Modular Ultrasonic Beacon System (MUBS) for Ultrasound-guided Interventional Surg

用于超声引导介入手术的模块化超声信标系统 (MUBS)

• 批准号: 8589815
• 负责人: Thomas Cummins
• 金额: $ 20.1万
• 依托单位: CLARITRAC, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-15 至 2015-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8589815
• 关键词: Adoption; Algorithms; Back; Biopsy; Breast; Caring; Cost Savings; Custom; Data; Detection; Devices; Distal; Drops; Electronics; Equilibrium; Failure; Fostering; Future; Generations; Goals; Healthcare Systems; Housing; Image; Image Enhancement; Imagery; Intervention; Learning; Legal patent; Location; Manufacturer Name; Medical; Medical Device; Methods; Modality; Monitor; Needle biopsy procedure; Needles; Nerve Block; Operative Surgical Procedures; Phase; Physiologic pulse; Play; Power Sources; Printing; Problem Solving; Procedures; Provider; Research; Research Personnel; Risk; Safety; Sampling; Scheme; Signal Transduction; Solutions; System; Tissues; Training; Transducers; Ultrasonic Therapy; Ultrasonic Transducer; Ultrasonics; Ultrasonography; Unnecessary Surgery; Woman; analog; base; breast cancer diagnosis; commercialization; computerized data processing; cost; cost effectiveness; design; hazard; imaging probe; innovation; innovative technologies; manufacturing process; miniaturize; minimally invasive; novel; patient safety; prototype; public health relevance; soft tissue; standard of care; tool

DESCRIPTION (provided by applicant): Each year 1.6 million US women undergo biopsy for breast cancer diagnosis. Fortunately fewer and fewer women suffer through open surgical biopsy but rather receive minimally invasive image-guided needle based biopsy. Ultrasound imaging guidance is the dominant modality for this intervention as it offers the greatest balance of safety, patient comfort, expediency, and cost effectiveness. However, for all its safety and convenience, ultrasound imaging quality remains strongly operator dependent. This problem is exacerbated by the fact that ultrasound is optimal for imaging soft tissue and not metallic tools such as needles. What this presents is a new barrier for adoption amongst many would-be practitioners: ultrasound guided needle-based interventions are difficult and require substantial training. ClariTrac Inc. is a startup medical device company that aims to solve this problem. Specifically, ClariTrac is developing a patent pending Modular Ultrasonic Beacon System (MUBS) that consists mainly of a disposable, miniature hardware component to be incorporated with the tip or shaft of needles or other interventional tools. The MUBS is a fully integrated ultrasound transducer with electronics and interconnection. The operating principle of the MUBS is like a beacon: it waits in stand-by to detect ultrasound energy emitted from the ultrasound imaging probe. Upon detecting the probe's energy, the MUBS in turn actively transmits energy back to the probe, in a marco-polo fashion. This returned energy appears as a bright, customizable marker on the ultrasound image that represents the precise location of the interventional tool. We hypothesize this marker will allow the care- provider to perform the procedure with greater ease and precision. Our ultimate goal is to design hardware that serves as a low-cost platform for future innovation in ultrasound enabled interventional tools. These applications extend to nerve block and line-placement, beyond image enhancement to imaging, tissue characterization, monitoring and therapy.

描述（由申请人提供）：每年有 160 万美国女性接受活检以诊断乳腺癌。幸运的是，越来越少的女性接受开放式手术活检，而是接受微创图像引导针刺活检。超声成像引导是这种干预的主要方式，因为它提供了安全性、患者舒适度、便利性和成本效益的最大平衡。然而，尽管其安全性和便利性，超声成像质量仍然强烈依赖于操作员。由于超声波最适合软组织成像而不是针等金属工具，这一事实加剧了这个问题。这给许多潜在的从业者带来了新的障碍：超声引导的基于针的干预措施很困难并且需要大量的培训。 ClariTrac Inc. 是一家初创医疗器械公司，旨在解决这个问题。具体来说，ClariTrac 正在开发一种正在申请专利的模块化超声波信标系统 (MUBS)，该系统主要由一次性微型硬件组件组成，可与针头或针杆或其他介入工具结合在一起。 MUBS 是一款具有电子和互连功能的完全集成超声换能器。 MUBS的工作原理就像一个信标：它处于待机状态，等待检测从超声成像探头发出的超声能量。一旦检测到探头的能量，MUBS 就会以马可波罗的方式主动将能量传输回探头。返回的能量在超声图像上显示为明亮的可定制标记，代表介入工具的精确位置。我们假设该标记将使护理人员能够更轻松、更精确地执行手术。我们的最终目标是设计硬件，作为超声介入工具未来创新的低成本平台。这些应用扩展到神经阻滞和线路放置，超越图像增强到成像、组织表征、监测和治疗。