A Durable Muscle-Prosthetic Bond For Artificial Tendons

描述（由申请人提供）：目前的肌腱重建方法，从同种异体移植和自体移植肌腱到可吸收“支架”生成的新肌腱，至少不能很好地服务于两类人群。首先，在切除癌变骨的假体置换后，没有一贯可靠的肌肉再附着的方法，否则相当足够的骨置换假体。其次，尽管传统的肌腱移植可以显著地帮助一些脑瘫或围产期神经损伤的儿童，但更多的儿童受到天然肌腱的长度和位置的限制。这些人和其他人都将受益于真正的人造肌腱——如果存在的话。骨置换重建将是直接连接惰性材料；肌腱移植将不再受长度和位置的限制：可以制作任何长度的假体。有理由相信，一种新的持久的肌肉-假体耦合技术，用于向循环支持装置提供肌肉动力，并在动物实验中取得了非常成功的结果（分离强度远远超过需求），可以产生一种完全满足这些矫形需求的耦合，甚至比其初衷更好。该装置通过在远端肌肉物质中分散超细聚合物纤维来显着增加力传递表面，并相应地显着减少界面应力。我们将模拟将天然肌腱重新连接到骨替代假体上的困境，通过开发一种适合将肌肉连接到先前插入部位而不是该区域的金属骨板上的装置。用这种方法将8只成年山羊的一块大肌肉固定在钢骨板表面60天。我们在一次试验中发展并完善了这个模型。机械结合强度相对于标准手术控制，和组织学组织-假体界面将被检查。对实验数据的意义进行分析。通过循环加速加载来检验器件的材料疲劳寿命。成功的可行性论证将证明第二阶段的发展——与这些假体的开发商建立战略合作伙伴关系，使用全骨假体进行广泛的、现实的长期重建，以及认真研究肌腱转移的应用。

DESCRIPTION (provided by applicant): Present means of tendon reconstruction, ranging from allografted and autografted tendons to neotendons generated by resorbable 'scaffolding', do not well serve at least two groups of people. First, after prosthetic replacement of extirpated cancerous bones there is no consistently reliable means of muscle reattachment to otherwise quite adequate bone replacement prostheses. Second, though traditional tendon transfer may dramatically aid some children with cerebral palsy or peripartum nerve injury, many more are limited by the length and position of native tendons. Both these people and others would benefit from a truly artificial tendon-if one existed. Bone-replacement reconstruction would then be straightforward joining of inert materials; tendon transfer would no longer be limited by length and location: a prosthesis could be made any length. There is reason to believe a new durable muscle-to-prosthesis coupling technology, developed for delivering muscle-power to circulatory support devices with very successful animal results (separation strengths far exceeding demand), could yield a coupling serving these orthopedic needs fully as well as-or better than- its original intent. This device works by dispersing ultrafine polymer fibers in the distal muscle substance to dramatically increase force-transfer surface, with proportionally dramatic interface-stress reduction. We will simulate the dilemma of reattaching native tendons to bone-replacement prostheses by developing a device suitable for joining muscles not to their previous insertions sites but rather to metal bone plates in the region. A large muscle in each of eight adult goats will be in this way fixed to the surface of asteel bone plate for 60 days. We have developed and refined this model in a plot trial. Mechanical bond strength relative to standard surgical controls, and histologic tissue-prosthetic interface will be examined. The experimental data will be analyzed for significance. Material fatigue life of devices will be examined through cyclic accelerated loading. Successful demonstration of feasibility would justify Phase II level development-extensive, realistically long-term reconstruction with full bone prostheses in strategic partnership with a developer of these prostheses, as well as serious study of tendon transfer application.