Vaginal Tactile Imager for Pelvic Floor Biomechanical Assessment

描述（由申请人提供）：盆腔器官脱垂是一种非常普遍的疾病，在美国至少有50%的女性在其一生中受到影响。大多数成年女性都会出现子宫阴道支持的丧失，然而，脱垂的真正病因和个体差异还不完全清楚。阴道壁、结缔支持组织和肌肉弹性的变化被认为是盆腔器官脱垂发展的重要因素。我们建议开发一种名为阴道触觉成像仪（VTI）的三维可视化和评估骨盆底组织的力学性能的设备。VTI基于触觉成像（TI）技术，该技术基于与手动触诊相似的原理。在第一和第二阶段，我们设计和建立了一个和原型的VTI与触觉传感器阵列和运动跟踪传感器，完成了VTI测试和验证与组织模仿体模，完成了第一阶段，并启动了第二阶段的临床研究。临床结果表明，所提出的方法的阴道和盆底支持结构的三维成像的能力。结果提示，VTI测定阴道及其支持结构弹性正常值范围可作为诊断盆底病变的指标。我们进一步证明了VTI在描述骨盆底重建手术结果方面的能力。Artann实验室开发的触觉成像技术具有高度创新性和独特性。雅坦的科学家是世界上第一个引进和开发 触觉成像技术的实际和证明成功的应用中描述了许多出版物和21个已颁发的专利。IIB阶段的主要目标是将II期VTI原型转化为准备接受监管审查和商业化的医疗器械。在完成VTI的法规合规性测试、验证和临床确认后，将准备技术和临床文件供FDA申请。该项目IIB期的终点是FDA 510（k）提交。VTI的商业化将遵循FDA的批准。拟议项目的完成有望获得科学知识，提供新的技术能力，提高妇科临床实践。

DESCRIPTION (provided by applicant): Pelvic organ prolapse is a highly prevalent condition affecting at least 50% of women in the US during their lifetimes. Some loss of utero-vaginal support occurs in most adult women, however, the true etiology of prolapse and differences seen among individuals is not entirely understood. Changes in the elasticity of the vaginal walls, connective support tissues and muscles are thought to be significant factors in the development of pelvic organ prolapse. We propose to develop a device entitled Vaginal Tactile Imager (VTI) for 3-D visualization and assessment of mechanical properties of pelvic floor tissues. VTI is based on the Tactile Imaging (TI) technology founded on the principles similar to those of manual palpation. In Phases I and II we designed and built a and prototypes of VTI with tactile sensor array and a motion tracking sensor, completed VTI testing and verification with the tissue mimicking phantoms, completed Phase I and initiated Phase II clinical study. Clinical results demonstrated capability of the proposed approach for 3-D imaging of the vagina and pelvic floor support structures. Our findings suggest that the normality ranges for tissue elasticity of vagina and its support structures evaluated by VTI might be used as the markers in diagnosis of pelvic floor conditions. We further demonstrated VTI capability in characterization of outcome of pelvic floor reconstructive surgery. Tactile Imaging technology developed at Artann Laboratories is highly innovative and unique. Artann scientists are the first in the world to introduce and develop Tactile Imaging technology into the practical and proven successful applications described in numerous publications and 21 issued patents. The main goal of Phase IIB is to transform the Phase II VTI ¿-prototype into medical device ready for regulatory review and commercialization. Upon completion of regulatory compliance testing, verification and clinical validation of the VTI, technical and clinical files will be prepared for FDA application. The endpoint for the Phase IIB of the project is the FDA 510(k) submission. The VTI commercialization will follow the FDA approval. The completion of proposed project promises to gain scientific knowledge, provide new technical capability and improve clinical practice in gynecology.