A stent and delivery system

Abstract

The embodiment of the utility model provides a kind of support and implantation system, it is related to medical instrument technical field.Support includes support body, sealing membrane, first liquid absorbing liquid storage and drainage tube, sealing membrane is set in support body, first liquid absorbing liquid storage is set to the outside of support body, the distal end of drainage tube is set between support body and sealing membrane, drainage tube is used to carry out liquid absorption or liquid release to first liquid absorbing liquid storage.Drainage tube can be connected to negative pressure device, under the action of negative pressure, the pus secreted by human body is extracted by first liquid absorbing liquid storage;Drainage tube can also be connected to liquid injection device, inject treatment liquid into first liquid absorbing liquid storage, and slowly release to fistula, so as to improve the treatment effect of fistula;And by setting drainage tube between support body and sealing membrane, when stitching and fixing drainage tube on support body, sealing membrane will not be broken, further improve the treatment effect.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and more specifically, to a stent and implantation system. Background Technology

[0002] A gastrointestinal fistula is an abnormal opening or passage in the wall of the digestive tract that allows contents to leak into other parts of the body. It is a serious, potentially life-threatening complication, often caused by surgery, trauma, inflammation, infection, or tumors. Based on the location of the fistula, gastrointestinal fistulas are generally classified as upper gastrointestinal fistulas (including esophageal fistulas, tracheoesophageal fistulas, tracheoesophageal fistulas, and esophageal anastomotic fistulas) and lower gastrointestinal fistulas (including jejunal fistulas, ileal fistulas, colonic fistulas, and rectal fistulas).

[0003] Currently, stents are typically placed at the fistula opening in the digestive tract. The stent's self-expanding properties prop open the tract wall, ensuring the patency of the body's lumen, followed by appropriate treatment to promote fistula healing. However, existing stents suffer from poor treatment outcomes. Utility Model Content

[0004] The purpose of this invention is to provide a stent and placement system that can improve the treatment effect of fistulas.

[0005] The embodiments of this utility model are implemented as follows: In a first aspect, this utility model provides a bracket, comprising: Support body; A sealing membrane is disposed within the support body; A first liquid-absorbing reservoir is disposed on the outer side of the support body; and A drainage tube, the distal end of which is disposed between the support body and the sealing membrane, is used to absorb or release liquid from the first liquid absorption and storage device.

[0006] In an optional embodiment, both the support body and the first liquid absorption reservoir are tubular, and the support body and the first liquid absorption reservoir are coaxially arranged.

[0007] In an optional embodiment, the stent further includes a second suture thread, which passes through the drainage tube and is fixedly connected to the stent body to suture and fix the drainage tube to the stent body.

[0008] In an optional embodiment, an end hole is provided on the distal end face of the drainage tube, and the drainage tube is used to draw or release liquid from the first liquid absorption and storage device through the end hole.

[0009] In an optional embodiment, a side hole is provided on the side of the drainage tube, and the drainage tube is used to draw or release liquid from the first liquid absorption and storage device through the side hole.

[0010] In an optional embodiment, the number of side holes is multiple, and the multiple side holes are spaced apart along the axial direction of the drainage tube.

[0011] In an optional embodiment, the side hole is located on the side of the drainage tube near the first liquid absorption and storage component.

[0012] In an optional embodiment, the first liquid-absorbing and storing element is a sponge, gauze, non-woven fabric, or gelatin sponge.

[0013] In an optional embodiment, the stent further includes a second liquid-absorbing reservoir disposed between the stent body and the sealing membrane, and the distal end of the drainage tube is disposed between the stent body and the second liquid-absorbing reservoir.

[0014] In an optional embodiment, the stent further includes a first suture thread, which passes through the second liquid-absorbing reservoir and is fixedly connected to the stent body to suture and fix the second liquid-absorbing reservoir to the stent body.

[0015] In an optional embodiment, the support body includes a first cup-mouth section and a middle section connected to each other, the first cup-mouth section is located at the proximal end of the middle section, and the outer diameter of the first cup-mouth section is larger than the outer diameter of the middle section; the first liquid-absorbing reservoir is sleeved on the middle section, and the proximal end of the first liquid-absorbing reservoir abuts against the first cup-mouth section. The sealing membrane is spaced apart from the middle section, and the sealing membrane covers the inner wall of the first cup opening section; the second liquid absorption and storage device is disposed between the middle section and the sealing membrane, and the distal end of the drainage tube is disposed between the middle section and the second liquid absorption and storage device.

[0016] In an optional embodiment, the support body includes a second cup-mouth section and a middle section connected together, the second cup-mouth section being located at the distal end of the middle section, and the outer diameter of the second cup-mouth section being larger than the outer diameter of the middle section; the first liquid-absorbing reservoir is sleeved on the middle section, and the distal end of the first liquid-absorbing reservoir abuts against the second cup-mouth section. The sealing membrane is spaced apart from the middle section, and the sealing membrane covers the inner wall of the second cup opening section; the second liquid absorption and storage device is disposed between the middle section and the sealing membrane, and the distal end of the drainage tube is disposed between the middle section and the second liquid absorption and storage device.

[0017] In an optional embodiment, the second liquid-absorbing reservoir is a sponge, gauze, non-woven fabric, or gelatin sponge.

[0018] In an optional embodiment, the support further includes a granulation barrier layer that covers a portion of the second liquid absorption reservoir.

