Anti-migration biodegradable composite esophageal stent and method of manufacturing the same

Abstract

The application discloses an anti-migration biodegradable composite esophageal stent and a manufacturing method thereof. The composite esophageal stent comprises, from inside to outside, a hydrogel film inner layer, a middle layer reinforcing body and a fiber film outer layer. The circumferential surface of the outer surface of both ends of the fiber film outer layer is provided with a suction cup. The hydrogel film inner layer, the middle layer reinforcing body, the fiber film outer layer and the suction cup are all made of biodegradable materials. The middle layer reinforcing body is composed of negative Poisson's ratio variable units with auxetic properties. The fiber film has a drug loading function. The hydrogel film inner layer, the middle layer reinforcing body and the fiber film outer layer are all made by 3D printing. The composite esophageal stent can effectively change its deformation and improve the tissue compatibility of the composite esophageal stent. The composite esophageal stent can move up and down with the esophagus of a patient to maintain good biological adhesion. The composite esophageal stent can be degraded and absorbed in the human body or discharged out of the body within a certain period of time, and does not need to be taken out by a secondary operation.

Description

Technical Field

[0001] This invention relates to the field of esophageal stent technology for medical devices, specifically to an anti-displacement biodegradable composite esophageal stent and its manufacturing method. Background Technology

[0002] Esophageal cancer ranks among the top ten in both incidence and mortality of malignant tumors worldwide. Early diagnosis and treatment are crucial for esophageal cancer management. Multiple international guidelines and consensus statements recommend endoscopic submucosal dissection (ESD) as the preferred treatment for early-stage esophageal cancer. As an endoscopic resection technique, ESD is widely used in the treatment of early-stage esophageal cancer patients due to its advantages such as minimal invasiveness and high en bloc resection rate. However, more than 30% of patients develop postoperative esophageal stricture after ESD. Studies have shown that surgically induced mucosal defects are an independent risk factor for esophageal stricture, which leads to difficulty eating and swallowing, severely reducing patients' quality of life. Postoperative scarring stricture after esophageal ESD is often a complex and refractory benign esophageal stricture, and there is currently no universally accepted standard treatment, which remains a challenge for gastroenterologists worldwide.

[0003] Currently, the main treatments for esophageal stricture include dilation with a probe or balloon, temporary stent placement, radial incision and resection, and combined treatments. While these methods can improve the symptoms of esophageal stricture accompanied by dysphagia, they increase patient discomfort during treatment and also increase the risk of complications such as esophageal perforation. Therefore, prevention of stricture after esophageal ESD is more important. The placement of a retrievable covered metal stent (Publication No.: CN203074935U, Name: Double Soft Skirt Cup-Mouth Perforated Esophageal Covered Stent; DOI: 10.1186 / s12876-020-01398-6Coveredmetallic stent for the treatment of malignant esophageal fistula combined with stricture; DOI: 10.14309 / 01.ajg.0000709928.85584.5e S1970 Utility of Covered Metal Stents in Esophageal Penetrating) Injuries are one of the effective means of preventing esophageal stricture after ESD. This method continuously and effectively dilates the stricture site of the esophagus and removes it after the stricture problem is relieved, which can reduce the incidence of esophageal stricture and the number of treatments for stricture dilation. However, the rigidity of metal stents is relatively large, so they are difficult to adapt to the peristaltic deformation process of the esophagus. They are prone to displacement after implantation in the esophagus, and can also cause granulation tissue hyperplasia, making stent removal difficult. Summary of the Invention

[0004] In order to overcome the shortcomings of the prior art, the present invention aims to provide an anti-displacement biodegradable composite esophageal stent and its manufacturing method. The composite esophageal stent has good tissue compatibility and drug loading characteristics, so it can better fit the esophagus and will not cause damage to the human body.

