LCH Based Cardiovascular Catheters Design by Karthik Bujuru

Design of catheters for treating heart diseases is a complex endeavor considering the complexity of patient anatomies. A typical cardiovascular catheter has requirements like being able to track patient vasculature without buckling, able to deliver torque without building up energy, able to flex and conform to the bends of the vasculature etc. Using laser cut hypotubes as support structure instead of conventional stainless-steel braid has opened a Pandora box of designs to achieve complex catheter functions using simple laser cut patterns. Often times medical device engineers have to go through several rounds of prototype iterations before achieving a catheter design that meets all the criteria. This is not efficient, especially for startup companies with an objective to bring working solutions to patients quickly and with tolerable R&D costs. With the experience of working at startup companies and considering that there is lack of structured methodology to design complex catheters using laser cut hypotubes, we have developed a design template that a medical device engineer could use to design Lasercut hypotube based catheters that can be tailored to meet their specific therapy requirements. This design template provides step by step instructions on characterizing and establishing specific design requirements, designing prototype Lasercut hypotubes, evaluating them using finite element analysis simulation software, analyzing the results in Minitab’s multi response surface methodology to identify most optimized solution for the targeted design. This, we believe, cuts down on the design iteration time by at least 3 to 5 rounds considering our experience following the same method to design a catheter solution to deliver nitinol-based prosthetic to replace diseased aortic valve. Overall, this design template makes the design process of complex cardiovascular catheters a science rather than an art which it is widely believed to be to this day.