Bendable cannula, preparation method thereof and gastric bypass stent recovery device

Abstract

The invention provides a bendable cannula, a preparation method of the bendable cannula and a gastric bypass stent recovery device, and relates to the technical field of medical instruments. The bendable sleeve comprises a drum-shaped cap, a bent pipe, a handle and a handle cover, the drum-shaped cap and the handle are connected to the two ends of the bent pipe respectively, and the handle cover is detachably connected with the end, away from the bent pipe, of the handle; the drum-shaped cap comprises a drum-shaped front section and a cylindrical rear section, the middle of the drum-shaped front section protrudes, the two sides of the drum-shaped front section retract inwards, and the cylindrical rear section is connected with the bent pipe. The bent pipe sequentially comprises an inner layer, a first middle layer, a second middle layer and an outer layer from inside to outside, the first middle layer is one of a spring winding wire layer and a woven mesh layer, and the second middle layer is the other of the spring winding wire layer and the woven mesh layer. The bendable cannula can straightly extend from the oral cavity to be connected to the duodenum bulb part, a middle channel is constructed, the whole digestive tract is protected, the risk that barbs of a gastric bypass stent are scratched is avoided, and the safety and convenience in the foreign matter taking-out operation process are remarkably improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a bendable sleeve and a preparation method thereof, and a gastric bypass stent recovery device. Background Art

[0002] With the continuous progress of science and technology, the quality of life of the people has been significantly improved. However, a series of health problems caused by overweight or obesity, such as common diseases such as fatty liver and diabetes, are increasingly having a negative impact on human health. At present, common ways to lose weight include surgery, drug therapy, and the use of medical devices implanted in the stomach and duodenum to reduce food absorption.

[0003] In recent years, the types of medical devices for weight loss have continued to increase. Among them, a gastric bypass stent is quite typical. It is fixed in the duodenal bulb and has a circle of anchor structure around the gastric bypass stent to prevent displacement. The existence of the anchor structure poses a great challenge to the recovery of the stent.

[0004] In the routine operation of retrieving the stent, there are problems such as inconvenient operation, affected vision, and high operation requirements, which puts high demands on the technical level of the doctor operating the gastroscope.

[0005] In view of this, the present invention is proposed. Summary of the invention

[0006] The purpose of the present invention includes providing a flexible sleeve and a preparation method thereof and a gastric bypass stent recovery device, wherein the flexible sleeve can extend directly from the oral cavity to connect to the duodenal bulb, thereby constructing an intermediate channel. With the help of this intermediate channel, the gastric bypass stent can be smoothly pulled out from it, and there is no need to worry about the barbs around the stent, thereby providing reliable protection for the digestive tract tissue. In this way, the head of the gastroscope no longer needs to be equipped with a tip cap or a recovery cap, which greatly reduces the difficulty and complexity of the operation of the gastroscopist, and significantly improves the safety and convenience of the foreign body removal operation.

[0007] The embodiments of the present invention can be implemented as follows:

[0008] In a first aspect, the present invention provides a bendable sleeve, comprising a drum-shaped cap, a bending tube, a handle and a handle cover, wherein the drum-shaped cap and the handle are respectively connected to two ends of the bending tube, and the handle cover is detachably connected to an end of the handle away from the bending tube;

[0009] The drum-shaped cap comprises a drum-shaped front section and a cylindrical rear section, the middle of the drum-shaped front section is protruding, and the two sides are inwardly contracted, the diameter of the cylindrical rear section is equal to the minimum diameter of the drum-shaped front section, and the cylindrical rear section is connected to the curved tube;

[0010] The bending tube includes an inner layer, a first middle layer, a second middle layer and an outer layer from inside to outside, wherein the first middle layer is one of a spring wire layer and a braided mesh layer, and the second middle layer is the other of the spring wire layer and the braided mesh layer.

[0011] In an optional embodiment, the spring wire layer is obtained by winding and coating a spring wire on the surface of the inner layer or the braided mesh layer using a spring winding machine;

[0012] Preferably, the thickness of the spring wire is 0.1-0.25 mm, the width is 0.35-0.75 mm, and the pitch of the spring wire layer is 1-2 mm;

[0013] Preferably, the spring wire is made of 303 stainless steel wire, 304 stainless steel wire or 316 stainless steel wire.

[0014] In an optional embodiment, the braided mesh layer is obtained by braiding and coating a plurality of strands of yarn on the surface of the inner layer or the spring wire layer through a spinning machine;

[0015] Preferably, the thickness of the yarn is 0.03-0.08 mm, the width is 0.08-0.2 mm, and the pitch of the woven mesh layer is 15-25 mm;

[0016] Preferably, the braiding parameters of the braided mesh layer 126 include: the number of braiding spindles is 16, 24 or 32, the number of braided PPI points is 15 to 25, and the braiding method is one-on-one, one-on-two or two-on-two;

[0017] Preferably, the yarn is made of 303 stainless steel wire, 304 stainless steel wire or 316 stainless steel wire.

