Stoma system

Abstract

The present application discloses a stoma system, including a handle, a sheath assembly and an electrode holder, the sheath assembly including the sheath and a push piece movably mounted on the sheath, the electrode holder fixed to the distal end of the push piece and accommodated in the sheath, the electrode holder establishes a shunt channel in the stoma tissue through expansion and ablation, the handle including a conveying device, the conveying device including a sheath joint structure, a push rod joint structure and a transmission structure, the sheath joint structure is fixedly connected to the proximal end of the sheath, the push rod joint structure is fixedly connected to the proximal end of the push piece, the push rod joint structure is connected to the sheath joint structure through the transmission structure; the sheath joint structure drives the sheath to move in the axial direction, the transmission structure drives the push rod joint structure to push the push piece to move in the direction opposite to the movement direction of the sheath, thereby releasing or recovering the electrode holder.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a stoma system. Background Art

[0002] Heart failure (HF) is a complex clinical syndrome characterized by impaired ventricular filling or ejection capacity due to any structural or functional abnormality of the heart. Its primary clinical manifestations include dyspnea and fatigue (limited exercise tolerance), as well as fluid retention (pulmonary congestion and peripheral edema). HF is a severe and terminal stage of various heart diseases, with a high incidence rate, making it one of the most important cardiovascular diseases today. HF can be categorized as left-sided, right-sided, or total heart failure based on its location.

[0003] Heart failure is a serious disease with a high incidence and mortality rate. The incidence of heart failure in my country is 2-3%, representing over 12 million people. The main causes of heart failure include hypertension, coronary artery disease, myocardial infarction, valvular heart disease, atrial fibrillation, and cardiomyopathy. Cardiovascular disease damages the left ventricle, leading to pathological remodeling and decreased cardiac function. Every successful treatment of a myocardial infarction patient creates a potential heart failure patient.

[0004] In terms of treatment, even after optimizing drug therapy, patients' symptoms still recur. Currently, drug therapy is effective only for patients with reduced ejection fraction, and the effect is not ideal for those with preserved ejection fraction. Cardiac resynchronization therapy is not suitable for all heart failure patients, and more than 20% of patients do not respond to cardiac resynchronization pacing. Left ventricular assist device surgery requires extracorporeal circulation, is highly invasive, has a high incidence of complications, is expensive, and is difficult to obtain, and is not available in China. Heart transplantation is the ultimate solution, but the source of donors is very limited and expensive.

[0005] Pulmonary hypertension, on the other hand, is a group of diseases characterized by a progressive increase in pulmonary arterial systemic resistance. Pathological changes include pulmonary vasoconstriction and remodeling, abnormal proliferation of pulmonary vascular smooth muscle and endothelial cells, and in situ thrombosis, ultimately leading to right heart failure and death. With the deepening of research into the pathogenesis of pulmonary hypertension, a growing number of treatment options are available. Treatment options for pulmonary hypertension should be both individualized and systemic, rather than a single drug. Treatment options include general therapy, nonspecific drug therapy, targeted drug therapy, nitric oxide inhalation therapy, gene therapy, interventional therapy, and surgical intervention. In the late stages of pulmonary hypertension, patients with these conditions often experience limited response to comprehensive treatments, resulting in low survival rates and an extremely poor prognosis. Surgical treatments such as atrial septostomy, lung transplantation, and combined heart-lung transplantation can be tried as life-saving options. However, these treatments are associated with significant surgical risks, donor shortages, graft rejection, and high subsequent costs.

[0006] Atrial septostomy is a procedure in which a septum is created in the patient's atrial septum, thereby forming a shunt between the left and right atria. It can be used to treat pulmonary hypertension (right-to-left shunt) or left heart failure (left-to-right shunt), and has proven clinically effective.

[0007] Traditional atrial septostomy methods, such as balloon atrial septostomy, have a tendency for myocardial tissue to rebound after the stoma is created, and the stoma will shrink or even completely close after a period of time. To address the problem of stoma shrinkage or even closure, the prior art provides a stoma stent and an implant for atrial shunt, which is characterized by percutaneous delivery of an implant to implant a shunt device at the atrial septal puncture site after percutaneous atrial septal puncture to maintain the patency of the shunt opening. However, the implantation of a shunt device is prone to thrombosis or device detachment, forming an embolism. In addition, endothelial adhesion can cause the device opening to be blocked, and the channel is closed, losing its shunt function. Summary of the Invention

[0008] In order to solve the aforementioned problems, the present application provides a stoma system.

[0009] A stoma system includes a handle, a sheath assembly and an electrode holder, the sheath assembly includes the sheath and a push piece movably mounted on the sheath, the electrode holder is fixed to the distal end of the push piece and accommodated in the sheath, the electrode holder is accommodated in the distal end of the sheath assembly, and the electrode holder establishes a shunt channel in the stoma tissue through expansion and ablation, the handle includes a conveying device, the conveying device includes a sheath joint structure, a push rod joint structure and a transmission structure, the sheath joint structure is fixedly connected to the proximal end of the sheath, the push rod joint structure is fixedly connected to the proximal end of the push piece, and the push rod joint structure is connected to the sheath joint structure through the transmission 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 push piece to move in the direction opposite to the movement direction of the sheath, thereby releasing or recovering the electrode holder.

[0010] The stoma system provided in the present application is connected to the sheath through the sheath joint structure in the delivery device, and the push rod joint structure is connected to the push piece. The sheath joint structure drives the push rod joint structure to move through the transmission structure, and the movement direction of the sheath joint structure is opposite to that of the push rod joint structure, that is, the movement direction of the sheath and the push piece is opposite, which improves the release and recovery speed of the electrode holder, and is beneficial to compressing the proximal end of the electrode holder in the radial direction through the sheath during the recovery process, so that the radial size of the electrode holder becomes smaller and the axial size becomes larger, and the recovery of the electrode holder is smoother. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] In order to more clearly illustrate the implementation methods of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the implementation methods or the description of the prior art. Obviously, the drawings described below are only some implementation methods of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0012] Figure 1 A three-dimensional schematic diagram of a stoma system provided in a first embodiment of the present application;

[0013] Figure 2 for Figure 1 A schematic exploded perspective view of the stoma system shown;

[0014] Figure 3 is a three-dimensional schematic diagram of the electrode holder;

[0015] Figure 4 is a cross-sectional view of the sheath assembly;

[0016] Figure 5 A three-dimensional schematic diagram of a partial structure of an ostomy system;

[0017] Figure 6 For the Figure 5 A cross-sectional view taken along line AA shown in FIG.

