Digestive tract fistula plugging device

Abstract

The utility model provides a digestive tract fistula plugging device which comprises a liquid-injectable plugging device body, the liquid-injectable plugging device body is formed by weaving weaving wires in a constraint state, the liquid-injectable plugging device body has an expansion state, and the expansion state comprises flanges at the two ends and a cylindrical area in the center. The plugging device comprises a plugging device body capable of being filled with liquid, the plugging device body is cylindrical, the cylindrical area in the center is not provided with an open internal channel, the plugging device body capable of being filled with liquid is covered with a plugging covering film and connected with a liquid injection pipe, and the liquid injection pipe injects liquid or semi-solid or medicine into the plugging device body capable of being filled with liquid. The digestive tract fistula plugging device overcomes the defect that an existing plugging device used for plugging digestive tract fistula has harm to surrounding tissue, tissue regeneration and fistula healing are facilitated, the device can be recycled, safety is high, and the living quality of a patient can be improved.

Description

Technical Field

[0001] The utility model relates to the technical field of minimally invasive surgery, in particular to a digestive tract fistula occluding device. Background Art

[0002] In 2006, Paulo RS et al. reported the first case of atrial septal occluder used to block a 5mm esophageal tracheal fistula, and the patient was discharged from the hospital 5 days after the operation. The occlusion is performed through the trachea via a catheter, which is less invasive, easy to operate, and has significant effects. Subsequently, more and more literatures reported cases of mechanical occlusion of digestive tract fistulas with congenital heart disease occluders, but the following disadvantages still exist: (1) The occluder has a head at the proximal and distal ends or is concave inward. Once the patient coughs or makes other movements, the occluder becomes pear-shaped, which can easily damage the surrounding tissues and cause massive bleeding and sudden death. (2) The occluder is susceptible to corrosion. Secondly, the occluder as a foreign body can cause an inflammatory reaction, causing damage to the mucosa around the fistula. (3) Generally, the occluder is inserted through the trachea, which affects the rescue channel, and it cannot be inserted under the direct vision of the doctor at any time, which poses certain risks. (4) The weight of the occluder itself and the pressure of the occluder on the surrounding tissues can cause ischemia and necrosis or even detachment of the occluder, blocking the airway and causing death. The treatment method of using traditional gastrointestinal stents to expand the circumference of the digestive tract seriously affects the patient's daily life, causing pain, nausea, vomiting and other discomforts to the patient, affecting the patient's quality of life.

[0003] In recent years, stem cell transplantation has been used in many diseases as an emerging and hot treatment. Stem cells are a type of cell with self-renewal and replication capabilities, high proliferation and multidirectional differentiation potential. Among adult stem cells, the most widely used are mesenchymal stem cells, which can be found in bone marrow, fat, blood, umbilical cord, etc. Stem cell therapy can enhance the regeneration and repair ability of damaged tissues, especially in environments that are not conducive to wound healing. In 2003, García-Olmo D et al. injected adipose-derived mesenchymal stem cells into the internal opening of the recto-vaginal fistula of Crohn's disease patients for the first time. After treatment, the external opening of the fistula gradually closed completely. Subsequently, more and more literature reports have reported the successful treatment of various complex and refractory gastrointestinal fistulas using autologous or allogeneic bone marrow, adipose-derived mesenchymal stem cells, and stem cell exosomes. In addition, the growth factors mainly involved in the wound healing process include platelet-derived growth factor (PDGF), transforming growth factor (TGF-α, TGF-β), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), fibroblast growth factor (FGF), etc., which play a major role in promoting the division and proliferation of various types of tissue cells in the body, matrix synthesis and deposition, the formation of fibrous tissue and granulation tissue, and increasing collagen synthesis capacity and promoting post-traumatic epithelial regeneration, mesenchymal hyperplasia and neovascularization. In addition, CXC is also a key participant in wound healing among chemokines, such as stromal cell-derived factor 1 and granulocyte-macrophage colony-stimulating factor (GM-CSF). Utility Model Content

[0004] The purpose of the utility model is to provide a digestive tract fistula occluder to solve the many defects in the above-mentioned background technology. It overcomes the shortcomings of existing digestive tract fistula occluding devices that are harmful to surrounding tissues, makes the device recyclable, improves the safety of the device, improves the quality of life of patients, and promotes tissue regeneration and fistula healing.

[0005] In order to achieve the above purpose, the utility model provides the following technical solutions:

[0006] A digestive tract fistula occluder, characterized by comprising:

[0007] The injectable occluder body 6-1 is woven from braided wires in a constrained state, and the injectable occluder body 6-1 has an expanded state, which includes flanges at both ends and a central cylindrical area, and the central cylindrical area has no open internal passage.

[0008] The injectable plugging device body 6-1 is covered by a plugging film E.

[0009] The injectable occluder body 6 - 1 is connected to an injection tube Y, and the injection tube Y injects liquid, semi-solid or medicine into the injectable occluder body 6 - 1 .

[0010] The two ends of the injectable plugger body 6-1 are flanges, and the two ends are at least larger than the middle. The middle is a cylindrical area integrally connected to the two ends, and there is no open internal passage in the center of the cylindrical area. The bottom surfaces of the two ends of the cylindrical area or the bottom surface of one end are covered with the sealing film E, and the cylindrical surface of the cylindrical area is covered with a porous film or a partial film or no film.

[0011] The plugging film E is a biological membrane: a sheep intestinal membrane, a pig small intestinal submucosal membrane, a collagen membrane, a membrane made of a biocompatible polymer material such as a silicone membrane, a polytetrafluoroethylene PTFE membrane, a polylactic acid membrane, or one or more thereof;

[0012] The blocking film E is provided with a single or multiple leakage holes A, and the leakage holes A are one or more of macropores, mesopores, small holes or micropores, which facilitate the passage of liquids, semi-solids or drugs.

[0013] A plurality of injection holes X are provided at the position where the end of the injection tube Y contacts the body 6 - 1 of the injectable occluder; the end of the injection tube Y is connected to the body 6 - 1 of the injectable occluder via a soft wire.

[0014] A digestive tract fistula occluder, characterized in that the digestive tract fistula occluder 6 comprises a distal flange occluding body 60 , a proximal flange occluding body 61 and a connecting portion 62 .

[0015] The shape of the distal flange sealing body 60 is umbrella-shaped, mushroom-shaped, cup-shaped, disc-shaped, bowl-shaped, hemispherical or spherical, and the shape of the proximal flange sealing body 61 is umbrella-shaped, mushroom-shaped, cup-shaped, disc-shaped or spherical. A sealed state is formed between the distal flange sealing body 60 and the proximal flange sealing body 61 by coating.

[0016] The surface of the connecting part 62 is fully or partially provided with a coating; the surface of the distal flange blocking body 60 is fully or partially provided with a coating, which is a medical soft tissue patch or a simple silicone membrane, specifically a biological membrane, which can be made of sheep intestine or pig small intestine submucosa, etc. The preparation method is based on the Cook related product manual as an example, which is beneficial to the distal side granulation hyperplasia and epithelialization, specifically the trachea side, covering the blocking body to promote fistula healing; the surface of the proximal flange blocking body 61 is fully or partially covered with a silicone film and then covered with an acid-resistant ePTFE film to prevent gastric acid corrosion.

