Optically Sensorized, Actuated Needles for Oncological Applications Intelligent Fiber Optic Systems Corporation (IFOS) 2363 Calle del Mundo, Santa Clara, CA 95054-1008 www.ifos.com PROJECT SUMMARY/ABSTRACT (MAXIMUM 30 LINES) In this Direct-to-Phase-II SBIR application, IFOS and Texas A&M University propose to develop and validate an actively steered, tendon-actuated, small-caliber needle for precise imaging-assisted percutaneous procedures with focus on deep tissue biopsies. Interviews with clinicians have confirmed that steering capability would greatly improve clinical methods for biopsy and drug delivery. With current methods, precise needle placement is not always possible in procedures targeting deep tissue, where routes of entry are restricted due to anatomical obstructions and the need to avoid vital organs. Furthermore, as the needle is inserted, forces from the surrounding tissue cause the needle to deflect off the planned path. Such deviations result in multiple reinsertions, adding to patient discomfort and procedure time, and compromising the effectiveness of minimally invasive procedures. The proposed active steering can compensate for deflection encountered during insertion, which becomes increasingly significant as the path to the target lengthens. The active steering concept is based on linear servo motors that actuate needle tip flexion through connected tendon fibers. The design feature of a hollow NiTi needle allows for applications like drug delivery and laser ablation when another needle is inserted within the host needle core. This design also incorporates a removable core with attached fiber Bragg gratings to sense obstructing internal body parts, reducing the need for assistive MR imaging during the procedure. Imaging technologies are still options if the operator wants to view these obstructions during the procedure, since the needle itself is MRI compatible. In prior work, bending rates of over 2 degrees per second have been repeatably achieved in phantoms that mimic the properties of human prostate tissue, and, we have implemented a thinner needle design, an intuitive console design concept, and a closed-loop control system that enables real-time needle curvature and in situ tissue reaction force measurements. The initial effort is designed to demonstrate still greater deflection efficiency using various needle insertion strategies and finalize the design of the clinically deployable needle and the associated controlling console with input from experts and potential consumers. This work will lead to further development activities, including thinner needle designs, an enhanced console design for implementation, and a closed-loop control system that enables real-time needle curvature and in situ tissue reaction force measurements. The IFOS team will also investigate steering protocols that would take advantage of axial rotation and other known passive control strategies, thereby adding bending degrees-of-freedom and dexterity to the needle system. These studies will culminate in a series of in vivo experiments, targeting liver/kidney biopsy and drug delivery procedures. Optimizing the needle for these specific clinical applications will drive the innovative IFOS product towards commercialization.
The proposed Phase II project will reduce the need for multiple biopsy needle reinsertions by commercializing an innovative steerable needle with optical sensorization. To achieve this, we will test our needle with an animal study to finalize the design and verify ease of use. This approach will ensure that the needle meets consumer needs and is ready for manufacturing so that we may provide a more accurate interventional device for oncologic applications.