Tracheal fistula plugging device and plugging system

Abstract

The utility model relates to a tracheal fistula plugging device and plugging system, the plugging device comprises a first plugging disc, a second plugging disc and a waist part, the waist part comprises a first end part and a second end part, the first plugging disc spirally extends along the circumferential direction from the first end part to form a first supporting disc surface, and the second plugging disc spirally extends along the circumferential direction from the second end part to form a second supporting disc surface; the first supporting disc surface comprises any first radial part passing through the first end part, the first supporting disc surface further comprises other first parts except the first radial part, and the flexibility of the first radial part is larger than that of the other first parts; and / or the second plugging disc spirally extends from the second end part in the circumferential direction to form a second supporting disc surface, the second supporting disc surface comprises any second radial part passing through the second end part, and the second supporting disc surface further comprises other second parts except the second radial part; and the flexibility of the second radial part is greater than that of the second other part. According to the plugging device provided by the utility model, the compliance of the plugging disc and the trachea or esophagus wall can be improved, so that the fitting and plugging effects of the plugging device are improved.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a tracheobronchial fistula occluder and occlusion system. Background Technology

[0002] A tracheoesophageal fistula is a condition where various factors cause an abnormal connection between the trachea and esophagus. It is classified into congenital and acquired types. Tracheoesophageal fistulas are commonly seen in patients with airway malignancies, lung cancer, trauma, esophageal foreign bodies, or those with endotracheal intubation. It leads to a connection between the trachea and esophagus, often resulting in 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. Furthermore, because the tracheal membranous portion is composed of elastic fibers, damage to it is difficult to heal, which is one reason why tracheoesophageal fistulas are difficult to treat once they occur.

[0003] The principles of treating tracheoesophageal fistula (TEF) are to determine the location of the fistula, restore esophageal continuity, prevent and control infection, drain the abscess cavity, and ensure adequate nutrition. Currently, surgery is the primary treatment for TEF, but postoperative complications often include pleural infection, bleeding, and stent slippage. Recurrence of TEF is particularly difficult to manage. In recent years, studies have shown successful closure of TEF using atrial / ventricular septal occluders. However, existing occluders, due to their own weight and the pressure they exert on surrounding tissues, can cause ischemia and necrosis, or even detachment, potentially leading to airway obstruction and death. Furthermore, the occluder's structural limitations and its inability to adapt well to the shape of the tracheoesophageal wall during closure result in gaps between the fistula opening and the surrounding tissues, increasing the risk of gas leakage and surgical failure. Additionally, the occluder's weak bond with surrounding tissues can lead to fluid seepage at the fistula site, causing recurrent fever and cough.

[0004] In summary, providing a tracheocutaneous fistula occluder with good adaptability and therapeutic effect is a problem that needs to be solved at this stage. Utility Model Content

[0005] One technical problem solved by this utility model is how to provide a tracheocutaneous fistula occluder and occlusion system with good adaptability.

[0006] This utility model provides a tracheocutaneous fistula occluder, comprising a first occluder disc, a second occluder disc, and a waist portion. The waist portion includes a first end and a second end. The first occluder disc extends circumferentially spirally from the first end to form a first support surface. The first support surface includes any first radial portion passing through the first end, and also includes a first other portion other than the first radial portion. The compliance of the first radial portion is greater than that of the first other portion. And / or the second occluder disc extends circumferentially spirally from the second end to form a second support surface. The second support surface includes any second radial portion passing through the second end, and also includes a second other portion other than the second radial portion. The compliance of the second radial portion is greater than that of the second other portion.

[0007] In one embodiment, the first support plate surface includes a first forming wire, the diameter of which at the first radial portion is smaller than the diameter at the first other portion; and / or the second support plate surface includes a second forming wire, the diameter of which at the second radial portion is smaller than the diameter at the second other portion.

[0008] In one embodiment, the first support disc surface includes a first shaped wire, and the first sealing disc further includes a first spring coil extending spirally around the first shaped wire; and / or the second support disc surface includes a second shaped wire, and the second sealing disc further includes a second spring coil extending spirally around the second shaped wire; and / or the waist portion includes a waist shaped wire, and the sealing device further includes a waist spring coil extending spirally around the waist shaped wire.

