Image-Guided Transurethral HIFU for Genitourinary Therapy

 描述（由申请人提供）：女性压力性尿失禁（SUI）是骨盆底顺应性增加，导致尿道压力降低，通常通过分娩，并在用力时表现为尿液泄漏。SUI对女性健康有重大影响，包括与抑郁水平增加有关。治疗选择仅限于限制尿道活动性的带状植入物的侵入性手术插入。在尿道周围组织中注射膨胀剂是长期有效但暂时的治疗方法。药物相对较新，价格昂贵，而且没有长期疗效的记录。剩下的1400万妇女只能采取使用吸收垫或尿布的姑息治疗方法。一个实质性的临床需要存在一个非侵入性的替代传统的手术方法与承诺的发病率较低 和恢复时间、更快的手术时间以及更低的成本。最近的微创热技术的临床研究表明，组织的靶向热修饰可以减少SUI的症状。这些技术已经显示出前景，但比当前的手术选择更具侵入性，并且效果较差。治疗性和间质性超声设备是我们集团正在开发的一项创新技术，用于提供治疗癌症以及子宫肌瘤的热疗法， 提供选择性加热模式的动态空间控制、更大的径向热渗透和更快的治疗时间。我们建议开发这种专门用于治疗SUI的超声技术;该技术有可能提供一种用于治疗SUI的上级微创加热技术，具有更准确和彻底的靶向，保护关键的非靶组织（例如，尿道，阴道壁），更容易接触到更多数量的SUI患者，以及更快的手术时间。本I期研究计划的目的是扩展现有技术，并开发经尿道治疗性超声施源器，用于成功治疗SUI所需的特定组织结构的选择性和适形热治疗。经验设计、台架实验、生物学和声学建模以及体外组织实验测试和老年母羊胃肠道中的初步体内研究将用于设计反馈和表征器械性能，以及评估技术和潜在临床可行性。这些结果将应用于开发和理解改进的器械和潜在的治疗方法，为II期产品开发和临床实施的最终目标做准备。

 DESCRIPTION (provided by applicant): Stress urinary incontinence (SUI) in women is an increase of pelvic floor compliance which results in decrease of urethral pressure, typically through childbirth, and presents as urine leakage during exertion. SUI has significant impact on women's health, including an association with increased levels of depression. Curative options are limited to the invasive surgical insertion of a tape implant which limits the mobility of the urethra. Bulking agents injected in the peri-urethral tissue are a longstanding effective but temporary treatment. Pharmaceuticals are relatively new, prohibitively expensive, and there is no track record of long term efficacy. The remaining 14 million women are relegated to the palliative approaches of wearing absorptive pads or diapers. A substantial clinical need exists for a noninvasive alternative to traditional surgical approaches with the promise of less morbidity and recovery time, faster procedure time, and lower cost. Recent clinical investigations of minimally-invasive thermal techniques have demonstrated targeted thermal modification of tissue can reduce symptoms of SUI. These techniques have shown promise, but are more invasive than the current surgical options and are less effective. Therapeutic and interstitial ultrasound devices are an innovative technology under development by our group for delivering thermal therapy for treating cancer, as well as uterine fibroids, with demonstrated capabilities to provide dynamic spatial control of selective heating patterns, greater radial thermal penetration, and fast treatment times. We propose to develop this ultrasound technology specifically for the treatment of SUI; this technology has potential to provide a superior minimally-invasive heating technique for treating SUI with the promise of more accurate and thorough targeting, protection of critical non-targeted tissue (e.g., urethra, vaginal wall), more accessibility to a larger numbe of SUI patients, and faster procedure times. The objective of this Phase I research plan is to extend existing technology and develop transurethral therapeutic ultrasound applicators specific for selective and conformal thermal therapy of specific tissue structures required for successful treatment of SUI. Empirical design, bench experiments, biothermal and acoustic modeling, together with experimental testing in both ex-vivo tissues and a pilot in-vivo study in older ewes GU tract will be used for design feedback and to characterize device performance, as well as assess the technical and potential clinical feasibility. These results will be applied to the development and understanding of refined devices and potential treatment approaches in preparation for the ultimate goal of product development and clinical implementation during Phase II.