SBIR Phase I: Nanostructured Calcium Phosphate Injectable Cements for Treatment of Osteoporosis

SBIR 第一期：用于治疗骨质疏松症的纳米结构磷酸钙可注射骨水泥

• 批准号: 0611039
• 负责人: Juchui Lin
• 金额: $ 10万
• 依托单位: Angstrom Medica, Incorporated
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-07-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=0611039&HistoricalAwards=false
• 关键词: SBIR; Phase; Nanostructured; Calcium; Phosphate

This Small Business Innovative Research (SBIR) Phase I project aims to develop an injectable orthopedic cement made from oligomers containing cross-linkable functional groups and a reinforcing phase of calcium phosphate nanocrystals that can be injected into low strength bone to provide mechanical strength and bioactivity. This system will have excellent handling properties, remain localized at the injection site, and rapidly harden at body temperature without chemical initiators and with a minimal heat generation, unlike current bone cements. The research will investigate the chemistry of these novel oligomer systems and the effect of calcium phosphate nanocrystal morphology, surface chemistry, and loading by examining properties such as cure time, cure temperature, heat of reaction, rheological behavior, chemical structure, strength and in vitro bioactivity. Commercially, the application provides an alternative surgical cement to what is in current use (in situ polymerization of methylmethacrylate) for total joint replacement. While current methods have been used safely, as the need for a surgical has spread to more sensitive tissues, such as the spine, and new procedures are developed, numerous safety and efficacy issues need to be addressed. About 700,000 vertebral fractures occur annually; patients not responsive to conservative treatment are potential candidates for minimally invasive procedures that use current bone cements off-label to treat vertebral compression fractures. However, leakage of liquid from low viscosity bone cements can result in soft tissue damage as well as nerve root pain and compression. Other reported complications, generally associated with the use of bone cements in the spine, include pulmonary embolism, respiratory and cardiac failure, abdominal intrusions/ileus, and death. The proposed project will alleviate many of these issues and open new methods and mechanisms for the treatment of osteoporosis.

该小型企业创新研究 (SBIR) 第一阶段项目旨在开发一种可注射骨科水泥，由含有可交联官能团的低聚物和磷酸钙纳米晶体增强相制成，可注入低强度骨中以提供机械强度和生物活性。与目前的骨水泥不同，该系统将具有优异的操作性能，保持局部在注射部位，并在体温下快速硬化，无需化学引发剂，并且产生的热量最少。该研究将通过检查固化时间、固化温度、反应热、流变行为、化学结构、强度和体外生物活性等特性，研究这些新型低聚物系统的化学性质以及磷酸钙纳米晶体形态、表面化学和负载的影响。在商业上，该应用为目前使用的全关节置换手术水泥（甲基丙烯酸甲酯的原位聚合）提供了一种替代手术水泥。虽然目前的方法已被安全使用，但随着手术的需要已扩展到更敏感的组织（例如脊柱），并且开发了新的手术，仍需要解决许多安全性和有效性问题。每年大约发生 700,000 起脊椎骨折；对保守治疗没有反应的患者是微创手术的潜在候选者，微创手术使用当前标签外的骨水泥来治疗椎体压缩性骨折。然而，低粘度骨水泥的液体渗漏会导致软组织损伤以及神经根疼痛和压迫。其他报告的并发症通常与脊柱中使用骨水泥有关，包括肺栓塞、呼吸和心力衰竭、腹部侵入/肠梗阻和死亡。拟议的项目将缓解其中许多问题，并为治疗骨质疏松症开辟新的方法和机制。