Design and <i>In Vitro</i> Experimental Study of an Endoscopic Multipleclip Applier_Journal of Biomedical Engineering

Authors：

GEShuchen ,  SONGChengli , YANShiju

Shanghai Institute for Minimally Invasive Therapy, University of Shanghai for Science and Technology, Shanghai 200093, China;

Corresponding author：

SONGChengli, Email: csong@usst.edu.cn

Keywords：

endoscope; metal clip; multiple-clip applier; gastric perforation

DOI：

10.7507/1001-5515.20160027

Video：

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Considering the problems such as reposition limited, easily detached and singly fired of the existing clip products, we developed an endoscopic multiple-clip applier which can apply 4 clips fired successively at a time. The instrument also equipped with an independent grasper which can be used to clamp target tissues. In order to explore its feasibility and effectiveness of endoluminal closure of gastric perforation, 22 pig stomachs were making a 1 cm full-thickness incision from outside and closed by multiple-clip applier (n=12) in vitro. Outcome was measured by bursting pressure and compared with negative control (n=5) and hand suture (n=5). We set a threshold pressure value (10 mm Hg) for a secure closure. Except 2 cases of invalid data, the mean bursting pressures of negative control, multiple-clip applier, hand suture were (1.5±0.3) mm Hg, (46.0±7.1) mm Hg, and (72.5±7.7) mm Hg, respectively. The results showed that bursting pressure of multiple-clip applier was significantly higher than that of negative control (P＜0.05) and threshold value. Multiple-clip applier can be served as an effective and safe device to perform the endoluminal closure of gastric perforation.

Citation： GEShuchen, SONGChengli, YANShiju. Design and In Vitro Experimental Study of an Endoscopic Multipleclip Applier. Journal of Biomedical Engineering, 2016, 33(1): 149-154. doi: 10.7507/1001-5515.20160027 Copy

1.	刘明. 消化内镜诊疗相关性穿孔的内镜治疗现状[J] .世界华人消化杂志, 2009, 17(30):3123-3127.
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5.	ALBERTI L E, ALBERTI-FLOR J J. Endoclip-assisted closure of infected gastrocutaneous fistulas: report of two cases[J] . Endoscopy, 2005, 37(4): 403.
6.	FAJARDO N, HUSSAIN K, KORSTEN M A. Prolonged ambulatory colonic manometric studies using endoclips[J] . Gastrointest Endosc, 2000, 51(2): 199-201.
7.	SRIRAM P V, DAS G, RAO G V, et al. Another novel use of endoscopic clipping: to anchor an esophageal endoprosthesis[J] . Endoscopy, 2001, 33(8): 724-726.
8.	WEYMAN R L, RAO S S. A novel clinical application for endoscopic mucosal clipping[J] . Gastrointest Endosc, 1999, 49(4 Pt 1): 522-524.
9.	GLDER S, STROTZER M, GRNE S, et al. Combination of colonoscopy and clip application with angiography to mark vascular malformation in the small intestine[J] . Endoscopy, 2003, 35(4): 378.
10.	MANTA R, GALLORO G, MANGIAVILLANO B, et al. Over-the-scope clip (OTSC) represents an effective endoscopic treatment for acute GI bleeding after failure of conventional techniques[J] . Surg Endosc, 2013, 27(9): 3162-3164.
11.	MATTHES K, JUNG Y, KATO M, et al. Efficacy of full-thickness GI perforation closure with a novel over-the-scope clip application device: an animal study[J] . Gastrointest Endosc, 2011, 74(6): 1369-1375.
12.	SALORD S, GORNALS J B, MAISTERRA S, et al. Endoscopic closure of duodenal perforation with an over-the-scope clip during endoscopic ultrasound-guided cholangiopancreatography[J] . Rev Esp Enferm Dig, 2012, 104(9): 489-490.
13.	KIRSCHNIAK A, SUBOTOVA N, ZIEKER D, et al. The Over-The-Scope clip (OTSC) for the treatment of gastrointestinal bleeding, perforations, and fistulas[J] . Surg Endosc, 2011, 25(9): 2901-2905.
14.	RAJU G S, GAJULA L. Endoclips for GI endoscopy[J] . Gastrointest Endosc, 2004, 59(2): 267-279.
15.	YEH R W, KALTENBACH T, SOETIKNO R. Endoclips[J] . Tech Gastrointest Endosc, 2006, 8(1): 2-11.
16.	宋成利, 马锬,周宇,等.一种生物管道闭合口爆破压测量装置:中国,102657534[P] .2012,09,12.
17.	JAGANNATH S B, KANTSEVOY S V, VAUGHN C A, et al. Peroral transgastric endoscopic ligation of fallopian tubes with long-term survival in a porcine model[J] . Gastrointest Endosc, 2005, 61(3): 449-453.
18.	DESILETS D J, ROMANELLI J R, EARLE D B, et al. Loop-anchor purse-string versus endoscopic clips for gastric closure: a natural orifice transluminal endoscopic surgery comparison study using burst pressures[J] . Gastrointest Endosc, 2009, 70(6): 1225-1230.
19.	RAJU G S, AHMED I, BRINING D, et al. Endoluminal closure of large perforations of colon with clips in a porcine model (with video)[J] . Gastrointest Endosc, 2006, 64(4): 640-646.
20.	刘靖正, 周平红, 姚礼庆, 等.应用金属夹缝合胃壁全层缺损的动物实验[J] .中华胃肠外科杂志, 2012, 15(1):72-75.

