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，影响了美国至少50%的女性。一些子宫阴道支持的丧失发生在大多数成年女性，然而，脱垂的真正病因和个体之间的差异尚不完全清楚。阴道壁、结缔组织和肌肉弹性的改变被认为是盆腔器官脱垂的重要因素。我们建议开发一种名为阴道触觉成像仪（VTI）的设备，用于骨盆底组织的三维可视化和机械特性评估。VTI是基于触觉成像（TI）技术，其原理与手动触诊相似。在第一阶段和第二阶段，我们设计并制造了一个带有触觉传感器阵列和运动跟踪传感器的VTI原型，完成了VTI模拟组织的测试和验证，完成了第一阶段并开始了第二阶段的临床研究。临床结果证明了该方法对阴道和骨盆底支撑结构的三维成像能力。我们的研究结果提示，VTI评估阴道组织弹性及其支撑结构的正常范围可作为盆底疾病诊断的标志。我们进一步证明了VTI在表征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是高度创新和独特的。Artann科学家是世界上第一个引进和开发的

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.