Expansion fistula plugging stent and implantation system

Abstract

The utility model relates to an expansion fistula plugging support and an implantation system, the expansion fistula plugging support is used for plugging a fistula opening formed between a first cavity and a second cavity which are adjacent, and the expansion fistula plugging support comprises a first fixing support, a second fixing support and a blocking film. The first fixing support is in a hollow tube shape and is provided with a near end, a far end and a first tube cavity extending between the near end and the far end in the axial direction, and the first fixing support is arranged in the first cavity channel. The second fixing support is arranged in the orificium fistulae and the second cavity, the second fixing support is provided with a first end and a second end, and the first end is connected with the first fixing support. The blocking film is arranged on the first fixing support or / and the second fixing support and used for blocking the orificium fistulae.

Description

Technical Field

[0001] The present application relates to the field of minimally invasive treatment technology, and in particular to an expansion fistula plugging stent and an implantation system. Background Art

[0002] Fistula is a disease that connects the cavities of two adjacent organs due to congenital or acquired reasons, such as trauma, esophageal cancer, etc. For example, esophageal tracheal fistula is a fistula formed between the esophagus and trachea, connecting the esophagus and trachea. The trachea and lungs are connected, and the inside of both is a sterile environment. When esophageal tracheal fistula occurs, substances in the esophagus, such as secretions and food, will enter the trachea through the fistula, causing serious and difficult-to-cure lung complications, such as aspiration pneumonia. In severe cases, patients cannot eat orally, which reduces the quality of life of patients.

[0003] The commonly used treatment method in the industry is to use an expandable fistula-blocking stent to block the fistula opening. In related technologies, the blocking effect of the expandable fistula-blocking stent is poor and may cause complications. Utility Model Content

[0004] Based on this, the present application provides an expandable fistula-blocking stent and an implantation system that can improve the blocking effect.

[0005] In a first aspect, the present application provides an expandable fistula blocking stent, which is used to block a fistula formed between a first cavity and a second cavity adjacent to each other, and the expandable fistula blocking stent comprises:

[0006] a first fixing bracket, the first fixing bracket being in a hollow tubular shape and having a proximal end, a distal end, and a first lumen extending axially between the proximal end and the distal end, the first fixing bracket being disposed in the first lumen to support an inner wall of the first lumen;

[0007] A second fixing bracket is disposed in the fistula opening and the second cavity, the second fixing bracket has a first end and a second end that are oppositely disposed, and the first end is connected to the first fixing bracket; and

[0008] A blocking film is arranged on the first fixing bracket and / or the second fixing bracket, and is used for blocking the fistula.

[0009] In one embodiment, the expandable fistula-blocking stent further includes a pull wire, and the pull wire is disposed at the second end. The second end can be contracted by tightening the pull wire.

[0010] Furthermore, the pulling wire is tightened and the second end is contracted, so that the second fixing bracket can enter the second cavity through the fistula, and the pulling wire is released and the second end is expanded to position the second fixing bracket.

[0011] Furthermore, the pull wire is circumferentially arranged at the second end, and when the second end is in a contracted state, the pull wire at least partially extends out of the second end. The pull wire extending out of the second end when the second end is in a contracted state is defined as a free segment, and the free segment is placed toward the distal end of the first fixed bracket.

[0012] Furthermore, the first fixing bracket and the second fixing bracket are configured as a split structure and are connected by sewing with soft wire.

[0013] Furthermore, the barrier film includes a first covering film that at least partially covers the first fixing bracket, the second fixing bracket is connected to the first fixing bracket to form a first connecting track, and the first covering film at least covers the first connecting track.

[0014] Further, the blocking film includes a first blocking film connected to the first fixing bracket and / or the second fixing bracket, the second fixing bracket is connected to the first fixing bracket to form a first connection track, and the first blocking film at least covers the first connection track.

[0015] Furthermore, the first barrier film is connected to the first fixing bracket to form a second connection track, the area enclosed by the second connection track is larger than the area enclosed by the first connection track, and the first connection track is located inside the second connection track.

[0016] Furthermore, the first barrier film is an acid-resistant film.

[0017] Furthermore, the barrier film also includes a second covering film at least partially covering the second fixing bracket and a second barrier film disposed in the second fixing bracket, and the second barrier film is disposed in a space enclosed by the second covering film to form a blockage.

[0018] Furthermore, the first end is provided with a fistula blocking section, the second end is provided with at least one flange, the diameter of the flange is larger than the diameter of the fistula blocking section, and the second covering film at least covers the fistula blocking section.

[0019] Furthermore, the flange is configured to be in a hollow tubular shape, and a central axis of the flange is parallel to a central axis of the first fixing bracket.

[0020] Further, in a first direction, a size of the flange is smaller than a size of the first fixing bracket, and the first direction is parallel to a central axis of the first fixing bracket 1 .

[0021] Furthermore, the first fixing bracket is woven from metal wires, and the second fixing bracket is woven from degradable silk threads or metal wires.

[0022] A second aspect of the present application provides an implantation system, comprising:

[0023] An inserter, the inserter comprising a first handle, a booster tube connected to the first handle, a middle tube connected to the booster tube, an inner tube connected to the middle tube, a pusher head connected to the inner tube, a second handle, an outer tube connected to the second handle, and a safety lock for locking or unlocking the relative position between the second handle and the booster tube, the first handle being closer to an operator than the second handle, the booster tube being connected to the middle tube after passing through the second handle, the inner tube being configured as a hollow structure for guiding a guide wire, the diameter of the inner tube being smaller than the diameters of the distal end of the middle tube and the proximal end of the pusher head, the inner tube, the distal end of the middle tube, the proximal end of the pusher head, and the outer tube being arranged to form a receiving space; and

[0024] The above-mentioned expandable fistula-blocking stent can be retracted in the accommodating space, and the safety lock is released, and the second handle is operated to retract the outer tube to release the expandable fistula-blocking stent from the accommodating space.

[0025] Furthermore, the pull wire is circumferentially arranged at the second end, and when the second end is in a contracted state, the pull wire at least partially extends out of the second end. The pull wire extending out of the second end when the second end is in a contracted state is defined as a free segment, and the free segment is placed toward the distal end of the first fixed bracket. A positioning mark is provided on the outer surface of the outer tube, and the positioning mark is provided corresponding to the free segment.

[0026] An expandable fistula-blocking stent provided in one embodiment of the present application is equipped with a barrier film arranged on the first fixed stent and / or the second fixed stent. The barrier film can isolate the first fixed stent and the second fixed stent to prevent liquid or food from flowing between the first cavity and the second cavity, thereby improving the blocking effect and reducing the possibility of causing complications. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 It is a three-dimensional schematic diagram of an expandable fistula blocking stent according to an embodiment of the present application, wherein the flange is configured to be mushroom-shaped.

[0028] Figure 2 It is a front view of an expandable fistula blocking stent according to an embodiment of the present application.

[0029] Figure 3 It is a side view of an expandable fistula blocking stent according to an embodiment of the present application.

[0030] Figure 4 It is a cross-sectional view of an expandable fistula-blocking stent according to an embodiment of the present application, wherein the second coating completely covers the fistula-blocking segment.

[0031] Figure 5 It is a cross-sectional view of an expandable fistula-blocking stent according to an embodiment of the present application, wherein the second coating does not completely cover the fistula-blocking segment.

[0032] Figure 6 It is a three-dimensional schematic diagram of an expandable fistula blocking stent according to an embodiment of the present application, wherein the flange is configured in an umbrella shape.

[0033] Figure 7 It is a three-dimensional schematic diagram of an expandable fistula blocking stent according to an embodiment of the present application, wherein the flange is configured as a hollow tube and is parallel to the first fixed stent.

