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Bedside ultrasound system for 3D guidance of bone marrow aspiration and biopsy procedures

用于骨髓抽吸和活检程序的 3D 引导的床边超声系统

基本信息

批准号：
10005652
负责人：
Frank William Mauldin
金额：
$ 67.08万
依托单位：
RIVANNA MEDICAL, INC.
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-05-01 至 2022-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10005652
关键词：
3-Dimensional 3D ultrasound Advanced Development Algorithms Anatomy Anxiety Biopsy Biopsy Specimen Bone Marrow Bone Marrow Aspiration Bone Surface Bone marrow biopsy Cadaver Clinic Clinical Clinical Trials Consumption Core Biopsy Data Detection Devices Diagnosis Diagnostic Diagnostic Errors Diagnostic radiologic examination Dimensions Direct Costs Elderly Ensure Exhibits Exposure to Failure Funding Goals Gold Growth Guidelines Hand Health Care Costs Health care facility Healthcare Healthcare Systems Hematologic Neoplasms Hematological Disease Hematologist Hematology Human Human Volunteers Image Image Analysis Imaging technology In Vitro Individual Interventional radiology Intuition Ionizing radiation Knowledge Learning Length Manuals Medical Medical Device Modeling Monitor Morphologic artifacts Needles Obesity Oncologist Oncology Oncology Group Palpation Pathology Patients Phase Physicians&apos Offices Plant Roots Positioning Attribute Privatization Procedures Provider Puncture biopsy Real-Time Systems Recommendation Reporting Resources Retrieval Sensitivity and Specificity Serious Adverse Event Services Site Specimen Surface System Techniques Technology Testing Three-Dimensional Image Time Trephine Biopsy Ultrasonography Validation Virginia Visualization Work World Health Organization arm automated algorithm base blind bone bone imaging bone quality commercial application cost cost effective design diagnosis standard human imaging image guided image guided intervention image processing imaging capabilities imaging probe imaging study imaging system improved improved outcome innovation miniaturize patient population patient safety point of care portability pre-clinical prevent procedure cost prototype reconstruction response stem success technological innovation technology development

项目摘要

PROJECT SUMMARY/ABSTRACT Bone marrow and trephine biopsy (BMTB) is the gold standard for diagnosing and monitoring hematological disorders and malignancies. Although BMTB procedures rarely cause serious adverse events, the number of non-diagnostic biopsies should be minimized because repeated testing delays diagnosis and treatment, consumes additional healthcare resources, and causes unnecessary patient anxiety and discomfort. World Health Organization guidelines recommend that bone marrow biopsy cores exceed 1.5 cm in length, however multiple clinical trials have reported that 20 – 50 % of core lengths are ≤ 1.0 cm, suggesting that these clinical recommendations are not regularly met. This conclusion is further supported by the finding that between 5 – 25 % of BMTB specimens are deemed non-diagnostic by pathology, often necessitating a repeat BMTB procedure, referral for radiographic guidance of the BMTB procedure, or ultimately resulting in an ambiguous or false negative diagnosis. The goal of this Phase II project is to finalize the design and fabrication of a clinical-trial-ready imaging system (Accuro 3S) for real-time 3D image guidance of bone marrow trephine biopsy procedures at the bedside. The key technological innovations of this project include: (i) the design of a miniaturized 3D ultrasound imaging probe, (ii) the development of advanced bone-specific imaging and 3D rendering technologies for generating volumetric reconstructions of the patient's iliac crest in real-time, and (iii) the implementation of an image processing algorithm that automatically detects the posterior iliac crest and assists with automated needle guidance to the target anatomy to facilitate biopsy acquisition. The intent of these technologies is to provide an intuitive visualization of the iliac crest and to avoid difficulties associated with ultrasound image interpretation when conducting an image-guided interventional procedure. Core technologies will be developed and tested via extensive in vitro imaging studies of anatomically correct phantoms prior to pre-clinical validation in a human cadaveric specimens. The impact of the proposed solution is a significant improvement in BMTB success rates and a reduced rate of referral for radiographic guidance. These effects are expected to reduce delays in BMTB acquisition, reduce patient exposure to ionizing radiation, and reduce costs due to the need for fewer repeat biopsies and fewer referrals for radiographic guidance. Together, the annual costs due to referral for radiographic guidance, repeat BMTB procedures, and costs stemming from diagnostic errors exceed $480M/yr. For these reasons, BMTB specimen retrieval at the bedside in the hematology clinic is the preferred biopsy technique. The technological solutions proposed in this Phase II application seek to enable improved outcomes of BMTB procedures performed at the bedside. Finally, the total US market size for this device is estimated to be $230M/yr, supporting the commercial viability of the proposed technology development efforts.

项目总结/摘要骨髓和环钻活检（BMTB）是诊断和监测的金标准血液病和恶性肿瘤。虽然BMTB手术很少引起严重的不良事件，应尽量减少非诊断性活检的数量，因为重复检测会延误诊断，治疗，消耗额外的医疗资源，并导致不必要的患者焦虑和不适。世界卫生组织指南建议骨髓活检芯长度超过1.5 cm，然而，多项临床试验报告称，20 - 50%的核心长度≤ 1.0 cm，这表明这些临床建议没有得到定期执行。这一结论得到以下研究结果的进一步支持： 5 - 25%的BMTB标本被病理学认为是非诊断性的， BMTB手术，转诊接受BMTB手术的放射学指导，或最终导致不明确或假阴性诊断。这个第二阶段项目的目标是完成临床试验准备成像的设计和制造系统（Accuro 3S），用于骨髓环钻活检程序的实时3D图像引导，床边该项目的主要技术创新包括：（i）设计一个小型化的3D 超声成像探头，（ii）开发先进的骨特异性成像和3D渲染用于实时生成患者髂嵴的体积重建的技术，以及（iii）实施图像处理算法，自动检测后髂嵴并辅助自动引导针到达目标解剖结构，以便于活检采集。这些的意图技术的目的是提供髂嵴的直观可视化，并避免与当进行图像引导介入手术时，超声图像解释。核心技术将通过解剖学上正确的体模的广泛体外成像研究进行开发和测试，在人体尸体标本中进行临床前确认。所提出的解决方案的影响是BMTB成功率的显著提高和影像学引导转诊率。这些影响预计将减少BMTB收购的延误，减少患者暴露于电离辐射，并由于需要较少的重复活检而降低成本，更少的转介放射学指导。总之，由于转诊放射学指导，重复BMTB程序，诊断错误导致的成本超过4.8亿美元/年。基于这些理由，在血液科门诊的床边进行BMTB标本回收是首选的活检技术。的在第二阶段申请中提出的技术解决方案旨在改善BMTB的结果在床边进行的手术。最后，该设备的美国市场总规模估计为 2.3亿美元/年，支持拟议技术开发工作的商业可行性。