[0018] In an optional embodiment, the wall thickness of the curved tube is 0.5-1.0 mm, the length is 900-1300 mm, and the diameter is 15-17 mm;

[0019] And / or, the Rockwell hardness of the bending tube is 70A to 100A;

[0020] And / or, the materials of the inner layer and the outer layer are respectively selected from silicone rubber, thermoplastic polyurethane, Pebax or polyvinyl chloride.

[0021] In an optional embodiment, the wall thickness of the drum-shaped cap is 0.6 mm to 1.2 mm, the height is 15 to 25 mm, the middle of the drum-shaped front section is connected to both sides in an arc shape, and the arc radius R is 5 to 15 mm;

[0022] Preferably, the drum-shaped cap is made of polyethylene, polypropylene, polycarbonate, polytetrafluoroethylene, polyphenylene sulfone, silicone rubber, silicone, thermoplastic polyurethane or Pebax;

[0023] Preferably, the inner diameter of the cylindrical rear section is 0.05-0.2 mm larger than the outer diameter of the curved tube.

[0024] In an optional embodiment, an anti-backflow valve is installed between the handle and the handle cover;

[0025] Preferably, a through hole for the gastroscope to enter and exit is provided in the middle of the anti-reflux valve, the anti-reflux valve cooperates with the gastroscope to block the flow of liquid, and the diameter of the through hole is 7-8 mm;

[0026] Preferably, the wall thickness of the anti-backflow valve is 0.3 to 3.5 mm;

[0027] Preferably, the handle and the handle cover are made of acrylonitrile-butadiene-styrene copolymer, polystyrene, polyethylene or polypropylene.

[0028] In an optional embodiment, the retrieving force of the bendable sleeve when retrieving the stent is no more than 30N.

[0029] In a second aspect, the present invention provides a method for preparing a bendable cannula as described in any one of the aforementioned embodiments, comprising:

[0030] S1. Preparation of bent tube:

[0031] A spring wire is wound and coated on the surface of the inner layer by a spring winding machine to form a spring wire layer, or a plurality of yarns are woven and coated on the surface of the inner layer by a spinning machine to form a woven mesh layer, so as to obtain a first intermediate layer coated on the inner layer;

[0032] The surface of the first intermediate layer is continuously coated with a spring wire layer or a braided mesh layer to form a second intermediate layer having a structure different from that of the first intermediate layer;

[0033] Covering the surface of the second intermediate layer with an outer layer to form a curved tube;

[0034] S2. Assemble the bendable casing:

[0035] A drum-shaped cap and a handle are respectively connected to both ends of the curved tube, and then a handle cover is connected to an end of the handle away from the curved tube.

[0036] In an optional embodiment, before the bending tube is connected to the drum-shaped cap and the handle, the surface of the bending tube is activated, and the activation treatment includes: activation treatment for 110 to 130 seconds under vacuum conditions of 25 to 30 Pa and temperature of 35 to 45°C.

[0037] In a third aspect, the present invention provides a gastric bypass stent retrieval device, which comprises the bendable sleeve as described in the aforementioned embodiment or the bendable sleeve prepared by the preparation method of the bendable sleeve as described in any one of the aforementioned embodiments.

[0038] The bendable sleeve and its preparation method and the gastric bypass stent recovery device provided by the embodiments of the present invention have the following beneficial effects:

[0039] The bendable sleeve provided by the present invention can realize that when the bendable sleeve passes through the throat, digestive tract, and stomach wall, the front end of the drum-shaped cap is retracted to facilitate introduction, and the arc-shaped protruding in the middle of the drum-shaped cap stretches the contacted tissue part to prevent the bendable sleeve from scratching the tissue when entering the human body; at the same time, the spring wire layer and the woven mesh layer are used as the middle layer of the bending tube, so that the bending tube has good elasticity and support, and it can bend with the bending of the gastroscope tube. The bendable sleeve can be extended directly from the oral cavity to the duodenal bulb, thereby constructing an intermediate channel, realizing the protection of the entire digestive tract from the pyloric orifice, stomach, cardia, esophagus, and oral cavity, and avoiding the risk of scratches by the barbs of the gastric bypass stent. With the help of this intermediate channel, the gastric bypass stent can be smoothly pulled out from it, and there is no need to worry about the barbs around the gastric bypass stent, thereby providing reliable protection for the digestive tract tissue. In this way, there is no need to install a tip cap or a retrieval cap on the head of the gastroscope, which greatly reduces the difficulty and complexity of the operation for the gastroscopy doctor and significantly improves the safety and convenience of the foreign body removal operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

[0041] Figure 1 A schematic diagram of the structure of the bendable sleeve provided by the present invention;

[0042] Figure 2 An exploded view of the bendable sleeve provided by the present invention;

[0043] Figure 3 A partial schematic diagram of the connection between the drum-shaped cap and the bending tube in the bendable sleeve provided by the present invention;

