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Journal of Materials Science & Technology 2019年第11期35卷 2682-2692页

作者： Xiaochen Zhou Fan Yang Xiaoyan Gong Ming Zhao Yufeng Zheng Zhili Sun Department of Materials Science and Engineering College of EngineeringPeking UniversityBeijing100871China Beijing Percutek Therapeutics Co. LtdBeijing102600China Suzhou Innomed Medical Device Co. LtdSuzhou215123China 1707 Ralston Branch Way Sugar LandTX77479USA State Key Laboratory for Turbulence and Complex System College of EngineeringPeking UniversityBeijing100871China

Endovascular repair of the thoracic aorta with self-expanding stent-grafts has been emerging as a less invasive alternative treatment compared with conventional open *** the promising efficacy and safety of endovascular stent grafting,the stent-graft failure remains a major concern in terms of stent migration,device fatigue,and the risk of *** associated with the stent-grafts involve optimized geometrical structure,lifetime fatigue resistance,and adequate radial *** this work,a novel endovascular stent-graft system is developed specially for the treatment of Stanford type B thoracic aortic dissections(TAD).Numerical study with finite element analysis(FEA)was utilized to evaluate the mechanical behaviors of the individual stent *** of the simulation were validated by experimental *** on the systematic analysis of the parametric variations,a final stent-graft system was developed by the selection and arrangement of the individual stent components,targeting an optimal performance for treatment of *** optimized solution of the stent-graft system was tested in clinical trials,showing advantageous therapeutic efficacy.

关键词： stent-graft Thoracic aortic dissection Seal zone Fatigue safety factor Radial force Finite element analysis Nitinol

New nitinol endovascular stent-graft system for abdominal aortic aneurysm with finite element analysis and experimental verification

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Rare Metals 2019年第6期38卷 495-502页

作者： Xiao-Chen Zhou Fan Yang Xiao-Yan Gong Ming Zhao Yu-Feng Zheng Zhi-Li Sun Department of Materials Science and Engineering College of EngineeringPeking UniversityBeijing 100871China Beijing Percutek Therapeutics Co. Ltd.Beijing 102600China Suzhou Innomed Medical Device Co. Ltd.Suzhou 215123China Schlumberger Technology Corporation HoustonTX 77054USA State Key Laboratory for Turbulence and Complex System College of EngineeringPeking UniversityBeijing 100871China

Abdominal aortic aneurysm(AAA) is one of the most common and catastrophic manifestations of the acute aortic syndrome that can be treated with endovascular aneurysm repair(EVAR) which requires a specially designed stent-graft *** this work, a self-expanding nickel–titanium(nitinol) stent-graft system is aiming at AAA using finite element analysis(FEA) methods to analyze both fatigue behaviors and radial *** on the systematic analysis of the parametric variations, a final stent-graft system was developed by the selection and arrangement of the individual stent components, targeting an optimal performance for the treatment of *** tests, animal tests and clinical trials were carried out to confirm the *** animal trials and clinical trials showed comparable curative effects with Medtronic Endurant stent-graft(SG) systems.

关键词： Nitinol stent-graft system Abdominal aortic aneurysm Fatigue safety factor Radial force Finite element analysis

Research and clinical translation of trilayer stent-graft of expanded polytetrafluoroethylene for interventional treatment of aortic dissection

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Regenerative Biomaterials 2022年第1期9卷 650-664页

作者： Gang Wang Caiyun Gao Benhao Xiao Jie Zhang Xunyuan Jiang Qunsong Wang Jingzhen Guo Deyuan Zhang Jianxiong Liu Yuehui Xie Chang Shu Jiandong Ding State Key Laboratory of Molecular Engineering of Polymers Department of Macromolecular ScienceFudan UniversityShanghai 200438China R&D Center Lifetech Scientific(Shenzhen)Co.Ltd.Shenzhen 518057China Department of Vascular Surgery the Second Xiangya Hospital of Central South UniversityChangsha 410011China State Key Laboratory of Cardiovascular Diseases Center of Vascular SurgeryFuwai HospitalNational Center for Cardiovascular DiseasesChinese Academy of Medical Science and Peking Union Medical CollegeBeijing 100037China

