机器臂辅助遥控推注改良载药磷酸钙骨水泥成形术微创治疗椎体骨质疏松症的相关研究

Spinal compressive fracture is a common disease which can lead to severe consequences. Percutaneous vertebroplasty has been a routine treatment to relieve pain and improve the life quality of patient with spinal compressive fractures. However, vertebroplasty needs to be performed by a scrubbed surgeon under fluoroscopic guidance intending to prevent the occurrence of severe complications; and the increased intra-vertebral pressure may lead to bone cement leakage, fat embolism or even fetal pulmonary embolism; furthermore, the bone cement of polymethylmethacrylate (PMMA) has excessive high mechanical strength and lacks the potential to remodel and/or integrate into adjacent bone. Remote controlled bone cement injection system (RCIM) may keep the operator out of the harmful radiation exposure; relieved intravertebral pressure may reduce the incidence of related complications. Calcium phosphate cements (CPC) offer the potential for osseous remodeling as they are biodegradable. We hypothesize that modified remote controlled bone cement injection system in combination with vertebroplasty filled with drug loaded calcium phosphate are optimal techniques in the treatment of osteoporotic compressive spinal fractures. By investigating a series of ex vivo and in vivo experiments including biological, biomechanical and animal studies, we are trying to systemically evaluate the therapeutic strategy of combined modified RCIM and drug load CPC vertebroplasty. Our research is supposed to provide a novel, effective approach in the minimal invasive treatment of osteoporotic spinal fractures.

经皮椎体成形术已成为临床上治疗与预防脊柱骨质疏松性压缩骨折、改善患者生活质量的重要方法。但是，向椎体内注入骨水泥，需在X线监控下操作，导致术者暴露于放射线；推注骨水泥时，椎体内高压可能会导致骨水泥、脂肪局部栓塞，甚至肺栓塞等并发症；再者，聚甲基丙烯酸甲酯骨水泥不可降解、强度过大，无法达到生物性重建。机器臂辅助遥控操作系统可以使术者避免暴露于放射线；控制推注骨水泥时椎体内压力，可能会有效减少相关手术并发症。磷酸钙骨水泥因其力学强度适中、可降解，载药后可促进骨形成，以在椎体内达到生物性重建。课题组推测，将以上几点结合用于椎体成形术，可以更加安全、有效的治疗脊柱骨质疏松症。本课题研究拟通过细胞学、生物力学、动物实验等一系列体外与体内实验，系统性评价机器臂辅助下改良载药磷酸钙骨水泥成形术微创治疗椎体骨质疏松症的安全性及有效性等方面，从而为临床治疗脊柱骨质疏松症提供新的思路并奠定理论基础。

微创经皮椎体成形术已成为临床上治疗与预防脊柱骨质疏松压缩骨折、改善患者生活质量的重要手段。但是，在向椎体内注入骨水泥的过程中，为防止骨水泥渗漏，需要在X线监控下操作，从而易导致术者暴露于放射线；再者，在推注骨水泥时，椎体内高压可能会导致骨水泥渗漏、脂肪局部栓塞，甚至肺栓塞等严重并发症的发生。本课题组通过引入机器臂辅助遥控骨水泥推注操作系统，在向椎体内推注骨水泥的整个过程由机器臂辅助推注完成，临床应用结果证实，该系统可以使术者在推注骨水泥的过程中避免暴露于放射线，同时又能保证骨水泥推注操作在X线实时监控下完成，从而确保了手术过程的安全性，减少骨水泥渗漏；另一方面，本课题组通过引入自行设计的椎体内单通道脉冲冲洗装置，在向椎体内推注骨水泥之前，首先通过脉冲通道装置对椎体行脉冲冲洗，以期减少骨水泥推注时椎体内压力。研究结果显示，经脉冲冲洗后，在向椎体内推注骨水泥时，椎体内的压力无论从峰值还是平均压力方面，均较未行脉冲冲洗者明显降低，而且椎体内骨水泥的分布亦更加均匀，骨水泥渗漏率降低，从而显著增加了骨水泥椎体成形的安全性。本课题通过以上实验结果，提高了微创经皮椎体成形术治疗脊柱骨质疏松骨折的安全性与有效性，为临床治疗脊柱骨质疏松症提供了新的思路并奠定了相关理论基础。