move in the same direction with the joint piece.7.如权利要求6所述的造口系统，其特征在于，所述主动齿条包括主体、第一弹性件及第二弹性件，所述主体容置于所述主轴的导向槽内，所述主体的远端沿轴向上设有容置槽，所述第一弹性件设于所述主体上，所述第二弹性件活动夹设于所述第一弹性件与所述主体之间，所述主体设有与所述容置槽连通的通孔，所述第二弹性件通过所述通孔伸入所述容置槽，所述卡合件在所述旋筒的带动下能够插入所述容置槽而与所述第二弹性件卡合相接。7. The ostomy system according to claim 6, wherein the driving rack comprises a main body, a first elastic part and a second elastic part, the main body is accommodated in the guide groove of the main shaft, and the The distal end of the main body is provided with an accommodating groove in the axial direction, the first elastic member is arranged on the main body, and the second elastic member is movably sandwiched between the first elastic member and the main body , the main body is provided with a through hole communicating with the accommodating groove, the second elastic member extends into the accommodating groove through the through hole, and the engaging member can be driven by the rotating cylinder. It is inserted into the accommodating groove to be engaged with the second elastic member.8.如权利要求7所述的造口系统，其特征在于，所述第二弹性件包括连接部及由所述连接部的端部弯折延伸形成的弯折部，所述连接部通过所述通孔伸入所述容置槽内，所述连接部夹设于所述第一弹性件及所述主体之间，所述卡合件包括凹槽，所述凹槽用于容置所述连接部以与所述第二弹性件卡合相接。8 . The ostomy system according to claim 7 , wherein the second elastic member comprises a connecting portion and a bending portion formed by bending and extending an end of the connecting portion, and the connecting portion passes through the The through hole extends into the accommodating groove, the connecting portion is sandwiched between the first elastic member and the main body, the engaging member includes a groove, and the groove is used for accommodating the The connecting portion is in engagement with the second elastic member.9.如权利要求8所述的造口系统，其特征在于，所述导向槽的侧壁上设有倾斜部，沿远端向近端方向，所述倾斜部与所述主轴的轴向平行方向之间的夹角为锐角，所述弯折部部分与所述倾斜部相接，所述旋筒驱动所述鞘管接头由近端向远端方向运动时，所述弯折部沿所述倾斜部运动，带动所述连接部脱离所述凹槽，所述卡合件从所述容置槽中脱出，所述鞘管接头脱离所述主动齿条。9 . The ostomy system according to claim 8 , wherein an inclined portion is provided on the side wall of the guide groove, and along the distal-to-proximal direction, the inclined portion is parallel to the axial direction of the main shaft. 10 . The included angle between the directions is an acute angle, the bent portion is partially connected to the inclined portion, and when the rotary cylinder drives the sheath joint to move from the proximal end to the distal direction, the bent portion moves along the The movement of the inclined portion drives the connecting portion to be separated from the groove, the engaging member is released from the accommodating groove, and the sheath tube joint is separated from the driving rack.10.如权利要求5所述的造口系统，其特征在于，所述鞘管接头与所述主动齿条固定相接，所述鞘管接头与所述旋筒的内表面啮合，所述主动齿条位于所述鞘管接头与所述传动齿轮组之间，所述主动齿条的近端间隔所述传动齿轮组设置。10. The ostomy system according to claim 5, wherein the sheath joint is fixedly connected with the driving rack, the sheath joint is engaged with the inner surface of the rotary barrel, and the driving The rack is located between the sheath joint and the transmission gear set, and the proximal end of the driving rack is arranged spaced from the transmission gear set.11.如权利要求5所述的造口系统，其特征在于，所述推杆接头结构包括推杆接头及与所述推杆接头的远端固定连接的从动齿条，所述推杆接头与所述推送件的近端固定连接，所述从动齿条与所述传动齿轮组啮合。11. The ostomy system according to claim 5, wherein the push rod joint structure comprises a push rod joint and a driven rack fixedly connected with the distal end of the push rod joint, the push rod joint Fixedly connected with the proximal end of the pushing member, the driven rack is engaged with the transmission gear set.12.如权利要求6或10所述的造口系统，其特征在于，所述输送装置还包括锁持件，所述导向槽的底部贯通设有收容孔，所述锁持件收容于所述收容孔，所述锁持件的远端与所述主轴连接，所述锁持件的近端用于与所述推杆接头结构锁持于一起，所述锁持件朝向所述主轴的一侧设有抵持部，12. The ostomy system according to claim 6 or 10, wherein the conveying device further comprises a locking member, a receiving hole is formed through the bottom of the guide groove, and the locking member is received in the A receiving hole, the distal end of the locking member is connected with the main shaft, the proximal end of the locking member is used to be locked together with the push rod joint structure, and the locking member faces one end of the main shaft. There is a resisting part on the side,所述鞘管接头还用于推动所述抵持部，使所述锁持件的近端向背离所述主轴的方向转动，并在所述主动齿条推动所述传动齿轮组转动前脱离所述推杆接头结构。