[0005] To achieve the above objectives, the present invention is implemented through the following technical solution:

[0006] A biodegradable composite esophageal stent with anti-displacement properties includes a hydrogel inner layer 1, an intermediate reinforcing layer 2, and a fibrous outer layer 3 arranged sequentially from the inside out. Suction cups 4 are provided on the circumferential surfaces at both ends of the outer surface of the fibrous outer layer 3. Flexible ends 5 are provided at both ends of the hydrogel inner layer 1. The hydrogel inner layer 1, the intermediate reinforcing layer 2, the fibrous outer layer 3, the suction cups 4, and the flexible ends 5 are all made of biodegradable biomaterials. The intermediate reinforcing layer 2 is composed of negative Poisson's ratio deformation units with tensile properties. The fibrous outer layer 3 has a drug-carrying function.

[0007] The flexible end 5 is an outwardly expanding structure that extends from both ends of the inner layer 1 of the hydrogel membrane beyond the two ends of the intermediate layer reinforcement 2, and the length of the flexible end 5 is no more than 10mm.

[0008] The outer surface of the fiber membrane 3 has multiple sets of suction cups on the circumferential surface of each end. Each set of suction cups consists of multiple suction cups 4 evenly distributed radially along the outer surface of the fiber membrane 3, and the multiple sets of suction cups are arranged axially along the outer surface of the fiber membrane 3.

[0009] The thickness of the inner layer 1 of the hydrogel membrane is ≥50μm and ≤1mm; the thickness of the intermediate layer reinforcement 2 is ≥0.5mm and ≤3mm, and the interior angle α of the negative Poisson's ratio deformation unit is ≥30° and ≤70°; the thickness of the outer layer 3 of the fiber membrane is ≥10μm and ≤500μm; the thickness of the flexible end 5 is ≥50μm and ≤1mm; the diameter of the anti-displacement biodegradable composite esophageal stent is ≥15mm and ≤40mm, and the length is ≥30mm and ≤60mm.

[0010] The inner layer 1 of the hydrogel membrane, the intermediate layer reinforcement 2, the outer layer 3 of the fiber membrane, the suction cup 4, and the flexible end 5 are all made by 3D printing.

[0011] The inner layer 1 and flexible end 5 of the hydrogel membrane are formed by spun biodegradable fibers or 3D printed hydrogel; the outer layer 3 of the fiber membrane is formed by electrostatic printing on the outer surface of the intermediate layer reinforcement 2.

[0012] The outer layer 3 of the fiber membrane uses a solution of biodegradable biomaterial and anticancer drug as the spinning raw material. The biodegradable biomaterial used in the outer layer 3 of the fiber membrane is one or a mixture of polycaprolactone and polylactide, and the anticancer drug is one of paclitaxel, doxorubicin and 5-fluorouracil.

[0013] The printing material for the intermediate layer reinforcement 2 is one or a mixture of polycaprolactone and polylactide.

[0014] The line diameter of the intermediate layer reinforcement 2 with negative Poisson's ratio deformation unit structure is 0.3 to 1 mm, which is thicker than the line diameter of the outer fiber membrane 3. It has a certain support and the deformation performance of the support can be adjusted by changing the inner angle α of the structure, so that the support has the tensile structure characteristics of negative Poisson's ratio.

[0015] The outer fiber membrane 3 is prepared by electrostatic printing on the intermediate layer reinforcement 2. The electrostatically printed outer fiber membrane 3 uses a solution of biodegradable material and anticancer drug as raw material, and has certain effects of sustained release of anticancer drugs, anti-inflammation, and promotion of cell adhesion and growth.

[0016] A method for manufacturing an anti-displacement biodegradable composite esophageal stent, using a 3D printing device. The 3D printing device includes a printing platform 6 and a first nozzle 7, a second nozzle 8, and a third nozzle 9 located above the printing platform 6. The printing platform 6 is movable along the X-axis, and the first nozzle 7, the second nozzle 8, and the third nozzle 9 are all movable along the Y-axis and the Z-axis. The printing process includes the following steps:

[0017] Step 1: Based on the patient's esophageal stricture, a roller 10 is custom-made. The roller 10 is rotated and set on the printing platform 6 and grounded. The axis of the roller 10 is parallel to the X-axis direction.