[0017] A first sealing coating 63 is provided between the distal flange sealing body 60 and the internal cavity of the connecting part 62, and / or a second sealing coating 64 is provided between the proximal flange sealing body 61 and the internal cavity of the connecting part 62; the diameter of the proximal flange sealing body 61 is greater than or equal to the diameter of the distal flange sealing body 60 to prevent the occluder from falling on the distal side, specifically preventing the occluder from falling into the airway, so as to reduce the risk of the occluder shifting to the trachea side or even suffocation.

[0018] A sealing film is provided inside the connecting portion 62 .

[0019] The distal flange sealing body 60 is an umbrella-shaped flange 1, the proximal flange sealing body 61 is a mushroom-shaped flange 2, the connecting portion 62 is an intermediate cylindrical region 3, the umbrella-shaped flange 1 and the mushroom-shaped flange 2 are connected as a whole through the intermediate cylindrical region 3, and the outer surfaces of the umbrella-shaped flange 1, the mushroom-shaped flange 2 and the intermediate cylindrical region 3 are all provided with a coating; the intermediate cylindrical region 3 is a tubular structure, and its two ends are sealed by the coating, the umbrella-shaped flange 1 is unfolded into an umbrella shape, and the mushroom-shaped flange 2 is unfolded into a mushroom cap shape.

[0020] The umbrella-shaped flange 1 includes an umbrella-shaped flange frame 101 and an umbrella-shaped flange coating 100 . The umbrella-shaped flange frame 101 is a dispersed structure or a woven structure, and the umbrella-shaped flange coating 100 covers the surface of the umbrella-shaped flange frame 101 .

[0021] The mushroom-shaped flange 2 includes a mushroom-shaped flange radial skeleton 21 and a mushroom-shaped flange coating 20 . The mushroom-shaped flange coating 20 is arranged on the surface of the mushroom-shaped flange radial skeleton 21 . The mushroom-shaped flange radial skeleton 21 includes a mushroom-shaped flange longitudinal skeleton 23 , a mushroom-shaped flange proximal skeleton 24 and a mushroom-shaped flange distal skeleton 25 .

[0022] The middle cylindrical region 3 includes a middle cylindrical region skeleton 31 and a cylindrical region coating 30 . The two ends of the middle cylindrical region skeleton 31 are respectively connected to the umbrella-shaped flange 1 and the mushroom-shaped flange 2 as a whole. The surface of the middle cylindrical region skeleton 31 is provided with a cylindrical region coating 30 .

[0023] One end of the middle cylindrical region 3 is provided with a proximal side blocking film 4 , and the other end of the middle cylindrical region 3 is provided with a distal side blocking film 5 .

[0024] The umbrella-shaped flange 1 is composed of a metal wire structure, and the material of the metal wire is any one or more combinations of biocompatible nickel-titanium alloy, bioresorbable polymer, shape memory polymer, resorbable metal, and biocompatible metal;

[0025] The mushroom-shaped flange 2 is composed of a metal wire structure, and the material of the metal wire is any one or more combinations of biocompatible nickel-titanium alloy, bioresorbable polymer, shape memory polymer, resorbable metal, and biocompatible metal;

[0026] The middle cylindrical area 3 is composed of a metal wire structure, and the material of the metal wire is any one or more combinations of biocompatible nickel-titanium alloy, bioresorbable polymer, shape memory polymer, resorbable metal, and biocompatible metal;

[0027] The outer surface of the metal wire is provided with an anti-corrosion coating, which is composed of polysilicone, and the antibacterial coating is composed of organic silicon cationic steroids, minocycline, rifampicin, gentamicin, vancomycin or hydrophobic materials or a combination thereof.

[0028] An occluder insertion device is characterized in that the occluder is loaded at the distal end of an outer tube, the proximal end of the outer tube is connected to a front handle, a middle tube is inside the outer tube, and the middle tube is connected to a rear handle. The front handle is retracted, the outer tube is retracted, the middle tube pushes out the distal flange of the occluder, releases it, the inserter is retracted into the proximal tissue, and then the proximal flange of the occluder is released.

[0029] A digestive tract fistula occluder insertion device, characterized in that it includes: a rear handle 8, a rear push rod 9 and a front handle 115, wherein the rear push rod 9 is fixedly connected to the rear handle 8, the rear push rod 9 passes through the front handle 115, the distal end of the rear push rod 9 is connected to the front push rod 92 through an internal connecting hose 91, the distal end of the front push rod 92 is connected to a mushroom-shaped front push head 93, the front push rod 92 is outerly provided with a flexible catheter 94, the proximal end of the front handle 115 is connected to the rear push rod locking knob 110 through a thread, the distal end of the rear push rod locking knob 110 is provided with a conical rubber plug 113, and the conical rubber plug 113 is in contact with the conical inner wall 111 inside the front handle 115.

[0030] The rear handle 8 is provided with a rear handle rear end cover 80 at the proximal end, and a rear handle front end cover 81 is connected to the distal end of the rear handle 8. The rear push rod 9 is fixedly connected to the rear handle 8 via a rear push rod fixing seat 90.

[0031] The front handle 115 is provided with a Luer connector tube 112 connected to its inner cavity 114. The distal end of the front handle 115 is connected to the front handle front end cover 117 via a connecting sleeve 116. The distal end of the front handle front end cover 117 is provided with a flexible sleeve hose connecting tube 118; the outer sleeve hose connecting tube 118 is connected to the flexible catheter 94; the conical rubber plug 113 is provided with a through hole 1131 for the rear push rod 9 to pass through, the conical rubber plug 113 has a conical surface 1132 in contact with the conical inner wall 111, and a cross groove 1133 is opened on the conical rubber plug 113.

[0032] The digestive tract fistula occluder insertion device is also provided with an inner hole, through which a guide wire can pass from one side of the digestive tract fistula occluder.

[0033] An adjustable distance mark is provided on the rear push rod 9 between the rear push rod locking knob 110 of the inserter and the front end cover 81 of the rear handle. The adjustable distance mark includes a positioning nut 805 located at the distal end and a distance adjuster 806 located at the proximal end and threadedly connected to the positioning nut 805. The positioning nut 805 is provided with an anti-slip rib 808, and the distance adjuster 806 is provided with a wing-shaped protrusion 807. The positioning nut 805 and the distance adjuster 806 are sleeved on the rear push rod 9. The distance between the rear push rod locking knob 110 and the front end cover 81 of the rear handle is adjusted by screwing in or out the distance adjuster 806.

[0034] A detachable mark is provided on the rear push rod 9 between the rear push rod locking knob 110 of the inserter and the front end cover 81 of the rear handle. The detachable mark is sleeved on the rear push rod 9 and includes a detachable sleeve 801 and an anti-slip handle 802. The detachable sleeve 801 and the anti-slip handle 802 are connected by a connector 804. A slot 803 for the rear push rod 9 to enter is provided on the side of the detachable sleeve 801. The detachable mark can be sleeved on the rear push rod 9 through the slot 803, and the connection is achieved by relying on the elastic force of the detachable sleeve 801, thereby achieving the locking of the distance between the rear push rod locking knob 110 and the front end cover 81 of the rear handle.

