Extendable digestive tract cannula and use thereof

Abstract

An extendable digestive tract cannula (100) and a use thereof, relating to the technical field of medical devices. The extendable digestive tract cannula (100) comprises a first cannula (110), a second cannula (120) and a degrading material (130). The first cannula (110) has two opposite ends, namely a proximal end and a distal end, the first cannula (110) and the second cannula (120) are sleeved, and a double-layer structure is formed at the distal end of the first cannula (110). The double-layer structure is fixed by means of the degrading material (130). When the degrading material (130) is degraded, the second cannula (120) moves toward an end surface of the distal end of the first cannula (110). By means of providing the movable second cannula (120), after the degrading material (130) is degraded, the second cannula (120) moves backward, thereby achieving the purpose of extending the digestive tract cannula (100). As the length of the digestive tract cannula (100) increases, the area preventing intestinal absorption also increases, which weakens the intestinal compensatory absorption function at a distal end of the digestive tract cannula (100), improves the isolation effect between chyme and the intestine, and can reduce the digestion and absorption effect of the intestine for a relatively long time.

Description

Extendable digestive tract cannula and its application

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This disclosure claims priority to application number 2023111596845 filed with the China Patent Office on September 8, 2023, entitled “Extendable digestive tract sleeve and its application,” the entire contents of which are incorporated by reference into this disclosure. Technical Field

[0003] The present disclosure relates to the technical field of medical devices, and in particular to an extendable digestive tract sleeve and applications thereof. Background Art

[0004] As living standards improve, obesity rates are also increasing year by year. Currently, global obesity costs approximately 2.8% of global GDP annually, confirming the fact that the number of obese people is increasing year by year. According to statistics, approximately 80-90% of obese people have type 2 diabetes, the most common type of diabetes, accounting for approximately 90% of all diabetes cases worldwide. Diabetes has become the third most common non-communicable disease after cardiovascular disease and cancer, with the number of people suffering from it increasing year by year, making it a global public health issue threatening human health.

[0005] At present, the pathogenesis of type 2 diabetes is still not fully understood. Even with existing oral medications and insulin treatment, some patients still have poor blood sugar control, and there are also cases of complications occurring and developing. Bariatric surgery has a good effect on the above diseases, but there are irreversible physiological trauma changes and a certain mortality rate and postoperative complications, such as gastrointestinal leakage, anastomotic stenosis or dumping syndrome. At present, the duodenal jejunal cannula has been developed by drawing on the principles of gastric bypass surgery. It inserts a cannula into the duodenum and proximal jejunum to isolate the contact between chyme and the intestinal wall. After the ingested nutrients enter the stomach, they pass through the cannula into the proximal jejunum; pancreatic juice and bile are naturally secreted, flow downward between the cannula and the intestinal wall, and mix with chyme in the distal end of the duodenal jejunal cannula (i.e., the jejunum) to reduce absorption and achieve the purpose of treating obesity and type 2 diabetes.

[0006] However, as the research gradually deepened, we found that the insertion of the digestive tract sleeve can reduce the intestinal absorption of food in the short term, but as time goes on, the intestinal absorption of food increases again, and it is impossible to achieve a more lasting effect of reducing intestinal digestion and absorption.

[0007] In view of this, the present disclosure is proposed.

[0008] Summary of the Invention

[0009] The purpose of the present disclosure is to provide an extendable digestive tract sleeve and its application, which can achieve controllable extension of the digestive tract sleeve, weaken the intestinal compensatory absorption function at the distal end of the digestive tract sleeve, and improve the isolation effect between chyme and the intestine.

[0010] The embodiments of the present disclosure are implemented as follows:

[0011] In a first aspect, the present disclosure provides an extendable digestive tract sleeve, comprising a first sleeve, a second sleeve, and a degradable material. The first sleeve has two opposite ends, a proximal end, and a distal end, respectively. The first sleeve is sleeved with the second sleeve, and a double-layer structure is formed at the distal end of the first sleeve. The double-layer structure is fixed by the degradable material. When the degradable material degrades, the second sleeve moves toward the end face of the distal end of the first sleeve.

