Schachtner Jaclyn, Frohbergh Michael, Hickok Noreen, Kurtz Steven
Department of Biomedical Engineering,Drexel University, 3440 Market Street, Suite 600, Philadelphia, PA 19104.
Exponent, Inc., 3440 Market Street, Suite 600, Philadelphia, PA 19104 e-mail:
J Med Device. 2019 Sep;13(3):0310081-310085. doi: 10.1115/1.4043841. Epub 2019 Jul 15.
Lumbar fusion surgery has grown in popularity as a solution to lower back pain. Surgical site infection (SSI) is a serious complication of spinal surgery, affecting as high as 8.5% of the patient population. If the SSI cannot be eradicated with intravenous antibiotics, the next step is second surgery, which increases the cost imposed on the patient and extends recovery time. An implantable ultrasound-triggered polyether ether ketone device for the dispersal of antibiotics has been developed as a potential solution. In this study, the device was constructed of bioabsorbable medical grade polymer, enabling gradual degradation, and manufactured via fused filament fabrication (FFF). A novel bioabsorbable filament was manufactured and validated with gel permeation chromatography (GPC) and differential scanning calorimetry (DSC). The filament was consistent in molecular weight and thermal properties (p = 0.348 and p = 0.487, respectively). The filament was utilized for FFF of the device. Dimensional accuracy of the device was assessed with μCT analysis. Dimensional differences between the printed device and intended design were minimal. Degradation of raw material, filament, and the device was performed in accordance to ASTM F1635-16 for a month to determine how melting the material impacted the degradation properties. The degradation rate was found to be similar among the samples weeks one through three however, the raw material degraded at a slower rate by the final week (p = 0.039). This study demonstrated the feasibility of utilizing medical grade bioabsorbable polymers in FFF.
腰椎融合手术作为治疗下背部疼痛的一种方法,越来越受欢迎。手术部位感染(SSI)是脊柱手术的一种严重并发症,影响高达8.5%的患者群体。如果静脉注射抗生素无法根除SSI,下一步就是二次手术,这会增加患者的费用并延长恢复时间。一种用于分散抗生素的可植入超声触发聚醚醚酮装置已被开发出来作为一种潜在的解决方案。在本研究中,该装置由可生物吸收的医用级聚合物构建而成,能够逐渐降解,并通过熔融沉积成型(FFF)制造。制造了一种新型的可生物吸收细丝,并用凝胶渗透色谱法(GPC)和差示扫描量热法(DSC)进行了验证。该细丝在分子量和热性能方面是一致的(分别为p = 0.348和p = 0.487)。该细丝被用于该装置的FFF制造。用μCT分析评估了该装置的尺寸精度。打印的装置与预期设计之间的尺寸差异最小。根据ASTM F1635 - 16对原材料、细丝和装置进行了为期一个月的降解实验,以确定材料熔化对降解性能的影响。在第一周至第三周期间,样品之间的降解速率相似,然而,到最后一周,原材料的降解速率较慢(p = 0.039)。本研究证明了在FFF中使用医用级可生物吸收聚合物的可行性。