A bendable sleeve, a preparation method thereof and a gastric bypass stent recovery device

Abstract

The application provides a bendable sleeve and a preparation method and a gastric bypass stent recovery device, and relates to the technical field of medical devices. The bendable sleeve comprises a drum cap, a curved tube, a handle and a handle cover, the drum cap and the handle are connected to two ends of the curved tube respectively, and the handle cover is detachably connected to an end of the handle away from the curved tube; the drum cap comprises a drum front section and a cylindrical rear section, the middle part of the drum front section is protruding, the two sides are inwardly recessed, and the cylindrical rear section is connected to the curved tube; the curved tube comprises an inner layer, a first intermediate layer and a second intermediate layer and an outer layer from inside to outside in sequence, the first intermediate layer is one of a coiled spring wire layer and a woven mesh layer, and the second intermediate layer is the other one of the coiled spring wire layer and the woven mesh layer. The bendable sleeve can be directly extended from the oral cavity to the duodenal bulb to construct an intermediate channel and realize protection of the entire digestive tract, so that the risk of gastric bypass stent barbs scratching is avoided, and the safety and convenience in the foreign body removal operation process are significantly 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 advancement of science and technology, people's quality of life has been significantly improved. However, the negative impact of overweight or obesity on human health, such as common conditions like fatty liver disease and diabetes, is increasing. Currently, common methods of weight loss include surgery, medication, and the use of medical devices implanted in the stomach and duodenum to reduce food absorption.

[0003] In recent years, the types of weight loss medical devices 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 structures 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 stents, there are problems such as inconvenient operation, affected vision, and high operation requirements, which put 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 be extended 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 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 for 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 cannula comprising a drum-shaped cap, a bendable tube, a handle, and a handle cover, wherein the drum-shaped cap and the handle are respectively connected to two ends of the bendable tube, and the handle cover is detachably connected to an end of the handle away from the bendable tube;

[0009] The drum-shaped cap includes a drum-shaped front section and a cylindrical rear section, wherein the middle portion of the drum-shaped front section is protruding and the two sides are inwardly contracted, and 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 spring wire has a thickness of 0.1 to 0.25 mm, a width of 0.35 to 0.75 mm, and a pitch of the spring wire layer of 1 to 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 yarns 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 PPI points is 15 to 25, and the braiding method is one-over-one, one-over-two or two-over-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 curved tube has a wall thickness of 0.5 to 1.0 mm, a length of 900 to 1300 mm, and a diameter of 15 to 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 portion 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-reflux 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, and 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-reflux 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 stent by the bendable sleeve 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 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 to obtain a first intermediate layer coated on the inner layer;

[0032] The surface of the first intermediate layer is continuously covered 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, the surface of the bending tube is activated before being connected to the drum-shaped cap and the handle, 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 includes the bendable sleeve as described in the aforementioned embodiment or the bendable sleeve prepared by the method for preparing the bendable sleeve as described in any one of the aforementioned embodiments.

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

[0039] The flexible sleeve provided by the present invention utilizes the drum-shaped cap at its end to achieve that when the flexible sleeve passes through the throat, digestive tract, and stomach wall, the front end of the drum-shaped cap retracts to facilitate introduction, and at the same time, the arc-shaped protrusion in the middle of the drum-shaped cap stretches out the tissue part in contact, preventing the flexible 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 curved tube, so that the curved tube has good elasticity and support, and it can bend along with the bending of the gastroscope tube. The flexible sleeve can be extended directly from the oral cavity to the duodenal bulb, thereby constructing an intermediate channel, realizing protection of the entire digestive tract from the pyloric orifice, stomach, cardia, esophagus, and oral cavity, and avoiding the risk of scratches caused 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 gastroscopist 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 following briefly introduces the drawings required for use in the embodiments. It should be understood that the following drawings only illustrate certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without paying any creative work.

