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Monday, September 24, 2007 - 11:00 AM

Batch Fabrication of Complex, Pre-Assembled, Miniature Medical Devices

A. L. Cohen, M. T. Wu, C. Folk, R. Chen, J. Lue, Microfabrica Inc., Van Nuys, CA

We present EFAB technology, a unique, cost-effective manufacturing process for producing intricate, miniaturized millimeter-scale medical devices. Using multiple layers of electrodeposited and planarized metals processed in a cleanroom, sophisticated “pre-assembled” devices with multiple, independent moving parts may be produced in production quantities.  Using this process, costly manual assembly under a microscope may be reduced or eliminated. The technology allows complex devices with features as small as 0.004 mm and overall sizes in the range of millimeters-centimeters to be designed using standard 3-D CAD software and fabricated in batches of hundreds to thousands using methods analogous to those used in semiconductor manufacturing. We will describe devices including moving elements such as hinges, slides, chains, and ratchets, and provide test results. We will also compare EFAB technology to conventional manufacturing processes and consider its relative benefits and limitations.

Summary: Through the use of a unique, net-shape, layered metal manufacturing process, sophisticated instruments for minimally-invasive medical procedures may be produced in large batches (e.g., 1000s at a time) and without the need for assembly of multiple components. This paper will describe the EFAB process, compare it with alternative processes for fabricating medical devices at the millimeter scale, and provide several examples of devices designed, fabricated, and tested.