[0044] Figure 4 A partial schematic diagram of the connection between the bending tube and the handle in the bendable sleeve provided by the present invention;

[0045] Figure 5 A partial schematic diagram of the anti-reflux valve installed in the handle of the bendable sleeve provided by the present invention;

[0046] Figure 6 A partial schematic diagram of the connection between the handle and the handle sleeve in the bendable sleeve provided by the present invention;

[0047] Figure 7 A schematic diagram of the structure of a bending tube in a bendable casing provided by the present invention;

[0048] Figure 8 A schematic structural diagram of a spring wire layer and a braided mesh layer of a bending tube in a bendable sleeve provided by the present invention;

[0049] Fig. 9 A physical picture of the bendable sleeve provided in Example 1 of the present invention;

[0050] Fig.10 A physical picture of a bending tube in a bendable casing provided in Example 1 of the present invention;

[0051] Fig.11 A physical picture of the bendable sleeve provided in Example 1 of the present invention during the experiment;

[0052] Fig.12 A real picture of the bendable cannula provided in Example 1 of the present invention when inserted into a pig during an experiment;

[0053] Fig.13 A physical picture of a gastroscope passing through the bendable sleeve provided in Example 1 of the present invention during an experiment;

[0054] Fig.14 A real picture of the bendable sleeve provided in Example 1 of the present invention grabbing a stent during an experiment;

[0055] Fig.15 A physical picture of the bendable sleeve provided in Example 1 of the present invention when the stent enters the bendable sleeve during the experiment;

[0056] Fig.16 A physical picture of the silicone drum-shaped cap provided in Example 3 of the present invention;

[0057] Fig.17 A physical picture of a bendable sleeve without a drum-shaped cap provided in Comparative Example 1 of the present invention;

[0058] Fig.18 This is a schematic diagram of the bendable sleeve provided in Comparative Example 3 of the present invention scratching the esophagus and stomach wall during the experiment;

[0059] Fig.19A physical picture of a bendable sleeve made of PVC material provided in Comparative Example 4 of the present invention;

[0060] Fig. 20 A schematic diagram of the bendable sleeve provided in Comparative Example 4 of the present invention showing wrinkles after the experiment.

[0061] Icons: 100-bendable sleeve; 110-drum-shaped cap; 111-drum-shaped front section; 112-cylindrical rear section; 120-bendable tube; 121-inner layer; 122-first middle layer; 123-second middle layer; 124-outer layer; 125-spring wire layer; 126-woven mesh layer; 130-handle; 140-handle cover; 150-anti-reflux valve; 151-through hole. DETAILED DESCRIPTION

[0062] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings here can be arranged and designed in various different configurations.

[0063] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. 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.

[0064] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0065] In the description of the present invention, it should be noted that if the terms "upper", "lower", "inside", "outside", etc. appear to indicate an orientation or position relationship, they are based on the orientation or position relationship shown in the accompanying drawings, or are the orientation or position relationship in which the product of the invention is usually placed when used. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0066] In addition, the terms “first”, “second”, etc., if used, are merely used to distinguish between the descriptions and should not be understood as indicating or implying relative importance.

[0067] It should be noted that, in the absence of conflict, the features in the embodiments of the present invention may be combined with each other.

[0068] See also Figure 1 and Figure 2 The present invention provides a bendable sleeve 100, including a drum-shaped cap 110, a bending tube 120, a handle 130 and a handle cover 140, wherein the drum-shaped cap 110 and the handle 130 are respectively connected to two ends of the bending tube 120, and the handle cover 140 is detachably connected to one end of the handle 130 away from the bending tube 120.

[0069] The drum-shaped cap 110 is a cap that is shaped like a drum, with a large middle and small ends. Figure 3 The drum-shaped cap 110 includes a drum-shaped front section 111 and a cylindrical rear section 112. The middle part of the drum-shaped front section 111 is protruding, and the two sides are retracted. The cylindrical rear section 112 is cylindrical, and its purpose is to be connected with the bending tube 120. The diameter of the cylindrical rear section 112 is equal to the minimum diameter of the drum-shaped front section 111. The cylindrical rear section 112 is connected to the bending tube 120, and the inner diameter of the cylindrical rear section 112 is larger than the outer diameter of the bending tube 120 by 0.05-0.2mm. In this embodiment, the connection is achieved by inserting the bending tube 120 into the cylindrical rear section 112 and utilizing its close fit. Specifically, glue can be applied on the inner wall of the cylindrical rear section 112, and then the bending tube 120 can be inserted into the cylindrical rear section 112 to achieve the connection between the bending tube 120 and the cylindrical rear section 112.

