Fused Filament Fabrication of Porous PEEK and PEKK Spinal Cages: Which 3D Printing Conditions Control Static and Fatigue Strength?

多孔 PEEK 和 PEKK 脊柱笼的熔丝制造：哪种 3D 打印条件可以控制静电强度和疲劳强度？

• 批准号: 2326537
• 负责人: Steven Kurtz
• 金额: $ 20万
• 依托单位: Drexel University
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-10-01 至 2025-09-30
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2326537&HistoricalAwards=false
• 关键词: Fused; Filament; Fabrication; Porous; PEEK

Non-Technical Abstract:When an individual complains of back pain, it is an indication that they may be experiencing soreness and discomfort in their spine, typically attributed to herniated discs. Herniated discs occur when the cushion-like structures in the spine bulge or slip out of place due to ruptures caused by sudden physical activities, resulting in the compression of nearby nerves. To repair herniated discs and reduce back pain, spinal implants are used to facilitate fusion between two vertebrae. However, for such implants to function effectively within the body, it is crucial for them to possess both strength and the ability to have nearby bone and tissue grow into the implant. Achieving this biological fixation serves as an indicator of successful healing while ensuring proper support of the spine. In this study, the researchers will utilize a specific additive manufacturing method called Fused Filament Fabrication (FFF). The technique involves the layer-by-layer deposition of melted polymer to construct a complete structure. Two polymers, polyetheretherketone (PEEK) and polyetherketoneketone (PEKK) will be used in this study based on their historic use in medical devices. Due to the significance of achieving a strong structure, the researchers will optimize the manufacturing process by systematically varying key parameters that have the potential to enhance the strength of the implant structures fabricated from PEEK and PEKK polymers. The ability to create such an implant using FFF printing technology not only contributes to a reduction in manufacturing costs, leading to more affordable healthcare, but also enhances the overall quality of life for patients.Technical Abstract:The purpose of this research project is to establish the correlation between the structural and mechanical properties of lumber spine cages made from Fused Filament Fabricated (FFF) polyetheretherketone (PEEK) and polyetherketoneketone (PEKK). The project ultimately seeks to contribute to the progression of knowledge of additively manufactured (AM) Intervertebral Body Fusion Devices (IBFDs) specifically used in treating intractable back pain. The research objectives that would help in achieving the overall goal include optimization of the FFF process for lumbar spine cages and assessing the performance of the printed cages. The optimal build parameters (speed and temperature) will be determined by a comprehensive material characterization process involving microCT, optical microscopy, calorimetry, mechanical testing, and Scanning Electron Microscopy (SEM). The established optimized build parameters will then be used to print both solid and porous lumbar spine cages. The printed cages would be assessed for durability under various loading conditions per ASTM F2077 (Test Methods for Intervertebral Body Fusion Devices) to establish the structure-properties relationship. Finite Element Analysis (FEA) and Monte Carlo simulations would be used to evaluate the iterative performance of the spine cages. The findings have the potential to contribute to the development of consistent and reliable AM spine cages utilized in surgical interventions, reducing the risk of device failure, and improving patient outcomes. The use of AM can increase accessibility to medical devices due to cost-effective and easily produced medical devices and ultimately contribute to affordable healthcare.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

非技术摘要：当一个人抱怨背痛时，这表明他们可能在脊柱上遭受酸痛和不适，通常归因于椎间盘突出。当由于突然的体育活动引起的破裂而导致附近的神经压缩时，椎间盘椎间盘发生时发生。为了修复椎间盘突出并减轻背部疼痛，脊柱植入物用于促进两个椎骨之间的融合。但是，对于这种植入物在体内有效发挥作用，对于它们具有强度和使附近的骨骼和组织生长成植入物的能力至关重要。实现这种生物学固定是成功愈合的指标，同时确保脊柱的适当支撑。在这项研究中，研究人员将利用一种称为融合细丝制造（FFF）的特定添加剂制造方法。该技术涉及熔化聚合物的逐层沉积以构建完整的结构。基于它们在医疗设备中的历史用途，将使用两种聚合物，聚醚酮（PEEK）和聚醚酮（PEKK）。由于实现了强大的结构的重要性，研究人员将通过系统地改变关键参数来优化制造过程，这些参数有可能增强用PEEK和PEKK聚合物制造的植入物结构的强度。使用FFF打印技术创建这种植入物的能力不仅有助于降低制造成本，从而导致更便宜的医疗保健，还可以提高患者的整体生活质量。技术摘要：该研究项目的目的是建立由熔融纤维纤维的结构和机械性能之间的相关性（peeek）（peeek）PEOLETER（PEETERKERETE）（PEETERTER）（PEETERKERETER）（PEETERTER）（PEETERTER）（PEETERTER）（PEE）。该项目最终旨在为添加性生产（AM）椎体融合设备（IBFD）的知识发展做出贡献，专门用于治疗棘手的背痛。有助于实现总体目标的研究目标包括优化腰椎笼的FFF过程以及评估印刷笼的性能。最佳构建参数（速度和温度）将由涉及微观的综合材料表征过程确定，光学显微镜，量热法，机械测试和扫描电子显微镜（SEM）。然后，已建立的优化构建参数将用于打印固体和多孔的腰椎笼。在每个ASTM F2077（椎体融合设备的测试方法）下，将评估印刷笼子在各种加载条件下的耐用性评估，以建立结构 - 培养物关系。有限元分析（FEA）和蒙特卡洛模拟将用于评估脊柱笼的迭代性能。这些发现有可能有助于在手术干预措施中使用一致可靠的AM脊柱笼的发展，降低设备故障的风险并改善患者结果。由于具有成本效益且易于生产的医疗设备，AM的使用可以增加对医疗设备的可访问性，并最终为负担得起的医疗保健做出了贡献。该奖项反映了NSF的法定任务，并被认为是值得通过基金会的知识分子评估来提供支持的，并具有更广泛的影响。