[0034] Figure 8 for Figure 7 Side view of the expanded fistula-blocking stent.

[0035] Fig. 9 It is a cross-sectional view of an inserter according to an embodiment of the present application.

[0036] Fig.10 It is a schematic diagram of the structure of the insertion system in one embodiment of the present application, wherein the distal end of the first fixing bracket is released from the inserter.

[0037] Fig.11 It is a structural schematic diagram of an insertion system in an embodiment of the present application, wherein the distal end of the first fixing bracket and the second fixing bracket are released from the inserter.

[0038] Fig.12 It is a structural schematic diagram of the insertion system in one embodiment of the present application, wherein the expandable fistula-blocking stent is completely released from the insertion device.

[0039] Fig.13 for Fig.10 Enlarged view of the area within circle A.

[0040] Fig.14 for Fig.11 Enlarged view of the area within circle B.

[0041] Fig.15 for Fig.12 Enlarged view of the area within circle C. DETAILED DESCRIPTION

[0042] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0043] In the following description, the terms “proximal end” and “proximal end” are referred to the operator, and the “proximal end” means the end closer to the operator, and the “distal end” means the end farther from the operator.

[0044] Reference Figures 1 to 3 As shown, the first embodiment of the present application discloses an expansion fistula plugging stent 100, which is used to plug the fistula formed between the adjacent first cavity and the second cavity. The expansion fistula plugging stent 100 includes a first fixed stent 1, a second fixed stent 2, and a barrier film 3 arranged on the first fixed stent 1 and / or the second fixed stent 2. The barrier film 3 can isolate the first fixed stent 1 and the second fixed stent 2 to prevent liquid or food from flowing between the first cavity and the second cavity, thereby improving the plugging effect and reducing the possibility of causing complications.

[0045] Specifically, the first fixed bracket 1 and the second fixed bracket 2 are both woven with silk threads, and the two are connected to form a first connection track. The blocking membrane 3 at least covers the first connection track, thereby preventing tissue fluid or food from passing through the first fixed bracket 1 and the second fixed bracket 2 and flowing between the first cavity and the second cavity.

[0046] The first fixed support 1 is arranged in the first cavity to support the inner wall of the first cavity. The first fixed support 1 is set to be a hollow tube, which has a proximal end, a distal end, and a first lumen extending axially between the proximal end and the distal end. The second fixed support 2 is arranged in the fistula opening and the second cavity. The second fixed support 2 has a first end 210 and a second end 220. The second fixed support 2 extends between the first end 210 and the second end 220, wherein the first end 210 is connected to the first fixed support 1. After the expansion fistula blocking support 100 is placed in the patient to be placed, the fistula opening is blocked, thereby preventing substances such as liquid or food from entering from one cavity to another cavity through the fistula opening.

[0047] This application describes the expansion fistula plugging stent 100 for plugging the fistula formed between the esophagus and the trachea as an example, that is, the first cavity is one of the esophageal cavity and the tracheal cavity, the second cavity is the other of the esophageal cavity and the tracheal cavity, the tracheal cavity is connected to the lung, the tracheal cavity and the inside of the lung are sterile environments, and other substances entering the lung will cause pneumonia and other diseases. The expansion fistula plugging stent 100 is used to plug the fistula formed between the trachea and the esophagus, preventing secretions, food and other substances in the esophagus from entering the tracheal cavity from the fistula and contaminating the respiratory tract, so as to control the occurrence of aspiration pneumonia.

[0048] Reference Figure 1 and Figures 10 to 15 As shown, the expanded fistula blocking stent 100 includes an initial state, a contracted state, and a released state. Figure 1As shown in FIG. 1 , the state of the expanded fistula blocking stent 100 before being contracted and placed in the inserter 200 is defined as the initial state. Before the expanded fistula blocking stent 100 is placed in the patient to be implanted, the expanded fistula blocking stent 100 is contracted in the tubular structure of the inserter 200 as a whole, and the state of the expanded fistula blocking stent 100 at this time is defined as the contracted state; Fig.10 , Fig.11 , Fig.13 and Fig.14 As shown, the expandable fistula-blocking stent 100 is transported from the tracheal cavity or the esophageal cavity to the target area by the inserter 200, and the inserter 200 is operated to slowly release the expandable fistula-blocking stent 100 from the inserter 200. Under its own elastic force and memory tension, the released part of the expandable fistula-blocking stent 100 gradually rebounds and partially recovers to the initial state, and the unreleased expandable fistula-blocking stent 100 is still in a contracted state. The state of the expandable fistula-blocking stent 100 at this time is defined as a released state. In this application, the target area refers to the area where the inserter 200 can start to release the expandable fistula-blocking stent 100. Fig.12 and Fig.15 As shown, the inserter 200 is operated continuously until the expandable fistula blocking stent 100 is completely released from the inserter 200, and the completely released expandable fistula blocking stent 100 is restored to the initial state. In the initial state, the expandable fistula blocking stent 100 elastically abuts against the inner wall of the trachea, esophagus and fistula opening, thereby fixing the expandable fistula blocking stent 100 in the trachea and esophagus and blocking the fistula opening.

[0049] In the following description of the shape and size of the expandable fistula plugging stent 100 , unless otherwise specified, the shape and size mentioned are the shape and size of the expandable fistula plugging stent 100 in an initial state.

[0050] Reference Figure 1 and Figure 2As shown, the direction parallel to the central axis of the first fixed bracket 1 is defined as the first direction, and the direction parallel to the central axis of the second fixed bracket 2 is defined as the second direction. The first direction and the second direction intersect, and the angle between the first direction and the second direction is set to 45° to 135°. In the first direction, the second fixed bracket 2 is located in the middle of the first fixed bracket 1. Preferably, the first direction and the second direction are perpendicular to each other. It should be noted that the parallel and perpendicular mentioned in this application are not absolute parallel and absolute perpendicular in the mathematical sense, but are roughly perpendicular and roughly parallel with certain manufacturing errors and errors caused by deformation. Optionally, the error range is ±15°. The first fixed bracket 1 is used to be placed in one of the tracheal cavity and the esophageal cavity, and is used to fix the position of the expansion fistula blocking bracket 100 in the esophagus or trachea to prevent the expansion fistula blocking bracket 100 from shifting relative to the trachea or esophagus; the second fixed bracket 2 passes through the fistula opening and is partially located in the other of the tracheal cavity and the esophageal cavity, and is used to block the fistula opening and limit the second fixed bracket 2.

[0051] Before the expandable fistula-blocking stent 100 is inserted, the expandable fistula-blocking stent 100 is contracted as a whole in the tubular structure of the inserter 200 and is in a contracted state, and the expandable fistula-blocking stent 100 is transported from the first cavity to the target area by the inserter 200; then the inserter 200 is operated to slowly send out the expandable fistula-blocking stent 100, and the second fixed stent 2 is gradually sent out and passed through the fistula opening under the action of external force and placed in the second cavity, and the inserter 200 is continued to be operated until the expandable fistula-blocking stent 100 is completely released from the inserter 200; the external force is removed, and Under its own elastic force and memory tension, the second fixed bracket 2 is unfolded, and part of the unfolded second fixed bracket 2 is located in the fistula opening and abuts against the inner wall of the fistula opening to complete the blocking of the fistula opening, and part of the unfolded second fixed bracket 2 is located in the second cavity and abuts against the inner wall of the second cavity to prevent the second fixed bracket 2 from detaching from the second cavity. After the first fixed bracket 1 is completely released, it is unfolded and restored to its initial state under its own elastic force and memory tension. The first fixed bracket 1 elastically abuts against the inner wall of the first cavity to prevent the expansion fistula blocking bracket 100 from moving relative to the first cavity, thereby realizing the positioning of the expansion fistula blocking bracket 100.

