Dilation fistula occlusion stent, implantation system and implantation method

Abstract

The application relates to a dilating fistula blocking stent, an implanting system and an implanting method. The dilating fistula blocking stent is used for blocking a fistula formed between adjacent first and second cavities. The dilating fistula blocking stent comprises a first fixed stent, a second fixed stent and a blocking film. The first fixed stent is a hollow tubular structure, which has a proximal end, a distal end and a first lumen extending axially between the proximal end and the distal end. The first fixed stent is arranged in the first cavity. The second fixed stent is arranged in the fistula and the second cavity. The second fixed stent has a first end and a second end. The first end is connected with the first fixed stent. The blocking film is arranged on the first fixed stent or / and the second fixed stent, and is used for blocking the fistula.

Description

Technical Field

[0001] This application relates to the field of minimally invasive treatment technology, and in particular to an expandable fistula occlusion stent, an insertion system, and an insertion method. Background Technology

[0002] A fistula is a disease that connects two adjacent organs due to congenital or acquired causes, such as trauma or esophageal cancer. For example, an esophagotracheal fistula is a fistula that forms between the esophagus and trachea, connecting them. The trachea and lungs are connected, and both are sterile environments. When an esophagotracheal fistula occurs, substances from the esophagus, such as secretions and food, will enter the trachea through the fistula, leading to serious and difficult-to-treat pulmonary complications, such as aspiration pneumonia. In severe cases, it can prevent patients from eating orally, significantly reducing their quality of life.

[0003] The commonly used treatment method in the industry is to use an expansion-occlusion stent to seal the fistula opening. However, among related techniques, the sealing effect of expansion-occlusion stents is relatively poor, leading to complications. Summary of the Invention

[0004] Based on this, this application provides an expansion occlusion stent, an insertion system, and an insertion method that can improve the occlusion effect.

[0005] The first aspect of this application provides an expansion-closing stent for sealing a fistula formed between adjacent first and second cavities, the expansion-closing stent comprising:

[0006] The first fixing bracket is a hollow tube having a proximal end, a distal end, and a first cavity extending axially between the proximal end and the distal end. The first fixing bracket is disposed within the first cavity to support the inner wall of the first cavity.

[0007] A second fixing bracket is disposed within the fistula and the second cavity. The second fixing bracket has a first end and a second end disposed opposite to each other, and the first end is connected to the first fixing bracket.

[0008] A barrier membrane, disposed on the first or / and second fixing bracket, is used to seal the fistula.

[0009] In one embodiment, the dilatation occlusion stent further includes a traction wire disposed at the second end, which can be tightened to retract the second end.

[0010] Furthermore, the traction wire is tightened, and the second end contracts to allow the second fixation bracket to enter the second cavity through the fistula. The traction wire is then released, and the second end expands to position the second fixation bracket.

[0011] Furthermore, the tension line is circumferentially threaded through the second end. When the second end is in a contracted state, the tension line extends at least partially beyond the second end. The tension line extending beyond the second end when the second end is in a contracted state is defined as a free segment, and the free segment is positioned toward the distal end of the first fixed bracket.

[0012] Furthermore, the first fixing bracket and the second fixing bracket are configured as separate structures and are connected by soft thread stitching.

[0013] Furthermore, the barrier membrane includes a first covering that at least partially covers the first fixing bracket, the second fixing bracket being connected to the first fixing bracket to form a first connection trajectory, and the first covering that at least covers the first connection trajectory.

[0014] Furthermore, the blocking membrane includes a first blocking membrane connected to the first fixed bracket and / or the second fixed bracket, the second fixed bracket being connected to the first fixed bracket to form a first connection track, and the first blocking membrane at least covering the first connection track.

[0015] Furthermore, the first barrier membrane is connected to the first fixed bracket to form a second connection trajectory, the area enclosed by the second connection trajectory is larger than the area enclosed by the first connection trajectory, and the first connection trajectory is located within the second connection trajectory.

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

[0017] Furthermore, the barrier membrane also includes a second covering that at least partially covers the second fixed bracket and a second barrier membrane disposed within the second fixed bracket, wherein the second barrier membrane is disposed within the space enclosed by the second covering to form a seal.

[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 as a hollow tube, and the central axis of the flange is parallel to the central axis of the first fixed bracket.

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

[0021] Furthermore, the first fixing bracket is made of woven metal wire, and the second fixing bracket is made of woven biodegradable yarn or metal wire.

[0022] A second aspect of this application provides an insertion system comprising:

[0023] An 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 is closer to the operator than the second handle. The booster tube passes through the second handle and connects to the middle tube. The inner tube is configured as a hollow structure for guide wire insertion. The diameter of the inner tube is smaller than the diameter 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 form an accommodating space.

[0024] The aforementioned expansion and occlusion stent is retractable within the receiving space. By releasing the safety lock and operating the second handle to retract the outer tube, the expansion and occlusion stent can be released out of the receiving space.

[0025] Furthermore, the pull line is circumferentially threaded through the second end. When the second end is in a contracted state, the pull line extends at least partially beyond the second end. The pull line extending beyond the second end when the second end is in a contracted state is defined as a free segment. The free segment is placed toward the far 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] A third aspect of this application provides a method for inserting an insertion system, wherein the dilatation and occlusion stent is inserted into the trachea, the first cavity being the trachea and the second cavity being the esophagus, and the insertion method includes the following steps:

[0027] Retract the expansion and occlusion stent into the receiving space and tighten the safety lock;

[0028] A cannula is inserted into the first cavity, and the first cavity endoscope enters the first cavity through the cannula. The first cavity endoscope passes the fistula position, a guide wire is placed, and the first cavity endoscope is withdrawn. The inserter enters the first cavity through the cannula through the guide wire.

[0029] The second endoscope is inserted into the second cavity and reaches the fistula position. The safety lock is released, and the second handle is operated to retract the outer tube to gradually release the dilation and fistula closure stent. When the traction line is observed through the second endoscope, the release of the dilation and fistula closure stent is paused. The foreign body forceps extend through the forceps channel of the second endoscope and cross the fistula to enter the first cavity to grab the traction line. The traction line is then dragged through the fistula to the second cavity.

[0030] Continue to retract the outer tube to gradually release the dilatation and occlusion stent, while the foreign body forceps continuously apply a force toward the second cavity to the traction line, so that as the dilatation and occlusion stent is gradually released, the second fixation stent is gradually pulled into the second cavity by the foreign body forceps through the fistula opening. Continue to retract the outer tube until the proximal end of the first fixation stent is released out of the outer tube.

[0031] The foreign object clamp releases the traction wire, causing the second end of the second fixing bracket to be released and spring back. The second end is located in the second cavity and abuts against the inner wall of the second cavity to prevent the second fixing bracket from moving from the second cavity to the first cavity.

[0032] The inserter and the guidewire are withdrawn from the first cavity.

[0033] Furthermore, when the second end is in a contracted state, the traction wire extends at least partially beyond the second end. The traction wire extending beyond the second end when the second end is in a contracted state is defined as a free segment. The free segment is positioned towards the distal end of the first fixed support. A positioning mark is provided on the outer surface of the outer tube, and the positioning mark is at least partially corresponding to the free segment. Before the step of releasing the dilatation occlusion stent, a step of positioning the positioning mark is also included. Specifically:

[0034] Rotate the inserter until the second endoscope can observe the positioning mark and the positioning mark is facing the fistula.

