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）在临床上明显见于50%的女性，通常需要手术切除有症状的肌瘤或子宫切除术。考虑生育的妇女的治疗选择仅限于有创手术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；微创腹腔镜切除是禁忌。临床仍然需要一种微创替代传统手术方法，以减少发病率和恢复时间，更快的手术时间和更低的成本。最近的临床研究表明，微创热消融（如射频、激光、冷冻治疗、HIFU）在减少肌瘤体积和缓解症状方面具有显著的潜力。这些技术的局限性包括无法在空间上控制能量分布以符合肌瘤体积，需要多次装置插入的单次治疗体积不足，手术时间长，或者由于肌瘤靠近关键组织结构（如膀胱、肠）而限制使用。用于体积肌瘤消融的高强度间质超声设备已在一期项目中开发出来，具有提供选择性加热模式的动态空间控制、增强径向热穿透和快速加热时间的能力。该超声技术为子宫肌瘤的体积消融治疗提供了一种优越的微创技术，具有更准确、更彻底的靶向性、对关键非靶向组织（如膀胱、肠）的保护、更大数量的肌瘤的可及性和更快的手术时间。该二期研究和商业化计划的目标是完成腹腔镜和经宫颈适形高强度间质超声设备和空间超声的开发

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.