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害会导致功能丧失，并在世界范围内造成严重的发病率。目前还没有一种植入式装置能像黄金标准的自体神经移植那样有效地治疗周围神经损伤(PNI)。然而，这些手术费用昂贵，需要患者供体部位的牺牲神经，而且成功率有限。每年有数以千计的此类手术进行，通过失去供体神经造成伤害，并带有移植神经发病率和缠绕神经的慢性疼痛的高风险。此外，在许多情况下，特别是在PNI来自直接创伤的情况下，不可能使用自体移植，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，将提供一系列现成的长度。长度为3厘米的支架将与自体移植(标准长度为2-3厘米)进行比较，可选择更长的长度(&lt；5厘米)。这座桥是一种全真丝生物兼容管状丝质管道，环绕着定制尺寸的真丝纤维。这些管腔纤维已被证明具有神经再生特性，袖管旨在保护生长的神经并促进血管形成。鉴于周围神经纤维在身体各处都是相同的，我们提供了一种新的方法来治疗因创伤或侵入性手术造成的损伤，目前这些患者将面临治疗方案的缺乏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.