INTEGRATING DESIGN AND MANUFACTURE OF COMPOSITE IMPLANTS

DESCRIPTION (Applicant's Abstract): Composite technology offers the opportunity to design a material for a specific structural application. In particular, carbon fiber reinforced polymer composites are radiolucent, making them ideal candidates for spinal fusion applications. However, manufacturers of current composite devices have not taken full advantage of these opportunities, and failure of composite intervertebral spacers has occurred. We will integrate the design of composite implants with manufacturing techniques that will allow us to optimize strength. Such practices are common in high tech industries, and commercial fabrication techniques should be suitable. Preliminary analyses indicate we will be able to double the strength of an existing device. We will demonstrate this concept by designing an intervertebral spacer, manufacturing test specimens, sterilizing the specimens,and evaluating their strength using an ASTM draft standard test. The new device will be inexpensive to produce, and will have an advantage over metal devices due to its radiolucency, and have an advantage over other composite devices due to its increased strength. This concept can be extended to the manufacture of plates, rods, and screws. PROPOSED COMMERCIAL APPLICATION: In the 3 years since intervertebral fusion devices were first approved the market has grown to over $400 million in the US alone. It is expected to continue growing at 20-50% per annum for the next several years. Current devices sell for approximately $1,500 and we expect the manufacturing cost for our device to be less than $50 including packaging and sterilization, and it will have superior performance.