Esophageal tracheal fistula blocking stent

Abstract

A tracheoesophageal fistula blocking stent, characterized in that it comprises an umbrella-shaped stent (1), a mushroom-shaped stent (2) and an intermediate stent (3), wherein the umbrella-shaped stent (1) and the mushroom-shaped stent (2) are connected as a whole through the intermediate stent (3), and the outer surfaces of the umbrella-shaped stent (1), the mushroom-shaped stent (2) and the intermediate stent (3) are all provided with a coating; the intermediate stent (3) is a tubular structure, and its two ends are sealed by the coating, the umbrella-shaped stent (1) is unfolded into an umbrella shape, and the mushroom-shaped stent (2) is unfolded into a mushroom shape. Since the far and near ends of the tracheoesophageal fistula blocking stent of the present invention are single-layer structures, compared with the disc-shaped structure of the vascular occluder, the weight is relatively light, and the risk of tissue necrosis around the fistula is reduced. In addition, the esophageal end is larger than the tracheal end, and the risk of the occluder falling into the trachea is further reduced.

Description

Technical Field

[0001] The invention relates to the field of minimally invasive technology, and in particular to an esophageal tracheal fistula blocking stent. 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, umbrella devices and other similar mechanical occlusion devices developed in large quantities from atrial septal defect devices were used to block esophageal tracheal fistulas, but they still have the following disadvantages:

[0003] (1) If the occluder has a cap at the proximal or distal end or is concave inward, once the patient coughs or makes other movements, the occluder may become pear-shaped, which can easily damage surrounding tissues, causing massive bleeding and leading to sudden death.

[0004] (2) The occluder is susceptible to corrosion. Secondly, as a foreign body, the occluder can cause an inflammatory reaction, which general occluding devices cannot resist.

[0005] (3) There is no retrieval device and once inserted, it cannot be removed through conservative medical treatment.

[0006] (4) Generally, the occluder is inserted through the trachea, which affects the rescue channel and cannot be inserted under the direct supervision of the physician at any time, which poses certain risks.

[0007] (5) The treatment method of using traditional stents to expand the circumference of the esophagus seriously affects the patient's daily life, causes long-term pain, and affects the patient's quality of life.

[0008] (6) The weight of the occluder and the pressure it exerts on surrounding tissues can cause ischemia and necrosis, or even detachment of the occluder, blocking the airway and causing death. Summary of the invention

[0009] The purpose of the present invention is to provide an esophageal tracheal fistula blocking stent to solve the many defects in the above-mentioned background technology. It overcomes the shortcomings of the existing esophageal tracheal fistula blocking devices that are harmful to surrounding tissues, makes the device recyclable, improves the safety of the device, improves the patient's life and treatment, and provides a new safe and effective esophageal tracheal fistula treatment method.

[0010] To achieve the above object, the present invention provides the following technical solutions:

[0011] A esophageal tracheal fistula blocking stent, characterized in that it comprises an umbrella-shaped stent (1), a mushroom-shaped stent (2) and an intermediate stent (3); the umbrella-shaped stent (1) and the mushroom-shaped stent (2) are connected as a whole via the intermediate stent (3); the outer surfaces of the umbrella-shaped stent (1), the mushroom-shaped stent (2) and the intermediate stent (3) are all provided with a coating; the intermediate stent (3) is a tubular structure, and its two ends are sealed by the coating; the umbrella-shaped stent (1) is unfolded into an umbrella shape, and the mushroom-shaped stent (2) is unfolded into a mushroom cap shape.

[0012] The umbrella-shaped support (1) comprises an umbrella-shaped support frame (101) and an umbrella-shaped support coating (100); the umbrella-shaped support frame (101) is a dispersed structure or a woven structure, and the umbrella-shaped support coating (100) covers the surface of the umbrella-shaped support frame (101).

[0013] The mushroom-shaped stent (2) comprises a mushroom-shaped stent radial skeleton (21) and a mushroom-shaped stent coating (20), wherein the mushroom-shaped stent coating (20) is arranged on the surface of the mushroom-shaped stent radial skeleton (21), and the mushroom-shaped stent radial skeleton (21) comprises a mushroom-shaped stent longitudinal skeleton (23), a mushroom-shaped stent proximal skeleton (24) and a mushroom-shaped stent distal skeleton (25).

[0014] The intermediate support (3) comprises an intermediate support frame (31) and an intermediate support coating (30); the two ends of the intermediate support frame (31) are respectively connected to the umbrella-shaped frame (1) and the mushroom-shaped frame (2) to form a whole; and the surface of the intermediate support frame (31) is provided with an intermediate support coating (30).

[0015] One end of the intermediate support (3) is provided with an esophageal end blocking film (4), and the other end of the intermediate support (3) is provided with a tracheal end blocking film (5).

