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

这个小企业创新研究（SBIR）一期项目旨在开发一种使用形状记忆织物的机械主动软组织增强装置，以改善慢性肩袖撕裂的组织质量。对于慢性撕裂，肩袖已经退化到不能使用标准的修复程序进行骨愈合的程度。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。这个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)施加由织物产生的力的效果。S形恢复，对肩袖组织质量的影响。这项工作的预期结果将是确定一种织物，这种织物可以在体温下在软组织重新附着所需的时间尺度上通过形状恢复而收缩。这项工作还将证明，张力可以连续施加于袖带组织，其强度代表了袖带上的生理拉伸负荷。该项目更广泛的影响/商业潜力是解决与慢性肩袖撕裂治疗有关的重要临床问题的潜力。每年有超过40万人进行肩袖修复手术，但失败率为20%。肩袖加固装置市场估计为9100万美元，每年增长16%。目前还没有商业上可用的增强装置可以帮助改善慢性袖带撕裂的组织质量。因此，一种能够施加持续拉伸力以改善组织质量的强化装置可以作为一项颠覆性技术在大市场中发挥作用，并对肩袖手术的实施产生重大影响。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体内机械刺激生物反应的基础知识，特别是拉伸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、疝气修复、战场/创伤性肌肉损伤和肌肉疾病。

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.