[0009] In one embodiment, the wire diameter of the first spring coil is smaller than the wire diameter of the first forming wire, wherein the wire diameter of the first forming wire ranges from 0.2mm to 0.4mm and the wire diameter of the first spring coil ranges from 0.02mm to 0.15mm; and / or the wire diameter of the second spring coil is smaller than the wire diameter of the second forming wire, wherein the wire diameter of the second forming wire ranges from 0.2mm to 0.4mm and the wire diameter of the second spring coil ranges from 0.02mm to 0.15mm; and / or the wire diameter of the waist spring coil is smaller than the wire diameter of the waist forming wire, wherein the wire diameter of the waist forming wire ranges from 0.2mm to 0.4mm and the wire diameter of the waist spring coil ranges from 0.02mm to 0.15mm.

[0010] In one embodiment, the waist is V-shaped or Z-shaped in its natural state without external force.

[0011] In one embodiment, under natural conditions without external force, the axial distance between the first end and the second end is 2mm to 5mm.

[0012] In one embodiment, the first support plate surface includes a first forming wire, the first forming wire including a radially adjacent first circumferential spiral portion and a second circumferential spiral portion, the radial distance Dr1 between the first circumferential spiral portion and the second circumferential spiral portion satisfies: 1mm≤Dr1≤3mm; and / or the second support plate surface includes a second forming wire, the second forming wire including a radially adjacent third circumferential spiral portion and a fourth circumferential spiral portion, the radial distance Dr2 between the third circumferential spiral portion and the fourth circumferential spiral portion satisfies: 1mm≤Dr2≤3mm.

[0013] In one embodiment, the first support disc surface includes a first forming wire, the first forming wire including a first tail end and a fifth circumferential spiral portion, the first tail end being the end of the outermost coil of the first forming wire spiral, the fifth circumferential spiral portion being radially adjacent to the first tail end, and the first tail end gradually approaching the fifth circumferential spiral portion in the direction toward the tail end end; and / or the first support disc surface includes a second forming wire, the second forming wire including a second tail end and a sixth circumferential spiral portion, the second tail end being the end of the outermost coil of the second forming wire spiral, the sixth circumferential spiral portion being radially adjacent to the second tail end, and the second tail end gradually approaching the sixth circumferential spiral portion in the direction toward the tail end end end.

[0014] In one embodiment, the first support plate surface is pre-bent along at least one side of the first radial portion toward a direction away from the waist, so that the first support plate surface is curved, and the pre-bending angle α satisfies: 10°≤α≤30°; and / or the second support plate surface is pre-bent along at least one side of the second radial portion toward a direction away from the waist, so that the second support plate surface is curved, and the pre-bending angle β satisfies: 10°≤β≤30°.

[0015] This utility model also provides a sealing system, including the sealing device as described above. The sealing system further includes a conveyor, and the sealing device is detachably connected to the distal end of the conveyor. The first sealing disc further includes a developing element, which is used to indicate the direction of the first radial portion.

[0016] One technical effect of one embodiment of this utility model is that by setting the flexibility of the first radial portion to be greater than that of the other first portions, and / or the flexibility of the second radial portion to be greater than that of the other second portions, when the first / second sealing disc is released into the trachea or esophagus, due to the tensile force of the waist on its support disc surface, its support disc surface can conformably fit into the arc-shaped trachea or esophagus wall along its radial portion, which can increase the compliance of the sealing disc with the trachea or esophagus wall, thereby increasing the fit and sealing effect of the sealing device. Attached Figure Description

[0017] Figure 1 A schematic diagram of the structure of a tracheocutaneous fistula occluder according to one embodiment of the present invention;

[0018] Figure 2 for Figure 1 Top view;

[0019] Figure 3 for Figure 1 Side view;

[0020] Figure 4 A schematic diagram of the structure of a tracheocutaneous fistula occluder according to another embodiment of the present invention;

[0021] Figure 5 A schematic diagram of the structure of a tracheo-fistula occluder according to another embodiment of the present invention;