[0035] Furthermore, the above-mentioned insertion method also includes a step to confirm whether the fistula closure surgery was successful, specifically:

[0036] The second endoscope injects staining solution near the fistula opening in the second cavity. The first endoscope enters from the first cavity and reaches the position of the dilated fistula-closing stent. The first endoscope observes whether the staining solution seeps from the second cavity into the first cavity. If not, the fistula closure surgery is successful.

[0037] A fourth aspect of this application provides a method for inserting an insertion system, wherein the dilatation and fistula-closing stent is inserted from the esophageal lumen, the first lumen being the esophageal lumen and the second lumen being the tracheal lumen, and the insertion method includes the following steps:

[0038] Retract the expansion and occlusion stent into the receiving space and tighten the safety lock;

[0039] The first cavity endoscope is inserted into the first cavity, the first cavity endoscope passes the fistula position, a guide wire is placed, the first cavity endoscope is withdrawn, and the inserter enters the first cavity through the guide wire;

[0040] The cannula is inserted into the second cavity, and the endoscope of the second cavity is inserted into the second cavity through the cannula and reaches the fistula position. The safety lock is released, and the second handle is operated to retract the outer tube to gradually release the dilation and fistula closure stent. When the traction line is observed through the second cavity endoscope, the release of the dilation and fistula closure stent is paused. The foreign body forceps extend through the forceps channel of the second cavity endoscope, cross the fistula, enter the first cavity, grab the traction line, and drag the traction line through the fistula into the second cavity.

[0041] Continue to retract the outer tube to gradually release the dilatation and fistula occlusion stent, while the foreign body forceps continuously apply a force toward the traction line toward the second cavity, so that as the dilatation and fistula occlusion stent is gradually released, the second fixation stent is gradually pulled into the second cavity by the foreign body forceps through the fistula opening. Continue to retract the outer tube until the proximal end of the first fixation stent is released out of the outer tube.

[0042] The foreign object clamp releases the traction wire, causing the second end of the second fixing bracket to be released and spring back. The second end is located in the second cavity and abuts against the inner wall of the second cavity to prevent the second fixing bracket from moving from the second cavity to the first cavity.

[0043] The inserter and the guidewire are withdrawn from the first cavity.

[0044] Furthermore, when the second end is in a contracted state, the traction wire extends at least partially beyond the second end. The traction wire extending beyond the second end when the second end is in a contracted state is defined as a free segment. The free segment is positioned toward the distal end of the first fixed bracket. A positioning mark is provided on the outer surface of the outer tube. The positioning mark is at least partially corresponding to the free segment. Before the step of releasing the dilatation and fistula occlusion bracket, a step of positioning the positioning mark is also included. Specifically, the inserter is rotated until the positioning mark can be observed by the second cavity endoscope and the positioning mark is facing the fistula opening.

[0045] Furthermore, the above-mentioned insertion method also includes a step to confirm whether the fistula closure surgery is successful. Specifically, the first cavity endoscope is inserted into the first cavity, and a staining solution is injected near the fistula opening in the first cavity through the first cavity endoscope. The staining solution is then observed through the second cavity endoscope to see if it seeps from the first cavity into the second cavity. If not, the fistula closure surgery is considered successful.

[0046] An embodiment of this application provides an expansion and closure stent configured with a blocking membrane disposed on a first fixed stent or / and a second fixed stent. The blocking membrane can isolate the first fixed stent and the second fixed stent to prevent liquids or food from flowing between the first cavity and the second cavity, thereby improving the closure effect and reducing the possibility of complications. Attached Figure Description

[0047] Figure 1 This is a three-dimensional schematic diagram of an expansion fistula occlusion stent according to an embodiment of this application, wherein the flange is configured as a mushroom shape.

[0048] Figure 2 This is a front view of an expansion fistula occlusion stent according to an embodiment of this application.

[0049] Figure 3 This is a side view of an expansion fistula occlusion stent according to an embodiment of this application.

[0050] Figure 4 This is a cross-sectional view of an expansion occlusion stent according to an embodiment of this application, wherein the second covering completely covers the occlusion segment.

[0051] Figure 5 This is a cross-sectional view of an expansion occlusion stent according to an embodiment of this application, wherein the second covering does not completely cover the occlusion segment.

[0052] Figure 6 This is a three-dimensional schematic diagram of an expansion fistula occlusion stent according to an embodiment of this application, wherein the flange is configured as an umbrella shape.

[0053] Figure 7 This is a three-dimensional schematic diagram of an expansion fistula occlusion stent according to an embodiment of this application, wherein the flange is configured as a hollow tube and is parallel to the first fixed stent.

[0054] Figure 8 for Figure 7 Side view of the expansion occlusion stent in the image.

[0055] Figure 9 This is a cross-sectional view of an implanter according to an embodiment of this application.

[0056] Figure 10 This is a schematic diagram of the implantation system in one embodiment of this application, wherein the distal end of the first fixing bracket is released from the implanter.

[0057] Figure 11 This is a schematic diagram of the implantation system in one embodiment of this application, wherein the distal end of the first fixing bracket and the second fixing bracket are released from the implanter.

[0058] Figure 12This is a schematic diagram of the implantation system in one embodiment of this application, wherein the dilatation occlusion stent is completely released from the implanter.

[0059] Figure 13 for Figure 10 Enlarged view inside circle A.

[0060] Figure 14 for Figure 11 Enlarged view inside circle B.

[0061] Figure 15 for Figure 12 Enlarged view inside circle C. Detailed Implementation

[0062] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0063] In the following description, the terms "proximal end" and "far end" are used with reference to the operator. "Proximal end" refers to the end closer to the operator, and "far end" refers to the end farther from the operator.

[0064] Reference Figures 1 to 3 As shown in Embodiment 1 of this application, an expansion-closure stent 100 is disclosed, which is used to seal a fistula formed between adjacent first and second cavities. The expansion-closure stent 100 includes a first fixing stent 1, a second fixing stent 2, and a barrier membrane 3 disposed on the first fixing stent 1 and / or the second fixing stent 2. The barrier membrane 3 can isolate the first fixing stent 1 and the second fixing stent 2 to prevent the flow of liquids or food between the first and second cavities, thereby improving the sealing effect and reducing the possibility of complications.

[0065] Specifically, the first fixation bracket 1 and the second fixation bracket 2 are both made of woven silk threads, and the two are connected to form a first connection track. The barrier membrane 3 covers at least the first connection track, thereby preventing tissue fluid or food from flowing between the first cavity and the second cavity through the first fixation bracket 1 and the second fixation bracket 2.

[0066] A first fixation bracket 1 is disposed within a first cavity to support the inner wall of the first cavity. The first fixation bracket 1 is configured as a hollow tube, having a proximal end, a distal end, and a first lumen extending axially between the proximal and distal ends. A second fixation bracket 2 is disposed within the fistula opening and the second cavity. The second fixation bracket 2 has a first end 210 and a second end 220, extending between the first end 210 and the second end 220, wherein the first end 210 is connected to the first fixation bracket 1. After the dilatation and occlusion bracket 100 is inserted into the patient, it seals the fistula opening, thereby preventing substances such as liquids or food from entering one cavity from another through the fistula opening.

[0067] This application describes the use of an expandable fistula-closing stent 100 to seal a fistula formed between the esophagus and trachea as an example. The first cavity is one of the esophageal lumen and the tracheal lumen, and the second cavity is the other of the esophageal lumen and the tracheal lumen. The tracheal lumen is connected to the lungs, and the interior of the trachea and lungs is a sterile environment. Other substances entering the lungs can cause diseases such as pneumonia. The expandable fistula-closing stent 100 is used to seal the fistula formed between the trachea and esophagus, preventing secretions, food, and other substances from the esophagus from entering the tracheal lumen through the fistula and contaminating the respiratory tract, thereby controlling the occurrence of aspiration pneumonia.