[0018] Figure 7 For the Figure 5 A cross-sectional view taken along line BB shown in FIG;

[0019] Figure 8 It is a three-dimensional schematic diagram of the diameter adjustment rack;

[0020] Figure 9 It is a three-dimensional schematic diagram of the diameter adjustment gear set;

[0021] Figure 10 is a three-dimensional schematic diagram of the sheath connector;

[0022] Figure 11 is a three-dimensional schematic diagram of an active rack from one perspective;

[0023] Figure 12 is a three-dimensional schematic diagram of the active rack from another perspective;

[0024] Figure 13 It is a three-dimensional schematic diagram of the sheath tube connector and the active rack in the engaged connection state;

[0025] Figure 14 For the Figure 13 A cross-sectional view taken along line XX shown;

[0026] Figure 15 A three-dimensional schematic diagram of the main axis;

[0027] Figure 16 A cross-sectional view of a portion of the stoma system structure when the hook portion moves to the most proximal end of the accommodating cavity;

[0028] Figure 17 for Figure 16 Enlarged schematic diagram of area I in

[0029] Figure 18 A perspective schematic diagram of a push rod joint structure;

[0030] Figure 19 A three-dimensional schematic diagram of the push rod joint structure from another perspective;

[0031] Figure 20 This is a three-dimensional exploded schematic diagram of the main shaft and locking parts of the stoma system;

[0032] Figure 21-23 Schematic diagrams of three-dimensional decomposition of the stoma system provided in the second embodiment of the present application from different perspectives;

[0033] Figure 24 A perspective schematic diagram of a sheath tube connector structure provided in a second embodiment of the present application;

[0034] Figure 25 A schematic diagram of a portion of the structure of the stoma system when the active rack interval transmission structure is set;

[0035] Figure 26 for Figure 25 Sectional view along line CC;

[0036] Figure 27 This is a partial structural diagram of the stoma system when the active rack is engaged with the transmission structure. DETAILED DESCRIPTION

[0037] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments of this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0038] In the field of interventional medical devices, the direction closest to the operator is generally defined as proximal, and the direction away from the operator is defined as distal. The direction of the rotational axis of objects such as cylinders and tubes is defined as the axial direction, and the direction perpendicular to the axial direction is defined as the radial direction. These definitions are for convenience only and do not constitute limitations of this application.

[0039] First embodiment

[0040] See also Figure 1 and Figure 2 , Figure 1 This is a three-dimensional schematic diagram of the stoma system provided in the first embodiment of the present application. Figure 2 for Figure 1 The stoma system 100 is shown as an exploded perspective view. The stoma system 100 includes an electrode holder 10, a sheath assembly 20, and a handle 30. The electrode holder 10 is received at the distal end of the sheath assembly 20 and establishes a shunt channel in the stoma tissue through expansion and ablation.

[0041] See also Figure 3 , Figure 3 It is a three-dimensional schematic diagram of the electrode holder. The electrode holder 10 is released when it reaches the puncture position of the patient's stoma tissue, and an artificial "defect" is formed in the patient's stoma tissue through radiofrequency ablation. The electrode holder 10 includes a proximal portion 11, a waist 13 and a distal portion 15 fixedly connected in sequence. The proximal portion 11 is accommodated in the distal end of the sheath assembly 20. In this embodiment, the diameter of the waist 13 is the smallest, that is, the electrode holder 10 is thick at both ends and thin in the middle, forming a waist drum shape. The waist 13 is conductive and is used to establish a shunt channel in the stoma tissue through expansion and ablation. Since the electrode holder 10 is used to establish a shunt channel for the stoma tissue through expansion and ablation, the shunt channel will not close in a short time. It can be understood that the waist 13 is not limited to being conductive, and other areas of the electrode holder 10 can also be conductive, such as the distal portion 15.

[0042] See Figure 4 , Figure 4 2 is a cross-sectional view of the sheath assembly. The sheath assembly 20 includes a sheath 21, a pusher 23, a first inner sheath core 24, and a second inner sheath core 25. The pusher 23 is movably mounted in the sheath 21. The proximal portion 11 of the electrode holder 10 is fixed to the distal end of the pusher 23 and accommodated in the sheath 21. After the electrode holder 10 is released from the sheath assembly 20, the electrode holder 10 is located at the distal end of the sheath assembly 20 and extends out of the sheath 21 ( Figure 2 ). The proximal end of the sheath tube 21 and the proximal end of the pushing member 23 are both connected to the handle 30. The first inner sheath core 24 and the second inner sheath core 25 are installed in the pushing member 23. There is a gap between the outer wall of the pushing member 23 and the inner wall of the sheath tube 21, and the pushing member 23 and the sheath tube 21 can move relative to each other. In the present embodiment, the pushing member 23 is a multi-lumen tube, and the pushing member 23 includes a first lumen 231 and a second lumen 233 that are spaced apart. The first inner sheath core 24 and the second inner sheath core 25 are installed in the same first lumen 231, and the first inner sheath core 24 and the second inner sheath core 25 are hollow lumens. The second inner sheath core 25 is used to wear a guide wire (not shown in the figure), and the sheath tube assembly 20 is used to run along the guide wire in the blood vessel to the stoma.

[0043] The stoma system 100 also includes a cable 40, which is inserted into the second lumen 233. The distal end of the cable 40 is used to connect to the electrode holder 10. Specifically, the distal end of the cable 40 is connected to the proximal portion 11 of the electrode holder 10. The outer layers of the proximal portion 11 and the distal portion 15 are provided with an insulating coating, and the portion wrapped within the insulating coating of the proximal portion 11 and the distal portion 15 is electrically connected to the waist 13. The proximal end of the cable 40 is used to connect to a radio frequency power supply so that the electrode holder 10 can expand and ablate the tissue at the stoma. In this embodiment, there are two second lumens 233 and two cables 40. Each cable 40 is inserted into one second lumen 233. The two cables 40 are used to transmit bipolar radio frequency signals to the electrode holder 10. In a modified embodiment, the cable 40 is omitted in one of the second lumens 233, that is, the electrode holder 10 is electrically connected to one cable 40, thereby transmitting a unipolar radio frequency signal.

[0044] Multiple cavities are arranged at intervals in the pushing member 23 to reduce interference between structures (such as the cable 40, the guide wire, etc.) installed in the pushing member 23, which is beneficial to improving the accuracy of the ostomy surgery.

[0045] In a modified embodiment, the electrode holder 10 ablates the stoma tissue by one of heat, cold, light, electricity, gas, mechanical waves, electromagnetic waves, radioactive particles, chemical agents, or any combination thereof. Accordingly, the second cavity 233 in the pusher 23 for accommodating the cable 40 can also be used to accommodate a medium for transmitting the above-mentioned substances.

[0046] It is understandable that the pushing member 23 may also be a single-lumen tube, and the cable 40 , the inner sheath core, etc. may be installed in the pushing member 23 .

[0047] Please refer to Figure 2 、 Figure 5 and Figure 6 , handle 30( Figure 1 ) includes a main shaft 31, a diameter adjustment device 33, and a delivery device 35. The diameter adjustment device 33 is located proximal to the main shaft 31, compared to the delivery device 35, and is used to adjust the diameter of the electrode holder 10 after it is released from the sheath 21, thereby adapting to the needs of different patients. A guide groove 311 is defined along the main shaft 31 along its axial direction. The delivery device 35 is received in the guide groove 311 and is used to deliver the electrode holder 10 to the stoma tissue.