[0019] In an optional embodiment, the granulation barrier layer is gauze, non-woven fabric, permeable membrane, biodegradable membrane, or silicone membrane.

[0020] In an optional embodiment, the support further includes a long sleeve, a portion of which is disposed within the support body and connected to the distal end of the support body; another portion of which extends from the proximal end of the support body.

[0021] In an optional embodiment, there are multiple drainage tubes, the distal ends of which are located between the support body and the sealing membrane, and the multiple drainage tubes are used to absorb or release liquid from the first liquid absorption and storage device.

[0022] Secondly, the present invention provides an insertion system, including an inserter and a stent as described in any of the foregoing embodiments, wherein the inserter is used to insert the stent into the lumen of the human body. The implant includes an inner tube and a middle tube, with the inner tube passing through the middle tube and the drainage tube passing through the middle tube.

[0023] In an optional embodiment, the inserter further includes an outer tube sleeved on the middle tube, and a receiving cavity is formed between the outer tube and the inner tube for accommodating the support, and the middle tube is used to push the support to move relative to the outer tube.

[0024] In an optional embodiment, the inserter further includes an outer tube flexible head disposed at the distal end of the outer tube, which can extend or retract from the outer tube flexible head when the middle tube moves relative to the outer tube.

[0025] In an optional embodiment, the outer tube flexible head includes a flexible head body and a plurality of elastic abutment portions. The flexible head body is disposed at the distal end of the outer tube, and the plurality of elastic abutment portions are circumferentially spaced on the flexible head body and located at the end of the flexible head body away from the distal end of the outer tube. The plurality of elastic abutment portions can abut against the middle tube.

[0026] In an optional embodiment, the outer tube has an auxiliary through hole for an auxiliary line to pass through.

[0027] In an optional embodiment, the inserter further includes a distal handle and a proximal handle, the distal handle being connected to the outer tube and the proximal handle being connected to the middle tube.

[0028] In an optional embodiment, the inserter further includes a developing ring disposed at the distal end of the central tube.

[0029] The beneficial effects of this utility model embodiment include: The stent includes a stent body, a sealing membrane, a first liquid absorption reservoir, and a drainage tube. The sealing membrane is disposed inside the stent body, the first liquid absorption reservoir is disposed on the outside of the stent body, and the distal end of the drainage tube is disposed between the stent body and the sealing membrane. The drainage tube is used to absorb or release liquid from the first liquid absorption reservoir.

[0030] The stent is inserted into the body's lumen using an inserter. The self-expansion of the stent body expands the inner wall of the lumen, and in conjunction with the sealing membrane, creates a sealed space between the stent and the inner wall of the lumen. By placing the drainage tube between the stent body and the sealing membrane, the sealing membrane is not punctured when the drainage tube is sutured and fixed to the stent body. This ensures a good seal in the sealed space and does not affect the drainage tube's aspiration and drainage capabilities, thereby improving the treatment outcome. Because the stent body has a mesh structure, pus and bodily fluids secreted at the fistula opening are absorbed and stored by the first aspirator reservoir. This reservoir, with its small holes, corresponds to the distal end of the drainage tube. Since the distal end of the drainage tube is also located within this sealed space, the drainage tube can be connected to an external negative pressure device. Through negative pressure adsorption, the pus and bodily fluids stored in the first aspirator reservoir are drawn to the outside, continuously keeping the fistula clean and reducing infection. Furthermore, because the fistula is also located within this sealed space, it can be sealed, thereby promoting fistula healing and improving treatment outcomes. In addition, the drainage tube can be connected to an external infusion device to inject therapeutic fluids (such as chemotherapy drugs) into the sealed space, which are then stored in the first aspirator reservoir. Due to the reservoir's function, the therapeutic fluid is slowly released to the fistula opening, further enhancing the treatment effect.

[0031] The implantation system includes an implanter and a stent. The implanter can place the stent into the fistula in the body's lumen and perform corresponding treatments, which can also improve the treatment effect of the fistula. Attached Figure Description

[0032] To more clearly illustrate the technical solutions of the embodiments of this utility model, the drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this utility model and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0033] Figure 1 This is a schematic diagram of the insertion system provided in an embodiment of the present utility model; Figure 2 This is a schematic diagram of the structure of the first type of bracket provided in an embodiment of the present utility model; Figure 3 A first cross-sectional view of the bracket provided in an embodiment of this utility model; Figure 4 A second cross-sectional view of the bracket provided in an embodiment of this utility model; Figure 5 This is a schematic diagram of the structure of the support body provided in an embodiment of the present utility model; Figure 6 This is a schematic diagram of the structure of the second type of bracket provided in an embodiment of the present utility model; Figure 7 This is a schematic diagram of the structure of the third type of bracket provided in the embodiment of this utility model; Figure 8 This is a partial structural schematic diagram of the insertion system provided in an embodiment of the present utility model; Figure 9 for Figure 8 Sectional view of section AA in the image; Figure 10 This is a schematic diagram of the structure of the flexible outer tube provided in an embodiment of the present invention.

