SBIR Phase I: Shape-Memory Fabric Device for Muscle Atrophy in Rotator Cuff Repair

SBIR 第一阶段：用于修复肩袖肌肉萎缩的形状记忆织物装置

• 批准号: 1315011
• 负责人: David Safranski
• 金额: $ 15万
• 依托单位: MedShape, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-07-01 至 2014-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1315011&HistoricalAwards=false
• 关键词: SBIR; Phase; Shape; Memory; Fabric

This Small Business Innovation Research (SBIR) Phase I project aims to develop a mechanically-active soft tissue reinforcement device using a shape-memory fabric to improve the tissue quality of chronic rotator cuff tears. With chronic tears, the rotator cuff has degenerated to a point that prevents its ability to heal back to bone using standard repair procedures. The intellectual merit of this project stems from using the shape-memory effect to apply a continuous force on the atrophied rotator cuff tissue in an effort to promote tissue regeneration and improve the overall healing capacity. The research for this project will focus on evaluating (1) how the physical attributes of the fabric will impact the shape-memory properties and (2) the effect of applying a force, generated by the fabric?s shape recovery, on the quality of the rotator cuff tissue. The anticipated results of this work will be the identification of a fabric that can contract via shape recovery at body temperature over a time scale required for soft tissue reattachment to occur. This work will also demonstrate that tension can be continuously applied to cuff tissue at a magnitude representative of physiological tensile loading on the cuff.The broader impact/commercial potential of this project is the potential to address a significant clinical problem pertaining to the treatment of chronic rotator cuff tears. Over 400,000 rotator cuff repairs are performed each year, but have a failure rate of 20%. The rotator cuff reinforcement device market is estimated to be $91 M and growing 16% annually. There are currently no reinforcement devices commercially available that can help improve tissue quality in chronic cuff tears. Thus, a reinforcement device that can apply continuous tensile force to improve tissue quality could serve as a disruptive technology in a large market and significantly impact how rotator cuff procedures are performed. From a technological/scientific standpoint, this project will provide the fundamental knowledge of how shape-memory materials can be applied to mechanically stimulate a biologic response in vivo, specifically the effect of tensile force on soft tissue regeneration. In addition, this shape-memory fabric technology could broadly lend itself to other clinical applications including Achilles tendon repair, hernia repair, battle-field/traumatic muscle injuries, and muscular disorders.

该小型企业创新研究（SBIR）I期项目旨在开发一种机械活性软组织加固器械，该器械使用形状记忆织物来改善慢性肩袖撕裂的组织质量。对于慢性撕裂，肩袖已经退化到阻止其使用标准修复程序愈合到骨的能力的程度。该项目的智力价值源于利用形状记忆效应对萎缩的肩袖组织施加持续的力，以促进组织再生并提高整体愈合能力。该项目的研究将集中在评估（1）织物的物理属性如何影响形状记忆特性和（2）施加力的效果，由织物产生？的形状恢复，对肩袖组织的质量。这项工作的预期结果将是识别一种织物，该织物可以在体温下通过形状恢复在软组织重新附着发生所需的时间尺度内收缩。这项工作还将证明，张力可以连续施加到袖组织在一个代表生理拉伸负荷的幅度上的curose.The更广泛的影响/商业潜力，这个项目是潜在的，以解决一个重大的临床问题有关的慢性肩袖撕裂的治疗。每年有超过40万例肩袖修复手术，但失败率为20%。肩袖加强装置市场估计价值9100万美元，每年增长16%。目前没有市售的加固器械可以帮助改善慢性袖带撕裂的组织质量。因此，可以施加连续张力以改善组织质量的增强装置可以在大市场中用作破坏性技术，并显著影响如何执行肩袖手术。从技术/科学的角度来看，该项目将提供形状记忆材料如何应用于机械刺激体内生物反应的基础知识，特别是张力对软组织再生的影响。此外，这种形状记忆织物技术可以广泛地应用于其他临床应用，包括跟腱修复、疝修复、战场/创伤性肌肉损伤和肌肉疾病。