SBIR Phase II: 4D scanner for image guided interventions

该项目更广泛的影响/商业潜力是手术准确性的显著提高，这将大大减少手术错误，改善结果并降低医疗成本。仅在脊柱外科方面，美国每年就有超过50万例使用螺钉等植入物的手术。在4%到11%的此类手术中，植入物的放置是不准确的。对于病人来说，这意味着更长的恢复期——从几天到几周——在许多情况下，还需要进行第二次修复手术。病人没有生产力，几周内无法进行日常生活，而医疗保健系统不得不承担较长时间的恢复和翻修手术的费用。对于医疗和经济系统来说，这些都是可以避免的成本。在这个项目中开发的医学成像技术有可能消除整个24亿美元的图像引导市场的手术不准确性，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。这项小企业创新研究（SBIR）第二阶段项目将展示一种新的成像方式，在手术过程中提供近实时的3D实时成像（4D）。这种新型系统将以比透视（目前标准）更低的x射线剂量提供手术成像，其几何形状允许在手术中同时成像。这种4D技术有可能显著减少手术不准确性，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置入中具有更高手术精度的潜力。这个第二阶段的项目将I)证明重建算法在各种用例中的鲁棒性，II)展示4D扫描仪的临床可用性，以及III)确认扫描仪的临床实用性。临床可用性将研究在外科设置的人体工程学模型。临床应用将通过建立系统原型和执行图像质量和x射线剂量比较，在现实的手术环境中与透视和3D进行比较。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、监管审批和商业化做好准备。

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.