Are Medical Grade Bioabsorbable Polymers a Viable Material for Fused Filament Fabrication?

Are Medical Grade Bioabsorbable Polymers a Viable Material for Fused Filament Fabrication?
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DOI:
10.1115/1.4043841
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发表时间:
2019-07
期刊:
Journal of medical devices
影响因子:
--
通讯作者:
J. Schachtner;M. Frohbergh;N. Hickok;S. Kurtz
J. Schachtner;M. Frohbergh;N. Hickok;S. Kurtz
中科院分区:
其他
文献类型:
--
作者:
J. Schachtner;M. Frohbergh;N. Hickok;S. Kurtz

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腰椎融合手术作为下背痛的一种解决方案越来越受欢迎。手术部位感染(SSI)是脊柱手术的严重并发症,影响高达8.5%的患者人群。如果SSI不能通过静脉注射抗生素根除,下一步就是第二次手术,这会增加患者的成本并延长恢复时间。一种用于抗生素分散的可植入超声触发聚醚醚酮装置已被开发为一种潜在的解决方案。在本研究中,该器械由可生物吸收的医用级聚合物构成,能够逐渐降解,并通过熔丝制造(FFF)制造。制备了一种新型生物可吸收长丝,并采用凝胶渗透色谱法(GPC)和差示扫描量热法(DSC)进行了验证。长丝的分子量和热性能一致(分别为p = 0.348和p = 0.487)。细丝用于器械的FFF。通过μ CT分析评估器械的尺寸准确度。印刷器械与预期设计之间的尺寸差异极小。根据ASTM F1635 - 16对原材料、细丝和器械进行了为期一个月的降解,以确定材料熔化如何影响降解性能。发现第1周至第3周样品的降解速率相似,但到最后一周,原材料的降解速率较慢(p = 0.039)。本研究证明了在FFF中使用医用级生物可吸收聚合物的可行性。
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.