[0034] Icons: 1000 - Insertion system; 100 - Support; 10 - Support body; 11 - First cup segment; 12 - Middle segment; 13 - Second cup segment; 20 - Sealing membrane; 60 - First aspiration reservoir; 40 - Drainage tube; 41 - End hole; 42 - Side hole; 51 - First suture; 52 - Second suture; 30 - Second aspiration reservoir; 70 - Granulation barrier layer; 80 - Long sleeve; 90 - Connector; 200 - Insertor; 201 - Inner tube; 202 - Middle tube; 203 - Outer tube; 2031 - Auxiliary through hole; 205 - Outer tube soft tip; 2051 - Soft tip body; 2052 - Elastic abutment part; 206 - Distal handle; 207 - Proximal handle; 208 - Imaging ring; 300 - Guide wire. Detailed Implementation

[0035] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, and not all embodiments. The components of the embodiments of this utility model described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0036] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0037] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0038] In the description of this utility model, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product of this utility model is in use. They are only for the convenience of describing this utility model 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. Therefore, they should not be construed as limitations on this utility model. In addition, the terms "first," "second," and "third," etc., are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0039] Furthermore, terms such as "horizontal" and "vertical" do not imply that components must be absolutely horizontal or suspended, but rather that they can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal than "vertical," and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0040] In the description of this utility model, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; 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; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0041] As described in the background section, currently, a stent is typically placed at the fistula opening in the digestive tract. The stent's self-expanding properties are used to open the inner wall of the digestive tract, thereby ensuring the patency of the human lumen. Then, appropriate treatment is performed to promote fistula healing.

[0042] However, research by the inventors of this utility model has revealed that existing stents require a liner before the drainage tube is sewn onto the stent during manufacturing; otherwise, the high temperature will melt the drainage tube. In practice, the drainage tube is placed on the outside of the stent, while the sealing liner is placed on the inside. This makes it easy to puncture the sealing liner when sewing the drainage tube onto the stent with sutures, resulting in poor sealing and affecting the drainage tube's aspiration and drainage capabilities, thus leading to poor treatment outcomes.

[0043] Based on this, please refer to Figures 1-10 The present invention provides a stent 100 and an insertion system 1000, which can effectively improve the aforementioned technical problems, that is, improve the treatment effect of fistula. The stent 100 and the insertion system 1000 will be described in detail below.

[0044] Please refer to Figure 1 , Figure 1 This is a structural schematic diagram of the implantation system 1000 provided in this embodiment. (In conjunction with...) Figure 1 The implantation system 1000 includes an implanter 200 and a stent 100, the implanter 200 being used to insert the stent 100 into a lumen of the human body.

[0045] For details, please refer to Figure 2 and Figure 3 , Figure 2 This is a structural schematic diagram of the first type of support 100 provided in this embodiment. Figure 3 This is a first cross-sectional view of the bracket 100 provided in this embodiment. (In conjunction with...) Figure 2 and Figure 3 The stent 100 includes a stent body 10, a sealing membrane 20, a first liquid absorption and storage component 60, and a drainage tube 40. The sealing membrane 20 is disposed inside the stent body 10, the first liquid absorption and storage component 60 is disposed on the outside of the stent body 10, and the distal end of the drainage tube 40 is disposed between the stent body 10 and the sealing membrane 20. The drainage tube 40 is used to absorb or release liquid from the first liquid absorption and storage component 60.

[0046] As is easily understood, during use, the stent 100 is inserted into the lumen of the human body through the inserter 200. Under the self-expansion of the stent body 10, it can expand the inner wall of the lumen, and with the cooperation of the sealing membrane 20, a certain sealed space is formed between the stent 100 and the inner wall of the lumen. By placing the drainage tube 40 between the stent body 10 and the sealing membrane 20, the sealing membrane 20 will not be punctured when the drainage tube 40 is sutured and fixed to the stent body 10. This ensures a good sealing effect of the sealed space and does not affect the aspiration and drainage effect of the drainage tube 40, thereby improving the treatment effect.

[0047] Understandably, since the stent body 10 has a mesh structure, the pus and body fluid secreted at the fistula will be absorbed and stored by the first aspirating reservoir 60, and will correspond to the distal end of the drainage tube 40 through the small holes of the mesh. Since the distal end of the drainage tube 40 is also located in this sealed space, the drainage tube 40 can be connected to an external negative pressure device, and under the action of negative pressure adsorption, the pus and body fluid stored in the first aspirating reservoir 60 will be drawn to the outside of the body, continuously keeping the fistula clean and reducing the infection of the fistula. Furthermore, since the fistula is also located in this sealed space, the fistula can be sealed, thereby promoting the recovery and healing of the fistula and improving the treatment effect.

[0048] In addition, the drainage tube 40 can be connected to an external injection device to inject therapeutic fluid (such as chemotherapy drugs) into the sealed space and store it in the first aspirating reservoir 60. Due to the reservoir function of the first aspirating reservoir 60, the therapeutic fluid can be slowly released to the fistula, thereby further improving the treatment effect.

[0049] It should be noted that the proximal end of the drainage tube 40 is used to connect to a negative pressure device or a liquid injection device, thereby facilitating negative pressure liquid aspiration or drainage operations. Figure 1 To facilitate the connection between the drainage tube 40 and the negative pressure device or the injection device, the bracket 100 also includes a connector 90, which is located at the proximal end of the drainage tube 40 and is used to connect to the negative pressure device or the injection device.

[0050] Optionally, the connector 90 is detachably connected to the proximal end of the drainage tube 40. Specifically, in this embodiment, the connector 90 is a Luer connector 90.

