The in vivo thrombosis evaluation for the biodegradable polymer stent.
10.7507/1001-5515.201707052
- Author:
Liping ZHENG
1
;
Lifang JIA
1
;
Tun YUAN
2
,
3
;
Jie LIANG
2
,
4
Author Information
1. Sichuan Testing Center for Biomaterials and Medical Devices, Chengdu 610063, P.R.China.
2. Sichuan Testing Center for Biomaterials and Medical Devices, Chengdu 610063, P.R.China
3. National Engineering Research Center for Biomaterials, Sichuan University, Chengdu 610063, P.R.China.
4. National Engineering Research Center for Biomaterials, Sichuan University, Chengdu 610063, P.R.China.Jie_L88@126.com.
- Publication Type:Journal Article
- Keywords:
GB/T 16886.4;
biodegradable intravascular stent;
biological evaluation;
coronary stent;
in vivo thrombus formation experiment
- MeSH:
Absorbable Implants;
adverse effects;
Animals;
Drug-Eluting Stents;
adverse effects;
Polymers;
Swine;
Thrombosis;
etiology;
Tomography, Optical Coherence;
Treatment Outcome
- From:
Journal of Biomedical Engineering
2019;36(2):232-237
- CountryChina
- Language:Chinese
-
Abstract:
New biodegradable intravascular stent can reduce risk of foreign bodies retained, thus, it is widely concerned and some of the products have been introduced into the clinic. However, the characteristic of biodegradable may lead to more safety concerns associated with thrombosis. To ensure the safety, the thrombus formation experiment needs to be carefully designed and evaluated based on GB/T 16886.4 standard, but current standard do not provide explicit testing and evaluating methods. Establishing animal model with experimental pigs, the study compares biodegradable coronary stents and metal stents by simulating clinical implantation on the thrombus formation in the implanting process, and after the short-term and long-term implantation. The evaluation methods include gross observation, digital subtraction angiography intraoperative analysis, optical coherence tomography analysis, scanning electron microscopy and so on. The results show that combining these methods could comprehensively evaluate the whole process of the thrombus formation from the beginning of implantation to the end of preclinical animal experiments, so that, it may better predict the clinical thrombosis risk, and the selection of the control was very important. The study tries to use the comparison examples of thrombosis on the new medical instrument to provide the clue for thrombosis evaluation on similar instruments and show the methodology on the preclinical evaluation.
