Minimally Invasive High Intensity Ultrasound Treatment of Uterine Fibroids

描述（由申请人提供）：良性子宫肿瘤（肌瘤）在临床上见于高达50%的女性，通常需要手术切除有症状的肌瘤或子宫切除术。考虑生育的女性的治疗选择仅限于侵入性开放性子宫肌瘤切除术，以最好地保持子宫壁的结构完整性;禁忌微创腹腔镜切除。临床上仍然需要一种微创手术方法来替代传统手术方法，该方法具有发病率低、恢复时间短、手术时间短和成本低的优点。最近使用微创热消融的临床研究（例如，射频、激光、冷冻疗法、高强度聚焦超声（HIFU）在缩小肌瘤体积和缓解症状方面具有显著潜力。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、需要多个装置插入的不充分的单个治疗体积、长的手术时间，或者使用可能受到肌瘤与关键组织结构（例如，膀胱、肠）。用于体积肌瘤消融的高强度间质超声设备已在I期项目中开发，具有提供选择性加热模式的动态空间控制、增强的径向热渗透和快速加热时间的能力。这种超声技术可以提供用于子宫肌瘤的体积消融治疗的上级微创技术，其具有更准确和彻底的靶向、保护关键的非靶组织（例如，膀胱、肠）、更大数量的肌瘤的可及性以及更快的手术时间。该第二阶段研究和商业化计划的目标是完成腹腔镜和经颅适形高强度间质超声设备的开发， 针对成功治疗所需的大体积适形热消融的控制能力，具有完整的输送系统和治疗策略，特定于精确的图像引导体积肌瘤消融，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.