[0068] Reference Figure 1 and Figures 10 to 15 As shown, the dilatation and occlusion stent 100 includes an initial state, a contracted state, and a released state. Specifically, refer to... Figure 1 As shown, the state of the dilatation occlusion stent 100 before it is retracted and inserted into the implanter 200 is defined as the initial state. Before the dilatation occlusion stent 100 is inserted into the patient, the dilatation occlusion stent 100 is retracted entirely within the tubular structure of the implanter 200; the state of the dilatation occlusion stent 100 at this time is defined as the retracted state; refer to... Figure 10 , Figure 11 , Figure 13 and Figure 14 As shown, the dilatation occlusion stent 100 is delivered from the trachea or esophagus to the target area via the inserter 200. The inserter 200 is then operated to slowly release the dilatation occlusion stent 100 from the inserter. Under its own elasticity and memory tension, the released portion of the dilatation occlusion stent 100 gradually rebounds and partially returns to its initial state, while the unreleased portion remains in a contracted state. This state of the dilatation occlusion stent 100 is defined as the release state. In this application, the target area refers to the area where the inserter 200 can begin releasing the dilatation occlusion stent 100. (Refer to...) Figure 12 and Figure 15As shown, continue operating the inserter 200 until the dilatation and fistula closure stent 100 is completely released from the inserter 200, and the fully released dilatation and fistula closure stent 100 returns to its initial state. In the initial state, the dilatation and fistula closure stent 100 elastically abuts against the inner wall of the trachea, esophagus and fistula opening, thereby fixing the dilatation and fistula closure stent 100 in the trachea and esophagus and sealing the fistula opening.

[0069] In the following description of the shape and dimensions of the dilatation occlusion stent 100, unless otherwise specified, the shape and dimensions mentioned refer to the shape and dimensions of the dilatation occlusion stent 100 in its initial state.

[0070] Reference Figure 1 and Figure 2 As shown, the direction parallel to the central axis of the first fixing bracket 1 is defined as the first direction, and the direction parallel to the central axis of the second fixing bracket 2 is defined as the second direction. The first and second directions intersect, and the included angle between the first and second directions is set to 45° to 135°. In the first direction, the second fixing bracket 2 is located in the middle of the first fixing bracket 1. Preferably, the first and second directions are perpendicular to each other. It should be noted that the parallelism and perpendicularity mentioned in this application are not absolute parallelism and absolute perpendicularity in a mathematical sense, but rather approximately perpendicular and approximately parallel with certain manufacturing errors and deformation errors. Optionally, the error range is ±15°. The first fixing bracket 1 is used to be placed in one of the tracheal lumen and the esophageal lumen to fix the position of the dilatation and fistula occlusion bracket 100 in the esophagus or trachea to prevent the dilatation and fistula occlusion bracket 100 from shifting relative to the trachea or esophagus; the second fixing bracket 2 passes through the fistula opening and is partially located in the other of the tracheal lumen and the esophageal lumen to seal the fistula opening and limit the position of the second fixing bracket 2.

[0071] Before the dilatation occlusion stent 100 is inserted, the dilatation occlusion stent 100 is retracted within the tubular structure of the inserter 200 and is in a contracted state. The dilatation occlusion stent 100 is delivered from the first cavity to the target area through the inserter 200. Then, the inserter 200 is operated to slowly deliver the dilatation occlusion stent 100, and the second fixation stent 2 is gradually delivered and, under the action of external force, passes through the fistula opening and is placed in the second cavity. The inserter 200 is operated continuously until the dilatation occlusion stent 100 is completely released from the inserter 200. The external force is then removed. Under its own elasticity and memory tension, the second fixation bracket 2 unfolds. Part of the unfolded second fixation bracket 2 is located inside the fistula and abuts against the inner wall of the fistula to seal the fistula. Part of it is located inside the second cavity and abuts against the inner wall of the second cavity to prevent the second fixation bracket 2 from detaching from the second cavity. After the first fixation bracket 1 is completely released, it unfolds under its own elasticity and memory tension and returns to its initial state. The first fixation bracket 1 elastically abuts against the inner wall of the first cavity to prevent the expansion and closure bracket 100 from moving relative to the first cavity, thereby achieving the positioning of the expansion and closure bracket 100.

[0072] To achieve better fixation, when the dilatation stent 100 is inserted into the tracheal lumen, the diameter of the first fixation stent 1 is larger than the diameter of the tracheal lumen. To improve the comfort of the patient, the diameter of the first fixation stent 1 is slightly larger than the diameter of the tracheal lumen. In one embodiment, the outer diameter of the first fixation stent 1 is 8mm-24mm, and the length is 25mm-45mm. Preferably, the outer diameter of the first fixation stent 1 is 12mm, 14mm, 16mm, 18mm, 20mm, 22mm, or 24mm, and the length is 40±5mm, 30±5mm, or 40±4mm. When the first fixation stent 1 is used to fix the main trachea, the outer diameter of the first fixation stent 1 is 14mm-24mm, and the length is 40±5mm or 30±5mm. Preferably, the outer diameter of the first fixation stent 1 is 16mm, 18mm, 20mm, 22mm, or 24mm. When the first fixation bracket 1 is used to fix in the bronchus, the outer diameter of the first fixation bracket 1 is set to 8mm-16mm and the length is 40±4mm. Optionally, the outer diameter of the first fixation bracket 1 is set to 12mm or 14mm.

[0073] The first fixing bracket 1 and the second fixing bracket 2 are separate structures, meaning they are manufactured separately and then connected together. In the embodiments disclosed in this application, the first fixing bracket 1 and the second fixing bracket 2 are connected together using a sewing process, and the aforementioned first connection trajectory is the first sewing trajectory generated by the sewing. Specifically, the first fixing bracket 1 and the second fixing bracket 2 are sewn together with soft thread; in one embodiment, the soft thread is PTFE (Polytetrafluoroethylene) soft thread.

[0074] Reference Figure 3 and Figure 4 As shown, the barrier membrane 3 includes a first covering membrane 31 that at least partially covers the first fixation bracket 1. The first covering membrane 31 at least covers the first connection track, that is, the first covering membrane 31 completely covers the first end 210 of the second fixation bracket 2 to prevent substances such as food and secretions from flowing between the two cavities through the fistula. The first covering membrane 31 is made of silicone membrane, which can prevent substances such as food and secretions from entering the interior of the first fixation bracket 1 from the inner cavity of the second fixation bracket 2.

[0075] In one embodiment, the first coating 31 and the first fixing bracket 1 are integrally formed. 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 with the coating solution adhering to it is taken out and cured, thereby fixing the first coating 31 to the first fixing bracket 1 to form an integral structure.

[0076] In an embodiment where the first fixation stent 1 and the second fixation stent 2 are connected using a suture technique, the first connection path includes several first pinholes formed through the first covering membrane 31. Fluid in the esophageal lumen, such as tissue fluid, can enter the inner lumen of the first fixation stent 1 through these first pinholes, and subsequently enter the tracheal lumen. This fluid can then travel down the trachea into the lungs, causing serious complications such as lung infection. Furthermore, the first covering membrane 31 is made of silicone. Silicone membranes have poor acid resistance. After the dilation and occlusion stent 100 has been in place for a period of time, the first covering membrane 31 may be corroded and damaged by acidic fluid in the esophagus. When the first covering membrane 31 is damaged, secretions and food from the esophagus will enter the trachea through the damaged area, causing complications such as lung infection. To prevent fluid in the esophagus from entering the lungs through the first pinholes and / or the damaged area of ​​the first covering membrane 31, combined with… Figure 1 and Figure 4 As shown, the barrier membrane 3 further includes a first barrier membrane 32 connected to the first fixed bracket 1 and / or the second fixed bracket 2, the first barrier membrane 32 at least covering the first connection trajectory. In one embodiment, the first barrier membrane 32 is connected to the first fixed bracket 1 and covers the first connection trajectory.