[0012] In an optional embodiment, the degradation time of the degradable material is ≥30 days.

[0013] Preferably, the degradation time of the degradable material is 60 to 90 days.

[0014] Preferably, the connection force between the degradation material and the first sleeve is ≥2.5N; more preferably, the connection force between the degradation material and the first sleeve is ≥10N.

[0015] Preferably, the degradation material is an annular diaphragm, and the thickness of the annular diaphragm is 0.01 to 0.06 mm.

[0016] In an alternative embodiment, the degradable material comprises at least one of polylactide and polyglycolide.

[0017] Preferably, the degradable material comprises one or more of poly (DL-lactide-glycolide), polyglycolide-polycaprolactone, poly (L-lactide-co-ε-caprolactone), poly (L-lactic acid) or poly (L-lactic acid-trimethylchitosan).

[0018] Preferably, the mass ratio of DL-lactide to glycolide in poly(DL-lactide-glycolide) is 0.8-1.2:0.8-1.2; the mass ratio of polyglycolide to polycaprolactone in polyglycolide-polycaprolactone is 7-8:2-3; the mass ratio of L-lactide to ε-caprolactone in poly(L-lactide-co-ε-caprolactone) is 6.5-7.5:2.5-3.5; the mass ratio of poly-L-lactic acid and trimethyl chitosan in poly-L-lactic acid-trimethyl chitosan is 6.5-7.5:2.5-3.5.

[0019] In an alternative embodiment, the degradable material is connected to the first sleeve by calendaring or RF welding.

[0020] In an optional embodiment, the first sleeve and the second sleeve are formed by folding a tube or welding two tubes, and the welding point of the two tubes is the distal end of the first sleeve.

[0021] Preferably, the second sleeve is located within the first sleeve.

[0022] In an optional embodiment, after the degradable material is degraded, the length of the second sleeve extending out of the first sleeve is 10 to 30 cm.

[0023] In an optional embodiment, the length of the first sleeve is ≥30 cm, and the length of the second sleeve is 15-80 cm.

[0024] In an optional embodiment, the thickness of the first sleeve and the second sleeve are both 0.01-0.03 mm.

[0025] In an optional embodiment, the material of the first sleeve and the second sleeve includes at least one of polytetrafluoroethylene, fluorinated ethylene propylene copolymer, expanded polytetrafluoroethylene, polyurethane, low-density polyethylene or linear low-density polyethylene.

[0026] In a second aspect, the present disclosure provides a use of an extendable digestive tract sleeve according to any one of the aforementioned embodiments in a product for reducing digestive tract absorption.

[0027] The beneficial effects of the embodiments of the present disclosure are:

[0028] The present disclosure provides an extendable digestive tract sleeve and its application. By providing a movable second sleeve, the second sleeve moves backward after the degradable material is degraded, thereby achieving the purpose of extending the digestive tract sleeve. As the length of the digestive tract sleeve increases, the area to avoid intestinal absorption is also increased, the compensatory absorption function of the intestine at the distal end of the digestive tract sleeve is weakened, the isolation effect between chyme and the intestine is improved, and the effect of intestinal digestion and absorption can be reduced for a relatively long time. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, 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 disclosure 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 creative work.

[0030] FIG1 is a schematic structural diagram of an extendable digestive tract cannula provided in an embodiment of the present disclosure;

[0031] FIG2 is a schematic diagram of the structure of the extendable digestive tract sleeve provided in an embodiment of the present disclosure after extension.

[0032] Icons: 100-Extendable digestive tract cannula; 110-First cannula; 120-Second cannula; 130-Degradable material. DETAILED DESCRIPTION

[0033] The embodiments of the present disclosure will be described in detail below with reference to the examples. However, those skilled in the art will appreciate that the following examples are intended only to illustrate the present disclosure and should not be construed as limiting the scope of the present disclosure. Where specific conditions are not specified in the examples, the experiments were performed under conventional conditions or the conditions recommended by the manufacturer. Where the manufacturer of the reagents or instruments is not specified, all are commercially available conventional products.

