WO2021136261A1 - Ostomy system - Google Patents

Abstract

An ostomy system (100, 200), including a handle (30), a sheath assembly (20), and a stentrode (10, 201); the stentrode (10, 201) is accommodated on the distal end of the sheath assembly (20); the stentrode (10, 201), by means of expansion and ablation, creates a diversion channel in the tissue at the location of ostomy; the handle (30) comprises a delivery device (35) and a diameter-adjusting device (33); the diameter-adjusting device (33) comprises a diameter-adjusting structure (331) and a diameter-adjusting wire (333); the diameter-adjusting structure (331) is fixed to the proximal end of the diameter-adjusting wire (333); the diameter-adjusting wire (333) is movably mounted to the delivery device (35) and the sheath assembly (20); the distal end of the diameter-adjusting wire (333) is wound around the stentrode (10, 201); the diameter-adjusting structure (331) is used for driving the diameter-adjusting wire (333) to move in the axial direction to adjust the diameter of the stentrode (10, 201) released from the sheath assembly (20). The diameter-adjusting structure (331) controls and adjusts the axial displacement of the diameter-adjusting wire (333) wound around the stentrode (10, 201) in order to adjust the diameter of the stentrode (10, 201) released from the sheath assembly (20), so that the size of the diversion channel may be adjusted according to different patient needs, which is beneficial to improving the efficiency of ostomy surgery.

Description

Stoma system

This application claims the priority of a Chinese patent application filed with the State Intellectual Property Office of China with application numbers 201911418636.7 and 201922501280.5, and the title of the invention "ostomy system" on December 31, 2019, the entire contents of which are incorporated in this application by reference .

Technical field

This application relates to the technical field of medical devices, in particular to a stoma system.

Background technique

Heart failure (abbreviated as heart failure) is a group of complex clinical syndromes in which the ventricular filling or ejection ability is impaired due to any abnormality in the structure or function of the heart. The main clinical manifestations are dyspnea and fatigue (restricted activity tolerance), and Fluid retention (pulmonary congestion and peripheral edema). Heart failure is the severe and terminal stage of various heart diseases, with a high incidence, and is one of the most important cardiovascular diseases today. According to the location of heart failure, it can be divided into left heart, right heart and total heart failure.

Heart failure is a serious disease with a high incidence and fatality rate. The incidence of heart failure in my country is 2-3%, which is above 12 million. The main causes of heart failure are hypertension, coronary heart disease, myocardial infarction, heart valve disease, atrial fibrillation, cardiomyopathy, etc. Cardiovascular disease causes damage to the left ventricle, leading to pathological remodeling of the left ventricle, resulting in hypofunction of the heart. Every time a patient with a myocardial infarction is successfully treated, a potential heart failure patient is brought.

In terms of treatment, after optimizing the drug treatment, the patient's symptoms are still recurrent, and the current drug treatment is almost only effective for patients with reduced ejection fraction, and the effect is not ideal for patients with preserved ejection fraction. Cardiac resynchronization therapy is not suitable for all patients with heart failure, and more than 20% of patients are ineffective for cardiac resynchronization pacing. Left ventricular assist device surgery requires extracorporeal circulation and has a high incidence of major traumatic complications, is expensive and difficult to obtain, and has not been listed in China. Heart transplantation is the ultimate solution, but the source of donors is very limited and expensive.

On the other hand, pulmonary hypertension is a group of diseases characterized by a progressive increase in the circulatory resistance of the pulmonary system. Its pathological changes include pulmonary vasoconstriction and remodeling, abnormal proliferation of pulmonary vascular smooth muscle and endothelial cells, and in situ thrombosis. Lead to right heart failure and death. At present, with the deeper and deeper research on the pathogenesis of pulmonary hypertension, there are more and more treatment methods. The treatment plan for pulmonary hypertension should be individualized and systematized. It is by no means a single drug that can be treated. The treatment methods include: general therapy, non-specific drug therapy, targeted drug therapy, NO inhalation therapy, gene therapy, intervention Treatment with surgery. Patients with pulmonary hypertension in the later stage of the disease, after the above-mentioned comprehensive treatment, the effect is often not obvious, the survival rate is low, and the prognosis is extremely poor. At this time, surgical treatments such as atrial septal fistula, lung transplantation, and combined heart-lung transplantation can be tried to save the patient’s life. However, this type of treatment has many factors such as high surgical risk, lack of donors, transplant rejection, and high follow-up treatment costs.

Atrial septal ostomy is a stoma in the patient's atrial septum to form a shunt between the left and right heart chambers. It can be used to treat pulmonary hypertension (right-to-left shunt) or left heart failure (left-to-right shunt), and it has been clinically proven Effectiveness.

Traditional atrial septostomy methods, such as balloon atrial septostomy, have a tendency for myocardial tissue to rebound after the stoma, and the stoma will shrink or even close completely after a period of time. In order to solve the problem of narrowing or even closing the stoma, the prior art provides a stoma stent, and can respectively publish an implant for atrial shunt. The feature is that after percutaneous atrial septal puncture, the The skin delivery implant is implanted with a shunt device at the atrial septal puncture to keep the shunt opening unobstructed. However, the aperture of the implant shunt device is usually fixed and cannot meet the needs of different patients.

Summary of the invention

In order to solve the aforementioned problems, the present application provides a stoma system capable of adjusting the size of the shunt channel.

A stoma system includes a handle, a sheath tube assembly, and an electrode stent. The electrode stent is housed at the distal end of the sheath tube assembly. The electrode stent establishes a shunt channel in the stoma tissue through expansion and ablation. The handle includes a delivery device and a diameter adjustment device, the delivery device is connected to the proximal end of the sheath assembly for controlling the delivery of the electrode stent, and the diameter adjustment device includes a diameter adjustment structure and a diameter adjustment wire. The diameter adjustment structure is arranged at the proximal end of the handle relative to the delivery device, and is fixed to the proximal end of the diameter adjustment wire, and the adjustment wire is movably threaded through the delivery device and the sheath assembly, The distal end of the adjusting wire is wound on the electrode holder, and the adjusting structure is used to drive the adjusting wire to move in the axial direction to adjust the electrode holder after being released from the sheath assembly. diameter.

In this application, an electrode stent is used to establish a shunt channel in the tissue at the stoma through expansion and ablation, so that a shunt channel that is not easy to close can be obtained. In addition, the diameter adjustment structure controls and adjusts the axial displacement of the diameter adjustment wire wound on the electrode holder to adjust the diameter of the electrode holder after being released from the sheath assembly, so as to realize the adjustment of the shunt channel size according to the needs of different patients. It is helpful to improve the efficiency and success rate of ostomy surgery.

Description of the drawings

In order to more clearly describe the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only These are some implementations of the present application. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative work.

Fig. 1 is a three-dimensional schematic diagram of the stoma system provided by the first embodiment of the application;

Figure 2 is a three-dimensional exploded schematic view of the stoma system shown in Figure 1;

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

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

Figure 5 is a perspective schematic view of a part of the structure of the stoma system;

Figure 6 is a cross-sectional view along the line A-A shown in Figure 5;

Figure 7 is a cross-sectional view along the line B-B shown in Figure 5;

Figure 8 is a three-dimensional schematic diagram of the adjustable rack;

Figure 9 is a three-dimensional schematic diagram of the adjusting gear set;

Figure 10 is a three-dimensional schematic diagram of a sheath tube joint;

Figure 11 is a perspective schematic view of the active rack;

Figure 12 is a three-dimensional schematic view of the active rack from another perspective;

Figure 13 is a three-dimensional schematic diagram of the sheath tube joint and the active rack in a snapped connection state;

Figure 14 is a cross-sectional view taken along the line X-X shown in Figure 13;

Figure 15 is a three-dimensional schematic diagram of the main shaft;

Figure 16 is a cross-sectional view of part of the structure of the stoma system when the hook is moved to the nearest end of the accommodating cavity;

FIG. 17 is an enlarged schematic diagram of area I in FIG. 16;

Fig. 18 is a perspective schematic view of the structure of the push rod joint;

Fig. 19 is another perspective schematic view of the structure of the push rod joint;

Figure 20 is a three-dimensional exploded schematic view of the main shaft and the locking member of the stoma system;

Figures 21-23 are three-dimensional exploded schematic diagrams of the stoma system provided by the second embodiment of this application from different perspectives;

FIG. 24 is a three-dimensional schematic diagram of the sheath joint structure provided by the second embodiment of the application; FIG.

