Project Objective:

Plaque buildup restricts blood-flow through arteries and causes Peripheral Arterial Disease (PAD) & Critical Limb Ischemia (CLI). It leads to approximately 150,000 amputations each year in the US. The challenge was to ”Design and Prototype a device that can enter and exit through a 2 mm access site and debulk an 8 mm diameter lesion in a Femoral Artery”. 

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My Role:

I participated in the early design process - understanding the clinical need and the surgeon's requirements for a catheter, brainstorming, prototyping different ideas and testing out these concept prototypes. It was followed by a more detailed analysis in designing and developing the actual prototype using tools like CAD, FEA & DFM. I also interacted with a lot of external suppliers, contractors and vendors to select the appropriate material and manufacturing process.

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Results:

A lot of bench-top testing and subsequent design modifications cycles were required in successfully developing the final prototype. The Catheter was capable of achieving the desired diameter inside the artery. All of this took place under a budget of $5000 and within 30 weeks.

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Project Contributors:

Team Members: Katherine O'Dell, Hiral Gandhi 

Project Mentor & Client: Dr. James Cezo