[0034] The endpoints of the ranges and any values ​​disclosed in this disclosure are not limited to the precise ranges or values, and these ranges or values ​​should be understood to include values ​​close to these ranges or values. For numerical ranges, the endpoints of each range, the endpoints of each range and individual point values, and the individual point values ​​can be combined with each other to obtain one or more new numerical ranges, and these numerical ranges should be considered to be specifically disclosed herein.

[0035] 1 and 2 , the present disclosure provides an extendable digestive tract sleeve 100, comprising a first sleeve 110, a second sleeve 120, and a degradable material 130. The first sleeve 110 has a proximal end and a distal end at opposite ends, respectively. The first sleeve 110 and the second sleeve 120 are sleeved together, forming a double-layer structure at the distal end of the first sleeve 110. The double-layer structure is secured by the degradable material 130. The degradable material 130 has degradable properties after the digestive tract sleeve has been used for a period of time. When the degradable material 130 degrades, the second sleeve 120 moves toward the distal end of the first sleeve 110.

[0036] Currently, the method of inserting a gastrointestinal cannula can reduce the intestinal wall's absorption of food, achieving the effect of weight loss or lowering blood sugar. However, as the gastrointestinal cannula is placed for a longer time, the jejunum at the distal end of the cannula will gradually form compensation, such as the intestinal mucosal villi becoming longer, the folds increasing, the intestinal glands deepening, the intestinal tube becoming thicker or longer, and the intestinal wall thickening. These compensatory phenomena increase the intestinal absorption capacity of food, thereby affecting changes in body weight and metabolism. Therefore, the inventors creatively proposed an extendable gastrointestinal cannula. By providing a second cannula 120, when the degradable material 130 degrades, the second cannula 120 will move away from the stomach with the peristalsis of the intestine, thereby achieving the purpose of extending the gastrointestinal cannula. The length of the gastrointestinal cannula is extended, which weakens the compensatory absorption function of the intestine at the distal end of the gastrointestinal cannula, improves the isolation effect between chyme and the intestine, and further reduces the digestion and absorption of food by the intestine.

[0037] In an optional embodiment, ideally, the second sleeve 120 should be extended after the first sleeve 110 reduces the digestion and absorption effect, that is, when the intestinal wall at the distal end of the original digestive tract sleeve begins to compensate for absorption, so as to achieve the effect of reducing digestion and absorption again. Therefore, it is necessary to control the degradation time of the degradable material 130 to be ≥30 days to ensure that the first sleeve 110 can fully play its role.

[0038] Preferably, in order to ensure that the first sleeve 110 can fully exert its effect of reducing intestinal digestion and absorption, the degradation time of the degradable material 130 is 60 to 90 days.

[0039] Preferably, in order to ensure that the degradable material 130 can be degraded according to the above time so that the second sleeve 120 can be smoothly extended, it is necessary to ensure that the connection force between the degradable material 130 and the first sleeve 110 is ≥2.5N; more preferably, the connection force between the degradable material 130 and the first sleeve 110 is ≥10N.

[0040] Preferably, the degradation material 130 is an annular diaphragm. To ensure that the degradation material 130 can be degraded according to the above time so that the second sleeve 120 can be smoothly extended, the thickness of the annular diaphragm is 0.01-0.06 mm.

[0041] In an optional embodiment, in order to ensure that the second sleeve 120 can extend out of the first sleeve 110 within a fixed time, the selection of the degradable material 130 is one of the key influencing factors.

[0042] Preferably, the degradable material 130 includes at least one of polylactide and polyglycolide.

[0043] Preferably, the degradable material 130 includes one or more of poly(DL-lactide-glycolide), polyglycolide-polycaprolactone, poly(L-lactide-co-ε-caprolactone), poly(L-lactic acid), or poly(L-lactic acid-trimethylchitosan).

