Degradable medical elastomer material and application thereof

A technology of elastomer material and composite material, used in stent for pancreatic duct drainage, degradable elastomer material and its application in the fields of ureter, bile duct, and biomedical materials, which can solve the limitation, the degradation speed of the elastomer is fast, and the drainage time cannot be reached. and other problems to achieve the effect of ensuring no breakage, reliable fixing effect and stable size

Pending Publication Date: 2021-03-19
ZHEJIANG ZHONGZAI MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, glycolide is a fast-degrading chain structure unit, which makes the degradation rate of the elastomer too fast and limits its application, and cannot meet the clinically required 2-8 week drainage time.
[0010] Therefore, the degradable ureteral stent obtained in the prior art cannot simultaneously take into account the controllability of its degradation rate, mechanical strength and dimensional stability after molding

Method used

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  • Degradable medical elastomer material and application thereof
  • Degradable medical elastomer material and application thereof
  • Degradable medical elastomer material and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] The preparation of embodiment 1 L-lactide / ε-caprolactone copolymer

[0045] 540 grams of recrystallization and purification of L-lactide (LLA) and 500 grams of ε-caprolactone monomer (CL) of vacuum dehydration and purification are placed in a 5000ml reactor, and then 0.015% stannous octoate catalyst is added , Polymerized at 150°C for 24 hours under the protection of nitrogen to obtain L-lactide / ε-caprolactone copolymer. The copolymer was dissolved in dichloromethane, precipitated with ethanol, and the precipitate was dried in a vacuum dryer at 60° C. for 48 hours to obtain L-lactide / ε-caprolactone copolymer 1 (PLC1). The product is made into a chloroform solution with a concentration of 0.1% by weight, and its intrinsic viscosity is tested at 30° C. with an Ubbelohde viscometer; 1 The ratio of L-lactide and ε-caprolactone segments is determined by H spectrum; the above materials are made into dumbbell strips with a thickness of 1mm or 2mm on a flat vulcanizing machine...

Embodiment 2

[0050] The preparation of embodiment 2 glycolide / ε-caprolactone copolymer

[0051] The glycolide monomer (GA) of 540 grams of recrystallization purification treatment and the 480 grams of epsilon-caprolactone monomer (CL) of vacuum dehydration purification treatment are placed in 3000ml reactor, add the stannous octoate catalyst of 0.02% again , under the protection of nitrogen, raise the temperature of the system to 150°C, react for 1 hour, then raise the temperature to 180°C and react for 12 hours, transfer the polymer out of the reactor, further crush it into particles smaller than 3mm, put it into 90 ℃ in a vacuum oven for 50 hours to remove unreacted monomers to obtain glycolide / ε-caprolactone copolymer 1 (PGC1). The product was made into a 0.1% by weight hexafluoroisopropanol solution, and its intrinsic viscosity was tested at 30°C with a Ubbelohde viscometer; with hexafluoroisopropanol as a solvent, the 1 The ratio of glycolide and ε-caprolactone segments is determined...

Embodiment 3

[0056] Example 3 Preparation of L-lactide / ε-caprolactone copolymer and glycolide / ε-caprolactone copolymer composite (PLC / PGC)

[0057] Dissolve 300 grams of the above-mentioned L-lactide / ε-caprolactone copolymer 1 (PLC1) and 100 grams of glycolide / ε-caprolactone copolymer (PGC1) in methylene chloride solution, stir and mix evenly , and then mixed the blended polymer solution with ethanol as a precipitating agent, washed the precipitated polymer, and vacuum-dried at 60° C. for 48 hours to obtain the PLC / PGC composite material 1 of the present invention. The above materials are made into dumbbell strips at 140°C-170°C on a flat vulcanizing machine by means of thermocompression molding. According to the method of Example 1, the tensile strength, elongation at break, Shore hardness A value and strength maintenance time of the composite material were tested. The preparation of the PLC / PGC composite material can also be realized by the following method.

[0058] The L-lactide / ε-ca...

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Abstract

The invention provides a degradable elastomer material and application of the degradable elastomer material to preparation of degradable medical pipes for drainage of human body duct tissue. The degradable elastomer material comprises degradable medical pipes for drainage of ureters, biliary tracts and pancreatic ducts. The adopted material is a composite material formed by two elastomers with different degradation speeds, the material with a lower degradation speed is an L-lactide / epsilon-caprolactone copolymer, and the material with a higher degradation speed is a glycolide / epsilon-caprolactone copolymer. The degradable ureteral stent prepared from the composite material has the advantages of higher tensile strength, controllable degradation time, more stable size after molding, excellent resilience and the like, can meet the degradation speed requirements required by different clinical indications, and can achieve better mechanical properties. The composite elastomer material can also be blended with a medical developer, a processing aid and the like, and a degradable medical tubular object is obtained through extrusion molding.

Description

technical field [0001] The invention belongs to the field of biomedical materials, and in particular relates to a degradable elastomer material and its application in the fields of ureter, biliary tract, pancreatic duct drainage stent and the like. Background technique [0002] Ureteral stents are widely used in urological surgery. They are suitable for upper urinary tract surgery, lithotripsy, and dilation of ureteral stenosis. After implanted in the ureter, they can play an important role in draining urine and preventing ureteral stenosis. . The ureteral stent currently used clinically is a tubular structure with elasticity and certain strength, and the two ends or one end are curled into a coil shape (double pigtail catheter, or D-J tube; single J tube). During the operation, it is implanted into the ureter connecting the kidney and the bladder. The upper curled part is hung on the renal pelvis for fixation, and the lower curled part enters the bladder for fixation. Usu...

Claims

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Application Information

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IPC IPC(8): C08L67/04C08K3/30C08G63/08C08G63/78C08G63/85
CPCC08L67/04C08G63/08C08G63/78C08G63/823C08G63/85C08L2201/06C08L2203/02C08L2203/18C08L2205/025C08K2003/3045C08K3/30
Inventor 包一红包一良朱晓珍周侗吴启岸徐秀忠
Owner ZHEJIANG ZHONGZAI MEDICAL TECH CO LTD
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