Figure 25 is a partial structural diagram of the ostomy system when the active rack spacing transmission structure is set;

Figure 26 is a cross-sectional view along line C-C in Figure 25;

Figure 27 is a partial structural diagram of the stoma system when the active rack engages the transmission structure.

Detailed ways

The technical solutions in the embodiments of the present application will be described clearly and completely in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all of them. Based on the implementation manners in this application, all other implementation manners obtained by those of ordinary skill in the art without creative work shall fall within the protection scope of this application.

In the field of interventional medical device technology, generally the position close to the operator is defined as the proximal end, and the position far away from the operator is defined as the distal end; the direction of the central axis of rotation of objects such as cylinders and tubes is defined as the axial direction. The direction perpendicular to the axial direction is defined as the radial direction. These definitions are only for the convenience of presentation and do not constitute a restriction on this application.

The first embodiment

Please refer to FIGS. 1 and 2. FIG. 1 is a three-dimensional schematic diagram of the ostomy system provided by the first embodiment of the application, and FIG. 2 is a three-dimensional exploded schematic diagram of the ostomy system shown in FIG. 1, and the ostomy system 100 includes an electrode holder 10 , Sheath assembly 20 and handle 30. The electrode stent 10 is housed at the distal end of the sheath assembly 20, and the electrode stent 10 establishes a shunt channel in the tissue at the stoma through expansion and ablation.

Please refer to Fig. 3, which is a perspective view of the electrode holder. The electrode holder 10 is released at the puncture position of the tissue at the stoma of the patient, and an artificial "defect" is formed in the tissue at the stoma of the patient through radiofrequency ablation. The electrode holder 10 includes a proximal portion 11, a waist portion 13, and a distal portion 15 fixedly connected in sequence. The proximal portion 11 is received at the distal end of the sheath assembly 20. In this embodiment, the diameter of the waist 13 is the smallest, that is, the two ends of the electrode stent 10 are thick, the middle is thin, and the waist is drum-shaped. The waist 13 is conductive, and is used to establish a shunt channel in the stoma tissue through expansion and ablation. Since the electrode stent 10 is used to establish a shunt channel for the tissue at the stoma 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 be conductive, and it can also be conductive in other areas of the electrode holder 10, such as the distal portion 15.

Please refer to Figure 4, which 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 pushing member 23 is movably installed in the sheath 21. The proximal portion 11 of the electrode holder 10 is fixed to the distal end of the pusher 23 and is contained in the sheath tube 21. After the electrode holder 10 is released from the sheath tube assembly 20, the electrode holder 10 is located at the distal end of the sheath tube assembly 20 and The sheath 21 protrudes (Figure 2). The proximal end of the sheath tube 21 and the proximal end of the pushing member 23 are both connected with the handle 30. The first inner sheath core 24 and the second inner sheath core 25 are inserted into the pushing member 23. The outer wall of the pushing member 23 and the inner wall of the sheath tube 21 have a gap, and the pushing member 23 and the sheath tube 21 can move relative to each other. In this embodiment, the pushing member 23 is a multi-lumen tube. The pushing member 23 includes a first cavity 231 and a second cavity 233 spaced apart, and the first inner sheath core 24 and the second inner sheath core 25 pass through the same In a first lumen 231, 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 pass 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.

The ostomy system 100 further includes a cable 40, which is threaded through the second cavity 233, and the distal end of the cable 40 is used to connect with 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 proximal portion 11 and the distal portion 15 are in the insulating coating. The wrapped part is electrically connected to the waist 13. The proximal end of the cable 40 is used to connect with a radio frequency power source for the electrode holder 10 to expand and ablate the tissue at the stoma. In this embodiment, the number of second channels 233 is two, and the number of cables 40 is two. Each cable 40 is placed in a second channel 233. The two cables 40 are used to transmit bipolar radio frequency. The signal is sent to the electrode holder 10. In the modified embodiment, the cable 40 is omitted from one of the second channels 233, that is, the electrode holder 10 is electrically connected with a cable 40 to transmit a unipolar radio frequency signal.

A plurality of cavities are arranged in the pusher 23 at intervals to reduce interference between the structures (such as cables 40, guide wires, etc.) inserted in the pusher 23, which is beneficial to improve the accuracy of the ostomy operation.

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

It can be understood that the pushing member 23 may also be a single-lumen tube, and the cable 40, the inner sheath core, etc. may be worn in the pushing member 23.

Please refer to FIGS. 2, 5 and 6 in combination. The handle 30 (FIG. 1) includes a spindle 31, a diameter adjusting device 33 and a conveying device 35. Compared with the delivery device 35, the diameter adjusting device 33 is provided at the proximal end of the main shaft 31, and is used to adjust the diameter of the electrode holder 10 after being released from the sheath 21, so as to adapt to the needs of different patients. The main shaft 31 is provided with a guide groove 311 along the axial direction. The delivery device 35 is housed in the guide groove 311 and is used to deliver the electrode stent 10 to the tissue at the stoma.

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

More specifically, the diameter adjusting structure 331 includes a diameter adjusting member 3311 and a diameter adjusting knob 3313. The diameter adjusting member 3311 is movably received in the guide groove 311. The adjusting knob 3313 is screwed to the adjusting member 3311, and the adjusting knob 3313 is used to drive the adjusting member 3311 to move along the axial direction in the guide groove 311 when rotating. In this embodiment, the diameter adjusting knob 3313 is disposed close to the proximal end of the main shaft 31. The adjusting wire 333 includes a drawing wire 3331 and a adjusting wire 3332 (as shown in FIG. 3). The proximal end of the wire drawing 3331 is fixedly connected with the diameter adjusting member 3311. The wire drawing 3331 is inserted into the delivery device 35 and the first inner sheath core 24 (as shown in FIG. 4).

The proximal end of the adjusting wire 3332 is fixedly connected with the distal end of the drawing wire 3331, and the distal end of the adjusting wire 3332 is wound around the waist 13 of the electrode holder 10 (as shown in FIG. 3). In this embodiment, the wire drawing 3331 is a wire made of a material with strong rigidity, such as a metal wire. In this way, the wire drawing 3331 moves back and forth in the first inner sheath core 24 without bending or entanglement, which is convenient for control; the adjusting wire 3332 A wire made of a more flexible material, such as a thinner high-molecular polymer suture, has a higher flexibility and is convenient for winding and adjusting the diameter of the waist 13. It can be understood that the material of the drawing wire 3331 is not limited, and the material of the adjusting wire 3332 is not limited. In the modified embodiment, the adjusting wire 333 is made of a material, such as a metal wire or a suture thread, and the diameter of the adjusting wire 333 is gradually tapered from the proximal end to the distal end.

