Development and validation of a high-fidelity gynecologic training platform for robotic-assisted surgery using 3D printing technology

ABSTRACT This Phase I Small Business Innovation and Research (SBIR) proposal aims to develop and validate a synthetic Soft-tissue Operative Female Training (SOFT) platform that improves training for complex and high-risk procedures in gynecology. The sedentary lifestyle of Americans is expected to increase the incidence of gynecological pathologies treated surgically, including uterine fibroids (UF), endometriosis (EM), and adenomyosis (AM). Minimally invasive and robotic-assisted surgery (MIS, RAS) are becoming popular choices of intervention for their unparalleled benefits to the patient. However, these procedures have a steep learning curve, requiring extensive surgical training. The lack of readily accessible training platforms hinders the safe acquisition and maintenance of relevant technical skills. To address this crisis, SOFT will be the first commercially available platform, providing hyper-realistic hands-on training for MIS and RAS in gynecology. Unlike current platforms, Lazarus 3D's technology utilizes soft materials with tunable mechanical properties, allowing the materials to be dissected, clamped, and stitched by the same instruments used in actual operations. This work will develop and validate a synthetic training platform for common pathologies treated with RAS. In Aim 1, Lazarus 3D will optimize synthetic polymers to mimic the biomechanics of the female reproductive system, including the uterus. These materials will behave similarly to soft tissue when operated on using RAS. Aim 2, Lazarus 3D will utilize its proprietary 3D printing technology to create the relevant female anatomy and pathologies (UF, EM, and AM). 3D models of the female reproductive system will be designed using publicly available radiological data and produced using the materials developed in aim 1. The expert surgical team at the collaborating medical institutes will provide insightful input on the realism of the anatomy and tissue properties. Aim 3, focus groups of 15 gynecologists in training from the participating institutes will assess SOFT’s validity by performing RAS procedures. The participants will determine the realism and validity of the platform using a 5-point scale Likert survey. The criteria for evaluating the realism and utility of the platform will include technical skill acquisition, confidence level, and perceived usefulness. The proposed Phase I project draws on Lazarus 3D’s expertise in the development of accurate and realistic lifelike synthetic anatomy. We anticipate the completion of this project to provide surgeons, for the first time, with a realistic training platform that can safely accommodate all surgical procedures and steps used in RAS. The successful completion of this project will lay the groundwork for a Phase II research project, in which the SOFT platform will be validated as the standard of training and skill assessment for gynecological RAS procedures.