[0022] Figure 6 for Figure 5 Top view;

[0023] Figure 7 for Figure 5 Side view;

[0024] Figure 8 A schematic diagram of the structure of the second sealing disc in one embodiment of this utility model;

[0025] Figure 9 A schematic diagram of the structure of the second sealing disc in another embodiment of this utility model;

[0026] Figure 10 A schematic diagram of the structure of the second tail end according to one embodiment of this utility model;

[0027] Figure 11 A schematic diagram of the structure of a sealing system according to one embodiment of the present invention;

[0028] Figure 12 The diagram shows the effect of the tracheoesophageal fistula occluder provided by this utility model when applied to tracheoesophageal fistula.

[0029] 100. Occlusion device; 10. First occlusion disc; 11. First support disc surface; 11a. First forming wire; 111. First radial portion; 112. First other portion; 113. First circumferential spiral portion; 114. Second circumferential spiral portion; 115. First tail end; 116. Fifth circumferential spiral portion; 12. First spring coil; 20. Second occlusion disc; 21. Second support disc surface; 21a. Second forming wire; 211. Second radial portion; 212. Second other portion; 213. Third circumferential spiral portion; 214. Fourth circumferential spiral portion; 215. Second tail end; 216. Sixth circumferential spiral portion; 22. Second spring coil; 23. Support rod; 24. Support membrane; 30. Waist portion; 31. First end; 32. Second end; 33. Waist portion forming wire; 34. Waist portion spring coil; 40. Development element; 41. Development point; 50. Fistula opening;

[0030] 700. Sealing system; 70. Conveyor; 71. Conveyor cable; 72. Sheath Detailed Implementation

[0031] To facilitate understanding of this utility model, a more complete description will be given below with reference to the accompanying drawings. The drawings illustrate preferred embodiments of this utility model. However, this utility model can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a more thorough and complete understanding of the disclosure of this utility model.

[0032] It should be noted that when an element is referred to as being "fixed to" another element, it can be directly attached to the other element or there may be an intervening element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "inner," "outer," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

[0033] This utility model provides a blocking device 100, such as Figure 1-9 As shown, the occluder 100 can be used to close a tracheoesophageal fistula, such as... Figure 1-3 As shown, the occluder 100 includes a first occlusion disc 10, a second occlusion disc 20, and a waist portion 30. The waist portion 30 includes a first end portion 31 and a second end portion 32. The first occlusion disc 10 extends circumferentially spirally from the first end portion 31 as its spiral center to form a first support disc surface 11. The first support disc surface 11 includes any first radial portion 111 passing through the first end portion 31, such as... Figure 1As shown, a dashed line L1 passing through the first end 31 runs along the first support disc surface 11. Multiple points where this dashed line intersects the first support disc surface 11 form a first radial portion 111. The first support disc surface 11 also includes a first other portion 112 besides the first radial portion 111. The flexibility of the first radial portion 111 is greater than that of the first other portion 112, so that when the first sealing disc 10 is released into the trachea or esophagus, due to the pulling force of the waist portion 30, the first support disc surface 11 can conformably fit into the arc-shaped trachea or esophagus wall along the first radial portion 111, increasing the compliance of the first sealing disc 10 with the trachea or esophagus wall, thereby increasing the fit and sealing effect of the sealing device 100; and / or the second sealing disc 20 extends circumferentially spirally from the second end 32 with the second end 32 as the spiral center to form a second support disc surface 21. The second support disc surface 21 includes any second radial portion 211 passing through the second end 32, such as... Figure 1 As shown, a dashed line L2 runs along the second support plate surface 21 through the second end 32. Multiple points where this dashed line intersects with the second support plate surface 21 form the second radial portion 211. The second support plate surface 21 also includes a second other portion 212 in addition to the second radial portion 211. The flexibility of the second radial portion 211 is greater than that of the second other portion 212. This allows the second support plate surface 21 to conform to the arc-shaped trachea or esophagus wall along the second radial portion 211 when the second sealing plate 20 is released into the trachea or esophagus due to the pulling force of the waist portion 30. This increases the conformity of the first sealing plate 10 to the trachea or esophagus wall, thereby increasing the fit and sealing effect of the sealing device 100.