[0016] The umbrella-shaped stent (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;

[0017] The mushroom-shaped stent (2) is composed of a metal wire structure, wherein 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;

[0018] The intermediate support (3) is composed of a metal wire structure, wherein 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; the outer surface of the metal wire is provided with an anti-corrosion coating, the anti-corrosion coating is composed of polysilicone, and the antibacterial coating is composed of organic silicon cationic steroids, minocycline, rifampicin, gentamicin, vancomycin or hydrophobic material or a combination thereof.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] Since the distal and proximal ends of the esophageal tracheal fistula blocking stent of the present invention are single-layer structures, compared with the disc-shaped structure of the vascular occluder, the weight is relatively light, and the risk of tissue necrosis around the fistula is reduced. In addition, the esophageal end is larger than the tracheal end, and the risk of the occluder falling into the trachea is further reduced. The stent has no head, and even if the occluder is deformed into a pear shape, it will not touch the surrounding tissues, and it can be released under direct vision of the gastroscope, making it more reliable for doctors to operate. A retrieval line is provided at the proximal end of the stent, which can be removed at any time by conservative medical treatment. Even if it falls into the trachea, the stent can be removed with foreign body forceps. It replaces the traditional stent treatment method of circumferentially expanding the esophagus without compressing the esophagus, relieves pain, and improves the quality of life of patients. It is lighter than the occluder, exerts less pressure on the surrounding tissues, and has a low risk of ischemic necrosis of the surrounding tissues. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 This is a schematic structural diagram of Example 1 of the stent of the present invention;

[0022] Figure 2 It is a side view of Example 1 of the bracket of the present invention;

[0023] Figure 3 This is one of the three-dimensional structural schematic diagrams of Example 1 of the bracket of the present invention;

[0024] Figure 4 This is one of the three-dimensional structural schematic diagrams of Example 1 of the bracket of the present invention;

[0025] Figure 5 This is a schematic structural diagram of Example 2 of the stent of the present invention;

[0026] Figure 6 Schematic diagram of the three-dimensional structure of Example 2 of the bracket of the present invention;

[0027] Figure 7 It is a schematic diagram of the cross-sectional structure of the stent of the present invention, wherein the stent is located in the inserter;

[0028] Figure 8 It is a schematic cross-sectional structure diagram of the stent of the present invention in a partially deployed state in a partially inserted device.

[0029] Figure 9a This is one of the cross-sectional structural schematic diagrams of the inserter of the present invention.

[0030] Figure 9b This is the second schematic cross-sectional view of the inserter of the present invention.

[0031] Fig.10 It is a schematic diagram of the exploded structure of the inserter of the present invention.

[0032] Fig.11 It is a schematic diagram of the overall assembly structure of the inserter of the present invention.

[0033] Fig.12 This is a schematic diagram of one of the steps of inserting the stent of the present invention into an esophageal tracheal fistula using an inserter.

[0034] Fig.13 This is a schematic diagram of the second step of decomposing the stent of the present invention into an esophageal tracheal fistula using an inserter.

[0035] Fig.14 This is a schematic diagram of the third step of decomposing the stent of the present invention into an esophageal tracheal fistula using an inserter.

[0036] Fig.15 This is one of the structural schematic diagrams of the tapered rubber plug of the present invention.

[0037] Fig.16 This is the second structural schematic diagram of the tapered rubber plug of the present invention.

[0038] Fig.17 This is the third structural schematic diagram of the tapered rubber plug of the present invention.

[0039] Fig.18 This is the fourth structural schematic diagram of the tapered rubber plug of the present invention.

[0040] Fig.19 It is a schematic structural diagram of another esophageal tracheal fistula blocking stent of the present invention.

[0041] Fig. 20 It is a schematic diagram of the structure of the first target and the second target of the present invention.

[0042] In the figure: 1, umbrella-shaped stent; 100, umbrella-shaped stent coating; 101, umbrella-shaped stent frame; 2, mushroom-shaped stent; 20, mushroom-shaped stent coating; 21, mushroom-shaped stent radial frame; 23, mushroom-shaped stent longitudinal frame; 24, mushroom-shaped stent proximal frame; 25, mushroom-shaped stent distal frame; 3, intermediate stent; 30, intermediate stent coating; 31, intermediate stent frame; 4, esophageal end blocking coating; 5, tracheal end 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; 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 hose connecting tube; 1131. Through hole; 1132. Conical surface; 1133. Cross groove; 1A. Mirrored umbrella bracket; 119. First target; 120. Second target. DETAILED DESCRIPTION

[0043] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0044] 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 orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0045] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0046] The term "proximal end" refers to the end closer to the operator, and the term "distal end" refers to the end farther from the operator.

