Feng Tang1, Chang Hu1, Shujie Huang2, Whitney Long1, Qian Wang1, Guangyang Xu1, Sibo Liu1, Bohan Wang1, Lei Zhang3, Lei Li4. 1. Vascular Department, Beijing Hua Xin Hospital (1st Hospital of Tsinghua University), Beijing, China. 2. Vascular Department in Qingdao Municipal Hospital East Branch, Shandong, China. 3. Department of Mechanical Engineering, Biomanufacturing Center, Tsinghua University, Beijing, China. 4. Vascular Department, Beijing Hua Xin Hospital (1st Hospital of Tsinghua University), Beijing, China. Electronic address: lilei@lilei.net.
Abstract
BACKGROUND: Commercially available thoracic aortic stent grafts rarely match the geometric characteristics of the aorta perfectly, which can lead to complications. Customization maybe a solution for this problem, but the delay inherent in the current manufacturing process makes it unable to meet the urgent requirement of acute aortic events. We established and optimized a rapid design and manufacture system for a customized aortic stent graft assisted by 3-dimensional (3D) printing technology. We also evaluated the preliminary feasibility and capability of this customized stent graft. METHODS: Seven essential production steps comprised the rapid design and manufacture process for the customized stent graft system assisted by 3D printing technology. Optimization of the manufacture process was refined over time in 3 stages. Bench test and in vivo experiments were used to verify the feasibility of this system and evaluate the preliminary usability of the customized stent graft. RESULTS: After optimization, the theoretical production time of the customized stent graft was reduced to approximately 12 hours. Bench test showed radial forces against the aorta wall were better distributed in the customized stent graft than in the control stent graft. In vivo experimental results showed that the customized stent graft system worked effectively. CONCLUSIONS: It was feasible to rapidly design and manufacture a customized aortic stent graft assisted by 3D printing technology, which demonstrated better geometric compliance and physical characters in the bench test and in in vivo experimentation. The manufacturing process could be accelerated to approximately 12 hours, which might be optimized further to meet urgent clinic requirements.
BACKGROUND: Commercially available thoracic aortic stent grafts rarely match the geometric characteristics of the aorta perfectly, which can lead to complications. Customization maybe a solution for this problem, but the delay inherent in the current manufacturing process makes it unable to meet the urgent requirement of acute aortic events. We established and optimized a rapid design and manufacture system for a customized aortic stent graft assisted by 3-dimensional (3D) printing technology. We also evaluated the preliminary feasibility and capability of this customized stent graft. METHODS: Seven essential production steps comprised the rapid design and manufacture process for the customized stent graft system assisted by 3D printing technology. Optimization of the manufacture process was refined over time in 3 stages. Bench test and in vivo experiments were used to verify the feasibility of this system and evaluate the preliminary usability of the customized stent graft. RESULTS: After optimization, the theoretical production time of the customized stent graft was reduced to approximately 12 hours. Bench test showed radial forces against the aorta wall were better distributed in the customized stent graft than in the control stent graft. In vivo experimental results showed that the customized stent graft system worked effectively. CONCLUSIONS: It was feasible to rapidly design and manufacture a customized aortic stent graft assisted by 3D printing technology, which demonstrated better geometric compliance and physical characters in the bench test and in in vivo experimentation. The manufacturing process could be accelerated to approximately 12 hours, which might be optimized further to meet urgent clinic requirements.