[0044] Preferably, to ensure the degradation characteristics of the degradable material 130, the ratio of the composite degradable material 130 needs to be controlled. For example, the mass ratio of DL-lactide to glycolide in poly(DL-lactide-glycolide) is 0.8-1.2:0.8-1.2; the mass ratio of polyglycolide to polycaprolactone in polyglycolide-polycaprolactone is 7-8:2-3; the mass ratio of L-lactide to ε-caprolactone in poly(L-lactide-co-ε-caprolactone) is 6.5-7.5:2.5-3.5; and the mass ratio of poly-L-lactic acid to trimethyl chitosan in poly-L-lactic acid-trimethyl chitosan is 6.5-7.5:2.5-3.5. By controlling the ratio of the degradable material 130 within the above range, the prepared degradable material 130 can meet the required connection strength with the first cannula 110.

[0045] In some embodiments, the performance of the degradable material 130 is related to the specific selection of its raw materials. Different raw material selections, or the same raw material selections but different ratios may result in different degradation times for the degradable material 130. For example, when the degradation time of the degradable material 130 is about 1 month, poly (L-lactic acid-trimethyl chitosan) and poly (DL-lactide-glycolide) can be selected as raw materials in a mass ratio of 1 to 2: 8 to 9; when the degradation time of the degradable material 130 is 1 to 2 months, poly (L-lactic acid-trimethyl chitosan) and poly (DL-lactide-glycolide) can be selected as raw materials in a mass ratio of 3 to 7; when the degradation time of the degradable material 130 is about 3 months, Poly (L-lactic acid-trimethyl chitosan) and poly (DL-lactide-glycolide) are used as raw materials in a mass ratio of 1:1. When the degradation time of the degradable material 130 is about 4 months, poly (L-lactide-co-ε-caprolactone) and poly (DL-lactide-glycolide) can be selected as raw materials in a mass ratio of 6-8:2-4, or poly (L-lactic acid-trimethyl chitosan) and poly (DL-lactide-glycolide) can be selected as raw materials in a mass ratio of 6-8:2-4.

[0046] In an optional embodiment, the preparation method of the degradable material 130 includes solvent molding or spinning.

[0047] In an optional embodiment, the degradable material 130 is connected to the first sleeve 110 by calendaring or RF welding.

[0048] In an optional embodiment, the first sleeve 110 and the second sleeve 120 are formed by folding a single tube or welding two tubes, with the welding point being the distal end of the first sleeve 110. When the first sleeve 110 and the second sleeve 120 are formed by folding a single tube, the diameters of the first sleeve 110 and the second sleeve 120 are the same. When the first sleeve 110 and the second sleeve 120 are formed by welding two tubes, the diameters may vary slightly depending on their positions, with the outer sleeve diameter being slightly larger than the inner sleeve diameter. Preferably, to simplify the manufacturing process, the first sleeve 110 and the second sleeve 120 are formed by folding a single tube.

[0049] After the degradable material 130 is degraded, the second sleeve 120 needs to move toward the distal end of the first sleeve 110. In order to facilitate better movement of the second sleeve 120, preferably, the second sleeve 120 is located inside the first sleeve 110. When the degradable material 130 fails, the second sleeve 120 can be flipped inside the first sleeve 110 under the push of the chyme and move toward the distal end of the first sleeve 110 without being hindered by the wall of the digestive tract.

[0050] Preferably, the second sleeve 120 moves toward the distal end by translation or flipping, more preferably by flipping, and more preferably, flipping into the digestive tract sleeve.

[0051] In an optional embodiment, after the degradable material 130 is degraded, the second sleeve 120 extends out of the first sleeve 110 by a length of 10 to 30 cm.

[0052] In an optional embodiment, the length of the first sleeve 110 is ≥30 cm, and the length of the second sleeve 120 is 15-80 cm.

[0053] In an optional embodiment, the thickness of the first sleeve 110 and the second sleeve 120 are both 0.01 to 0.03 mm. The thickness of the first sleeve 110 and the second sleeve 120 can be the same or different, as long as they are both within the above range.