[0018] Step 2: The first nozzle 7 moves above the roller 10 and extrudes the printing material of the hydrogel film inner layer 1 and the flexible end 5. While the printing platform 6 moves along the X-axis, the roller 10 rotates, thereby printing the hydrogel film inner layer 1 and the flexible end 5 on the surface of the roller 10.

[0019] Step 3: The second nozzle 8 moves above the roller 10 and extrudes the printing material of the intermediate layer reinforcement 2. While the printing platform 6 moves along the X-axis, the roller 10 rotates, printing the intermediate layer reinforcement 2 on the outer surface of the hydrogel film inner layer 1. The length of the intermediate layer reinforcement 2 is less than the length of the hydrogel film inner layer 1 to avoid collision and interference between the nozzle and the flexible end 5. The intermediate layer reinforcement 2 is composed of negative Poisson's ratio deformation units with tensile properties.

[0020] Step 4: The third nozzle 9 moves above the roller 10. The third nozzle 9 is connected to high voltage and generates a jet at the end of the nozzle. The extremely fine filaments generated by the jet fall onto the outer surface of the intermediate layer reinforcement 2. While the printing platform 6 moves along the X-axis, the roller 10 rotates. The third nozzle 9 prints the fiber membrane outer layer 3 on the outer surface of the intermediate layer reinforcement 2. The two end faces of the fiber membrane outer layer 3 are flush with the two end faces of the intermediate layer reinforcement 2.

[0021] Step 5: The first nozzle 7 or the second nozzle 8 moves above the roller 10 and extrudes the printing material. The first nozzle 7 or the second nozzle 8 descends along the Z-axis and cooperates with the movement of the printing platform 6 along the X-axis and the rotation of the roller 10. The first nozzle 7 or the second nozzle 8 prints a three-dimensional suction cup 4 on the circumferential surface at both ends of the outer surface of the fiber membrane outer layer 3.

[0022] Step 6: Cool and shape the printed anti-displacement biodegradable composite esophageal stent, and then remove it from roller 10.

[0023] The outer layer 3 of the fiber membrane is made by electrostatic printing. First, the intermediate layer reinforcement 2 is heated to 70°C on the roller 10 to soften it, ensuring that the intermediate layer reinforcement 2 is softened and sticky, and then the outer layer 3 of the fiber membrane is printed.

[0024] Compared with the prior art, the present invention has the following beneficial effects:

[0025] 1. A biodegradable composite esophageal stent with anti-displacement properties has multiple functional layers. By rationally designing the structure of the composite esophageal stent, the deformation characteristics of its functional layers can be effectively changed, improving the compatibility and peristalsis of the composite esophageal stent with tissues. The suction cup structure on the outside of the stent and the flexible end can play an anti-displacement role by adsorption and adhesion to the esophageal cavity. The stent material can deliver therapeutic drugs to achieve anti-cancer, anti-inflammatory and other functional effects. Since each functional layer uses biocompatible materials, the composite esophageal stent can degrade and be absorbed or excreted from the human body within a certain period of time without the need for secondary surgery to remove it. Its degradation products are non-toxic and have no toxic side effects on the human body.

[0026] 2. The composite esophageal stent is directly formed on the roller base. By switching different nozzles as needed and printing different materials with corresponding processes, the integrated printing of multi-layered structural features (inner hydrogel membrane, middle reinforcement, outer fiber membrane and suction cup structure) composite multi-material anti-displacement biodegradable composite esophageal stents can be completed on one platform. This avoids the manufacturing errors caused by multiple process switching due to clamping and improves printing efficiency.

