Development of tubular silk conduits for housing nerve-regenerating silk fibres

创伤和癌症手术对周围神经的损伤导致世界范围内的功能丧失和显著的发病率。目前，对于周围神经损伤（PNI），还没有像金标准自体神经移植物那样有效的可植入装置。然而，这些手术执行起来很昂贵，需要从患者的供体部位牺牲神经，并且成功率有限。每年进行数千次这样的手术，通过供体神经的损失造成伤害，并对移植神经和缠结神经的慢性疼痛带来高发病风险。此外，在许多情况下，特别是直接创伤导致的PNI，无法使用自体移植物，但可以使用替代的现成支架。我们的第一个（IP保护）产品是具有标准化设计的周围神经修复桥，将提供各种长度的现成支架。将3 cm长的支架与自体移植物（标准为2-3 cm）进行比较，可选择更长的支架（<5 cm）。该桥是围绕定制尺寸的丝纤维的全丝生物相容性管状丝导管。这些管腔纤维已被证明具有神经再生特性，套管设计用于保护生长的神经并促进血管形成。鉴于周围神经纤维在体内各处都是相同的，我们提供了一种新的方法来治疗由创伤或侵入性手术引起的损伤，这些损伤目前将面临缺乏治疗选择或遭受自体移植修复的发病率。

Damage to peripheral nerves through trauma and cancer surgery results in loss of function and significant morbidity worldwide. There are currently no implantable devices for peripheral nerve injury (PNI) as effective as the gold standard autologous nerve grafts. However, these are expensive to perform, require sacrificial nerves from a donor site in the patient and have limited success. Thousands of these procedures are performed each year and cause harm through the loss of the donor nerve and carry high risk of morbidity for transplanted nerves and chronic pain from tangled nerves. In addition, there are many cases, particularly where PNI is from direct trauma, where it is not possible to use an autograft, but an alternate off-the-shelf stent could be used.Our first (IP protected) product is a peripheral nerve repair bridge with a standardised design that will be available off-the-shelf in a range of lengths. Stents 3 cm in length will be compared to autografts (2-3 cm as standard) with the option for longer lengths (<5 cm). The bridge is an all silk biocompatible tubular silk conduit surrounding silk fibres of bespoke dimensions. These luminal fibres have proven nerve-regenerating properties with the sleeve tube designed to protect the growing nerves and encourage vascularisation.Given that peripheral nerve fibres are the same everywhere in the body we provide a new approach to treating patients for injuries caused by trauma or invasive surgery that would currently face absence of treatment options or suffer the morbidity of autograft repairs.