[0051] Please continue to combine Figure 2 and Figure 3In this embodiment, both the stent body 10 and the first liquid absorption reservoir 60 are tubular, and the stent body 10 and the first liquid absorption reservoir 60 are coaxially arranged. It is easy to understand that the tubular stent body 10 and the first liquid absorption reservoir 60 can better adapt to the shape of the human body's lumen; thus, the sealing effect of the sealed space formed by the tubular stent body 10 and the inner wall of the lumen is better, and it is less likely to scratch the lumen wall; and the tubular first liquid absorption reservoir 60, being coaxial with the stent body 10, can adapt to the shape of the stent body 10, better cover different parts of the human body's lumen, and enable liquid aspiration and drainage treatment at different locations on the lumen wall.

[0052] Combination Figure 3 Furthermore, to improve the installation stability of the drainage tube 40, in this embodiment, the stent 100 also includes a second suture 52. The second suture 52 passes through the drainage tube 40 and is fixedly connected to the stent body 10 to suture and fix the drainage tube 40 to the stent body 10. It is understood that during suturing, the second suture 52 will not pass through the sealing membrane 20, that is, it will not puncture the sealing membrane 20, thus ensuring the sealing effect of the closed space for fluid aspiration and drainage, and will not affect the fluid aspiration and drainage effect of the drainage tube 40, thereby improving the treatment effect.

[0053] Specifically, multiple first mounting holes and multiple second mounting holes can be opened on opposite sides of the drainage tube 40, with the multiple first mounting holes and multiple second mounting holes spaced apart along the axial direction of the drainage tube 40. During suturing, one end of the second suture 52 is fixedly connected to the stent body 10, while the other end of the second suture 52 passes sequentially through the first and second mounting holes located at the end, then loops back through the mesh structure of the stent body 10, and then passes through adjacent first and second mounting holes, repeating the operation until it passes through all the first and second mounting holes, and is then knotted and fixed on the stent body 10. Fixing the drainage tube 40 with the second suture 52 also improves the stability of the drainage tube 40 during negative pressure adsorption or infusion treatment, thereby further improving the treatment effect.

[0054] Please continue to combine Figure 3 In this embodiment, an end hole 41 is provided on the distal end face of the drainage tube 40. The drainage tube 40 is used to absorb or release liquid from the first liquid absorption reservoir 60 through the end hole 41. That is, the drainage tube 40 directly absorbs pus and body fluids under negative pressure through the distal end hole 41, or allows the treatment fluid to flow into the first liquid absorption reservoir 60 through the end hole 41.

[0055] Of course, a side hole 42 can also be provided on the side of the drainage tube 40, and the drainage tube 40 is used to draw or release liquid from the first liquid absorption and storage component 60 through the side hole 42. In this way, the drainage tube 40 can perform liquid drawing and releasing operations on the first liquid absorption and storage component 60 at different positions.

[0056] Specifically, in this embodiment, the side hole 42 is located on the side of the drainage tube 40 near the first liquid absorption and storage component 60, such as... Figure 3 As shown, the side hole 42 is directly opposite the first liquid absorption reservoir 60, so that the side hole 42 can fit with the surface of the first liquid absorption reservoir 60, thereby improving the treatment effect.

[0057] To further improve the suction and drainage effect of the drainage tube 40 and thus enhance the healing speed of the fistula, the number of side holes 42 can be set to multiple, with multiple side holes 42 spaced apart along the axial direction of the drainage tube 40.

[0058] Optionally, in other embodiments, the number of drainage tubes 40 can be set to multiple, with the distal ends of the multiple drainage tubes 40 located between the support body 10 and the sealing membrane 20, and the multiple drainage tubes 40 being used to absorb or release liquid from the first liquid absorption and storage component 60.

[0059] As is easily understood, in actual operation, the specific number of drainage tubes 40, and the setting for each drainage tube 40 to perform aspiration or drainage, can be determined according to the treatment needs and specific circumstances. For example, if there are two drainage tubes 40, one drainage tube 40 can perform negative pressure aspiration of pus and body fluids, while the other drainage tube 40 can perform drainage of treatment fluids; of course, both drainage tubes 40 can also perform aspiration, or both drainage tubes 40 can perform drainage. Through different combinations, the treatment needs can be met, further promoting the healing of the fistula.

[0060] It should be noted that, specifically in this embodiment, the first liquid-absorbing and storing component 60 is a sponge, that is, the first liquid-absorbing and storing component 60 is an annular tubular structure made of sponge, which can utilize the properties of the sponge itself to absorb or release liquid. Of course, in other embodiments, the first liquid-absorbing and storing component 60 can also be gauze, non-woven fabric, or gelatin sponge, as long as it can achieve the function of absorbing and storing liquid.

[0061] Please refer to Figure 4 , Figure 4 This is a second cross-sectional view of the bracket provided in this embodiment, combined with... Figure 4To facilitate the absorption and storage of pus and bodily fluids at the fistula opening, and to increase the storage capacity of the treatment fluid flowing out of the drainage tube 40, thereby improving the treatment effect, in this embodiment, the stent 100 further includes a second fluid-absorbing reservoir 30, which is disposed between the stent body 10 and the sealing membrane 20. The distal end of the drainage tube 40 is disposed between the stent body 10 and the second fluid-absorbing reservoir 30.