[0027] 3. The manufacturing method of anti-displacement biodegradable composite esophageal stent based on cylindrical forming has higher stability. The forming process of complex multi-layer barrel-shaped structure is carried out directly on the cylindrical surface. Compared with traditional FDM printing, it does not require printing of the main support structure. The step effect of printing is eliminated in the length direction of the stent, resulting in better continuity. Furthermore, by switching processes, high-precision electrostatically printed fiber structures with micron-level features can be directly manufactured on the outermost layer of the stent. Attached Figure Description

[0028] Figure 1 This is a three-dimensional schematic diagram of the anti-displacement biodegradable composite esophageal stent according to an embodiment of the present invention.

[0029] Figure 2 This is a front view of the anti-displacement biodegradable composite esophageal stent according to an embodiment of the present invention.

[0030] Figure 3 This is a side view of the anti-displacement biodegradable composite esophageal stent according to an embodiment of the present invention.

[0031] Figure 4 This is an exploded schematic diagram of the anti-displacement biodegradable composite esophageal stent according to an embodiment of the present invention.

[0032] Figure 5 This is a schematic diagram of an intermediate layer reinforcement composed of hourglass-shaped negative Poisson's ratio deformation units in an embodiment.

[0033] Figure 6 This is a schematic diagram of the 3D printing equipment used in an embodiment of the present invention. Detailed Implementation

[0034] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0035] like Figures 1-5 As shown, an anti-displacement biodegradable composite esophageal stent is made of biodegradable biomaterials and includes a hydrogel membrane inner layer 1, an intermediate layer reinforcement 2, a fibrous membrane outer layer 3 and a flexible end 5 arranged sequentially from the inside to the outside. The cross-sections of the hydrogel membrane inner layer 1, the intermediate layer reinforcement 2 and the fibrous membrane outer layer 3 are circular. Suction cups 4 are covered on the circumferential surfaces at both ends of the outer surface of the fibrous membrane outer layer 3. With the help of the suction cups 4, the esophageal stent is adsorbed onto the esophageal wall.

[0036] The suction cup 4 is made of the same material as the inner layer 1 of the hydrogel membrane to form a flexible suction cup; it can also be made of the same material as the intermediate layer reinforcement 2 to form a rigid suction cup. Since patients have different sensitivities to stents of different hardness, the suction cup 4 can be customized into a flexible suction cup or a rigid suction cup according to the patient's needs.

[0037] The inner layer 1 of the hydrogel membrane is an elastic hydrogel membrane covering the inner surface of the intermediate layer reinforcement 2. The inner flow channel surface of the elastic hydrogel membrane is flat and smooth, which facilitates the passage of food. The two ends of the inner layer 1 of the hydrogel membrane extend out of the intermediate layer reinforcement 2 to form flexible ends 5. The length of the flexible ends 5 is not greater than 10 mm. The flexible ends 5 can effectively prevent granulation tissue from growing at the contact point. The thickness of the inner layer 1 of the hydrogel membrane is ≥50 μm and ≤1 mm. It can be manufactured by 3D printing, either by spinning biodegradable fibers with a diameter of 50 to 500 nm or by directly printing hydrogel.

[0038] The intermediate layer reinforcement 2 is a flexible scaffold with anti-displacement properties, customized using biodegradable biomaterials according to the patient's surgical needs. It is a cylindrical structure composed of tensile-stretching units. Specifically, the intermediate layer reinforcement 2 is composed of closely arranged negative Poisson's ratio deformable units. The structure of the negative Poisson's ratio deformable units includes, but is not limited to, hourglass, star, and sinusoidal structures with tensile-stretching properties. The diameter of the negative Poisson's ratio deformable units is 0.3mm to 1mm, and the interior angle t of the negative Poisson's ratio deformable unit structure is between 30° and 70°. The tensile-stretching properties of the scaffold can be adjusted according to the patient's esophageal condition. The thickness of the intermediate layer reinforcement 2 is 0.5mm to 3mm, and it can be manufactured by 3D printing.