[0048] The diameter adjustment device 33 includes a diameter adjustment structure 331, a diameter adjustment wire 333, and a scale assembly 335. The proximal end of the diameter adjustment wire 333 is fixedly connected to the diameter adjustment structure 331, and the distal end of the diameter adjustment wire 333 is wound around the waist portion 13 of the electrode holder 10. When the diameter adjustment structure 331 controls the diameter adjustment wire 333 to adjust the waist portion 13, it can drive the scale assembly 335 to display the diameter of the waist portion 13 of the electrode holder 10 or diameter change information.

[0049] More specifically, the diameter adjustment structure 331 includes a diameter adjustment member 3311 and a diameter adjustment knob 3313. The diameter adjustment member 3311 is movably accommodated in the guide groove 311. The diameter adjustment knob 3313 is screwed to the diameter adjustment member 3311, and the diameter adjustment knob 3313 is used to drive the diameter adjustment member 3311 to move axially in the guide groove 311 when it is rotated. In this embodiment, the diameter adjustment knob 3313 is set near the proximal end of the main shaft 31. The diameter adjustment wire 333 includes a drawing wire 3331 and a diameter adjustment wire 3332 (such as Figure 3 The proximal end of the wire drawing 3331 is fixedly connected to the diameter adjusting member 3311. The wire drawing 3331 is passed through the conveying device 35 and the first inner sheath core 24 (as shown). Figure 4 shown).

[0050] The proximal end of the diameter adjusting wire 3332 is fixedly connected to the distal end of the drawing wire 3331, and the distal end of the diameter adjusting wire 3332 is wound around the waist 13 of the electrode holder 10 (eg Figure 3 As shown). In this embodiment, the wire drawing 3331 is a wire made of a relatively rigid material, such as a metal wire. In this way, the wire drawing 3331 will not bend or entangle when moving back and forth in the first inner sheath core 24, and is convenient for control; the diameter adjustment wire 3332 is a wire made of a relatively flexible material, such as a thinner high molecular polymer suture, which has higher flexibility and is convenient for winding and adjusting the diameter of the waist 13. It can be understood that the material of the wire drawing 3331 is not limited, and the material of the diameter adjustment wire 3332 is not limited. In a modified embodiment, the diameter adjustment wire 333 is made of a material, such as a metal wire or a suture, and the diameter of the diameter adjustment wire 333 gradually becomes thinner from the proximal end to the distal end.

[0051] The scale assembly 335 includes a stacked pointer plate 3351 and a scale plate 3353. The pointer plate 3351 is provided on the main shaft 31 and covers the opening of the guide groove 311. The pointer plate 3351 is connected to the diameter adjusting member 3311. The scale plate 3353 is connected to the cover 36 (such as Figure 2The cover 36 is fixed to the main shaft 311 (as shown). In other words, the cover 36 and the main shaft 311 are relatively stationary, and the cover 36 is used to carry the dial 3353. The dial 3353 can be carried by providing a groove on the cover 36. The pointer plate 3351 is located between the dial 3353 and the diameter adjusting member 3311. A pointer (not shown), such as a vertical line, is provided on the side of the pointer plate 3351 facing the dial 3353. In this embodiment, the dial 3353 is a transparent structure, and a scale (not shown) is provided on the dial 3353. When the diameter adjusting member 3311 moves in the guide groove 311, it drives the pointer plate 3351 to move synchronously, so that the pointer points to the corresponding scale on the dial 3353. It can be understood that the setting position and connection relationship of the scale component 335 on the main shaft 31 are not limited. For example, the pointer plate 3351 can also be accommodated in the guide groove 311, and the scale plate 3353 is directly fixed to the main shaft 31. The pointer plate 3351 can move along with the diameter adjusting member 3311 and indicate the scale corresponding to the scale plate 3353.

[0052] For more details, see Figure 7 and Figure 8 The diameter adjusting member 3311 includes a diameter adjusting joint 3321 and a diameter adjusting rack 3323. The diameter adjusting joint 3321 and the diameter adjusting knob 3313 ( Figure 2 ) is screwed. The diameter adjustment joint 3321 is fixedly connected to the proximal end of the diameter adjustment rack 3323. A plate rack (not shown) is provided on the pointer plate 3351. The diameter adjustment device 33 also includes a diameter adjustment gear set 337 rotatably received in the guide groove 311. The plate rack faces the diameter adjustment gear set 337 and meshes with the diameter adjustment gear set 337. Figure 9 The diameter-adjusting gear set 337 includes a first gear 3371 and a second gear 3373 arranged concentrically. The diameter of the first gear 3371 is smaller than the diameter of the second gear 3373. The first gear 3371 is engaged with the diameter-adjusting rack 3323, and the second gear 3373 is engaged with the plate rack, so that the smaller displacement changes of the diameter-adjusting line 333 along the axial direction are magnified and displayed on the dial 3353, which makes it convenient for the operator to obtain the diameter or diameter change information of the waist 13 of the electrode holder 10.

[0053] The stoma system 100 provided in this application can be used in stoma surgeries such as atrial septal tissue stoma, gastrointestinal stoma, and arteriovenous fistula. When the electrode holder 10 is pre-installed in the sheath tube 20 and not released, the diameter of the waist portion 13 of the electrode holder 10 is adjusted to the minimum to facilitate delivery and release. The waist portion 13 is used to be delivered to the puncture site of the stoma tissue. The proximal portion 11 and the distal portion 15 ( Figure 3 ) are respectively located at the openings on both sides of the puncture position, and a preset stoma diameter can be calculated according to the patient's condition. Subsequently, the diameter of the waist 13 is adjusted to be equal to or close to (for example, within an error range of 5%) the preset stoma diameter.

[0054] Specifically, first, the diameter of the waist 13 of the electrode holder 10 is increased, and the diameter adjusting knob 3313 is used to drive the diameter adjusting rack 3323 to move distally, thereby driving the drawing wire 3331 and the diameter adjusting wire 3332 to move distally, and the diameter adjusting wire 3332 wrapped around the waist 13 becomes loose, and the diameter of the waist 13 of the electrode holder 10 will increase, and the diameters of the proximal part 11 and the distal part 15 will also increase accordingly; accordingly, the diameter adjusting rack 3323 drives the pointer on the pointer plate 3351 to move relative to the dial 3353 through the diameter adjusting gear set 337 and indicate a larger size on the dial 3353.

[0055] When the waist 13 is adjusted too large, exceeding the preset stoma diameter, the diameter of the waist 13 of the electrode holder 10 needs to be reduced. Specifically, the diameter adjustment knob 3313 drives the diameter adjustment rack 3323 toward the proximal end, thereby driving the draw wire 3331 and the diameter adjustment wire 3332 toward the proximal end. The diameter adjustment wire 3332 wrapped around the waist 13 becomes tighter, and the diameter of the waist 13 of the electrode holder 10 decreases, and the diameters of the proximal portion 11 and the distal portion 15 also decrease accordingly. Correspondingly, the diameter adjustment rack 3323 drives the pointer on the pointer plate 3351 to move relative to the scale 3353, indicating a smaller size on the scale 3353.