[0054] Preferably, in order to better flip the second sleeve 120 , the length of the second sleeve 120 is shorter than that of the first sleeve 110 .

[0055] In an optional embodiment, the material of the first and second sleeves 110 and 120 includes at least one of polytetrafluoroethylene (PTFE), fluorinated ethylene propylene copolymer (FEP), expanded polytetrafluoroethylene (ePTFE), polyurethane (PU), low-density polyethylene (LDPELLDPE), or linear low-density polyethylene (LLDPE). The aforementioned materials of the first and second sleeves 110 and 120 complement the material of the degradable material 130 to ensure smooth extension of the second sleeve 120.

[0056] In a second aspect, the present disclosure provides a use of the extendable digestive tract sleeve 100 according to any one of the aforementioned embodiments in a product for reducing digestive tract absorption.

[0057] Example 1

[0058] This embodiment provides an extendable digestive tract cannula 100, comprising a first cannula 110, a second cannula 120, and a degradable material 130. The first cannula 110 has a proximal end and a distal end, respectively. The first cannula 110 and the second cannula 120 are secured together by the degradable material 130, forming a double-layer structure at the distal end of the first cannula 110. The degradable material 130 degrades after the cannula has been used for a period of time. Once the degradable material 130 degrades, the second cannula 120 moves distally.

[0059] In this embodiment, the first and second sleeves 110, 120 are formed by folding a single tube, with the second sleeve 120 positioned within the first sleeve 110. When the degradable material 130 loses its effectiveness, the second sleeve 120 folds toward the digestive tract sleeve lumen and, propelled by chyme, moves toward the distal end of the first sleeve 110, completing the extension of the digestive tract sleeve. Therefore, the first and second sleeves 110, 120 have the same diameter of 25 mm.

[0060] In this embodiment, the first sleeve 110 is made of low-density polyethylene, has a length of 30 cm, and a thickness of 0.02 mm; the second sleeve 120 is made of low-density polyethylene, has a length of 15 cm, and a thickness of 0.02 mm.

[0061] In this embodiment, the degradable material 130 is a mixture of poly(L-lactide-co-ε-caprolactone) and poly(DL-lactide-glycolide) in a ratio of 8:2. The mass ratio of lactide to caprolactone in poly(L-lactide-co-ε-caprolactone) is 7:3, while the mass ratio of lactide to glycolide in poly(DL-lactide-glycolide) is 1:1.

[0062] The degradable material 130 is prepared by solution molding to form an annular diaphragm, which is connected to the first sleeve 110 by laser welding. In this embodiment, the thickness of the annular diaphragm is 0.03 mm.

[0063] Example 2

[0064] This embodiment provides an extendable digestive tract cannula 100 , which has the same structure as that of embodiment 1. The only differences are: 1. The length of the first cannula 110 is 40 cm; the length of the second cannula 120 is 20 cm.

[0065] 2. Different ratios of degradation materials: The mass ratio of poly(L-lactide-co-ε-caprolactone) to poly(DL-lactide-glycolide) in the degradation material of this embodiment is 1:1.

[0066] Example 3

[0067] This embodiment provides an extendable digestive tract cannula 100, comprising a first cannula 110, a second cannula 120, and a degradable material 130. The first cannula 110 has a proximal end and a distal end, respectively. The first cannula 110 and the second cannula 120 are secured together by the degradable material 130, forming a double-layer structure at the distal end of the first cannula 110. The degradable material 130 degrades after the cannula has been used for a period of time. Once the degradable material 130 degrades, the second cannula 120 moves distally.

[0068] In this embodiment, the first sleeve 110 and the second sleeve 120 are formed by welding two tubes. The weld point is at the distal end of the first sleeve 110, and the second sleeve 120 is located within the first sleeve 110. When the degradable material 130 loses its effectiveness, the second sleeve 120 folds into the digestive tract sleeve and, driven by the chyme, extends toward the distal end of the first sleeve 110. Because the weld point secures the first and second sleeves 110, the second sleeve 120 will not separate from the first sleeve 110 even after extension.