[0039] The material of the intermediate layer reinforcement 2 is preferably polycaprolactone with a molecular weight of 80,000. The selection of the intermediate layer reinforcement 2 material needs to be determined according to the required degradation time of the esophagus to determine the type and ratio of the material. Within a certain period of time, the biodegradable flexible stent can be degraded and absorbed in the human body without the need for a second surgery to remove it. Its degradation products are non-toxic and will not produce toxic side effects on the human body. The selection of biomaterials makes the esophageal stent flexible, which can fully adapt to the peristaltic environment of the esophagus in the human body and facilitates surgical placement.

[0040] The outer fiber membrane 3 is a fiber layer tightly wrapped around the outer surface of the intermediate layer reinforcement 2. Its structure is composed of micro-scale fibers arranged in a cross pattern and has a drug-carrying function. The outer fiber membrane 3 is electrostatically printed on the outer surface of the intermediate layer reinforcement 2. A solution of biodegradable biomaterials and anticancer drugs mixed in a certain mass ratio is used as the spinning raw material. The esophageal stent can achieve anticancer, anti-inflammatory and other functional effects through the drug delivery and sustained release of the outer fiber membrane 3, while improving cell compatibility.

[0041] The outer fiber membrane 3 is a drug-loaded fiber membrane fabricated on the outside of the intermediate reinforcement 2 using electrostatic printing technology. The printing material for the outer fiber membrane 3 is a solution of biodegradable biomaterials and anticancer drugs mixed in a mass ratio of 1:0.01 to 1:0.2, wherein the anticancer drugs include, but are not limited to, one or more of paclitaxel, doxorubicin, and 5-fluorouracil. The thickness of the outer fiber membrane 3 is 10 μm to 500 μm, and the diameter of the biodegradable filaments used for printing is 500 nm to 100 μm.

[0042] The intermediate layer reinforcement 2 and the hydrogel inner layer 1 use biodegradable biomaterials that have thermal stability and can maintain mechanical properties at 10℃ to 70℃. The materials include, but are not limited to, one or more of polycaprolactone, polylactide, polylactic acid, and polylactic acid-glycolic acid; or biodegradable hydrogels, including but not limited to one or more of carboxymethyl chitosan hydrogel (CMCS-gel) and polylactic acid-carboxymethyl chitosan copolymer hydrogel (CMCS-PLA-gel).

[0043] The dimensions of the anti-displacement biodegradable composite esophageal stent can be customized according to the extent of the esophageal injury in the patient, with an overall diameter ranging from 15mm to 40mm and an overall length ranging from 30mm to 60mm. Preferably, the thickness of the intermediate reinforcing layer 2 is ≥0.5mm and ≤3mm, and the average diameter of the biodegradable coarse filaments is 0.4mm. Preferably, the thickness of the outer fibrous membrane layer 3 is 10μm to 500μm, and the average diameter of the biodegradable fine filaments is 500nm to 100μm. The overall dimensions of the composite stent can effectively ensure the comprehensive mechanical performance of the stent structure and meet the deformation requirements of human esophageal peristalsis.

[0044] The principle of anti-migration biodegradable composite esophageal stent: Anti-migration biodegradable composite esophageal stents are surgically implanted in patients with esophageal stricture after ESD to achieve therapeutic function. The intermediate layer reinforcement 2 is composed of tightly arranged hourglass-shaped unit structures made of polycaprolactone, a biodegradable material with relatively large fiber diameter. By changing the size of the inner angle α of the unit structure, stents with different tensile ratios and flexibility characteristics can be customized for different patients to adapt to the stricture environment and peristalsis of different patients' esophagi. The outermost fibrous membrane layer 3 of the anti-migration biodegradable composite esophageal stent is made of finer fibers. Because it is a mixture of biodegradable and drug materials, it has certain therapeutic functions. By controlling the ratio of drug materials to biodegradable materials, the dosage and release rate of drugs can be controlled, and personalized treatment can also be achieved for different patients. The flexible material characteristics and negative Poisson's ratio effect of the intermediate layer reinforcement 2 ensure that the esophageal stent can deform accordingly with the peristalsis of the patient's esophagus.