[0041] Figure 1 A schematic structural diagram 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 This is a partial schematic diagram of the connection between the bending tube and the handle of the bendable cannula provided by the present invention;

[0045] Figure 5 This is a partial schematic diagram of the anti-reflux valve installed in the handle of the flexible cannula provided by the present invention;

[0046] Figure 6 This is a partial schematic diagram of the connection between the handle and the handle sleeve of the bendable cannula provided by the present invention;

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

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

[0049] Figure 9 A physical diagram of the bendable sleeve provided in Example 1 of the present invention;

[0050] Figure 10 A physical diagram of the bending tube in the bendable casing provided in Example 1 of the present invention;

[0051] Figure 11 A photo of the bendable cannula provided in Example 1 of the present invention during an experiment;

[0052] Figure 12 A photo of the bendable cannula provided in Example 1 of the present invention being inserted into a pig during an experiment;

[0053] Figure 13 A photo of a gastroscope passing through the flexible cannula provided in Example 1 of the present invention during an experiment;

[0054] Figure 14 A photo of the bendable cannula provided in Example 1 of the present invention grabbing a stent during an experiment;

[0055] Figure 15 A photo of a stent entering the flexible sleeve provided in Example 1 of the present invention during an experiment;

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

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

[0058] Figure 18 This is a schematic diagram of the esophagus and stomach wall scratched by the flexible cannula provided in Comparative Example 3 of the present invention during the experiment;

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

[0060] Figure 20 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 intermediate layer; 123-second intermediate layer; 124-outer layer; 125-spring wire layer; 126-braided mesh layer; 130-handle; 140-handle cover; 150-anti-reflux valve; 151-through hole. DETAILED DESCRIPTION

[0062] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings of 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. Generally, the components of the embodiments of the present invention described and shown in the drawings herein 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 as claimed, but rather merely represents selected embodiments of the present invention. All other embodiments derived by persons of ordinary skill in the art based on the embodiments of the present invention without creative effort are intended to fall 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, it does not need to be further defined or explained 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, the orientation or position relationship indicated is based on the orientation or position relationship shown in the accompanying drawings, or is the orientation or position relationship in which the product of the invention is usually placed when in use. It is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it should not be understood as a limitation on the present invention.

[0066] In addition, the terms "first", "second", etc., if used, are merely used to distinguish and describe, 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 flexible sleeve 100, including a drum-shaped cap 110, a bending tube 120, a handle 130 and a handle cover 140. The drum-shaped cap 110 and the handle 130 are respectively connected to the two ends of the bending tube 120, and the handle cover 140 is detachably connected to the end of the handle 130 away from the bending tube 120.

[0069] The drum-shaped cap 110 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 the two 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 chamfers of the drum-shaped cap 110 are relatively smooth. When the flexible 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 contacted tissue part, and the inward retraction on both sides is conducive to guiding the entry, 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 is possible to ensure that the drum-shaped cap 110 has a certain degree of elasticity to accommodate the gastric bypass stent, and at the same time, it can also prevent the drum-shaped cap 110 from causing damage to human tissue when it is introduced into the human body.

[0072] See also Figure 7 and Figure 8Bend tube 120 can bend and deform under external force, facilitating passage through the throat, digestive tract, stomach wall, and other areas. Bend tube 120 has a wall thickness of 0.5 to 1.0 mm, a length of 900 to 1300 mm, and a diameter of 15 to 17 mm. Its Rockwell hardness is 70A to 100A. Bend tube 120 is radially compressive, and when a force is applied to the tube wall to flatten it to 50% of its diameter and the force is released, it returns to its original shape.

[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 formed by winding a single spring wire onto the surface of the inner layer 121 or the braided mesh layer 126 using a spring winding machine. The spring wire forms a spring-like structure, and the spring wire layer 125 exhibits excellent elasticity. The spring wire utilizes the elasticity and structural characteristics of the material to produce significant elastic deformation when loaded and return to its original shape after unloading, thereby facilitating bending of the bending tube 120. Preferably, the spring wire has a thickness of 0.1 to 0.25 mm, a width of 0.35 to 0.75 mm, and a pitch of 1 to 2 mm. Preferably, the spring wire is made of 303, 304, or 316 stainless steel.

[0075] The woven 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 woven mesh layer 126 formed by weaving also has good elasticity. By combining the spring wire layer 125 and the woven 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 mouth 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 installed 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.