[0056] The scale assembly 335 accurately indicates the diameter of the waist portion 13 of the electrode holder 10, thereby facilitating operator control of the desired shunt channel size. Specifically, the diameter adjustment range is 4.0-16.0 mm. It is understood that the diameter adjustment range is not limited to 4.0-16.0 mm, and the diameter adjustment wire 3332 wound around the waist portion 13 can be adjusted based on the patient's actual condition and the determined waist portion 13 size.

[0057] It can be understood that the structure of the diameter adjusting gear set 337 is not limited. The diameter adjusting gear set 337 is engaged with the diameter adjusting rack 3323, and the diameter adjusting gear set 337 is engaged with the pointer plate 3351. The diameter adjusting gear set 337 can drive the pointer plate 3351 to move.

[0058] It is understandable that the diameter adjustment gear set 337 can be omitted, and the diameter adjustment member 3311 can directly drive the pointer plate 3351 to move; the scale component 335 can be omitted, that is, the stoma system 100 does not have the function of displaying the diameter or diameter change information of the electrode bracket 10.

[0059] Please refer again Figure 2 、 Figure 5 and Figure 7The conveying device 35 includes a rotary cylinder 351, a sheath tube joint structure 353, a push rod joint structure 355 and a transmission structure 356. The rotary cylinder 351 is sleeved on the outside of the main shaft 31 and is used to drive the sheath tube joint structure 353, the push rod joint structure 355 and the transmission structure 356 to move. The sheath tube joint structure 353, the push rod joint structure 355 and the transmission structure 356 are all accommodated in the guide groove 311 of the main shaft 31. The sheath tube joint structure 353 is engaged with the inner surface of the rotary cylinder 351. The sheath tube joint structure 353 is fixedly connected to the proximal end of the sheath tube 21, and the push rod joint structure 355 is fixedly connected to the proximal end of the push member 23. The push rod joint structure 355 is connected to the sheath tube joint structure 353 through the transmission structure 356.

[0060] The sheath tube joint structure 353 drives the sheath tube 21 to move in the axial direction, and the transmission structure 356 drives the push rod joint structure 355 to push the pushing member 23 to move in the opposite direction of the movement of the sheath tube 21, that is, the movement direction of the pushing member 23 is opposite to that of the sheath tube 21, thereby releasing or retrieving the electrode bracket 10.

[0061] When the rotor 351 rotates relative to the main shaft 31 along the first direction, the sheath tube joint structure 353 drives the sheath tube 21 to move along the axial direction of the main shaft 31 from the distal end to the proximal end, and the transmission structure 356 can drive the push rod joint structure 355 to push the push member 23 to move along the axial direction of the main shaft 31 from the proximal end to the distal end, so as to release the electrode holder 10 accommodated in the sheath tube 21, that is, the electrode holder 10 is exposed at the distal end of the sheath tube 21.

[0062] When the rotor 351 rotates relative to the main shaft 31 along the second direction, the sheath tube joint structure 353 drives the sheath tube 21 to move from the proximal end to the distal end along the axial direction of the main shaft 31, and the transmission structure 356 can drive the push rod joint structure 355 to push the push member 23 to move from the distal end to the proximal end along the axial direction of the main shaft 31, so that the electrode bracket 10 retracts and is accommodated in the sheath tube 21.

[0063] By rotating the rotary cylinder 351, the sheath joint structure 353 and the push rod joint structure 355 can be driven to make opposite linear motions on the main shaft 312, that is, the conveying device 35 is a linkage device, which facilitates control and simplifies the conveying steps of the electrode holder 10, which is beneficial to improving the efficiency of ostomy surgery.

[0064] In this embodiment, the transmission structure 356 is a transmission gear set. The sheath tube joint structure 353 includes a sheath tube joint 3531 and an active rack 3532 arranged at intervals along the axial direction of the main shaft 31. In addition, please refer to Figure 7 As shown, in this embodiment, a push rod 27 is also provided in the sheath assembly 20. The push rod 27 passes through the first cavity 231 and is clamped between the push member 23 and the sheath 21. It is used to prevent the push member 23 from rubbing against the sheath connector 3531 in the main shaft, thereby increasing the mechanical and electrical performance protection of the inner sheath core.

[0065] See also Figure 10 The sheath connector 3531 includes a connector 3533 and a snap-fitting member 3534 protruding from the proximal end of the connector 3533. The bottom surface of the connector 3533 facing away from the guide groove 311 is provided with a first thread 3535. The inner surface of the rotating cylinder 351 is provided with a second thread 3511 (such as Figure 2 As shown, the first thread 3535 engages with the second thread 3511. Rotating the drum 351 drives the sheath connector 3531 axially within the guide groove 311. The engaging member 3534 includes a connected groove 3536 and a hook 3537. The hook 3537 is located proximal to the engaging member 3534, distal to the connector 3533. The groove 3536 is configured to engage with the active rack 3532.

[0066] The active rack 3532 is located between the sheath connector 3531 and the transmission structure 356. The active rack 3532 is engaged with the transmission structure 356. Figure 11 The active rack 3532 includes a main body 3541, a first elastic member 3542 and a second elastic member 3543. The main body 3541 is accommodated in the guide groove 311 of the main shaft 31. The proximal end of the main body 3541 is provided with a plurality of teeth that engage with the transmission structure 356. The distal end of the main body 3541 is provided with an accommodating groove 3545 (such as Figure 12 35, and is used to insert the engaging member 3534. The main body 3541 is provided with a through hole 3546 communicating with the accommodating groove 3545.

[0067] The first elastic member 3542 is disposed on a side of the main body 3541 that is away from the bottom surface of the guide groove 311. In this embodiment, the first elastic member 3542 extends in the axial direction.

[0068] The second elastic member 3543 is movably disposed between the first elastic member 3542 and the main body 3541. When the sheath connector 3531 moves from the distal end to the proximal end, it can engage with the active rack 3532. Figure 13 and Figure 14 , Figure 13 It is a three-dimensional schematic diagram of the sheath tube connector and the active rack in the engaged connection state; Figure 14 For the Figure 13 A cross-sectional view along line XX is shown.

[0069] The second elastic member 3543 is generally in an "n" shape. The second elastic member 3543 includes a connecting portion 3547 and a bent portion 3548 formed by bending and extending the end of the connecting portion 3547. The connecting portion 3547 extends into the accommodating groove 3545 ( Figure 12). The connecting portion 3547 is sandwiched between the first elastic member 3542 and the main body 3541. When the engaging member 3534 is inserted into the receiving groove 3545, the connecting portion 3547 is received in the groove 3536, thereby achieving an engaging connection between the active rack 3532 and the sheath connector 3531. When the engaging member 3534 is inserted into the receiving groove 3545, the hook 3537 lifts the connecting portion 3547 into the nearest end of the receiving groove 3545, where the connecting portion 3547 is received in the groove 3536.

