Wong Jordan B, Henninger Dwight D, Clymer Jeffrey W, Ricketts Crystal D, Fryrear Raymond S
Ethicon, Inc., Cincinnati, OH 45242, USA.
Med Devices (Auckl). 2020 Jan 29;13:23-29. doi: 10.2147/MDER.S234156. eCollection 2020.
Staple line reinforcement (SLR) is a popular tool used by surgeons to increase staple line strength and improve peri-operative hemostasis. However, currently marketed buttress materials require special attention in attachment to the staple anvil and cartridge and may come loose during typical maneuvering of stapling procedures. We have evaluated a new SLR that has an attachment material that affixes buttress across the entire anvil and cartridge face to prevent slipping, twisting, sliding and/or bunching.
In benchtop and preclinical testing, the new buttress material (ECHELON ENDOPATH™ Staple Line Reinforcement) was compared to a commercially available SLR for physical characteristics, including strength, absorption, security on the anvil and cartridge during stapler manipulation, impact on the tissue healing response and tissue abrasion. The two SLR's were also compared to a staple line without buttress for hemostasis.
The new SLR was 180% stronger initially and maintained a greater strength for up to 14 days of exposure to an in vitro solution (p≤0.001), even though it was lighter and exhibited a faster rate of degradation. The new buttress material maintained complete adherence to the anvil and cartridge throughout tissue manipulation, whereas the commercial product lost substantial coverage in 72% of samples. Both SLR's provided superior hemostasis to the non-buttress control, with minimal impact on tissue healing or abrasion.
Because the new buttress material comes with attachment material affixed across the entire anvil and cartridge face of the stapler and maintains coverage during manipulations, it should be much easier to use. The physical characteristics of the new SLR were as good as or better than current product that requires the buttress to be applied to the cartridge and anvil. In addition, the new SLR is similar in hemostasis to standard products and superior to stapling without the use of buttress. Further research is needed to determine whether these preclinical benefits carry over into a clinical setting.
吻合器钉合线加固（SLR）是外科医生常用的一种工具，用于增强钉合线强度并改善围手术期止血效果。然而，目前市场上销售的支撑材料在与吻合器钉砧和钉仓连接时需要特别注意，并且在钉合操作的常规过程中可能会松动。我们评估了一种新型的SLR，它具有一种连接材料，可将支撑物固定在整个钉砧和钉仓表面，以防止滑动、扭曲、移位和/或聚集。
在台式和临床前测试中，将新型支撑材料（ECHELON ENDOPATH™吻合器钉合线加固材料）与一种市售的SLR进行比较，评估其物理特性，包括强度、吸收性、在吻合器操作过程中在钉砧和钉仓上的固定性、对组织愈合反应的影响以及组织磨损情况。还将这两种SLR与无支撑物的钉合线进行止血效果比较。
新型SLR最初强度高180%，并且在体外溶液中暴露长达14天仍保持较高强度（p≤0.001），尽管它更轻且降解速度更快。新型支撑材料在整个组织操作过程中始终与钉砧和钉仓完全贴合，而市售产品在72%的样本中失去了大量覆盖。两种SLR在止血方面均优于无支撑物对照组，对组织愈合或磨损的影响最小。
由于新型支撑材料带有固定在吻合器整个钉砧和钉仓表面的连接材料，并且在操作过程中能保持覆盖，因此使用起来应该更加容易。新型SLR的物理特性与目前需要将支撑物应用于钉仓和钉砧的产品相当或更好。此外，新型SLR在止血方面与标准产品相似，且优于不使用支撑物的钉合。需要进一步研究以确定这些临床前的优势是否能转化到临床环境中。
