Lead Extraction Catheter System

System consisting of catheter and associated generator intended to assist with removal of cardiac implant from the vasculature.

Lead Mechanical Engineer on the program, responsible for mechanical design and development of catheter. Led exploration and prototyping of different aspects of the program ranging from proprietary coating of stainless steel tip to catheter braiding and processing.

Interfaced with manufacturers and users, establishing communication pathway to ensure all stakeholder needs are met throughout the entire product lifecycle.

Prototyping

Sourced materials ranging from elastomer, textiles, and metals. Interfaced with suppliers for processes such as extrusion, machining, MIM, Direct Metal Laser Sintering (DMLS) and overmolding. Established relationships with subject matter experts for catheter construction.

Constructed devices from start to finish in house utilizing skills such as soldering, oven & box reflow, hand operations under microscope.

Designed and conducted mechanical and electrical experiments in house to build confidence in the device. Ranging from destructive pull testing, stiffness testing to high potential material breakdown (IEC 60601-1)

Fixture Design

In addition to design and development of the product, associated fixturing was created in order to address all phases of the lifecycle. A specific pain point for the device was the proprietary coating process associated with smooth RF cutting.

Extensive collaboration with the the material scientist and process operator was key to successful design. Several iterations were experimented before a solid solution was provided.

Design A to the left utilized magnets in order to create an organized way to coat many parts at once. In addition, the fixture allowed for clean perpendicular removal of the magnets upon completion.

Design B below utilized mechanical method to interface with the stainless steel component. A single tool could be used to place and removal all parts. This fixture was fit to withstand all phases of the coating cycle.