[0035] A method for inserting a digestive tract fistula occluder comprises the following steps:

[0036] S1. Locate the specific location of the fistula under endoscopy;

[0037] S2. Under endoscopic monitoring, a flexible catheter 94 equipped with a digestive tract fistula occluder is placed into the fistula opening, and specifically, the catheter can be placed into the fistula opening through a gastroscopic clamp channel;

[0038] S3, push the rear handle 8 to the distal end, and then push the mushroom-shaped flange 2 of the distal flange blocking body 60 of the digestive tract fistula occluder out of the flexible catheter 94 through the front pushing head 93, and release it to the distal side;

[0039] S4, rotating the rear push rod locking knob 110, axially squeezing the conical rubber plug 113, so that the conical rubber plug 113 holds the rear push rod 9 tightly under the action of the conical inner wall 111, so that the rear push rod 9 is fixed to the front handle 115;

[0040] S5, continuously moving the front handle 115 toward the proximal end, so that the distal flange blocking body 60 is blocked by the distal inner wall, thereby releasing the umbrella-shaped flange 1 of the proximal flange blocking body 61 of the digestive tract fistula occluder and releasing it to the proximal side;

[0041] S6. After confirming that the gastrointestinal fistula occluder is in the ideal position, the flexible catheter 94 is withdrawn, and endoscopic observation is performed again. If there is no abnormality, the endoscope is withdrawn.

[0042] A method for inserting an injectable occluder comprises the following steps:

[0043] S1. Locate the specific location of the fistula under endoscopy;

[0044] S2. Under endoscopic monitoring, the flexible catheter 94 equipped with the injectable occluder body 6-1 is placed into the fistula, specifically, it can be placed into the trachea side of the fistula through the gastroscopic forceps channel;

[0045] S3, pushing the rear handle 8 toward the distal end, and then pushing the distal flange of the injectable occluder body 6-1 out of the flexible catheter 94 through the front push head 93, and releasing it at the distal end;

[0046] S4, rotating the rear push rod locking knob 110, axially squeezing the conical rubber plug 113, so that the conical rubber plug 113 holds the rear push rod 9 tightly under the action of the conical inner wall 111, so that the rear push rod 9 is fixed to the front handle 115;

[0047] S5, continuously moving the front handle 115 toward the proximal end, so that the injectable occluder body 6-1 is blocked by the distal side wall, and then the proximal flange of the injectable occluder body 6-1 is released at the proximal side;

[0048] S6, after confirming that the injectable occluder body 6-1 is elastically inflated at the ideal position, the flexible catheter 94 is withdrawn;

[0049] S7, using an endoscope to penetrate into the proximal side, specifically the esophageal side 001, spraying tube 016 at the proximal flange plugging body 61 to inject methylene blue, and then observing under the distal endoscope or naked eyes, specifically bronchoscope 005, there is no methylene blue leakage, and the test fistula is successfully blocked;

[0050] S8. Use the injection tube Y to inject stem cells or stem cell exosomes or growth factors or chemokines. The specific operation is as follows: connect the injection tube Y of the digestive tract fistula occluder 6 to regularly inject stem cells or stem cell exosomes or growth factors or chemokines into the connecting part 6 of the digestive tract fistula occluder through the in vitro injection interface to promote tissue regeneration and fistula healing.

[0051] S9: Endoscopic observation again, if no abnormality is found, the endoscope is withdrawn;

[0052] S10. The injection tube Y is left in the patient's body to prepare for regular and repeated injections of stem cells or stem cell exosomes or growth factors or chemokines through the injection tube Y.

[0053] An application of a digestive tract fistula occluder or an injectable occluder, characterized in that the digestive tract fistula occluder or the injectable occluder is applied to but not limited to esophageal tracheal fistula, residual stomach tracheal fistula, thoracic gastrotracheal fistula, esophageal mediastinal fistula, esophageal pleural fistula, esophageal thoracic fistula, gastrothoracic fistula, gastrojejunal fistula, gastrocolonic fistula, gastro-abdominal wall fistula, gallbladder gastric fistula, gallbladder duodenal fistula, gallbladder colon fistula, bladder intestinal fistula, uterine colon fistula, recto-vaginal fistula, anal fistula, intestinal fistula, anastomotic fistula, bronchopleural fistula, and tracheomediastinal fistula; a digestive tract fistula refers to a pathological channel between the digestive tract, between the digestive tract and adjacent tissues and organs, and between the digestive tract and the chest / abdominal cavity or skin.

[0054] Compared with the prior art, the beneficial effects of the utility model are:

[0055] The utility model can reduce the risk of compression necrosis of tissues around the fistula. In addition, the diameter of the proximal flange is greater than or equal to the distal flange, and the risk of the occluder falling into the distal end is reduced. There are no caps at both ends of the occluder, and the possibility of damaging surrounding tissues when the occluder is deformed into a pear shape can be reduced. It can also be released under the direct vision of a gastroscope or a combined bronchoscope, making it more reliable for doctors to operate. A recovery line is provided at the proximal end of the flange, which can be taken out. Even if it falls into the distal end, it can be taken out with foreign body forceps. The utility model replaces the traditional treatment method of the digestive tract stent to circumferentially expand the digestive tract, avoids compression of the digestive tract, relieves pain, and improves the quality of life of patients. In addition, tissue regeneration and fistula healing can be promoted by repeated injection of stem cells or stem cell exosomes or growth factors or chemokines, which not only overcomes the shortcomings of existing occluding devices for blocking digestive tract fistulas that are harmful to surrounding tissues, but also improves our goal from mechanical closure of the fistula to promoting tissue regeneration and biological healing of the fistula. BRIEF DESCRIPTION OF THE DRAWINGS

[0056] Figure 1 This is a schematic structural diagram of Embodiment 1 of the occluder of the utility model; Figure 2 It is a side view of the embodiment 1 of the occluder of the utility model; Figure 3 This is one of the three-dimensional structural schematic diagrams of the embodiment 1 of the occluder of the utility model; Figure 4 This is one of the three-dimensional structural schematic diagrams of the embodiment 1 of the occluder of the utility model; Figure 5 This is a schematic structural diagram of Embodiment 2 of the occluder of the utility model; Figure 6 It is a three-dimensional structural schematic diagram of Example 2 of the occluder of the utility model; Figure 7 This is a schematic diagram of the cross-sectional structure of the occluder of the utility model located in the inserter; Figure 8 It is a schematic cross-sectional structural diagram of the occluder of the utility model in a partially unfolded state in which the occluder is partially located in the inserter. Figure 9a This is one of the cross-sectional structural schematic diagrams of the inserter of the present utility model. Figure 9b This is the second schematic cross-sectional view of the inserter of the present invention. Fig.10 It is a schematic diagram of the exploded structure of the inserter of the present utility model. Fig.11 It is a schematic diagram of the overall assembly structure of the inserter of the utility model. Fig.12 This is a schematic diagram of one of the decomposition steps of inserting the occluder of the utility model into the esophageal tracheal fistula using the inserter. Fig.13 This is a schematic diagram of the second decomposition step of inserting the occluder of the utility model into the esophageal tracheal fistula using the inserter. Fig.14 This is a schematic diagram of the third step of inserting the occluder of the utility model into the esophageal tracheal fistula using the inserter. Fig.15 This is one of the structural schematic diagrams of the conical rubber plug of the utility model. Fig.16 This is the second structural schematic diagram of the conical rubber plug of the utility model. Fig.17 This is the third structural schematic diagram of the conical rubber plug of the utility model. Fig.18 This is the fourth structural schematic diagram of the conical rubber plug of the utility model. Fig.19 The utility model is a schematic structural diagram of another digestive tract fistula occluder. Fig. 20 It is a schematic structural diagram of the first target and the second target of the utility model. Fig.21 It is a structural schematic diagram of Example 8 of the present utility model. Fig. 22 This is a side structural schematic diagram of the gastrointestinal fistula occluder in Example 9 of the utility model. Fig.23 This is a schematic diagram of the overall structure of the gastrointestinal fistula occluder in Example 9 of the utility model. Fig.24 This is one of the three-dimensional schematic diagrams of the gastrointestinal fistula occluder in Example 9 of the utility model. Fig.25 This is the second stereoscopic schematic diagram of the gastrointestinal fistula occluder in Example 9 of the utility model. Fig.26 This is a side structural schematic diagram of the gastrointestinal fistula occluder in Example 10 of the utility model. Fig. 27 This is a schematic diagram of the overall structure of the gastrointestinal fistula occluder in Example 10 of the utility model. Fig.28 It is a three-dimensional schematic diagram of the gastrointestinal fistula occluder in Example 10 of the utility model. Fig.29 This is a side structural schematic diagram of the gastrointestinal fistula occluder in Example 11 of the utility model. Fig.30 This is a schematic diagram of the overall structure of the gastrointestinal fistula occluder in Example 11 of the utility model. Fig.31 This is one of the three-dimensional schematic diagrams of the gastrointestinal fistula occluder in Example 11 of the utility model.