[0045] The anti-displacement biodegradable composite esophageal stent material is softer than conventional metal esophageal stents, reducing patient discomfort during implantation, minimizing physiological stimulation of esophageal abnormalities, and preventing stent dislodgement and secondary damage to the esophagus. Furthermore, drug release (such as anti-inflammatory and anticancer drugs) can alleviate discomfort and provide functional therapy. The finer fibrous outer membrane 3, electrostatically printed, also promotes the adhesion, proliferation, and differentiation of esophageal epithelial cells, facilitating esophageal wound healing. Suction cups 4 ensure the stent is not easily dislodged after adsorption. The outwardly flared flexible end 5 further enhances the stent's anti-displacement capability. Within a certain period, the composite stent can self-degrade and be absorbed by the body, eliminating the need for secondary surgery. Its degradation products are non-toxic and do not cause any adverse effects on the human body.

[0046] A method for manufacturing an anti-displacement biodegradable composite esophageal stent, using 3D printing equipment, refers to... Figure 6 The 3D printing equipment includes a printing platform 6 and a first nozzle 7, a second nozzle 8, and a third nozzle 9 located above the printing platform. The printing platform 6 can move along the X-axis, and the first nozzle 7, the second nozzle 8, and the third nozzle 9 can all move along the Y-axis and the Z-axis. The printing process includes the following steps:

[0047] Step 1: Based on the patient's esophageal stenosis, a roller 10 is customized as a printing rotary base. The composite esophageal stent is printed on the printing rotary base. The roller 10 is rotatably set on the printing platform 6 and grounded. The axis of the roller 10 is parallel to the X-axis direction.

[0048] Step 2: The first nozzle 7 moves above the roller 10 and extrudes the printing material of the hydrogel film inner layer 1 and the flexible end 5. While the printing platform 6 moves along the X-axis, the roller 10 rotates, thereby printing the hydrogel film inner layer 1 and the flexible end 5 on the surface of the roller 10. The thickness of the hydrogel film inner layer 1 is 50μm to 1mm, and the thickness of the flexible end 5 is 50μm to 1mm.

[0049] Step 3: The second nozzle 8 moves above the roller 10 and extrudes the printing material of the intermediate layer reinforcement 2. While the printing platform 6 moves along the X-axis, the roller 10 rotates. The intermediate layer reinforcement 2, which is composed of negative Poisson's ratio deformation units, is printed on the outer surface of the hydrogel film inner layer 1. The thickness of the intermediate layer reinforcement 2 is 0.5mm to 3mm, the line diameter of the negative Poisson's ratio deformation unit is 0.3mm to 1mm, and the length of the intermediate layer reinforcement 2 is less than the length of the hydrogel film inner layer 1.

[0050] Step 4: The fiber membrane outer layer 3 is printed using electrostatic printing technology. The third nozzle 9 moves above the roller 10. The third nozzle 9 is connected to a high voltage, which causes the end of the printing nozzle to generate an extremely fine jet. The extremely fine filaments (nanoscale or microscale) generated by the jet fall onto the outer surface of the intermediate layer reinforcement 2. While the printing platform 6 moves along the X-axis, the roller 10 rotates. The third nozzle 9 prints the fiber membrane outer layer 3 on the outer surface of the intermediate layer reinforcement 2. The two end faces of the fiber membrane outer layer 3 are flush with the two end faces of the intermediate layer reinforcement 2. The thickness of the fiber membrane outer layer 3 is 10μm to 500μm, and the diameter of the biodegradable filaments is 500nm to 100μm.

