In-situ Guidance for Ultrasound Needle-based Interventions

描述(申请人提供)：针刺活检和影像引导治疗是癌症诊断和治疗的快速增长领域。它们的优势在于其微创性质，但由此导致的针对感兴趣区域的困难是治疗失败的既定原因。对更有效的针基手术的渴望激发了人们对图像引导的极大兴趣。在可用的成像选择中，超声波既经济有效又安全。然而，由于需要同时管理针和探头，并同时对针和靶区进行成像，传统的B型成像可能会使针对准具有挑战性。因此，超声引导的有效使用依赖于高水平的临床医生培训和经验。最近开发的导航系统试图提供定向指导。遗憾的是，这些系统存在一些缺点，包括成本高、可用性低、精度有限，所有这些都极大地阻碍了它们的有效性和在实践中的广泛采用。Clear Guide医学项目将通过提供具有成本效益的、准确的、符合人体工程学的超声图像引导方法来改进临床实践。这种方法的关键是开发一种紧凑的直接连接到超声波探头上的引导平台。通过硬件和软件组件的独特组合，Clear Guide Fusion将把探头对准身体和目标，跟踪基于针头的介入仪器，并将直接在原位提供直观的导航信息，引导临床医生指向超声图像本身或术前患者扫描中可用的目标。这项技术将作为手持式超声探头的卡扣式支架提供，因此将消除当前跟踪系统的侵入性和随之而来的要求，包括确保适当的系统校准和介入工具的无菌。我们的紧凑型设备将提供对患者表面和任何针头或介入工具的实时跟踪，从而支持对临床医生的现场视觉指导，而无需更改典型的工作流程、额外的复杂硬件或确保无菌的额外准备。因此，靶向准确性将得到提高，时间将会减少，有效诊断或治疗所需的临床专业知识水平将会降低。该系统将作为临床原型开发，并在活体动物研究中得到验证，以解释探头和针的运动，以及呼吸运动和组织相互作用和变形。总而言之，Clear Guide医学项目的意义在于通过简化针对癌症病变的活检和治疗来提高癌症的诊断和治疗水平。其影响将是降低成本和更广泛地获得指导技术，使诊断干预在更多的医院成为可能。 与公共卫生相关：我们的项目名为“清晰的引导融合：超声引导针基介入的现场指导”，将开发一种设备，通过提高诊断或治疗的针头放置的准确性，为癌症的治疗做出贡献。我们的系统将是第一个可以直接集成到超声探头的系统，并将提供比现有任何竞争系统更具成本效益和更易于使用的系统。

DESCRIPTION (provided by applicant): Needle-based biopsy and image-guided therapy are rapidly growing areas of cancer diagnosis and treatment. Their advantage is their minimally-invasive nature, but the resulting difficulty in targeting the area of interest is an established cause of treatment failure. The desire for more effective needle-based procedures has spurred immense interest in image guidance. Of the available imaging options, ultrasound is both cost-effective and safe. However, traditional B-mode imaging can make targeting of the needle challenging due to the need to simultaneously manage needle and probe, and to image both needle and the targeted area. As a result, effective use of ultrasound guidance depends on a high level of clinician training and experience. Recently developed navigation systems attempt to provide targeting guidance. Unfortunately, these systems suffer from a number of drawbacks, including high cost, low usability, and limited accuracy, all of which greatly impede their effectiveness and wide adoption in practice. The Clear Guide Medical project will improve clinical practice by providing a cost-effective, accurate, and ergonomic approach to ultrasound image guidance. Key to this approach is the development of a compact guidance platform that attaches directly to the ultrasound probe. Through a unique combination of hardware and software components, Clear Guide Fusion will register the probe to the body and the target, will track needle-based interventional instruments, and will provide intuitive navigation information directly in situ that will guide a clinician towards targets that are available either in the ultraound image itself or in a preoperative patient scan. This technology will be available as a snap-on bracket for handheld ultrasound probes, and hence will eliminate the intrusiveness of current tracking systems and the attendant requirements including ensuring proper system calibration and the sterility of interventional tools. Our compact device will provide real time tracking of th patient surface and any needle or interventional tool, thus supporting in-situ visual guidance to the clinician without changes to the typical workflow, additional complex hardware, or additional preparation to ensure sterility. As a result, targeting accuracy will be improved, time will be reduced, and the level of clinical expertise needed for effective diagnosis or treatment will decrease. The system will be developed as a clinical prototype, and validated in a live animal study to account for probe and needle motions, as well as for breathing motion and tissue interaction and deformation. In summary, the significance of the Clear Guide Medical project is to improve both the diagnosis and the treatment of cancer by simplifying the targeting of cancer lesions for biopsy and treatment. The impact will be reduced cost and wider access to guidance technology making diagnostic interventions possible in more hospitals. PUBLIC HEALTH RELEVANCE: Our project entitled "Clear Guide Fusion: In-Situ Guidance for Ultrasound-Guided Needle-Based Interventions" will develop a device that will contribute to the treatment of cancer by improving the accuracy of needle placement for diagnosis or therapy. Our system will be the first that can be integrated directly to the the ultrasound probe-head, and will provide a more cost-effective and easy-to-use system than any competing system currently available.