[0057] Fig.32 This is the second stereoscopic schematic diagram of the gastrointestinal fistula occluder in Example 11 of the utility model. Fig.33 This is a side structural schematic diagram of the gastrointestinal fistula occluder in Example 12 of the utility model. Fig.34 This is a schematic diagram of the overall structure of the gastrointestinal fistula occluder in Example 12 of the utility model. Fig.35 This is one of the three-dimensional schematic diagrams of the gastrointestinal fistula occluder in Example 12 of the utility model. Fig.36 This is the second stereoscopic schematic diagram of the gastrointestinal fistula occluder in Example 12 of the utility model. Fig.37 This is a side structural schematic diagram of the gastrointestinal fistula occluder in Example 13 of the utility model. Fig.38 This is a schematic diagram of the overall structure of the gastrointestinal fistula occluder in Example 13 of the utility model. Fig.39 This is one of the three-dimensional schematic diagrams of the gastrointestinal fistula occluder in Example 13 of the utility model. Fig.40This is the second stereoscopic schematic diagram of the gastrointestinal fistula occluder in Example 13 of the utility model. Fig.41 This is a side structural schematic diagram of the gastrointestinal fistula occluder in Example 14 of the utility model. Fig.42 This is a schematic diagram of the overall structure of the gastrointestinal fistula occluder in Example 14 of the utility model. Fig.43 This is one of the three-dimensional schematic diagrams of the gastrointestinal fistula occluder in Example 14 of the utility model. Fig.44 This is the second stereoscopic schematic diagram of the gastrointestinal fistula occluder in Example 14 of the utility model. Fig.45 This is a side structural schematic diagram of the gastrointestinal fistula occluder in Example 15 of the utility model. Fig.46 This is a schematic diagram of the overall structure of the gastrointestinal fistula occluder in Example 15 of the utility model. Fig.47 This is one of the three-dimensional schematic diagrams of the gastrointestinal fistula occluder in Example 15 of the utility model. Fig.48 This is the second stereoscopic schematic diagram of the gastrointestinal fistula occluder in Example 15 of the utility model. Fig.49 It is a partial schematic diagram of the connection part of the gastrointestinal fistula occluder in Example 15 of the utility model. Fig.50 This is a schematic diagram of the structure of the adjustable distance mark in Example 16 of the utility model. Fig.51 This is a schematic diagram of the structure of the detachable mark in Example 17 of the utility model. Fig.52 This is one of the pictures showing the location of the esophageal tracheal fistula. Fig.53 This is the second diagram for finding the location of the esophageal tracheal fistula. Fig.54 Schematic diagram of the gastrointestinal fistula occluder inserter entering the trachea side. Fig.55 Schematic diagram of releasing the distal end of the occluder under direct bronchoscope vision. Fig.56 Schematic diagram of the distal details of the occluder released under direct bronchoscope vision. Fig.57 Schematic diagram of releasing the proximal end of the occluder and withdrawing the bronchoscope. Fig.58 Schematic diagram of injecting methylene blue at the proximal end to observe whether there is infiltration on the tracheal side. Fig.59 Schematic diagram of successful occlusion without finding methylene blue under bronchoscopy. Fig.60 Schematic diagram of injecting stem cells into the occluder. Fig.61 Detailed diagram of the injection head. Fig.62 This is an overall schematic diagram of the in vitro injection interface and the in vivo injection head. Fig.63 It is a schematic diagram of the structure of a digestive tract fistula occluder with an injection tube; Fig.64 It is a schematic diagram of the trumpet-shaped flange structure of the injectable plugger; Fig.65 This is a structural schematic diagram of the connection method between the injection tube and the main body of the injectable occluder.

[0058] In the figure: 1, umbrella-shaped flange; 100, umbrella-shaped flange coating; 101, umbrella-shaped flange skeleton; 2, mushroom-shaped flange; 20, mushroom-shaped flange coating; 21, mushroom-shaped flange radial skeleton; 23, mushroom-shaped flange longitudinal skeleton; 24, mushroom-shaped flange proximal skeleton; 25, mushroom-shaped flange distal skeleton; 3, middle cylindrical area; 30, cylindrical area coating; 31, middle cylindrical area skeleton; 4, proximal side blocking coating; 5, distal side blocking coating; 7, recovery line; 8, rear handle; 80, rear end cover of rear handle; 81, front end cover of rear handle; 9, rear push rod; 90, rear push rod fixing seat; 91, internal connecting hose; 92, front push rod; 93, front push head; 94, flexible catheter; 95. Precision positioning sleeve; 110. Rear push rod locking knob; 111. Conical inner wall; 112. Luer connector tube; 113. Conical rubber plug; 114. Inner cavity; 115. Front handle; 116. Connecting sleeve; 117. Front handle front end cover; 118. Outer sleeve hose connecting tube; 1131. Through hole; 1132. Conical surface; 1133. Cross groove; 1A. Mirrored umbrella-shaped flange; 119. First target; 120. Second target; 6. Gastrointestinal fistula occluder; 60. Distal flange occluding body; 61. Proximal flange occluding body; 62. Connecting part; 63. First occluding film; 64. Second occluding film; 65. First occluding end; 66. Second occluding end. 801, detachable sleeve; 802, anti-slip handle; 803, slot; 804, connector; 805, positioning nut; 806, distance adjuster; 807, wing-shaped protrusion; 808, anti-slip rib; 001, esophageal side; 002, tracheal side; 003, esophageal tracheal fistula; 004, duodenoscope or colonoscope; 005, bronchoscope; 006, ordinary gastroscope; 016, spray tube; X, injection hole; 6-1, occluder; E, occluding film; A, leakage hole; X, injection hole; Y, injection tube. DETAILED DESCRIPTION

[0059] The following will be combined with the drawings in the embodiments of the utility model to clearly and completely describe the technical solutions in the embodiments of the utility model. Obviously, the described embodiments are only part of the embodiments of the utility model, not all of the embodiments. Based on the embodiments in the utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the utility model.

[0060] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the equipment or components referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. It should be particularly noted that the expression "proximal end" in the present invention refers to the end closer to the operator, and "distal end" refers to the end farther from the operator.

