SBIR Phase I: Design and Development of Minimally-Invasive Orthopedic Fracture Fixation Using Intramedullary Sleeve and Injectable, Light-Triggered Bone Cement

SBIR 第一阶段：使用髓内套管和可注射光触发骨水泥的微创骨科骨折固定的设计和开发

• 批准号: 2322411
• 负责人: Krishna Kolan
• 金额: $ 27.36万
• 依托单位: MEDICARBONE, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-10-01 至 2024-09-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2322411&HistoricalAwards=false
• 关键词: SBIR; Phase; Design; Development; Minimally

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project addresses the current challenges associated with an increase in the incidence of orthopedic injuries and surgeries. The technology will stabilize and repair broken bones in the US and globally. Trauma, degenerative bone diseases, and bone tumors often result in broken bones that require a procedure called intramedullary nailing. Intramedullary nailing involves nailing metallic implants to bones stabilize bone fractures. This procedure often results in complications such as infection, rotated limbs, and failure to achieve complete rigidity, which may eventually lead to patient discomfort and significantly increased costs due to revision surgeries. Consequently, there is an urgent need for an intramedullary nail technology that is less invasive, cost effective, and customizable to the patient’s anatomical requirements to enable improved bone fracture healing and avoid burdensome revision surgeries. When additional corrective surgery is required to treat any post-operative infections or surgical placement mistakes, the implant removal should be less invasive and not cause any additional morbidity. There are currently no such proven technologies available that meet the above criteria. This project will primarily focus on the development of an intramedullary (IM) sleeve system with an in situ, photocurable, and removable polymeric resin system. There are four main objectives: 1) design and development of a multi-layered IM sleeve prototype, 2) synthesis and optimization of am in situ photopolymerizable polymeric resin system in the IM sleeve, 3) removal of the cured polymeric resin system from the IM sleeve using minimally invasive tools and methods, and 4) in vitro, in vivo biocompatibility, and demonstration of the customized IM prototype device in a sheep cadaveric tibia bone. The research will generate new knowledge in designing and synthesizing a novel polymer formulation with additives that helps in fast setting with improved mechanical properties. The project will also enable extraction of photocured polymers using existing removal technologies. For physicians, this research could result in novel, minimally invasive treatments that could drastically reduce the surgical time and improve the patient recovery times.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

这项小型企业创新研究（SBIR）I阶段项目的更广泛的影响/商业潜力解决了与骨科损伤和手术发生率增加有关的当前挑战。该技术将在美国和全球范围内稳定和修复骨折的骨骼。创伤，退化性骨骼疾病和骨肿瘤通常会导致骨折，需要一种称为髓内钉的手术。髓内钉子涉及将金属牙齿钉骨稳定骨折。该程序通常会导致并发症，例如感染，旋转的四肢和无法达到完全刚性，这最终可能导致患者不适，并由于修订手术而大大增加了成本。因此，迫切需要进行髓内指甲技术，该技术侵入性较小，具有成本效益且可根据患者的解剖学要求进行定制，以改善骨折愈合并避免进行一些修订手术。当需要进行其他纠正手术以治疗任何术后感染或手术放置错误时，植入物的去除应减少侵入性，不会引起任何额外的发病率。目前尚无符合上述标准的这种可靠的技术。该项目将主要集中于具有原位，可光化和可移动的聚合物树脂系统的髓内（IM）套筒系统的开发。主要目标有四个主要目标：1）设计和开发多层IM套筒原型，2）在IM袖子中合成和优化AM的原位光聚合性聚合物树脂系统的合成和优化，3）使用IM袖子从IM袖子中删除固化的聚合物树脂系统，并使用最小的动荡工具和方法及时供应，以及Imavisive and Ounder and Ounder and Onderaution and Onder and Onder and viv in viv in viv inviv and viv in viv inviv and viv inviv绵羊尸体胫骨骨骼中的原型装置。这项研究将在设计和合成新型聚合物配方的添加剂方面产生新知识，从而有助于快速设置机械性能。该项目还将使用现有的去除技术来提取光接种聚合物。对于医生而言，这项研究可能会导致新颖的，微创的治疗方法，可以大大减少手术时间并改善患者的康复时间。该奖项反映了NSF的法定任务，并且是否通过使用基金会的智力优点和更广泛的影响审查标准来评估我们是否被认为是诚实的支持。