title: Beyond the "B": a new concept of the surgical staple enabling miniature staplers.
abstract: BACKGROUND
  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 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.
  
  
  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. 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.
  
  
  CONCLUSIONS
  This 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.
authors: Cardiocentro Ticino & University of Bern, Lugano, Switzerland. demertzis@cardiocentro.org.
authors: Stefanos
authors: S
authors: Demertzis
authors: Experimental Surgery Institute, University of Bern, Bern, Switzerland.
authors: Oligca
authors: O
authors: Beslac
authors: Experimental Surgery Institute, University of Bern, Bern, Switzerland.
authors: Daniel
authors: D
authors: Mettler
authors: Experimental Surgery Institute, University of Bern, Bern, Switzerland.
authors: Daniel
authors: D
authors: Zalokar
authors: VDx Veterinary Diagnostics, Davis, CA, USA.
authors: Taylor
authors: T
authors: Spangler
authors: Cardica Inc, Redwood City, CA, USA.
authors: Bernard
authors: B
authors: Hausen
authors: The Oregon Clinic, Portland, OR, USA.
authors: Lee
authors: L
authors: Swanstrom
mesh_terms: D000818:Animals; D004195:Disease Models, Animal; D004867:Equipment Design; D007410:Intestinal Diseases / Q000601:surgery*; D007813:Laparotomy / Q000379:methods*; D008904:Miniaturization; D013528:Surgical Staplers; D017792:Surgical Stapling / Q000295:instrumentation*; D013536:Suture Techniques / Q000295:instrumentation*; D013552:Swine
keywords: Anastomosis; Laparoscopy; Staples; Surgical staplers