[0069] The thickness of the second sleeve 120 of the first sleeve 110 is 0.01 to 0.03 mm. Since the second sleeve 120 is inserted into the surface of the first sleeve 110, the diameter of the second sleeve 120 must be larger than that of the first sleeve 110. To ensure that the second sleeve 120 extends smoothly and does not extend beyond the first sleeve 110, the diameter of the second sleeve 120 is larger than that of the first sleeve 110.

[0070] In this embodiment, the material of the first sleeve 110 is expanded polytetrafluoroethylene / polyperfluoroethylene propylene composite, with a length of 50 cm, a thickness of 0.013 mm, and a diameter of 23 mm; the material of the second sleeve 120 is expanded polytetrafluoroethylene / polyperfluoroethylene propylene composite, with a length of 25 cm, a thickness of 0.013 mm, and a diameter of 25 mm.

[0071] In this embodiment, the degradable material 130 is poly-L-lactic acid-trimethyl chitosan, wherein the mass ratio of poly-L-lactic acid to trimethyl chitosan is 7:3.

[0072] The degradable material 130 is prepared by solution molding and connected to the first sleeve 110 by RF welding.

[0073] Example 4

[0074] This embodiment provides an extendable digestive tract cannula 100, whose structure is identical to that of Example 3. The only differences are: 1. The length of the first cannula 110 is 40 cm; the length of the second cannula 120 is 20 cm. Both the first and second cannula 110, 120 have a diameter of 25 mm and a thickness of 0.03 mm. Both the first and second cannula 110, 120 are made of the same low-density polyethylene.

[0075] 2. Different Degradable Materials: The degradable material in this embodiment is a mixture of poly (L-lactic acid-trimethyl chitosan) and poly (DL-lactide-glycolide) at a mixing ratio of 1:1.

[0076] Example 5

[0077] This embodiment provides an extendable digestive tract cannula 100, which has the same structure as Example 1. The only differences are: 1. The length of the first cannula 110 is 60 cm; the length of the second cannula 120 is 20 cm, and the diameter of the second cannula 120 is 28 mm. Both the first and second cannula 110, 120 are made of linear low-density polyethylene, and are 0.05 mm thick.

[0078] 2. Different ratios of degradation materials: In this embodiment, the mass ratio of poly(L-lactide-co-ε-caprolactone) to poly(DL-lactide-glycolide) in the degradation material is 7:3, and the thickness of the annular diaphragm used as the degradation material is 0.06 mm.

[0079] Example 6

[0080] This embodiment provides an extendable digestive tract cannula 100, which has the same structure as Example 3. The only differences are: 1. The length of the first cannula 110 is 30 cm; the length of the second cannula 120 is 30 cm. The diameters of the first and second cannula 110, 120 are both 25 mm and 0.03 mm thick. The first and second cannula 110, 120 are made of the same material: polyurethane.

[0081] 2. Different Degradable Materials: The degradable material in this embodiment is a mixture of poly (L-lactic acid-trimethyl chitosan) and poly (DL-lactide-glycolide) at a ratio of 2:8, and the annular membrane used as the degradable material has a thickness of 0.04 mm.

[0082] Example 7

[0083] This embodiment provides an extendable digestive tract cannula 100, whose structure is identical to that of Example 1. The only differences are: 1. The length of the first cannula 110 is 70 cm, and the diameter of the first cannula 110 is 20 mm; the length of the second cannula 120 is 30 cm, and the diameter of the second cannula 120 is 23 mm. Both the first and second cannula 110 and 120 are made of a mixture of linear low-density polyethylene and low-density polyethylene in a 1:1 mass ratio, and are 0.015 mm thick.

[0084] 2. Different ratios of degradation materials. The degradation material in this example is a mixture of poly (L-lactic acid-trimethyl chitosan) and poly (DL-lactide-glycolide) in a mass ratio of 3:7. The annular diaphragm used as the degradation material is 0.05 mm thick.

