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

这个小企业创新研究（SBIR）一期项目解决了重要的未满足的临床需求，使骨科医生能够从患者身上收集骨移植物。目前标准的骨移植采收方法所固有的特点是，在没有患者发病率和增加手术时间的情况下，以微创的方式切除骨盆骨。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性和有效性水平（技术可行性），并确定该技术达到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核查测试来完成，以将目前的概念证明发展为功能原型。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颠覆外科医生目前用于采集骨移植物的方法，从而改善患者的治疗效果、手术时间和医院成本。这个项目的更广泛的影响/商业潜力可以强烈地影响医疗保健系统。与目前的方法相比，拟议项目的技术有可能通过降低进行骨移植手术的风险来产生更广泛的影响，从而增加选择收集患者的外科医生数量。自体骨移植代替劣质骨移植替代品/代用品。此外，虽然目前很少有新的，没有经验的外科医生接受培训，以利用病人？由于目前的采伐方法存在风险，这些外科医生可能会被鼓励进行采伐手术，并引入拟议的概念。病人使用率的增加？自体骨移植与合成或外源性替代方案相比具有广泛接受的临床益处，因此自体骨移植将使患者受益。拟议的技术也可能对医院产生重大的商业影响，因为可能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）以及降低每次手术产品的成本（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).