Expandable Shape-Memory Polymers for Suture Anchors

用于缝合锚钉的可膨胀形状记忆聚合物

• 批准号: 8305875
• 负责人: CHRISTOPHER M YAKACKI
• 金额: $ 10万
• 依托单位: MEDSHAPE SOLUTIONS, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-07 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8305875
• 关键词: Acute; Address; Age; Age-Years; Aging; Animals; Back; Biological; Bone Density; Cadaver; Chemicals; Development; Device Designs; Devices; Doctor of Philosophy; Equipment Malfunction; European Union; Failure; Guns; Health; Industry; Injury; Lead; Link; Marketing; Mechanics; Medical; Medical Device; Memory; Modeling; Muscle; Operating Rooms; Operative Surgical Procedures; Orthopedics; Osteolysis; Osteoporosis; Pain; Patients; Performance; Phase; Physiological; Polymers; Population; Process; Product Labeling; Quality of life; Reporting; Research; Risk; Rotator Cuff; Running; Safety; Sales; Secure; Shapes; Sheep; Shoulder; Shoulder Pain; Site; Solutions; Sterility; Sterilization; Surgeon; Surgical sutures; Technology; Tendon structure; Testing; Time; Toxic effect; Wing; Work; biomaterial compatibility; bone; bone mass; bone quality; cytotoxicity; density; design; experience; functional restoration; genotoxicity; implant material; implantation; in vivo; injured; injury and repair; instrumentation; irritation; manufacturing scale-up; migration; professor; prototype; repaired; sample fixation; verification and validation

DESCRIPTION (provided by applicant): This project will develop a shape-memory polymer suture anchor capable of dynamic expansion that will be 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 back onto the bone. Rotator cuff repairs are common surgical procedures involving suture anchors to reduce pain and restore use to an injured shoulder. In 2007, over 460,000 rotator cuff repairs were performed in the US using 1,030,000 suture anchors. Approximately 25 to 35% of rotator cuff repairs are considered unsuccessfully. A general challenge and constraint in rotator cuff repair is the large amount of soft cancellous bone where the anchors 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. In recent studies, over 54% of patients over the age of 60 with shoulder pain had evidence of rotator cuff tears. Patients with poor bone mass densities are highly at risk of device failure as bone density have been correlated to the fixation strength of the suture anchors. The proposed shape-memory suture anchor will be developed as a tap-in style device, in which the shape- memory effect will be mechanically activated to expand into a wing-shaped device and offer instant fixation. The main advantages of this device are its superior fixation strength in soft bone and increased cyclic performance due to the design's use of shape-memory polymers. The shape-memory suture anchor will also offer reduced complexity and time during installation as a tap-in device, which can utilize a knotless suture approach. Knotless suture anchors instantly secure tendon fixation upon anchor insertion and do not require the surgeon to tie and pass knots of suture from the anchor to the tendon as in traditional anchors. The broad impact of this work will challenge the paradigm of how suture anchors are designed to work in soft bone by utilizing shape-memory materials and a model to predict pullout strength, which was developed in Phase I. This Phase II looks to continue and expand upon the feasibility demonstrated and fundamental information obtained in the successful Phase I efforts of this project. The aims of the Phase II have specifically been designed to fundamentally investigate the design and performance of suture anchors while following an aggressive path towards regulatory approval. The aims involve (1) finalizing the design, (2) developing instrumentation, (3) assessing biocompatibility, (4) validating sterilization, (5) validating performance, and (6) performing a pilot animal study to prove the use of shape-memory suture anchors in-vivo. The primary research team will consist of Chris Yakacki PhD (PI), who is an expert in shape-memory polymers and device testing; Ken Gall PhD, a full professor from Georgia Tech who specializes in shape-memory materials and medical device testing; and Reed Bartz MD, an orthopedic surgeon and expert in arthroscopic shoulder repair. PUBLIC HEALTH RELEVANCE: 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 and suffer from poor bone quality. This project will provide a means to restore function to repaired injury sites with less occurrence of surgical failure and increase patient quality of life.

描述（由申请人提供）：该项目将开发出能够动态膨胀的形状内存聚合物缝合线锚，该锚定是专为骨骼密度较差的患者而设计的。缝合锚是螺钉或楔形的设备，可将螺丝固定在骨骼中，并用于将脱离的肌腱固定在骨头上。肩袖维修是涉及缝合锚的常见外科手术程序，可减轻疼痛并恢复受伤的肩膀。 2007年，在美国使用1,030,000个缝合线进行了超过460,000个肩袖维修。大约25％至35％的肩袖修理被认为没有成功。肩袖修复中的一般挑战和约束是必须放置锚的大量软骨，这使得锚更容易迁移，松动/隧道扩大和拉动。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。在最近的研究中，超过54％的60岁患者患有肩部疼痛，有肩袖撕裂的证据。骨骼质量密度较差的患者高度高，因为骨密度与缝合线锚的固定强度相关。所提出的形状内存缝合线将作为一种Tap-in Style设备开发，其中形状 - 内存效果将被机械激活以扩展到机翼形设备中并提供即时固定。该设备的主要优点是由于设计使用了形状 - 内存聚合物，因此其在软骨中的优势固定强度和循环性能提高。 Shape-Memory缝合线还将在安装过程中作为Tap-In设备提供减少的复杂性和时间，该设备可以利用无结的缝合方法。无结缝线锚锚在锚固插入时立即固定肌腱固定，不需要外科医生像传统锚一样从锚定向肌腱的缝合线并通过缝合线。这项工作的广泛影响将挑战缝合线锚方式如何通过利用形状记忆材料和模型来预测拉动强度的范围，该阶段II阶段旨在继续并扩展。根据在该项目成功的第一阶段努力中获得的可行性和基本信息。第二阶段的目的是专门设计的，目的是从根本上研究缝合线锚的设计和性能，同时遵循监管批准的积极途径。目的涉及（1）完成设计，（2）开发仪器，（3）评估生物相容性，（4）验证灭菌，（5）验证性能以及（6）进行试验动物研究以证明使用形状 - 内存缝合线锚定在体内。主要研究团队将由Chris Yakacki PhD（PI）组成，他是形状内存聚合物和设备测试的专家；佐治亚理工学院的完整教授肯·加尔（Ken Gall Phd）专门研究形状记忆材料和医疗设备测试；以及骨科外科医生，关节镜肩部修复专家Reed Bartz MD。公共卫生相关性：随着年龄的增长，越来越多的人口保持身体活跃。该项目与这一比例的人相关，这些人遭受了令人衰弱的伤害，例如肩袖撕裂，并且骨质质量差。该项目将提供一种恢复功能的方法，以减少手术衰竭的发生并提高患者生活质量。

项目成果

The effect of the trabecular microstructure on the pullout strength of suture anchors.

• DOI: 10.1016/j.jbiomech.2010.03.013
• 发表时间: 2010-07-20
• 期刊: JOURNAL OF BIOMECHANICS
• 影响因子: 2.4
• 作者: Yakacki, Christopher M.;Poukalova, Mariya;Guldberg, Robert E.;Lin, Angela;Saing, Minn;Gillogly, Scott;Gall, Ken
• 通讯作者: Gall, Ken