DESIGNED DEGRADABLE INTERBODY CAGES

设计的可降解体内保持架

• 批准号: 7230315
• 负责人: Chia-Ying James Lin
• 金额: $ 18.4万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-05-01 至 2009-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7230315
• 关键词: Address; Affect; Animal Model; Animals; Anterior; Arthrodesis; Attention; Back Pain; Bone Regeneration; Bone Transplantation; Cells; Cervical; Clinical Trials; Collagen; Condition; Deformity; Device Designs; Devices; Diffusion; Equilibrium; Evaluation; Excision; Failure; Foundations; Funding Mechanisms; Gel; Gold; Histology; Human; Image; Implant; In Vitro; Infiltration; Lasers; Lead; Lymphatic Spread; Mechanics; Methods; Miniature Swine; Modality; Modeling; Morphologic artifacts; Nerve; Numbers; Operative Surgical Procedures; Pain; Performance; Permeability; Physiological; Pilot Projects; Plant Roots; Polymers; Porifera; Porosity; Postoperative Period; Procedures; Proteins; Radiculopathy; Range; Rate; Recombinants; Reporting; Research Personnel; Simulate; Skeletal system; Solid; Spinal; Spinal Fusion; Standards of Weights and Measures; Stress; Synovitis; Techniques; Testing; Time; Tissues; Titanium; Vertebral column; Week; Weight-Bearing state; X-Ray Computed Tomography; base; biodegradable polymer; bone; bone morphogenetic protein 2; bone morphogenic protein; carbon fiber; clinical application; copolymer; design; experience; implantation; improved; in vivo; in vivo Model; irritation; migration; poly(lactide); polycaprolactone; polyetheretherketone; programs; prototype; recombinant human bone morphogenetic protein-2; reconstruction; tissue regeneration

DESCRIPTION (provided by applicant): The current gold standard surgical intervention for spinal deformity correction and for discogenic axial back pain with or without concomitant radiculopathy is a segmental spinal fusion. Currently, over 250,000 spine fusions are performed yearly in the US. However, current fusion approaches suffer from significant drawbacks including subsidence, stress shielding, and the inability to direct delivery of bone morphogenic protein (BMP) for bone regeneration. We propose to develop degradable polymeric fusion cages that are designed to have sufficient mechanical integrity for withstanding surgical implantation and spinal loads, while at the same time providing directed delivery of BMP for bone fusion. Specifically, we will create and test prototype interbody degradable spinal fusion cages to meet these load bearing and biofactor delivery requirements by computationally optimizing device design for both load carrying and directed permeability requirements, fabricating the cages from degradable polymer using Solid Free-Form Fabrication (SFF) techniques, and testing these in vivo in a Yucatan minipig spine fusion model. We hypothesize that optimizing degradable spine interbody fusion cages to meet both the initial and the intermediate- term load carry as well as directed biofactor delivery requirements will provide superior arthrodesis compared to current degradable cages fabricated from designs previously used for titanium cages. This global design hypothesis will be tested through the following 3 specific aims: Specific Aim 1: Computational Optimization of Spinal Fusion Cages. Specific Aim 2: Device Fabrication and In Vitro Evaluation. Specific Aim 3: Test Fusion Performance in an In Vivo Yucatan minipig Model. The end result will verify if the designed degradable fusion device provides superior fusion results compared to conventional designs, and more broadly, whether the optimization approach could be utilized to improve performance of other skeletal reconstruction devices.

描述（由申请人提供）：目前治疗脊柱畸形矫正和伴有或不伴有神经根病的椎间盘源性轴性背痛的金标准手术干预是节段性脊柱融合术。目前，美国每年进行超过25万例脊柱融合术。然而，目前的融合方法存在明显的缺陷，包括下沉、应力屏蔽以及无法直接递送骨形态发生蛋白（BMP）用于骨再生。我们建议开发可降解的聚合物融合器，其设计具有足够的机械完整性以承受手术植入和脊柱负荷，同时为骨融合提供BMP的定向递送。具体来说，我们将创建和测试原型体间可降解脊柱融合器，以满足这些承载和生物因子传递要求，通过计算优化设备设计，同时满足负载和定向渗透性要求，使用固体自由形式制造（SFF）技术从可降解聚合物制造笼子，并在尤卡坦迷你猪脊柱融合模型中对这些笼子进行体内测试。我们假设，优化可降解的脊柱椎间融合器，以满足初始和中期负重以及定向生物因子递送的要求，将提供比目前使用的钛金属笼子设计制造的可降解笼子更好的关节融合术。这一全球设计假设将通过以下3个具体目标进行验证：具体目标1：脊柱融合器的计算优化。具体目标2：器械制造和体外评价。具体目标3：在体内尤卡坦迷你猪模型中测试融合性能。最终结果将验证所设计的可降解融合装置是否比传统设计提供更好的融合效果，更广泛地说，是否可以利用优化方法提高其他骨骼重建装置的性能。