HIGH INTENSITY FOCUSED ULTRASOUND THERAPY SYSTEM

高强度聚焦超声治疗系统

• 批准号: 2712753
• 负责人: RICHARD Bruce BERNARDI
• 金额: $ 31.41万
• 依托单位: SPECTRASONICS, INC.
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-07-15 至 1999-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2712753
• 关键词: biomedical equipment development; clinical biomedical equipment; imaging /visualization /scanning; liver; neoplasm /cancer palliative treatment; noninvasive diagnosis; swine; ultrasound therapy

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.

该计划致力于开发实用的治疗方法 用于非侵入性治疗目前存在的疾病的超声系统 现代医疗保健面临的挑战性问题。 第一个目标是 提供姑息治疗和转移性管理系统 肝癌，使无法治愈的患者受益 目前的方式。 将设计一个实用的治疗系统 完整的功能，结合可靠的校准方法， 临床易用性，用于瞄准和病变的超声成像 监控。 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 批准用于治疗难治性青光眼。 新单位还将 将诊断成像设备与先进的频谱分析相集成 功能，还获得了 FDA 510-K 的一般批准 腹部应用。 光谱分析技术将用于 估计亚分辨率组织散射体特性（例如大小），并 检测临床超声治疗引起的微观结构变化。 将形成组织参数图像以帮助识别病变 特征。 开发一种方法的潜力是存​​在的 实时监控和控制高强度的过程 超声治疗可显着提高其疗效 治疗方式。 拟议的商业应用 Spectrasonics 将向临床医生和生化人员推销这些系统 希望研究广泛治疗方法的研究人员 应用包括治疗胰腺癌、前列腺癌、 和乳房。 最终预计该方法将 成为公认的传统微创替代方案 外科手术。