In-situ Guidance for Ultrasound Needle-based Interventions

超声针干预的现场指导

• 批准号: 8394704
• 负责人: Philipp Stolka
• 金额: $ 14.83万
• 依托单位: CLEAR GUIDE MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-10 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8394704
• 关键词: Ablation; Accounting; Adoption; Algorithms; Anatomy; Animals; Area; Biopsy; Breathing; Calibration; Clinic; Clinical; Community Hospitals; Complex; Computer software; Data; Development; Devices; Diagnosis; Diagnostic; Effectiveness; Ensure; Goals; Head; Health Personnel; Hospitals; Image; Imagery; In Situ; Injection of therapeutic agent; Intervention; Lasers; Lesion; Life; Malignant Neoplasms; Manuals; Marketing; Medical; Methods; Monitor; Motion; Nature; Navigation System; Needles; Outcome; Patients; Performance; Phase; Pilot Projects; Preparation; Procedures; Radiation therapy; Relative (related person); Reporting; Research; Rural; Scanning; Scheme; Solutions; Specific qualifier value; Speed; Sterility; Surface; System; Technology; Testing; Time; Tissues; Training; Treatment Failure; Ultrasonography; Update; Visual; base; cancer diagnosis; cancer therapy; case-based; clinical efficacy; clinical practice; commercial application; cost; cost effective; ergonomics; experience; image guided therapy; improved; innovation; instrument; interest; minimally invasive; phantom model; phase 1 study; prototype; response; sensor; tool; usability; visual tracking

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.

描述（由申请人提供）：基于针头的活检和图像引导的治疗是癌症诊断和治疗的迅速增长的领域。他们的优势是它们的最低侵入性质，但瞄准感兴趣领域的困难是既定的治疗失败原因。对更有效的基于针的程序的渴望激发了对图像指导的极大兴趣。在可用的成像选项中，超声既具有成本效益又安全。但是，由于需要同时管理针和探针，并同时对针和目标区域进行成像，因此传统的B模式成像可以使针头挑战针头。结果，有效使用超声指导取决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目标指导。不幸的是，这些系统遭受了许多缺点，包括高成本，低可用性和有限的准确性，所有这些都极大地阻碍了它们在实践中的有效性和广泛的采用。 清晰的指南医疗项目将通过为超声图像指导提供一种具有成本效益，准确和人体工程学的方法来改善临床实践。这种方法的关键是开发直接附在超声探针上的紧凑型指导平台。通过硬件和软件组件的独特组合，清晰的指南融合将注册到身体和目标的探针，将跟踪基于针头的介入仪器，并将直接提供直观的导航信息，直接原位，该信息将指导临床医生朝着超出图像本身或术前患者扫描中可用的目标。该技术将作为用于手持超声探针的快照支架，因此将消除当前跟踪系统的侵入性和随之而来的要求，包括确保正确的系统校准和介入工具的无菌性。我们的紧凑型设备将提供对TH患者表面和任何针头或介入工具的实时跟踪，从而支持临床医生的原位视觉指导，而无需更改典型的工作流程，额外的复杂硬件或其他准备工作以确保无菌。结果，定位准确性将提高，时间将减少，有效诊断或治疗所需的临床专业知识水平将降低。该系统将作为临床原型开发，并在实时动物研究中得到验证，以说明探针和针头运动，以及呼吸运动以及组织相互作用和变形。 总而言之，清晰的指南医学项目的重要性是通过简化癌症病变进行活检和治疗来改善癌症的诊断和治疗。影响将降低成本，并更广泛地获得指导技术，从而使更多医院成为可能。 公共卫生相关性：我们的项目标题为“明确指南融合：基于针头的基于针头干预措施的原地指南”将开发一种设备，该设备将通过提高针刺诊断或治疗的准确性来有助于治疗癌症。我们的系统将是第一个可以直接集成到超声探针头的系统，并且将提供比当前可用的任何竞争系统更具成本效率且易于使用的系统。