[0070] The bent portion 3548 is received in the main body 3541 and partially exposed outside the main body 3541. Figure 15 As shown, the side wall of the guide groove 311 is provided with an inclined portion 313 extending in the axial direction (also see Figure 6 (As shown). From the distal end to the proximal end, the angle between the inclined portion 313 and the axis parallel to the main shaft 31 is acute. In other words, the proximal end of the inclined portion 313 moves closer to the axis parallel to the main shaft 31, while the distal end of the inclined portion 313 moves away from the axis parallel to the main shaft 31. The portion of the bent portion 3548 exposed from the main body 3541 is connected to the inclined portion 313.

[0071] When the sheath connector 3531 is separated from the active rack 3532, the bent portion 3548 is located at the distal end of the inclined portion 313. Driven by the rotary cylinder 351, the sheath connector 3531 moves from the distal end to the proximal end, that is, the sheath connector 3531 moves toward the active rack 3532, and the sheath connector 3531 is inserted into the receiving groove 3545 of the active rack 3532. The hook portion 3537 contacts the connecting portion 3547 of the second elastic member 3543 in the receiving groove 3545. As the sheath connector 3531 gradually moves toward the proximal end, the hook portion 3537 pushes up the connecting portion 3547 in the receiving groove 3545 (as shown in FIG. Figure 7 ), and inserted into the farthest end of the receiving groove 3545 through the connecting portion 3547 (ie, Figure 16 As shown), the sheath connector 3531 is engaged with the active rack 3532; the sheath connector 3531 drives the active rack 3232 to continue to move from the distal end to the proximal end, and the bending portion 3548 moves along the distal end of the inclined portion 313 to the proximal end, and the proximal end of the active rack 3232 can drive the transmission structure 356 to move.

[0072] When the sheath connector 3531 and the active rack 3532 are integrally connected, if the active rack 3532 moves from the proximal end to the distal end, the bent portion 3548 moves along the inclined portion 313. Since the bottom wall of the inclined portion 313 of the main shaft 31 is inclined, the second elastic member 3543 is lifted until the hook portion 3537 and the bottom of the connecting portion 3547 no longer overlap in the axial direction. The bottom of the connecting portion 3547 cannot block the hook portion 3537, thereby disengaging the hook portion 3537 of the engaging member 3534 from the receiving groove 3545, and the sheath connector 3531 is disengaged from the active rack 3532. The inclined portion 313 guides the movement of the bent portion 3548, thereby achieving automatic unlocking between the sheath connector 3531 and the active rack 3532, thereby improving the efficiency of the ostomy system 100. In this embodiment, the inclined portion 313 is a groove structure, and the end wall of the inclined portion 313 can abut against the bent portion 3548 , thereby limiting the movement displacement of the active rack 3532 .

[0073] Please also refer to Figure 16 、 Figure 18 and Figure 19 The push rod joint structure 355 includes a push rod joint 3551 and a driven rack 3553 fixedly connected to the distal end of the push rod joint 3551. The push rod joint 3551 is fixedly connected to the proximal end of the push member 23. The wire drawing 3331 is provided through the sheath tube joint 3531 and the push rod joint 3551. The driven rack 3553 is engaged with the transmission structure 356.

[0074] Please also refer to Figure 16 and Figure 20 The conveying device 35 also includes a locking member 357. A receiving hole 315 is provided through the bottom of the guide groove 311, and the receiving hole 315 includes a first receiving hole 3151 and a second receiving hole 3153 spaced apart at the bottom of the guide groove 311. The locking member 357 includes a connecting portion 3571, a supporting portion 3573 and a locking portion 3575 connected in sequence. The distal end of the connecting portion 3571 is pivotally connected to the distal end of the first receiving hole 3151. The connecting portion 3571 and the supporting portion 3573 can be received in the first receiving hole 3151. The supporting portion 3573 is a boss formed by bending and extending the proximal end of the connecting portion 3571 toward the side where the main shaft 31 is located. The proximal end of the locking portion 3575 can be received in the second receiving hole 3153. A first locking tooth 3576 is provided on the proximal end of the locking portion 3575 facing the main shaft 31, and a second locking tooth 3554 is provided on the side of the push rod connector 3551 facing the main shaft 31 for engaging with the first locking tooth 3576. It will be understood that the abutting portion 3573 is not limited to a boss and can also be other structures capable of abutting against the sheath connector 3531.

[0075] When the first locking tooth 3576 is received in the second receiving hole 3153 and meshes with the second locking tooth 3554 , the push rod joint structure 355 is positioned by the locking member 357 and cannot move. That is, the locking member 357 is in a locked position.

[0076] When the first locking tooth 3576 is not engaged with the second locking tooth 3554 , that is, the first locking tooth 3576 is disengaged from the second locking tooth 3554 , the push rod joint structure 355 is not positioned by the locking member 357 , and the push rod joint structure 355 can move axially driven by the transmission gear set 357 .

[0077] In this embodiment, the active rack 3532 is always engaged with the transmission joint 356, and the driven rack 3553 is always engaged with the transmission joint 356. When the active rack 3532 is not engaged with the sheath joint 3531, the sheath joint 3531 is separated from the active rack 3532, the active rack 3532 does not move synchronously with the sheath joint 3531, and the locking member 357 is in the locked position. As the sheath joint 3531 is driven by the rotary cylinder 351 from the distal end to the proximal end within the guide groove 311, when the maximum diameter of the proximal portion 11 of the electrode holder 10 is released from the sheath 21, the sheath joint 3531 pushes the abutment 3573, causing the locking portion 3575 (proximal end) of the locking member 357 to rotate away from the main shaft 31 and disengage from the push rod joint structure 355 before the active rack 3532 drives the transmission gear train to rotate, thereby unlocking the push rod joint structure 355.

[0078] When the rotary cylinder 351 drives the sheath tube joint 3531 to move from the proximal end to the distal end in the guide groove 311, the sheath tube joint 3531 continues to push the abutting portion 3573, and before the proximal portion 11 of the electrode holder 10 is recovered or withdrawn into the sheath tube 21 at the point of maximum diameter, the active rack 3532 is disengaged from the transmission structure 356, and the sheath tube joint 3531 moves away from the abutting portion 3573, and the locking member 357 is engaged with the push rod joint structure 355, thereby realizing the positioning of the push rod joint structure 355.

[0079] The conveying device 35 further includes an elastic member 358, one end of which is fixed to the side of the locking portion 3575 away from the main shaft 31 by welding. The handle 30 further includes a housing 37 (such as Figure 2 As shown) and handle 38 (as Figure 2(as shown). The housing 37 is sleeved over the proximal end of the spindle 31. The elastic member 358 is located between the locking portion 3575 and the inner wall of the housing 37. It is used to reset the locking member 357 when the sheath connector 3531 is away from (not in contact with) the abutment portion 3573, pushing the locking portion 3575 toward the spindle 31, locking the proximal end of the locking member 357 with the push rod connector structure 355. Specifically, the first locking tooth 3576 engages the second locking tooth 3554. The handle 38 is sleeved over the distal end of the spindle 31, with the rotary cylinder 351 located between the handle 38 and the housing 37. The housing 37, handle 38, and rotary cylinder 351 together form the outer shell of the handle 30.