The aortic dissection(AD)is a life-threatening *** transcatheter endovascular aortic repair(EVAR)affords a minimally invasive technique to save the lives of these critical patients,and an appropriate stent-graft gets to be the key medical device during an EVAR ***,we report a trilayer stent-graft and corresponding delivery system used for the treatment of the AD *** stent-graft is made of nitinol stents with an asymmetric Z-wave design and two expanded polytetrafluoroethylene(ePTFE)*** of the inner and outer surfaces of the stent-graft was covered by an ePTFE membrane,and the two membranes were then sintered *** biological studies of the sintered ePTFE membranes indicated that the stent-graft had excellent cytocompatibility and hemocompatibility in *** the stent-graft and the delivery system exhibited satisfactory mechanical properties and *** safety and efficacy of this stent-graft and the corresponding delivery system were demonstrated in *** nine canine experiments,the blood vessels of the animals implanted with the stent-grafts were of good patency,and there were no thrombus and obvious stenosis by angiography after implantation for ***,all of the nine clinical cases experienced successful implantation using the stent-graft and its postrelease delivery system,and the 1-year follow-ups indicated the preliminary safety and efficacy of the trilayer stent-graft with an asymmetric Z-wave design for interventional treatment.

关键词： aortic dissection stent-graft expanded polytetrafluoroethylene delivery system for interventional treatment clinical translation of biomaterials

Total endovascular repair of aberrant right subclavian artery using caster branched stent-graft

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Journal of Geriatric Cardiology 2018年第12期15卷 751-754页

作者： Guo-Yi SUN Wei GUO Xiao-Ping LIU Xin JIA Jiang XIONG Hong-Peng ZHANG Xiao-Hui MA Feng CHEN Sen-Hao JIA Jie LIU Yang-Yang GE Department of Vascular and Endovascular Surgery Chinese PLA General HospitalBeijingChina Department of ICU PLA Rocket Force Characteristic Medical CenterBeijingChina

A 57-year-old man has 20-year history of hypertension presented with intermittent chronic pain in the chest area and shoulder blades over the last three *** tomographic angiography(CTA)on admission revealed a chronic type B aortic dissection(TBAD)with an aberrant right subclavian artery(ARSA)crossed behind the trachea and bovine aortic arch(Figure IB).

关键词： Aberrant right subclavian artery Aortic dissection Branch stent-graft Thoracic endovascular aortic repair

Short-term results in canines of novel stent-graft design for chimney technique in TEVAR

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Journal of Interventional Medicine 2020年第3期3卷 128-131页

作者： Ming Li Chang Shu Benhao Xiao Dingxiao Liu Weichang Zhang Department of Vascular Surgery The Second Xiangya HospitalCentral South UniversityChangsha410011China Department of Vascular Surgery Fuwai HospitalChinese Academy of Medical SciencesBeijing100037China Lifetech Scientific Co.Ltd China

Introduction:Parallel stent-stent grafting is a major endovascular technique used to preserve the supra-aortic branches during thoracic endovascular aortic repair(TEVAR)of aortic pathologies involving the aortic *** short-and mid-term results of this technique are satisfactory;however,endoleak remains a major ***,here we designed a new chimney stent-graft to decrease the endoleak ***:To testify the feasibility and safety of the new chimney stent-graft system in a canine *** and methods:Six Labrador retrievers were ***-operative data were collected and all operations were performed under general *** main and chimney stent-grafts were implanted through the abdominal aorta and left subclavian artery approaches,*** digital subtraction angiography(DSA)was performed to confirm the immediate *** dogs were fed separately for 6 months and sacrificed after aortic *** thoracic aorta and the main and chimney stent-grafts were harvested for histopathologic ***:No complications were found in follow-up *** branch arteries were ***?ammatory responses were observed around the stent-grafts in 3 experimental animals,and slight hyperplasia was observed in the surrounding tissues compared with the normal *** was no mural thrombus in the stent,endothelial cells were noted on the inner surface of the stent,and thrombus was formed in the outer skirt and gutter *** histopathologic examinations revealed similar results to those of gross necropsy ***:This study demonstrated the feasibility and safety of the Longuette stent-graft and the first to report a revised stent-graft specific for chimney technique.

