Hydrogel composition for gastrointestinal submucosal injection and application of hydrogel composition

Abstract

The invention belongs to the fields of high polymer materials and mechanical instruments and relates to a hydrogel composition for gastrointestinal submucosal injection and an application of the hydrogel composition. The hydrogel composition provided by the invention is composed of a mixture, a solvent and a color indicator, wherein the mixture is composed of two or more segmented copolymers; water is taken as a main body by the solvent; a water solution of the hydrogel composition has thermotropic gelatinization property; a polymer mixture can be dissolved in water at a room temperature or a low temperature to form a low-viscosity solution; the water solution of the mixture can be subjected to reversible sol-gel transition along with temperature rise. The hydrogel composition material provided by the invention can be applied to preparation of the composition material for endoscopic submucosal dissection and is capable of reducing complications such as perforation and bleeding in an ESD operation when applied to ESD; the operation safety is improved; the operation difficulty is reduced; the time required for finishing operation is shortened; and convenience is provided for ESD diagnosis and treatment of cancers such as colon cancer and rectal cancer.

Description

technical field

[0001] The invention belongs to the field of polymer materials and medical devices, and in particular relates to a novel hydrogel composition material for submucosal injection of the digestive tract and its application, especially in the preparation of composition materials for endoscopic submucosal dissection application. Background technique

[0002] According to reports, affected by factors such as eating habits, gastric cancer is one of the most common malignant tumors in Orientals. In Japan, nearly 50,000 people die from gastric cancer every year, accounting for a quarter of cancer deaths in Japan. In my country, the morbidity and mortality of gastric cancer remain high, and surgical resection is currently the main method for the treatment of gastric cancer.

[0003] According to the development stage of gastric cancer, gastric cancer is divided into early gastric cancer and advanced gastric cancer. Among them, the 5-year survival rate of advanced gas...

Examples

Embodiment 1

[0075] Add 30g PEG1500 into a 250ml four-neck bottle, heat the oil bath to 140°C under vacuum to melt the PEG, and stir for 2 hours to remove a small amount of water contained in the PEG. Lower the temperature of the oil bath to 85°C, and add 45 g of DL-lactide (LA) and glycolide (GA) at a molar ratio of 8:1 to the four-necked flask under an argon atmosphere, and add 0.1 wt % stannous octoate (containing a small amount of toluene) as a catalyst. The reaction was stirred at 150° C. for 12 hours while maintaining an argon atmosphere. After the reaction was completed, vacuum was applied at 120° C. for 3 hours to remove unreacted monomers and low-boiling components. Pour the crude product from the four-necked bottle into water several times its weight while it is hot, wash at 80°C and wait for the polymer to fully settle, pour off the upper water layer, repeat several times, and then freeze-dry to remove residual water. The yield is about 75wt%. The number average molecular wei...

Embodiment 2

[0077] Take 12.5g PEG5000 and dissolve in 120mL toluene, distill to 50mL to remove the residual water in the polymer. Add 5g of caprolactone (CL) and 0.2wt% stannous octoate as a catalyst, and reflux at 120°C for 24h. Then ether was added to the above solution, and the initial product was obtained by precipitation. The obtained primary product was dissolved in 30 mL of dichloromethane, ether was slowly added to precipitate it, and the residual solvent in the product was removed by vacuuming to obtain a PCL-PEG-PCL triblock copolymer material with a yield of about 80%. The number average molecular weight and weight average molecular weight of the BAB triblock copolymer PCL-PEG-PCL (Polymer-8) measured by gel permeation chromatography (GPC) (using polystyrene as a standard sample) are 8230 and 9710 respectively , Molecular weight distribution coefficient Mw / Mn is 1.18. This copolymer (Polymer-8) can be dissolved in water, but the sol-gel transition cannot occur with the increa...

