SBIR Phase II: 4D scanner for image guided interventions

SBIR 第二阶段：用于图像引导干预的 4D 扫描仪

• 批准号: 1456352
• 负责人: Cristian Atria
• 金额: $ 75万
• 依托单位: nView medical Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-04-15 至 2020-09-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1456352&HistoricalAwards=false
• 关键词: SBIR; Phase; II; 4D; scanner

The broader impact/commercial potential of this project is the significant improvement ofsurgical accuracy, which will dramatically reduce surgical errors, improve outcomes andreduce healthcare costs. In spine surgery alone, there are more than 500,000procedures every year in the US utilizing implants such as screws. In 4% to 11% ofthese surgeries, the implant placement is inaccurate. For the patient this translates intolonger recoveries - from days to weeks - and in many cases into a second revisionsurgery. The patient is non-productive, unable to carry out their daily routines for weeks,while the healthcare system has to absorb the costs of the longer recovery as well asthe revision surgeries. For both the healthcare and economic systems these areavoidable costs. The medical imaging technology being developed in this project hasthe potential to eliminate surgical inaccuracies across the $2.4B market of imageguidance, improving clinical applications that range from orthopedic surgery to minimallyinvasive vascular interventions, to cancer diagnosis and treatments.This Small Business Innovation Research (SBIR) Phase 2 project will demonstrate anovel imaging modality, which provides near-real-time 3D live imaging - 4D - duringsurgery. This novel system will provide surgical imaging at a lower x-ray dose thanfluoroscopy (current standard), with a geometry that allows concurrent imaging withsurgery. This 4D technology has the potential to significantly reduce surgicalinaccuracies, improve outcomes and reduce costs. Phase 1 successfully demonstratedthe feasibility of the reconstruction algorithm used by the proposed imaging modality byshowing its potential of higher surgical accuracy in a single spinal screw insertion. ThisPhase 2 project will I) prove the robustness of the reconstruction algorithm across avariety of use-cases, II) demonstrate the clinical usability of the 4D scanner, and III)confirm the clinical utility of the scanner. The clinical usability will be studied with anergonomic model in a surgical setting. The clinical utility will be proven by building asystem prototype and performing image quality and x-ray dose comparisons versusfluoroscopy and 3D in a realistic surgical setting. Preliminary results show that theseobjectives are achievable. This research is readying the technology for clinical research,regulatory clearance and commercialization.

该项目更广泛的影响/商业潜力是手术准确性的显著提高，这将极大地减少手术错误，改善结果并降低医疗成本。仅在脊柱手术方面，美国每年就有超过50万例手术使用螺丝钉等植入物。在这些手术中，有4%到11%的植入物放置不准确。对于患者来说，这意味着更长的恢复时间--从几天到几周--在许多情况下，还会变成第二次手术。患者没有生产力，连续数周无法进行日常工作，而医疗保健系统必须承担较长时间恢复以及翻修手术的成本。对于医疗和经济体系而言，这些都是可以避免的成本。该项目正在开发的医学成像技术有可能在价值24亿美元的成像引导市场上消除手术误差，改善从骨科手术到微创血管介入，再到癌症诊断和治疗的临床应用。这个小型企业创新研究(SBIR)第二阶段项目将展示一种新的成像方式，它在手术过程中提供近乎实时的3D实时成像-4D。这一新的系统将提供比透视(当前标准)更低的X射线剂量的手术成像，其几何结构允许同时进行成像和手术。这种4D技术有可能显著减少手术的不准确性，改善结果并降低成本。第一阶段成功地证明了所提出的成像模式所使用的重建算法的可行性，显示了其在单个脊柱螺钉植入中具有更高的手术精度的潜力。这个第二阶段的项目将一)证明重建算法在各种用例中的健壮性，二)展示4D扫描仪的临床可用性，以及三)确认扫描仪的临床实用性。临床可用性将在手术环境中通过人体工程学模型进行研究。临床应用将通过建立一个系统原型，并在真实的外科环境中与透视和3D进行图像质量和X射线剂量比较来证明。初步结果表明，这些目标是可以实现的。这项研究正在为临床研究、监管审批和商业化准备技术。