[0034] In one implementation, such as Figure 1-3As shown, the first support plate 11 includes a first forming filament 11a. The diameter of the first forming filament 11a at the first radial portion 111 is smaller than the diameter of the first forming filament 11a at the first other portion 112, so that the flexibility of the first radial portion 111 is greater than the flexibility of the first other portion 112. The first forming filament 11a includes a radially adjacent first circumferential spiral portion 113 and a second circumferential spiral portion 114. The radial distance Dr1 between the first circumferential spiral portion 113 and the second circumferential spiral portion 114 satisfies: 1mm≤Dr1≤3mm. The second support plate 21 includes a second forming filament 21a. The diameter of the second forming filament 21a at the second radial portion 211 is smaller than the diameter of the second forming filament 21a at the second other portion 212, so that the flexibility of the second radial portion 211 is greater than that of the second other portion 212. The second support plate 21 includes the second forming filament 21a, which includes a radially adjacent third circumferential spiral portion 213 and a fourth circumferential spiral portion 214. The radial spacing between the third circumferential spiral portion 213 and the fourth circumferential spiral portion 214 is Dr2. The following conditions must be met: 1mm ≤ Dr2 ≤ 3mm. A certain radial interval is defined between adjacent circumferential spiral portions in the first occlusion disc 10 and the second occlusion disc 20. On the one hand, this facilitates the maintenance of the disc shape and prevents the disc from becoming misshapen due to an excessively large radial interval; on the other hand, it avoids the radial interval being too small, which would be detrimental to glue filling. Defining the size of the radial interval facilitates the filling of glue into the waist 30 of the occluder 100, which can completely seal the tracheocutaneous fistula 50, prevent gas from overflowing into the esophagus, and also save glue filling time, thereby saving surgical time and reducing the implantation risk of the occluder 100. The waist 30 includes a waist shaping wire 33, and the occluder 100 also includes a waist spring coil 34, which extends spirally around the waist shaping wire 33.

[0035] In this embodiment, the first forming wire 11a, the waist forming wire 33, and the second forming wire 21a are integrally bent from a single elastic metal wire. The wire diameter of the first radial portion 111 and the second radial portion 211 can be reduced by corrosion treatment, thereby making the first radial portion 111 more flexible than the other first portions 112, and the second radial portion 211 more flexible than the other second portions 212. This makes the sealing device 100... When released into the trachea or esophagus, the first support disc 11 and the second support disc 21 are subjected to the pulling force of the waist portion 30 or conform to the shape of the trachea or esophageal wall. This allows the first support disc 11 and the second support disc 21 to deform into an arc shape along their respective more flexible radial portions. This enables the two discs of the occluder 100 to conformably fit against the arc-shaped trachea or esophageal wall, increasing the adhesion and conformity of the first occluder disc 10 and the second occluder disc 20 to the trachea or esophageal wall during release, thereby increasing the fit and occlusion effect of the occluder 100. The diameter of the first forming wire 11a ranges from 0.2mm to 0.4mm; the diameter of the second forming wire 21a ranges from 0.2mm to 0.4mm; and the diameter of the waist forming wire 33 ranges from 0.2mm to 0.4mm. In this embodiment, the first forming wire 11a, the second forming wire 21a and the waist 30 are formed by bending a single elastic metal wire, and the diameter of the entire elastic metal wire can be selected as 0.3mm.

