Towards Bespoke Bio-Hybrid Prosthesis - Manufacturing bio-inductive interfaces in 3D

近年来，生物集成和神经连接假肢领域的研究取得了许多令人兴奋的进展。然而，研究表明，由于神经和肌肉界面的故障，功能的范围和寿命受到限制，分别导致信号丢失和机械故障。我们的愿景是挑战假肢是一个完全不同的和不匹配的实体的思维定势，在那里它可能真正互动，并与残肢解剖学和生理学相结合。我们设想的假体将通过组织工程的非生物/生物导管在人工假体和剩余的生物肌肉和神经之间响应生物反馈。这将为神经系统的传入和传出连接提供自然和全方位的通信和反馈，重点是集成和长期可靠性。这将通过探索和理解定制3D耦合结构的基础工程和制造来实现，这些结构鼓励并促进了与组织工程骨骼肌和神经及其辅助结构的强大集成和接口。这项研究将需要通过一个由制造工程、生物科学和化学组成的多学科团队，开发一种新的制造工艺和相关科学。考虑到工业规模扩大，良好生产规范（GMP）和监管要求是贯穿始终的。这项工作将与世界领先的英国假肢制造公司合作进行，并进行临床参与。

There have been a number of exciting research developments in the field of bio-integrated and neural connected limb prosthetics. However, it has been shown that the range and lifetime of functionality is limited due to failures at both nerve and muscle interfaces, leading to signal loss and mechanical failure, respectively. Our vision is to challenge the mind-set of limb prosthesis being a disparate and mismatched entity to one where it may be truly interactive and integrated with the residual anatomy and physiology. Our envisaged prosthesis will respond to biological feedback via a tissue engineered abiotic/biotic conduit between the artificial prosthetic and remaining biological muscle and nerves. This will provide the natural and full range of communication and feedback with afferent and efferent connections to the neural system with an emphasis on integration and long-term reliability. This will be achieved through exploration and understanding the fundamental engineering and manufacture of bespoke 3D coupling constructs that encourage and facilitate the robust integration and interface with tissue-engineered skeletal muscle and nerves, and their ancillary structures. The researching will entail developing a new manufacturing process, and the associated sciences, through a multidisciplinary team comprising of manufacturing engineering, biological science and chemistry. Considerations for industrial scale-up, good manufacturing practice (GMP) and regulatory requirements are integrated throughout. The work will be conducted in partnership with a world-leading UK prosthetic manufacturing company along with clinical engagement.