HIGH INTENSITY FOCUSED ULTRASOUND THERAPY SYSTEM

该计划涉及实际治疗的发展 用于非侵入性治疗疾病的超声系统 现代医疗保健的挑战性问题。 第一个目标是 提供了一种用于缓解和管理转移性肿瘤的系统， 肝癌，使无法治疗的患者受益， 目前的模式。 将设计一个实用的治疗系统， 完整的功能，包括可靠的校准方法， 临床易用性、超声成像瞄准和病变 监测. 为了实现这些目标，Spectrasonics将调整其 超声波治疗系统，已获得FDA上市前 批准用于治疗难治性青光眼。 新单位还将 将诊断成像设备与高级频谱分析集成 能力，还获得了510-K FDA批准， 腹部应用。 光谱分析技术将用于 估计亚分辨率组织散射体属性（例如，尺寸），以及 检测临床超声治疗引起的微结构变化。 将形成组织参数图像，以帮助识别病变 特色 有可能制定一种方法， 监控，真实的时间，高强度的过程 超声波治疗显著提高了这种治疗的效果， 治疗方式 建议的商业应用 Spectrasonics将把这些系统销售给临床医生和生化 希望研究广谱治疗药物的研究人员 包括胰腺癌，前列腺癌， 和乳房。 最终，预计这一方法将 成为一种公认的微创替代传统 手术

This program addresses the development of practical therapeutic ultrasound systems for non-invasive treatment of diseases that present challenging problems to modern health care. The first goal is the provision of a system for palliation and management of metastatic carcinoma in the liver, to benefit patients that are untreatable with current modalities. A practical therapy system will be designed with complete capabilities, incorporating reliable calibration methods, clinical ease-of-use, ultrasonic imaging for aiming, and lesion monitoring. To achieve these objectives, Spectrasonics will adapt its ultrasonic therapy system, which has received FDA Pre-Market Approval for treating refractory glaucoma. The new unit will also integrate a diagnostic imaging device with advanced spectrum analysis capabilities, also having received 510-K FDA approval for general abdominal applications. Spectral analysis techniques will be used to estimate sub-resolution tissue-scatterer properties (e.g., size), and to detect microstructural changes induced by clinical ultrasonic therapy. Tissue Parameter Images will be formed to aid in identifying lesion characteristics. The potential exists for developing a methodology to monitor and control, in real time, the course of the high intensity ultrasound treatment which improves significantly the efficacy of this therapy modality. PROPOSED COMMERCIAL APPLICATION Spectrasonics will market these systems to clinicians and biochemical researchers who wish to investigate a broad spectrum of therapeutic applications including treatments of cancers of the pancreas, prostate, and breast. Ultimately it is anticipated that this methodology will become an accepted minimally invasive alternative to conventional surgery.