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

使用 3D 打印技术开发和验证用于机器人辅助手术的高保真妇科培训平台

• 批准号: 10821242
• 负责人: Smriti Agrawal Zaneveld
• 金额: $ 37.1万
• 依托单位: LAZARUS 3D, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-21 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10821242
• 关键词: 3-Dimensional; 3D Print; Address; Adenomyosis; Adopted; American; Anatomy; Awareness; Biomechanics; Cadaver; Caring; Closure by clamp; Collaborations; Competence; Complex; Data; Decision Making; Development; Diathermy; Disease; Dissection; Elasticity; Ensure; Environment; Failure; Family suidae; Female; Fertility; Focus Groups; Foundations; Future; Goals; Gynecologic; Gynecologic Pathology; Gynecologic Surgical Procedures; Gynecologist; Gynecology; Health; Incidence; Intervention; Knowledge; Learning; Legal patent; Life; Maintenance; Medical; Medicine; Modeling; Modulus; Morbidity - disease rate; Operative Surgical Procedures; Oregon; Organ; Outcome; Pap smear; Participant; Pathology; Patient-Focused Outcomes; Patients; Phase; Pilot Projects; Polymers; Pregnancy; Prevalence; Procedures; Property; Puncture procedure; Radiology Specialty; Recommendation; Research; Research Project Grants; Research Proposals; Risk; Risk Reduction; Robotics; Sex Functioning; Small Business Innovation Research Grant; Stretching; Surgeon; Surveys; Technical Expertise; Technology; Testing; Time; Tissues; Training; Universities; Uterine Fibroids; Uterus; Vagina; Validation; Woman; Women' s Health; Work; aging population; college; comparative; cost; design; empowerment; endometriosis; female reproductive system; high risk; improved; improved outcome; instrument; interest; mechanical properties; minimally invasive; mortality; operation; patient population; patient safety; preservation; prototype; rehearsal; reproductive; safety outcomes; sedentary lifestyle; skill acquisition; skills; skills training; soft tissue; surgery outcome; three-dimensional modeling; tool

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.

抽象的 I阶段I小型企业创新与研究（SBIR）提案旨在开发和验证合成 软组织手术女性培训（软）平台，可改善复杂和高风险的培训 妇科的程序。预计美国人久坐的生活方式将增加 通过手术治疗的妇科病理学，包括子宫纤维（UF），子宫内膜异位症（EM）和 腺肌病（AM）。微创和机器人辅助手术（MIS，RAS）正在成为流行选择 对患者无与伦比的益处的干预措施。但是，这些过程有钢铁学习 曲线，需要大量的手术训练。缺乏易于访问的培训平台阻碍了安全 获取和维护相关的技术技能。为了解决这一危机，柔软将是第一个商业上的 可用的平台，为妇科中的MIS和RAS提供了超现实的动手培训。与电流不同 平台，Lazarus 3D的技术利用具有可调机械性能的软材料，从而允许 要解剖，夹紧和缝制的材料，并由实际操作中使用的相同仪器缝制。 这项工作将开发并验证用于用RAS治疗的常见病理的合成训练平台。在 AIM 1，Lazarus 3D将优化合成聚合物以模仿女性生殖的生物力学 系统，包括子宫。使用RAS操作时，这些材料的行为与软组织相似。 AIM 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学和 病理学（UF，EM和AM）。女性生殖系统的3D模型将使用公开设计 可用的放射学数据并使用AIM 1中开发的材料生产。 协作医学机构将为解剖学和组织特性的现实主义提供深刻的意识。 AIM 3，参加参与机构的培训中的15名妇科医生组成的焦点小组将评估Soft的有效性 通过执行RAS程序。参与者将使用A来确定平台的现实主义和有效性 5分制李克特调查。评估平台的现实主义和实用性的标准将包括技术 技能获取，信心水平和感知的有用性。 拟议的I阶段项目借鉴了Lazarus 3D在制定准确和现实方面的专业知识 栩栩如生的合成解剖结构。我们预计该项目的完成将首次提供外科医生 一个现实的培训平台，可以安全地适应RAS中使用的所有外科手术程序和步骤。这 该项目的成功完成将为II期研究项目奠定基础，在该项目中 平台将作为妇科RAS程序的培训和技能评估的标准进行验证。