Vaginal Tactile Imager for Pelvic Floor Biomechanical Assessment

用于盆底生物力学评估的阴道触觉成像仪

• 批准号: 8591302
• 负责人: Vladimir Egorov
• 金额: $ 82.8万
• 依托单位: ARTANN LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8591302
• 关键词: 3-Dimensional; Adult; Affect; Biomechanics; Clinical; Clinical Data; Clinical Research; Computer software; Data Analyses; Development; Device Designs; Devices; Diagnosis; Disease; Disinfection; Documentation; Elasticity; Etiology; Goals; Grant; Gynecology; Image; Imagery; Imaging Device; Imaging technology; Individual; Knowledge; Laboratories; Legal patent; Managed Care; Manuals; Mechanics; Medical Device; Metric; Motion; Muscle; Normalcy; Operative Surgical Procedures; Organ; Outcome; Palpation; Patients; Pelvic floor structure; Pelvis; Performance; Phase; Population; Production; Property; Prostate; Ptosis; Publications; Quality of life; Reconstructive Surgical Procedures; Reporting; Risk; Safety; Scientist; Software Design; Staging; Structure; Tactile; Testing; Three-Dimensional Image; Three-Dimensional Imaging; Time; TimeLine; Tissues; United States; United States National Institutes of Health; Update; Vagina; Validation; Variant; Woman; base; clinical practice; clinical research site; commercialization; comparative; data acquisition; design; improved; innovation; lifetime risk; operation; performance tests; prototype; public health relevance; sensor; software systems; tool; validation studies

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.

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%的女性在她们的一生中受到影响。大多数成年女性会发生子宫-阴道支持的丧失，然而，脱垂的真正原因和个体之间的差异并不完全清楚。阴道壁、结缔组织和肌肉弹性的变化被认为是盆腔器官脱垂发生的重要因素。我们建议开发一种名为阴道触觉成像仪(VTI)的设备，用于三维可视化和评估盆底组织的机械特性。VTI基于触觉成像(TI)技术，其原理类似于手动触诊。在第一阶段和第二阶段，我们设计并制作了具有触觉传感器阵列和运动跟踪传感器的虚拟仪器样机，利用组织模拟体模完成了虚拟仪器的测试和验证，完成了第一阶段和启动第二阶段的临床研究。临床结果表明，所提出的方法能够对阴道和盆底支撑结构进行三维成像。结果提示，VTI评价的阴道组织弹性及其支持结构的正常范围可作为诊断盆底状况的指标。我们进一步证明了VTI在描述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很高的创新性和独特性。阿坦纳大学的科学家是世界上第一个引进和开发 将触觉成像技术转化为实际和经过验证的成功应用，在众多出版物和21项已颁发的专利中进行了描述。第二阶段B的主要目标是将第二阶段的VTI？原型转化为医疗设备，为监管审查和商业化做好准备。在完成VTI的法规遵从性测试、验证和临床验证后，将准备技术和临床文件，供FDA申请。该项目第二阶段B的终点是FDA提交的510(K)。VTI的商业化将在FDA批准之后进行。拟议项目的完成有望获得科学知识，提供新的技术能力，并改善妇科的临床实践。