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
基本信息
- 批准号:10821242
- 负责人:
- 金额:$ 37.1万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:3-Dimensional3D PrintAddressAdenomyosisAdoptedAmericanAnatomyAwarenessBiomechanicsCadaverCaringClosure by clampCollaborationsCompetenceComplexDataDecision MakingDevelopmentDiathermyDiseaseDissectionElasticityEnsureEnvironmentFailureFamily suidaeFemaleFertilityFocus GroupsFoundationsFutureGoalsGynecologicGynecologic PathologyGynecologic Surgical ProceduresGynecologistGynecologyHealthIncidenceInterventionKnowledgeLearningLegal patentLifeMaintenanceMedicalMedicineModelingModulusMorbidity - disease rateOperative Surgical ProceduresOregonOrganOutcomePap smearParticipantPathologyPatient-Focused OutcomesPatientsPhasePilot ProjectsPolymersPregnancyPrevalenceProceduresPropertyPuncture procedureRadiology SpecialtyRecommendationResearchResearch Project GrantsResearch ProposalsRiskRisk ReductionRoboticsSex FunctioningSmall Business Innovation Research GrantStretchingSurgeonSurveysTechnical ExpertiseTechnologyTestingTimeTissuesTrainingUniversitiesUterine FibroidsUterusVaginaValidationWomanWomen&aposs HealthWorkaging populationcollegecomparativecostdesignempowermentendometriosisfemale reproductive systemhigh riskimprovedimproved outcomeinstrumentinterestmechanical propertiesminimally invasivemortalityoperationpatient populationpatient safetypreservationprototyperehearsalreproductivesafety outcomessedentary lifestyleskill acquisitionskillsskills trainingsoft tissuesurgery outcomethree-dimensional modelingtool
项目摘要
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.
摘要
项目成果
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