[0051] Step 5: The first nozzle 7 or the second nozzle 8 moves above the roller 10 and extrudes the printing material. While the printing platform 6 moves along the X-axis, the roller 10 rotates. The first nozzle 7 or the second nozzle 8 descends along the Z-axis and prints a suction cup 4 of a certain height on the circumferential surface at both ends of the outer surface of the fiber membrane outer layer 3.

[0052] Step 6: Cool and shape the printed anti-displacement biodegradable composite esophageal stent, and then remove it from roller 10 to obtain the final structure.

[0053] In the above printing process, the 3D printing technology is FDM or FFF method.

[0054] During the printing process in steps 2-5, printing in the Y direction is achieved by controlling the rotation of the printing base along the X-axis, and this is coordinated with the movement of the printing nozzle along the X and Z axes, ultimately realizing the fabrication of a three-dimensional structure of an anti-displacement biodegradable composite esophageal stent.

[0055] The outer layer 3 of the fiber membrane is achieved by electrostatic printing. In step 3, the intermediate layer reinforcement 2 is first heated to 70°C on the roller 10 to soften it, so as to ensure that the intermediate layer reinforcement 2 is sufficiently softened and has a certain degree of stickiness. Then the outer layer 3 of the fiber membrane is printed to ensure that the inner and outer layers of the composite scaffold are tightly bonded and to prevent the inner and outer layer structures from falling off.

[0056] The above-described embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features therein. These modifications or substitutions do not cause the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention. Therefore, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of the present invention.

Claims

1. A biodegradable composite esophageal stent with anti-displacement properties, characterized in that: The membrane consists of an inner hydrogel membrane (1), an intermediate layer reinforcement (2), and a fiber membrane outer layer (3) arranged sequentially from the inside to the outside. Suction cups (4) are provided on the circumferential surfaces at both ends of the outer surface of the fiber membrane outer layer (3). The inner hydrogel membrane (1) has outwardly extending flexible ends (5) at both ends. The inner hydrogel membrane (1), the intermediate layer reinforcement (2), the fiber membrane outer layer (3), the suction cups (4), and the flexible ends (5) are all made of biodegradable biomaterials. The flexible end (5) is an outwardly expanding structure that extends beyond the two ends of the intermediate layer reinforcement (2) of the inner layer (1) of the hydrogel membrane, and the length of the flexible end (5) is no more than 10 mm. The outer surface of the fiber membrane (3) is provided with multiple sets of suction cups on the circumferential surface of each end. Each set of suction cups consists of multiple suction cups (4) evenly distributed along the radial direction of the outer surface of the fiber membrane (3). The multiple sets of suction cups are arranged along the axial direction of the outer surface of the fiber membrane (3). The thickness of the inner layer (1) of the hydrogel membrane is ≥50μm and ≤1mm. The inner layer (1) and the flexible end (5) are 3D printed from biodegradable fiber spinning or hydrogel material. The thickness of the intermediate layer reinforcement (2) is ≥0.5mm and ≤3mm. The intermediate layer reinforcement (2) is composed of negative Poisson's ratio deformation units with tensile properties. The interior angle α of the negative Poisson's ratio deformation unit is ≥30° and ≤70°. The line diameter of the negative Poisson's ratio deformation unit structure is 0.3~1mm. The thickness of the outer layer (3) of the fiber membrane is ≥10μm and ≤5mm. 00μm, the outer layer of the fiber membrane (3) is obtained by electrostatic printing on the outer surface of the intermediate layer reinforcement (2). The solution of biodegradable biomaterials and anticancer drugs mixed in a mass ratio of 1:0.01~1:0.2 is used as the spinning raw material. The diameter of the electrostatically printed biodegradable filament is 500nm~100μm. The outer layer of the fiber membrane (3) has drug loading function; the thickness of the flexible end (5) is ≥50μm and ≤1mm; the diameter of the anti-displacement biodegradable composite esophageal stent is ≥15mm and ≤40mm, and the length is ≥30mm and ≤60mm.

