Medical Devices: Evidence and Research (Jan 2020)
A Novel, Easy-to-Use Staple Line Reinforcement for Surgical Staplers
Abstract
Jordan B Wong, Dwight D Henninger, Jeffrey W Clymer, Crystal D Ricketts, Raymond S Fryrear II Ethicon, Inc., Cincinnati, OH 45242, USACorrespondence: Jeffrey W ClymerEthicon, Inc., 4545 Creek Road, Cincinnati, OH 45242, USATel +1 513 337 3318Email [email protected]: 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.Methods: 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.Results: 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.Conclusion: 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.Keywords: stapler, buttress, staple line reinforcement, hemostasis, anastomosis