Embodiment 3

[0079] Add 20g of PEG1000 into a 250ml four-neck bottle, heat the oil bath to 140°C under vacuum to melt the PEG, and stir for 2 hours to remove a small amount of water contained in the PEG. Lower the temperature of the oil bath to 85°C, under an argon atmosphere, add a total of 57 g of DL-lactide (LA) and glycolide (GA) at a molar ratio of 8:1, and add 0.1 wt % stannous octoate (containing a small amount of toluene) as a catalyst. The reaction was stirred at 150° C. for 12 hours while maintaining an argon atmosphere. After the reaction was completed, vacuum was applied at 120° C. for 3 hours to remove unreacted monomers and low-boiling components. Pour the crude product from the four-necked bottle into water several times its weight while it is hot, wash at 80°C and wait for the polymer to fully settle, pour off the upper water layer, repeat several times, and then freeze-dry to remove residual water. The yield is about 85wt%. The number average molecular weight and weight...

technical field

[0001] The invention belongs to the field of polymer materials and medical devices, and in particular relates to a novel hydrogel composition material for submucosal injection of the digestive tract and its application, especially in the preparation of composition materials for endoscopic submucosal dissection application. Background technique

[0002] According to reports, affected by factors such as eating habits, gastric cancer is one of the most common malignant tumors in Orientals. In Japan, nearly 50,000 people die from gastric cancer every year, accounting for a quarter of cancer deaths in Japan. In my country, the morbidity and mortality of gastric cancer remain high, and surgical resection is currently the main method for the treatment of gastric cancer.

[0003] According to the development stage of gastric cancer, gastric cancer is divided into early gastric cancer and advanced gastric cancer. Among them, the 5-year survival rate of advanced gas...

Examples

Embodiment 1

[0075] Add 30g PEG1500 into a 250ml four-neck bottle, heat the oil bath to 140°C under vacuum to melt the PEG, and stir for 2 hours to remove a small amount of water contained in the PEG. Lower the temperature of the oil bath to 85°C, and add 45 g of DL-lactide (LA) and glycolide (GA) at a molar ratio of 8:1 to the four-necked flask under an argon atmosphere, and add 0.1 wt % stannous octoate (containing a small amount of toluene) as a catalyst. The reaction was stirred at 150° C. for 12 hours while maintaining an argon atmosphere. After the reaction was completed, vacuum was applied at 120° C. for 3 hours to remove unreacted monomers and low-boiling components. Pour the crude product from the four-necked bottle into water several times its weight while it is hot, wash at 80°C and wait for the polymer to fully settle, pour off the upper water layer, repeat several times, and then freeze-dry to remove residual water. The yield is about 75wt%. The number average molecular wei...

Embodiment 2

[0077] Take 12.5g PEG5000 and dissolve in 120mL toluene, distill to 50mL to remove the residual water in the polymer. Add 5g of caprolactone (CL) and 0.2wt% stannous octoate as a catalyst, and reflux at 120°C for 24h. Then ether was added to the above solution, and the initial product was obtained by precipitation. The obtained primary product was dissolved in 30 mL of dichloromethane, ether was slowly added to precipitate it, and the residual solvent in the product was removed by vacuuming to obtain a PCL-PEG-PCL triblock copolymer material with a yield of about 80%. The number average molecular weight and weight average molecular weight of the BAB triblock copolymer PCL-PEG-PCL (Polymer-8) measured by gel permeation chromatography (GPC) (using polystyrene as a standard sample) are 8230 and 9710 respectively , Molecular weight distribution coefficient Mw / Mn is 1.18. This copolymer (Polymer-8) can be dissolved in water, but the sol-gel transition cannot occur with the increa...

Embodiment 3

[0079] Add 20g of PEG1000 into a 250ml four-neck bottle, heat the oil bath to 140°C under vacuum to melt the PEG, and stir for 2 hours to remove a small amount of water contained in the PEG. Lower the temperature of the oil bath to 85°C, under an argon atmosphere, add a total of 57 g of DL-lactide (LA) and glycolide (GA) at a molar ratio of 8:1, and add 0.1 wt % stannous octoate (containing a small amount of toluene) as a catalyst. The reaction was stirred at 150° C. for 12 hours while maintaining an argon atmosphere. After the reaction was completed, vacuum was applied at 120° C. for 3 hours to remove unreacted monomers and low-boiling components. Pour the crude product from the four-necked bottle into water several times its weight while it is hot, wash at 80°C and wait for the polymer to fully settle, pour off the upper water layer, repeat several times, and then freeze-dry to remove residual water. The yield is about 85wt%. The number average molecular weight and weight...

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