[0052] In order to achieve a better fixation effect, when the expansion fistula plugging stent 100 is inserted from the tracheal cavity, the diameter of the first fixed stent 1 is greater than the diameter of the tracheal cavity. In order to improve the comfort of the person to be inserted, the diameter of the first fixed stent 1 is slightly greater than the diameter of the tracheal cavity. In one embodiment, the outer diameter of the first fixed stent 1 is 8mm-24mm, and the length is 25mm-45mm. Preferably, the outer diameter of the first fixed stent 1 is set to 12mm, 14mm, 16mm, 18mm, 20mm, 22mm or 24mm, and the length is set to 40±5mm, 30±5mm or 40±4mm. When the first fixed stent 1 is used to be fixed in the main trachea, the outer diameter of the first fixed stent 1 is set to 14mm-24mm, and the length is 40±5mm or 30±5mm. Preferably, the outer diameter of the first fixed stent 1 is set to 16mm, 18mm, 20mm, 22mm or 24mm. When the first fixing bracket 1 is used to be fixed in the bronchus, the outer diameter of the first fixing bracket 1 is set to 8 mm-16 mm, and the length is 40±4 mm. Optionally, the outer diameter of the first fixing bracket 1 is set to 12 mm or 14 mm.

[0053] The first fixed bracket 1 and the second fixed bracket 2 are split structures, that is, the two are connected together after being manufactured separately. In the embodiment disclosed in the present application, the first fixed bracket 1 and the second fixed bracket 2 are connected together by a suturing process, and the first connection track is the first suturing track generated by suturing. Specifically, the first fixed bracket 1 and the second fixed bracket 2 are connected together by suturing with a soft wire. In one embodiment, the soft wire is a PTFE (Polytetra fluoroethylene) soft wire.

[0054] Reference Figure 3 and Figure 4 As shown, the barrier film 3 includes a first coating 31 that at least partially covers the first fixing bracket 1, and the first coating 31 at least covers the first connection track, that is, the first coating 31 completely covers the first end 210 of the second fixing bracket 2 to prevent food, secretions and other substances from flowing between the two cavities through the fistula. The first coating 31 is made of a silicone film, which can prevent food, secretions and other substances from entering the interior of the first fixing bracket 1 from the inner cavity of the second fixing bracket 2.

[0055] In one embodiment, the first coating 31 is an integrally formed structure with the first fixing bracket 1. Specifically, the manufactured first fixing bracket 1 is immersed in a container containing a coating solution, and after standing for a predetermined time, the bracket adhered with the coating solution is taken out for curing, so that the first coating 31 is fixed to the first fixing bracket 1 to form an integral structure.

[0056] In the embodiment in which the first fixed bracket 1 and the second fixed bracket 2 are connected by suturing, the first connection track includes a plurality of first pinholes formed through the first coating 31. Liquid in the esophageal cavity, such as tissue fluid, can enter the inner cavity of the first fixed bracket 1 through the first pinholes, and then enter the tracheal cavity. The liquid enters the lungs along the trachea, which will cause serious complications such as lung infection. In addition, the first coating 31 is configured as a silicone membrane, which has poor acid resistance. After the expansion fistula plugging stent 100 is placed in the patient for a period of time, the first coating 31 may be corroded and damaged by the acidic liquid in the esophagus. When the first coating 31 is damaged, secretions and food in the esophagus will enter the trachea from the damaged part of the first coating 31, causing complications such as lung infection. In order to prevent the liquid in the esophagus from entering the lungs from the first pinholes and / or the damaged part of the first coating 31, a combination of Figure 1 and Figure 4 As shown, the barrier film 3 further includes a first barrier film 32 connected to the first fixing bracket 1 and / or the second fixing bracket 2, and the first barrier film 32 at least covers the first connection track. In one embodiment, the first barrier film 32 is connected to the first fixing bracket 1 and covers the first connection track.

[0057] The first barrier film 32 is connected to the inner side and / or the outer side of the first fixed bracket 1, so that a receiving cavity is formed between the first barrier film 32 and the first fixed bracket 1. The track formed by connecting the first barrier film 32 and the first fixed bracket 1 is defined as the second connection track, the area enclosed by the second connection track is larger than the area enclosed by the first connection track, and the second connection track completely surrounds the first connection track, so that the first connection track is located in the receiving cavity. When the liquid flows from the first needle hole and / or the damaged part of the first coating 31 to the first fixed bracket 1, the liquid is stored in the receiving cavity and does not flow into the trachea, thereby effectively preventing the liquid from flowing into the lungs from the first needle hole to avoid lung infection.

[0058] In the embodiment disclosed in the present application, a suturing process is used to sew the first barrier film 32 to the first fixed bracket 1. The above-mentioned second connection track is a second suturing track. During the suturing process, a plurality of second pinholes are formed on the first covering film 31 and the first barrier film 32. The plurality of second pinholes are sealed with silicone to prevent liquid from entering the lungs through the second pinholes.

[0059] In one embodiment, the first barrier film 32 is an acid-resistant film, which is made of materials such as PTFE (Polytetra fluoroethylene) or FEP (Fluorinated ethylene propylene) or ePTE (polytetrafluoroethylene). In an alternative embodiment, the barrier film 3 can be made of other acid-resistant materials.

[0060] Since the shrinkage performance and elastic deformation ability of the PTFE membrane are relatively poor, if the area of ​​the first barrier membrane 32 is too large, it will hinder the placement of the expandable fistula-blocking stent 100. Therefore, when designing, it is necessary to make the size of the first barrier membrane 32 as small as possible while ensuring that the first barrier membrane 32 can prevent liquid from entering the lungs from the first pinhole or the damaged part of the first coating 31.

[0061] Specifically, the first barrier film 32 does not completely cover the first fixing bracket 1 , but completely covers the first connecting track, that is, the area of ​​the first barrier film 32 is smaller than the surface area of ​​the first fixing bracket 1 , but larger than the area surrounded by the first connecting track.

[0062] In the embodiment disclosed in the present application, in the first direction, the size of the first barrier film 32 is smaller than the size of the first fixed bracket 1 and larger than the size of the first connection track, and in the circumferential direction of the first fixed bracket 1, the two ends of the first barrier film 32 are spaced apart from each other, that is, in the circumferential direction of the first fixed bracket 1, the size of the first barrier film 32 is smaller than the circumference of the first fixed bracket 1 and larger than the size of the first connection track, so that the first barrier film 32 can completely cover the first connection track. In the first direction and the circumferential direction of the first fixed bracket 1, the first connection track is located in the middle of the first barrier film 32, so that the first barrier film 32 can completely cover the first connection track while minimizing the size of the first barrier film 32. In one embodiment, a certain stitching margin is reserved between the edge of the first barrier film 32 and the second connection track to ensure the stitching stability of the first barrier film 32.

[0063] In an alternative embodiment, the first barrier film 32 can be set to be continuous in the circumferential direction of the first fixed bracket 1, that is, the first barrier film 32 is set to be a hollow cylinder, so that the first barrier film 32 completely covers the surface of the first fixed bracket 1 in the circumferential direction. Similar to the implementation disclosed in the present application, in the first direction, the size of the first barrier film 32 is smaller than the size of the first fixed bracket 1 and larger than the size of the first connection track. In this embodiment, the first barrier film 32 is sewn to the first fixed bracket 1 to form the above-mentioned second connection track, and also forms a third connection track. The third connection track does not intersect with the second connection track, and the third connection track completely surrounds the second connection track. The first barrier film 32 is sewn to the first fixed bracket 1 at multiple locations, which can ensure the connection stability of the first barrier film 32 and the first fixed bracket 1. A certain sewing margin is reserved between the edge of the first barrier film 32 and the third connection track, which can ensure the sewing stability of the first barrier film 32.