The sheath tube joint is also used to push the abutting portion, so that the proximal end of the locking member rotates in a direction away from the main shaft, and is disengaged from the lock before the driving rack pushes the transmission gear set to rotate. The push rod joint structure.13.如权利要求12所述的造口系统，其特征在于，所述锁持件的近端朝向所述主轴一侧设有第一锁定齿，所述推杆接头结构设有与所述第一锁定齿啮合的第二锁定齿。13. The ostomy system according to claim 12, wherein the proximal end of the locking member is provided with a first locking tooth on the side facing the main shaft, and the push rod joint structure is provided with a first locking tooth. A locking tooth engages a second locking tooth.14.如权利要求12所述的造口系统，其特征在于，还包括壳体，所述壳体套设于所述主轴外，所述输送装置还包括弹性件，所述弹性件连接于所述锁持件的近端与所述壳体的内壁之间，在所述鞘管接头未接触所述抵持部时，所述弹性件推动所述锁持件的近端向邻近所述主轴的方向转动，使得所述锁持件的近端与所述推杆接头结构锁持于一起。14. The ostomy system according to claim 12, further comprising a casing sleeved on the outside of the main shaft, and the conveying device further comprising an elastic member connected to the Between the proximal end of the locking member and the inner wall of the housing, when the sheath joint is not in contact with the abutting portion, the elastic member pushes the proximal end of the locking member to be adjacent to the main shaft Rotate in the direction of rotation, so that the proximal end of the locking member and the push rod joint structure are locked together.15.如权利要求5所述的造口系统，其特征在于，所述电极支架包括依次固定连接的近端部分、腰部及远端部分，所述近端部分固定于所述推送件的远端，所述鞘管接头在所述旋筒的驱动下沿所述主轴由远端向近端方向运动过程中，在所述近端部分的最大直径处露出所述鞘管后，通过所述主动齿条带动所述推杆接头结构由近端朝向远端运动；所述鞘管接头在所述旋筒的驱动下沿所述主轴由近端向远端方向运动过程中，在所述近端部分的最大直径处回撤至所述鞘管内之前，通过所述主动齿条带动所述推杆接头结构由远端朝向近端运动。15. The ostomy system according to claim 5, wherein the electrode support comprises a proximal end portion, a waist portion and a distal end portion that are fixedly connected in sequence, and the proximal end portion is fixed to the distal end of the pusher , during the movement of the sheath joint from the distal end to the proximal end along the main shaft under the driving of the rotary cylinder, after the sheath tube is exposed at the maximum diameter of the proximal end portion, the The rack drives the push rod joint structure to move from the proximal end to the distal end; the sheath tube joint moves from the proximal end to the distal end along the main shaft under the drive of the rotary cylinder, the proximal end Before the part with the largest diameter is retracted into the sheath tube, the push rod joint structure is driven by the driving rack to move from the distal end to the proximal end.16.如权利要求1所述的造口系统，其特征在于，所述造口系统还包括电缆，所述电缆穿设于所述推送件，所述电缆的近端用于与射频电源电连接，所述电缆的远端与所述电极支架电连接。16. The ostomy system according to claim 1, wherein the ostomy system further comprises a cable, the cable is passed through the pusher, and the proximal end of the cable is used for electrical connection with a radio frequency power supply , the distal end of the cable is electrically connected with the electrode holder.17.如权利要求16所述的造口系统，其特征在于，所述推送件为多腔管，所述推送件包括第二腔道，所述电缆穿装于所述第二腔道。The ostomy system according to claim 16, wherein the pusher is a multi-lumen tube, the pusher comprises a second lumen, and the cable is passed through the second lumen.18.如权利要求17所述的造口系统，其特征在于，所述推送件包括与所述第二腔道间隔设置的第一腔道，所述鞘管组件还包括第二内鞘芯，所述第二内鞘芯穿装于所述第一腔道，所述第二内鞘芯用于穿设导丝。18. The ostomy system according to claim 17, wherein the pushing member comprises a first lumen spaced from the second lumen, and the sheath tube assembly further comprises a second inner sheath core, The second inner sheath core is inserted into the first cavity, and the second inner sheath core is used for threading a guide wire.

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