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

摘要 此第一阶段小型企业创新和研究(SBIR)计划旨在开发和验证 软组织手术女性训练(SOFT)平台，改善复杂和高危人群的训练 妇科的程序。美国人久坐不动的生活方式预计会增加 手术治疗的妇科病理，包括子宫肌瘤(UF)、子宫内膜异位症(EM)和 子宫腺肌病(AM)。微创手术和机器人辅助手术(MIS、RAS)正在成为流行的选择 给患者带来了无与伦比的好处。然而，这些程序有一个陡峭的教训 曲线，需要广泛的外科训练。缺乏随时可用的培训平台阻碍了外管局 相关技术技能的获取和维护。为了解决这一危机，Soft将成为第一个商业化的 可用的平台，为妇科管理信息系统和RAS提供超现实的动手培训。与当前不同 平台，Lazarus 3D的技术利用具有可调机械性能的软材料，允许 材料要用实际操作中使用的相同仪器进行解剖、夹紧和缝合。 这项工作将开发和验证一个用于RAS治疗的常见病理的综合培训平台。在……里面 目标1，Lazarus 3D将优化合成聚合物以模拟女性生殖的生物力学 系统，包括子宫。当使用RAS进行手术时，这些材料的行为类似于软组织。 目标2，Lazarus 3D将利用其专有的3D打印技术来创建相关的女性解剖和 病理(UF、EM和AM)。女性生殖系统的3D模型将使用公开的 可获得的放射学数据，并使用AIM 1中开发的材料制作。 合作的医疗机构将在解剖和组织属性的真实性方面提供有洞察力的投入。 目标3，来自参与机构的15名妇科医生参加培训的焦点小组将评估SOFT的有效性 通过执行RAS程序。参与者将使用一个 5点比例尺利克特测量。评估平台的现实性和实用性的标准将包括技术 技能获得、信心水平和感知的有用性。 拟议的第一阶段项目利用了Lazarus 3D在开发准确和逼真的 栩栩如生的合成解剖学。我们预计这个项目的完成将首次为外科医生提供 一个现实的培训平台，可以安全地适应RAS中使用的所有手术程序和步骤。这个 该项目的成功完成将为第二阶段研究项目奠定基础，在该项目中，软件 该平台将被确认为妇科RAS程序的培训和技能评估标准。

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.