For the past few decades, tissue sealants and adhesives have been developed as an alternative to sutures and staples to close and seal wounds or incisions. These materials are advantageous because of their ease of use, short application time and minimal tissue damage, making them suitable for minimally invasive procedures. However, there is a large gap between the amount of research into tissue adhesives and the number of products available. To bridge this gap, there is a need to better understand the challenges to clinical translation of tissue adhesives. In particular, adhesive design must be informed by a deep understanding of the target tissue’s surface characteristics and environment, which vary considerably among tissue types. Moreover, understanding and monitoring the long-term performance of a material post-implantation is crucial; this includes monitoring the chemical and physical properties of the implanted adhesives over time, tissue responses and the resultant changes in adhesion and cohesion. In addition, early-stage consideration of the unmet clinical need and the regulatory and development paths could lower the barriers in the development cost and effort, facilitating clinical translation. In this Review, we identify challenges in the development of tissue adhesives and provide design criteria to translate tissue-adhesive technologies into clinical practice.

在过去的几十年中，已经开发出组织密封剂和粘合剂作为缝合线和钉书钉的替代品，以闭合和密封伤口或切口。这些材料的优点是易于使用，使用时间短且组织损伤最小，从而使其适合于微创手术。但是，对组织粘合剂的研究量与可用产品的数量之间存在很大的差距。为了弥合这一差距，需要更好地了解组织粘合剂临床翻译面临的挑战。特别是，必须对目标组织的表面特征和环境有深刻的了解，才能对粘合剂的设计有所了解，而目标组织的表面特征和环境在组织类型之间差异很大。此外，了解和监测材料植入后的长期性能至关重要。这包括随着时间的推移监视植入的粘合剂的化学和物理特性，组织反应以及由此产生的粘附力和内聚力变化。此外，对未满足的临床需求以及监管和开发路径的早期考虑可以降低开发成本和工作量的障碍，从而促进临床翻译。在这篇综述中，我们确定了组织粘合剂开发中的挑战，并提供了将组织粘合剂技术转化为临床实践的设计标准。对未满足的临床需求以及监管和开发路径的早期考虑可以降低开发成本和工作量的障碍，从而促进临床翻译。在这篇综述中，我们确定了组织粘合剂开发中的挑战，并提供了将组织粘合剂技术转化为临床实践的设计标准。对未满足的临床需求以及监管和开发路径的早期考虑可以降低开发成本和工作量的障碍，从而促进临床翻译。在这篇综述中，我们确定了组织粘合剂开发中的挑战，并提供了将组织粘合剂技术转化为临床实践的设计标准。