[0077] The first blocking membrane 32 is connected to the inner and / or outer side of the first fixing bracket 1, forming a receiving cavity between the first blocking membrane 32 and the first fixing bracket 1. The trajectory formed by connecting the first blocking membrane 32 and the first fixing bracket 1 is defined as the second connection trajectory. The area enclosed by the second connection trajectory is larger than the area enclosed by the first connection trajectory, and the second connection trajectory completely surrounds the first connection trajectory, so that the first connection trajectory is located within the receiving cavity. When liquid flows from the first needle hole and / or the damaged portion of the first covering membrane 31 into the first fixing bracket 1, the liquid is stored in the receiving cavity and will not flow into the trachea, thereby effectively preventing liquid from flowing into the lungs from the first needle hole and avoiding lung infection.

[0078] In the embodiments disclosed in this application, the first barrier membrane 32 is sewn to the first fixed bracket 1 using a suturing process. The second connection trajectory mentioned above is the second suturing trajectory. During the suturing process, a plurality of second pinholes are formed on the first covering membrane 31 and the first barrier membrane 32. The plurality of second pinholes are sealed with silicone to prevent liquid from entering the lungs through the second pinholes.

[0079] In one embodiment, the first barrier membrane 32 is an acid-resistant membrane made of materials such as PTFE (Polytetrafluoroethylene), FEP (Fluorinated ethylene propylene), or ePTE (polytetrafluoroethylene). In alternative embodiments, the barrier membrane 3 can be made of other acid-resistant materials.

[0080] Because PTFE membranes have poor shrinkage and elastic deformation capabilities, if the area of ​​the first blocking membrane 32 is too large, it will hinder the insertion of the expansion and occlusion stent 100. Therefore, when designing, the size of the first blocking membrane 32 should be made as small as possible while ensuring that the first blocking membrane 32 can prevent liquid from entering the lung from the first pinhole or the damaged part of the first covering membrane 31.

[0081] Specifically, the first blocking membrane 32 does not completely cover the first fixed bracket 1, but it completely covers the first connection trajectory. That is, the area of ​​the first blocking membrane 32 is smaller than the surface area of ​​the first fixed bracket 1, but larger than the area enclosed by the first connection trajectory.

[0082] In the embodiments disclosed in this application, in the first direction, the size of the first blocking membrane 32 is smaller than the size of the first fixed bracket 1 but larger than the size of the first connecting track. Furthermore, in the circumferential direction of the first fixed bracket 1, the two ends of the first blocking membrane 32 are spaced apart. That is, in the circumferential direction of the first fixed bracket 1, the size of the first blocking membrane 32 is smaller than the circumference of the first fixed bracket 1 but larger than the size of the first connecting track, so that the first blocking membrane 32 can completely cover the first connecting track. In both the first direction and the circumferential direction of the first fixed bracket 1, the first connecting track is located in the middle of the first blocking membrane 32, so that the first blocking membrane 32 can completely cover the first connecting track while minimizing its size. In one embodiment, a certain stitching allowance is reserved between the edge of the first blocking membrane 32 and the second connecting track to ensure the stitching stability of the first blocking membrane 32.

[0083] In an alternative embodiment, the first blocking membrane 32 can be continuous in the circumferential direction of the first fixed bracket 1, i.e., the first blocking membrane 32 is a hollow cylindrical shape, so that the first blocking membrane 32 completely covers the surface of the first fixed bracket 1 in the circumferential direction. Similar to the embodiment disclosed in this application, in the first direction, the size of the first blocking membrane 32 is smaller than the size of the first fixed bracket 1 but larger than the size of the first connecting trajectory. In this embodiment, while the first blocking membrane 32 is sewn to the first fixed bracket 1 to form the aforementioned second connecting trajectory, a third connecting trajectory is also formed. The third connecting trajectory does not intersect with the second connecting trajectory and completely surrounds the second connecting trajectory. The first blocking membrane 32 is connected to the first fixed bracket 1 by multiple stitches, which ensures the connection stability between the first blocking membrane 32 and the first fixed bracket 1. A certain stitching allowance is reserved between the edge of the first blocking membrane 32 and the third connecting trajectory to ensure the stitching stability of the first blocking membrane 32.

[0084] In other alternative embodiments, a first barrier membrane 32 is disposed between the first fixing bracket 1 and the second fixing bracket 2 and connected to the second fixing bracket 2. Specifically, before connecting the first fixing bracket 1 and the second fixing bracket 2 together, the first barrier membrane 32 is covered over the opening of the first end 210 of the second fixing bracket 2, and the first barrier membrane 32 is connected to the second fixing bracket 2. Then, the second fixing bracket 2 is connected to the first fixing bracket 1, and the needle holes formed by the stitching are sealed with silicone.

[0085] Continue to refer to Figure 3 and Figure 4As shown, to improve the sealing effect, the barrier membrane 3 also 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 integrally formed. Specifically, the manufactured second fixing bracket 2 is immersed in a container containing a coating solution, and after standing for a predetermined time, the bracket with the coating solution adhering to it is taken out and cured, thereby fixing the second coating 33 to the second fixing bracket 2 to form an integral structure.

[0086] To further improve the sealing effect, the barrier membrane 3 also includes a second barrier membrane 34 disposed inside the second fixed support 2 to form a seal. The second barrier membrane 34 is disposed within the space enclosed by the second covering membrane 33 to form a seal.

[0087] Specifically, the first end 210 of the second fixed support 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 membrane 33 covers the fistula-blocking section 21 and the flange 22, and the second blocking membrane 34 is disposed inside the fistula-blocking section 21 and / or the flange 22 to form a seal. After the expansion fistula-blocking support 100 is inserted, the fistula-blocking section 21 is located inside the fistula opening. The fistula-blocking section 21, the second covering membrane 33, and the second blocking membrane 34 work together to support and seal the fistula opening. The flange 22 is located inside the second cavity and is used to limit the entire expansion fistula-blocking support 100, which can effectively prevent the flange 22 from moving from the second cavity to the first cavity, thereby effectively preventing the expansion fistula-blocking support 100 from shifting.

[0088] Reference Figure 5 As shown, to better promote fistula healing, the expansion fistula-blocking stent 100 of this application can be configured such that the second covering membrane 33 does not completely cover the fistula-blocking segment 21 of the second fixing stent 2. This allows the granulation tissue at the fistula to gradually pass through the gaps between the braided threads of the fistula-blocking segment 21 and enter the interior of the fistula-blocking segment 21 during its growth process. Eventually, the granulation tissue heals and squeezes part of the second fixing stent 2 away from the first fixing stent 1, thus facilitating fistula healing. In this embodiment, the fistula-blocking segment 21 includes a hollow segment 211 and a covering segment 212. The hollow segment 211 is closer to the first fixing stent 1 than the covering segment 212. The hollow segment 211 does not have the second covering membrane 33 on its inner and outer sides, while the covering segment 212 has the second covering membrane 33. The second blocking membrane 34 is disposed within the space enclosed by the second covering membrane 33 of the covering segment 212 to form a seal.

[0089] In an alternative embodiment, the barrier membrane 3 comprises only a first coating 31, which uses silicone to seal a plurality of first pinholes to ensure a sealing effect.

