SBIR Phase I: Minimally Invasive Device for Harvesting Autologous Bone Graft

这个小型企业创新研究(SBIR)第一阶段项目旨在解决尚未得到满足的重要临床需求，即骨科医生能够以微创方式从患者S骨盆骨中收集骨移植，而不会出现患者并发症，并增加了当前标准骨移植获取方法固有的手术时间。拟议项目的研究目标是确保该技术在模拟使用环境中达到可接受的安全和效率水平(技术可行性)，并确定达到该技术所需制造成本点的可行性(商业可行性)。这些目标将通过调查各种材料和制造工艺以及进行几项关键的验证测试来实现，以将目前的概念验证发展成功能原型。这个项目具有很强的智力价值，因为这个变革性的技术概念有可能通过引入一种新的解决方案来改善患者结果、手术时间和医院成本，从而颠覆外科医生目前用于获取骨移植的方法。该项目更广泛的影响/商业潜力可能会对医疗保健系统产生强烈影响。与目前的方法相比，拟议项目的技术有可能产生更广泛的影响，因为它降低了执行植骨采集程序的风险，从而增加了选择采集患者的外科医生数量-S自己的植骨，而不是使用劣质植骨替代品/替代品。此外，由于目前采集方法的风险，目前正在接受培训以利用患者S自己的骨移植的新的、缺乏经验的外科医生较少，但随着拟议概念的引入，这些外科医生可能会被鼓励执行采集程序。患者S自体骨使用量的增加将使患者受益，因为与合成或外源性替代方案相比，自体骨移植具有广泛接受的临床好处。拟议中的技术还可能对医院产生重大的商业影响，因为可能会减少手术室时间和术后患者住院时间(与标准采集程序相比)，以及降低每个程序的产品成本(与替代骨移植产品相比)。

This Small Business Innovation Research (SBIR) Phase I project addresses the important unmet clinical need of enabling orthopaedic surgeons to collect bone graft from the patient?s pelvic bone in a minimally invasive manner without the patient morbidity and added surgical time intrinsic to the current standard bone graft harvesting methods. The research objectives of the proposed project are to ensure an acceptable level of safety and efficacy of the technology in a simulated use environment (technical feasibility) and to determine the feasibility of attaining the desired manufacturing cost point for this technology (commercial feasibility). These objectives will be completed by investigating various materials and manufacturing processes as well as conducting several key verification tests to develop the current proof of concept into a functional prototype. This project has strong intellectual merit because this transformative technological concept has the potential to disrupt the current methods that surgeons employ for harvesting bone graft by introducing a novel solution that improves patient outcomes, surgical time, and hospital costs. The broader impact/commercial potential of this project can strongly influence the healthcare system. The technology of the proposed project has the potential to make a broader impact by decreasing the risk of performing the bone graft harvesting procedure compared to current methods and consequently increase the number of surgeons who choose to collect a patient?s own bone graft in lieu of using inferior bone graft alternatives/substitutes. Furthermore, whereas fewer new, inexperienced surgeons are currently being trained to utilize the patient?s own bone graft because of the risks of current harvesting methods, these surgeons may be encouraged to perform the harvesting procedure with the introduction of the proposed concept. The increase in use of the patient?s own bone will benefit patients because of the widely accepted clinical benefits of autogenous bone graft compared to synthetic or exogenous alternative solutions. The proposed technology may also have a significant commercial impact to hospitals because of potential decreases in operating room time and post-operative patient hospitalization time (compared to the standard harvesting procedure) as well as decreased per-procedure product costs (compared to substitute bone graft products).