[0085] Example 8

[0086] This embodiment provides an extendable digestive tract cannula 100, whose structure is identical to that of Example 1. The only differences are: 1. The length of the first cannula 110 is 90 cm, and the diameter of the first cannula 110 is 20 mm; the length of the second cannula 120 is 30 cm, and the diameter of the second cannula 120 is 23 mm. Both the first cannula 110 and the second cannula 120 are made of expanded polytetrafluoroethylene / fluoroethylene propylene composite, and are 0.018 mm thick.

[0087] 2. The degradation material is polydioxanone (PDO), and the thickness of the annular diaphragm used as the degradation material is 0.05 mm.

[0088] Comparative Example 1

[0089] This comparative example provides a digestive tract sleeve, which has the same structure as Example 1. The only difference is that the connection between the second sleeve and the first sleeve is made of no degradable material and is directly connected by laser welding.

[0090] Comparative Example 2

[0091] This comparative example provides a digestive tract sleeve, which has the same structure as Example 2. The only difference is that the connection between the second sleeve and the first sleeve is directly connected by laser welding without degradable materials.

[0092] Comparative Example 3

[0093] This comparative example provides a digestive tract sleeve having the same structure as that of Example 3. The only difference is that the connection between the second sleeve and the first sleeve is made of no degradable material and is directly connected by RF welding.

[0094] Comparative Example 4

[0095] This comparative example provides a digestive tract sleeve having the same structure as that of Example 4. The only difference is that the connection between the second sleeve and the first sleeve is made of no degradable material and is directly connected by RF welding.

[0096] Comparative Example 5

[0097] This comparative example provides a digestive tract sleeve, which has the same structure as Example 5. The only difference is that the connection between the second sleeve and the first sleeve is made of no degradable material and is directly connected by laser welding.

[0098] Comparative Example 6

[0099] This comparative example provides a digestive tract sleeve having the same structure as that of Example 6. The only difference is that the connection between the second sleeve and the first sleeve is made of no degradable material and is directly connected by RF welding.

[0100] Comparative Example 7

[0101] This comparative example provides a digestive tract sleeve, which has the same structure as Example 7. The only difference is that the connection between the second sleeve and the first sleeve is made of no degradable material and is directly connected by laser welding.

[0102] Comparative Example 8

[0103] This comparative example provides a digestive tract sleeve having the same structure as that of Example 8. The only difference is that the connection between the second sleeve and the first sleeve is made of no degradable material and is directly connected by laser welding.

[0104] Test Example 1

[0105] The extendable digestive tract sleeves 100 provided in Examples 1 to 8 and Comparative Examples 1 to 8 were tested using the following test methods:

[0106] 1. The extendable digestive tract cannulas 100 prepared in Examples 1-8 and Comparative Examples 1-8 were completely immersed in simulated intestinal fluid (preparation methods were based on the 2022 edition of the Pharmacopoeia of the People's Republic of China). The cannulas were shaken at 40 rpm in a shaker at 37±2°C for varying durations until the set time. The cannulas were then gently removed from the simulated intestinal fluid and the surface liquid was absorbed with absorbent paper. The first cannula was fixed at one end, the distal end of the second cannula was cut, and the extendable portion was fixed to the fixture of a computerized materials testing machine at a set speed of 20 mm / min. The connection force was measured. If the force required to separate the second cannula from the first was less than 1 N, the degradation time was considered reached.

[0107] After the degradation test, the digestive tract cannula was placed in a U-shaped pipe test apparatus and the extension of the second cannula was observed under a transient pressure difference of 30 cmH2O. The extension distance ratio = actual extension distance / theoretical extension distance, resulting in the results shown in Table 1.

[0108] Table 1 Disintegration of degradable materials * Note: The connection force between the degradation material and the first sleeve of Comparative Examples 1 to 8 in Table 1 is the connection force between the second sleeve and the first sleeve.