[0076] Preferably, the thickness of the yarn is 0.03 to 0.08 mm, the width is 0.08 to 0.2 mm, and the pitch of the woven mesh layer 126 is 15 to 25 mm; preferably, the weaving parameters of the woven mesh layer 126 include: 16, 24, or 32 weaving spindles, 15 to 25 PPI points, and a weaving method of 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 weaving parameters will have a certain impact on the structure and elasticity of the woven mesh layer 126. In the present invention, the woven mesh layer 126 obtained by weaving with the above-mentioned weaving 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 the spring wire layer 125, the spring wire covers the entire inner layer 121 tube from beginning to end, and the braided mesh layer 126 is provided on the surface of the spring wire layer 125. The braided wire is shorter than or the same length as the spring wire. When the outer surface of the inner layer 121 is provided with the 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 outer layer 124 are respectively selected from silicone rubber, thermoplastic polyurethane, Pebax, or polyvinyl chloride. By specifying the materials of the inner layer 121 and outer layer 124, the inner layer 121 and outer layer 124 of the curved tube 120 are ensured to have a certain degree of elasticity, sufficient to accommodate the gastric bypass stent. Furthermore, the curved tube 120 is prevented from causing damage to human tissue when it is introduced into the human body.

[0079] See also Figure 4 、 Figure 5 and Figure 6 The handle 130 is designed to facilitate the operator to hold the flexible cannula 100, thereby improving the flexibility of the flexible cannula 100. In this embodiment, the handle 130 is connected to the bending tube 120. The inner diameter of the handle 130 is 0.05 to 0.2 mm larger than the outer diameter of the bending tube 120. By applying glue to the inner wall of the handle 130 and then inserting the bending tube 120 into the handle 130, the connection between the bending tube 120 and the handle 130 is achieved. 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 entry and exit of the gastroscope is provided 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 7-8 mm; the wall thickness of the anti-reflux valve 150 is 0.3 to 3.5 mm.

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

[0083] Also, see Figures 1-8 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 on the surface of the inner layer 121 by a spring winding machine to form a spring wire layer 125, or a plurality of yarns are woven and coated on the surface of the inner layer 121 by a spinning machine to form a woven mesh layer 126, thereby forming a first intermediate layer 122 coated on the inner layer 121;

[0086] The surface of the first intermediate layer 122 is continuously covered 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 an 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. The activation treatment includes: activation treatment for 110 to 130 seconds under the conditions of vacuum degree 25 to 30 Pa and temperature 35 to 45°C.

[0091] The above-mentioned preparation method is simple and easy to operate. The prepared flexible 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 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 for 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 retrieval device, which includes the aforementioned flexible sleeve 100 or the flexible sleeve 100 prepared by the aforementioned method for preparing the flexible sleeve 100. The gastric bypass stent retrieval device can conveniently and quickly retrieve a gastric bypass stent. It should be understood that in addition to the aforementioned flexible sleeve 100, the gastric bypass stent retrieval device may also include a conventional gastroscope and a retrieval hook, etc. The specific structure of the device is the same as that of conventional devices and will not be elaborated in detail in the present invention.

[0093] Example 1

[0094] See also Figure 9 、 Figure 10 and Figure 11 This embodiment provides a flexible sleeve 100, which consists 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 drum-shaped cap 110 is made of polyethylene (PE) with a wall thickness of 0.9 mm. The R-arc radius of the drum-shaped part is 9 mm, the height is 21 mm, the height of the cylindrical part is 11 mm, and the inner diameter of the cylinder is 16 mm.

[0096] The bending tube 120 comprises an inner layer 121, a first intermediate layer 122 (a spring wire layer 125), a second intermediate layer 123 (a braided mesh layer 126), and an outer layer 124. The bending tube 120 has a wall thickness of 0.8 mm, a length of 1250 mm, and a diameter of 15.8 mm. Both the inner layer 121 and the outer layer 124 of the bending tube 120 are made of TPU, while the spring wire layer 125 and the braided mesh layer 126 are made of 304 stainless steel wire. The spring wire has a thickness of 0.15 mm, a width of 0.5 mm, and a pitch of 1.5 mm. The braided wire has a thickness of 0.05 mm, a width of 0.13 mm, and 24 braids, with a one-on-two braiding pattern and a braid length of 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 drum-shaped cap 110 is made of silicone.

[0102] Example 4

[0103] This embodiment is basically the same as the first embodiment, with the only difference being that the wall thickness of the curved 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 spring wire layer 125 and the braided mesh layer 126 are both made of 316 stainless steel wire.

[0106] Comparative Example 1

[0107] This comparative example is basically the same as Example 1, with the only difference being 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, with the only difference being 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, with the only difference being that the bending tube 120 has only a spring wire layer 125 structure and no braided mesh layer 126 structure.

