<p>A Novel, Easy-to-Use Staple Line Reinforcement for Surgical Staplers</p>

Abstract

Background: 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.

Efficacy of surgical staple line reinforcement in Glissonean stapling: A single‐center pilot study

“…7 A previous study evaluated the safety of a stapler with preattached buttress material and found that there were no cases of bleeding >50 mL that required intervention of the staple line, and only three cases (8%) experienced minor leaks that were treated conservatively. 6 Regarding the application of stapling devices in hepatic surgery, it was considered that an SLR technique with an absorbable polymer membrane or radiofrequency ablation assistance may be needed for the safe application of stapling devices in liver surgery. Overall, the benefits of using staple line reinforcement during hepatectomy are increased staple line strength and improved perioperative hemostasis, which can reduce the risk of complications such as leaks or bleeding.…”

“…Notably, SLR also has a lower risk of bleeding, which can potentially lead to a reduction in intraoperative and postoperative complications. 6 The complete absorption of PGA within approximately 15 weeks further underscores its safety. Beyond liver resection, SLR has been used in various surgical contexts, including thoracic surgery, 7 upper gastrointestinal reconstruction, 8 and pancreatic resection, 9 as well as in animal experiments.…”

“…To mitigate these complications, we introduced SLR, a technique that has shown promise in reducing leakage along the staple line by applying a polyglycolic acid (PGA) reinforcement material. Notably, SLR also has a lower risk of bleeding, which can potentially lead to a reduction in intraoperative and postoperative complications 6 . The complete absorption of PGA within approximately 15 weeks further underscores its safety.…”

“…Studies on SLR in thoracic surgery have demonstrated that reinforced staple lines are less prone to leakage or bleeding, which may result in decreased morbidity and postoperative complications 7 . A previous study evaluated the safety of a stapler with preattached buttress material and found that there were no cases of bleeding >50 mL that required intervention of the staple line, and only three cases (8%) experienced minor leaks that were treated conservatively 6 . Regarding the application of stapling devices in hepatic surgery, it was considered that an SLR technique with an absorbable polymer membrane or radiofrequency ablation assistance may be needed for the safe application of stapling devices in liver surgery.…”

Safety and usability of an endo staple line reinforcement device for pulmonary resections

“…Absorbable materials, such as polyglycolic acid or polyglactin, provide temporary reinforcement and are eventually absorbed by the body ( 13 , 14 ). Overall, buttressing distributes tension evenly across the staple line and provides a broad pressure profile around the individual staples, reducing staple line dehiscence and improving hemostasis ( 15 ).…”