[0080] The following briefly describes the stoma system 100 as an example of establishing a shunt channel in the atrial septum of the heart. The stoma is located in the atrial septum between the left atrium and the right atrium of the heart, that is, the stoma system 100 is used to establish a shunt channel in the atrial septum of the heart.

[0081] First, the atrial septum is punctured using the puncture mechanism. After puncture, a guidewire is passed into the left superior pulmonary vein, and the puncture kit is removed. The dilator and sheath assembly 20 are pushed along the guidewire of the second inner sheath core 25 into the left atrium, and the guidewire and dilator are removed. The electrode holder 10 is pushed along the guidewire through the lumen of the second inner sheath core 25 into the left atrium.

[0082] Assume that the stoma system 100 is in its initial state when the electrode holder 10 is not released: at the distal end of the stoma system 100, the opening of the pusher 23 is retracted within the opening of the sheath 21. The diameter of the waist 13 is contracted to a smaller range by the diameter-adjusting wire 3332, and the waist 13 is fixed to the distal end of the pusher 23 by the diameter-adjusting wire 3332, preventing the electrode holder 10 from moving forward or backward in the axial direction. The electrode holder 10 is stretched axially, resulting in radial compression, completely contained within the opening of the sheath 21. The distal portion 15 of the electrode holder 10 does not extend from the distal end of the sheath 21. The sheath connector 3531 is spaced apart from the active rack 3532 and does not contact it. The connecting portion 3536 of the second elastic member 3543 is contained within the accommodating cavity 3545, in its initial position. The active rack 3532 is engaged with the transmission structure 356, and the driven rack 3553 is engaged with the transmission structure 356. The sheath connector 3531 is away from the abutting portion 3573 of the locking member 357. The elastic member 358 abuts against the inner wall of the housing 37, and the locking member 357 is located in the locked position, that is, the first locking tooth 3576 engages with the second locking tooth 3554.

[0083] The process of releasing the electrode holder 10 includes:

[0084] The first period: the distal portion 15 of the electrode holder 10 is released in the left atrium, the waist portion 13 is released at the site of atrial septal perforation, and a portion of the proximal portion 11 is released in the right atrium, especially the portion with the largest diameter of the proximal portion 11.

[0085] Specifically, hold the handle 38 and rotate the rotary cylinder 351 in a first direction (for example, clockwise when viewed from the proximal end to the distal end of the stoma system 100). The rotary cylinder 351 drives the sheath tube connector 3531 to move axially toward the proximal end. The sheath tube connector 3531 drives the sheath tube 21 to move proximally. The sheath tube connector 3531 gradually approaches the active rack 3532, and the electrode holder 10 is gradually released from the sheath tube 21.

[0086] After the maximum diameter of the proximal portion 11 of the electrode holder 10 is released from the sheath 21, the hook portion 3537 contacts the connecting portion 3547 of the second elastic member 3543 in the receiving groove 3545, and as the sheath connector 3531 gradually moves toward the proximal end, the hook portion 3537 pushes up the connecting portion 3547 in the receiving groove 3545 (as shown in FIG. Figure 7 ), and is inserted through the connecting portion 3547 to the farthest end of the receiving groove 3545 (as shown Figure 14 and Figure 16 As shown), at this time, the groove 3536 is opposite to the connecting portion 3547, and the connecting portion 3547 falls to the initial position; at the same time, or before this moment, the bottom of the sheath tube connector 3531 abuts the abutting portion 3573 of the locking member 357, and pushes the abutting portion 3573 to drive the locking portion 3575 of the locking member 357 (the proximal end of the locking member 357) to rotate in the direction away from the main shaft 31, so that the abutting member 357 is changed from the locked position to the unlocked position, so that the push rod connector 3551 can drive the push member 23 to slide axially in the guide groove 311 of the main shaft 31.

[0087] Second period: further releasing the proximal portion 11 in the right atrium until the electrode holder 10 is completely released.

[0088] Specifically, such as Figure 2As shown, the rotary cylinder 351 continues to rotate in the first direction, the sheath connector 3531 drives the active rack 3532 to move axially toward the proximal end, and the sheath 21 moves proximally; multiple teeth at the proximal end of the active rack 3532 engage with the transmission structure 356 and drive the transmission structure 356 to rotate, and the driven rack 3553 engaged with the transmission structure 356 moves distally under the drive of the transmission structure 356, and the push rod connector 3551 drives the push member 23 to move distally until the distal end of the push member 23 extends from the sheath 21, and the electrode holder 10 is completely released from the sheath 21. After complete release, since the inner wall of the sheath 21 no longer compresses the electrode holder 10, the diameter of the proximal part 11 of the electrode holder 10 is expanded relative to that before complete release, making it easier to fit the atrial anatomical structure. In the second period, the sheath 21 moves proximally and the pushing piece 23 moves distally, that is, the sheath 21 and the pushing piece 23 are linked. During the release of the electrode holder 10, since the sheath 21 and the pushing piece 23 are linked, that is, the sheath 21 moves proximally and the pushing piece 23 moves distally, when the waist 13 is fixed, it is beneficial to further expand the diameter of the proximal part 11 and better fit the diaphragm between the left and right atria. The waist 13 is tightened by the diameter adjusting wire 3332 so as to be accurately fixed at the puncture position, thereby accurately locating the position where ablation is required later.

[0089] Diameter adjustment process: After the second period, the appropriate size of the burn can be selected according to the patient's specific situation, and the diameter of the waist 13 of the electrode holder 10 can be adjusted to establish a suitable atrial septal shunt channel.

[0090] Pulse ablation process: After confirming that the stoma tissue is completely adhered to the electrode holder 10, connect the proximal end of the cable 40 to the RF power supply (ablation power supply, not shown), set the heating parameters (e.g., power 20-80W, duration 10-50s), and start heating. After heating stops, the electrode holder 10 can be retracted into the sheath 21 and removed from the body. The stoma diameter can then be measured to ensure it has reached the desired diameter.

[0091] The process of recycling the electrode holder 10 includes:

[0092] During the third phase, the rotor 351 is rotated in the second direction (e.g., counterclockwise when viewed from the proximal end of the stoma system 100). The rotor 351 drives the sheath connector 3531 to move axially toward the distal end, which in turn drives the sheath 21 to move distally. The sheath 21 gradually receives the proximal end of the electrode holder 10. Simultaneously, the hook 3537 of the active rack 3532 pulls the bottom of the main body 3541, driving the active rack 3532 distally. The active rack 3532, through the transmission structure 356, drives the driven rack 3553, the push rod connector 3551, and the push member 23 proximally.