The scale assembly 335 includes a pointer plate 3351 and a scale 3353 that are stacked. The pointer plate 3351 is arranged on the main shaft 31 and covers the opening of the guide groove 311. The pointer board 3351 is connected with the adjusting member 3311. The dial 3353 is fixed on the main shaft 311 through a cover 36 (as shown in FIG. 2). 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 arranging 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 has a transparent structure, and the dial 3353 is provided with scales (not shown). When the diameter adjusting member 3311 moves in the guide groove 311, the pointer plate 3351 is driven 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 assembly 335 on the main shaft 31 are not limited. For example, the pointer plate 3351 can also be accommodated in the guide groove 311, the scale plate 3353 is directly fixed to the main shaft 31, and the pointer plate 3351 can be accompanied by the adjusting member 3311 moves and indicates the scale corresponding to the dial 3353.

More specifically, referring to FIGS. 7 and 8, the diameter adjusting member 3311 includes a diameter adjusting joint 3321 and a diameter adjusting rack 3323. The adjusting joint 3321 is screwed to the adjusting knob 3313 (Figure 2). The diameter adjusting joint 3321 is fixedly connected to the proximal end of the diameter adjusting rack 3323. The pointer plate 3351 is provided with a plate rack (not shown), the diameter adjusting device 33 also includes a diameter adjusting gear set 337 rotatably received in the guide groove 311, and the plate rack faces the adjusting gear set 337, And it meshes with the adjusting gear set 337. Referring to FIG. 9, the adjusting gear set 337 includes a first gear 3371 and a second gear 3373 that are concentrically arranged. The diameter of the first gear 3371 is smaller than the diameter of the second gear 3373. The first gear 3371 meshes with the adjusting rack 3323. The second gear 3373 meshes with the plate rack, so that the small displacement change of the diameter adjustment line 333 in the axial direction is enlarged and displayed on the dial 3353, which is convenient for the operator to obtain the diameter or diameter change of the waist 13 of the electrode holder 10 information.

The ostomy system 100 provided in the present application can be applied to ostomy operations such as cardiac atrial septal tissue stoma, gastrointestinal stoma, and arteriovenous fistula. When the electrode stent 10 is pre-installed in the sheath 20 and is not released, the diameter of the waist 13 of the electrode stent 10 is adjusted to a minimum to facilitate delivery and release. The waist 13 is used to transport the tissue to the puncture position of the stoma. The proximal portion 11 and the distal portion 15 (Figure 3) are respectively located at the openings on both sides of the puncture position. 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, the error range is within 5%) the preset stoma diameter.

Specifically, first, increase the diameter of the waist 13 of the electrode holder 10, and use the adjusting knob 3313 to drive the adjusting rack 3323 to move to the distal end, thereby driving the drawing wire 3331 and the adjusting wire 3332 to move distally, and the adjustment wound around the waist 13 When the diameter wire 3332 becomes loose, the diameter of the waist 13 of the electrode holder 10 will increase, and the diameters of the proximal portion 11 and the distal portion 15 will also increase accordingly; accordingly, the adjustment rack 3323 drives the pointer plate through the adjustment gear set 337 The pointer on the 3351 moves relative to the dial 3353 and indicates the larger size on the dial 3353.

When the size of the waist 13 is adjusted too large and exceeds the preset stoma diameter, the diameter of the waist 13 of the electrode holder 10 needs to be adjusted. Specifically, the adjusting knob 3313 is used to drive the adjusting rack 3323 to move proximally, thereby driving the drawing wire 3331 and the adjusting wire 3332 to move proximally, the adjusting wire 3332 wound around the waist 13 is tightened, and the electrode holder 10 The diameter of the waist 13 will become smaller, and the diameters of the proximal part 11 and the distal part 15 will also decrease accordingly. Correspondingly, the diameter adjusting rack 3323 drives the pointer on the pointer plate 3351 to move relative to the dial 3353 and indicate to the dial 3353 On the smaller size.

The scale component 335 can accurately indicate the diameter of the waist 13 of the electrode holder 10, thereby facilitating the operator to control the size of the shunt channel required for establishment. Specifically, the diameter adjustment range is 4.0-16.0mm. It can be understood that the diameter adjustment size range is not limited to 4.0-16.0 mm, and the diameter adjustment wire 3332 wound on the waist 13 can be adjusted according to the actual condition of the patient according to the determined size of the waist 13.

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

It can be understood that the adjusting gear set 337 can be omitted, and the adjusting member 3311 can directly drive the pointer plate 3351 to move; the scale assembly 335 can be omitted, that is, the ostomy system 100 does not have the function of displaying the diameter or diameter change information of the electrode holder 10.

Please refer to FIGS. 2, 5 and 7 again, the conveying device 35 includes a rotating drum 351, a sheath tube joint structure 353, a push rod joint structure 355 and a transmission structure 356. The rotating cylinder 351 is sleeved outside the main shaft 31 and used to drive the sheath joint structure 353, the push rod joint structure 355, and the transmission structure 356 to move. The sheath joint structure 353, the push rod joint structure 355 and the transmission structure 356 are all received in the guide groove 311 of the main shaft 31. The sheath joint structure 353 is engaged with the inner surface of the spin barrel 351. The sheath 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 pushing member 23. The push rod joint structure 355 is connected to the sheath joint structure 353 through the transmission structure 356.

When the rotating drum 351 rotates relative to the main shaft 31 in the first direction, the sheath tube joint structure 353 drives the sheath tube 21 to move in the axial direction of the main shaft 31 from the distal end to the proximal direction, and the transmission structure 356 can drive the push rod joint structure 355 to push the pusher. 23 moves from the proximal end to the distal direction along the axial direction of the main shaft 31 to release the electrode holder 10 contained in the sheath tube 21, that is, the electrode holder 10 exposes the distal end of the sheath tube 21.

When the rotating drum 351 rotates relative to the main shaft 31 in the second 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 proximal end to the distal direction, and the transmission structure 356 can drive the push rod joint structure 355 to push the pusher. 23 moves from the distal end to the proximal direction along the axial direction of the main shaft 31, so that the electrode holder 10 is retracted and contained in the sheath 21.

By rotating the rotary drum 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. Conducive to improving the efficiency of ostomy surgery.

In this embodiment, the transmission structure 356 is a transmission gear set. The sheath joint structure 353 includes a sheath joint 3531 and an active rack 3532 that are spaced apart along the axial direction of the main shaft 31. In addition, please refer to FIG. 7 again. 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 sandwiched between the pusher 23 and the sheath 21. In between, it is used to prevent friction between the pusher 23 and the sheath tube joint 3531 in the main shaft, and increase the protection of the mechanical and electrical properties of the inner sheath core.

Please refer to FIG. 10, the sheath tube connector 3531 includes a connector member 3533 and an engaging member 3534 protruding from the proximal end of the connector member 3533. A first thread 3535 is provided on the bottom surface of the joint 3533 away from the guide groove 311. The inner surface of the barrel 351 is provided with a second thread 3511 (as shown in Figure 2), the first thread 3535 is engaged with the second thread 3511, so that when the barrel 351 rotates, the sheath tube connector 3531 can be driven in the guide groove 311 Move along the axis. The engaging member 3534 includes a groove 3536 and a hook portion 3537 connected to each other, wherein the hook portion 3537 is located at the proximal end of the engaging member 3534 away from the joint member 3533. The groove 3536 is used for engaging with the active rack 3532.

The active rack 3532 is located between the sheath tube joint 3531 and the transmission structure 356. The active rack 3532 meshes with the transmission structure 356. Please refer to FIG. 11, the active rack 3532 includes a main body 3541, a first elastic member 3542 and a second elastic member 3543, and the main body 3541 is received 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 engaged with the transmission structure 356. The distal end of the main body 3541 is provided with a receiving groove 3545 (as shown in FIG. 12) along the axial direction for inserting the engaging member 3534. The main body 3541 is provided with a through hole 3546 communicating with the accommodating groove 3545.

