Abstract
BackgroundSurgical staplers currently all rely on the same staple form—the “B” which necessitates a high delivery profile (12 mm). A novel “D” shape staple allows for an extremely low profile of the applicator. The acute and long-term efficacy of a D-shaped staple (Cardica, Redwood City, CA, USA) was compared to conventional B-form staples (Covidien, Norwalk, CN, USA) in an animal model for intestinal transections and anastomoses.MethodsJejunojejunal anastomoses (JJ) were performed via mini-laparotomy in a swine model. White & blue D- and B-shaped staples were studied in three groups (planned survival 14–84 days). Intraoperative assessment included completeness of staple line, hemostasis, and need for intervention. Postoperatively, animals were evaluated for complications. At the time of sacrifice, gross pathological and histological assessments were performed.ResultsTwenty-three animals had 40 anastomoses (23 “D” and 17 “B” staple anastomoses) with no intraoperative mortalities. One “D” staple application required a manual extension of the cut. Acute hemostasis was 100 %. Group 1 (n = 5) compared white staples in JJs (D staple n = 5; B staple n = 5; 14-day survival = 100 %). Group 2 (n = 12) compared white staples in JJs (D staple n = 12; B staple n = 6; 34-day survival = 92 %). One animal died on day 4 for a non-staple related cause. Group 3 (n = 6) compared blue staples in JJs (D staple n = 6; B staple n = 6; 84 day survival = 84 %). One animal died on day 18 due to an obstruction at the B staple JJ caused by stricture. There were no other bleeding, leaks or strictures in any of the groups. Gross pathology and histology were unremarkable in all JJs.ConclusionsThis study showed no difference in intraoperative performance and the chronic healing response in JJs between D- and B-shaped staples. Based on these findings, the D-shaped staple elicits a normal healing response in jejunostomies and offers the possibility of clinical use of this advance in staple design.
Highlights
Surgical staplers currently all rely on the same staple form—the ‘‘B’’ which necessitates a high delivery profile (12 mm)
This study showed no difference in intraoperative performance and the chronic healing response in JJs between D- and B-shaped staples
In one of the deployments with the D-shaped stapler, the handle failed during deployment and required use of a replacement handle
Summary
Surgical staplers currently all rely on the same staple form—the ‘‘B’’ which necessitates a high delivery profile (12 mm). A novel ‘‘D’’ shape staple allows for an extremely low profile of the applicator. The acute and long-term efficacy of a D-shaped staple (Cardica, Redwood City, CA, USA) was compared to conventional B-form staples (Covidien, Norwalk, CN, USA) in an animal model for intestinal transections and anastomoses. Methods Jejunojejunal anastomoses (JJ) were performed via mini-laparotomy in a swine model. White & blue Dand B-shaped staples were studied in three groups (planned survival 14–84 days). Intraoperative assessment included completeness of staple line, hemostasis, and need for intervention. Results Twenty-three animals had 40 anastomoses (23 ‘‘D’’ and 17 ‘‘B’’ staple anastomoses) with no intraoperative mortalities. One ‘‘D’’ staple application required a manual extension of the cut.
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