[0062] It should be noted that pus and bodily fluids at the fistula opening can flow directly into the first aspiration reservoir 60 for storage. Of course, if there is a large amount of fluid, it will also flow into the second aspiration reservoir 30 for storage. The drainage tube 40 is located between the first and second aspiration reservoirs 60 and 30. A side hole 42 can be further opened on the side of the drainage tube 40 closest to the second aspiration reservoir 30. This allows for negative pressure adsorption of the fluids stored in both reservoirs simultaneously, thereby increasing the amount of fluid adsorbed and thus improving the treatment effect. It is understandable that the treatment fluid can also be transported through the drainage tube 40 to both the first and second aspiration reservoirs 60 and 30 for storage, increasing the amount of treatment fluid stored and similarly improving the treatment effect. Furthermore, placing the second aspiration reservoir 30 outside the sealing membrane 20 also improves the sealing effect to some extent, further enhancing the subsequent treatment effect.

[0063] Please continue to combine Figure 4 Furthermore, in order to improve the installation stability of the second liquid absorption reservoir 30, the bracket 100 also includes a first suture 51, which passes through the second liquid absorption reservoir 30 and is fixedly connected to the bracket body 10 to suture and fix the second liquid absorption reservoir 30 to the bracket body 10.

[0064] During suturing, one end of the first suture 51 can be fixedly connected to the stent body 10, while the other end of the first suture 51 first passes through the second aspirator reservoir 30, then passes back in the opposite direction and is fixedly connected to the stent body 10. This ensures the stable installation of the second aspirator reservoir 30, preventing it from shaking during treatment and allowing for smooth aspiration and drainage operations, thereby further improving the treatment effect.

[0065] It should be noted that during suturing, the first suture 51 will not pass through the sealing membrane 20, that is, it will not puncture the sealing membrane 20, thus ensuring the sealing effect of the sealed space for aspiration and drainage, resulting in good subsequent treatment effects.

[0066] Similarly, in this embodiment, the second liquid-absorbing and storing component 30 is specifically a sponge, that is, the second liquid-absorbing and storing component 30 is an annular tubular structure made of sponge, which can utilize the properties of the sponge itself to absorb or release liquid. Of course, in other embodiments, the second liquid-absorbing and storing component 30 can also be gauze, non-woven fabric, or gelatin sponge, as long as it can achieve the function of absorbing and storing liquid.

[0067] Please refer to Figure 5 , Figure 5 This is a structural schematic diagram of the support body 10 provided in this embodiment, combined with... Figures 2-5 The support body 10 includes a first cup-mouth section 11, a middle section 12, and a second cup-mouth section 13 connected in sequence. The first cup-mouth section 11 is located at the proximal end of the middle section 12, and the second cup-mouth section 13 is located at the distal end of the middle section 12. The outer diameters of both the first cup-mouth section 11 and the second cup-mouth section 13 are larger than the outer diameter of the middle section 12. A first liquid-absorbing reservoir 60 is sleeved on the middle section 12, and both ends of the first liquid-absorbing reservoir 60 abut against the first cup-mouth section 11 and the second cup-mouth section 13, respectively.

[0068] By setting the outer diameter of the first cup segment 11 and the second cup segment 13 to be larger than the outer diameter of the middle segment 12, when the stent body 10 is inserted into the human lumen, the first cup segment 11 and the second cup segment 13 abut against and fit against the two ends of the lumen respectively, so that the gap between the middle segment 12 and the inner wall of the lumen forms a sealed space with good sealing effect. In this way, the fistula can also be sealed in the sealed space of the middle segment 12, so that the first aspiration reservoir 60 can better treat the fistula by aspiration and drainage.

[0069] Furthermore, the sealing membrane 20 is spaced apart from the intermediate section 12, and the sealing membrane 20 covers the inner walls of the first cup-mouth section 11 and the second cup-mouth section 13; the second liquid-absorbing and storing component 30 is disposed between the intermediate section 12 and the sealing membrane 20, and the distal end of the drainage tube 40 is disposed between the intermediate section 12 and the second liquid-absorbing and storing component 30. By sealing the first cup-mouth section 11 and the second cup-mouth section 13 with the sealing membrane 20, the sealing effect of the space formed by the second liquid-absorbing and storing component 30, the intermediate section 12, the first cup-mouth section 11, the second cup-mouth section 13 and the inner wall of the tube can be further improved.

[0070] It should be noted that in some other embodiments, the first cup segment 11 or the second cup segment 13 may not be provided. For example, please refer to [reference needed]. Figure 6 , Figure 6 This is a structural schematic diagram of the second type of support 100 provided in this embodiment. (In conjunction with...) Figure 6In other embodiments, the stent body 10 includes a first cup-mouth section 11 and an intermediate section 12 connected to each other. The first cup-mouth section 11 is located at the proximal end of the intermediate section 12, and the outer diameter of the first cup-mouth section 11 is larger than the outer diameter of the intermediate section 12. The first liquid absorption reservoir 60 is sleeved on the intermediate section 12, and the proximal end of the first liquid absorption reservoir 60 abuts against the first cup-mouth section 11.

[0071] For example, please refer to Figure 7 , Figure 7 This is a structural schematic diagram of the third type of support 100 provided in this embodiment. (In conjunction with...) Figure 7 In other embodiments, the support body 10 includes a second cup-mouth section 13 and an intermediate section 12 connected to each other. The second cup-mouth section 13 is located at the far end of the intermediate section 12, and the outer diameter of the second cup-mouth section 13 is larger than the outer diameter of the intermediate section 12. The first liquid absorption reservoir 60 is sleeved on the intermediate section 12, and the far end of the first liquid absorption reservoir 60 abuts against the second cup-mouth section 13.