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

The second elastic member 3543 is movably sandwiched 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 be engaged with the active rack 3532. Please refer to FIG. 13 and FIG. 14. FIG. 13 is a three-dimensional schematic diagram of the sheath tube joint and the active rack in an engaged state; FIG. 14 is a cross-sectional view along the line X-X shown in FIG. 13.

The second elastic member 3543 is substantially in an "n" shape. The second elastic member 3543 includes a connecting portion 3547 and a bending portion 3548 formed by bending and extending the end of the connecting portion 3547. The connecting portion 3547 extends through the through hole 3546 into the accommodating groove 3545 (FIG. 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 accommodating groove 3545, the connecting portion 3547 is received in the groove 3536, so that the active rack 3532 and the sheath tube connector 3531 are engaged with each other. When the engaging member 3534 is inserted into the accommodating groove 3545, the hook portion 3537 pushes the connecting portion 3547 into the nearest end of the accommodating groove 3545, and the connecting portion 3547 is received in the groove 3536.

The bending portion 3548 is received in the main body 3541 and partially exposed outside the main body 3541. Please refer to FIG. 15, the side wall of the guide groove 311 is provided with an inclined portion 313 extending in the axial direction (see also FIG. 6 ). Along the distal to proximal direction, the angle between the inclined portion 313 and the axial parallel direction of the main shaft 31 is an acute angle. In other words, the proximal end of the inclined portion 313 moves closer to the axial parallel direction, and the distal end of the inclined portion 313 The ends move away from the axial parallel direction. The bent portion 3548 exposes the portion of the main body 3541 to be in contact with the inclined portion 313.

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 rotating barrel 351, the sheath tube connector 3531 moves from the distal end to the proximal direction, that is, the sheath tube 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, and the hook part 3537 contacts the connecting portion 3547 of the second elastic member 3543 in the accommodating groove 3545, and as the sheath connector 3531 gradually moves proximally, the hook 3537 lifts the connecting portion 3547 in the accommodating groove 3545 (as shown in Figure 7). Shown), and inserted into the most distal end of the accommodating groove 3545 through the connecting portion 3547 (ie, as shown in Figure 16) to realize the sheath joint 3531 and the active rack 3532 snap-fitting; the sheath joint 3531 drives the active tooth The bar 3232 continues to move from the distal end to the proximal direction, the bent portion 3548 moves proximally along the distal end of the inclined portion 313, and the proximal end of the active rack 3232 can drive the transmission structure 356 to move.

When the sheath joint 3531 and the active rack 3532 are integrated, if the active rack 3532 moves from the proximal end to the distal direction, the bending part 3548 moves along the inclined part 313, because the bottom wall of the inclined part 313 of the main shaft 31 is Inclinedly, the second elastic member 3543 is lifted until the bottom of the hook portion 3537 and the connecting portion 3547 do not overlap in the axial direction, and the bottom of the connecting portion 3547 cannot block the hook portion 3537, so that the hook portion 3537 of the engaging member 3534 It is removed from the accommodating groove 3545, and the sheath tube connector 3531 is separated from the active rack 3532. Through the guiding effect of the inclined portion 313 on the movement of the bending portion 3548, the automatic unlocking between the sheath tube joint 3531 and the active rack 3532 is realized, and the efficiency of the stoma system 100 is improved. In this embodiment, the inclined portion 313 has a groove structure, and the end wall of the inclined portion 313 can abut the bending portion 3548, so as to limit the movement displacement of the active rack 3532.

Please refer to Figure 16, Figure 18 and Figure 19 together, 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 and the pusher 23 Fixed proximal connection. The wire drawing 3331 passes through the sheath tube connector 3531 and the push rod connector 3551. The driven rack 3553 meshes with the transmission structure 356.

Please refer to FIG. 16 and FIG. 20 together, the conveying device 35 further includes a locking member 357. The bottom of the guide groove 311 is provided with a receiving hole 315 through the bottom, and the receiving hole 315 includes a first receiving hole 3151 and a second receiving hole 3153 arranged at the bottom of the guide groove 311 at intervals. The locking member 357 includes a connecting portion 3571, a resisting portion 3573, and a locking portion 3575 that are 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 resisting portion 3573 can be received in the first receiving hole 3151. The resisting 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. The proximal end of the locking portion 3575 is provided with a first locking tooth 3576 on the side facing the main shaft 31, and the push rod joint 3551 is provided with a second locking tooth 3554 for meshing with the first locking tooth 3576 on the side of the push rod joint 3551 facing the main shaft 31. It can be understood that the resisting portion 3573 is not limited to be a boss, and it may also have other structures capable of resisting the sheath connector 3531.

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 be moved, that is, the locking member 357 is in the locked position.

When the first locking tooth 3576 and the second locking tooth 3554 are not engaged, that is, when 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 is in position Driven by the transmission gear set 357, axial movement can be carried out.

In this embodiment, the driving rack 3532 is always meshed with the transmission joint 356, and the driven rack 3553 is always meshed with the transmission joint 356. When the active rack 3532 is not engaged with the sheath connector 3531, the sheath connector 3531 is separated from the active rack 3532, the active rack 3532 does not move synchronously with the sheath connector 3531, and the locking member 357 is in the locked position. During the movement of the sheath tube connector 3531 from the distal end to the proximal direction in the guide groove 311 by the rotating cylinder 351, when the largest diameter of the proximal portion 11 of the electrode holder 10 is released from the sheath tube 21, the sheath tube connector 3531 pushes the resisting portion 3573, the locking portion 3575 (proximal end) of the locking member 357 rotates in a direction away from the main shaft 31, and disengages the push rod joint structure 355 before the driving rack 3532 pushes the transmission gear set to rotate, The unlocking of the push rod joint structure 355 is realized.

While the rotating cylinder 351 drives the sheath tube connector 3531 to move from the proximal end to the distal direction in the guide groove 311, the sheath tube connector 3531 continues to push the resisting portion 3573 and is positioned at the largest diameter of the proximal portion 11 of the electrode holder 10 Before being recovered or retracted into the sheath tube 21, after the active rack 3532 is disengaged from the transmission structure 356, the sheath tube connector 3531 is away from the resisting portion 3573, and the locking member 357 engages with the push rod connector structure 355 to realize the push rod Positioning of the joint structure 355.

The conveying device 35 further includes an elastic member 358, one end of the elastic member 358 is fixed to the side of the locking portion 3575 away from the main shaft 31 by welding. The handle 30 also includes a housing 37 (as shown in FIG. 2) and a handle 38 (as shown in FIG. 2). The housing 37 is sleeved on the proximal end of the main shaft 31. The elastic member 358 is located between the locking portion 3575 and the inner wall of the housing 37, and is used to reset the locking member 357 when the sheath tube connector 3531 is away from (not in contact with) the resisting portion 3573, and pushing the locking portion 3575 to the adjacent main shaft 31 Turning in the direction, the proximal end of the locking member 357 and the push rod joint structure 355 are locked together, that is, the first locking tooth 3576 engages with the second locking tooth 3554. The handle 38 is sleeved on the distal end of the main shaft 31, and the rotating drum 351 is located between the handle 38 and the housing 37. The housing 37, the handle 38 and the rotating drum 351 together constitute the outer shell of the handle 30.

In the following, a simple description will be given by taking the ostomy system 100 to establish a shunt channel for the atrial septum of the heart as an example. The stoma is the atrial septum between the left atrium and the right atrium of the heart, that is, the ostomy system 100 is used to treat the atrial septum of the heart. Establish a shunt channel.