[0064] In other alternative embodiments, the first barrier film 32 is disposed between the first fixing bracket 1 and the second fixing bracket 2, and is connected to the second fixing bracket 2. Specifically, before the first fixing bracket 1 and the second fixing bracket 2 are connected together, the first barrier film 32 covers the opening of the first end 210 of the second fixing bracket 2, and the first barrier film 32 is connected to the second fixing bracket 2, and then the second fixing bracket 2 is connected to the first fixing bracket 1, and the pinholes formed by suturing are sealed with silicone.

[0065] Continue to refer to Figure 3 and Figure 4 As shown, in order to improve the blocking effect, the barrier film 3 further includes a second coating 33 that at least partially covers the second fixing bracket 2. The second coating 33 and the second fixing bracket 2 are an integrally formed structure. Specifically, the manufactured second fixing bracket 2 is immersed in a container filled with a coating solution, and after standing for a predetermined time, the bracket adhered with the coating solution is taken out for curing, so that the second coating 33 is fixed to the second fixing bracket 2 to form an integral structure.

[0066] To further improve the blocking effect, the blocking film 3 further includes a second blocking film 34 disposed inside the second fixing bracket 2 to form a blockage. The second blocking film 34 is disposed in a space surrounded by the second covering film 33 to form a blockage.

[0067] Specifically, the first end 210 of the second fixed stent 2 is provided with a fistula blocking section 21, and the second end 220 is provided with at least one flange 22, the diameter of the flange 22 is larger than the diameter of the fistula blocking section 21, the second covering film 33 covers the fistula blocking section 21 and the flange 22, and the second blocking film 34 is arranged inside the fistula blocking section 21 and / or the flange 22 to form a blockage. After the expansion fistula blocking stent 100 is implanted, the fistula blocking section 21 is located in the fistula opening, and the fistula blocking section 21, the second covering film 33 and the second blocking film 34 work together to support and block the fistula opening, and the flange 22 is located in the second cavity, which is used to limit the entire expansion fistula blocking stent 100, and can effectively prevent the flange 22 from shifting from the second cavity to the first cavity, thereby effectively preventing the expansion fistula blocking stent 100 from shifting.

[0068] Reference Figure 5As shown, in order to better promote the healing of the fistula, the expansion fistula blocking stent 100 of the present application can be set to a structure in which the second coating 33 does not completely cover the fistula blocking section 21 of the second fixed stent 2, so that the granulation tissue at the fistula gradually passes through the gap between the braided wires of the fistula blocking section 21 during the growth process and enters the inside of the fistula blocking section 21, and finally the granulation tissue grows together and squeezes part of the second fixed stent 2 and separates from the first fixed stent 1, so as to facilitate the healing of the fistula. In this embodiment, the fistula blocking section 21 includes a hollow section 211 and a coating section 212, the hollow section 211 is closer to the first fixed stent 1 than the coating section 212, the inner and outer sides of the hollow section 211 are not provided with the second coating 33, the coating section 212 is provided with the second coating 33, and the second barrier film 34 is provided in the space surrounded by the second coating 33 of the coating section 212 to form a blockage.

[0069] In an alternative embodiment, the barrier film 3 only includes the first covering film 31, and silicone is used to seal the first pinholes to ensure the sealing effect.

[0070] In an alternative embodiment, the barrier film 3 only includes the first barrier film 32 covering the first connection track.

[0071] In an alternative embodiment, the barrier film 3 only includes the second covering film 33 and the second barrier film 34 disposed in the space surrounded by the second covering film 33 to form a blockage.

[0072] To achieve a better blocking effect, the minimum outer diameter of the fistula blocking segment 21 is larger than the maximum inner diameter of the fistula opening. To prevent the fistula opening from being excessively enlarged by the fistula blocking segment 21 and causing secondary damage to the recipient, the minimum outer diameter of the fistula blocking segment 21 is slightly larger than the maximum inner diameter of the fistula opening.

[0073] In one embodiment, the outer diameter of the fistula blocking section 21 is set to 4mm-30mm. Optionally, the outer diameter of the fistula blocking section 21 is set to 4mm, 6mm, 9mm, 12mm, 15mm, 18mm, 20mm, 22mm, 25mm or 30mm. The operator selects an expandable fistula blocking stent 100 of appropriate size according to the size of the fistula.

[0074] The first fixed bracket 1 and the second fixed bracket 2 are woven by wires of the same or different materials. In one embodiment, the first fixed bracket 1 and the second fixed bracket 2 are both woven by metal wires. In one embodiment, the first fixed bracket 1 is woven by metal wires, and the second fixed bracket 2 is woven by non-metallic degradable wires. More specifically, the material of the metal wire is a nickel-titanium alloy or an absorbable magnesium alloy with good biocompatibility, and the non-metallic degradable material is PLA (PolyLactic Acid) or PLG (Lactide-co-Glycolide).

[0075] The manufacturing process of the first fixing bracket 1 and the second fixing bracket 2 is not limited to the weaving process, and 3D printing process, engraving process, etc. can also be used.

[0076] When the manufacturing material of the second fixing bracket 2 is a degradable material, during the slow degradation of the second fixing bracket 2, the fistula is closed by clamping or nylon ligation at the second cavity end, and dry cells or PRP (Platelet-rich plasma) can also be injected to promote the healing of the fistula tissue. When the fistula is completely closed and healed, after the injection of methylene blue to confirm that it is correct, the first fixing bracket 1 is pulled out of the first cavity, and the fistula treatment is completed.

[0077] The outer surface of the metal wire is provided with an anti-corrosion coating or an antibacterial coating. The anti-corrosion coating is composed of polysilicone, and the antibacterial coating is composed of one or more of organic silicon cationic steroids, minocycline, rifampicin, gentamicin, vancomycin, and hydrophobic materials.

[0078] In an optional embodiment, the expandable fistula-blocking stent 100 also includes a pull wire 4 arranged at the second end 220, and the pull wire 4 is circumferentially passed through the second end 220. The second end 220 can be contracted by tightening the pull wire 4. The second end 220 in the contracted state has a smaller volume, so that the second end 220 can be smoothly dragged from the first cavity through the fistula opening into the second cavity, thereby reducing the difficulty of insertion and improving the efficiency of insertion. At the same time, during the insertion process, the friction between the second fixed stent 2 and the fistula opening is reduced, thereby reducing the probability of secondary injury to the patient.

[0079] Reference Figure 1 , Figure 3 , Fig.10 and Fig.13 As shown, the second end 220 can be contracted by tightening the pulling wire 4. The second end 220 in the contracted state is smaller in size, so that the second end 220 can be smoothly dragged from the first cavity through the fistula into the second cavity, which reduces the difficulty of insertion and improves the efficiency of insertion. At the same time, the friction between the second fixed bracket 2 and the fistula is reduced during the insertion process, which reduces the probability of secondary injury to the patient. The pulling wire 4 is released, and the second end 220 is expanded to position the second fixed bracket 2.

[0080] The pulling wire 4 is circumferentially arranged in the second end 220. When the second end 220 is in a contracted state, the pulling wire 4 at least partially extends out of the second end 220. The pulling wire 4 extending out of the second end 220 when the second end 220 is in a contracted state is defined as a free section 42. The free section 42 is placed toward the distal end of the first fixed bracket 1 for the operator to grasp and apply force to contract and shift the second fixed bracket 2.

