Smart Surgical Needle Actuated by Shape Memory Alloys for Percutaneous Procedures

Abstract

Background: Majority of cancer interventions today are performed percutaneously using needle-based procedures, i.e. through the skin and soft tissue. Needle insertion is known as one of the recent needle-based techniques that is used in several diagnostic and therapeutic medical procedures such as brachytherapy, thermal ablations and breast biopsy. The difficulty in most of these procedures is to attain a precise navigation through tissue reaching target locations. Insufficient accuracy using conventional surgical needles motivated researchers to provide actuation forces to the needle’s body for compensating the possible errors of surgeons/physicians. Therefore, active needles were proposed recently where actuation forces provided by shape memory alloys (SMAs) are utilized to assist the maneuverability and accuracy of surgical needles. This work also aims to introduce a novel needle insertion simulation to predict the deflection of a bevel tip needle inside the tissue. Development of a model to predict the behavior of the needle steering in the soft tissue has been always a point of interest as it could improve the performance of many percutaneous needle-based procedures. Methods: In this work first, the actuation capability of a single SMA wire was studied. The complex response of SMAs was investigated via a MATLAB implementation of the Brinson model and verified via experimental tests. The material characteristics of SMAs were simulated by defining multilinear elastic isothermal stress-strain curves. Rigorous experiments with SMA wires were performed to determine the material properties as well as to show the capability of the code to predict a stabilized SMA transformation behavior with sufficient accuracy. The isothermal stress-strain curves of SMAs were simulated and defined as a material model for the Finite Element Analysis of the active needle. In the second part of this work, a three-dimensional finite element (FE) model of the active steerable needle was developed to demonstrate the feasibility of using SMA wires as actuators to bend the surgical needle. In the FE model, birth and death method of defining boundary conditions, available in ANSYS, was used to achieve the pre-strain condition on SMA wire prior to actuation. This numerical model was validated with needle deflection experiments with developed prototypes of the active needle. The third part of this work describes the design optimization of the active using genetic algorithm aiming for its maximum flexibility. Design parameters influencing the steerability include the needle’s diameter, wire diameter, pre-strain, and its offset from the needle. A simplified model was developed to decrease the computation time in iterative analyses of the optimization algorithm. In the fourth part of this work a design of an active needling system was proposed where actuation forces of SMAs as well as shape memory polymers (SMPs) were incorporated. SMP elements provide two major additional advantages to the design: (i) recovery of the SMP’s plastic deformation by heating the element above its glass transition temperature, and (ii) achieving a higher needle deflection by having a softer stage of SMP at higher temperatures with less amount of actuation force. Finally, in the fifth and last part of this study, an Arbitrary-Lagrangian-Eulerian formulation in LS-DYNA software was used to model the solid-fluid interactions between the needle and tissue. A 150mm long needle was considered to bend within the tissue due to the interacting forces on its asymmetric bevel tip. Some additional assumptions were made to maintain a reasonable computational time, with no need of parallel processing, while having practical accuracies. Three experimental tests of needle steering in a soft phantom were performed to validate the simulation. Results: The finite element model of the active needle was first validated experimentally with developed prototypes. Several design parameters affecting the needle’s deflection such as the needle’s Young’s modulus, the SMA’s pre-strain and its offset from the neutral axis of the cannula were studied using the FE model. Then by the integration of the SMA characteristics with the automated optimization schemes an improved design of the active needle was obtained. Real-time experiments with different prototypes showed that the quickest response and the maximum deflection were achieved by the needle with two sections of actuation compared to a single section of actuation. Also the feasibility of providing actuation forces using both SMAs and SMPs for the surgical needle was demonstrated in this study. The needle insertion simulation was validated while observing less than 10% deviation between the estimated amount of needle deflection by the simulation and by the experiments. Using this model the effect of needle diameter and its bevel tip angle on the final shape of the needle was investigated. Conclusion: The numerical and experimental studies of this work showed that a highly maneuverable active needle can be made using the actuation of multiple SMA wires in series. To maneuver around the anatomical obstacles of the human body and reach the target location, thin sharp needles are recommended as they would create a smaller radius of curvature. The insertion model presented in this work is intended to be used as a base structure for path planning and training purposes for future studies.