[0047] like Figures 1 to 20 :

[0048] Example 1

[0049] like Figures 1 to 4 A esophageal tracheal fistula blocking stent, characterized in that it comprises an umbrella-shaped stent (1), a mushroom-shaped stent (2) and an intermediate stent (3), wherein the umbrella-shaped stent (1) and the mushroom-shaped stent (2) are connected as a whole via the intermediate stent (3), and the outer surfaces of the umbrella-shaped stent (1), the mushroom-shaped stent (2) and the intermediate stent (3) are all provided with a coating; the intermediate stent (3) is a tubular structure, and its two ends are sealed by the coating, the umbrella-shaped stent (1) is unfolded into an umbrella shape, and the mushroom-shaped stent (2) is unfolded into a mushroom cap shape.

[0050] The umbrella-shaped support (1) comprises an umbrella-shaped support frame (101) and an umbrella-shaped support coating (100); the umbrella-shaped support frame (101) is a dispersed structure or a woven structure, and the umbrella-shaped support coating (100) covers the surface of the umbrella-shaped support frame (101).

[0051] The mushroom-shaped stent (2) comprises a mushroom-shaped stent radial skeleton (21) and a mushroom-shaped stent coating (20), wherein the mushroom-shaped stent coating (20) is arranged on the surface of the mushroom-shaped stent radial skeleton (21), and the mushroom-shaped stent radial skeleton (21) comprises a mushroom-shaped stent longitudinal skeleton (23), a mushroom-shaped stent proximal skeleton (24) and a mushroom-shaped stent distal skeleton (25).

[0052] The intermediate support (3) comprises an intermediate support frame (31) and an intermediate support coating (30); the two ends of the intermediate support frame (31) are respectively connected to the umbrella-shaped frame (1) and the mushroom-shaped frame (2) to form a whole; and the surface of the intermediate support frame (31) is provided with an intermediate support coating (30).

[0053] One end of the intermediate support (3) is provided with an esophageal end blocking film (4), and the other end of the intermediate support (3) is provided with a tracheal end blocking film (5).

[0054] The umbrella-shaped stent (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;

[0055] The mushroom-shaped stent (2) is composed of a metal wire structure, wherein 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;

[0056] The intermediate support (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.

[0057] 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.

[0058] The umbrella-shaped support (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.

[0059] Example 2

[0060] like Figure 5 , Figure 6 , a esophageal tracheal fistula blocking stent, the metal wire adopts a braiding structure and form different from that of Example 1, characterized in that it includes an umbrella-shaped stent (1), a mushroom-shaped stent (2) and an intermediate stent (3), the umbrella-shaped stent (1) and the mushroom-shaped stent (2) are connected as a whole through the intermediate stent (3), and the outer surfaces of the umbrella-shaped stent (1), the mushroom-shaped stent (2) and the intermediate stent (3) are all provided with a coating; the intermediate stent (3) is a tubular structure, and its two ends are sealed by the coating, the umbrella-shaped stent (1) is unfolded into an umbrella shape, and the mushroom-shaped stent (2) is unfolded into a mushroom cap shape.

[0061] Example 3

[0062] like Figure 7 The cross-sectional structure diagram of the stent of the present invention is located in the inserter; the stent is compressed and folded in the tubular structure of the inserter and delivered to the target fistula area.

[0063] like Figure 8 , is a schematic diagram of the cross-sectional structure of the stent of the present invention in a partially deployed state in the inserter. One end of the stent located on the esophagus side or the trachea side is delivered by the inserter, and is deployed under its own elastic force and memory tension. Then, during the retraction of the inserter, the other end of the stent is delivered and released to complete the occlusion of the fistula.

[0064] Example 4

[0065] Figure 9a This is one of the cross-sectional structural schematic diagrams of the inserter of the present invention. 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 invention. Fig.11 It is a schematic diagram of the overall assembly structure of the inserter of the present invention.

[0066] A device for inserting a stent for esophageal tracheal fistula occlusion 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 outer sleeve of the front push rod (92) is provided with a flexible catheter (94), the proximal end of the front handle (115) is connected to a 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) contacts the conical inner wall (111) inside the front handle (115).

[0067] 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 internal connecting hose (91) and the flexible conduit (94) are hoses made of flexible materials.

[0068] The proximal end of the rear handle (8) is provided with a rear handle rear end cover (80), the distal end of the rear handle (8) is connected to a rear handle front end cover (81), and the rear push rod (9) is fixedly connected to the rear handle (8) via a rear push rod fixing seat (90);

[0069] 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 cover (117) through a connecting sleeve (116); the distal end of the front handle front 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 the conical rubber plug (113) is provided with a cross groove (1133).