[0112] Comparative Example 4

[0113] This comparative example is substantially the same as Example 1, with the only difference being that the bending tube 120 is made of PVC and does not have the spring wire layer 125 and the braided mesh layer 126 as the intermediate layer.

[0114] Comparative Example 5

[0115] This comparative example is basically the same as Example 1, with the only difference being that the diameter of the curved tube 120 is 13.5 mm.

[0116] Comparative Example 6

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

[0118] Comparative Example 7

[0119] This comparative example is basically the same as Example 1, except that the spring wire in the spring wire layer has a thickness of 0.3 mm, a width of 1.0 mm, and a pitch of 1 mm; and the yarn in the braided mesh layer has a thickness of 0.1 mm and a width of 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 placed in 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 the gastric bypass stent 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 flexible sleeve 100;

[0132] (2) The flexible sleeve 100 is placed on the gastroscope, with the serpentine portion of the gastroscope 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 enters the duodenal bulb, and the lower retrieval hook retracts the stent;

[0134] (4) After the stent is folded, the flexible sleeve 100 is pushed forward, and the stent is recovered into the flexible 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 through the pyloric orifice using the middle channel of the flexible sleeve;

[0136] Each time the stent is removed, a gastroscope is used to observe whether there are any 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] As can be seen from the table above, 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. Therefore, the force of the line under the hook is smaller than that of the line above the hook. Please refer to the table for more details. Figure 12 、 Figure 13 、 Figure 14 and Figure 15 In the process of animal experiment simulation, Examples 1 to 5 formed a good protective effect on the esophagus, stomach wall, pyloric orifice, and duodenal bulb, and the recovery force was very small, with the maximum average value less than 15N. Figure 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. Figure 17 In Example 1, the drum cap 110 is missing for protection, and the stent barb will get stuck at the head end of the spring tube, which may scratch the cardia and the stent recovery effect is not very good. In Example 2, the anti-reflux valve 150 is missing, which has no effect on the recovery of the stent, but the operation feel is not good, and the gastric fluid refluxes to the handle 130, affecting the operation; please refer to Figure 18 In Example 3, the braided mesh layer 126 is missing. The curved tube 120 may scratch the esophagus and stomach wall when being pushed into the body. The curved tube 120 may have some wrinkles when being pushed, resulting in a relatively large retraction force. Figure 19 and Figure 20In Comparative Example 4, the curved tube 120 lacks the spring wire layer 125 and the braided mesh layer 126 as the middle layer, resulting in poor support and elasticity. When the curved tube 120 is pushed into the body, the curved tube 120 wrinkles and cannot be pushed to the pyloric orifice, resulting in the inability to recover the stent. The inner diameter of the curved 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. The size in Comparative Example 7 is too large, resulting in it being too hard to pass through the throat synchronously with the gastroscope, and thus the stent cannot be removed.

[0140] In summary, the flexible sleeve 100 provided by the present invention can achieve that when the flexible 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 protrusion in the middle of the drum-shaped cap 110 stretches the contacted tissue part to prevent the flexible 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 curved tube 120, so that the curved tube 120 has good elasticity and support, and the curved tube 120 can bend as the gastroscope tube bends. The flexible sleeve 100 can extend directly from the mouth to connect to the duodenal bulb, thereby constructing an intermediate channel, realizing protection of the entire digestive tract from the pyloric opening, stomach, cardia, esophagus, and mouth, and avoiding the risk of scratches by the barbs of the gastric bypass stent. This central channel allows the gastric bypass stent to be smoothly removed without worrying about barbs around the stent, thus providing reliable protection for the digestive tract tissue. This eliminates the need for a tip cap or retrieval cap on the endoscope head, significantly reducing the difficulty and complexity of the operation for the gastroscopist and significantly improving the safety and convenience of foreign body removal.