[0072] In addition, in some other embodiments, the cup openings may not be provided at either end of the intermediate section 12, and the first liquid absorption and storage component 60 may be directly fitted onto the intermediate section 12.

[0073] Please continue to combine Figure 2 and Figure 3 To prevent granulation tissue from penetrating into the first liquid absorption reservoir 60 and thus avoid damage caused by pulling on the granulation tissue when the stent 100 is withdrawn from the lumen, in this embodiment, the stent 100 further includes a granulation tissue barrier layer 70, which covers a portion of the first liquid absorption reservoir 60.

[0074] It should be noted that the granulation barrier layer 70 is specifically fitted to the lumen of the non-fistula portion. Therefore, in actual installation, the granulation barrier layer 70 does not completely cover the first liquid absorption reservoir 60.

[0075] To improve the barrier effect, multiple granulation tissue barrier layers 70 can be provided, with the multiple granulation tissue barrier layers 70 arranged sequentially and at intervals along the extension direction of the first liquid absorption reservoir 60. This further improves the treatment effect when the lumen has multiple fistula openings, making it suitable for applications requiring multiple fistula openings.

[0076] It should be noted that in this embodiment, the granulation tissue barrier layer 70 is specifically gauze; of course, in other embodiments, the granulation tissue barrier layer 70 can also be non-woven fabric, permeable membrane, biodegradable membrane or silicone membrane, etc., as long as it can achieve the function of granulation tissue barrier.

[0077] Furthermore, the support 100 also includes a long sleeve 80, a portion of which is disposed within the support body 10 and connected to the distal end of the support body 10; the other portion of which extends from the proximal end of the support body 10.

[0078] The long sleeve 80 is used when there is trauma to the intestine (usually the large intestine) but a fistula has not yet formed. It prevents the trauma from worsening and forming a fistula. The long sleeve 80 isolates feces from the intestine, thus preventing feces from contaminating and irritating the wound on the intestine, and preventing fistula formation. The first absorbent reservoir 60 in the stent 100 further prevents feces from entering the intestine isolated by the long sleeve 80 through the gaps in the stent 100. In actual use, one end of the long sleeve 80 is attached to the stent body 10 and extends all the way to the outside of the anus.

[0079] Please refer to Figure 8 , Figure 8 This is a partial structural diagram of the implantation system 1000 provided in this embodiment, combined with... Figure 1 , Figure 2 and Figure 8 The implanter 200 includes an inner tube 201 and a middle tube 202. The inner tube 201 passes through the middle tube 202, and the drainage tube 40 passes through the middle tube 202.

[0080] In other words, during the assembly of the stent 100 and the implanter 200, the proximal end of the drainage tube 40 passes through the central tube 202 and is then connected to the connector 90. It is easy to understand that the connector 90 can be further connected to a negative pressure device or an infusion device in subsequent treatment processes.

[0081] Please refer to Figure 9 , Figure 9 for Figure 8 Sectional view of section AA in the figure, combined with Figure 8 and Figure 9 In order to guide the distal end of the inserter 200 into the lumen of the human body, the insertion system 1000 also includes a guide wire 300, which is used to pass through the inner tube 201. In actual operation, the guide wire 300 needs to be used in conjunction with an endoscope to guide the distal end of the inserter 200 into the lumen.

[0082] Furthermore, the implanter 200 also includes an outer tube 203, which is sleeved on the middle tube 202, and a receiving cavity is formed between the outer tube 203 and the inner tube 201. The receiving cavity is used to receive the support 100, and the middle tube 202 is used to push the support 100 to move relative to the outer tube 203.

[0083] It should be noted that the stent 100 itself is elastic. Before insertion, the stent 100 needs to be retracted as a whole and placed in the receiving cavity, ensuring that the stent 100 is completely placed inside the outer tube 203. When the stent 100 arrives at the fistula of the human body lumen with the inserter 200, the tube 202 moves relative to the outer tube 203 during operation, thereby pushing the stent 100 out of the outer tube 203; then, under the action of self-expansion, the stent 100 is released at the preset fistula position.

[0084] To facilitate the insertion of the bracket 100 into the inserter 200, i.e., its placement within the receiving space, in this embodiment, the outer tube 203 is provided with an auxiliary through hole 2031 for the passage of an auxiliary wire. Specifically, during assembly, the bracket 100 is compressed and pulled into the receiving space for fixation by passing the auxiliary wire through the auxiliary through hole 2031.

[0085] It should be noted that, in order to ensure the installation effect of the bracket 100, the distance between the auxiliary through hole 2031 and the far end of the outer tube 203 needs to be greater than the length of the bracket 100 after compression.

[0086] Furthermore, the inserter 200 also includes a distal handle 206 and a proximal handle 207. The distal handle 206 is connected to the outer tube 203, and the proximal handle 207 is connected to the middle tube 202. In other words, by operating the proximal handle 207 and the distal handle 206, changing the distance between them, the middle tube 202 and the outer tube 203 can be moved relative to each other, thereby releasing the stent 100.

[0087] Please continue to combine Figure 8 The inserter 200 also includes an outer tube flexible head 205, which is located at the distal end of the outer tube 203. When the middle tube 202 moves relative to the outer tube 203, the middle tube 202 can extend or retract from the outer tube flexible head 205. By providing the outer tube flexible head 205, the smoothness of the movement of the middle tube 202 relative to the outer tube 203 can be improved, ensuring the stable release of the stent 100, while reducing the impact of the tube 202 on the human body lumen during release.