First, a puncture mechanism is used to puncture the atrial septum. After puncture, the guide wire is fed into the left upper pulmonary vein, and the puncture kit is removed. The dilator and sheath tube assembly 20 is pushed into the left atrium along the guide wire of the second inner sheath core 25, and the guide wire and dilator are removed. The electrode holder 10 is pushed through the inner cavity of the second inner sheath core 25 along the guide wire into the left atrium.

When the electrode holder 10 is not released, the state of the ostomy system 100 is the initial state: at the distal end of the ostomy system 100, the opening of the pusher 23 is retracted inside the opening of the sheath 21, and the diameter of the waist 13 is adjusted by the diameter adjustment wire 3332. When contracted to a smaller range, the waist 13 is fixed to the distal end of the pusher 23 by the adjusting wire 3332, so that the electrode holder 10 cannot move back and forth in the axial direction. The electrode holder 10 is elongated in the axial direction so that it is compressed in the radial direction, and is completely accommodated in the opening of the sheath tube 21, and the distal end portion 15 of the electrode holder 10 does not protrude from the distal end of the sheath tube 21. The sheath joint 3531 and the active rack 3532 are spaced apart and not in contact with each other. The connecting portion 3536 of the second elastic member 3543 is accommodated in the accommodating cavity 3545, and its position is the initial position. The active rack 3532 and the transmission structure 356 Engaged, the driven rack 3553 engages with the transmission structure 356. The sheath connector 3531 is away from the resisting 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 at the locking position, that is, the first locking tooth 3576 engages the second locking tooth 3554.

The process of releasing the electrode holder 10 includes:

The first period: release the distal part 15 of the electrode stent 10 in the left atrium, release the waist 13 at the perforation of the atrial septum, release a part of the proximal part 11 in the right atrium, especially the diameter of the proximal part 11 Biggest place.

Specifically, holding the handle 38, rotating the barrel 351 in a first direction (for example, in a clockwise direction as viewed from the proximal end to the distal end of the ostomy system 100), the barrel 351 drives the sheath connector 3531 to the proximal end along the axial direction. Movement, 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.

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 accommodating groove 3545, and gradually moves toward the sheath connector 3531. With the proximal movement, the hook portion 3537 lifts the connecting portion 3547 in the accommodating slot 3545 (as shown in Figure 7), and inserts it to the farthest end of the accommodating slot 3545 through the connecting portion 3547 (as shown in Figures 14 and 16). Show), at this time, the groove 3536 is facing the connecting portion 3547, and the connecting portion 3547 drops to the initial position; at the same time, or before this moment, the bottom of the sheath tube connector 3531 abuts against the resisting portion 3573 of the locking member 357, and pushes against The holding part 3573 drives the locking part 3575 of the locking part 357 (the proximal end of the locking part 357) to rotate in a direction away from the main shaft 31, so that the resisting part 357 is transformed from the locked position to the unlocked position, so that the push rod joint 3551 can be The pushing member 23 is driven to slide in the guide groove 311 of the main shaft 31 in the axial direction.

The second period: the proximal portion 11 is further released in the right atrium until the electrode stent 10 is completely released.

Specifically, as shown in Fig. 2, continue to rotate the barrel 351 in the first direction, the sheath tube connector 3531 drives the active rack 3532 to move axially toward the proximal end, and the sheath 21 moves toward the proximal end; the proximal end of the active rack 3532 The multiple teeth of the gears mesh with the transmission structure 356 and drive the transmission structure 356 to rotate. The driven rack 3553 meshed with the transmission structure 356 moves distally under the drive of the transmission structure 356, and the push rod joint 3551 drives the pusher 23 to the distal end. Move until the distal end of the pushing member 23 protrudes from the sheath tube 21, the electrode holder 10 is completely released from the sheath tube 21, and after the complete release, since the inner wall of the sheath tube 21 no longer compresses the electrode holder 10, the electrode holder 10 The diameter of the proximal portion 11 of the 10 is enlarged relative to the diameter before the incomplete release, making it easier to fit the anatomical structure of the atrium. In the second period, the sheath 21 moves to the proximal end, and the pushing member 23 moves to the distal end, that is, the sheath 21 and the pushing member 23 are linked. During the release of the electrode holder 10, the sheath 21 and the pushing member 23 are linked, namely The sheath 21 moves to the proximal end, and the pusher 23 moves to the distal end. When the waist 13 is fixed, the diameter of the proximal portion 11 is further enlarged, which can better fit the diaphragm between the left and right atria. The waist 13 is tightened by the adjusting wire 3332 so as to be accurately fixed at the puncture position, thereby accurately positioning the position where subsequent ablation is required.

Diameter adjustment process: After the second period, an appropriate size can be selected for cauterization according to the specific conditions of the patient, and the diameter of the waist 13 of the electrode holder 10 can be adjusted to establish a proper atrial septal shunt channel.

Pulse ablation process: After confirming that the tissue at the stoma is completely attached to the electrode holder 10, connect the proximal end of the cable 40 to the radio frequency power supply (ablation power supply, not shown), and set the heating parameters (for example, power 20-80W, duration 10-50S), and then start heating. After the heating is stopped, the electrode stent 10 can be recovered to the sheath 21 and removed from the body, and whether the diameter of the stoma reaches the expected value is measured.

The process of recovering the electrode holder 10 includes:

The third period: rotate the barrel 351 in the second direction (for example, in the counterclockwise direction viewed from the proximal end to the distal end of the ostomy system 100), the barrel 351 drives the sheath connector 3531 to move axially toward the distal end, and the sheath tube The joint 3531 drives the sheath 21 to move distally. The sheath 21 gradually receives the proximal end of the electrode holder 10 therein; at the same time, the hook 3537 of the active rack 3532 pulls the bottom of the main body 3541 to drive the active rack 3532 to move distally, and the active rack 3532 passes through the transmission structure 356 Drive the driven rack 3553, the push rod joint 3551 and the pushing member 23 to move proximally.

In the third period, the largest diameter of the proximal portion 11 of the electrode holder 10 is outside the sheath 21, and a part of the proximal portion 11 is contained in the sheath 21, under the action of the push rod connector 3551 being pulled proximally , The radial dimension of the electrode stent 10 is compressed by the inner wall of the sheath tube 21, and the axial length becomes longer, which facilitates the further recovery of the electrode stent 10 into the sheath tube 21, because the radial dimension of the electrode stent 10 can be compressed during the recovery process The recovery of the electrode stent 10 is relatively smooth, so the diameter of the proximal portion 11 of the electrode stent 10 can be designed to be larger to better fit the diaphragm between the left and right atria, thereby improving the accuracy of positioning the ablation site.

The sheath tube connector 3531 drives the sheath tube 21 to move distally, and the proximal end of the active rack 3532 is limited by the hook 3537 in the direction perpendicular to the axial direction (cannot be lifted). Since the connecting portion 3547 is disposed on the top surface of the main body 3541 away from the bottom of the guide groove 311, the two bending portions 3548 are connected to one end of the main body 3541 and extend to opposite sides of the main body 3541, that is, the bending portion 3548 exposes 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 portion 3548. During the movement of the active rack 3532 along the inclined portion 313 to the distal end, before the maximum diameter of the proximal portion 11 is retracted into the sheath 21, the second elastic member 3543 is lifted until the hook portion 3537 and the connecting portion The bottom of the 3547 does not overlap in the axial direction, and the bottom of the connecting portion 3547 cannot block the hook 3537, so the hook 3537 comes out of the accommodating groove 3545, and the sheath joint 3531 is separated from the active rack 3532. At this time, or after this moment, the sheath connector 3531 and the resisting portion 3573 of the locking member 357 disengage from each other and slide distally, and the elastic member 358 abuts against the inner wall of the housing 37, so that the proximal end of the locking member 357 is attached to the inner wall of the housing 37. The main shaft 31 is closed, and the lock member 357 is transformed from the unlocked position to the locked position.