[0036] In other implementations, such as Figure 4-7 As shown, the first sealing disc 10 further includes a first spring coil 12, which extends spirally around the first forming wire 11a. The diameter of the first spring coil 12 is smaller than the diameter of the first forming wire 11a, and the diameter range of the first spring coil is 0.02mm to 0.15mm. The second sealing disc 20 further includes a second spring coil 22, which extends spirally around the second forming wire 21a. The diameter of the second spring coil 22 is smaller than the diameter of the second forming wire 21a, and the diameter range of the second spring coil is 0.02mm to 0.15mm. The diameter of the waist spring coil 34 is smaller than the diameter of the waist forming wire 33, and the diameter range of the waist spring coil is 0.02mm to 0.15mm. During manufacturing, a single nickel-titanium wire with a small diameter can be evenly wound into a spring coil with a specific inner diameter. Then, the entire elastic metal wire is shaped into a first forming wire 11a, a second forming wire 21a, and a waist forming wire 33, and passed through the inner diameter of the spring coil. This fixes the entire shaped elastic metal wire to the spring coil. The spring coil can increase the adhesive adhesion area on the surface of the plugger 100, allowing the adhesive to better adhere to the surface of the plugger 100 and the waist 30, resulting in a better sealing effect of the fistula 50.

[0037] In its natural state without external force, the axial distance D between the first end 31 and the second end 32 of the waist portion 30 satisfies: 2mm ≤ D ≤ 5mm. This distance is generally smaller than the distance of the fistula 50 channel, so that after the occluder 100 is implanted, the waist portion 30 is in a stretched state, allowing the waist portion 30 at the fistula 50 to exert a pulling force on the two occluding discs, thereby adhering the two occluding discs to the esophageal and tracheal walls respectively under stress. In one embodiment, in its natural state without external force, the waist portion 30 is V-shaped or Z-shaped, which facilitates the stretching deformation of the waist portion 30 after the occluder 100 is implanted, increasing the clamping force of the occluder 100 when sealing the fistula 50, and adapting to tracheal and esophageal walls of different thicknesses. Here, axial direction refers to the direction of delivery when delivering the occluder 100, which is consistent with the direction of retracting the occluder 100. In one embodiment, the first sealing disc 10 and the second sealing disc 20 are symmetrically and parallelly arranged at both ends of the waist forming wire 33 relative to the waist portion 30. The waist forming wire 33 is symmetrically V-shaped, and the waist spring coil 34 extends spirally around the waist forming wire 33. Here, the axis refers to the direction perpendicular to the two sealing discs. Figure 3 and Figure 7 As shown.

[0038] In one implementation, such as Figure 5-6 As shown, the first forming filament 11a includes a first tail end 115 and a fifth circumferential spiral portion 116. The first tail end 115 is the end of the outermost spiral of the first forming filament 11a. The fifth circumferential spiral portion 116 is radially adjacent to the first tail end 115. The first tail end 115 gradually approaches the fifth circumferential spiral portion 116 in the direction toward the tail end. The second support disk surface 21 includes a second forming filament 21a. The second forming filament 21a includes a second tail end 215 and a sixth circumferential spiral portion 216. The second tail end 215 is the end of the outermost spiral of the second forming filament 21a. The sixth circumferential spiral portion 216 is radially adjacent to the second tail end 215. The second tail end 215 gradually approaches the sixth circumferential spiral portion 216 in the direction toward the tail end. In other embodiments, the first tail end 115 may gradually approach the fifth circumferential spiral portion 116 in the direction toward the tail end, and the second tail end 215 may extend at equal intervals with the sixth circumferential spiral portion 216; or, the first tail end 115 may extend at equal intervals with the fifth circumferential spiral portion 116, and the second tail end 215 may gradually approach the sixth circumferential spiral portion 216 in the direction toward the tail end, without limitation. The first tail end 115 and / or the second tail end 215 being spherical allows the tail end of the occluder 100 to adhere to the esophageal or tracheal wall in a smooth spherical shape, thereby reducing irritation to the esophageal or tracheal wall and preventing granulation tissue growth.