[0061] Example 1

[0062] like Fig.63 As shown, a liquid-injectable plugging device is characterized by comprising:

[0063] The injectable occluder body 6-1 is woven from a woven fabric with a restrained state, and the injectable occluder body 6-1 has an expanded state, which includes bulges at both ends and a central cylindrical area, and the central cylindrical area has no open internal passage.

[0064] The injectable plugging device body 6-1 is covered by a plugging film E.

[0065] The injectable occluder body 6 - 1 is connected to an injection tube Y, and the injection tube Y injects liquid into the occluder 6 - 1 .

[0066] The two ends of the injectable occluder body 6-1 are elastically inflated support frames, which are at least larger than the middle. The middle is a cylindrical area integrally connected to the two ends. The cylindrical area has no open internal passage, and the two ends of the cylindrical area are covered by the sealing film E.

[0067] The blocking film (E) is a biological membrane: a sheep intestinal membrane, a pig small intestinal submucosal membrane, a collagen membrane, or a membrane made of a biocompatible polymer material such as a silicone membrane, a polytetrafluoroethylene (PTFE) membrane, a polylactic acid membrane, etc.; the blocking film E is provided with a plurality of leakage holes A to facilitate the passage of liquid, thereby penetrating into the fistula tissue and exerting its effect.

[0068] In the case of intestinal fistula, a single-layer silicone membrane is used without an acid-resistant membrane; or the proximal end can be used in the same way as the distal end, with a combination of a biological membrane sheet or a superimposed silicone membrane.

[0069] A plurality of stem cell or stem cell exosome or growth factor or chemokine injection holes are provided at the position where the end of the injection tube Y contacts the injectable occluder body 6-1; the end of the injection tube Y is connected to the injectable occluder body 6-1 by a binding wire with medical standards, specifically a medical suture.

[0070] like Figures 1 to 4 A digestive tract fistula occluder, characterized in that it includes an umbrella-shaped flange 1, a mushroom-shaped flange 2 and an intermediate cylindrical area 3. The umbrella-shaped flange 1 and the mushroom-shaped flange 2 are connected as a whole through the intermediate cylindrical area 3. The outer surfaces of the umbrella-shaped flange 1, the mushroom-shaped flange 2 and the intermediate cylindrical area 3 are all provided with a coating; the intermediate cylindrical area 3 is a tubular structure, and its two ends are sealed by the coating. The umbrella-shaped flange 1 is unfolded into an umbrella shape, and the mushroom-shaped flange 2 is unfolded into a mushroom cap shape.

[0071] The umbrella-shaped flange 1 includes an umbrella-shaped flange frame 101 and an umbrella-shaped flange coating 100 . The umbrella-shaped flange frame 101 is a dispersed structure or a woven structure, and the umbrella-shaped flange coating 100 covers the surface of the umbrella-shaped flange frame 101 .

[0072] The mushroom-shaped flange 2 includes a mushroom-shaped flange radial skeleton 21 and a mushroom-shaped flange coating 20 . The mushroom-shaped flange coating 20 is arranged on the surface of the mushroom-shaped flange radial skeleton 21 . The mushroom-shaped flange radial skeleton 21 includes a mushroom-shaped flange longitudinal skeleton 23 , a mushroom-shaped flange proximal skeleton 24 and a mushroom-shaped flange distal skeleton 25 .

[0073] The middle cylindrical region 3 includes a middle cylindrical region skeleton 31 and a cylindrical region coating 30 . The two ends of the middle cylindrical region skeleton 31 are respectively connected to the umbrella-shaped flange 1 and the mushroom-shaped flange 2 as a whole. The surface of the middle cylindrical region skeleton 31 is provided with a cylindrical region coating 30 .

[0074] One end of the middle cylindrical region 3 is provided with a proximal side blocking film 4 , and the other end of the middle cylindrical region 3 is provided with a distal side blocking film 5 .

[0075] The umbrella-shaped flange 1 is composed of a metal wire structure, and the material of the metal wire is any one or more combinations of biocompatible nickel-titanium alloy, bioresorbable polymer, shape memory polymer, resorbable metal, and biocompatible metal;

[0076] The mushroom-shaped flange 2 is composed of a metal wire structure, and the material of the metal wire is any one or more combinations of biocompatible nickel-titanium alloy, bioresorbable polymer, shape memory polymer, resorbable metal, and biocompatible metal;

[0077] The middle cylindrical region 3 is composed of a metal wire structure, and the material of the metal wire is any one or more combinations of biocompatible nickel-titanium alloy, bioresorbable polymer, shape memory polymer, resorbable metal, and biocompatible metal.

[0078] The outer surface of the metal wire is provided with an anti-corrosion coating, which is composed of polysilicone, and the antibacterial coating is composed of organic silicon cationic steroids, minocycline, rifampicin, gentamicin, vancomycin or hydrophobic materials or a combination thereof.

[0079] The umbrella-shaped flange 1 is connected to a recovery line 7 , which can be a metal wire of the above-mentioned material, or a non-metallic material with good biocompatibility.

[0080] Example 2

[0081] like Figure 5 , Figure 6 , a digestive tract fistula occluder, the metal wire adopts a braiding structure and form different from that of Example 1, characterized in that it includes an umbrella-shaped flange 1, a mushroom-shaped flange 2 and an intermediate cylindrical region 3, the umbrella-shaped flange 1 and the mushroom-shaped flange 2 are connected as a whole through the intermediate cylindrical region 3, and the outer surfaces of the umbrella-shaped flange 1, the mushroom-shaped flange 2 and the intermediate cylindrical region 3 are all provided with a coating; the intermediate cylindrical region 3 is a tubular structure, and its two ends are sealed by the coating, the umbrella-shaped flange 1 is unfolded into an umbrella shape, and the mushroom-shaped flange 2 is unfolded into a mushroom cap shape.

[0082] Example 3

[0083] like Figure 7 As shown, the occluder is compressed and folded in the tubular structure of the inserter and delivered to the target fistula area.

[0084] like Figure 8 As shown, one end flange of the occluder is sent out by the inserter at one end on the trachea side, and unfolds under its own elastic force and memory tension. Then, during the retraction of the inserter, the other end flange of the occluder is sent out and released to unfold, completing the closure of the fistula.

[0085] Example 4

[0086] Figure 9a This is one of the cross-sectional structural schematic diagrams of the inserter of the present utility model. Figure 9b This is the second schematic cross-sectional view of the inserter of the present invention. Fig.10 It is a schematic diagram of the exploded structure of the inserter of the present utility model. Fig.11 It is a schematic diagram of the overall assembly structure of the inserter of the utility model.

[0087] A digestive tract fistula occluder insertion device comprises a rear handle 8, a rear push rod 9 and a front handle 115, wherein the rear push rod 9 is fixedly connected to the rear handle 8, the rear push rod 9 passes through the front handle 115, the distal end of the rear push rod 9 is connected to the front push rod 92 via an internal connecting hose 91, the distal end of the front push rod 92 is connected to a mushroom-shaped front push head 93, the front push rod 92 is outerly provided with a flexible catheter 94, the proximal end of the front handle 115 is connected to the rear push rod locking knob 110 via a thread, the distal end of the rear push rod locking knob 110 is provided with a conical rubber plug 113, and the conical rubber plug 113 is in contact with the conical inner wall 111 inside the front handle 115.

[0088] The rear push rod 9 is a metal rod, and the front push head 93, the rear handle 8 and the front handle 115 can be made of plastic through a mold. The inner connecting hose 91 and the flexible conduit 94 are hoses made of flexible materials.