[0093] In the third period, the maximum diameter of the proximal part 11 of the electrode holder 10 is located outside the sheath 21, and a part of the proximal part 11 is accommodated in the sheath 21. Under the action of the push rod joint 3551 pulling toward the proximal end, the radial dimension of the electrode holder 10 is compressed by the inner wall of the sheath 21, and the axial length becomes longer, which is conducive to further recovery of the electrode holder 10 into the sheath 21. Since the radial dimension of the electrode holder 10 can be compressed during the recovery process, the recovery of the electrode holder 10 is relatively smooth. Therefore, the diameter of the proximal part 11 of the electrode holder 10 can be designed to be larger to better fit the diaphragm between the left and right atria, thereby improving the accuracy of locating the ablation site.

[0094] The sheath connector 3531 drives the sheath 21 distally, while the proximal end of the active rack 3532 is restrained in a direction perpendicular to the axial direction by the hook 3537 (preventing it from lifting). The connecting portion 3547 is located on the top surface of the main body 3541, facing away from the bottom of the guide groove 311. The two bent portions 3548 are connected to one end of the main body 3541 and extend to opposite sides of the main body 3541, exposing the bent portions 3548 to the main body 3541. The bottom wall of the inclined portion 313 of the main shaft 31 is inclined and abuts the bottom of the bent portions 3548. As the active rack 3532 moves distally along the inclined portion 313, before the maximum diameter of the proximal portion 11 retracts into the sheath 21, the second elastic member 3543 is lifted until the hook portion 3537 and the bottom of the connecting portion 3547 no longer overlap axially. The bottom of the connecting portion 3547 is unable to block the hook portion 3537, causing the hook portion 3537 to disengage from the receiving groove 3545, and the sheath connector 3531 is separated from the active rack 3532. At this point, or after this point, the sheath connector 3531 and the abutting portion 3573 of the locking member 357 disengage from each other and slide distally. The elastic member 358 abuts the inner wall of the housing 37, causing the proximal end of the locking member 357 to contact the spindle 31, and the locking member 357 transitions from the unlocked position to the locked position.

[0095] During the third period, the sheath connector 3531 drives the sheath 21 distally, and the pusher 23 proximally, effectively interlocking the sheath 21 and pusher 23. At the end of the third period, the maximum diameter of the proximal portion 11 of the electrode holder 10 lies outside the sheath 21. Furthermore, during the first period, as the connecting portion 3547 of the second elastic member 3543 is lifted by the hook portion 3537, the bent portion 3548 is also lifted by the inclined portion 313.

[0096] Fourth period: The rotary drum 351 continues to rotate in the second direction, driving the sheath tube connector 3531 to move axially distally. The sheath tube connector 3531 drives the sheath tube 21 to move distally. The active rack 3532 and the pusher 23 remain stationary relative to the main shaft 31. The sheath tube 21 retracts the remaining portion of the electrode holder 10 into it.

[0097] In the fourth period, after the proximal part 11 is completely withdrawn into the sheath 21 and before the distal part is recovered into the sheath 21, that is, when the waist 13 is at the distal opening position of the sheath 21, the diameter adjusting wire 3332 around the waist 13 is tightened, so as to avoid the operator rotating the parts on the handle 30 to recover the electrode holder 10 after tightening the waist 13, causing the electrode holder 10 to move back and forth between the left and right atria and damage the heart tissue.

[0098] It can be understood that the stoma system 100 can also be used in stoma surgeries such as gastrointestinal stoma and arteriovenous fistula.

[0099] Second embodiment

[0100] See also Figure 21-23 , Figure 21 This is a perspective exploded diagram of the stoma system 200 provided in the second embodiment of the present application. The structure of the stoma system 200 provided in the second embodiment of the present application is roughly similar to that of the stoma system 100 provided in the first embodiment. The difference is that please refer to Figure 24 As shown, the sheath tube connector structure 653 includes a fixedly connected sheath tube connector 6531 and an active rack 6532, and the active rack 6532 is arranged at intervals of the transmission structure 656 (as shown in FIG. Figure 25 and Figure 26 In the initial state where the electrode holder 201 does not need to be released, the active rack 6532 is spaced apart from the transmission structure 656, the connecting portion 6571 of the locking member 657 is pivotally connected to the main shaft 611, and the locking portion 6575 of the locking member 657 is locked together with the bottom of the push rod joint structure 655.

[0101] The sheath tube connector 6531 is always connected to the active rack 6532. Before the active rack 6532 drives the transmission structure 356 to rotate, the locking member 657 needs to be disengaged from the push rod connector structure 655 to prevent the push rod connector structure 655 from being stuck.

[0102] It is understood that the sheath connector 6531 and the active rack 6532 are not limited to being fixedly connected, as long as the sheath connector 6531 and the active rack 6532 can move synchronously. The sheath connector structure 353 omits the engaging member, the first elastic member, the second elastic member, the accommodating groove, etc.

[0103] The main differences between the process of releasing and recovering the electrode holder 201 and the first embodiment include:

[0104] The first period: the sheath tube joint structure 653 slides toward the proximal end as a whole, and the active rack 6532 does not contact the transmission structure 656 when it is at the distal end (eg Figure 25 and Figure 26As shown), when the sheath tube joint structure 653 moves from the distal end to the proximal end, until the active rack 6532 engages with the transmission structure 656 (as shown), Figure 27 As shown), at the same time or before this moment, the bottom of the sheath joint structure 653 abuts the abutting portion 6573 of the locking member 657, and pushes the abutting portion 6573 to drive the proximal end of the locking member 657 to rotate in the direction away from the main shaft 611, and the locking member 657 is changed from the locked position to the unlocked position, so that the push rod joint structure 655 can drive the pushing member 623 to slide axially in the main shaft 611.

[0105] Second period: the sheath joint structure 653 slides toward the proximal end as a whole.

[0106] The third period: the sheath joint structure 653 slides as a whole toward the distal end until the active rack 6532 is disengaged from the transmission structure 656 and the locking member 657 is converted to a locked state.

[0107] The fourth period: the rotary cylinder 651 drives the sheath tube joint structure 653 to move axially distally as a whole.

[0108] In the stoma system 200 provided in the second embodiment, the sheath connector 6531 and the active rack 6532 of the sheath connector structure 653 are integral components, which reduces the number of components of the stoma system 200 and simplifies the structure of the stoma system 200 .

[0109] It should be noted that, without violating the technical principles of the present invention, the specific technical solutions in the above embodiments can be applied to each other.

[0110] The above disclosure is only a preferred embodiment of the present application, and certainly cannot be used to limit the scope of rights of the present application. Therefore, equivalent changes made according to the claims of the present application are still within the scope covered by the present application.