[0070] In the present invention, the wall thickness of the drum-shaped cap 110 is 0.6mm-1.2mm, the height is 15-25mm, the middle part of the drum-shaped front section 111 is connected to both sides in an arc shape, and the arc radius R is 5-15mm; in the present invention, by limiting the arc structure of the drum-shaped cap 110, it can be ensured that the chamfer of the drum-shaped cap 110 is relatively smooth, and when the bendable bending tube 120 passes through the throat, digestive tract, and stomach wall, the protruding arc in the middle of the drum-shaped cap 110 stretches the contacting tissue part, and the inward retraction on both sides is conducive to guiding the entry, thereby preventing the tissue from being scratched when entering the human body.

[0071] Preferably, the material of the drum-shaped cap 110 includes but is not limited to polyethylene (PE), polypropylene (PP), polycarbonate (PC), polytetrafluoroethylene (PTFE), polyphenylene sulfone (PPSU), silicone rubber, silicone, thermoplastic polyurethane (TPU), Pebax, etc. By limiting the material of the drum-shaped cap 110, it can be ensured that the drum-shaped cap 110 has a certain elasticity and can accommodate the gastric bypass stent. At the same time, when the drum-shaped cap 110 is guided into the human body, it can also avoid causing damage to human tissue.

[0072] See also Figure 7 and Figure 8The bending tube 120 can be bent and deformed under the action of external force, so as to facilitate passing through the throat, digestive tract, stomach wall and other parts. The wall thickness of the bending tube 120 is 0.5-1.0 mm, the length is 900-1300 mm, and the diameter is 15-17 mm; the Rockwell hardness of the bending tube 120 is 70A-100A; the bending tube 120 has radial compression resistance, and after a certain external force is applied to the outside of the tube wall to flatten the tube diameter to 50% and then the external force is released, the bending tube 120 can return to its original state.

[0073] Specifically, the bending tube 120 includes an inner layer 121, a first intermediate layer 122, a second intermediate layer 123 and an outer layer 124 from the inside to the outside, the first intermediate layer 122 is one of the spring wire layer 125 and the braided mesh layer 126, and the second intermediate layer 123 is the other of the spring wire layer 125 and the braided mesh layer 126.

[0074] The spring wire layer 125 is a spring wire that is wound and coated on the surface of the inner layer 121 or the braided mesh layer 126 by a spring winding machine; the spring wire forms a structure similar to a spring, and the spring wire layer 125 has good elasticity. The spring wire, which utilizes the elasticity and structural characteristics of the material, can produce a large elastic deformation when loaded, and return to its original shape after unloading, so as to facilitate the bending of the bending tube 120. Preferably, the thickness of the spring wire is 0.1-0.25 mm, the width is 0.35-0.75 mm, and the pitch of the spring wire layer 125 is 1-2 mm; preferably, the material of the spring wire is 303 stainless steel wire, 304 stainless steel wire or 316 stainless steel wire.

[0075] The braided mesh layer 126 is obtained by weaving and coating multiple strands of yarn on the surface of the inner layer 121 or the spring wire layer 125 through a spinning machine; in this embodiment, the braided mesh layer 126 formed by weaving also has good elasticity. By combining the spring wire layer 125 and the braided mesh layer 126, it can achieve better lateral extensibility and longitudinal deformability, so that the curved tube 120 can bend along the above-mentioned curvature when passing through the throat, digestive tract, stomach wall and other parts with curvature, and then smoothly extend straight from the oral cavity to the duodenal bulb, thereby constructing an intermediate channel. With the help of this intermediate channel, the stent can be pulled out smoothly without worrying about the barbs around the stent, thereby providing reliable protection for the digestive tract tissue. In this way, the head of the gastroscope no longer needs to be equipped with a tip cap or a recovery cap, which greatly reduces the difficulty and complexity of the operation of the gastroscope doctor and significantly improves the safety and convenience of the foreign body removal operation.

[0076] Preferably, the thickness of the yarn is 0.03-0.08 mm, the width is 0.08-0.2 mm, and the pitch of the braided mesh layer 126 is 15-25 mm; preferably, the braiding parameters of the braided mesh layer 126 include: the number of braiding spindles is 16, 24 or 32, the number of braided PPI points is 15-25, and the braiding method is one-on-one, one-on-two or two-on-two; preferably, the material of the yarn is 303 stainless steel wire, 304 stainless steel wire or 316 stainless steel wire. Among them, the change of braiding parameters will have a certain influence on the structure and elasticity of the braided mesh layer 126. In the present invention, the braided mesh layer 126 obtained by braiding with the above-mentioned braiding parameters not only has good deformation characteristics, but also has a certain support force and pushing force, which can ensure the stability of the middle channel constructed by the curved tube 120.

[0077] In the present invention, the outer surface of the inner layer 121 can be provided with a spring wire layer 125 or a braided mesh layer 126. When the outer surface of the inner layer 121 is provided with a spring wire layer 125, the spring wire covers the entire inner layer 121 pipe from beginning to end, and the braided mesh layer 126 is provided on the surface of the spring wire layer 125. The length of the braided wire is shorter than or equal to the spring wire. When the outer surface of the inner layer 121 is provided with a braided mesh layer 126, the spring wire layer 125 is provided on the surface of the braided mesh layer 126.

