BONE REGENERATION ON SURFACE-MODIFIED POLYMERIC IMPLANTS

表面修饰聚合物植入物的骨再生

基本信息

批准号：
2432860
负责人：
SHALABY W SHALABY
金额：
$ 10万
依托单位：
POLY-MED, INC.
依托单位国家：
美国
项目类别：
财政年份：
1997
资助国家：
美国
起止时间：
1997-09-29 至 1998-06-30
项目状态：
已结题

项目摘要

Two major areas of biomaterials which present the biomedical industry and orthopedic community with a formidable challenge pertain to their use in joint replacement and tissue engineering. Inability of most materials used in orthopedic implants to form an interfacial bond with bone is often associated with loosening and failure. This, and the growing interest in tissue engineering and the great promise this technology holds for use in critical biomedical applications directed our attention to explore the use of proprietary surface activation and microcellular foam technologies to develop unique substrates to achieve tissue regeneration about key polymeric implants. Thus, the primary objective of Phase I of this program is to determine the feasibility of achieving bone regeneration about surface-phosphonylated polypropylene (PP), polyethylene (PE), and polylactide/glycolide (PLG) substrates with and without microporous skin, when placed at 6 to 8 weeks as transcortical implants in goat femur. Thus, Phase I entails (1) the preparation of an absorbable PLG; (2) conversion of PLG, PE and PP to implantable rods; (3) formation of microporous skin on one set of rods; (4) surface phosphonylation and characterization of the rods with and without microporous skin; (5) implanting surface modified PLG rods as in 5, which have been treated with a cell attachment factor; and (7) conducting a histological examination and push-out tests of the retrieved femur segments to determine bone regeneration and/or ingrowth, and bone/implant interfacial bond strength. Results of Phase I study will be used in the design of Phase II plans which include conducting (1) detailed animal study on optimally surface-modified ultrahigh molecular weight polyethylene (UHMW-PE) bone implants; (2) development of a selected orthopedic device and completing safety study on an implant prototype; and (3) pursuing in vitro and in vivo studies on the sue of unique phosphonylated microporous PLG copolymers as scaffold for bone regeneration. PROPOSED COMMERCIAL APPLICATION: Successful application of the surface phosphonylation technology in conjunction with an easily formed microporous and/or surface-microtextured implant is expected to have an immediate, positive impact on the development of cementless, polymeric bone prostheses with hybridized bone/implant interface. This is expected to (1) find immediate application in high and low load- bearing components of artificial joints and hard tissue resurfacing, and (2) provide a new incentive to pursue development of fiber-reinforced polymeric composites as substitutes for metals in several orthopedic implants.

生物材料两大领域代表生物医药产业和骨科界面临着巨大的挑战用于关节置换和组织工程。大多数人无能为力用于骨科植入物的材料，与骨形成界面结合骨骼通常与松动和衰竭有关。这个，还有那个人们对组织工程的兴趣日益浓厚，并且前景广阔技术适用于关键的生物医学应用，指导我们注意探索使用专有的表面活化和微孔泡沫技术开发独特的基材以实现有关关键聚合物植入物的组织再生。因此，初级该计划第一阶段的目标是确定实现表面磷酸化骨再生聚丙烯 (PP)、聚乙烯 (PE) 和聚丙交酯/乙交酯 (PLG) 带或不带微孔表皮的基材，放置在 6 至 8 时山羊股骨中的经皮层植入物数周。因此，第一阶段需要 (1)可吸收PLG的制备； (2)PLG、PE的转换和 PP 植入式棒； (3)在其上形成微孔皮一组杆； (4) 表面膦酰化及表征有或没有微孔外皮的棒； (5)植入表面改性 PLG 棒如 5 所示，已用细胞附件处理因素; (7) 进行组织学检查和推出试验回收的股骨段以确定骨再生和/或向内生长和骨/种植体界面结合强度。阶段结果我的研究将用于第二阶段计划的设计，其中包括进行 (1) 最佳表面改性的详细动物研究超高分子量聚乙烯（UHMW-PE）骨植入物； (2) 开发选定的骨科器械并完成安全性研究植入物原型； (3) 追求体外和体内独特的膦酰化微孔PLG的性能研究共聚物作为骨再生的支架。拟议的商业应用：成功应用表面磷酸化技术与简单的结合形成的微孔和/或表面微纹理植入物预计对无水泥的发展产生立竿见影的积极影响，具有混合骨/种植体界面的聚合物骨假体。这预计 (1) 在高负载和低负载中立即应用人工关节和硬组织表面重修的轴承部件，以及 (2)为纤维增强材料的发展提供新的动力聚合物复合材料在多种骨科领域作为金属的替代品植入物。