[0081] Before the expansion fistula blocking stent 100 is placed in the inserter 200, a force is applied to the free segment 42 of the pulling wire 4 to shrink the second end 220 of the second fixed stent 2, so that the second fixed stent 2 can be easily dragged into the second cavity through the fistula opening during the release of the expansion fistula blocking stent 100. After the expansion fistula blocking stent 100 reaches the target area, the inserter 200 is operated to slowly send the expansion fistula blocking stent 100 out. When the operator observes that the free segment 42 of the pulling wire 4 is exposed from the inserter 200, the operator pulls the free segment 42 to apply an external force toward the second cavity to the second fixed stent 2, thereby gradually dragging the second fixed stent 2 into the second cavity through the fistula opening. After the expansion fistula blocking stent 100 is released, the external force is removed, and the second fixed stent 2 is unfolded under its own elastic force and memory tension, completing the blocking of the fistula opening and the fixation of the second fixed stent 2.

[0082] The material of the pulling wire 4 can be the same as that of the second fixing bracket 2, or can be a non-metallic material with good biocompatibility. Figure 1 and Figure 3 As shown, the expandable fistula plugging stent 100 further includes a retrieval line 5 connected to the first fixed stent 1, and the retrieval line 5 is circumferentially arranged at the proximal end of the first fixed stent 1. The retrieval line 5 is used for the operator to grab and apply force to drag the expandable fistula plugging stent 100 out of the implanted body, and to shrink the first fixed stent 1 so as to shrink the expandable fistula plugging stent 100 into the implanter 200.

[0083] In the present application, the shape of the flange 22 is not limited, and it can be set as follows: Figure 1 The mushroom shape shown can also be set to other shapes. Figure 6 As shown, the flange 22' of the expansion fistula blocking stent 100' is configured in an umbrella shape, such as Figure 7 and Figure 8 As shown, the flange 22 ″ of the expandable fistula plugging stent 100 ″ is configured as a hollow tube, so that the expandable fistula plugging stent 100 ″ is H-shaped as a whole. Figure 6 , Figure 7 and Figure 8 Compared with the above-mentioned embodiment, only the structure of the flanges 22 ′, 22 ″ is changed in the illustrated embodiment. For other identical structures, the same reference numerals are used in this embodiment and are not described in detail.

[0084] Reference Figure 7 and Figure 8 As shown, specifically, the flange 22" of the expansion fistula plugging stent 100" is set to a hollow tubular shape, and the central axis of the flange 22" is parallel to the central axis of the first fixed stent 1. In the first direction, the size of the flange 22" is smaller than the size of the first fixed stent 1, and is arranged in the middle of the first fixed stent 1. The above-mentioned second end 220 is the distal end and proximal end of the flange 22", and the pull wire 4 is arranged at the proximal end and / or distal end of the flange 22".

[0085] In other embodiments, in the first direction, the size of the flange 22 ″ may be set to be greater than or equal to the size of the first fixing bracket 1 .

[0086] Since the inner diameter of the esophageal cavity of a person is usually 16mm-20mm, and the inner diameter of the tracheal cavity is 16mm-20mm, when the inner diameter of the fistula opening is greater than 16mm, the diameter of the protrusions at both ends of the fistula opening is 22mm. When the expansion fistula blocking stents 100, 100' with mushroom-shaped or umbrella-shaped flanges 22, 22' are used for blocking, in order to achieve a better blocking effect, the outer diameter of the flanges 22, 22' needs to be set larger than the inner diameter of the esophageal cavity or the inner diameter of the tracheal cavity, which will affect the normal swallowing of food or cause tracheal stenosis. When the flange 22" is set to an umbrella shape, the edge of the flange 22' may cut the tracheal wall and cause complications. Therefore, when the inner diameter of the fistula opening is greater than 16mm-24mm, it is used as follows Figure 8 The expanded fistula blocking stent 100 ″ shown is used for blocking, and the expanded fistula blocking stent 100 ″ is inserted from the esophageal cavity.

[0087] In an alternative embodiment, the first coating 31 and the first fixed bracket 1, the second coating 33 and the second fixed bracket 2 are respectively formed and then connected together. The shape and size of the first coating 31 match the shape and size of the first fixed bracket 1, and the shape and size of the second coating 33 match the shape and size of the second fixed bracket 2. After the first fixed bracket 1, the second fixed bracket 2, the first coating 31 and the second coating 33 are respectively manufactured, the first coating 31 is installed to the inner side or outer side of the first fixed bracket 1, and the second coating 33 is installed to the inner side or outer side of the second fixed bracket 2. The coating and the fixed bracket can be connected by a hot melt process or by utilizing the elasticity of the coating and the fixed bracket themselves. When the connection is achieved by utilizing the elasticity of the coating and the fixed bracket themselves, when the coating is set on the outside of the fixed bracket, the outer diameter of the fixed bracket is greater than or equal to the inner diameter of the coating, so that the fixed bracket and the coating can fit tightly; when the coating is set on the inside of the fixed bracket, the inner diameter of the fixed bracket is less than or equal to the outer diameter of the coating, so that the two can fit tightly together.

[0088] In an alternative embodiment, the pull wire 4 may not be provided. In an embodiment where the pull wire 4 is not provided, the second end 220 of the second fixing bracket 2 is contracted in other ways, or the second end 220 of the second fixing bracket 2 may not be contracted.

[0089] Combination Figure 1 and Figures 9 to 14As shown, the present application also provides an insertion system, which includes an inserter 200 and the above-mentioned expandable fistula plugging stent 100, 100', 100", and the expandable fistula plugging stent 100, 100', 100" is inserted into the body of a person to be inserted through the inserter 200. The inserter 200 includes a first handle 201, a booster tube 202 connected to the first handle 201, a middle tube 203 connected to the booster tube 202, an inner tube 204 connected to the middle tube 203, a pusher head 205 connected to the inner tube 204, a second handle 206, an outer tube 207 connected to the second handle 206, and a safety lock 208 for locking the relative position between the second handle 206 and the booster tube 202. The first handle 201 is closer to the operator than the second handle 206. The booster tube 202 passes through the second handle 206 and is connected to the middle tube 203. The outer tube 207 is covered on the outside of the booster tube 202, the middle tube 203 and the inner tube 204. The expanded fistula blocking stents 100, 100', 100" are contracted and placed between the inner tube 204 and the outer tube 207. The safety lock 208 is opened, and the second handle 206 is operated to move the second handle 206 relative to the booster tube 202, which can drive the outer tube 207 to move relative to the inner tube 204. After the outer tube 207 is moved into place, the safety lock 208 is tightened to lock the relative position of the second handle 206 and the booster tube 202.

[0090] The outer diameter of the inner tube 204 is smaller than that of the middle tube 203, so that there is a gap between the inner wall of the outer tube 207 and the outer wall of the inner tube 204, and the gap forms an accommodation space for accommodating the expanded fistula plugging stent 100, 100', 100" in a contracted state.

[0091] The middle tube 203 includes a distal end connected to the inner tube 204, and the push head 205 includes a proximal end connected to the inner tube 204. The outer diameter of the inner tube 204 is smaller than the outer diameters of the distal end of the middle tube 203 and the proximal end of the push head 205. The outer wall of the inner tube 204, the inner wall of the outer tube 207, the distal end surface of the middle tube 203, and the proximal end surface of the push head 205 are arranged to form the above-mentioned accommodation space. Since the outer diameter of the inner tube 204 is smaller than the outer diameters of the proximal ends of the middle tube 203 and the push head 205, a step is formed at the connection between the inner tube 204 and the middle tube 203 and at the connection between the inner tube 204 and the push head 205, so that the axial relative position relationship between the expanded fistula plugging stent 100, 100', 100" in a contracted state installed in the accommodation space and the inner tube 204 is fixed, thereby improving the placement accuracy.