关键词： Thoracic endovascular aortic repair Chimney technique Canine model In vivo experiment stent-graft

Experimental and computational studies on the flow fields in aortic aneurysms associated with deployment of AAA stent-grafts

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Acta Mechanica Sinica 2007年第5期23卷 495-501页

作者： Xiwen Zhang Zhaohui Yao Yan Zhang Shangdong Xu Department of Engineering Mechanics Tsinghua University Beijing 100084 China Institute of Heart Pulmonary and Vascular Diseases Capital University of Medical Science Affiliated Beijing Anzhen Hospital Beijing 100029 China

Pulsatile flow fields in rigid abdominal aortic aneurysm （AAA） models were investigated numerically, and the simulation results are found in good agreement with particle image velocimetry （PIV） measurements. There are one or more vortexes in the AAA bulge, and a fairly high wall shear stress exists at the distal end, and thus the AAA is in danger of rupture. Medical treatment consists of inserting a vascular stent-graft in the AAA, which would decrease the blood impact to the inner walls and reduce wall shear stress so that the rupture could be prevented. A new computational model, based on porous medium model, was developed and results are documented. Therapeutic effect of the stent-graft was verified numerically with the new model.

关键词： Abdominal aortic aneurysm Numerical simulation Particle image velocimetry Wall shear stress stent-graft

Fatigue Performance of Fabrics of stent-grafts Supported with Z-stents vs. Ringed stents

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Journal of Donghua University(English Edition) 2013年第5期30卷 367-370页

作者：林婧宋戈管晓宁王璐杜佳 NUTLEY Mark GUIDOIN Robert Key Laboratory of Textile Science and Technology Ministry of EducationDonghua University College of Textiles Donghua University Division of Vascular Surgery Peter Lougheed Health Center Departments of Surgery and Radiology Laval University and Québec Biomaterials Institute

stent-grafts were commercialized rapidly and gained a broad clinical acceptance over the past two decades. However,relatively more recent recognition of particular stent-graft design shortcomings have been identified which need to be addressed. It appears that various stent-graft designs may be more or less resistant to metal fatigue and /or fabric abrasions which can lead to type III and type IV endoleaks over the long term. Therefore,it is necessary to investigate the fatigue performance of the most common stentgraft designs: Z-stents and ringed stents,in a long-term in vitro fatigue simulation environment. This paper aimed to analyze nondestructively( gross observations) and destructively( fabric characteristics,mechanical and chemical properties) in order to put forward suggestions to improve the fabric and stent characteristics that may prevent type III and IV endoleaks. The fabric supported with ringed stent-grafts remained nearly completely intact after 168h. However, the fabric supported with Z-stents demonstrated significant damage. Fabric characteristics and tensile strength of the fibers did not present a significant difference between the control and fatigue simulated specimens. The crystallinity declined for both specimens. The fatigue performance of fabrics supported with ringed stents appears to be superior to that supported with Z-stents. The potential for a dynamic and destructive interaction between the apices of Z-stents which can lead to fraying and /or tearing of the graft fabric must be addressed in future designs.

关键词： stent-graft fatigue performance fabrics Z-stents ringed stents

stent-grafts placement for treatment of massive hemorrhage from ruptured hepatic artery after pancreaticoduodenectomy

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World Journal of Gastroenterology 2010年第29期16卷 3716-3722页

作者： Mao-Qiang Wang Feng-Yong Liu Feng Duan Zhi-Jun Wang Peng Song Qing-Sheng Fan Department of Interventional Radiology Chinese PLA General HospitalBeijing 100853China

AIM:To present a series of cases with life-threatening hemorrhage from ruptured hepatic artery pseudoaneurysm after pancreaticoduodenectomy(PD) treated with placement of ***:Massive hemorrhage from ruptured hepatic artery pseudoaneurysm after PD in 9 patients(6 men,3 women) at the age of 23-75 years(mean 48 years),were treated with placement of percutaneous endovascular balloon-expandable coronary *** patients were not suitable for embolization because of a non-patent portal *** or more stent-grafts,ranging 3-6 mm in diameter and 16-55 mm in length,were placed to exclude ruptured *** data,including clinical condition,liver function tests,and Doppler ultrasound examination,were recorded at the outpatient ***:Immediate technical success was achieved in all the 9 *** stent-grafts were deployed in the intended position for immediate cessation of bleeding and preservation of satisfactory hepatic arterial blood *** significant procedure-related complications *** bleeding occurred in 2 patients at 16 and 24 h,respectively,after placement of stent-grafts and treated with surgical *** patient died of sepsis 12 d after the interventional *** remaining 6 patients were survived when they were *** mean follow-up time was 10.5 mo(range 4-16 mo).No patient had recurrent bleeding after *** ultrasound examination verified the patency of hepatic artery and stent-grafts during the ***:Placement of stent-grafts is an effective and safe procedure for acute life-threatening hemorrhage from ruptured hepatic artery pseudoaneurysm.

