Degradable material for digestive tract as well as preparation method and application of degradable material

Abstract

The invention discloses a degradable material for a digestive tract and a preparation method and application thereof, and the degradable material for the digestive tract provided by the invention comprises the main component of a polymer containing a glycolide component. The polymer containing the glycolide component has good biodegradability and can be gradually degraded in vivo, the digestive tract implantation intervention medical device made of the degradable material has high initial mechanical strength after being placed into the intestinal tract, can be completely disintegrated within one week, has the characteristics of high strength and fast disintegration, and can be used for preparing the digestive tract implantation intervention medical device. Therefore, the risks of intestinal stenosis and obstruction are greatly reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a degradable material for the digestive tract and a preparation method and application thereof. Background Art

[0002] At present, medical devices implanted in the gastrointestinal tract and digestive tract have been widely used in clinical practice. For example, digestive tract stents and staplers can be used in digestive tract reconstruction surgery in anorectal and gastrointestinal surgery. Digestive tract stents can support or block the cavity in the early stage, which is helpful for the reconstruction and anastomosis of the digestive tract (such as the intestine). After the healing period of digestive tract reconstruction, the digestive tract stents need to be detached regularly to restore the digestive tract to smoothness and function. However, some digestive tract stents and staplers are not well adapted to the human body and are prone to cause long-term complications such as foreign body inflammatory reaction and intimal hyperplasia. For example, in recent years, drawing on the principle of gastric bypass in weight loss surgery, a sleeve is inserted in the duodenum-jejunum segment to isolate the contact between chyme and the intestine to reduce intestinal absorption, which is used for weight loss and treatment of type 2 diabetes. After the digestive tract sleeve is inserted, it can reduce the intestinal absorption of food in the short term. However, it cannot be ignored that the digestive tract sleeve and the release ball core used for the distal release of the digestive tract sleeve have a certain probability of device obstruction after implantation in the human body, and in severe cases, it can also cause intestinal folding. Therefore, when preparing implantable medical devices in the gastrointestinal tract and digestive tract, it is expected that the implantable medical devices will be set to a controllable in vivo fragmentation cycle so that they will disintegrate and be excreted under the action of intestinal peristalsis.

[0003] In view of this, the present invention is proposed. Summary of the invention

[0004] The invention provides a degradable material for the digestive tract, the main component of which is a polymer containing glycolide.

[0005] The present invention also provides a method for preparing the above-mentioned degradable material for the digestive tract, which comprises: processing a polymer containing glycolide components by injection molding to prepare the degradable material for the digestive tract.

[0006] The present invention also provides a use of the above-mentioned degradable material for the digestive tract or the degradable material for the digestive tract prepared by the above-mentioned preparation method in the preparation of digestive tract implantable medical devices.

[0007] The present invention has the following beneficial effects:

[0008] The present invention provides a degradable material for the digestive tract, a preparation method thereof and an application thereof. The degradable material for the digestive tract provided by the present invention has a main component of a polymer containing a glycolide component. The degradable material for the digestive tract has a high initial mechanical strength, achieves complete disintegration within one week, has the characteristics of high strength and fast disintegration, thereby greatly reducing the risk of intestinal stenosis and obstruction. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments are 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 creative work.

[0010] Figure 1 It is a schematic diagram of the structure of the inner core of the releasing ball for the distal release of the digestive tract sleeve; the figure numbers are: 1-protrusion, 2-ball body, 3-base. DETAILED DESCRIPTION

[0011] In order to make the purpose, technical scheme and advantages of the embodiments of the present invention clearer, the technical scheme in the embodiments of the present invention will be described clearly and completely below. If the specific conditions are not specified in the embodiments, they are carried out according to conventional conditions or conditions recommended by the manufacturer. If the manufacturer of the reagents or instruments used is not specified, they are all conventional products that can be purchased commercially.

[0012] The following is a detailed description of a degradable material for the digestive tract provided in an embodiment of the present invention, and a preparation method and application thereof.

[0013] In a first aspect, an embodiment of the present invention provides a degradable material for the digestive tract, wherein the main component of the material is a polymer containing glycolide. The polymer containing glycolide has good biodegradability and can be gradually degraded in the body.

[0014] In some optional embodiments, the polymer containing a glycolide component includes at least one of a blend of polyglycolide and polyvinyl alcohol, a poly(glycolide-D,L-lactide)-polyethylene glycol copolymer, and a blend of poly(glycolide-D,L-lactide)-polyethylene glycol copolymer and polyvinyl alcohol.