[0088] For details, please refer to Figure 10 , Figure 10 This is a schematic diagram of the structure of the outer tube flexible head 205 provided in this embodiment, combined with... Figure 8 and Figure 10 In this embodiment, the outer tube flexible head 205 includes a flexible head body 2051 and a plurality of elastic abutment portions 2052. The flexible head body 2051 is disposed at the far end of the outer tube 203, and the plurality of elastic abutment portions 2052 are annularly spaced on the flexible head body 2051 and located at the end of the flexible head body 2051 away from the far end of the outer tube 203. The plurality of elastic abutment portions 2052 can abut against the middle tube 202.

[0089] As is easily understood, the elastic abutment portion 2052 is elastic and can abut against the middle tube 202 under the action of elastic force. During the release of the support 100, the middle tube 202 moves relative to the outer tube 203, causing the multiple elastic abutment portions 2052 to form a slightly open state and elastically abut against the outer wall of the middle tube 202 to ensure the smooth movement of the middle tube 202. When the middle tube 202 retracts into the outer tube 203, the multiple elastic abutment portions 2052 will form a slightly closed state to ensure the stable placement of the middle tube 202.

[0090] Optionally, the implanter 200 also includes a contrast ring 208, which is disposed at the distal end of the central tube 202. The contrast ring 208 can be visualized under X-ray, allowing the physician to easily confirm the release position of the stent 100 by observing the X-ray visualization of the contrast ring 208 during implantation.

[0091] In summary, embodiments of this utility model provide a stent 100 and an insertion system 1000, relating to the field of medical device technology. The stent 100 includes a stent body 10, a sealing membrane 20, a first liquid-absorbing reservoir 60, and a drainage tube 40. The sealing membrane 20 is disposed within the stent body 10, the first liquid-absorbing reservoir 60 is disposed on the outside of the stent body 10, and the distal end of the drainage tube 40 is disposed between the stent body 10 and the sealing membrane 20. The drainage tube 40 is used to absorb or release liquid from the first liquid-absorbing reservoir 60.

[0092] In other words, the stent 100 is inserted into the lumen of the human body through the inserter 200. Under the self-expansion of the stent body 10, it can expand the inner wall of the lumen and, with the cooperation of the sealing membrane 20, form a certain sealed space between the stent 100 and the inner wall of the lumen. By placing the drainage tube 40 between the stent body 10 and the sealing membrane 20, the sealing membrane 20 will not be punctured when the drainage tube 40 is sutured and fixed to the stent body 10. This ensures a good sealing effect of the sealed space and does not affect the aspiration and drainage effect of the drainage tube 40, thereby improving the treatment effect. Because the stent body 10 has a mesh structure, the pus and body fluid secreted at the fistula opening are absorbed and stored by the first aspirating reservoir 60. This reservoir connects to the distal end of the drainage tube 40 through small holes in the mesh. Since the distal end of the drainage tube 40 is also located within this sealed space, the drainage tube 40 can be connected to an external negative pressure device. Under negative pressure adsorption, the pus and body fluid stored in the first aspirating reservoir 60 are drawn to the outside, continuously keeping the fistula clean and reducing infection. Furthermore, because the fistula is also located within this sealed space, it can be sealed, promoting fistula healing and improving treatment efficacy. In addition, the drainage tube 40 can be connected to an external injection device to inject therapeutic fluids (such as chemotherapy drugs) into the sealed space, which are then stored in the first aspirating reservoir 60. Due to the reservoir function of the first aspirating reservoir 60, the therapeutic fluid is slowly released to the fistula opening, further enhancing the treatment effect.

[0093] The implantation system 1000 includes an implanter 200 and a stent 100. The implanter 200 can insert the stent 100 into the fistula of the human body lumen and perform corresponding treatments, which can reduce the infection of the fistula, promote the recovery and healing of the fistula, and thus improve the treatment effect.

[0094] The above description is merely a specific embodiment of this utility model and is not intended to limit the utility model. Various modifications and variations can be made to this utility model by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this utility model should be included within the protection scope of this utility model.

Claims

1. A support, characterized in that, include: Support body (10); A sealing film (20) is disposed inside the support body (10); A first liquid-absorbing reservoir (60) is disposed on the outside of the support body (10); and The distal end of the drainage tube (40) is disposed between the support body (10) and the sealing membrane (20), and the drainage tube (40) is used to absorb or release liquid from the first liquid absorption and storage device (60).

2. The bracket according to claim 1, characterized in that, The support body (10) and the first liquid absorption and storage device (60) are both tubular, and the support body (10) and the first liquid absorption and storage device (60) are coaxially arranged.

3. The bracket according to claim 1, characterized in that, The stent (100) also includes a second suture (52), which passes through the drainage tube (40) and is fixedly connected to the stent body (10) to suture and fix the drainage tube (40) to the stent body (10).

4. The bracket according to claim 1, characterized in that, The distal end of the drainage tube (40) is provided with an end hole (41), and the drainage tube (40) is used to draw or release liquid from the first liquid absorption and storage device (60) through the end hole (41).

5. The bracket according to claim 1, characterized in that, The drainage tube (40) has a side hole (42) on its side, and the drainage tube (40) is used to draw or release liquid from the first liquid absorption storage device (60) through the side hole (42).

6. The bracket according to claim 5, characterized in that, The number of side holes (42) is multiple, and the multiple side holes (42) are spaced apart along the axial direction of the drainage tube (40).

