Sentinel lymph node biopsy system for breast cancer

描述（申请人提供）：本研究的长期目标 是设计和开发一个专用的，计算机化的，微创的哨兵， 用于乳腺癌分期的淋巴结活检系统。而腋窝淋巴结 淋巴结清扫仍然是乳腺癌分期的金标准， 超过70%的患有小乳腺肿瘤的女性接受腋窝淋巴结转移， 发现淋巴结清扫术具有阴性腋窝淋巴结。拟议 微创活检系统可以避免腋窝淋巴结的发病率 每年为超过32，000名属于这一类别的妇女进行解剖。在 第一阶段，我们将建立准确识别的技术可行性 定位前哨淋巴结在第二阶段，我们将证明临床 通过一个非常小的安全提取前哨淋巴结的可行性 腋窝切口，并比较该系统的临床疗效， 腋窝解剖作为分期工具所提出的系统在空间上集成 相关的超声和核医学成像技术，以及 计算机驱动的专用活检设备，以提供标准化平台 进行微创前哨淋巴结活检我们相信电脑化的 平台将导致前哨淋巴结活检的更广泛使用， 临床上合适的患者。 拟定商业应用： 我们的分析表明，微创前哨淋巴结活检的市场将 支持最初的年销售量为70台，价格约为90，000美元/台 单位 初始单位将作为专用乳腺芯活检系统的辅助设备提供 安装在世界各地的手术中心。

DESCRIPTION (Provided by Applicant): The long-term objective of this research is to design and develop a dedicated, computerized, minimally invasive sentinel lymph node biopsy system for staging of breast cancer. While axillary lymph node dissection remains the gold standard of care for staging of breast cancer, over 70 percent of women with small breast tumors who undergo axillary lymph node dissection are found to have negative axillary nodes. The proposed minimally invasive biopsy system could spare the morbidity of axillary node dissection for over 32,000 women who fall into this category each year. In Phase I, we will establish the technical feasibility of accurately identifying and localizing the sentinel node. In Phase II, we will demonstrate the clinical feasibility of safely extracting the sentinel node intact through a very small incision in the axilla, and compare the clinical efficacy of the system to axillary dissection as a staging tool. The proposed system integrates spatially correlated ultrasound and nuclear medicine imaging technologies, as well as computer driven, specialized biopsy devices, to provide a standardized platform for minimally invasive sentinel node biopsy. We believe that the computerized platform will lead to more widespread use of sentinel node biopsy for clinically appropriate patients. PROPOSED COMMERCIAL APPLICATION: Our analysis indicates that the market for minimally invasive sentinel lymph node biopsy will support an initial annual sales volume of 70 units at an approximate price of $90,000 per unit. Initial units will be offered as an adjunct to the dedicated breast core biopsy systems installed in surgical centers worldwide.