[0090] In an alternative embodiment, the barrier membrane 3 includes only a first barrier membrane 32 covering the first connection trajectory.

[0091] In an alternative embodiment, the barrier membrane 3 includes only a second covering 33 and a second barrier membrane 34 disposed within the space enclosed by the second covering 33 to form a seal.

[0092] To achieve a better sealing effect, the minimum outer diameter of the plugging segment 21 is greater than the maximum inner diameter of the fistula opening. To prevent the fistula opening from being excessively stretched by the plugging segment 21 and causing secondary damage to the patient, the minimum outer diameter of the plugging segment 21 is slightly larger than the maximum inner diameter of the fistula opening.

[0093] In one embodiment, the outer diameter of the fistula-blocking segment 21 is set to 4mm-30mm. Optionally, the outer diameter of the fistula-blocking segment 21 is set to 4mm, 6mm, 9mm, 12mm, 15mm, 18mm, 20mm, 22mm, 25mm or 30mm. The operator selects an expansion fistula-blocking stent 100 of appropriate size according to the size of the fistula opening.

[0094] The first fixation bracket 1 and the second fixation bracket 2 are woven from the same or different materials. In one embodiment, both the first fixation bracket 1 and the second fixation bracket 2 are woven from metal wire. In another embodiment, the first fixation bracket 1 is woven from metal wire, and the second fixation bracket 2 is woven from non-metallic biodegradable wire. More specifically, the metal wire is made of biocompatible nickel-titanium alloy or absorbable magnesium alloy, and the non-metallic biodegradable material is PLA (Polylactic Acid) or PLG (Lactide-co-Glycolide).

[0095] The manufacturing process of the first fixed bracket 1 and the second fixed bracket 2 is not limited to weaving process, but can also adopt 3D printing process, engraving process, etc.

[0096] When the second fixation stent 2 is made of a biodegradable material, during the slow degradation of the second fixation stent 2, the fistula is sealed at the end of the second cavity using clamps or nylon ligation. Alternatively, stem cells or PRP (platelet-rich plasma) can be injected to promote fistula tissue healing. Once the fistula is completely sealed and healed, and after confirming the injection of methylene blue, the first fixation stent 1 is pulled out of the first cavity, and the fistula treatment is complete.

[0097] 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 polysilicon, and the antibacterial coating is composed of one or more of the following: organosilicon cationic steroids, dimethylamine tetracycline, rifampin, gentamicin, vancomycin, and hydrophobic materials.

[0098] In an optional embodiment, the dilatation and fistula closure stent 100 further includes a traction wire 4 disposed at the second end 220. The traction wire 4 is circumferentially inserted through the second end 220. By tightening the traction wire 4, the second end 220 can be contracted. The second end 220 in the contracted state has a smaller volume, so that the second end 220 can be smoothly pulled from the first cavity through the fistula opening into the second cavity, reducing the difficulty of insertion and improving the insertion efficiency. At the same time, the friction between the second fixation stent 2 and the fistula opening is reduced during the insertion process, reducing the probability of causing secondary injury to the patient.

[0099] Reference Figure 1 , Figure 3 , Figure 10 and Figure 13 As shown, by tightening the traction wire 4, the second end 220 can be contracted. The second end 220 in the contracted state has a smaller volume, so it can be smoothly pulled from the first cavity through the fistula into the second cavity, reducing the difficulty of insertion and improving the insertion efficiency. At the same time, the friction between the second fixation bracket 2 and the fistula is reduced during the insertion process, reducing the probability of causing secondary damage to the patient. When the traction wire 4 is released, the second end 220 expands to position the second fixation bracket 2.

[0100] The pull line 4 is circumferentially threaded through the second end 220. When the second end 220 is in a contracted state, the pull line 4 extends at least partially beyond the second end 220. The pull line 4 extending beyond the second end 220 when the second end 220 is in a contracted state is defined as the free segment 42. The free segment 42 is placed toward the far end of the first fixed bracket 1 for the operator to grasp and apply force to retract and shift the second fixed bracket 2.

[0101] Before inserting the dilatation occlusion stent 100 into the inserter 200, force is applied to the free segment 42 of the traction wire 4 to cause the second end 220 of the second fixation stent 2 to contract. During the release of the dilatation occlusion stent 100, this facilitates the pulling of the second fixation stent 2 through the fistula opening into the second cavity. After the dilatation occlusion stent 100 reaches the target area, the inserter 200 is operated to slowly deliver the dilatation occlusion stent 100. When the operator observes that the free segment 42 of the traction wire 4 is exposed in the inserter 200, the operator pulls the free segment 42 to apply an external force toward the second fixation stent 2 in the direction of the second cavity, thereby gradually pulling the second fixation stent 2 through the fistula opening into the second cavity. After the dilatation occlusion stent 100 is released, the external force is removed, and the second fixation stent 2 unfolds under its own elasticity and memory tension, completing the closure of the fistula opening and the fixation of the second fixation stent 2.

[0102] The material of the tension wire 4 can be the same as that of the second fixation bracket 2, or it can be a non-metallic material with good biocompatibility. (Refer to...) Figure 1 and Figure 3As shown, the dilatation occlusion stent 100 also includes a retrieval line 5 connected to the first fixation bracket 1. The retrieval line 5 is circumferentially inserted through the proximal end of the first fixation bracket 1. The retrieval line 5 is used by the operator to grasp and apply force to pull the dilatation occlusion stent 100 out of the implanted body, and to retract the first fixation bracket 1 so as to retract the dilatation occlusion stent 100 into the implanter 200.

[0103] In this application, the shape of the flange 22 is not limited, and it can be configured as follows: Figure 1 The mushroom shape shown can also be set to other shapes. For example... Figure 6 As shown, the flange 22' of the expansion and occlusion stent 100' is configured in an umbrella shape, as... Figure 7 and Figure 8 As shown, the flange 22” of the expansion and closure stent 100” is set as a hollow tube, so that the expansion and closure stent 100” is H-shaped as a whole. Figure 6 , Figure 7 and Figure 8 Compared with the above embodiments, the embodiments shown only differ in the structure of flanges 22' and 22"; for other identical structures, the same reference numerals are used in this embodiment and will not be described in detail.

[0104] Reference Figure 7 and Figure 8 As shown, specifically, the flange 22” of the expansion and occlusion stent 100” is configured as a hollow tube, and the central axis of the flange 22” is parallel to the central axis of the first fixation stent 1. In the first direction, the size of the flange 22” is smaller than the size of the first fixation stent 1, and it is located in the middle of the first fixation stent 1. The second end 220 is the distal end and proximal end of the flange 22”, and the traction wire 4 is located at the proximal end and / or distal end of the flange 22”.

[0105] In other embodiments, in the first direction, the size of the flange 22” can be set to be greater than or equal to the size of the first fixed bracket 1.

[0106] Since the inner diameter of the human esophagus is typically 16mm-20mm and the inner diameter of the trachea is also typically 16mm-20mm, when the inner diameter of the fistula is greater than 16mm, the diameter of the protrusions at both ends of the fistula is 22mm. When using mushroom-shaped or umbrella-shaped expansion fistula occlusion stents 100 and 100' with flanges 22 and 22' for occlusion, to achieve a better occlusion effect, the outer diameter of flanges 22 and 22' needs to be set larger than the inner diameter of the esophagus or trachea. This will affect normal swallowing or cause tracheal stenosis. When flange 22" is set in an umbrella shape, the edge of flange 22' may cut the tracheal wall, leading to complications. Therefore, when the inner diameter of the fistula is greater than 16mm-24mm, using an expansion fistula occlusion stent 100 and 100' with flanges 22 and 22' is necessary, the outer diameter of flanges 22 and 22' should be larger than the inner diameter of the esophagus or trachea. Figure 8 The expansion and closure stent 100” shown is used for closure, and the expansion and closure stent 100” is inserted from the esophageal lumen.