2. The anti-displacement biodegradable composite esophageal stent according to claim 1, characterized in that: The inner layer (1), intermediate reinforcement (2), outer fiber membrane (3), suction cup (4) and flexible end (5) of the hydrogel membrane are all made by 3D printing.

3. The anti-displacement biodegradable composite esophageal stent according to claim 2, characterized in that: The biodegradable biomaterial used in the outer layer (3) of the fiber membrane is one or a mixture of polycaprolactone and polylactide, and the anticancer drug is one of paclitaxel, doxorubicin and 5-fluorouracil.

4. The anti-displacement biodegradable composite esophageal stent according to claim 2, characterized in that: The printing material for the intermediate layer reinforcement (2) is one or a mixture of polycaprolactone, polylactide, or both.

5. The method for manufacturing a biodegradable composite esophageal stent with anti-displacement as described in claim 1, characterized in that, The printing is performed using a 3D printing device, which includes a printing platform (6) and a first nozzle (7), a second nozzle (8), and a third nozzle (9) located above the printing platform (6). The printing platform (6) can move along the X-axis, and the first nozzle (7), the second nozzle (8), and the third nozzle (9) can all move along the Y-axis and the Z-axis. The printing process includes the following steps: Step 1: Based on the patient's esophageal stenosis, a roller (10) is customized. The roller (10) is rotated and set on the printing platform (6) and grounded. The axis of the roller (10) is parallel to the X-axis direction. Step 2: The first nozzle (7) moves above the roller (10) and extrudes the printing material of the hydrogel film inner layer (1) and the flexible end (5). The printing platform (6) moves along the X-axis while the roller (10) rotates, thereby printing the hydrogel film inner layer (1) and the flexible end (5) on the surface of the roller (10). Step 3: The second nozzle (8) moves above the roller (10) and extrudes the printing material of the intermediate layer reinforcement (2). While the printing platform (6) moves along the X-axis, the roller (10) rotates and prints the intermediate layer reinforcement (2) on the outer surface of the hydrogel film inner layer (1). The length of the intermediate layer reinforcement (2) is less than the length of the hydrogel film inner layer (1). The intermediate layer reinforcement (2) is composed of negative Poisson's ratio deformation units with tensile properties. Step 4: The third nozzle (9) moves above the roller (10), the third nozzle (9) is connected to high voltage and a jet is generated at the end of the nozzle. The extremely fine filaments generated by the jet fall onto the outer surface of the intermediate layer reinforcement (2). While the printing platform (6) moves along the X-axis, the roller (10) rotates. The third nozzle (9) prints the fiber membrane outer layer (3) on the outer surface of the intermediate layer reinforcement (2). The two end faces of the fiber membrane outer layer (3) are flush with the two end faces of the intermediate layer reinforcement (2). Step 5: The first nozzle (7) or the second nozzle (8) moves above the roller (10) and extrudes the printing material. The first nozzle (7) or the second nozzle (8) descends along the Z-axis and cooperates with the movement of the printing platform (6) along the X-axis and the rotation of the roller (10). The first nozzle (7) or the second nozzle (8) prints a three-dimensional suction cup (4) on the circumferential surface at both ends of the outer surface of the outer layer of the fiber membrane (3). Step 6: Cool and shape the printed anti-displacement biodegradable composite esophageal stent, and then remove it from the roller (10).

6. The manufacturing method according to claim 5, characterized in that: The outer layer of the fiber membrane (3) is made by electrostatic printing. First, the intermediate layer reinforcement (2) is heated to 70°C on the roller (10) to soften it, ensuring that the intermediate layer reinforcement (2) is softened and sticky, and then the outer layer of the fiber membrane (3) is printed.

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