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可喷涂水凝胶,用于即时血管吻合密封。

Sprayable Hydrogel for Instant Sealing of Vascular Anastomosis.

机构信息

BioDevek Inc., Cambridge, MA, 02139, USA.

Institut Químic de Sarrià, Univeritat Ramon Llull, Barcelona, 08017, Spain.

出版信息

Adv Mater. 2022 Oct;34(43):e2203087. doi: 10.1002/adma.202203087. Epub 2022 Oct 3.

DOI:10.1002/adma.202203087
PMID:36029172
Abstract

Bleeding-related complications following vascular surgeries occur in up to half of the patients-500 000 cases annually in the United States alone. This results in additional procedures, increased mortality rate, and prolonged hospitalization, posing a burden on the healthcare system. Commercially available materials rely, in large, on forming covalent bonds between the tissue and the biomaterial to achieve adhesion. Here, it is shown that a biomaterial based on oxidized alginate and oxidized dextran together with polyamidoamine (PAMAM) dendrimer amine provides simultaneous electrostatic and covalent interactions between the biomaterial and the tissue, maximizing adhesion. This study finds that the material withstands supraphysiological pressures (≈300 mmHg) and prevents bleeding in a rabbit aortic puncture model and in a pig carotid bilateral poly(tetrafluoroethylene) graft model-achieving superior performance to commercially available materials such as Tisseel and BioGlue. Material biocompatibility is validated in comprehensive in vitro and in vivo studies in accordance with the US Food and Drug Administration (FDA) guidelines, including in vitro neutral red uptake test, subcutaneous implantation in rabbits, ames genotoxicity, and guinea pig maximization test. This material has the potential to provide with adequate seal and reduced complications following complex vascular surgeries, including hard-to-seal tissue-graft interfaces.

摘要

血管手术后的出血相关并发症在多达一半的患者中发生-仅在美国每年就有 50 万例。这导致了额外的手术、死亡率的增加和住院时间的延长,给医疗保健系统带来了负担。市售材料主要依赖于在组织和生物材料之间形成共价键来实现粘附。在这里,研究表明,基于氧化海藻酸钠和氧化葡聚糖以及聚酰胺-胺(PAMAM)树状大分子胺的生物材料提供了生物材料与组织之间的静电和共价相互作用,从而实现了最大的粘附性。这项研究发现,该材料能够承受超生理压力(≈300mmHg),并防止兔主动脉穿刺模型和猪颈动脉双侧聚四氟乙烯移植物模型中的出血-实现了优于商品化材料如 Tisseel 和 BioGlue 的性能。根据美国食品和药物管理局(FDA)的指导方针,进行了全面的体外和体内研究来验证材料的生物相容性,包括体外中性红摄取试验、兔皮下植入、ames 遗传毒性和豚鼠最大耐受试验。这种材料有可能在复杂的血管手术后提供足够的密封和减少并发症,包括难以密封的组织-移植物界面。

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