关键词： Pancreaticoduodenectomy Hemorrhage Hepatic artery Pseudoaneurysm stent-graft

Endovascular stent-grafts for acute and chronic type B aortic dissection: comparison of clinical outcomes

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Journal of Geriatric Cardiology 2007年第2期4卷 67-71页

作者： Quanming Jing Yaling Han Xiaozheng Wang Jie Deng Bo Luan Hongxu Jin Xiaojiang Liu Fei Li Ying Liu Department of Cardiology General Hospital of Shenyang Military Region Shenyang China Department of Cardiology General Hospital of Shenyang Military Region Shenyang China Department of Cardiology General Hospital of Shenyang Military Region Shenyang China Department of Cardiology General Hospital of Shenyang Military Region Shenyang China Department of Cardiology General Hospital of Shenyang Military Region Shenyang China Liaoning Medical College China Department of Cardiology General Hospital of Shenyang Military Region Shenyang China Department of Cardiology General Hospital of Shenyang Military Region Shenyang China Department of Cardiology General Hospital of Shenyang Military Region Shenyang China

Objective To evaluate the early and mid-term results of endovascular repair for acute and chronic type B aortic dissection, and to compare the clinical outcomes between the 2 groups. Methods From May 2002 to December 2006, 50 patients with type B aortic dissection were treated by endovascular stent-graft. There were 23 patients in the acute aortic dissection (AAD) group and 27 patients in the chronic aortic dissection (CAD) group. All patients were followed up from 1 to 54 months (average, 17±16 months).The immediate and follow-up clinical outcomes were documented and compared between the 2 groups. Results Placement of endovascular stent-grafts across the primary entry tears was technically successful in all 50 patients. Compared to the CAD group, the AAD group had a higher percentage of pleural effusion (17.4% vs. 0%, P=0.04) and visceral /leg ischemia (26.1% vs 3.7%, P=0.04). Procedure related complications, including endoleak and post-implantation syndrome, occurred more frequently in the AAD group than in the CAD group (21.7% vs 3.7% and 30.4% vs 11.1%, respectively; P=0.08 and P=0.04). Kaplan–Meier analysis showed no difference in the survival rate at 4 years between the 2 groups (86.4% vs 92.3%, P=0.42 by log-rank test). However, the event-free survival rate was higher in patients with chronic dissection than in patients with acute aortic dissection(96.2% vs 73.9%; P=0.02 by log-rank test). Conclu- sions Endovascular repair with stent-graft was safe and effective for the treatment of both acute and chronic type B aortic dissection. However, both immediate and long term major complications occurred more frequently in patients with acute dissection than in those with chronic dissection.

关键词： aortic dissection endovascular repairing stent-graft

A novel pressure difference-induced perforation aortic stent-grafts system： an experimental study

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Chinese Medical Journal 2013年第7期126卷 1264-1268页

作者： DENG Guo-yu ZHOU Jian LU Qing-sheng WANG Lu HOU Le-wei DONG Jian WANG Jian-nan ZHANG Shu-ming ZHAO Zhi-qing JING Zai-ping Department of Vascular Surgery Changhai Hospital Second Military Medical University Shanghai 200433 China Department of Surgery Changhai Hospital Second Military Medical University Shanghai 200433 China College of Textiles Donghua University Shanghai 200433 China

Background Most of endovascular stent-graft modifications to preserve side branch must be customized according to extensive pre-operative assessment, which may not be possible in many hospitals and emergency settings. The study was to develop a novel stent-grafts system that would allow in situ ＂fenestration＂, with less reliance on preoperative imaging. Methods The magnitude of pressure difference （PD） between left subclavian artery （LSA） and aortic arch were measured in 12 experimental pigs. Changes of PD before and after LSA was covered were analyzed respectively. The novel stent graft was made by multi-dimensional and multiple textiles forming technology. According to the PD measurement in pigs, we evaluated the feasibility of the stent-graft in a mock circulation system. Results In pigs, the blood pressure of aortic arch was significantly higher than that of LSA after it was covered （P 〈0.001） and PD was （42.78±5.17） mmHg. After target vessel was covered and when PD between the LSA and aorta reached the magnitude measured in pigs, contrast media oozed from the cranny of graft to the LSA, which was generated by sliding and deformation of yarns of novel stent-graft. Conclusions The study proposes the design of pressure difference-induced perforation aortic stent-grafts system and verifies that the PD between LSA and aortic arch is high enough to allow in situ ＂fenestration＂ by stent graft made by multi-dimensional and multiple textiles forming technoloav.

关键词： aorta left subclavian artery stent-graft pressure difference mock circulation