In the third period, the sheath tube connector 3531 drives the sheath tube 21 to move distally, and the pusher 23 moves proximally, that is, the sheath tube 21 and the pusher 23 are linked together. At the end of the third period, the largest diameter of the proximal portion 11 of the electrode holder 10 is outside the sheath 21. In the first time period, when the connecting portion 3547 of the second elastic member 3543 is pushed up by the hook portion 3537, the bent portion 3548 is also pushed up by the inclined portion 313.

Fourth period: continue to rotate the barrel 351 in the second direction, the barrel 351 drives the sheath tube connector 3531 to move distally in the axial direction, the sheath tube connector 3531 drives the sheath tube 21 to move distally, the active rack 3532 and the pusher 23 It does not move with respect to the main shaft 31. The sheath tube 21 recovers the remaining part of the electrode holder 10 into it.

In the fourth period, after the proximal part 11 is completely retracted into the sheath 21, before the distal part is recovered into the sheath 21, that is, when the waist 13 is at the position of the distal opening of the sheath 21, adjust the circumference of the waist 13 The diameter wire 3332 is tightened to prevent the operator from rotating the parts on the handle 30 to recover the electrode holder 10 after the waist 13 has been tightened, causing the electrode holder 10 to move back and forth between the left and right atria and damage the heart tissue. .

It can be understood that the ostomy system 100 can also be used in ostomy operations such as gastrointestinal stoma and arteriovenous fistula.

In one embodiment, the handle includes a main shaft, the main shaft is provided with a guide groove along the axial direction, the diameter adjustment structure is provided at the proximal end of the main shaft compared to the conveying device, and the conveying device accommodates于The guide groove.

In one embodiment, the diameter adjusting structure includes a diameter adjusting member and a diameter adjusting knob, the diameter adjusting member is movably received in the guide groove and fixedly connected to the proximal end of the diameter adjusting wire, and The diameter adjusting knob is screwed to the diameter adjusting member, and the diameter adjusting knob is used to drive the diameter adjusting member to move in the axial direction in the guide groove when rotating.

In one embodiment, the diameter adjusting device further includes a scale assembly, the scale assembly includes a pointer plate and a dial, the pointer plate is arranged on the main shaft and connected with the diameter adjusting member, the dial Fixedly connected to the main shaft, the pointer plate is located between the dial and the adjusting member, the pointer plate is provided with a pointer on the side facing the dial, and the adjusting member is located on the When moving in the guide groove, the pointer plate is driven to move synchronously, so that the pointer points to the corresponding scale on the dial.

In an embodiment, the diameter adjusting device further includes a diameter adjusting gear set, the diameter adjusting member includes a diameter adjusting joint and a diameter adjusting rack, the diameter adjusting joint is screwed with the diameter adjusting knob, the The adjusting joint is fixedly connected with the proximal end of the adjusting rack, the adjusting gear set is meshed with the adjusting rack, the pointer plate is provided with a plate rack, and the plate rack is connected with the The adjusting gear set meshes.

In one embodiment, the adjusting gear set includes a first gear and a second gear arranged concentrically, the diameter of the first gear is smaller than the diameter of the second gear, and the first gear and the adjusting gear The radial rack meshes, and the second gear meshes with the plate rack.

In one embodiment, the sheath tube assembly includes the sheath tube and a pushing member movably mounted on the sheath tube, and the electrode holder is fixed to the distal end of the pushing member and is accommodated in the sheath tube , The adjusting wire is threaded through the pushing member.

In one embodiment, the delivery device includes a sheath tube joint structure, a push rod joint structure, and a transmission structure. The sheath tube joint structure, the push rod joint structure, and the transmission structure are all housed in the main shaft. In the guide groove, the sheath tube joint structure is fixedly connected to the proximal end of the sheath tube, the push rod joint structure is fixedly connected to the proximal end of the pusher, and the push rod joint structure is connected to the proximal end of the pusher through the transmission structure. The sheath tube joint structure is connected, and when the sheath tube joint structure drives the sheath tube to move from the distal end to the proximal direction along the axial direction of the main shaft, the transmission structure can drive the push rod joint structure to push the shaft The pushing member moves from the proximal end to the distal direction along the axial direction of the main shaft to release the electrode holder contained in the sheath tube, and the sheath tube joint structure drives the sheath tube along the axis of the main shaft When moving from the proximal end to the distal direction, the transmission structure can drive the push rod joint structure to push the pusher to move from the distal end to the proximal direction along the axial direction of the main shaft, so as to recover the electrode holder Into the sheath.

In one embodiment, the delivery device further includes a rotating drum, the rotating drum is sleeved outside the main shaft, the sheath tube joint structure is engaged with the inner surface of the rotating drum, and when the rotating drum rotates The sheath tube joint structure can be driven to move along the axial direction of the main shaft.

In an embodiment, the transmission structure includes a transmission gear set, the sheath tube joint structure includes a sheath tube joint and an active rack arranged along the axial direction of the main shaft, the sheath tube joint and the spin barrel The drive rack is located between the sheath tube 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 sheath tube joint can drive the driving rack and the transmission gear set to move under the drive of the rotating drum, so that the push rod joint structure can move in the axial direction of the main shaft.

In one embodiment, the sheath tube connector is spaced apart from the active rack, and the sheath tube connector includes a connector member and an engaging member protruding from the proximal end of the connector member. The inner surface of the rotating barrel is engaged, the rotation of the rotating barrel can drive the sheath tube joint to move from the distal end to the proximal direction along the axis of the main shaft, and the engaging member moves toward the active rack and finally It is in engagement with the active rack to drive the active rack to move in the same direction with the joint member.

In one embodiment, 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, and the distal end of the main body is arranged upward in the axial direction. There is a accommodating groove, the first elastic member is provided on the main body, the second elastic member is movably sandwiched between the first elastic member and the main body, and the main body is provided with the accommodating The second elastic member extends into the accommodating groove through the through hole, and the engaging member can be inserted into the accommodating groove under the drive of the rotating cylinder to communicate with the accommodating groove. The second elastic member is buckled and connected.

In one embodiment, the second elastic member includes a connecting portion and a bending portion formed by bending and extending the end of the connecting portion, and the connecting portion extends into the receiving groove through the through hole Inside, 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 to accommodate the connecting portion to communicate with the second elastic member. The pieces are snapped together.

In one embodiment, an inclined portion is provided on the side wall of the guide groove, and the angle between the inclined portion and the axial parallel direction of the main shaft is an acute angle along the direction from the distal end to the proximal end. The bent portion is connected to the inclined portion, and when the rotating cylinder drives the sheath tube joint to move from the proximal end to the distal direction, the bent portion moves along the inclined portion to drive the connecting portion When detached from the groove, the engaging member is detached from the accommodating groove, and the sheath tube joint is detached from the active rack.

In one embodiment, the sheath tube connector is fixedly connected to the active rack, the sheath tube connector is engaged with the inner surface of the spin barrel, and the active rack is located between the sheath tube connector and the active rack. Between the transmission gear sets, the proximal end of the driving rack is spaced apart from the transmission gear set.

In one embodiment, 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, and the push rod joint is fixedly connected to the proximal end of the pusher. , The driven rack meshes with the transmission gear set.