[0078] Furthermore, in the present invention, the materials of the inner layer 121 and the outer layer 124 are respectively selected from silicone rubber, thermoplastic polyurethane, Pebax or polyvinyl chloride. By limiting the materials of the inner layer 121 and the outer layer 124, it can be ensured that the inner layer 121 and the outer layer 124 of the curved tube 120 also have a certain elasticity, which can meet the requirements of accommodating the gastric bypass stent. At the same time, when the curved tube 120 is guided into the human body, it can also avoid causing damage to human tissue.

[0079] See also Figure 4 , Figure 5 and Figure 6 The handle 130 is for the operator to hold the bendable sleeve 100, thereby improving the flexibility of the bendable sleeve 100. In this embodiment, the handle 130 is connected to the bending tube 120, and the inner diameter of the handle 130 is 0.05 to 0.2 mm larger than the outer diameter of the bending tube 120. The bending tube 120 and the handle 130 are connected by applying glue to the inner wall of the handle 130 and then inserting the bending tube 120 into the handle 130. The handle cover 140 is used to seal the handle 130 to prevent foreign matter from entering the bending tube 120 through the handle 130 during operation. There are many ways to detachably connect the handle 130 and the handle cover 140. This embodiment provides a typical but non-limiting example. The handle 130 and the handle cover 140 are connected by a rotating buckle and can be detached.

[0080] The handle 130 and the handle cover 140 are made of acrylonitrile-butadiene-styrene copolymer, polystyrene, polyethylene or polypropylene.

[0081] Furthermore, an anti-reflux valve 150 is installed between the handle 130 and the handle cover 140; the anti-reflux valve 150 can effectively prevent the backflow of liquid in the human body. Specifically, a through hole 151 for the gastroscope to enter and exit is set in the middle of the anti-reflux valve 150. The anti-reflux valve 150 cooperates with the gastroscope to block the flow of liquid. The diameter of the through hole 151 is 7-8mm; the wall thickness of the anti-reflux valve 150 is 0.3~3.5mm.

[0082] The retrieving force of the bendable sleeve 100 provided by the present invention when retrieving the stent is no more than 30N.

[0083] Also, see Figure 1-Figure 8 The present invention also provides a method for preparing the above-mentioned bendable sleeve 100, which comprises:

[0084] S1. Preparation of curved tube 120:

[0085] A spring wire is wound and coated on the surface of the inner layer 121 by a spring winding machine to form a spring wire layer 125, or a plurality of strands of yarn are woven and coated on the surface of the inner layer 121 by a spinning machine to form a woven mesh layer 126, so as to obtain a first intermediate layer 122 coated on the inner layer 121;

[0086] The surface of the first intermediate layer 122 is continuously coated with a spring wire layer 125 or a braided mesh layer 126 to form a second intermediate layer 123 having a structure different from that of the first intermediate layer 122;

[0087] The outer layer 124 is coated on the surface of the second intermediate layer 123 to form a curved tube 120;

[0088] S2. Assembling the bendable sleeve 100:

[0089] The drum-shaped cap 110 and the handle 130 are respectively connected to both ends of the curved tube 120 , and then the handle cover 140 is connected to one end of the handle 130 away from the curved tube 120 .

[0090] Before the bending tube 120 is connected to the drum-shaped cap 110 and the handle 130, the surface of the bending tube 120 is activated, and the activation treatment includes: the activation treatment is performed for 110 to 130 seconds under the conditions of vacuum degree 25 to 30 Pa and temperature 35 to 45°C.

[0091] The above preparation method is simple and easy to operate. The prepared bendable sleeve 100 can be extended directly from the oral cavity to the duodenal bulb, thereby constructing an intermediate channel. With the help of this intermediate channel, the gastric bypass stent can be smoothly pulled out from it without worrying about the barbs around the stent, thereby providing reliable protection for the digestive tract tissue. In this way, the head of the gastroscope no longer needs to be equipped with a tip cap or a recovery cap, which greatly reduces the difficulty and complexity of the operation of the gastroscopist, and significantly improves the safety and convenience of the foreign body removal operation.

[0092] In addition, the present invention also provides a gastric bypass stent recovery device, which includes the above-mentioned bendable sleeve 100 or the bendable sleeve 100 prepared by the preparation method of the above-mentioned bendable sleeve 100. The gastric bypass stent recovery device can realize the recovery of the gastric bypass stent conveniently and quickly. It should be understood that the gastric bypass stent recovery device can also include a conventional gastroscope and a recovery hook in addition to the above-mentioned bendable sleeve 100. Its specific structure is the same as the conventional setting, and the present invention will not be specifically described.

[0093] Example 1

[0094] See also Fig. 9 , Fig.10 and Fig.11 The present embodiment provides a bendable sleeve 100, which is composed of a drum-shaped cap 110, a bending tube 120, a handle 130, a handle cover 140 and an anti-reflux valve 150. One end of the bending tube 120 is connected to the drum-shaped cap 110, and the other end is connected to the handle 130. The anti-reflux valve 150 is placed in the handle 130 and locked using the handle cover 140.

