Ibrahim Mohamad M, Green Jason L, Everitt Jeffrey, Ruppert David, Glisson Richard, Leopardi Frank, Risoli Thomas, Kuchibhatla Maragatha, Reynolds Randall, Levinson Howard
Division of Plastic, Maxillofacial, and Oral Surgery, Department of Surgery, Duke University Medical Center, DUMC 3181, Durham, NC 27710.
Duke University School of Medicine, 487 Medical Science Research Building 1, 203 Research Drive, Durham, NC 27710.
J Med Device. 2019 Dec 1;13(4):0450021-450029. doi: 10.1115/1.4043740. Epub 2019 Sep 20.
One opportunity to reduce hernia occurrence and recurrence rates (currently estimated to be 30% at 10 years postoperatively) is by enhancing the ability of hernia meshes to anchor into tissue to prevent mesh migration, mesh contraction, and mesh tearing away from tissue. To address this, we developed a novel moderate-weight, macroporous, polypropylene mesh (termed the T-line mesh) with mesh extensions to optimize anchoring. We examined the physical properties, biomechanical performance, and biocompatibility of this novel mesh versus a predicate mesh anchored with #0-suture. The physical properties of the T-line mesh and predicate mesh were measured using American Society for Testing and Materials (ASTM) standards. Meshes were implanted into a swine hernia model and harvested after one day to determine anchoring strength of the meshes in the perioperative period. A separate group was implanted into a swine hernia model and harvested at 30 days and 90 days for semiquantitative histological analysis of biocompatibility. T-line mesh physical properties were similar to commonly used moderate-weight meshes in thickness and areal density. The T-line mesh outperformed the predicate mesh in all mechanical testing (P < 0.05). In the perioperative period, the T-line mesh was ∼275% stronger (P < 0.001) than the standard of care. Histological analysis of biocompatibility demonstrated no significant difference between the T-line mesh and predicate mesh (P > 0.05). The T-line mesh is a novel hernia mesh that outperforms a predicate mesh in mechanical and biomechanical performance testing while exhibiting similar biocompatibility. The T-line mesh has the potential to reduce hernia occurrence and recurrence caused by mechanical failure.
降低疝气发生率和复发率(目前估计术后10年复发率为30%)的一个机会是提高疝气补片锚定到组织中的能力,以防止补片移位、收缩以及与组织分离。为解决这一问题,我们开发了一种新型的中等重量、大孔聚丙烯补片(称为T线补片),其带有补片延伸部分以优化锚定效果。我们研究了这种新型补片与用0号缝线固定的对照补片相比的物理性能、生物力学性能和生物相容性。T线补片和对照补片的物理性能按照美国材料与试验协会(ASTM)标准进行测量。将补片植入猪疝气模型,术后一天取出以确定补片在围手术期的锚定强度。另一组植入猪疝气模型,在30天和90天时取出,用于生物相容性的半定量组织学分析。T线补片的物理性能在厚度和面密度方面与常用的中等重量补片相似。T线补片在所有力学测试中均优于对照补片(P < 0.05)。在围手术期,T线补片比标准治疗方法强约275%(P < 0.001)。生物相容性的组织学分析表明,T线补片和对照补片之间无显著差异(P > 0.05)。T线补片是一种新型疝气补片,在力学和生物力学性能测试中优于对照补片,同时表现出相似的生物相容性。T线补片有潜力降低因机械故障导致的疝气发生和复发。