7. The bracket according to claim 5, characterized in that, The side hole (42) is located on the side of the drainage tube (40) near the first liquid absorption and storage component (60).

8. The stent according to any one of claims 1-7, characterized in that, The first liquid-absorbing storage component (60) is a sponge, gauze, non-woven fabric or gelatin sponge.

9. The bracket according to claim 1, characterized in that, The stent (100) further includes a second liquid absorption reservoir (30), which is disposed between the stent body (10) and the sealing membrane (20), and the distal end of the drainage tube (40) is disposed between the stent body (10) and the second liquid absorption reservoir (30).

10. The stent according to claim 9, characterized in that, The stent (100) further includes a first suture (51), which passes through the second liquid absorption reservoir (30) and is fixedly connected to the stent body (10) to suture and fix the second liquid absorption reservoir (30) to the stent body (10).

11. The bracket according to claim 9, characterized in that, The support body (10) includes a first cup-mouth section (11) and a middle section (12) connected to each other. The first cup-mouth section (11) is located at the proximal end of the middle section (12), and the outer diameter of the first cup-mouth section (11) is larger than the outer diameter of the middle section (12). The first liquid absorption reservoir (60) is sleeved on the middle section (12), and the proximal end of the first liquid absorption reservoir (60) abuts against the first cup-mouth section (11). The sealing membrane (20) is spaced apart from the middle section (12), and the sealing membrane (20) covers the inner wall of the first cup mouth section (11); the second liquid absorption and storage component (30) is disposed between the middle section (12) and the sealing membrane (20), and the distal end of the drainage tube (40) is disposed between the middle section (12) and the second liquid absorption and storage component (30).

12. The stent according to claim 9, characterized in that, The support body (10) includes a second cup-mouth section (13) and a middle section (12) connected to each other. The second cup-mouth section (13) is located at the distal end of the middle section (12), and the outer diameter of the second cup-mouth section (13) is larger than the outer diameter of the middle section (12). The first liquid absorption reservoir (60) is sleeved on the middle section (12), and the distal end of the first liquid absorption reservoir (60) abuts against the second cup-mouth section (13). The sealing membrane (20) is spaced apart from the middle section (12), and the sealing membrane (20) covers the inner wall of the second cup mouth section (13); the second liquid absorption and storage component (30) is disposed between the middle section (12) and the sealing membrane (20), and the distal end of the drainage tube (40) is disposed between the middle section (12) and the second liquid absorption and storage component (30).

13. The stent according to any one of claims 9-12, characterized in that, The second liquid-absorbing storage component (30) is a sponge, gauze, non-woven fabric or gelatin sponge.

14. The bracket according to claim 1, characterized in that, The support (100) also includes a granulation barrier layer (70) which covers a portion of the first liquid absorption reservoir (60).

15. The stent according to claim 14, characterized in that, The granulation barrier layer (70) is made of gauze, non-woven fabric, permeable membrane, biodegradable membrane or silicone membrane.

16. The stent according to claim 1, characterized in that, The support (100) also includes a long sleeve (80), a portion of which is disposed within the support body (10) and connected to the distal end of the support body (10); another portion of which extends from the proximal end of the support body (10).

17. The bracket according to claim 1, characterized in that, The number of drainage tubes (40) is multiple, and the distal ends of the multiple drainage tubes (40) are located between the support body (10) and the sealing membrane (20). The multiple drainage tubes (40) are used to absorb or release liquid from the first liquid absorption and storage device (60).

18. An insertion system, characterized in that, Includes an inserter (200) and a stent (100) according to any one of claims 1-17, the inserter (200) being used to insert the stent (100) into a lumen of a human body; The implanter (200) includes an inner tube (201) and a middle tube (202), the inner tube (201) passing through the middle tube (202), and the drainage tube (40) passing through the middle tube (202).

19. The implantation system according to claim 18, characterized in that, The implanter (200) also includes an outer tube (203), which is sleeved on the middle tube (202), and a receiving cavity is formed between the outer tube (203) and the inner tube (201). The receiving cavity is used to receive the support (100), and the middle tube (202) is used to push the support (100) to move relative to the outer tube (203).

20. The implantation system according to claim 19, characterized in that, The inserter (200) also includes an outer tube soft head (205), which is disposed at the distal end of the outer tube (203). When the middle tube (202) moves relative to the outer tube (203), the middle tube (202) can extend or retract from the outer tube soft head (205).

21. The implantation system according to claim 20, characterized in that, The outer tube flexible head (205) includes a flexible head body (2051) and a plurality of elastic abutment parts (2052). The flexible head body (2051) is disposed at the far end of the outer tube (203). The plurality of elastic abutment parts (2052) are arranged in a ring at intervals on the flexible head body (2051) and are located at the end of the flexible head body (2051) away from the far end of the outer tube (203). The plurality of elastic abutment parts (2052) can abut against the middle tube (202).

22. The implantation system according to claim 19, characterized in that, The outer tube (203) has an auxiliary through hole (2031) for the passage of auxiliary lines.

23. The implantation system according to claim 19, characterized in that, The inserter (200) also includes a distal handle (206) and a proximal handle (207), the distal handle (206) being connected to the outer tube (203) and the proximal handle (207) being connected to the middle tube (202).

24. The implantation system according to any one of claims 18-23, characterized in that, The inserter (200) also includes a developing ring (208) disposed at the distal end of the central tube (202).

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