[0089] The rear end of the rear handle 8 is provided with a rear handle rear cover 80, the rear end of the rear handle 8 is connected with a rear handle front cover 81, and the rear push rod 9 is fixedly connected to the rear handle 8 through a rear push rod fixing seat 90;

[0090] The front handle 115 is provided with a Luer connector tube 112 connected to its inner cavity 114. The distal end of the front handle 115 is connected to the front handle front end cover 117 via a connecting sleeve 116. The distal end of the front handle front end cover 117 is provided with a flexible sleeve hose connecting tube 118; the outer sleeve hose connecting tube 118 is connected to the flexible catheter 94; the conical rubber plug 113 is made of rubber and has elasticity. The conical rubber plug 113 is provided with a through hole 1131 for the rear push rod 9 to pass through. The conical rubber plug 113 has a conical surface 1132 in contact with the conical inner wall 111, and a cross groove 1133 is opened on the conical rubber plug 113.

[0091] The Luer connector tube 112 can be connected to a syringe or the like, and can be used to flush, aspirate, or inject liquid into the inner cavity 114 .

[0092] Example 5

[0093] A method for inserting a digestive tract fistula occluder comprises the following steps:

[0094] S1. Locate the specific location of the fistula under gastroscopy;

[0095] S2, such as Fig.12 Under gastroscopy, a flexible catheter 94 equipped with a digestive tract fistula occluder is placed into the fistula through the gastroscope channel;

[0096] S3, such as Fig.13 , push the rear handle 8 to the distal end, and then push the distal flange blocking body 60 of the digestive tract fistula occluder out of the flexible catheter 94 through the front pushing head 93, and release it to the distal side;

[0097] S4, rotating the rear push rod locking knob 110, axially squeezing the conical rubber plug 113, so that the conical rubber plug 113 holds the rear push rod 9 tightly under the action of the conical inner wall 111, so that the rear push rod 9 is fixed to the front handle 115;

[0098] S5, such as Fig.14 , the front handle 115 is continuously moved toward the proximal end, so that the distal flange blocking body 60 is blocked by the distal inner wall, and then the proximal flange blocking body 61 of the digestive tract fistula occluder is released and released to the proximal side;

[0099] S6. After confirming that the gastrointestinal fistula occluder is in the ideal position, the flexible catheter 94 is withdrawn, and gastroscopy is performed again. If there is no abnormality, the endoscope is withdrawn.

[0100] Example 6

[0101] Fig.19 The utility model is a schematic structural diagram of another digestive tract fistula occluder.

[0102] The mushroom-shaped flange 2 can also be replaced by a mirror-image umbrella-shaped flange 1A, with both ends being mirror images.

[0103] Example 7

[0104] like Fig. 20 , which is a schematic diagram of the structure of the first target and the second target of the utility model. The rear push rod 9 is also provided with a first target 119 and a second target 120, and the first target 119 and the second target 120 are yellow scale lines and red scale lines, respectively, representing the start of releasing the tracheal side flange and the completion of releasing the tracheal side flange.

[0105] Example 8

[0106] like Fig.21 The front push head 93 has a round head at the distal end, which is convenient for pushing out the flange better and will not damage the sealing film. The proximal end is drop-shaped, which is more beautiful and easy to clean. A precise positioning sleeve 95 is also provided at the proximal end of 92 to limit the relative position between the front push rod 92 and the internal connecting hose 91, which is conducive to the precise installation of the flange at a specific position of the inserter.

[0107] Example 9

[0108] like Figure 22 to Figure 25 As shown,

[0109] The digestive tract fistula occluder 6 comprises a distal flange occluding body 60 , a proximal flange occluding body 61 and a connecting portion 62 ; the outer surfaces of the distal flange occluding body 60 , the proximal flange occluding body 61 and the connecting portion 62 may be provided with a coating.

[0110] In addition, a first sealing film 63 is provided between the first sealing end 65 outside the distal flange sealing body 60 and the bottom surface of the cylindrical area of ​​the connecting part 62; a second sealing film 64 is provided between the second sealing end 66 outside the proximal flange sealing body 61 and the internal cavity of the connecting part 62.

[0111] The distal flange blocking body 60 is in the shape of a bowl that is recessed inwards.

[0112] A first sealing film 63 is provided between the first sealing end 65 at a diameter contraction point and the inner cavity of the connecting portion 62 .

[0113] The proximal flange blocking body 61 is umbrella-shaped or trumpet-shaped.

[0114] A second sealing coating 64 is provided between the diameter contraction portion of the second sealing end 66 and the inner cavity of the connecting portion 62 .

[0115] Prevent food or foreign objects from entering the trachea from the esophagus.

[0116] The coating in this embodiment can be made of silicone coating that meets medical standards or materials with similar functions.

[0117] Example 10

[0118] like Figure 26 to Figure 28 ,

[0119] The digestive tract fistula occluder 6 comprises a distal flange occluding body 60, a proximal flange occluding body 61 and a connecting portion 62; the outer surfaces of the distal flange occluding body 60, the proximal flange occluding body 61 and the connecting portion 62 are all provided with a coating.

[0120] In addition, a first sealing film 63 is provided between the first sealing end 65 outside the distal flange sealing body 60 and the internal cavity of the connecting part 62 ; a second sealing film 64 is provided between the second sealing end 66 outside the proximal flange sealing body 61 and the internal cavity of the connecting part 62 .

[0121] The distal flange blocking body 60 is in the shape of a bowl that is recessed inwards.

[0122] A first sealing film 63 is provided between the first sealing end 65 at a diameter contraction point and the inner cavity of the connecting portion 62 .

[0123] The proximal flange blocking body 61 is in the shape of a bowl that is recessed inwards.

[0124] A second sealing coating 64 is provided between the diameter contraction portion of the second sealing end 66 and the inner cavity of the connecting portion 62 .

[0125] Prevent food or foreign objects from entering the trachea from the esophagus.

[0126] In addition, in this embodiment, several, for example, 4 tantalum markers may be evenly distributed on one side of the flange.

[0127] The coating in this embodiment can be made of silicone coating that meets medical standards or materials with similar functions.

[0128] Embodiment 11

[0129] like Figure 29 to Figure 32 ,

[0130] The digestive tract fistula occluder 6 comprises a distal flange occluding body 60, a proximal flange occluding body 61 and a connecting portion 62; the outer surfaces of the distal flange occluding body 60, the proximal flange occluding body 61 and the connecting portion 62 are all provided with a coating.

[0131] In addition, a first sealing film 63 is provided between the first sealing end 65 outside the distal flange sealing body 60 and the internal cavity of the connecting part 62 ; a second sealing film 64 is provided between the second sealing end 66 outside the proximal flange sealing body 61 and the internal cavity of the connecting part 62 .

[0132] The distal flange blocking body 60 is disc-shaped or umbrella-shaped.

[0133] A first sealing film 63 is provided between the first sealing end 65 at a diameter contraction point and the inner cavity of the connecting portion 62 .

[0134] The proximal flange blocking body 61 is disc-shaped or umbrella-shaped.

[0135] A second sealing film 64 is provided between the diameter contraction portion of the second sealing end 66 and the inner cavity of the connecting portion 62 .

[0136] Prevent food or foreign objects from entering the trachea from the esophagus.

[0137] The coating in this embodiment can be made of silicone coating that meets medical standards or materials with similar functions.