[0107] In an alternative embodiment, the first film 31, the first fixing bracket 1, the second film 33, and the second fixing bracket 2 are formed separately and then connected together. The shape and size of the first film 31 match the shape and size of the first fixing bracket 1, and the shape and size of the second film 33 match the shape and size of the second fixing bracket 2. After the first fixing bracket 1, the second fixing bracket 2, the first film 31, and the second film 33 are manufactured, the first film 31 is installed to the inner or outer side of the first fixing bracket 1, and the second film 33 is installed to the inner or outer side of the second fixing bracket 2. The film and the fixing bracket can be connected by a hot-melt process or by utilizing the elasticity of the film and the fixing bracket themselves. When the connection is achieved by utilizing the elasticity of the film and the fixing bracket, when the film is placed on the outer side of the fixing bracket, the outer diameter of the fixing bracket is greater than or equal to the inner diameter of the film, so that the fixing bracket and the film can fit tightly together; when the film is placed on the inner side of the fixing bracket, the inner diameter of the fixing bracket is less than or equal to the outer diameter of the film, so that the two can fit tightly together.

[0108] In alternative embodiments, the tension wire 4 may be omitted. In embodiments where the tension wire 4 is not provided, the second end 220 of the second fixing bracket 2 may be contracted in other ways, or the second end 220 of the second fixing bracket 2 may not be contracted at all.

[0109] Combination Figure 1 and Figures 9 to 14 As shown, this application also provides an insertion system, which includes an inserter 200 and the aforementioned dilatation and occlusion stents 100, 100', 100" which are inserted into the body of the patient through the inserter 200. The inserter 200 includes a first handle 201, a push tube 202 connected to the first handle 201, a middle tube 203 connected to the push tube 202, an inner tube 204 connected to the middle tube 203, a push 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 push tube 202. The first handle 201 is closer to the operator than the second handle 206. The push tube 202 passes through the second handle 206 and connects to the middle tube 203. The outer tube 207 covers the outside of the push tube 202, the middle tube 203, and the inner tube 204. The expansion and occlusion stents 100, 100', and 100" are retracted 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 relative to the push tube 202, which can drive the outer tube 207 to move relative to the inner tube 204. After the outer tube 207 is in place, the safety lock 208 is tightened to lock the relative position of the second handle 206 and the push tube 202.

[0110] The outer diameter of the inner tube 204 is smaller than the outer diameter of the middle tube 203, resulting in a gap between the inner wall of the outer tube 207 and the outer wall of the inner tube 204. This gap forms a receiving space, which is used to accommodate the expanded fistula occlusion stents 100, 100', and 100 in their contracted state.

[0111] The middle tube 203 includes a distal end connected to the inner tube 204, and the pusher 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 pusher 205. The outer wall of the inner tube 204, the inner wall of the outer tube 207, the distal end face of the middle tube 203, and the proximal end face of the pusher 205 enclose the aforementioned receiving space. Because the outer diameter of the inner tube 204 is smaller than the outer diameters of the middle tube 203 and the proximal end of the pusher 205, steps are formed at the connection points between the inner tube 204 and the middle tube 203, and between the inner tube 204 and the pusher 205. This fixes the axial relative position between the expanded fistula occlusion stents 100, 100', 100" installed in the receiving space in a contracted state and the inner tube 204, improving the insertion accuracy.

[0112] 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 retracting the expansion and occlusion stents 100, 100', and 100" into the receiving space; after the expansion and occlusion stents 100, 100', and 100" are completely retracted into the receiving space, tighten the safety lock 208 to lock the relative position of the second handle 206 and the push tube 202, operate the first handle 201 to insert the expansion and occlusion stents 100, 100', and 100" into the recipient; when it is necessary to release the expansion and occlusion stents 100, 100', and 100", release the safety lock 208, operate the second handle 206 to retract the outer tube 207, thereby gradually releasing the expansion and occlusion stents 100, 100', and 100" from the outer tube 207.

[0113] To improve the insertion accuracy of the expansion and occlusion stents 100, 100', and 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 expansion and occlusion stents 100, 100', and 100" have reached the target area. The target area in this application refers to the area where the outer tube 207 can begin to release the expansion and occlusion stents 100, 100', and 100" .

[0114] Specifically, in one embodiment, a positioning mark 2071 is set at the end of the outer tube 207 near the second handle 206. In this embodiment, before the expansion and occlusion stents 100, 100', and 100" are inserted into the first cavity, the location information of the fistula is obtained by an imaging scanning device or endoscope. Combined with the location information of the fistula and the size data of the inserter 200, the required insertion depth of the inserter 200 is obtained, and then the relative positional 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 expansion and occlusion stents 100, 100', and 100" have reached the target area, and the insertion of the inserter 200 into the first cavity is stopped.

[0115] In an alternative embodiment, the positioning mark 2071 may be located at the end of the outer tube 207 furthest from the second handle 206, as shown in the reference. Figure 11 and Figure 13 As shown, in this embodiment, before inserting the expansion and occlusion stents 100, 100', and 100" into the first cavity, the first cavity endoscope is inserted into the first cavity. The position of the first cavity endoscope can capture the location information of the fistula. The positioning mark 2071 is set in the area of ​​the outer tube 207 corresponding to the first connection trajectory of the expansion and occlusion stents 100, 100', and 100" When the first cavity endoscope captures the positioning mark 2071 and the positioning mark 2071 is located within the fistula range in the first direction, it indicates that the expansion and occlusion stents 100, 100', and 100" have reached the target area, and the insertion of the inserter 200 into the first cavity is stopped.

[0116] During the insertion of the expansion and occlusion stents 100, 100', and 100" into the target area, the entire inserter 200 undergoes rotation at an uncertain angle. This makes it highly likely that the free segment 42 of the traction wire 4 is outside the observation range of the second-cavity endoscope in the circumferential direction, preventing the operator from promptly capturing the traction wire 4 and pulling it into the second cavity. In this situation, it is necessary to rotate the first handle 201 to bring the free segment 42 of the traction wire 4 into the observation range of the second-cavity endoscope. In addition, to facilitate the clamping of the free segment 42 after the foreign body forceps passes through the fistula opening, the free segment 42 needs to be facing the fistula opening. However, the light in the first cavity is weak, making it difficult for the second-cavity endoscope to accurately identify the position of the free segment 42 through the outer tube 207.

[0117] To address the aforementioned issues, the outer tube 207 of the inserter 200 of this application is further provided with a positioning mark 2072. The positioning mark 2072 is located on the outer surface of the outer tube 207 and is a conspicuous line segment. The positioning mark 2072 corresponds to the free segment 42 of the expanded fistula occlusion stents 100, 100', and 100" in their contracted state. After the expanded fistula occlusion stents 100, 100', and 100" reach the target area, the first handle 201 is rotated to bring the positioning mark 2072 within the observation range of the second cavity endoscope, thereby facilitating the operator to accurately and promptly pull the traction wire 4 into the second cavity.

[0118] In other alternative embodiments, the positioning mark 2072 may be configured as a marker that is detachably connected to the outer tube 207.