[0092] Release the safety lock 208, operate the second handle 206 to move the outer tube 207 toward the distal end of the inner tube 204, thereby gradually shrinking the expandable fistula-blocking stent 100, 100', 100" into the accommodating space; when the expandable fistula-blocking stent 100, 100', 100" is completely shrunk into the accommodating space, tighten the safety lock 208 to lock the relative position of the second handle 206 and the booster tube 202, operate the first handle 201, and insert the expandable fistula-blocking stent 100, 100', 100" into the person to be implanted; when it is necessary to release the expandable fistula-blocking stent 100, 100', 100", release the safety lock 208, operate the second handle 206 to move the outer tube 207 back, thereby gradually releasing the expandable fistula-blocking stent 100, 100', 100" from the outer tube 207.

[0093] In order to improve the placement accuracy of the expandable fistula-blocking stent 100, 100', 100", a positioning mark 2071 is set on the outer tube 207. When the positioning mark 2071 reaches the predetermined position, it indicates that the expandable fistula-blocking stent 100, 100', 100" has reached the target area. The target area of ​​the present application refers to the area where the outer tube 207 can start to release the expandable fistula-blocking stent 100, 100', 100".

[0094] Specifically, in one embodiment, the positioning mark 2071 is set at one end of the outer tube 207 close to the second handle 206. In this embodiment, before the expandable fistula-blocking stent 100, 100', 100" is sent into the first cavity, the fistula position information is obtained by an image scanning device or an endoscope, and the depth of insertion of the inserter 200 is obtained by combining the fistula position information and the size data of the inserter 200, and then the relative position relationship between the outer tube 207 and the mouth or other organs of the person to be inserted is obtained when the inserter 200 reaches the target area. The positioning mark 2071 is marked at the corresponding position of the outer tube 207. When the positioning mark 2071 reaches the corresponding position of the person to be inserted, it indicates that the expandable fistula-blocking stent 100, 100', 100" has reached the target area, and the insertion of the inserter 200 into the first cavity is stopped.

[0095] In an alternative embodiment, the positioning mark 2071 can be set at the end of the outer tube 207 away from the second handle 206, referring to Fig.11 and Fig.13As shown, in this embodiment, before the expandable fistula plugging stent 100, 100', 100" is sent into the first cavity, the first cavity endoscope is sent into the first cavity, and the position of the first cavity endoscope can capture the position information of the fistula opening. The positioning mark 2071 is set in the area of ​​the outer tube 207 corresponding to the first connection track of the expandable fistula plugging stent 100, 100', 100". When the first cavity endoscope captures the positioning mark 2071 and the positioning mark 2071 is located within the fistula opening in the first direction, it indicates that the expandable fistula plugging stent 100, 100', 100" has reached the target area, and the insertion device 200 into the first cavity is stopped.

[0096] In the process of delivering the expandable fistula blocking stent 100, 100', 100" into the target area, the entire inserter 200 rotates at an undetermined angle, so that the free segment 42 of the puller wire 4 is very likely not within the observation range of the second cavity endoscope in the circumferential direction, so that the operator cannot capture the puller wire 4 in time and drag the puller wire 4 into the second cavity. In this case, it is necessary to rotate the first handle 201 to make the free segment 42 of the puller wire 4 within the observation range of the second cavity endoscope. In addition, in order to facilitate the foreign body forceps to pass through the fistula opening and clamp the free segment 42, it is necessary to make the free segment 42 face the fistula opening, and the light in the first cavity is weak, and it is difficult for the second cavity endoscope to accurately identify the position of the free segment 42 through the outer tube 207.

[0097] To solve the above problems, the outer tube 207 of the inserter 200 of the present application is also provided with a positioning mark 2072, which is arranged on the outer surface of the outer tube 207 and is a conspicuous line segment. The positioning mark 2072 is arranged corresponding to the free section 42 of the expanded fistula plugging stent 100, 100', 100" in the contracted state. After the expanded fistula plugging stent 100, 100', 100" reaches the target area, the first handle 201 is rotated to make the positioning mark 2072 within the observation range of the second cavity endoscope, so that the operator can accurately and timely drag the traction wire 4 into the second cavity.

[0098] In other alternative embodiments, the positioning mark 2072 can be configured as a marker that is detachably connected to the outer tube 207 .

[0099] In one embodiment, the expandable fistula plugging stent 100 is inserted from the tracheal cavity. After the insertion is completed, the first fixed stent 1 is placed in the trachea, and the second fixed stent 2 passes through the fistula and is partially placed in the esophagus. Compared with the esophageal cavity, no liquid or solid passes through the tracheal cavity, and the inner diameter of the tracheal cavity fluctuates less. Therefore, placing the first fixed stent 1 inside and against the inner wall of the tracheal cavity can ensure the positioning stability of the expandable fistula plugging stents 100, 100', 100".

[0100] In the embodiment where the pulling wire 4 is not provided, the positioning mark 2072 is provided corresponding to the second fixing bracket 2. After the foreign body forceps pass through the fistula opening, the second fixing bracket 2 is clamped. After the fistula blocking bracket 100, 100', 100" is expanded to reach the target area, the first handle 201 is rotated to make the positioning mark 2072 within the observation range of the second cavity endoscope, so that the operator can accurately and timely drag the second fixing bracket 2 into the second cavity.

[0101] When implanting from the tracheal cavity, the expandable fistula blocking stent 100, 100' is selected, the first cavity is the tracheal cavity, and the second cavity is the esophageal cavity. The implantation method of the implantation system of the present application includes the following steps:

[0102] S11: shrinking the expanded fistula blocking stent 100, 100' into the accommodation space of the inserter 200, specifically:

[0103] The first fixed stent 1 of the expansion fistula plugging stent 100, 100' is sleeved on the outer side of the inner tube 204 of the inserter 200. The operator applies force to the recovery line 5 and the pulling line 4 to shrink the proximal end of the first fixed stent 1 and the second end 220 of the second fixed stent 2, and releases the safety lock 208. The operator operates the second handle 206 of the inserter 200 to move the outer tube 207 of the inserter 200 toward the distal end of the inserter 200 and gradually accommodate the first fixed stent 1 into the outer tube 207. The operator continues to operate the second handle 206 of the inserter 200 to move the outer tube 207 toward the distal end of the inserter 200 until the expansion fistula plugging stent 100, 100' is completely accommodated in the accommodation space between the outer tube 207 and the inner tube 204, and then tightens the safety lock 208.

[0104] S12: inserting the inserter 200 into the first cavity, specifically:

[0105] Insert a cannula into the first lumen, and the first lumen endoscope enters the first lumen through the cannula. The inner diameter of the first lumen exceeds the fistula position. Leave a guide wire in place, withdraw the first lumen endoscope, and insert the inserter 200 from the cannula into the first lumen through the guide wire.

[0106] S13: Positioning the positioning mark 2072 of the inserter 200, specifically:

[0107] The second cavity endoscope is inserted from the second cavity and reaches the fistula opening. The second cavity endoscope can observe through the fistula opening whether the expansion fistula blocking stent 100, 100' in the first cavity is inserted in place. The inserter 200 is rotated until the second cavity endoscope can observe the positioning mark 2072, and the positioning mark 2072 faces the fistula opening.

