BACKGROUND: The team creating and conducting this study consisted of surgeons and engineers. A specific project was made and divided into 4 phases.
METHODS: The process of development and implantation was divided into 4 milestones: CT scans and modeling based on predefined subgroups, mesh manufacture, certification and clinical evaluation.
RESULTS: The result of the study was the first individually designed hernia mesh to have been implanted in a human subject. After 12 months of follow-up, no recurrences or other complications were reported.
CONCLUSIONS: The new mesh provides a better anatomic fit to the patients\' inguinal region geometry. Mechanical stability is ensured by the multiple contact points between the implant and the tissues, which generate friction forces. Together with the possibility of shape design (proper overlap), the authors believe that there is no need for mesh fixation. If so, the use of such design meshes can change the guidelines in laparoendoscopic hernia repair in the future.
背景:创建和实施这项研究的团队由外科医生和工程师组成。制定了一个具体项目,分为4个阶段。
方法:发育和植入的过程分为4个里程碑:基于预定义亚组的CT扫描和建模,网格制造,认证和临床评估。
结果:该研究的结果是第一个单独设计的疝网片被植入人类受试者体内。经过12个月的随访,未报告复发或其他并发症.
结论:新的网格为患者腹股沟区的几何形状提供了更好的解剖配合。植入物和组织之间的多个接触点确保了机械稳定性,产生摩擦力。连同形状设计的可能性(适当的重叠),作者认为不需要网片固定。如果是,这种设计网格的使用可以改变将来腹腔镜疝修补术的指南。