Expandable Shape-Memory Polymers for Suture Anchors

用于缝合锚钉的可膨胀形状记忆聚合物

基本信息

批准号：
7480798
负责人：
CHRISTOPHER M YAKACKI
金额：
$ 9.75万
依托单位：
MEDSHAPE SOLUTIONS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-04-07 至 2008-10-06
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7480798
关键词：
Accounting Address Age Age-Years Aging Alloys Animal Model Biocompatible Materials Biological Biomechanics Bone Density Cadaver Chronic Class Clinical Data Depth Device Designs Devices Doctor of Philosophy Ensure Environment Equipment Malfunction Failure Family suidae Freedom Glass Healed Incidence Injury Institutes Lead Link Literature Localized Location Marketing Mechanics Memory Modeling Numbers Operative Surgical Procedures Orthopedics Osteolysis Osteoporosis Patients Performance Phase Placement Polymers Population Principal Investigator Procedures Purpose Quality of life Radial Range Recovery Reporting Research Risk Rotator Cuff Safety Sampling Scientist Secure Shapes Shoulder Site Small Business Funding Mechanisms Small Business Innovation Research Grant Solutions Standards of Weights and Measures Structure Surgeon Surgical sutures System Technology Tendon structure Testing Time Titanium Transition Temperature USA Georgia Week Western Asia Georgia Work base biomaterial compatibility bone commercialization density design experience functional restoration healing implantation improved migration older patient poly(lactide)professor prototype repaired sample fixation size soft tissue

项目摘要

DESCRIPTION (provided by applicant): This project will develop a shape-memory polymer suture anchor capable of dynamic expansion and is specifically designed for patients with poor bone mass density. Suture anchors are screw or wedge-like devices that fasten into the bone and are used to secure a detached tendon to the bone. After a 12-week period, the tendon should achieve natural biological fixation to be considered successfully repaired. Rotator cuff repair is the most common surgical procedure involving suture anchors and are performed over 75,000 times annually. A general challenge and constraint in repair is the large amount soft cancellous bone where the anchor must be placed, which makes the anchors more susceptible to migration, loosening/tunnel widening, and pullout. Furthermore, a growing number of patients over 60 years of age are receiving rotator cuff repairs and suffer from osteoporosis. Patients with poor bone mass density are highly at risk to device failure as bone density have been correlated to the fixation strength of suture anchors. The proposed shape-memory polymer suture anchor will be (i) designed to match its expansion forces to the bone's performance limits to optimize fixation strength and (ii) be able to dynamically adapt to tunnel widening to ensure stable fixation during the healing period. The broad impact of this work will introduce a new type of shape-memory biomaterial into the market as well as potentially revolutionize rotator cuff repair and reach into all procedures involving suture anchors. The SBIR Phase I is designed to not only provide feasibility to the shape-memory polymer suture anchor, but also to generate fundamental material information to move into Phase II. The two main aims of this Phase I are (i) link the polymer structure and device design to the radial recovery force, while proving biocompatibility and (ii) provide sufficient pullout data compared to current devices and illustrate the polymer can adapt to tunnel widening. The first aim will primarily consist of material synthesis, network and shape-memory characterization, and cytocompatibility testing. The second aim will make use of a porcine bone model to perform and compare monotonic and cyclic pullout testing of commercially available devices and shape-memory polymer prototypes. The primary research team will consist of a principal investigator from MedShape Solutions, Christopher Yakacki PhD, who has experience in synthesis and characterization of shape-memory polymers; a materials scientists from The Georgia Institute of Technology, Ken Gall PhD, who is a full professor specializing in shape-memory materials; and an orthopedic surgeon, Reed Bartz MD, who is an expert in arthroscopic shoulder repair. Project Narrative A growing percentage of the population is remaining physically active as they age. This project is relevant to this percentage of people that experience a debilitating injury such as a rotator cuff tear. This project will provide a means to restore function to their shoulders with less occurrence of surgical failure and increase their quality of life.

描述（由申请人提供）：该项目将开发出能够动态扩张的形状内存聚合物缝合线锚，并专门针对骨骼密度较差的患者设计。缝合线锚是螺丝或楔形的设备，可将其固定在骨骼中，并用于将分离的肌腱固定在骨头上。经过12周的时间后，肌腱应实现自然的生物固定，以被认为可以成功修复。肩袖修复是涉及缝合锚的最常见手术程序，每年进行75,000次以上。维修的一般挑战和限制是必须放置锚的大量软骨，这使锚更容易迁移，松动/隧道扩大和拔出。此外，越来越多的60岁以上的患者正在接受肩袖维修并患有骨质疏松症。骨质量密度较差的患者对设备故障的风险很高，因为骨密度与缝合锚的固定强度相关。所提出的形状内存 - 内存聚合物缝合线将是（i）旨在将其膨胀力与骨骼的性能限制相匹配，以优化固定强度，并且（ii）能够动态适应隧道的拓宽，以确保在愈合期间确保稳定的固定。这项工作的广泛影响将向市场引入一种新型的形状内存生物材料，并有可能彻底改变肩袖修复并伸入涉及缝合锚的所有程序。 SBIR I期旨在不仅为形状内存聚合物缝合线提供可行性，还可以生成基本的材料信息以进入II期。该阶段的两个主要目的是（i）将聚合物结构和设备设计与径向恢复力联系起来，同时证明生物相容性和（ii）与当前设备相比提供了足够的拔出数据，并说明了聚合物可以适应隧道的拓宽。第一个目的主要包括材料合成，网络和形状内存表征以及细胞相容性测试。第二个目的将利用猪骨模型来执行和比较市售设备和形状 - 内存聚合物原型的单调和循环拔出测试。主要研究团队将由Medshape Solutions的首席研究员Christopher Yakacki PhD组成，他在形状内存聚合物的合成和表征方面经验丰富；佐治亚理工学院的材料科学家Ken Gall PhD，他是一位专门从事Shape-Memory材料的完整教授；以及骨科医生里德·巴茨（Reed Bartz）医学博士，他是关节镜肩部修复专家。项目叙事随着年龄的增长，人口越来越多的人口保持身体活跃。该项目与这一比例的人有关，遭受衰弱的伤害（例如肩袖撕裂）。该项目将提供一种恢复肩膀功能的方法，而手术失败的发生率较小并提高其生活质量。