[0138] Example 12

[0139] like Figure 33 to Figure 36 The digestive tract fistula occluder 6 comprises a distal flange occluding body 60, a proximal flange occluding body 61 and a connecting portion 62; the outer surfaces of the distal flange occluding body 60, the proximal flange occluding body 61 and the connecting portion 62 are all provided with a coating.

[0140] In addition, a first sealing film 63 is provided between the first sealing end 65 outside the distal flange sealing body 60 and the internal cavity of the connecting part 62 ; a second sealing film 64 is provided between the second sealing end 66 outside the proximal flange sealing body 61 and the internal cavity of the connecting part 62 .

[0141] The distal flange blocking body 60 is umbrella-shaped and covers inwardly, that is, if the first blocking end 65 is likened to an umbrella surface, the umbrella surface faces outwardly.

[0142] A first blocking film 63 is provided between the first blocking end 65 and the inner cavity of the connecting portion 62 .

[0143] The proximal flange blocking body 61 is umbrella-shaped and covers inwardly, that is, if the first blocking end 65 is likened to an umbrella surface, the umbrella surface faces outward.

[0144] A second blocking film 64 is disposed between the second blocking end 66 and the inner cavity of the connecting portion 62 .

[0145] Prevent food or foreign objects from entering the trachea from the esophagus.

[0146] The coating in this embodiment can be made of silicone coating that meets medical standards or materials with similar functions.

[0147] Example 13

[0148] like Figures 37 to 40 The digestive tract fistula occluder 6 comprises a distal flange occluding body 60, a proximal flange occluding body 61 and a connecting portion 62; the outer surfaces of the distal flange occluding body 60, the proximal flange occluding body 61 and the connecting portion 62 are all provided with a coating.

[0149] The distal flange blocking body 60 is umbrella-shaped or disc-shaped.

[0150] A third sealing film 67 is provided in the inner cavity of the connecting portion 62 .

[0151] The proximal flange blocking body 61 is umbrella-shaped or disc-shaped.

[0152] The middle of the cavity of the connecting part 62 is blocked with a silicone membrane, while the two ends of the connecting part 62 are not blocked, or one of the two ends of the connecting part 62 is blocked, so as to prevent food or foreign matter from entering the trachea from the esophagus.

[0153] The coating in this embodiment can be made of silicone coating that meets medical standards or materials with similar functions.

[0154] Embodiment 14

[0155] like Figure 41 to Figure 44 The digestive tract fistula occluder 6 comprises a distal flange occluding body 60, a proximal flange occluding body 61 and a connecting portion 62; the outer surfaces of the distal flange occluding body 60, the proximal flange occluding body 61 and the connecting portion 62 are all provided with a coating.

[0156] The distal flange blocking body 60 is disc-shaped or umbrella-shaped.

[0157] The proximal flange blocking body 61 is disc-shaped or umbrella-shaped.

[0158] The first plugging end 65 is provided with a first plugging film 63 between the diameter contraction part and the inner cavity of the connecting part 62, or the second plugging end 66 is provided with a second plugging film 64 between the diameter contraction part and the inner cavity of the connecting part 62. That is, only one end of the connecting part 62 is sealed with a silicone film, and the other end is not sealed.

[0159] The proximal flange plugging body 61 is disc-shaped or umbrella-shaped. In the figure, a first plugging film 63 is provided between the first plugging end 65 at the diameter contraction point and the inner cavity of the connecting part 62 as an example.

[0160] Prevent food or foreign objects from entering the trachea from the esophagus.

[0161] The coating in this embodiment can be made of silicone coating that meets medical standards or materials with similar functions.

[0162] Embodiment 15

[0163] like Figures 45 to 49 The digestive tract fistula plugger 6 comprises a distal flange plugging body 60, a proximal flange plugging body 61 and a connecting portion 62; the outer surfaces of the distal flange plugging body 60 and the proximal flange plugging body 61 are both provided with a coating. The outer surface of the connecting portion 62 is partially provided with a coating, specifically, the outer surface of the connecting portion 62 near the middle is exposed, and the outer surface near the two ends is provided with a coating.

[0164] The distal flange blocking body 60 is disc-shaped or umbrella-shaped.

[0165] The proximal flange blocking body 61 is disc-shaped or umbrella-shaped.

[0166] The first blocking end 65 is provided with a first blocking film 63 between the diameter contraction point and the inner cavity of the connecting part 62 and / or the second blocking end 66 is provided with a second blocking film 64 between the diameter contraction point and the inner cavity of the connecting part 62 .

[0167] Prevent food or foreign objects from entering the trachea from the esophagus.

[0168] The coating in this embodiment can be made of silicone coating that meets medical standards or materials with similar functions.

[0169] In the above embodiment, the placement position of the distal flange sealing body 60 is not limited to the esophageal side or the tracheal side, the placement position of the proximal flange sealing body 61 is not limited to the esophageal side or the tracheal side, and the placement position of the connecting portion 62 is located between the esophagus and the trachea, but it does not exclude that a small part or more than half of the connecting portion 62 is located on the esophageal side or the tracheal side.

[0170] Example 16

[0171] Fig.50This is a schematic diagram of the structure of the adjustable distance mark in Example 16 of the utility model.

[0172] An adjustable distance mark is provided on the rear push rod 9 between the rear push rod locking knob 110 of the inserter and the front end cover 81 of the rear handle. The adjustable distance mark includes a positioning nut 805 located at the distal end and a distance adjuster 806 located at the proximal end and threadedly connected to the positioning nut 805. The positioning nut 805 is provided with an anti-slip rib 808, and the distance adjuster 806 is provided with a wing-shaped protrusion 807. The positioning nut 805 and the distance adjuster 806 are sleeved on the rear push rod 9. The distance between the rear push rod locking knob 110 and the front end cover 81 of the rear handle is adjusted by screwing in or out the distance adjuster 806.

[0173] The adjustable distance mark is used to indicate that the blocking body of the digestive tract fistula occluder at the distal end is opened. When the distance between the rear push rod locking knob 110 and the front end cover 81 of the rear handle is completely occupied by the adjustable distance mark during the process of pushing the rear handle to the distal end, it indicates that the rear handle is pushed to the predetermined position, that is, the blocking body of the digestive tract fistula occluder at the distal end has been opened. Then, the rear handle is stopped from being pushed, and the inserter is pulled out to the proximal end, so that the blocking body of the digestive tract fistula occluder at the proximal end is opened, completing the flange insertion and blocking between the esophagus and the trachea.

[0174] The adjustable distance mark can be used for over-the-wire or non-over-the-wire inserters.

[0175] Embodiment 17

[0176] Fig.51 This is a schematic diagram of the structure of the detachable mark in Example 17 of the utility model.

[0177] A detachable mark is provided on the rear push rod 9 between the rear push rod locking knob 110 of the inserter and the front end cover 81 of the rear handle. The detachable mark is sleeved on the rear push rod 9 and includes a detachable sleeve 801 and an anti-slip handle 802. The detachable sleeve 801 and the anti-slip handle 802 are connected by a connector 804. A slot 803 for the rear push rod 9 to enter is provided on the side of the detachable sleeve 801. The detachable mark can be sleeved on the rear push rod 9 through the slot 803, and the connection is achieved by relying on the elastic force of the detachable sleeve 801, thereby achieving the locking of the distance between the rear push rod locking knob 110 and the front end cover 81 of the rear handle.