[0095] The material of the drum-shaped cap 110 is polyethylene (PE), with a wall thickness of 0.9 mm, an R-arc radius of the drum-shaped part of 9 mm, a height of 21 mm, a height of the cylindrical part of 11 mm, and an inner diameter of the cylinder of 16 mm.

[0096] The bending tube 120 includes an inner layer 121, a first intermediate layer 122 (spring wire layer 125), a second intermediate layer 123 (woven mesh layer 126) and an outer layer 124. The wall thickness of the bending tube 120 is 0.8 mm, the length is 1250 mm, and the diameter is 15.8 mm. Among them, the materials of the inner layer 121 and the outer layer 124 of the bending tube 120 are both TPU, the materials of the spring wire layer 125 and the woven mesh layer 126 are both 304 stainless steel wire, the thickness of the spring wire is 0.15 mm, the width is 0.5 mm, and the pitch is 1.5 mm; the thickness of the braided wire is 0.05 mm, the width is 0.13 mm, the number of braided spindles is 24, the braiding method is one on two, and the braiding length is 900 mm.

[0097] The handle 130 , handle cover 140 , and anti-reflux valve 150 used in other embodiments and comparative examples are consistent.

[0098] Example 2

[0099] This embodiment is basically the same as the embodiment 1, with the only difference being that the braiding length of the braided wire of the bending tube 120 is 1250 mm.

[0100] Example 3

[0101] This embodiment is basically the same as the first embodiment, with the only difference being that the material of the drum-shaped cap 110 is silicone.

[0102] Example 4

[0103] This embodiment is basically the same as the embodiment 1, except that the wall thickness of the bending tube 120 is 0.6 mm.

[0104] Example 5

[0105] This embodiment is substantially the same as the first embodiment, with the only difference being that the material of the spring wire layer 125 and the braided mesh layer 126 are both 316 stainless steel wire.

[0106] Comparative Example 1

[0107] This comparative example is basically the same as Example 1, except that no drum-shaped cap 110 is used at one end of the curved tube 120 .

[0108] Comparative Example 2

[0109] This comparative example is basically the same as Example 1, except that the anti-backflow valve 150 is not used at one end of the curved tube 120 .

[0110] Comparative Example 3

[0111] This comparative example is basically the same as Example 1, except that the bending tube 120 has only a spring wire layer 125 structure but no braided mesh layer 126 structure.

[0112] Comparative Example 4

[0113] This comparative example is basically the same as Example 1, except that the bending tube 120 is made of PVC, and there is no spring wire layer 125 and braided mesh layer 126 as the intermediate layer.

[0114] Comparative Example 5

[0115] This comparative example is basically the same as Example 1, except that the diameter of the bending tube 120 is 13.5 mm.

[0116] Comparative Example 6

[0117] This comparative example is basically the same as Example 1, except that: the thickness of the spring wire in the spring wire layer is 0.08 mm, the width is 0.3 mm, and the pitch is 3 mm; the thickness of the yarn in the braided mesh layer is 0.03 mm, and the width is 0.05 mm.

[0118] Comparative Example 7

[0119] This comparative example is basically the same as Example 1, except that: the thickness of the spring wire in the spring wire layer is 0.3 mm, the width is 1.0 mm, and the pitch is 1 mm; the thickness of the yarn in the braided mesh layer is 0.1 mm, and the width is 0.2 mm.

[0120] Experimental example

[0121] (1) This experiment mainly uses pigs as experimental subjects

[0122] variety Bama Pig supplier Shanghai Jiagan Biotechnology Co., Ltd. gender male weight 25~50kg quantity 5 (It should be understood that the experiment can be repeated on unscratched subjects) age >3 months

[0123] (2) Pig breeding institutions

[0124] Institution Name Animal Experiment Research Center, Zhejiang Chinese Medical University address No. 548, Binwen Road, Binjiang District, Hangzhou City, Zhejiang Province

[0125] (3) Equipment required for the experiment

[0126] Gastroscope, gastric bypass stent, retrieval hook, flexible cannula, digital dynamometer, etc. as well as anesthetics, ventilators, monitors, etc. given to animals during the experiment.

[0127] Before the experiment began, the pigs were anesthetized and placed on the experimental table. A gastric bypass stent was inserted into the duodenal bulb as required. After the stent was placed, the flexible cannula recovery experiment was started.

