SBIR Phase I: High Strength, Surface Porous Devices for Improved Spinal Fusions

SBIR 第一阶段：用于改善脊柱融合的高强度、表面多孔装置

• 批准号: 1415805
• 负责人: Christopher Lee
• 金额: $ 15万
• 依托单位: Vertera, Inc
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-01 至 2015-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1415805&HistoricalAwards=false
• 关键词: SBIR; Phase; Strength; Surface; Porous

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a novel high strength, surface porous layer that can improve integration of non-metal orthopedic implants, resulting in better clinical outcomes. This improvement to orthopedic implants is especially important for lumbar fusion devices, which are used to alleviate chronic back and leg pain in over 240,000 patients annually. Non-metal, polymer implants are most commonly used for lumbar fusions because of their compatibility with medical imaging. However, these devices have smooth surfaces that do not integrate well with bone, which leads to a complication and revision surgery rate of approximately 11 to 15%.The proposed project will investigate the feasibility of the high strength, surface porous layer for use on lumbar fusion cages. The research objectives are to determine the effect the architecture of the surface porous layer has on the mechanical properties and the biological response for improved bone integration. The research will use standard mechanical tests to determine the static and fatigue properties of different polymer constructs with the surface porous layer and to determine the mechanical properties of the surface porous layer itself. Additionally, the research will use cell studies to determine the effect the porous layer architecture has on improving the osteoconductive response of cells to the implant surface. Finally, devices with the surface layer will be prototyped and tested under physiological conditions. It is anticipated that the architecture will have a minimal effect on bulk mechanical properties while significantly improving the osteoconductive response.

该小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是一种新型高强度表面多孔层，可改善非金属骨科植入物的整合，从而获得更好的临床结局。骨科植入物的这一改进对于腰椎融合器械尤其重要，腰椎融合器械每年用于缓解超过240，000名患者的慢性背痛和腿部疼痛。非金属聚合物植入物最常用于腰椎融合，因为它们与医学成像兼容。然而，这些器械表面光滑，与骨结合不好，导致并发症和翻修手术率约为11%至15%。本项目将研究高强度、表面多孔层用于腰椎融合器的可行性。研究目的是确定表面多孔层的结构对机械性能和生物学反应的影响，以改善骨整合。该研究将使用标准力学测试来确定具有表面多孔层的不同聚合物结构的静态和疲劳性能，并确定表面多孔层本身的力学性能。此外，该研究将使用细胞研究来确定多孔层结构对改善细胞对植入物表面的骨传导反应的影响。最后，将对具有表面层的装置进行原型制作并在生理条件下进行测试。预计该结构对整体机械性能的影响最小，同时显著改善骨传导反应。