In one embodiment, the conveying device further includes a locking member, a receiving hole is formed through the bottom of the guide groove, the locking member is received in the receiving hole, and the distal end of the locking member is connected to The main shaft is connected, the proximal end of the locking member is used for locking with the push rod joint structure, the side of the locking member facing the main shaft is provided with a resisting portion, the sheath tube joint It is also used to push the resisting portion to rotate the proximal end of the locking member in a direction away from the main shaft, and to disengage the push rod joint structure before the driving rack pushes the transmission gear set to rotate .

In one embodiment, the proximal end of the locking member is provided with a first locking tooth toward the side of the main shaft, and the push rod joint structure is provided with a second locking tooth meshing with the first locking tooth.

In one embodiment, it further includes a housing, the housing is sleeved outside the main shaft, and the conveying device further includes an elastic member connected to the proximal end of the locking member and the Between the inner walls of the housing, when the sheath tube joint is not in contact with the resisting portion, the elastic member pushes the proximal end of the locking member to rotate in a direction adjacent to the main shaft, so that the locking member The proximal end of the rod is locked together with the push rod joint structure.

In one embodiment, 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 the adjusting wire is wound around the waist.

In one embodiment, during the movement of the sheath tube joint from the distal end to the proximal direction along the main shaft under the drive of the spin barrel, the sheath tube is exposed at the maximum diameter of the proximal end portion After that, the push rod joint structure is driven to move from the proximal end to the distal end by the active rack; the sheath joint is driven by the rotating barrel along the main shaft from the proximal end to the distal direction during the process Before retracting into the sheath tube at the maximum diameter of the proximal part, the push rod joint structure is driven by the active rack to move from the distal end to the proximal end.

In one embodiment, the ostomy system further includes a cable, the cable runs through the pusher, the proximal end of the cable is used for electrical connection with a radio frequency power supply, and the distal end of the cable is connected to the The electrode holder is electrically connected.

In one embodiment, the pushing member is a multi-lumen tube, the pushing member includes a first cavity and a second cavity arranged at intervals, and the adjusting wire is movably threaded through the first cavity, The cable is threaded through the second cavity.

In one embodiment, the sheath tube assembly further includes a first inner sheath core and a second inner sheath core, and the first inner sheath core and the second inner sheath core are pierced in the first lumen The adjusting wire is movably threaded on the first inner sheath core, and the second inner sheath core is used for threading a guide wire.

In one embodiment, the adjusting wire includes a drawing wire and an adjusting wire, the drawing wire is movably installed on the delivery device and the sheath assembly, and the drawing wire is fixed to the distal end of the adjusting wire Connected, the adjusting wire is wound on the electrode holder.

Second embodiment

Please refer to FIGS. 21-23. FIG. 21 is a three-dimensional exploded schematic view of the ostomy system 200 provided by the second embodiment of the present application. The ostomy system 200 provided by the second embodiment of the present application is compared with the ostomy system provided by the first embodiment. The structure of 100 is roughly similar. The difference is that, referring to Figure 24, the sheath tube joint structure 653 includes a fixedly connected sheath tube joint 6531 and an active rack 6532. The active rack 6532 is provided with an interval transmission structure 656 (as shown in FIGS. 25 and 26). ). When there is no need to release the electrode holder 201 in the initial state, the active rack 6532 is provided with an interval 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 connected to the push rod joint structure The bottom of the 655 is locked together.

The sheath joint 6531 and the active rack 6532 are always connected in one body. Before the active rack 6532 pushes the transmission structure 356 to rotate, the locking member 657 needs to be separated from the push rod joint structure 655 to prevent the push rod joint structure 655 from being jammed.

It can be understood that the sheath connector 6531 and the active rack 6532 are not limited to be fixedly connected, and the sheath connector 6531 and the active rack 6532 can move synchronously. In the sheath joint structure 353, the engaging member, the first elastic member, the second elastic member, the accommodating groove, etc. are omitted.

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

The first period: the sheath joint structure 653 slides toward the proximal end as a whole, and the active rack 6532 does not contact the transmission structure 656 at the distal end (as shown in FIGS. 25 and 26). When the sheath joint structure 653 moves from the distal end Move proximally until the active rack 6532 engages with the transmission structure 656 (as shown in Figure 27). At the same time or before this, the bottom of the sheath joint structure 653 abuts against the resisting portion 6573 of the locking member 657 and pushes The resisting portion 6573 drives the proximal end of the locking member 657 to rotate in a direction away from the main shaft 611, and the locking member 657 transforms from the locked position to the unlocked position, so that the push rod joint structure 655 can drive the pushing member 623 in the axial direction on the main shaft 611. Sliding inside.

Second period: The sheath joint structure 653 slides proximally as a whole.

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

The fourth period: the rotating cylinder 651 drives the sheath joint structure 653 as a whole to move along the distal end of the axial direction.

In the ostomy system 200 provided by the second embodiment, the sheath joint 6531 of the sheath joint structure 653 and the active rack 6532 are integral parts, which reduces the components of the ostomy system 200 and simplifies the structure of the ostomy system 200.

It should be noted that, without violating the technical principle of the present invention, the specific technical solutions in the above embodiments may be mutually applicable.

What is disclosed above is only the preferred embodiments of this application, and of course it cannot be used to limit the scope of rights of this application. Therefore, equivalent changes made according to the claims of this application still fall within the scope of this application.

Claims (25)