[0015] In some optional embodiments, in the blend of polyglycolide and polyvinyl alcohol, the intrinsic viscosity of polyglycolide is 1.2 dl / g-2.0 dl / g; the molecular weight of polyvinyl alcohol is 50000-100000 g / mol, and the degree of alcoholysis is 70%-99%; and the mixing mass ratio of polyglycolide to polyvinyl alcohol is 80:20-40:60.

[0016] In some optional embodiments, in the poly(glycolide-D,L-lactide)-polyethylene glycol copolymer, the molar ratio of glycolide to D,L-lactide is 90:10-50:50, the molecular weight of polyethylene glycol is 4000-8000 g / mol, and the copolymerization molar ratio of poly(glycolide-D,L-lactide) and polyethylene glycol is 96:4-90:10.

[0017] In some optional embodiments, in the blend of poly(glycolide-D,L-lactide)-polyethylene glycol copolymer and polyvinyl alcohol, the mixing mass ratio of poly(glycolide-D,L-lactide)-polyethylene glycol copolymer to polyvinyl alcohol is 80:20-40:60.

[0018] The degradable material for the digestive tract provided by the embodiment of the present invention is mainly composed of a polymer containing glycolide components, wherein: the polymer containing glycolide components includes one or more of two blends and one copolymer, and both blends contain polyvinyl alcohol, which is water-soluble and quickly dissolves in an aqueous solution. The glycolide-containing component is very prone to chain scission degradation, and the degradation rate is closely related to temperature and humidity. After the polyvinyl alcohol is dissolved, a large number of cavities or gaps will be formed in the glycolide-containing polymer, and water molecules can quickly penetrate into the material. On the one hand, the contact area with the material is increased and the degradation is accelerated; on the other hand, the formed cavities will collapse after the material is degraded to a certain extent, thereby achieving rapid disintegration. If the polyvinyl alcohol content is too high, the final material will be soft and the initial mechanical strength will be insufficient. Therefore, it must be controlled within an appropriate content range.

[0019] In a second aspect, an embodiment of the present invention provides a method for preparing the above-mentioned degradable material for the digestive tract, which comprises: processing a polymer containing glycolide components by injection molding to prepare the degradable material for the digestive tract.

[0020] In some optional embodiments, a crosslinking agent 4,4-diaminodiphenylmethane tetraglycidylamine (TGDDM) is added during the preparation of the blend of polyglycolide and polyvinyl alcohol or the blend of poly(glycolide-D,L-lactide)-polyethylene glycol copolymer and polyvinyl alcohol.

[0021] In some optional embodiments, the preparation of a blend of polyglycolide and polyvinyl alcohol or a blend of poly(glycolide-D,L-lactide)-polyethylene glycol copolymer and polyvinyl alcohol comprises the following steps: after mixing the raw materials, adding a crosslinking agent 4,4-diaminodiphenylmethane tetraglycidylamine (TGDDM), or adding a crosslinking agent 4,4-diaminodiphenylmethane tetraglycidylamine (TGDDM) and a crosslinking agent bis(2-hydroxyethyl)amino-tris(hydroxymethyl)methane (BIS-TRIS) to blend and crosslink to obtain a dynamically crosslinked blend;

[0022] Preferably, the raw materials are poured into an internal mixer or a torque rheometer and mixed at 30-50° C. above the melting point for 5-15 minutes, and then 0.5%-3% of 4,4-diaminodiphenylmethane tetraglycidylamine (TGDDM) accounting for the total weight of the raw materials is added, and the mixing is continued for 3-10 minutes, and then extruded to obtain a dynamically crosslinked blend;

[0023] Preferably, the raw materials are poured into an internal mixer or a torque rheometer and mixed at 30-50° C. above the melting point for 5-15 minutes, and then 1%-4% of bis(2-hydroxyethyl)amino-tris(hydroxymethyl)methane (BIS-TRIS) is added and mixed for 3-10 minutes, and finally 0.5%-3% of 4,4-diaminodiphenylmethane tetraglycidylamine (TGDDM) accounting for the total mass of the raw materials is added, and the mixture is continued to be mixed for 3-10 minutes, and then extruded to obtain a dynamically cross-linked blend.

