3D Printed Silicon Nitride Porous PEEK Composite Spinal Cages for Anti-Infection

3D 打印氮化硅多孔 PEEK 复合脊柱笼用于抗感染

• 批准号: 10819309
• 负责人: Ryan Bock
• 金额: $ 122.74万
• 依托单位: SINTX TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-15 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10819309
• 关键词: 3D Print; Address; Adverse event; Animal Testing; Animals; Anti-Bacterial Agents; Back Pain; Bacteria; Benchmarking; Biomechanics; Cervical; Cervical spine; Congenital failure of fusion; Consensus; Development; Devices; Documentation; Elasticity; Ethers; Failure; Fatigue; Financial cost; Foundations; Fracture; Freezing; Funding; Goat; Growth; Guidelines; Health; Human; Image; Implant; Incidence; Industry; Infection; International; Ketones; Literature; Manufacturer; Marketing; Mechanics; Medical Device Designs; Modeling; Neck Pain; Notification; Operative Surgical Procedures; Orthopedics; Osseointegration; Pathway interactions; Patient-Focused Outcomes; Patients; Performance; Perioperative; Phase; Porosity; Positioning Attribute; Predisposition; Process; Property; Quality of life; Recording of previous events; Resistance; Resistance to infection; Risk Management; Small Business Innovation Research Grant; Spinal; Spinal Fusion; Sterilization; Surgeon; Testing; Torsion; Vertebral column; antimicrobial; arm; biomaterial compatibility; bone; commercialization; cost; design; experimental arm; hazard; implant material; improved; in vivo; instrumentation; manufacture; medical implant; novel; post-market; prevent; research clinical testing; risk minimization; silicon nitride; standard care

PROJECT SUMMARY Spinal fusion is the standard treatment for persistent neck and back pain, but the hardware used to stabilize the fusion can harbor or even promote bacteria that lead to persistent, difficult-to-treat infections that are costly and damaging to patient health. Among the available materials for spinal fusion, polyether-ether-ketone (PEEK) cages stand out due to their strength, biocompatibility, and radiolucency, but like other materials, they are susceptible to spinal infections. Silicon nitride (Si3N4) spacers have been used in other spinal applications where their rates of reportable adverse events due to infection are much lower than industry norms, but they are not ideal for stabilizing spinal fusions due to their potential for subsidence and brittle fracture. To address this challenge, SINTX used Phase I SBIR funding to develop and test a 3D-printed Si3N4-PEEK material that incorporates the antimicrobial and osseointegrative properties of Si3N4 with the strength and elasticity of PEEK. In this Phase II SBIR, SINTX proposes to use this material to develop a 3D-printed anti-microbial spinal fusion cage that promotes osseointegration, withstands in vivo loading, and facilitates imaging. The project includes long-term biomechanical performance and in vivo fusion property testing in both normal and contaminated operative scenarios. Successful completion of these activities will position SINTX to prepare a 510(k) premarket notification application for FDA. SINTX anticipates further development and commercialization of a 3D-printed Si3N4-PEEK spinal fusion cage will provide orthopedic surgeons a high-performance fusion device that could greatly reduce the incidence of fusion-associated infections. Aim 1. Minimize potential design and manufacturing hazards by formal design and process risk management analyses in accordance with ISO 14971. Milestone: Completion of the design FMEA and process FMEA per ISO 14971 to minimize risks associated with the novel cervical cages and design freeze. Aim 2. Verify that the finalized 3DP Si3N4-PEEK cervical cage meets the static and fatigue loading requirements of ASTM F2077 and subsidence requirements of ASTM F2267. Milestone: Following the design freeze in Aim 1, demonstrate static and fatigue compression, shear, and torsion strength and subsidence resistance of the finalized 3DP Si3N4-PEEK’s porous cage meets or exceeds the guidelines for cervical cages established by ASTM F2077 and ASTM F2267 and benchmarked for many cage manufacturers in the literature. Aim 3. Determine antimicrobial activity (experimental arm) and in vivo biocompatibility and osteointegration (biocompatibility GLP arm) for a 3DP Si3N4-PEEK cervical cage in a caprine model of cervical spinal fusion. Milestone: Final, packaged, and validated implants will pass requirements in ISO 10993. 3DP Si3N4-PEEK implants will have biocompatibility, bone ingrowth, fusion, and resistance to infection comparable to or better than control 3DP PEEK spinal cages.

项目摘要 脊柱融合是持续颈部和背痛的标准治疗方法，但用于稳定的硬件 融合可以携带甚至促进细菌，从而导致持久，难以治疗的感染，这些感染是昂贵的 并损害患者健康。在可用的脊柱融合材料中，聚醚 - 酮（PEEK） 笼子由于其强度，生物相容性和放射线尺寸而脱颖而出，但与其他材料一样，它们是 容易受到脊柱感染的影响。氮化硅（SI3N4）垫片已在其他脊柱应用中使用 他们因感染引起的可报告不良事件的发生率远低于行业规范，但并不是 由于脊柱融合的潜力和脆性骨折的可能性，是稳定脊柱融合的理想选择。解决这个问题 挑战，sintx使用I期SBIR资金来开发和测试3D打印的SI3N4-PEEK材料 将Si3n4的抗菌和骨整合性质具有peek的强度和弹性。 在此II阶段SBIR中，SINTX建议使用该材料开发3D打印的抗微生物脊柱融合 促进骨整合，承受体内载荷并促进成像的笼子。该项目包括 正常和受污染的长期生物力学性能和体内融合性能测试 手术方案。这些活动的成功完成将定位Sintx以准备510（k）上市 FDA的通知申请。 SINTX预计将进一步开发和商业化3D打印 Si3n4-peek脊柱融合笼将为骨科医生提供一个高性能融合装置 大大减少了融合相关感染的发生率。 目标1。通过正式设计和过程风险最大程度地减少潜在的设计和制造危害 管理分析根据ISO 14971。里程碑：设计FMEA和 工艺FMEA每ISO 14971最大程度地降低与新型宫颈笼和设计冻结相关的风险。 AIM 2。验证最终确定的3DP SI3N4-PEEK宫颈笼可以符合静态和疲劳负荷 ASTM F2077的要求和ASTM F2267的沉降要求。里程碑：跟随 在AIM 1中的设计冻结，展示静态和疲劳压缩，剪切和扭转强度和沉降 最终确定的3DP SI3N4-PEEK多孔笼的阻力符合或超过宫颈笼的准则 由ASTM F2077和ASTM F2267建立，并为文献中的许多笼子制造商提供了标准。 目标3。确定抗菌活性（实验组）和体内生物相容性和 3DP SI3N4-PEEK宫颈笼中的稳定性（生物相容性GLP ARM） 颈脊柱融合。里程碑：最终，包装和经过验证的Impans将通过ISO 10993的要求。 3DP Si3n4-peek即将具有生物相容性，骨头融合，融合和对感染的抗性 与对照3DP PEEK脊柱笼相当或更好。