A Durable Muscle-Prosthetic Bond For Artificial Tendons

描述(申请人提供)：目前的肌腱重建方法，从同种异体和自体移植的肌腱到由可吸收的脚手架产生的新腱，至少不能很好地服务于两组人。首先，在切除的癌骨的假体置换后，没有稳定可靠的方法使肌肉重新附着到原本相当充足的骨置换假体上。其次，尽管传统的肌腱移位术可能会极大地帮助一些患有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--如果真的存在的话。骨替代重建将是惰性材料的直接连接；肌腱转移将不再受长度和位置的限制：可以制造任何长度的假体。我们有理由相信，一种新的耐用的肌肉-假体耦合技术，为循环支持设备提供肌肉-动力，并取得了非常成功的动物结果(分离强度远远超过需求)，可能会产生完全满足这些整形外科需求的耦合，或者比它的初衷更好。这种装置的工作原理是将超细聚合物纤维分散在远端肌肉实质中，显著增加力传递表面，并按比例显著降低界面应力。我们将通过开发一种设备来模拟将天然肌腱重新连接到骨替换假体上的困境，该设备适用于将肌肉连接到该区域的金属骨板上，而不是连接到以前的插入位置。用这种方法将8只成年山羊每只的一块大肌肉固定在钢板表面60天。我们在一次小区试验中开发和改进了这个模型。将检查相对于标准手术对照的机械结合强度和组织学组织-假体界面。将对实验数据进行分析，以确定其意义。将通过循环加速加载来检查器件的材料疲劳寿命。可行性的成功证明将证明第二阶段的开发是合理的--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、现实的长期重建，以及认真研究肌腱转移应用。

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.