[0039] In other implementations, such as Figure 5-7As shown, the first support plate 11 is pre-bent along at least one side of the first radial portion 111 toward a direction away from the waist 30 to form a pre-bending angle α, making the first support plate 11 curved. The pre-bending angle α satisfies: 10° ≤ α ≤ 30°. The second support plate 21 is pre-bent along at least one side of the second radial portion 211 toward a direction away from the waist 30 to form a pre-bending angle β, making the second support plate 21 curved. The pre-bending angle β satisfies: 10° ≤ β ≤ 30°. The pre-bending of the first support plate 11 and the second support plate 21 allows the first and second occlusion plates 10 and 20 to be released initially on both sides of the fistula 50, and to more easily adapt to the tracheal or esophageal wall according to their respective pre-bending trends. After release, the occluder 100 only requires a small adaptive deformation to achieve better wall adhesion. In one embodiment, as... Figure 5 Combination Figure 7 As shown, the waist 30 has a symmetrical V-shaped structure. The first support plate 11 and the second support plate 21 are symmetrically arranged on both sides of the waist 30. The first support plate 11 is pre-bent into an arc shape along both sides of the first radial portion 111 in a direction away from the waist 30. The second support plate 21 is pre-bent into an arc shape along both sides of the second radial portion 211 in a direction away from the waist 30. The pre-bending angle α=β=20°.

[0040] In other embodiments, the first support plate 11 may include a first forming filament 11a, the first sealing plate 10 may include a first spring coil 12 extending spirally around the first forming filament 11a, and the second sealing plate 20 may include a support plate surface formed by multiple independent petal-shaped structures and a support film 24 covering the support plate surface, such as... Figure 8 As shown, or including a support disk surface formed by multiple support rods 23 radiating circumferentially from the second end 32 as the center, and a support membrane 24 covering the support disk surface, such as Figure 9 As shown.

[0041] This utility model also provides a sealing system 700, including the sealing device 100 as described above, such as... Figure 11 As shown, the sealing system 700 also includes a conveyor 70, with the sealer 100 detachably connected to the distal end of the conveyor 70. The conveyor 70 includes a conveying cable 71 and a sheath 72, the sheath 72 being arranged around the conveying cable 71, and the distal end of the sheath 72 extending beyond the conveying cable 71. Figure 10 As shown, the second tail end 215 of the second sealing disc 20 of the occluder 100 is provided with an internal or external thread, and the distal end of the delivery cable 71 is correspondingly provided with an external or internal thread that matches the second tail end 215, so that the distal end of the delivery cable 71 and the occluder 100 can be detachably connected, which facilitates the occluder 100 being coiled in the sheath 72 and delivered to the fistula 50 for release and deployment. Figure 12As shown.

[0042] The occluder 100 also includes a highlighting element 40. Taking the first occluder disc 10 located at the far end of the delivery device 70 (released first) in the occlusion system 700 as an example, the highlighting element 40 is set on the first occluder disc 10. The highlighting element 40 is used to indicate the direction of the first radial portion 111 so that when the occluder 100 is released at the fistula 50 using the occlusion system 700, the circumference of the first occluder disc 10 can be distinguished, so that the first radial portion 111 is along the esophagus or the trachea, so that the released first occluder disc 10 can better fit the esophageal wall or the tracheal wall after adaptively bending along the first radial portion 111. In one embodiment, the developing element 40 includes at least two developing points 41, wherein the line connecting the two developing points 41 is perpendicular to the first radial line L1 passing through the first radial portion 111, facilitating the circumferential adjustment of the first sealing disc 10 in its natural state. When the two developing points 41 overlap, the first radial portion 111 follows the esophageal or tracheal passages. In one embodiment, the developing element includes two developing points 41, which are symmetrically arranged on both sides of the line containing the first radial portion 111, such as... Figure 5 As shown.

[0043] 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.

[0044] The embodiments described above are merely illustrative of several implementations of this utility model, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the utility model patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this utility model, and these all fall within the protection scope of this utility model. Therefore, the protection scope of this utility model patent should be determined by the appended claims.

Claims

1. A tracheobronchial fistula occluder, characterized in that, The occluder includes a first occluder disc, a second occluder disc, and a waist portion. The waist portion includes a first end and a second end. The first occluder disc extends circumferentially spirally from the first end to form a first support disc surface. The first support disc surface includes any first radial portion passing through the first end. The first support disc surface also includes a first other portion other than the first radial portion. The compliance of the first radial portion is greater than the compliance of the first other portion. And / or the second occluder disc extends circumferentially spirally from the second end to form a second support disc surface. The second support disc surface includes any second radial portion passing through the second end. The second support disc surface also includes a second other portion other than the second radial portion. The compliance of the second radial portion is greater than the compliance of the second other portion.

