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：
10153741
负责人：
Frank William Mauldin
金额：
$ 82.92万
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 2022-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10153741
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.

项目摘要/摘要骨髓和Trephine活检（BMTB）是诊断和监测的金标准尽管BMTB程序很少引起严重的不良事件，但由于重复测试延迟诊断和治疗，消耗额外的医疗资源，并引起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核心长度超过1.5厘米，但是，多次临床试验报告说，核心长度的20-50％≤1.0cm，表明这些临床建议不经常满足。这一发现进一步支持了这个结论在5 - 25％的BMTB标本之间被视为非诊断，通常是必需的重复 BMTB程序，用于BMTB程序的放射学指导的转诊，或最终导致模棱两可或假阴性诊断。该第二阶段项目的目标是最终确定临床预审成像的设计和制造用于实时3D图像指导的系统（准确3s）骨髓trephine活检程序床头。该项目的关键技术创新包括：（i）设计小型3D的设计超声成像探针，（ii）高级骨特异性成像和3D渲染的发展实时生成患者iLiac Crest的体积重建的技术，以及（iii）实施图像处理算法，该算法自动检测后峰和协助通过对目标解剖结构进行自动指导，以促进活检。这些意图技术是为了提供iLiac波峰的直观可视化，并避免与与进行图像引导的介入程序时，超声图像解释。核心技术将通过大量的体外成像研究进行开发和测试。人尸体标本中的临床前验证。提出的解决方案的影响是BMTB成功率的显着提高和降低放射学指导的转介率。这些影响有望减少BMTB获取的延迟，减少患者接触电离辐射的暴露，并降低需要减少重复活检和的成本放射学指导的推荐更少。一起，由于转介射线照相指导而导致的年费用，重复BMTB程序，以及由于诊断错误的成本超过4.8亿美元/年。由于这些原因，血液学诊所床边的BMTB标本检索是首选的活检技术。这在此II阶段申请中提出的技术解决方案旨在提高BMTB的结果程序在床边执行。最后，该设备的美国总市场规模估计为每年2.3亿美元，支持拟议技术开发工作的商业可行性。