[0108] S14: Partially release the expanded fistula blocking stents 100, 100' and pull the free section 42 of the pulling wire 4 into the second cavity. Specifically:

[0109] Release the safety lock 208, operate the second handle 206 to retract the outer tube 207 to gradually release the expansion fistula blocking stent 100, when the free segment 42 of the pulling wire 4 is observed from the second cavity endoscope, stop releasing the expansion fistula blocking stent 100, 100', extend the foreign body forceps through the forceps channel of the second cavity endoscope, cross the fistula opening and enter the first cavity to grab the free segment 42 of the pulling wire 4, and drag the free segment 42 of the pulling wire 4 through the fistula opening into the second cavity;

[0110] S15: Completely releasing the expanded fistula blocking stents 100 and 100', specifically:

[0111] The outer tube 207 is continuously retracted to gradually release the expanded fistula blocking stents 100, 100', and at the same time, the foreign body forceps continuously apply a force toward the second lumen to the free section 42, so that during the gradual release of the expanded fistula blocking stents 100, 100', the second fixed stent 2 is gradually dragged into the second lumen through the fistula opening by the foreign body forceps, and the outer tube 207 is continuously retracted until the proximal end of the first fixed stent 1 is released from the outer tube 207;

[0112] S16: completing the positioning of the expansion and fistula blocking stents 100 and 100', specifically:

[0113] The foreign body forceps release the free section 42 of the pulling wire 4, so that the second end 220 of the second fixing bracket 2 is released and rebounds to expand, and the expanded fistula blocking bracket 100, 100' is restored to the initial state, the flange 22 is located in the second cavity and abuts against the inner wall of the second cavity to prevent the second fixing bracket 2 from shifting from the second cavity to the first cavity, the fistula blocking section 21 abuts against the inner wall of the fistula opening to achieve the blocking and support of the fistula opening, and the first fixing bracket 1 elastically abuts against the inner wall of the first cavity to achieve the fixation of the expanded fistula blocking bracket 100, 100';

[0114] S17: withdrawing the inserter 200 and the guide wire from the first lumen;

[0115] S18: Confirm whether the fistula plugging surgery is successful, specifically:

[0116] The dyeing liquid is injected near the fistula opening in the second cavity through the second cavity endoscope, and the first cavity endoscope enters from the first cavity to reach the position of the expanded fistula blocking stent 100, 100'. The first cavity endoscope is used to observe whether the dyeing liquid penetrates from the second cavity into the first cavity. If not, it indicates that the fistula blocking operation is successful.

[0117] When the inner diameter of the fistula is greater than 16 mm to 24 mm, use Figure 8The expandable fistula-blocking stent 100" shown is used for blocking, and the expandable fistula-blocking stent 100" is inserted from the esophageal cavity. In addition, after esophagectomy, the stomach needs to be moved upward to suture the two ends of the esophagus. In this case, the anastomotic fistula formed is relatively narrow, and it is appropriate to place the first fixed stent 1 in the esophageal cavity and the second fixed stent 2 in the tracheal cavity to block the fistula. In one embodiment, the expandable fistula-blocking stent 100, 100', 100" is inserted from the esophageal cavity. After the insertion is completed, the first fixed stent 1 is placed in the esophagus, and the second fixed stent 2 is placed in the tracheal cavity after passing through the fistula.

[0118] When the expandable fistula blocking stent 100, 100', 100" is inserted into the esophageal cavity, the first cavity is the esophageal cavity and the second cavity is the tracheal cavity. The insertion method of the insertion system of the present application includes the following steps:

[0119] S21: Contracting the expanded fistula blocking stents 100, 100', 100" into the inserter 200, specifically:

[0120] The first fixed stent 1 of the expansion fistula plugging stent 100, 100', 100" is sleeved on the outer side of the inner tube 204 of the inserter 200. The operator applies force to the recovery line 5 and the pulling line 4 to shrink the proximal end of the first fixed stent 1 and the second end 220 of the second fixed stent 2, and releases the safety lock 208. The operator operates the second handle 206 of the inserter 200 to move the outer tube 207 of the inserter 200 toward the distal end of the inserter 200 and gradually accommodate the first fixed stent 1 into the outer tube 207. The operator continues to operate the second handle 206 of the inserter 200 to move the outer tube 207 toward the distal end of the inserter 200 until the expansion fistula plugging stent 100, 100', 100" is completely accommodated in the accommodation space between the outer tube 207 and the inner tube 204, and then tightens the safety lock 208.

[0121] S22: inserting the inserter 200 into the first cavity, specifically:

[0122] Inserting a first cavity endoscope from the first cavity, passing the first cavity endoscope over the fistula, leaving a guide wire, withdrawing the first cavity endoscope, and allowing the inserter 200 to enter the first cavity via the guide wire;

[0123] S23: Positioning the positioning mark 2072 of the inserter 200, specifically:

[0124] Insert the cannula into the second lumen, insert the second lumen endoscope from the cannula into the second lumen and reach the fistula opening, the second lumen endoscope can observe through the fistula opening whether the expansion fistula blocking stent 100, 100', 100" in the first lumen is properly placed, rotate the inserter 200 until the second lumen endoscope can observe the positioning mark 2072, and the positioning mark 2072 faces the fistula opening;

[0125] S24: Partially release the expanded fistula blocking stents 100, 100', 100" and drag the free segment 42 of the pulling wire 4 into the second cavity. Specifically:

[0126] Release the safety lock 208, operate the second handle 206 to retract the outer tube 207 to gradually release the expansion and blocking stents 100, 100', 100", and when the free segment 42 of the pulling wire 4 is observed from the second cavity endoscope, stop releasing the expansion and blocking stents 100, 100', 100", extend the foreign body forceps through the forceps channel of the second cavity endoscope, cross the fistula opening and enter the first cavity to grab the free segment 42 of the pulling wire 4, and drag the free segment 42 of the pulling wire 4 through the fistula opening into the second cavity;

[0127] S25: Completely release the expanded fistula blocking stent 100, 100', 100", specifically:

[0128] The outer tube 207 is continuously retracted to gradually release the expanded fistula blocking stents 100, 100', 100", and at the same time, the foreign body forceps continuously apply a force toward the second lumen to the free section 42, so that during the gradual release of the expanded fistula blocking stents 100, 100', 100", the second fixed stent 2 is gradually dragged into the second lumen through the fistula opening by the foreign body forceps, and the outer tube 207 is continuously retracted until the proximal end of the first fixed stent 1 is released from the outer tube 207;

[0129] S26: Positioning of the expansion and blocking fistula stents 100, 100', 100" is completed. Specifically:

[0130] The foreign body forceps release the free section 42 of the pulling wire 4, so that the second end 220 of the second fixing bracket 2 is released and rebounds to expand, and the expanded fistula blocking bracket 100, 100', 100" is restored to the initial state, and the flange 22 is located in the second cavity and abuts against the inner wall of the second cavity to prevent the second fixing bracket 2 from shifting from the second cavity to the first cavity, and the fistula blocking section 21 abuts against the inner wall of the fistula opening to achieve the blocking and support of the fistula opening, and the first fixing bracket 1 elastically abuts against the inner wall of the first cavity to achieve the fixation of the expanded fistula blocking bracket 100, 100', 100";

[0131] S27: withdraw the inserter and the guide wire from the first lumen;

[0132] S28: Confirm whether the fistula plugging surgery is successful, specifically:

[0133] Insert the first cavity endoscope into the first cavity, inject dyeing solution near the fistula opening of the first cavity through the first cavity endoscope, and observe through the second cavity endoscope whether the dyeing solution seeps from the first cavity into the second cavity. If not, it indicates that the fistula blocking operation is successful.

[0134] In the embodiments disclosed in the present application, the staining solution is methylene blue.

[0135] In other alternative embodiments, after the expansion fistula blocking stent 100, 100', 100" is placed, the fistula blocking surgery is deemed to be successful, and the placement method of the placement system may not include the step of confirming whether the fistula blocking surgery is successful.