[0024] The embodiment of the present invention provides a method for preparing the above-mentioned degradable material for the digestive tract, wherein the degradable material for the digestive tract is prepared by injection molding, wherein: in the preparation process of the blend before injection molding, one or two of TGDDM and BIS-TRIS need to be added, and BIS-TRIS containing a large number of hydroxyl groups and TGDDM containing a multifunctional epoxy group containing tertiary amines are used as grafting agents and crosslinking agents, respectively. The blend prepared by this method has both the processability of thermoplastics and the strength and temperature resistance of thermosetting plastics, thereby solving the degradation of degradable materials during the thermoforming process and the obtained molded parts have excellent mechanical strength without affecting the degradation performance.

[0025] When only TGDDM is added, the raw materials are first mixed evenly and poured into an internal mixer or torque rheometer at 30-50°C above the melting point for 5-15 minutes, and then 0.5%-3% of TGDDM is added, and the mixture is continued to be mixed for 3-10 minutes, and then extruded to obtain a dynamic cross-linked blend. The preparation principle is that the epoxy groups on the TGDDM with a tertiary amine structure react with the two component segments of the blend to form a dynamic cross-linked structure.

[0026] When TGDDM and BIS-TRIS are added at the same time, the raw materials are first mixed evenly and poured into an internal mixer or torque rheometer for 5-15 minutes at 30-50°C above the melting point, then 1%-4% BIS-TRIS is added and mixed for 3-10 minutes, and finally 0.5%-3% TGDDM is added by mass, and the mixture is mixed for 3-10 minutes, and then the mixture is extruded to obtain a dynamic cross-linked blend. The preparation principle is that BIS-TRIS with a tertiary amine structure breaks the chains of the two blend components through ester exchange and bridges the two component segments together, thereby avoiding phase separation of the blend components. The TGDDM with a tertiary amine structure added last, its multiple epoxy groups can react with the abundant hydroxyl groups in the bridged blend to form a dynamic cross-linked structure. In addition, the tertiary amine can catalyze and accelerate the ring-opening reaction between the epoxy group and the end group of the blend chain, so that no additional catalyst needs to be added, and the obtained blend can be guaranteed to have good biosafety.

[0027] In a third aspect, an embodiment of the present invention further provides a use of the above-mentioned degradable material for the digestive tract or the degradable material for the digestive tract prepared by the above-mentioned preparation method in the preparation of digestive tract implantable medical devices.

[0028] In some optional embodiments, the digestive tract implant medical device includes at least one of a digestive tract sleeve, a digestive tract stent and a digestive tract anastomosis device, preferably a digestive tract sleeve, and more preferably a release ball inner core for the distal release of the digestive tract sleeve. Based on the good degradation performance of the degradable material for the digestive tract provided in the embodiment of the present invention, it can be used to prepare common digestive tract implant medical devices such as digestive tract sleeves, digestive tract stents and digestive tract anastomosis devices. Preferably, the above-mentioned degradable material for the digestive tract can be used to make a digestive tract sleeve. Further preferably, the above-mentioned degradable material for the digestive tract can be used to make a release ball inner core for the distal release of the digestive tract sleeve.

[0029] In a fourth aspect, an embodiment of the present invention further provides a release sphere inner core for the distal end of a digestive tract cannula, the main component of which is a polymer containing glycolide. Multiple experimental studies have shown that the release sphere inner core for the distal end of a digestive tract cannula made with a polymer containing glycolide as the main component can disintegrate and be discharged under the action of intestinal peristalsis after being set to a controllable in vivo fragmentation cycle, and will not block the cannula body for a long time after successfully completing the self-expansion of the cannula body.

[0030] In some optional embodiments, the polymer containing glycolide components and the developing filler are composed, and the mass ratio of the polymer containing glycolide components to the developing filler is 100: (10-40). The developing filler is added to the raw materials for preparing the release ball inner core. The developing ability of the developing filler can make the position of the release ball inner core in the digestive tract better observed after it is placed in the digestive tract, so as to judge whether the digestive tract sleeve is delivered to the right place.

[0031] In some optional embodiments, the polymer containing a glycolide component includes at least one of a blend of polyglycolide and polyvinyl alcohol, a poly(glycolide-D,L-lactide)-polyethylene glycol copolymer, and a blend of poly(glycolide-D,L-lactide)-polyethylene glycol copolymer and polyvinyl alcohol.

[0032] In some optional embodiments, the developer filler includes at least one of barium sulfate, tungsten powder and bismuth dioxide.

[0033] In some optional embodiments, the inner core of the release ball for the distal release of the digestive tract sleeve is a hollow structure as a whole, which can maintain strength for 12-24 hours in the intestine and completely disintegrate within 7 days. The hollow structure of the release ball inner core enables it to disintegrate more quickly and completely, reducing residues and having better biosafety.