[0128] The steps for retrieving a gastric bypass stent are as follows:

[0129] Steps for recovering gastric bypass stents using Examples 1 to 5 and Comparative Examples 1 to 7:

[0130] Method steps:

[0131] (1) Apply lubricating oil to the inside and outside of the bendable sleeve 100;

[0132] (2) The flexible sleeve 100 is put on the gastroscope, the snake bone part of the gastroscope is exposed, the gastroscope is first inserted into the body, and then the flexible sleeve 100 is guided into the body together;

[0133] (3) The front end of the gastroscope snake bone part enters the duodenal bulb, and the lower retrieval hook retracts the stent;

[0134] (4) After the stent is folded, the bendable sleeve 100 is pushed forward, and the stent is recovered into the bendable sleeve 100;

[0135] (5) The gastroscope and the flexible sleeve 100 are pulled out of the pig together, or the stent is pulled out of the pig from the pyloric orifice by using the middle channel of the flexible sleeve;

[0136] Each time after the stent is removed, a gastroscope is used to observe whether there are scratches on the esophagus, stomach wall, pyloric orifice, and duodenal bulb; the above steps are repeated multiple times to verify the effects of the embodiment and the comparative example.

[0137]

[0138]

[0139] From the table above, we can see that when the hook is under the hook, the bracket is gathered into a bundle, and when the hook is above the hook, the bracket is gathered into a trumpet shape, so the force of the hook under the hook is smaller than that of the upper hook. For further information, please refer to Fig.12 , Fig.13 , Fig.14 and Fig.15 In the process of animal experiment simulation, the esophagus, stomach wall, pyloric orifice and duodenal bulb of Examples 1 to 5 were well protected, and the recovery force was very small, with the maximum average value less than 15N. Fig.16 In Example 3, the drum-shaped cap 110 is made of silicone, which also has good elasticity and can provide good protection for the esophagus, stomach wall, pyloric orifice, and duodenal bulb. Its recovery force is slightly greater than that of other examples, but significantly lower than that of comparative examples 1-5. Fig.17 , Example 1 lacks the drum-shaped cap 110 for protection, the stent barb will get stuck at the head end of the spring tube, there is a risk of scratching the cardia and the stent recovery effect is not very good, Example 2 lacks the anti-reflux valve 150, although it has no effect on the recovery of the stent, but the operation feel is not good, gastric fluid refluxes to the handle 130 position affecting the operation; please refer to Fig.18 , Comparative Example 3 lacks the braided mesh layer 126 structure, and the curved tube 120 will scratch the esophagus and stomach wall when it is pushed into the body. The curved tube 120 will have some wrinkles when it is pushed, resulting in a relatively large retraction force; please refer to Fig.19 and Fig. 20In Comparative Example 4, the bending tube 120 lacks the spring wire layer 125 and the braided mesh layer 126 as the middle layer, resulting in poor support force and elasticity. When the bending tube 120 is pushed into the body, the bending tube 120 is wrinkled and cannot be pushed to the pyloric orifice, resulting in the inability to recover the stent. The inner diameter of the bending tube 120 in Comparative Example 5 is small, which affects the success rate of recovering the stent. In Comparative Examples 6 and 7, the size requirements of the spring wire in the spring wire layer 125 and the yarn in the braided mesh layer 126 are not within the scope of this application. Among them, the size in Comparative Example 6 is too small, resulting in it being too soft and unable to be pushed, which in turn causes scratches on the stomach wall. In Comparative Example 7, the size is too large, which will cause it to be too hard and unable to pass through the throat synchronously with the gastroscope, and thus the stent cannot be removed.

[0140] In summary, the bendable sleeve 100 provided by the present invention can utilize the drum-shaped cap 110 at its end to achieve that when the bendable sleeve 100 passes through the throat, digestive tract, and stomach wall, the front end of the drum-shaped cap 110 is retracted to facilitate introduction. At the same time, the arc-shaped protruding middle of the drum-shaped cap 110 stretches the contacted tissue part to prevent the bendable sleeve 100 from scratching the tissue when entering the human body; at the same time, the spring wire layer 125 and the woven mesh layer 126 are used as the middle layer of the bendable tube 120, so that the bendable tube 120 has good elasticity and support, and the bendable tube 120 can bend as the gastroscope tube is bent. The bendable sleeve 100 can extend directly from the oral cavity to the duodenal bulb, thereby constructing an intermediate channel, realizing protection of the entire digestive tract from the pyloric opening, stomach, cardia, esophagus, and oral cavity, and avoiding the risk of scratches by the barbs of the gastric bypass stent. With the help of this middle channel, the gastric bypass stent can be pulled out smoothly without worrying about the barbs around the gastric bypass stent, thus providing reliable protection for the digestive tract tissue. In this way, the head of the gastroscope no longer needs to be equipped with a tip cap or a recovery cap, which greatly reduces the difficulty and complexity of the gastroscopy doctor's operation and significantly improves the safety and convenience of the foreign body removal operation.

[0141] The above are only specific embodiments of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily conceived by a technician familiar with the technical field within the technical scope disclosed by the present invention should be covered within the protection scope of the present invention.