2. The tracheobronchial fistula occluder according to claim 1, characterized in that, The first support plate surface includes a first forming wire, the diameter of which at the first radial portion is smaller than the diameter of which at the first other portion; and / or the second support plate surface includes a second forming wire, the diameter of which at the second radial portion is smaller than the diameter of which at the second other portion.

3. The tracheobronchial fistula occluder according to claim 1, characterized in that, The first support plate includes a first shaped wire, and the first sealing plate also includes a first spring coil, the first spring coil extending spirally around the first shaped wire; and / or the second support plate includes a second shaped wire, and the second sealing plate also includes a second spring coil, the second spring coil extending spirally around the second shaped wire; and / or the waist portion includes a waist shaped wire, and the sealing device also includes a waist spring coil, the waist spring coil extending spirally around the waist shaped wire.

4. The tracheobronchial fistula occluder according to claim 3, characterized in that, The diameter of the first spring coil is smaller than the diameter of the first forming wire, wherein the diameter of the first forming wire ranges from 0.2mm to 0.4mm and the diameter of the first spring coil ranges from 0.02mm to 0.15mm; and / or the diameter of the second spring coil is smaller than the diameter of the second forming wire, wherein the diameter of the second forming wire ranges from 0.2mm to 0.4mm and the diameter of the second spring coil ranges from 0.02mm to 0.15mm; and / or the diameter of the waist spring coil is smaller than the diameter of the waist forming wire, wherein the diameter of the waist forming wire ranges from 0.2mm to 0.4mm and the diameter of the waist spring coil ranges from 0.02mm to 0.15mm.

5. The tracheobronchial fistula occluder according to claim 1, characterized in that, In its natural state without external force, the waist is V-shaped or Z-shaped.

6. The tracheobronchial fistula occluder according to claim 1, characterized in that, Under natural conditions without external force, the axial distance between the first end and the second end is 2mm~5mm.

7. The tracheobronchial fistula occluder according to claim 1, characterized in that, The first support plate surface includes a first forming wire, the first forming wire including a first circumferential spiral portion and a second circumferential spiral portion that are radially adjacent, the radial distance Dr1 between the first circumferential spiral portion and the second circumferential spiral portion satisfies: 1mm≤Dr1≤3mm; and / or the second support plate surface includes a second forming wire, the second forming wire including a third circumferential spiral portion and a fourth circumferential spiral portion that are radially adjacent, the radial distance Dr2 between the third circumferential spiral portion and the fourth circumferential spiral portion satisfies: 1mm≤Dr2≤3mm.

8. The tracheobronchial fistula occluder according to claim 1, characterized in that, The first support plate includes a first forming wire, the first forming wire including a first tail end and a fifth circumferential spiral portion, the first tail end being the end of the outermost coil of the first forming wire spiral, the fifth circumferential spiral portion being radially adjacent to the first tail end, and the first tail end gradually approaching the fifth circumferential spiral portion in the direction toward the tail end end; and / or the first support plate includes a second forming wire, the second forming wire including a second tail end and a sixth circumferential spiral portion, the second tail end being the end of the outermost coil of the second forming wire spiral, the sixth circumferential spiral portion being radially adjacent to the second tail end, and the second tail end gradually approaching the sixth circumferential spiral portion in the direction toward the tail end end end.

9. The tracheobronchial fistula occluder according to claim 1, characterized in that, The first support plate surface is pre-bent along at least one side of the first radial portion toward a direction away from the waist to form a pre-bending angle α, so that the first support plate surface is curved, and the pre-bending angle α satisfies: 10°≤α≤30°; and / or the second support plate surface is pre-bent along at least one side of the second radial portion toward a direction away from the waist to form a pre-bending angle β, so that the second support plate surface is curved, and the pre-bending angle β satisfies: 10°≤β≤30°.

10. A plugging system comprising a plugging device as described in any one of claims 1-9, characterized in that, The occlusion system also includes a conveyor, and the occluder is detachably connected to the distal end of the conveyor. The first occlusion disc also includes a developing element, which is used to indicate the direction of the first radial portion.

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