[0034] In some optional embodiments, the structure of the release ball inner core for the distal release of the digestive tract sleeve includes: a protrusion, a ball body and a base, wherein: the diameter of the ball body is 10-30mm, and the wall thickness is 0.5-3mm; the diameter of the base is 5-20mm, the height is 2-5mm, and the maximum height of the protrusion is 1-5mm. The release ball inner core with the above structure can be better combined with the sleeve body (see CN202311152577.X, the release ball inner core for the distal release of the digestive tract sleeve and its preparation method and application), so that the sleeve body can self-expand in the digestive tract, the operation is simple and convenient, and the insertion operation time of the digestive tract sleeve is greatly shortened.

[0035] The present invention will be further described below in conjunction with the embodiments.

[0036] Example 1

[0037] Polyglycolide (intrinsic viscosity 1.3dl / g) and polyvinyl alcohol (molecular weight 65000g / mol, alcoholysis degree 88%) were selected as raw materials. Polyglycolide and polyvinyl alcohol were first weighed in a mass ratio of 50:50 and placed in a vacuum drying oven at 50°C for 6h, then 2% BIS-TRIS was added to the blend and poured into an internal mixer and mixed at 240°C for 5min, then 1.5% TGDDM was added, and mixing continued for 5min, and finally extruded into granules. The granulated blend was physically mixed with 20% II type barium sulfate, poured into the barrel of an injection molding machine, and injection molded to obtain a degradable material for the digestive tract.

[0038] The above-mentioned degradable material for the digestive tract is made into a release ball inner core for the distal release of the digestive tract sleeve. Figure 1 The inner core of the released ball is a hollow structure as a whole, and its structure includes: a protrusion, a ball body and a base, wherein: the diameter of the ball body is 10mm and the wall thickness is 0.5mm; the diameter of the base is 5mm and the height is 2mm, and the maximum height of the protrusion is 1mm.

[0039] Example 2

[0040] A poly(glycolide-D,L-lactide)-polyethylene glycol copolymer (intrinsic viscosity 1.8 dl / g) was selected, wherein the molar ratio of glycolide to D,L-lactide was 70:30, the molecular weight of polyethylene glycol was 6000 g / mol, and the molar ratio of poly(glycolide-D,L-lactide) to polyethylene glycol was 95:5. Polyvinyl alcohol (molecular weight 65000 g / mol, alcoholysis degree 88%) was used as the raw material.

[0041] First, poly (glycolide-D, L-lactide)-polyethylene glycol copolymer and polyvinyl alcohol were weighed at a mass ratio of 50:50 and placed in a vacuum drying oven at 50°C for 6 hours, then 2% BIS-TRIS was added to the blend and poured into an internal mixer for mixing at 210°C for 5 minutes, then 1.5% TGDDM was added, and mixing was continued for 5 minutes, and finally extruded into granules. The granulated blend was physically mixed with 20% type I and II barium sulfate, and then poured into the barrel of an injection molding machine for injection molding to obtain a degradable material for the digestive tract.

[0042] The above-mentioned degradable material for the digestive tract is made into a release ball inner core for the distal release of the digestive tract sleeve. Figure 1 The inner core of the released ball is a hollow structure as a whole, and its structure includes: a protrusion, a ball body and a base, wherein: the diameter of the ball body is 30mm and the wall thickness is 3mm; the diameter of the base is 20mm and the height is 5mm, and the maximum height of the protrusion is 5mm.

[0043] Example 3

[0044] Different from Example 1, only 1.5% TGDDM was added to the blend, and the mixture was kneaded at 240° C. for 5 minutes before extrusion granulation.

[0045] Example 4

[0046] Different from Example 2, only 1.5% TGDDM was added to the blend, and the mixture was kneaded at 210° C. for 5 minutes before extrusion granulation.

[0047] Comparative Example 1

[0048] The difference from Example 1 is that only polyglycolide (intrinsic viscosity 1.3 dl / g) is dried in a vacuum drying oven at 50°C for 6 hours, 20% type II barium sulfate is added and mixed, and then poured into the barrel of an injection molding machine for injection molding of the released ball core.

[0049] Comparative Example 2

[0050] Different from Example 1, BIS-TRIS and TGDDM were not added in the preparation process of the blend, and polyglycolide (intrinsic viscosity 1.3 dl / g) and polyvinyl alcohol (molecular weight 65000 g / mol, alcoholysis degree 88%) were dried and granulated at a mass ratio of 50:50. The granulated blend was then physically mixed with 20% II type barium sulfate, poured into the barrel of an injection molding machine, and injection molded to obtain a release ball inner core.