Claims

1. A stoma system, characterized in that: The invention comprises a handle, a sheath assembly and an electrode holder, wherein the sheath assembly comprises a sheath and a pushing piece movably mounted on the sheath, the electrode holder is fixed to the distal end of the pushing piece and accommodated in the sheath, and the electrode holder establishes a shunt channel in the tissue at the stoma through expansion and ablation, the handle comprises a conveying device, and the conveying device comprises a sheath joint structure, a push rod joint structure and a transmission structure, the sheath joint structure is fixedly connected to the proximal end of the sheath, the push rod joint structure is fixedly connected to the proximal end of the pushing piece, and the push rod joint structure is connected to the sheath joint structure through the transmission 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 pushing piece to move in the direction opposite to the movement direction of the sheath, thereby releasing or retrieving the electrode holder; The transmission structure includes a transmission gear set, and the sheath joint structure includes a sheath joint and an active rack, and is configured so that the sheath joint and the active rack can switch between a spaced-apart state and a locked-together state, and the active 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 meshed with the push rod joint structure; The process of the delivery device for releasing the electrode holder includes two periods. In the first period, the sheath tube connector drives the sheath tube to move toward the proximal end, the sheath tube connector gradually approaches the active rack, and part of the electrode bracket is gradually released from the sheath tube. In the second period, the sheath tube connector and the active rack are engaged with each other, the sheath tube and the pushing member are linked, the sheath tube moves toward the proximal end, and the pushing member moves toward the distal end, so as to completely release the electrode holder.

2. The stoma system according to claim 1, wherein The handle comprises a main shaft, and a guide groove is provided on the main shaft along the axial direction. The sheath joint structure, the push rod joint structure and the transmission structure are all accommodated in the guide groove of the main shaft.

3. The stoma system according to claim 2, wherein When the sheath tube joint structure drives the sheath tube to move axially from the distal end to the proximal end along the main shaft, the transmission structure can drive the push rod joint structure to push the pushing member to move axially from the proximal end to the distal end along the main shaft, so as to release the electrode bracket accommodated in the sheath tube; When the sheath tube joint structure drives the sheath tube to move axially 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 to move axially from the distal end to the proximal end along the main shaft to recycle the electrode bracket into the sheath tube.

4. The stoma system according to claim 3, wherein The conveying device also includes a rotary cylinder, which is sleeved outside the main shaft. The sheath tube joint structure is engaged with the inner surface of the rotary cylinder. When the rotary cylinder rotates, it can drive the sheath tube joint structure to move along the axial direction of the main shaft.

5. The stoma system according to claim 4, wherein The sheath tube joint is engaged with the inner surface of the rotary cylinder. Under the drive of the rotary cylinder, the sheath tube joint can drive the active rack and the transmission gear set to move, so that the push rod joint structure moves axially along the main shaft.

6. The stoma system according to claim 5, wherein The sheath tube joint is spaced apart from the active rack, and the sheath tube joint includes a joint part and a clamping part protruding from the proximal end of the joint part. The joint part is engaged with the inner surface of the rotary cylinder. The rotation of the rotary cylinder can drive the sheath tube joint to move along the axial direction of the main shaft from the distal end to the proximal end. The clamping part moves toward the active rack and finally engages with the active rack, thereby driving the active rack to move in the same direction as the joint part.

7. The stoma system according to claim 6, wherein The active rack includes a main body, a first elastic member and a second elastic member. The main body is accommodated in the guide groove of the main shaft. The distal end of the main body is provided with an accommodating groove along the axial direction. The first elastic member is provided on the main body. The second elastic member is movably clamped between the first elastic member and the main body. The main body is provided with a through hole connected to the accommodating groove. The second elastic member extends into the accommodating groove through the through hole. The engaging member can be inserted into the accommodating groove and engaged with the second elastic member under the drive of the rotating cylinder.

8. The stoma system according to claim 7, wherein The second elastic member includes a connecting portion and a bent portion formed by bending and extending the end portion of the connecting portion, the connecting portion extends into the accommodating groove through the through hole, the connecting portion is clamped between the first elastic member and the main body, and the engaging member includes a groove, the groove is used to accommodate the connecting portion so as to engage with the second elastic member.

9. The stoma system according to claim 8, wherein An inclined portion is provided on the side wall of the guide groove. From the distal end to the proximal end, the angle between the inclined portion and the axial parallel direction of the main shaft is an acute angle. The bent portion is partially connected to the inclined portion. When the rotary cylinder drives the sheath tube joint to move from the proximal end to the distal end, the bent portion moves along the inclined portion, driving the connecting portion to disengage from the groove, the engaging member disengages from the accommodating groove, and the sheath tube joint disengages from the active rack.

10. The stoma system according to claim 5, wherein The sheath tube joint is fixedly connected to the active rack, the sheath tube joint is engaged with the inner surface of the rotary cylinder, the active rack is located between the sheath tube joint and the transmission gear set, and the proximal end of the active rack is spaced apart from the transmission gear set.

11. The stoma system according to claim 5, wherein The push rod joint structure includes a push rod joint and a driven rack fixedly connected to the distal end of the push rod joint. The push rod joint is fixedly connected to the proximal end of the pushing member, and the driven rack is meshed with the transmission gear set.

12. The stoma system according to claim 6 or 10, wherein The conveying device also includes a locking member, a receiving hole is provided at the bottom of the guide groove, and the locking member is received in the receiving hole. The distal end of the locking member is connected to the main shaft, and the proximal end of the locking member is used to lock together with the push rod joint structure. The locking member is provided with a supporting portion on the side facing the main shaft, and the sheath tube joint is also used to push the supporting portion to rotate the proximal end of the locking member in a direction away from the main shaft and disengage from the push rod joint structure before the active rack pushes the transmission gear set to rotate.

13. The stoma system according to claim 12, wherein A first locking tooth is provided on a proximal end of the locking member facing the main shaft, and a second locking tooth is provided on the push rod joint structure to engage with the first locking tooth.

14. The stoma system according to claim 12, wherein It also includes a shell, which is sleeved on the outside of the main shaft. The conveying device also includes an elastic member, which is connected between the proximal end of the locking member and the inner wall of the shell. When the sheath tube connector does not contact the abutting portion, the elastic member pushes the proximal end of the locking member to rotate in the direction adjacent to the main shaft, so that the proximal end of the locking member is locked together with the push rod connector structure.

15. The stoma system according to claim 5, wherein The electrode holder includes a proximal portion, a waist portion and a distal portion that are fixedly connected in sequence, the proximal portion is fixed to the distal end of the pushing member, and during the movement of the sheath tube joint from the distal end to the proximal end along the main shaft driven by the rotary cylinder, after the sheath tube is exposed at the maximum diameter of the proximal portion, the push rod joint structure is driven from the proximal end to the distal end by the active rack; during the movement of the sheath tube joint from the proximal end to the distal end along the main shaft driven by the rotary cylinder, before the sheath tube is withdrawn into the sheath tube at the maximum diameter of the proximal portion, the push rod joint structure is driven from the distal end to the proximal end by the active rack.

16. The stoma system according to claim 1, wherein The stoma system further includes a cable, which is passed through the pushing member. The proximal end of the cable is used to be electrically connected to a radio frequency power source, and the distal end of the cable is electrically connected to the electrode holder.

17. The stoma system according to claim 16, wherein The pushing member is a multi-lumen tube, and the pushing member includes a second lumen, and the cable is installed in the second lumen.

18. The stoma system according to claim 17, wherein The pushing member includes a first lumen spaced apart from the second lumen, and the sheath tube assembly further includes a second inner sheath core, which is inserted into the first lumen and used for inserting a guide wire.

Images