[0119] In one embodiment, an expansion and occlusion stent 100 is inserted into the trachea. After insertion, a first fixation stent 1 is placed inside the trachea, and a second fixation stent 2 passes through the fistula and is partially placed inside the esophagus. Compared to the esophageal lumen, no liquid or solid matter passes through the trachea, and the inner diameter of the trachea fluctuates less. Therefore, placing the first fixation stent 1 inside and abutting against the inner wall of the trachea can ensure the positioning stability of the expansion and occlusion stents 100, 100', and 100".

[0120] In embodiments where the traction wire 4 is not provided, the positioning mark 2072 is correspondingly set with the second fixed bracket 2. After the foreign body forceps passes through the fistula, it clamps the second fixed bracket 2. After the expansion and occlusion brackets 100, 100', and 100" reach the target area, the first handle 201 is rotated so that the positioning mark 2072 is within the observation range of the second cavity endoscope, thereby facilitating the operator to accurately and promptly pull the second fixed bracket 2 into the second cavity.

[0121] When inserted through the trachea, dilatation stents 100 and 100' are selected. The first cavity is the trachea and the second cavity is the esophagus. The insertion method of the insertion system of this application includes the following steps:

[0122] S11: Retract the expansion and occlusion stents 100 and 100' into the receiving space of the inserter 200, specifically:

[0123] The first fixing bracket 1 of the expansion and occlusion brackets 100 and 100' is sleeved on the outside of the inner tube 204 of the inserter 200. The operator applies force to the retrieval line 5 and the traction line 4 to retract the proximal end of the first fixing bracket 1 and the second end 220 of the second fixing bracket 2. The safety lock 208 is released. 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 retract the first fixing bracket 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 and occlusion brackets 100 and 100' are completely retracted into the receiving space between the outer tube 207 and the inner tube 204. The safety lock 208 is then tightened.

[0124] S12: Insert the inserter 200 into the first cavity, specifically:

[0125] Insert a cannula into the first cavity, and the endoscope of the first cavity enters the first cavity through the cannula. The inner diameter of the first cavity passes the fistula position. A guide wire is placed, and the endoscope of the first cavity is withdrawn. The inserter 200 enters the first cavity through the cannula via the guide wire.

[0126] S13: Positioning mark 2072 of positioning device 200, specifically:

[0127] The second-channel endoscope is inserted into the second channel and reaches the fistula opening. The second-channel endoscope can observe through the fistula opening whether the expansion and occlusion stents 100 and 100' in the first channel are in place. Rotate the inserter 200 until the second-channel endoscope can observe the positioning mark 2072 and the positioning mark 2072 is facing the fistula opening.

[0128] S14: Partially release the dilation and occlusion stents 100 and 100' and pull the free segment 42 of the traction wire 4 into the second cavity, specifically:

[0129] Release the safety lock 208, operate the second handle 206 to retract the outer tube 207 to gradually release the expansion and closure stent 100. When the free segment 42 of the traction wire 4 is observed through the endoscope of the second cavity, pause the release of the expansion and closure stent 100 and 100'. The foreign body forceps extend through the forceps channel of the endoscope of the second cavity and cross the fistula to enter the first cavity to grab the free segment 42 of the traction wire 4. The free segment 42 of the traction wire 4 is dragged through the fistula to the second cavity.

[0130] S15: Completely release the expansion and occlusion stents 100 and 100', specifically:

[0131] Continue to retract the outer tube 207 to gradually release the expansion and occlusion stents 100 and 100'. At the same time, the foreign body forceps continue to apply a force toward the second cavity to the free segment 42. As the expansion and occlusion stents 100 and 100' are gradually released, the second fixation stent 2 is gradually pulled into the second cavity through the fistula opening by the foreign body forceps. Continue to retract the outer tube 207 until the proximal end of the first fixation stent 1 is released out of the outer tube 207.

[0132] S16: Complete the positioning of the expansion and occlusion stents 100 and 100', specifically:

[0133] The foreign body forceps release the free section 42 of the traction wire 4, causing the second end 220 of the second fixing bracket 2 to be released and spring back, and the expansion and closure brackets 100 and 100' return to their 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 moving from the second cavity to the first cavity. The closure section 21 abuts against the inner wall of the fistula to achieve the sealing and support of the fistula. The first fixing bracket 1 elastically abuts against the inner wall of the first cavity to fix the expansion and closure brackets 100 and 100'.

[0134] S17: Remove the inserter 200 and guidewire from the first cavity;

[0135] S18: Confirm whether the fistula closure surgery was successful, specifically:

[0136] The dye solution is injected near the fistula opening in the second cavity through the second cavity endoscope. The first cavity endoscope enters from the first cavity and reaches the position of the dilation and fistula closure stent 100, 100'. The dye solution is observed through the first cavity endoscope to see if it seeps from the second cavity into the first cavity. If not, it means that the fistula closure surgery is successful.

[0137] When the inner diameter of the fistula is greater than 16mm-24mm, the following method should be used: Figure 8 The dilatation-blocking stent 100” shown is used for sealing, and the dilatation-blocking stent 100” is inserted from the esophageal lumen. Additionally, after esophagectomy, the stomach needs to be moved upwards to suture the two ends of the esophagus. In this case, the resulting anastomotic fistula is relatively narrow. It is appropriate to place the first fixing stent 1 in the esophageal lumen and the second fixing stent 2 in the tracheal lumen to seal the fistula opening. In one embodiment, the dilatation-blocking stents 100, 100', and 100” are inserted from the esophageal lumen. After insertion, the first fixing stent 1 is placed in the esophagus, and the second fixing stent 2 is passed through the fistula opening and placed in the tracheal lumen.

[0138] When the dilatation and fistula-closing stents 100, 100', and 100" are inserted into the esophageal lumen, the first cavity is the esophageal lumen and the second cavity is the tracheal lumen. The insertion method of the insertion system of this application includes the following steps:

[0139] S21: Retract the expansion and occlusion stents 100, 100', and 100" into the inserter 200. Specifically:

[0140] The first fixing bracket 1 of the expansion and occlusion stents 100, 100', and 100" is sleeved outside the inner tube 204 of the inserter 200. The operator applies force to the retrieval line 5 and the traction line 4 to retract the proximal end of the first fixing bracket 1 and the second end 220 of the second fixing bracket 2. The safety lock 208 is released. 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 retract the first fixing bracket 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 and occlusion stents 100, 100', and 100" are completely retracted into the receiving space between the outer tube 207 and the inner tube 204. The safety lock 208 is then tightened.

[0141] S22: Insert the inserter 200 into the first cavity, specifically:

[0142] The first cavity endoscope is inserted into the first cavity, the first cavity endoscope passes the fistula position, a guide wire is placed, the first cavity endoscope is withdrawn, and the inserter 200 enters the first cavity through the guide wire;

[0143] S23: Positioning mark 2072 of positioning device 200, specifically:

[0144] The cannula is inserted into the second cavity. The endoscope of the second cavity is inserted into the second cavity through the cannula and reaches the fistula opening. The endoscope of the second cavity can observe through the fistula opening whether the dilation and fistula occlusion stents 100, 100', and 100" in the first cavity are in place. Rotate the inserter 200 until the positioning mark 2072 can be observed by the endoscope of the second cavity and the positioning mark 2072 is facing the fistula opening.

[0145] S24: Partially release the dilation and occlusion stents 100, 100', and 100" and pull the free segment 42 of the traction wire 4 into the second cavity. Specifically:

[0146] Release the safety lock 208, operate the second handle 206 to retract the outer tube 207 to gradually release the expansion and occlusion stents 100, 100', 100". When the free segment 42 of the traction wire 4 is observed through the endoscope of the second cavity, stop releasing the expansion and occlusion stents 100, 100', 100". The foreign body forceps extend through the forceps channel of the endoscope of the second cavity, cross the fistula opening and enter the first cavity to grab the free segment 42 of the traction wire 4, and drag the free segment 42 of the traction wire 4 through the fistula opening into the second cavity.