[0051] Comparative Example 3

[0052] Different from Example 1, only BIS-TRIS was added in the preparation process of the blend. Polyglycolide (intrinsic viscosity 1.3 dl / g) and polyvinyl alcohol (molecular weight 65000 g / mol, alcoholysis degree 88%) were weighed at a mass ratio of 50:50 and placed in a vacuum drying oven at 50°C for 6 hours. After that, 2% BIS-TRIS was added to the blend and poured into an internal mixer and mixed at 240°C for 5 minutes, and finally extruded into granules. The granulated blend was physically mixed with 20% II type barium sulfate, poured into the barrel of an injection molding machine, and injection molded to obtain a release ball inner core.

[0053] Comparative Example 4

[0054] The difference from Example 1 is that the mass ratio of polyglycolide to polyvinyl alcohol is 30:70.

[0055] Comparative Example 5

[0056] The difference from Example 1 is that the molecular weight of the polyvinyl alcohol is 150000 g / mol and the alcoholysis degree is 88%.

[0057] Experimental Example 1

[0058] The granulated blends obtained in the examples and comparative examples were pressed into rectangular strips with a width of 15 mm, a length of 60 mm, and a thickness of 0.5 mm, and then subjected to a tensile strength test using a tensile testing machine at a tensile speed of 50 mm / min, and the elongation at break (%) and tensile strength (MPa) were recorded.

[0059] Elongation at break (%) Tensile strength(MPa) Example 1 8 72 Example 2 12 66 Example 3 7 78 Example 4 10 70 Comparative Example 1 6 68 Comparative Example 2 36 47 Comparative Example 3 27 53 Comparative Example 4 32 24 Comparative Example 5 9 69

[0060] The tensile strength test shows that after the glycolide-containing polymer is blended with polyvinyl alcohol and then blended with BIS-TRIS and TGDDM, the elongation at break and tensile strength of the blend are significantly higher than those of the sample without TGDDM. At the same time, when the polyvinyl alcohol content is 70%, the mechanical strength of the blend decreases sharply.

[0061] Experimental Example 2

[0062] The release ball cores obtained in the examples and comparative examples were weighed one by one and placed in artificial intestinal fluid at 37°C (refer to the Chinese Pharmacopoeia 2020 edition for the preparation method). Samples were taken every 24 hours for weighing and extrusion strength testing. The extrusion strength test method is: place the release ball core between the two plates of the tensile testing machine, set the speed to 50mm / min, until the release ball core breaks, and record the maximum force value (N) during the extrusion process.

[0063]

[0064] Note: “ / ” means that sampling and testing are not possible. 1 day = 24 hours

[0065] Through the degradation experiment, it can be seen that the mass loss of the release ball core obtained by blending the glycolide-containing polymer with polyvinyl alcohol in simulated intestinal fluid can reach more than 15% in one day, and most of the mass is completely lost after 5 days. In contrast, the polyglycolide in comparative example 1 that was not blended with polyvinyl alcohol still lost less than 10% in 7 days.

[0066]

[0067]

[0068] Through the degradation experiment, it can be seen that the release ball core obtained after the polymer containing glycolide component is blended with polyvinyl alcohol and blended with BIS-TRIS and TGDDM has higher extrusion strength, and the initial extrusion strength is almost twice that of the one without BIS-TRIS and TGDDM. After 12 hours of degradation, the extrusion strength decreased by more than 70%; complete disintegration was achieved in 24 hours. The loss rate of extrusion strength of unmodified polyglycolide (Comparative Example 1) after 24 hours was less than 15%. In addition, when the polyvinyl alcohol content is too high, the initial extrusion strength is too small; when the molecular weight of polyvinyl alcohol is too high, the disintegration time is longer.

[0069] From the above, it can be seen that the release ball inner core for the distal release of the digestive tract sleeve made of the degradable material for the digestive tract provided by the embodiment of the present invention has a high initial mechanical strength, and can maintain strength for 12-24 hours in the intestine, and can smoothly drive the sleeve body to extend to full expansion, after which the release ball inner core is separated from the sleeve body, the digestive tract sleeve is delivered, and the release ball itself completely disintegrates within 7 days. The application of the above-mentioned release ball inner core not only shortens the insertion operation time of the digestive tract sleeve, but also enables the digestive tract sleeve to quickly play its role in treating obesity and type 2 diabetes, thereby greatly reducing the risk of intestinal stenosis and intestinal obstruction.