[0109] As can be seen from Table 1, the degradable material 130 of the extendable digestive tract sleeve 100 provided in the embodiment of the present disclosure has good disintegration ability and can be controlled to disintegrate after 30 days. The longest disintegration time can reach 180 days, which can achieve a better extension effect of the digestive tract sleeve.

[0110] The above are merely preferred embodiments of the present disclosure and are not intended to limit the present disclosure. Those skilled in the art will readily appreciate that various modifications and variations of the present disclosure are possible. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present disclosure shall be included within the scope of protection of the present disclosure. Industrial Applicability

[0111] The present invention can achieve controllable extension of the digestive tract sleeve, weaken the intestinal compensatory absorption function at the distal end of the digestive tract sleeve, and improve the isolation effect between chyme and the intestine, thus having good utilization value.

Claims

1. An extendable digestive tract cannula, characterized in that: The invention comprises a first sleeve, a second sleeve and a degradable material. The two opposite ends of the first sleeve are respectively a proximal end and a distal end. The first sleeve is sleeved with the second sleeve and a double-layer structure is formed at the distal end of the first sleeve. The double-layer structure is fixed by the degradable material. When the degradable material is degraded, the second sleeve moves toward the end surface of the distal end of the first sleeve.

2. The extendable digestive tract sleeve according to claim 1, characterized in that: The degradation time of the degradable material is ≥30 days; Preferably, the degradation time of the degradable material is 60 to 180 days; Preferably, the connection force between the degradable material and the first sleeve is ≥2.5N; more preferably, the connection force between the degradable material and the first sleeve is ≥10N; Preferably, the degradation material is an annular diaphragm, and the thickness of the annular diaphragm is 0.01-0.06 mm.

3. The extendable digestive tract sleeve according to claim 2, characterized in that: The degradable material includes at least one of polylactide and polyglycolide; Preferably, the degradable material comprises one or more of poly (DL-lactide-glycolide), polyglycolide-polycaprolactone, poly (L-lactide-co-ε-caprolactone), poly-L-lactic acid, poly-L-lactic acid-trimethyl chitosan or polydioxanone; Preferably, the mass ratio of DL-lactide to glycolide in the poly(DL-lactide-glycolide) is 0.8-1.2:0.8-1.2; the mass ratio of polyglycolide to polycaprolactone in the polyglycolide-polycaprolactone is 7-8:2-3; the mass ratio of L-lactide to ε-caprolactone in the poly(L-lactide-co-ε-caprolactone) is 6.5-7.5:2.5-3.5; the mass ratio of poly-L-lactic acid and trimethyl chitosan in poly-L-lactic acid-trimethyl chitosan is 6.5-7.5:2.5-3.

5.

4. The extendable digestive tract sleeve according to claim 1, characterized in that: The degradable material is connected to the first sleeve by laser welding or RF welding.

5. The extendable digestive tract sleeve according to claim 1, characterized in that: The first sleeve and the second sleeve are formed by folding a tube or welding two tubes, and the welding point of the two tubes is the distal end of the first sleeve; Preferably, the second sleeve is located inside the first sleeve.

6. The extendable digestive tract sleeve according to claim 1 or 5, characterized in that: After the degradable material is degraded, the second sleeve extends out of the first sleeve by a length of 10 to 30 cm.

7. The extendable digestive tract sleeve according to claim 6, characterized in that: The length of the first sleeve is ≥30 cm, and the length of the second sleeve is 15-80 cm.

8. The extendable digestive tract sleeve according to claim 6, characterized in that: The thickness of the first sleeve and the second sleeve are both 0.01-0.03 mm.

9. The extendable digestive tract sleeve according to claim 6, characterized in that: The materials of the first sleeve and the second sleeve include one or more composites of polytetrafluoroethylene, fluorinated ethylene propylene copolymer, expanded polytetrafluoroethylene, polyperfluoroethylene propylene, polyurethane, low-density polyethylene or linear low-density polyethylene.

10. Use of the extendable digestive tract sleeve according to any one of claims 1 to 9 in a product for reducing digestive tract absorption.

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