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

Claims

1. A bendable sleeve, characterized in that: It includes 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 the end of the handle away from the curved tube; The drum-shaped cap includes a drum-shaped front section and a cylindrical rear section. The middle portion of the drum-shaped front section is protruding and the two sides are indented. 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 wall thickness of the drum-shaped cap is 0.6mm-1.2mm, and the height is 15-25mm. The middle portion of the drum-shaped front section is connected to the two sides in an arc shape, and the arc radius R is 5-15mm. The bending tube includes an inner layer, a first intermediate layer, a second intermediate layer and an outer layer from the inside to the outside, the first intermediate layer is one of the spring wire layer and the braided mesh layer, the second intermediate layer is the other of the spring wire layer and the braided mesh layer, 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 by a spring winding machine; the thickness of the spring wire is 0.1~0.25mm, the width is 0.35~0.75mm, and the pitch of the spring wire layer is 1~2mm; the braided mesh layer is obtained by braiding and coating multiple strands of yarn on the surface of the inner layer or the spring wire layer by a spinning machine; the thickness of the yarn is 0.03~0.08mm, the width is 0.08~0.2mm, and the pitch of the braided mesh layer is 15~25mm.

2. The bendable sleeve according to claim 1, characterized in that: 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 weaving parameters of the braided mesh layer include: the number of weaving spindles is 16, 24 or 32, the number of weaving PPI points is 15 to 25, and the weaving method is one-on-one, one-on-two or two-on-two.

4. The bendable sleeve according to claim 1, characterized in that: The material of the yarn is 303 stainless steel wire, 304 stainless steel wire or 316 stainless steel wire.

5. The bendable sleeve according to claim 1, characterized in that: 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; And / or, the Rockwell hardness of the bending tube is 70A~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.

6. The bendable sleeve according to claim 1, characterized in that: The drum-shaped cap is made of polyethylene, polypropylene, polycarbonate, polytetrafluoroethylene, polyphenylene sulfone, silicone rubber, silicone, thermoplastic polyurethane or Pebax.

7. The bendable sleeve according to claim 1, characterized in that: The inner diameter of the cylindrical rear section is 0.05-0.2 mm larger than the outer diameter of the curved tube.

8. The bendable sleeve according to claim 1, wherein: An anti-backflow valve is installed between the handle and the handle cover.

9. The bendable sleeve according to claim 8, characterized in that: 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. The diameter of the through hole is 7-8 mm.

10. The bendable sleeve according to claim 8, characterized in that: The wall thickness of the anti-reflux valve is 0.3-3.5 mm.

11. The bendable sleeve according to claim 8, characterized in that: The handle and the handle cover are made of acrylonitrile-butadiene-styrene copolymer, polystyrene, polyethylene or polypropylene.

12. The bendable sleeve according to claim 1, wherein: The retrieving force of the bendable sleeve when retrieving the stent is no more than 30N.

13. A method for preparing the bendable sleeve according to any one of claims 1 to 12, characterized in that: It includes: S1. Preparation of bent tube: A spring wire is wound 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 to obtain a first intermediate layer coated on the inner layer; A spring wire layer or a braided mesh layer is continuously coated on the surface of the first intermediate layer to form a second intermediate layer having a structure different from that of the first intermediate layer; 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; the spring wire has a thickness of 0.1-0.25 mm, a width of 0.35-0.75 mm, and a pitch of 1-2 mm; the braided mesh layer is obtained by braiding and coating a plurality of yarns on the surface of the inner layer or the spring wire layer using a spinning machine; the yarn has a thickness of 0.03-0.08 mm, a width of 0.08-0.2 mm, and a pitch of 15-25 mm; Covering the surface of the second intermediate layer with an outer layer to form a curved tube; S2. Assemble the bendable casing: Connect the drum-shaped cap and the handle to the two ends of the curved tube respectively, and then connect the handle cover to the end of the handle away from the curved tube; the drum-shaped cap includes a drum-shaped front section and a cylindrical rear section, the middle part of the drum-shaped front section is protruding, and the two sides are retracted, 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 wall thickness of the drum-shaped cap is 0.6mm~1.2mm, and the height is 15~25mm. The middle part of the drum-shaped front section is connected to the two sides in an arc shape, and the arc radius R is 5~15mm.

14. The method for preparing a bendable cannula according to claim 13, wherein: Before the bending tube is connected to the drum-shaped cap and the handle, the surface of the bending tube is activated. The activation treatment includes: activation treatment for 110-130s under the conditions of vacuum degree 25-30pa and temperature 35-45°C.

15. A gastric bypass stent recovery device, characterized in that: The invention comprises the bendable sleeve according to claims 1 to 12 or the bendable sleeve prepared by the preparation method of the bendable sleeve according to any one of claims 13 to 14.

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