Minimally Invasive High Intensity Ultrasound Treatment of Uterine Fibroids

描述(申请人提供)：良性子宫肿瘤(肌瘤)在临床上可见于多达50%的女性，通常需要手术切除有症状的子宫肌瘤或子宫切除术。对于考虑生育的妇女，治疗选择仅限于侵入性的开腹子宫肌瘤切除术，以最好地保持子宫壁的结构完整性；禁止使用侵入性较小的腹腔镜手术。临床上仍然需要一种替代传统手术方法的微创方法，以减少发病率和恢复时间，缩短手术时间，降低成本。最近使用微创热消融(如射频、激光、冷冻治疗、HIFU)的临床研究表明，在减少肌瘤体积和缓解症状方面具有巨大的潜力。这些技术的局限性包括不能在空间上控制能量的分布以符合肌瘤体积、不足以满足需要多个装置插入的单一治疗体积、较长的程序时间或可能因肌瘤接近关键组织结构(例如，膀胱、肠道)而限制使用。在一期工程中已经开发了用于体积式纤维瘤消融术的高强度间质超声设备，具有提供选择性加热模式的动态空间控制、增强的径向热穿透和快速加热的能力。这种超声技术可以为子宫肌瘤的体积消融治疗提供一种卓越的微创技术，有望实现更准确和彻底的靶向，保护关键的非靶向组织(如膀胱、肠道)，可以接触到更多的肌瘤，并缩短手术时间。这一第二阶段研究和商业化计划的目标是最终完成腹腔镜和经宫颈适形高强度间质超声设备和空间 针对成功治疗所需的大容量适形热消融的特定控制能力，具有完整的输送系统和治疗策略，专用于精确图像引导的容积式纤维瘤消融术，并已批准用于临床研究。

DESCRIPTION (provided by applicant): Benign uterine tumors (fibroids) are clinically apparent in up to 50% of women and typically require surgical removal of symptomatic fibroids or hysterectomy. Treatment options for women considering bearing children are limited to the invasive surgical open myomectomy to best maintain structural integrity of the uterine wall; the less invasive laparoscopic removal is contraindicated. There remains a substantial clinical need for a minimally-invasive alternative to traditional surgical approaches with the promise of less morbidity and recovery time, faster procedure time, and lower cost. Recent clinical investigations using minimally-invasive thermal ablation (e.g., RF, laser, cryotherapy, HIFU) have demonstrated significant potential in reducing fibroid volume and providing symptomatic relief. Limitations of these techniques include an inability to spatially control the distribution f energy to conform to the fibroid volume, inadequate single treatment volumes requiring multiple device insertions, long procedural times, or use may be limited by the proximity of a fibroid to critical tissue structures (e.g., bladder, bowel). High-intensity interstitial ultrasound devices fr volumetric fibroid ablation have been developed in a Phase I project, with demonstrated capabilities to provide dynamic spatial control of selective heating patterns, enhanced radial thermal penetration, and fast heating times. This ultrasound technology can provide a superior minimally-invasive technique for volumetric ablation treatment of uterine fibroids with the promise of more accurate and thorough targeting, protection of critical non-targeted tissue (e.g., bladder, bowel), accessibility to a larger number of fibroids, and faster procedure times. The objective of this Phase II research & commercialization plan is to finalize development of laparoscopic and transcervical conformal high-intensity interstitial ultrasound devices and spatial control capabilities specific for conformal thermal ablation of large volumes required for successful treatment, with complete delivery system and treatment strategies, specific to precision image-guided volumetric fibroid ablation and approved for clinical study.