[0147] S25: Fully release the dilatation and occlusion stent 100", 100', 100", specifically:

[0148] Continue to retract the outer tube 207 to gradually release the expansion and occlusion stents 100, 100', 100" while the foreign body forceps continuously apply force toward the free segment 42 toward the second cavity. As the expansion and occlusion stents 100, 100', 100" are gradually released, the second fixation stent 2 is gradually pulled into the second cavity by the foreign body forceps through the fistula opening. Continue to retract the outer tube 207 until the proximal end of the first fixation stent 1 is released out of the outer tube 207.

[0149] S26: Complete the positioning of the expansion and occlusion stents 100", 100'", and 100"; specifically:

[0150] The foreign body forceps release the free section 42 of the traction wire 4, causing the second end 220 of the second fixing bracket 2 to be released and spring back, and the expansion and occlusion brackets 100, 100', and 100” return to their 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 occlusion section 21 abuts against the inner wall of the fistula to achieve the sealing and support of the fistula. The first fixing bracket 1 elastically abuts against the inner wall of the first cavity to fix the expansion and occlusion brackets 100, 100', and 100”.

[0151] S27: Remove the inserter and guidewire from the first cavity;

[0152] S28: Confirm whether the fistula closure surgery was successful, specifically:

[0153] The first endoscope is inserted into the first cavity, and staining solution is injected near the fistula in the first cavity through the first endoscope. The staining solution is then observed through the second endoscope to see if it seeps from the first cavity into the second cavity. If not, the fistula closure surgery is successful.

[0154] In the embodiments disclosed in this application, the staining solution is methylene blue.

[0155] In other alternative embodiments, after the expansion occlusion stents 100, 100', and 100" are placed, the occlusion surgery is assumed to be successful, and the placement method of the placement system may not include the step of confirming whether the occlusion surgery is successful.

[0156] In other alternative embodiments, the placement system may not set the positioning mark 2072, and correspondingly, the placement method does not include the step of positioning the positioning mark 2072.

[0157] In the embodiments disclosed in this 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 merely illustrative and do not constitute any limitation on this application.

[0158] In embodiments where the traction wire 4 is not provided, the second end 220 of the second fixed bracket 2 can be retracted in other ways, or it can be inserted while the second end 220 is in its initial state; during the insertion process, the foreign object clamp can directly apply force to the second fixed bracket 2, or apply force to the second fixed bracket 2 through other components, so as to drag the second fixed bracket 2 into the second cavity.

[0159] In the description of this application, it should be understood that if terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0160] Furthermore, where the terms "first" and "second" appear, these terms are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, where the term "multiple" appears, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0161] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0162] In this application, unless otherwise expressly specified and limited, the use of descriptions such as "above" or "below" the second feature indicates that the first and second features are in direct contact or indirect contact via an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. Similarly, "below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0163] It should be noted that if an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. If an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. If so, 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 possible implementation.

[0164] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above 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.

[0165] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. An expansion and closure stent (100, 100', 100'') for sealing a fistula formed between adjacent first and second cavities, characterized in that, The expandable fistula occlusion stent (100) includes: The first fixed support (1) is a hollow tube with a proximal end, a distal end and a first cavity extending axially between the proximal end and the distal end. The first fixed support (1) is disposed in the first cavity to support the inner wall of the first cavity. A second fixation bracket (2) is disposed within the fistula and the second cavity. The second fixation bracket (2) has a first end (210) and a second end (220) disposed opposite to each other. The first end (210) is connected to the first fixation bracket (1). A barrier membrane (3), which is disposed on the first fixing bracket (1) and / or the second fixing bracket (2), is used to seal the fistula. The first fixed bracket (1) and the second fixed bracket (2) are separate structures. The second fixed bracket (2) is connected to the first fixed bracket (1) to form a first connection trajectory. The blocking membrane (3) includes a first blocking membrane (32) connected to the first fixed bracket (1) and / or the second fixed bracket (2). The first blocking membrane (32) at least covers the first connection trajectory. The expansion and closure stent (100) also includes a traction wire (4), which is disposed at the second end (220). The second end (220) can be contracted by tightening the traction wire (4).

2. The expansion and occlusion stent (100, 100', 100'') according to claim 1, characterized in that, Tighten the traction wire (4), and the second end (220) contracts so that the second fixation bracket (2) can enter the second cavity through the fistula. Release the traction wire (4), and the second end (220) expands to position the second fixation bracket (2).

3. The expansion and occlusion stent (100, 100', 100'') according to claim 1, characterized in that, The pull wire (4) is circumferentially threaded through the second end (220). When the second end (220) is in a contracted state, the pull wire (4) extends at least partially 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 far end of the first fixed bracket (1).

4. The expansion and occlusion stent (100, 100', 100'') according to claim 1, characterized in that, The first fixing bracket (1) and the second fixing bracket (2) are configured as separate structures and are connected by soft thread stitching.

5. The expansion and occlusion stent (100, 100', 100'') according to claim 1, characterized in that, The barrier membrane (3) includes a first covering (31) that at least partially covers the first fixed bracket (1), the second fixed bracket (2) is connected to the first fixed bracket (1) to form a first connection trajectory, and the first covering (31) at least covers the first connection trajectory.

6. The expansion and occlusion stent (100, 100', 100'') according to claim 1, characterized in that, The first barrier membrane (32) is connected to the first fixed bracket (1) to form a second connection trajectory. The area enclosed by the second connection trajectory is larger than the area enclosed by the first connection trajectory, and the first connection trajectory is located within the second connection trajectory.

7. The expansion and occlusion stent (100, 100', 100'') according to claim 1, characterized in that, The first barrier membrane (32) is an acid-resistant membrane.

8. The expansion and occlusion stent (100, 100', 100'') according to claim 1, characterized in that, The barrier membrane (3) further includes a second cover (33) that at least partially covers the second fixed bracket (2) and a second barrier membrane (34) disposed within the second fixed bracket (2), wherein the second barrier membrane (34) is disposed within the space enclosed by the second cover (33) to form a seal.

9. The expansion and occlusion stent (100, 100') according to claim 8, characterized in that, The first end (210) 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), and the second covering membrane (33) covers at least the fistula-blocking section (21).

10. The expandable fistula occlusion stent (100'') according to claim 8, 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 fixed bracket (1).

11. The expansion and occlusion stent (100, 100', 100'') according to claim 1, characterized in that, The first fixing bracket (1) is made of woven metal wire, and the second fixing bracket (2) is made of biodegradable yarn or metal wire.

12. An insertion system, characterized in that, include: An 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 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 push tube (202) passes through the second handle (206) and connects to the middle tube (203). The inserter (200) is configured as a hollow structure for the guide wire to pass through 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 (205). The inner tube (204), the distal end of the middle tube (203), the proximal end of the pusher (205), and the outer tube (207) form an accommodating space. The expandable occlusion stent (100, 100', 100'') as described in any one of claims 1-11 is retractable within the receiving space. The safety lock (208) is released, and the second handle (206) is operated to retract the outer tube (207) to release the expandable occlusion stent (100) from the receiving space.

13. The implantation system according to claim 12, characterized in that, The expansion and closure stent (100, 100', 100'') also includes a traction wire (4), which is circumferentially threaded through the second end (220). When the second end (220) is in a contracted state, the traction wire (4) extends at least partially out of the second end (220). The traction 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 correspondingly provided with the free segment (42).

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