[0070] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A degradable material for the digestive tract, characterized in that: Its main component is a polymer containing glycolide.

2. The degradable material for the digestive tract according to claim 1, characterized in that: The polymer containing glycolide components includes at least one of a blend of polyglycolide and polyvinyl alcohol, a poly(glycolide-D,L-lactide)-polyethylene glycol copolymer, and a blend of poly(glycolide-D,L-lactide)-polyethylene glycol copolymer and polyvinyl alcohol.

3. The degradable material for the digestive tract according to claim 2, characterized in that: In the polyglycolide and polyvinyl alcohol blend, the intrinsic viscosity of the polyglycolide is 1.2dl / g-2.0dl / g; the molecular weight of the polyvinyl alcohol is 50000-100000g / mol, and the alcoholysis degree is 70%-99%; and the mixing mass ratio of the polyglycolide to the polyvinyl alcohol is 80:20-40:

60.

4. The degradable material for the digestive tract according to claim 2, characterized in that: In the poly(glycolide-D,L-lactide)-polyethylene glycol copolymer, the molar ratio of glycolide to D,L-lactide is 90:10-50:50, the molecular weight of the polyethylene glycol is 4000-8000 g / mol, and the copolymerization molar ratio of the poly(glycolide-D,L-lactide) and the polyethylene glycol is 96:4-90:

10.

5. The degradable material for the digestive tract according to claim 2, characterized in that: In the blend of the poly(glycolide-D,L-lactide)-polyethylene glycol copolymer and the polyvinyl alcohol, the mixing mass ratio of the poly(glycolide-D,L-lactide)-polyethylene glycol copolymer to the polyvinyl alcohol is 80:20-40:

60.

6. A method for preparing a degradable material for the digestive tract according to any one of claims 1 to 5, characterized in that: It includes: The polymer containing glycolide component is processed by injection molding to prepare a degradable material for the digestive tract.

7. The preparation method according to claim 6, characterized in that: During the preparation of the polyglycolide and polyvinyl alcohol blend or the blend of the poly(glycolide-D,L-lactide)-polyethylene glycol copolymer and polyvinyl alcohol, a crosslinking agent 4,4-diaminodiphenylmethane tetraglycidylamine (TGDDM) is added.

8. The preparation method according to claim 7, characterized in that: The preparation of the polyglycolide and polyvinyl alcohol blend or the blend of the poly(glycolide-D,L-lactide)-polyethylene glycol copolymer and polyvinyl alcohol comprises the following steps: after mixing the raw materials, adding a crosslinking agent 4,4-diaminodiphenylmethane tetraglycidylamine (TGDDM), or adding a crosslinking agent 4,4-diaminodiphenylmethane tetraglycidylamine (TGDDM) and a grafting agent bis(2-hydroxyethyl)amino-tris(hydroxymethyl)methane (BIS-TRIS) to perform blending and crosslinking to obtain a dynamically crosslinked blend; Preferably, the raw materials are poured into an internal mixer or a torque rheometer and mixed at 30-50° C. above the melting point for 5-15 minutes, and then 0.5%-3% of 4,4-diaminodiphenylmethane tetraglycidylamine (TGDDM) accounting for the total weight of the raw materials is added, and the mixing is continued for 3-10 minutes, and then extruded to obtain a dynamically crosslinked blend; Preferably, the raw materials are poured into an internal mixer or a torque rheometer and mixed at 30-50° C. above the melting point for 5-15 minutes, and then 1%-4% of bis(2-hydroxyethyl)amino-tris(hydroxymethyl)methane (BIS-TRIS) is added and mixed for 3-10 minutes, and finally 0.5%-3% of 4,4-diaminodiphenylmethane tetraglycidylamine (TGDDM) accounting for the total mass of the raw materials is added, and the mixture is continued to be mixed for 3-10 minutes, and then extruded to obtain a dynamically cross-linked blend.

9. Use of the degradable material for the digestive tract according to any one of claims 1 to 5 or the degradable material for the digestive tract prepared by the preparation method according to any one of claims 6 to 8 in the preparation of digestive tract implantable medical devices.

10. The use according to claim 9, characterized in that: The digestive tract implant medical device also contains a developing filler, which includes at least one of barium sulfate, tungsten powder and bismuth dioxide, and the mass of the developing filler accounts for 10-40% of the total mass.

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