Session: 06-05-02: Biomedical Devices, Sensors, and Actuators

Paper Number: 144741

144741 - Innovative Y-Shaped Stent Fabrication: A Leap Forward in Bifurcation Lesion Treatment 

This research presents an innovative approach to the fabrication of Y-shaped medical stents for addressing obstructions in the abdominal-iliac bifurcation, diverging from traditional methods by employing Nitinol sheets instead of wire braiding or tube cutting. This novel technique aims to surmount the inherent limitations of conventional stent manufacturing processes, which are primarily restricted by the geometrical constraints and mechanical performance of the resulting stents. The motivation behind this study is to explore and develop a manufacturing method capable of creating complex-patterned stents from Nitinol sheets using waterjet machining, an approach not conventionally applied to stent fabrication. This method offers a potential pathway to significantly enhance the design flexibility and mechanical properties of stents, particularly for applications involving intricate geometries like those required for the abdominal-iliac bifurcation.

The research methodology encompasses a comprehensive exploration of the capabilities of waterjet machining in the context of Nitinol sheet processing. This involves the development of an interlocking mechanism to facilitate the assembly of the stent from two-dimensional components into a three-dimensional functional device. The process begins with a thorough analysis and design phase, wherein a complex stent pattern is conceptualized and optimized for waterjet machining. This pattern aims to improve upon the mechanical properties essential for stent performance, such as crush resistance and flexibility, which are critical in reducing complications during surgery and enhancing the efficacy of the stent in maintaining vessel patency.

Preliminary results from this research are promising, demonstrating notable improvements in the mechanical performance of the fabricated stents compared to traditional wire-braided models. The stents manufactured from Nitinol sheets exhibit a 23% improvement in crush resistance and a substantial decrease in bending resistance. These outcomes suggest a lower likelihood of arterial wall stress, potentially reducing the risk of surgical complications such as restenosis. Furthermore, successful deployment tests, including insertion into a simulated artery model and controlled expansion, underscore the practical viability and effectiveness of the novel manufacturing approach.

In conclusion, this study contributes significantly to the advancement of medical device manufacturing, specifically in the domain of stent development for vascular interventions. By introducing a unique method that leverages waterjet machining of Nitinol sheets to create Y-shaped stents, this work sets a new benchmark in the design and fabrication of medical stents. The improved mechanical properties and design flexibility afforded by this technique have the potential to enhance the treatment of conditions involving the abdominal-iliac bifurcation, ultimately leading to better surgical outcomes and patient well-being. This research expands the existing body of knowledge on stent manufacturing and opens new avenues for the application of advanced manufacturing techniques in the biomedical device industry.

Presenting Author: Saleh Gharaie Deakin University

Presenting Author Biography: Dr. Gharaie obtained his Ph.D. in Mechanical Engineering from Swinburne University of Technology, followed by postdoctoral training at Weill Cornell Medicine in New York, USA. His postdoctoral work was characterised by productive collaborations with medical device companies, focusing on the development of cardiac devices.

Currently, Dr. Gharaie holds the position of Senior Lecturer in the School of Engineering at Deakin University, Australia. His research is primarily concerned with the development and evaluation of cardiovascular devices, in addition to elucidating the mechanisms, treatment, and detection of cardiovascular diseases. By integrating engineering expertise with medical knowledge, Dr. Gharaie makes a significant contribution to the field of biomedical devices, with a particular emphasis on technologies that address cardiovascular disease

Authors:

Saleh Gharaie Deakin University
Ali Zolfagharian Deakin University
Amir Ali Amiri Moghadam Kennesaw State University