1. A stoma system, which is characterized by comprising a handle, a sheath tube assembly and an electrode stent. The electrode stent is housed at the distal end of the sheath tube assembly, and the electrode stent is established on the stoma by expansion and ablation. A shunt channel, the handle includes a delivery device and a diameter adjustment device, the delivery device is connected to the proximal end of the sheath assembly for controlling the delivery of the electrode stent, the diameter adjustment device includes a diameter adjustment structure and a diameter adjustment device The diameter adjustment structure is arranged at the proximal end of the handle relative to the delivery device, and is fixed to the proximal end of the adjustment wire, and the adjustment wire is movably installed on the delivery device and the The sheath assembly, the distal end of the adjusting wire is wound on the electrode holder, and the adjusting structure is used to drive the adjusting wire to move in the axial direction, so as to adjust the total amount after being released from the sheath assembly. The diameter of the electrode holder.
2. The ostomy system of claim 1, wherein the handle includes a main shaft, the main shaft is provided with a guide groove along the axial direction, and the diameter adjustment structure is compared with that of the conveying device provided on the main shaft. At the proximal end, the conveying device is accommodated in the guide groove.
3. The ostomy system of claim 2, wherein the diameter adjusting structure comprises a diameter adjusting member and a diameter adjusting knob, and the diameter adjusting member is movably received in the guide groove and connected to the diameter adjusting wire. The proximal end is fixedly connected, the diameter adjusting knob is screwed to the diameter adjusting member, and the diameter adjusting knob is used to drive the diameter adjusting member to move in the axial direction in the guide groove when rotating.
4. The ostomy system of claim 3, wherein the diameter adjusting device further comprises a scale component, the scale component includes a pointer plate and a dial, the pointer plate is arranged on the main shaft and is connected to the adjusting plate. The diameter member is connected, the dial is fixedly connected with the main shaft, the pointer plate is located between the dial and the diameter adjusting member, and the pointer plate is provided with a pointer on the side facing the dial; The adjusting member drives the pointer plate to move synchronously when moving in the guide groove, so that the pointer points to the corresponding scale on the dial.
5. The ostomy system of claim 4, wherein the diameter adjusting device further comprises a diameter adjusting gear set, and the diameter adjusting member includes a diameter adjusting joint and a diameter adjusting rack, the diameter adjusting joint and the The adjusting knob is screwed, the adjusting joint is fixedly connected with the proximal end of the adjusting rack, the adjusting gear set is meshed with the adjusting rack, and the pointer plate is provided with a plate rack , The plate body rack meshes with the adjusting gear set.
6. The ostomy system of claim 5, wherein the adjusting gear set comprises a first gear and a second gear arranged concentrically, the diameter of the first gear is smaller than the diameter of the second gear, so The first gear meshes with the diameter adjusting rack, and the second gear meshes with the plate rack.
7. The ostomy system according to any one of claims 2-6, wherein the sheath tube assembly includes the sheath tube and a pusher movably installed on the sheath tube, and the electrode holder is fixed to the sheath tube. The distal end of the pushing member is accommodated in the sheath, and the adjusting wire is passed through the pushing member.
8. The ostomy system according to claim 7, wherein the delivery device comprises a sheath tube joint structure, a push rod joint structure, and a transmission structure, the sheath tube joint structure, the push rod joint structure, and the transmission The structures are all accommodated in the guide groove of the main shaft, the sheath tube joint structure is fixedly connected to the proximal end of the sheath tube, the push rod joint structure is fixedly connected to the proximal end of the pushing member, and the push rod The joint structure is connected to the sheath tube joint structure through the transmission structure. When the sheath tube joint structure drives the sheath tube to move in the axial direction of the main shaft from the distal end to the proximal end, the transmission structure can drive The push rod joint structure pushes the pushing member to move from the proximal end to the distal direction along the axial direction of the main shaft to release the electrode holder contained in the sheath, and the sheath joint structure drives the When the sheath moves in the axial direction of the main shaft from the proximal end to the distal direction, the transmission structure can drive the push rod joint structure to push the pusher from the distal end to the proximal direction in the axial direction of the main shaft Movement to recover the electrode holder into the sheath.
9. The ostomy system of claim 8, wherein the delivery device further comprises a rotating drum, the rotating drum is sleeved outside the main shaft, and the sheath tube joint structure is connected to the inner surface of the rotating drum. Engaged, when the rotating drum rotates, the sheath tube joint structure can be driven to move along the axial direction of the spindle.
10. The ostomy system according to claim 9, wherein the transmission structure comprises a transmission gear set, the sheath tube joint structure comprises a sheath tube joint and an active rack arranged along the axial direction of the main shaft, the The sheath tube joint meshes with the inner surface of the spin barrel, the active rack is located between the sheath tube joint and the transmission gear set for meshing with the transmission gear set, and the transmission gear set is engaged with the transmission gear set. The push rod joint structure is engaged, and the sheath tube joint can drive the active rack and the transmission gear set to move under the drive of the rotating drum, so that the push rod joint structure moves axially along the main shaft.
11. The ostomy system according to claim 10, wherein the sheath tube connector is spaced apart from the active rack, and the sheath tube connector includes a connector piece and a snap protruding from the proximal end of the connector piece. The joint member is engaged with the inner surface of the rotating drum, the rotation of the rotating drum can drive the sheath joint to move in the axial direction of the main shaft from the distal end to the proximal end, and the engaging member faces The active rack moves and finally engages with the active rack, thereby driving the active rack to move in the same direction along with the joint member.
12. The ostomy system according to claim 11, wherein the active rack comprises 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, and the main body The distal end is provided with a accommodating groove in the axial direction, the first elastic member is provided on the main body, and the second elastic member is movably sandwiched between the first elastic member and the main body, so 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 inserted into the accommodating groove under the driving of the rotating cylinder. The accommodating groove is in engagement with the second elastic member.
13. The ostomy system according to claim 12, wherein the second elastic member includes a connecting portion and a bending portion formed by bending and extending the end of the connecting portion, and the connecting portion passes through the connecting portion. The 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 to accommodate the connection The part is in engagement with the second elastic member.
14. The ostomy system of claim 13, wherein the side wall of the guide groove is provided with an inclined portion along the distal to proximal direction, and the inclined portion is in a direction parallel to the axial direction of the main shaft. The angle between the two is an acute angle, and the bent portion is connected to the inclined portion. When the rotating cylinder drives the sheath joint to move from the proximal end to the distal direction, the bent portion follows the inclined portion. The movement of the connecting part drives the connecting part to escape from the groove, the engaging member escapes from the accommodating groove, and the sheath tube joint escapes from the active rack.
15. The ostomy system of claim 10, wherein the sheath tube joint is fixedly connected to the active rack, the sheath tube joint is engaged with the inner surface of the spin barrel, and the active rack Located between the sheath tube joint and the transmission gear set, the proximal end of the driving rack is spaced apart from the transmission gear set.
16. The ostomy system according to claim 10, wherein the push rod joint structure comprises a push rod joint and a driven rack fixedly connected to the distal end of the push rod joint, and the push rod joint is connected to the The proximal end of the pushing member is fixedly connected, and the driven rack is meshed with the transmission gear set.
17. The ostomy system of claim 11 or 15, wherein the delivery 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 receiving hole , The distal end of the locking member is connected with the main shaft, the proximal end of the locking member is used for locking with the push rod joint structure, and the locking member is provided on a side facing the main shaft There is a resistance department,

    The sheath tube joint is also used to push the resisting portion, so that the proximal end of the locking member rotates in a direction away from the main shaft, and is separated from the driving gear before the driving rack pushes the transmission gear set to rotate.述Push rod joint structure.
18. The ostomy system according to claim 17, wherein the proximal end of the locking member is provided with a first locking tooth toward the side of the main shaft, and the push rod joint structure is provided with the first locking tooth. The second locking tooth for tooth engagement.
19. The ostomy system of claim 17, further comprising a housing, the housing is sleeved outside the main shaft, and the delivery device further includes an elastic member connected to the lock Between the proximal end of the holding member and the inner wall of the housing, when the sheath tube joint does not contact the resisting portion, the elastic member pushes the proximal end of the locking member in a direction adjacent to the main shaft Rotate so that the proximal end of the locking member and the push rod joint structure are locked together.
20. The ostomy system according to claim 10, wherein the electrode holder includes a proximal portion, a waist portion, and a distal portion that are fixedly connected in sequence, and the proximal portion is fixed to the distal end of the pushing member, so The diameter adjustment thread is wound around the waist.
21. The ostomy system according to claim 20, wherein the sheath tube joint is driven by the rotating barrel along the main axis from the distal end to the proximal direction during the movement process, in the proximal part of the After the sheath tube is exposed at the largest diameter, the push rod joint structure is driven by the active rack to move from the proximal end to the distal end; the sheath tube joint is driven by the spin barrel from the proximal end along the main shaft. During the movement of the end in the distal direction, the active rack drives the push rod joint structure to move from the distal end to the proximal end before retracting into the sheath tube at the maximum diameter of the proximal end portion.
22. The ostomy system according to claim 7, wherein the ostomy system further comprises a cable, the cable runs 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.
23. The ostomy system of claim 22, wherein the pushing member is a multi-lumen tube, the pushing member includes a first cavity and a second cavity arranged at intervals, and the adjusting wire is movably installed In the first cavity, the cable is threaded through the second cavity.
24. The ostomy system of claim 23, wherein the sheath tube assembly further comprises a first inner sheath core and a second inner sheath core, and the first inner sheath core and the second inner sheath core pass through It is installed in the first lumen, the adjusting wire is movably installed in the first inner sheath core, and the second inner sheath core is used for threading a guide wire.
25. The ostomy system according to claim 1, wherein the adjusting wire comprises a drawing wire and a adjusting wire, the drawing wire is movably threaded on the delivery device and the sheath assembly, and the drawing wire is movably mounted on the delivery device and the sheath assembly. The distal ends of the adjusting wire are fixedly connected, and the adjusting wire is wound on the electrode holder.

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