[0178] The detachable mark is used to indicate that the occluding body of the gastrointestinal fistula occluder at the distal end is opened. When the distance between the rear push rod locking knob 110 and the front end cover 81 of the rear handle is completely occupied by the detachable mark during the process of pushing the rear handle to the distal end, it indicates that the rear handle has been pushed to the predetermined position, that is, the occluding body of the gastrointestinal fistula occluder at the distal end has been opened. Then, the rear handle is stopped from being pushed, and the inserter is pulled out to the proximal end, so that the occluding body of the gastrointestinal fistula occluder at the proximal end is opened, completing the flange insertion and occlusion between the esophagus and the trachea.

[0179] The removable marker can be used with or without an over-the-wire inserter.

[0180] Embodiment 18

[0181] The digestive tract fistula occluder insertion device is also provided with an inner hole, through which a guide wire can pass from one side of the digestive tract fistula occluder.

[0182] Embodiment 19

[0183] A method for blocking esophageal tracheal fistula using a digestive tract fistula occluder and promoting tissue regeneration and fistula healing.

[0184] The first step, such as Figure 52-Figure 53 As shown, the lesion, i.e., esophageal tracheal fistula 003, was found using duodenoscope or enteroscope 004;

[0185] The second step is, Fig.54 As shown, a bronchoscope 005 is inserted from the tracheal side 002, and an occluder inserter is used to insert the bronchoscope from the esophageal side 001 into the tracheal side 002;

[0186] The third step is Figure 55-Figure 56 As shown, the distal flange blocking body 60 is released under direct vision of the bronchoscope 005;

[0187] The fourth step is Fig.57 As shown, the proximal flange blocking body 61 is released, the occluder inserter is withdrawn, and the duodenoscope or colonoscope 004 is withdrawn. At this time, the digestive tract fistula occluder 6 has completely blocked the esophageal tracheal fistula 003;

[0188] Step 5: Figure 58-Figure 59 As shown, a common gastroscope 006 is used to penetrate into the esophagus side 001, and a spray tube 016 is used to inject methylene blue at the proximal flange blocking body 61. At this time, no methylene blue is observed to leak out under the bronchoscope 005, and the fistula is successfully blocked;

[0189] Step 6: Fig.60As shown, by connecting the injection tube Y of the digestive tract fistula occluder 6, stem cells or stem cell exosomes or growth factors or chemokines are regularly injected into the digestive tract fistula occluder 6 through the in vitro injection interface to promote tissue regeneration and fistula healing.

[0190] In particular, such as Fig.61 As shown, a plurality of injection holes X are left at the end of the injection tube Y; the injection tube Y is made of a winding material to adapt to the shape of the patient's body.

[0191] Embodiment 20

[0192] A method for inserting an injectable occluder comprises the following steps:

[0193] S1. Locate the specific location of the fistula under endoscopy;

[0194] S2. Under endoscopic monitoring, the flexible catheter 94 equipped with the injectable occluder body 6-1 is placed into the fistula, specifically, it can be placed into the trachea side of the fistula through the gastroscopic forceps channel;

[0195] S3, pushing the rear handle 8 toward the distal end, and then pushing the distal flange of the injectable occluder body 6-1 out of the flexible catheter 94 through the front push head 93, and releasing it at the distal end;

[0196] S4, rotating the rear push rod locking knob 110, axially squeezing the conical rubber plug 113, so that the conical rubber plug 113 holds the rear push rod 9 tightly under the action of the conical inner wall 111, so that the rear push rod 9 is fixed to the front handle 115;

[0197] S5, continuously moving the front handle 115 toward the proximal end, so that the injectable occluder body 6-1 is blocked by the inner wall of the trachea side, and then the proximal flange of the injectable occluder body 6-1 is released at the proximal side;

[0198] S6, after confirming that the injectable occluder body 6-1 is elastically inflated at the ideal position, the flexible catheter 94 is withdrawn;

[0199] S7, use a common gastroscope 006 to penetrate into the proximal side, specifically the esophageal side 001, spray the tube 016 at the proximal flange plugging body 61 to inject methylene blue, and observe under the distal end endoscope or naked eyes, specifically the bronchoscope 005, no methylene blue seepage, and the test fistula is successfully blocked;

[0200] S8. Use the injection tube Y to inject stem cells or stem cell exosomes or growth factors or chemokines. The specific operation is as follows: connect the injection tube Y of the digestive tract fistula occluder 6 to regularly inject stem cells or stem cell exosomes or growth factors or chemokines into the connecting part 6 of the occluder through the in vitro injection interface to promote tissue regeneration and fistula healing.

[0201] S9. Observe the endoscope again, and if there is no abnormality, withdraw the endoscope.

[0202] Digestive tract fistula refers to a pathological passage between the digestive tract, between the digestive tract and adjacent tissues and organs, between the digestive tract and the chest / abdomen or skin. The digestive tract fistula occluder or the injectable occluder described in this embodiment is applied to but not limited to esophageal tracheal fistula, residual stomach tracheal fistula, thoracic gastrotracheal fistula, esophageal mediastinal fistula, esophageal pleural fistula, esophageal thoracic fistula, gastrothoracic fistula, gastrojejunal fistula, gastrocolonic fistula, gastroabdominal wall fistula, gallbladder gastric fistula, gallbladder duodenal fistula, gallbladder colonic fistula, bladder intestinal fistula, uterine colonic fistula, recto-vaginal fistula, anal fistula, intestinal fistula, anastomotic fistula, bronchopleural fistula, tracheo-mediastinal fistula.

[0203] The above shows and describes the basic principle, main features and advantages of the utility model. Those skilled in the art should understand that the utility model is not limited by the above embodiments. The above embodiments and descriptions are only preferred examples of the utility model and are not used to limit the utility model. Without departing from the spirit and scope of the utility model, the utility model may have various changes and improvements, which fall within the scope of the utility model to be protected. The scope of protection of the utility model is defined by the attached claims and their equivalents.

Claims

1. A digestive tract fistula occluder, characterized in that: include: The injectable occluder body (6-1) is woven from braided wires in a constrained state, the injectable occluder body (6-1) has an expanded state, the expanded state includes flanges at both ends and a central cylindrical area, and the central cylindrical area has no open internal passage, the injectable occluder body (6-1) is covered by a sealing film (E), the injectable occluder body (6-1) is connected to an injection tube (Y), and the injection tube (Y) injects liquid, semi-solid or medicine into the injectable occluder body (6-1).

2. The digestive tract fistula occluder according to claim 1, characterized in that: The two ends of the injectable plugger body (6-1) are flanges, the two ends are at least larger than the middle, the middle is a cylindrical area connected to the two ends in an integral manner, there is no open internal passage in the center of the cylindrical area, the bottom surface of the two ends of the cylindrical area or the bottom surface of one end is covered with the plugging film (E), and the cylindrical surface of the cylindrical area is covered with a porous film or partially covered with a film or not covered with a film.

3. The digestive tract fistula occluder according to claim 1, characterized in that: The blocking film (E) is provided with a single or multiple leakage holes (A), and the leakage holes (A) are one or more of macropores, mesopores, small pores or micropores, so as to facilitate the passage of liquids, semi-solids or drugs.

4. The digestive tract fistula occluder according to claim 1, characterized in that: A plurality of injection holes (X) are provided at a position where the end of the injection tube (Y) contacts the body (6-1) of the injectable occluder; and the end of the injection tube (Y) and the body (6-1) of the injectable occluder are connected via a soft wire.

Images