[0070] The Luer connector tube (112) can be connected to a syringe or the like to flush or aspirate the inner cavity (114).

[0071] Example 5

[0072] A method for inserting a stent for esophageal tracheal fistula occlusion, characterized by comprising the following steps:

[0073] S1. Locate the specific location of the fistula under gastroscopy;

[0074] S2, such as Fig.12 Under gastroscopy, a flexible catheter (94) equipped with an esophageal tracheal fistula blocking stent is placed into the fistula through the gastroscopic clamp channel;

[0075] S3, such as Fig.13 , pushing the rear handle (8) distally, and then pushing the mushroom-shaped stent (2) of the esophageal tracheal fistula blocking stent out of the flexible catheter (94) through the front pushing head (93), and releasing the mushroom-shaped stent (2) on the tracheal side;

[0076] S4, rotating the rear push rod locking knob (110) to axially squeeze the conical rubber plug (113), so that the conical rubber plug (113) tightly embraces the rear push rod (9) under the action of the conical inner wall (111), so that the rear push rod (9) and the front handle (115) are fixed;

[0077] S5, Fig.14 , the front handle (115) is continuously moved toward the proximal end, so that the mushroom-shaped stent (2) is blocked by the inner wall of the trachea, and then the umbrella-shaped stent (1) of the esophageal tracheal fistula blocking stent is pulled out and released on the esophageal side;

[0078] S6. After confirming that the esophageal tracheal fistula blocking stent 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.

[0079] Example 6

[0080] Fig.19 It is a schematic structural diagram of another esophageal tracheal fistula blocking stent of the present invention.

[0081] The mushroom-shaped support (2) can also be replaced by a mirror-image umbrella-shaped support (1A), with both ends being mirror images of the same.

[0082] Example 7

[0083] like Fig. 20 , which is a schematic diagram of the structure of the first target and the second target of the present invention. The rear push rod (9) is also provided with a first target (119) and a second target (120), wherein 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 stent and the completion of releasing the tracheal side stent.

[0084] The above shows and describes the basic principles, main features and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited by the above embodiments. The above embodiments and descriptions are only preferred examples of the present invention and are not intended to limit the present invention. Without departing from the spirit and scope of the present invention, the present invention may have various changes and improvements, which fall within the scope of the present invention. The scope of protection of the present invention is defined by the attached claims and their equivalents.

Claims

1. An esophageal tracheal fistula blocking stent, characterized in that The invention comprises an umbrella-shaped support (1), a mushroom-shaped support (2) and an intermediate support (3), wherein the umbrella-shaped support (1) and the mushroom-shaped support (2) are connected as a whole via the intermediate support (3), and the outer surfaces of the umbrella-shaped support (1), the mushroom-shaped support (2) and the intermediate support (3) are all provided with a coating; the intermediate support (3) is a tubular structure, and its two ends are sealed by the coating; the umbrella-shaped support (1) is unfolded into an umbrella shape, and the mushroom-shaped support (2) is unfolded into a mushroom umbrella shape; the umbrella-shaped support (1) comprises an umbrella-shaped support frame (101) and an umbrella-shaped support covering The membrane (100) is a dispersed structure or a woven structure of the umbrella-shaped support frame (101), and the umbrella-shaped support film (100) covers the surface of the umbrella-shaped support frame (101); the mushroom-shaped support (2) comprises a mushroom-shaped support radial frame (21) and a mushroom-shaped support film (20), and the mushroom-shaped support film (20) is arranged on the surface of the mushroom-shaped support radial frame (21), and the mushroom-shaped support radial frame (21) comprises a mushroom-shaped support longitudinal frame (23), a mushroom-shaped support proximal frame (24) and a mushroom-shaped support distal frame (25); The intermediate support (3) comprises an intermediate support frame (31) and an intermediate support coating (30); the two ends of the intermediate support frame (31) are respectively connected to the umbrella-shaped frame (1) and the mushroom-shaped frame (2) to form a whole; and the surface of the intermediate support frame (31) is provided with an intermediate support coating (30); One end of the intermediate support (3) is provided with an esophageal end blocking coating (4), and the other end of the intermediate support (3) is provided with a tracheal end blocking coating (5).

2. The esophageal tracheal fistula blocking stent according to claim 1, characterized in that: The umbrella-shaped stent (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; The mushroom-shaped stent (2) is composed of a metal wire structure, wherein 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; The intermediate support (3) is composed of a metal wire structure, wherein 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; the outer surface of the metal wire is provided with an anti-corrosion coating, the anti-corrosion coating is composed of polysilicone, and the antibacterial coating is composed of organic silicon cationic steroids, minocycline, rifampicin, gentamicin, vancomycin or hydrophobic material or a combination thereof.

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