Principal investigator: Fei Ren, Parsaoran Hutapea

University: Temple University

Industry partners: NextFab, Inteprod, Inc.

Surgical needles play important roles in many medical procedures, including biopsies, drug delivery, and cancer treatment. Effectiveness of such procedures highly depends on the maneuverability of needles, which is affected by the device’s construction and human control. While most commercial needling devices consist of rigid components, their control is achieved by physicians maneuvering the needles from the proximity ends. This practice not only results in occasional needle deviation, but also sometimes prevents needling devices from conducting complex medical procedures; for example, reaching a target behind certain vulnerable organs.

Various designs have been proposed to enhance the maneuverability of surgical needles. One example is to include actuation elements based on shape memory alloy (SMA) elements in the needle body, which offers in situ control over the needle shape during the procedure. Although such an approach has been demonstrated in large-scale prototypes, implementing this mechanism in commercial needles-which are typically a millimeter or smaller in diameter-is limited by current design methodologies and manufacturing technologies. In this project, we propose a new, composite design of surgical needles with integrated SMA elements and a novel fabrication method utilizing additive manufacturing (AM).

In this design, a biocompatible polymer coating will be printed onto metallic needle cores and SMA elements will be embedded in this coating layer. The AM fabricated polymer layer will ensure bonding between the core needle and the SMA elements, while also providing other functionality such as electrical and thermal insulation and friction reduction. Successful development of this new type of needles will improve the accuracy and therefore effectiveness of commonly used needling procedures. On the other hand, the manufacturing method developed in this project will add to the portfolio of AM technologies in Pennsylvania, especially in the high value-added medical device industry.