Claims

1. A bendable sleeve, characterized in that: It comprises a drum-shaped cap, a curved tube, a handle and a handle cover, wherein the drum-shaped cap and the handle are respectively connected to two ends of the curved tube, and the handle cover is detachably connected to one end of the handle away from the curved tube; The drum-shaped cap comprises a drum-shaped front section and a cylindrical rear section, the middle of the drum-shaped front section is protruding, and the two sides are inwardly contracted, the diameter of the cylindrical rear section is equal to the minimum diameter of the drum-shaped front section, and the cylindrical rear section is connected to the curved tube; The bending tube includes an inner layer, a first middle layer, a second middle layer and an outer layer from inside to outside, wherein the first middle layer is one of a spring wire layer and a braided mesh layer, and the second middle layer is the other of the spring wire layer and the braided mesh layer.

2. The bendable sleeve according to claim 1, characterized in that: The spring wire layer is obtained by winding and coating a spring wire on the surface of the inner layer or the braided mesh layer through a spring winding machine; Preferably, the thickness of the spring wire is 0.1-0.25 mm, the width is 0.35-0.75 mm, and the pitch of the spring wire layer is 1-2 mm; Preferably, the spring wire is made of 303 stainless steel wire, 304 stainless steel wire or 316 stainless steel wire.

3. The bendable sleeve according to claim 1, characterized in that: The braided mesh layer is obtained by braiding and coating a plurality of strands of yarn on the surface of the inner layer or the spring wire layer through a spinning machine; Preferably, the thickness of the yarn is 0.03-0.08 mm, the width is 0.08-0.2 mm, and the pitch of the woven mesh layer is 15-25 mm; Preferably, the braiding parameters of the braided mesh layer include: the number of braiding spindles is 16, 24 or 32, the number of braided PPI points is 15 to 25, and the braiding method is one-over-one, one-over-two or two-over-two; Preferably, the yarn is made of 303 stainless steel wire, 304 stainless steel wire or 316 stainless steel wire.

4. The bendable sleeve according to claim 1, characterized in that: The wall thickness of the bending tube is 0.5-1.0 mm, the length is 900-1300 mm, and the diameter is 15-17 mm; And / or, the Rockwell hardness of the bending tube is 70A to 100A; And / or, the materials of the inner layer and the outer layer are respectively selected from silicone rubber, thermoplastic polyurethane, Pebax or polyvinyl chloride.

5. The bendable sleeve according to claim 1, characterized in that: The wall thickness of the drum-shaped cap is 0.6 mm to 1.2 mm, the height is 15 to 25 mm, the middle part of the drum-shaped front section is connected to both sides in an arc shape, and the arc radius R is 5 to 15 mm; Preferably, the drum-shaped cap is made of polyethylene, polypropylene, polycarbonate, polytetrafluoroethylene, polyphenylene sulfone, silicone rubber, silicone, thermoplastic polyurethane or Pebax; Preferably, the inner diameter of the cylindrical rear section is 0.05-0.2 mm larger than the outer diameter of the curved tube.

6. The bendable sleeve according to claim 1, characterized in that: An anti-backflow valve is installed between the handle and the handle cover; Preferably, a through hole for the gastroscope to enter and exit is provided in the middle of the anti-reflux valve, the anti-reflux valve cooperates with the gastroscope to block the flow of liquid, and the diameter of the through hole is 7-8 mm; Preferably, the wall thickness of the anti-backflow valve is 0.3 to 3.5 mm; Preferably, the handle and the handle cover are made of acrylonitrile-butadiene-styrene copolymer, polystyrene, polyethylene or polypropylene.

7. The bendable sleeve according to claim 1, characterized in that: The retrieving force of the bendable sleeve when retrieving the stent is no more than 30N.

8. A method for preparing a bendable sleeve according to any one of claims 1 to 7, characterized in that: It includes: S1. Preparation of bent tube: A spring wire is wound and coated on the surface of the inner layer by a spring winding machine to form a spring wire layer, or a plurality of yarns are woven and coated on the surface of the inner layer by a spinning machine to form a woven mesh layer, so as to obtain a first intermediate layer coated on the inner layer; The surface of the first intermediate layer is continuously coated with a spring wire layer or a braided mesh layer to form a second intermediate layer having a structure different from that of the first intermediate layer; Covering the surface of the second intermediate layer with an outer layer to form a curved tube; S2. Assemble the bendable casing: A drum-shaped cap and a handle are respectively connected to both ends of the curved tube, and then a handle cover is connected to an end of the handle away from the curved tube.

9. The method for preparing the bendable sleeve according to claim 8, characterized in that: Before the bending tube is connected with the drum-shaped cap and the handle, the surface of the bending tube is activated, and the activation treatment includes: activation treatment for 110 to 130 seconds under the conditions of vacuum degree of 25 to 30 Pa and temperature of 35 to 45°C.

10. A gastric bypass stent recovery device, characterized in that: The invention comprises the bendable sleeve as claimed in claims 1 to 7 or the bendable sleeve prepared by the preparation method of the bendable sleeve as claimed in any one of claims 8 to 9.

Images