具有自塑能力可吸收注射型纳米骨浆

BIORESORBABLE SELF-SETTING INJECTABLE NANOBONE PUTTY

目的 :为研制一种适应整形外科微创技术发展的一种可注射、可吸收、无致热、原位立即变硬的骨替代材料。方法 :通过合成研制一种有缓冲性的粘滞性骨浆 ,在体外研究其生物相容性 ,同时在犬的双侧肱骨缺损模型上研究其自塑形和生物吸收特性。结果 :实验证明这种植入材料具有极好的塑形性能 ,在 12～ 18周内完全吸收 ,临床上治疗骨折的X线显像证实 ,植入物吸收和骨再生存在一个合适的比例。结论 :本文阐述了一种生物可吸收可调节硬化时间的注射性骨浆 ,这种骨浆的特性符合多数骨增生过程 ,具有自动充填 ,不产热 ,即便在潮湿和血运丰富的情况下亦能硬化 ,植入成分被设计为产生中性 pH值的骨浆能重建骨组织 ,不含有聚合体或可塑剂。大量体外研究表明这一材料具有高度生物相容性和非致热源性。

Objective: To develope an injectable, bioresorbable bone substitute that can immediately harden isothermally in situ for meeting developments in minimally invasive techniques for orthopedic surgery.Methods: A buffered viscous bone putty was produce by synthezation; biocompatibility was studied in vitro, and its characteristics of self-set and bioresorbability were investigated through canine bilateral humerus defect model.Results:The experiments demonstrated excellent remodeling of implanted material with full resorbtion at 12 to 18 weeks. Radiographic observations of healing fractures in clinical evaluation studies have confirmed that implant resorbtion and bone regeneration occur at a clinically acceptable rate. Conclusion:An injectable bioresorbable bone putty with adjustable hardening time is described. The performance characteristics of the putty meet the requirements for numerous bone augmentation procedures. The putty is self-setting, nearly isothermic, and can harden in situ even in wet or bloody environments. The components of the implant are designed to produce a neutral-pH putty that resembles bone hard tissue and do not contain polymers or plasticizers. Numerous in vitro studies demonstrate that the putty is highly biocompatible and non-pyrogenic.