[0136] In other alternative embodiments, the implantation system may not be provided with the positioning mark 2072 , and accordingly, the implantation method does not include the step of positioning the positioning mark 2072 .

[0137] In the embodiment disclosed in the present application, the guidewire is a zebra guidewire with a diameter of 0.89 mm, the outer diameter of the outer tube 207 of the inserter 200 is less than or equal to 6.7 mm, and the inner diameter of the cannula is 7.5 mm. Of course, these dimensions are only for illustration and do not impose any limitation on the present application.

[0138] In an embodiment where the pulling wire 4 is not provided, the second end 220 of the second fixed bracket 2 can be retracted in other ways, or the second end 220 can be inserted when it is in an initial state; during the insertion process, the foreign body forceps can directly apply force to the second fixed bracket 2, or apply force to the second fixed bracket 2 through other components to drag the second fixed bracket 2 into the second cavity.

[0139] In the description of the present application, it should be understood that if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application.

[0140] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0141] In this application, unless otherwise clearly specified and limited, if the terms "installed", "connected", "connected", "fixed" and the like appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to the specific circumstances.

[0142] In the present application, unless otherwise clearly specified and limited, if there is a description that a first feature is "above" or "below" a second feature, etc., or similar descriptions appear, it may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "above" and "above" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. The first feature being "below", "below" and "below" the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0143] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. If an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. If any, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are for illustrative purposes only and do not represent the only implementation method.

[0144] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0145] The above-described embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be construed as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent application shall be subject to the attached claims.

Claims

1. An expandable fistula blocking stent (100, 100', 100") for blocking a fistula formed between a first cavity and a second cavity adjacent to each other. It is characterized in that The expandable fistula blocking stent (100) comprises: A first fixing bracket (1), the first fixing bracket (1) is in the shape of a hollow tube, and has a proximal end, a distal end, and a first lumen extending axially between the proximal end and the distal end, the first fixing bracket (1) being arranged in the first lumen to support the inner wall of the first lumen; a second fixing bracket (2), disposed in the fistula opening and the second cavity, the second fixing bracket (2) having a first end (210) and a second end (220) arranged opposite to each other, the first end (210) being connected to the first fixing bracket (1); and A barrier film (3), which is arranged on the first fixing bracket (1) and / or the second fixing bracket (2) and is used to block the fistula; The second fixing bracket (2) is connected to the first fixing bracket (1) to form a first connection track, and the blocking film (3) at least covers the first connection track.

2. The expandable fistula blocking stent (100, 100', 100") according to claim 1, It is characterized in that The expandable fistula blocking stent (100) further comprises a pulling wire (4), wherein the pulling wire (4) is arranged at the second end (220), and the second end (220) can be contracted by tightening the pulling wire (4).

3. The expandable fistula blocking stent (100, 100', 100") according to claim 2, It is characterized in that The pulling wire (4) is tightened, and the second end (220) contracts to enable the second fixing bracket (2) to enter the second cavity through the fistula; the pulling wire (4) is released, and the second end (220) expands to position the second fixing bracket (2).

4. The expandable fistula blocking stent (100, 100', 100") according to claim 2, It is characterized in that The pull wire (4) is circumferentially arranged at the second end (220). When the second end (220) is in a contracted state, the pull wire (4) at least partially extends out of the second end (220). The pull wire (4) extending out of the second end (220) when the second end (220) is in a contracted state is defined as a free segment (42). The free segment (42) is placed toward the distal end of the first fixed bracket (1).

5. The expandable fistula blocking stent (100, 100', 100") according to claim 1, It is characterized in that The first fixing bracket (1) and the second fixing bracket (2) are arranged as a split structure and are connected by sewing with soft wire.

6. The expandable fistula blocking stent (100, 100', 100") according to claim 1, It is characterized in that The barrier film (3) comprises a first covering film (31) which at least partially covers the first fixing bracket (1), and the first covering film (31) at least covers the first connecting track.

7. The expandable fistula blocking stent (100, 100', 100") according to any one of claims 1 to 5, It is characterized in that The blocking film (3) comprises a first blocking film (32) connected to the first fixing bracket (1) and / or the second fixing bracket (2), the second fixing bracket (2) being connected to the first fixing bracket (1) to form a first connection track, and the first blocking film (32) at least covers the first connection track.

8. The expandable fistula blocking stent (100, 100', 100") according to claim 7, It is characterized in that The first blocking film (32) is connected to the first fixing bracket (1) to form a second connection track, the area enclosed by the second connection track is larger than the area enclosed by the first connection track, and the first connection track is located inside the second connection track.

9. The expandable fistula blocking stent (100, 100', 100") according to claim 7, It is characterized in that The first barrier film (32) is an acid-resistant film.

10. The expandable fistula blocking stent (100, 100', 100") according to claim 7, It is characterized in that The barrier film (3) further comprises a second covering film (33) at least partially covering the second fixing bracket (2) and a second barrier film (34) arranged in the second fixing bracket (2), wherein the second barrier film (34) is arranged in a space enclosed by the second covering film (33) to form a blockage.

11. The expandable fistula blocking stent (100, 100') according to claim 10, It is characterized in that The first end (210) is provided with a fistula-blocking section (21), the second end (220) is provided with at least one flange (22), the diameter of the flange (22) is larger than the diameter of the fistula-blocking section (21), and the second coating (33) at least covers the fistula-blocking section (21).

12. The expandable fistula blocking stent (100") according to claim 10, It is characterized in that The first end (210) is provided with a fistula blocking section (21), and the second end (220) is provided with a flange (22"), the flange (22") is configured as a hollow tube, and the central axis of the flange (22") is parallel to the central axis of the first fixing bracket (1).

13. The expandable fistula-blocking stent (100, 100', 100") according to claim 1, It is characterized in that The first fixing bracket (1) is braided with metal wires, and the second fixing bracket (2) is braided with degradable silk threads or metal threads.

14. An implantation system, It is characterized in that include: An inserter (200), the inserter (200) comprising a first handle (201), a booster tube (202) connected to the first handle (201), a middle tube (203) connected to the booster tube (202), an inner tube (204) connected to the middle tube (203), a pusher head (205) connected to the inner tube (204), a second handle (206), an outer tube (207) connected to the second handle (206), and a safety lock (208) for locking or unlocking the relative position between the second handle (206) and the booster tube (202). ), the first handle (201) is closer to the operator than the second handle (206), the booster tube (202) passes through the second handle (206) and is connected to the middle tube (203), the inserter (200) is configured as a hollow structure for the guide wire to be inserted for guidance, the diameter of the inner tube (204) is smaller than the diameter of the distal end of the middle tube (203) and the proximal end of the pusher head (205), and the inner tube (204), the distal end of the middle tube (203), the proximal end of the pusher head (205) and the outer tube (207) are surrounded to form a receiving space; and According to the expandable fistula-blocking stent (100, 100', 100") as described in any one of claims 1 to 13, the expandable fistula-blocking stent (100) can be retracted in the accommodating space, the safety lock (208) is released, and the second handle (206) is operated to retract the outer tube (207) to release the expandable fistula-blocking stent (100) from the accommodating space.

15. The implantation system according to claim 14, It is characterized in that The expandable fistula blocking stent (100, 100', 100") also includes a pull wire (4), which is circumferentially arranged at the second end (220). When the second end (220) is in a contracted state, the pull wire (4) at least partially extends out of the second end (220). The pull wire (4) extending out of the second end (220) when the second end (220) is in a contracted state is defined as a free segment (42). The free segment (42) is placed toward the distal end of the first fixed stent (1). A positioning mark (2072) is provided on the outer surface of the outer tube (207), and the positioning mark (2072) is provided corresponding to the free segment (42).

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