1. 刘明. 消化内镜诊疗相关性穿孔的内镜治疗现状[J] .世界华人消化杂志, 2009, 17(30):3123-3127.
2. 周晓, 李鹏, 张澍田.消化道穿孔的内镜闭合治疗[J] .中华消化内镜杂志, 2012, 29(6):357-358.
3. AABAKKEN L. Endoscopic haemostasis[J] . Best Pract Res Clin Gastroenterol, 2008, 22(5): 899-927.
4. LEE S O, JEONG Y J. Colonoscopic clipping of fecal fistula that occurred as a postoperative complication in patients with perforated appendicitis: two case reports[J] . Gastrointest Endosc, 2001, 54(2): 245-247.
5. ALBERTI L E, ALBERTI-FLOR J J. Endoclip-assisted closure of infected gastrocutaneous fistulas: report of two cases[J] . Endoscopy, 2005, 37(4): 403.
6. FAJARDO N, HUSSAIN K, KORSTEN M A. Prolonged ambulatory colonic manometric studies using endoclips[J] . Gastrointest Endosc, 2000, 51(2): 199-201.
7. SRIRAM P V, DAS G, RAO G V, et al. Another novel use of endoscopic clipping: to anchor an esophageal endoprosthesis[J] . Endoscopy, 2001, 33(8): 724-726.
8. WEYMAN R L, RAO S S. A novel clinical application for endoscopic mucosal clipping[J] . Gastrointest Endosc, 1999, 49(4 Pt 1): 522-524.
9. GLDER S, STROTZER M, GRNE S, et al. Combination of colonoscopy and clip application with angiography to mark vascular malformation in the small intestine[J] . Endoscopy, 2003, 35(4): 378.
10. MANTA R, GALLORO G, MANGIAVILLANO B, et al. Over-the-scope clip (OTSC) represents an effective endoscopic treatment for acute GI bleeding after failure of conventional techniques[J] . Surg Endosc, 2013, 27(9): 3162-3164.
11. MATTHES K, JUNG Y, KATO M, et al. Efficacy of full-thickness GI perforation closure with a novel over-the-scope clip application device: an animal study[J] . Gastrointest Endosc, 2011, 74(6): 1369-1375.
12. SALORD S, GORNALS J B, MAISTERRA S, et al. Endoscopic closure of duodenal perforation with an over-the-scope clip during endoscopic ultrasound-guided cholangiopancreatography[J] . Rev Esp Enferm Dig, 2012, 104(9): 489-490.
13. KIRSCHNIAK A, SUBOTOVA N, ZIEKER D, et al. The Over-The-Scope clip (OTSC) for the treatment of gastrointestinal bleeding, perforations, and fistulas[J] . Surg Endosc, 2011, 25(9): 2901-2905.
14. RAJU G S, GAJULA L. Endoclips for GI endoscopy[J] . Gastrointest Endosc, 2004, 59(2): 267-279.
15. YEH R W, KALTENBACH T, SOETIKNO R. Endoclips[J] . Tech Gastrointest Endosc, 2006, 8(1): 2-11.
16. 宋成利, 马锬,周宇,等.一种生物管道闭合口爆破压测量装置:中国,102657534[P] .2012,09,12.
17. JAGANNATH S B, KANTSEVOY S V, VAUGHN C A, et al. Peroral transgastric endoscopic ligation of fallopian tubes with long-term survival in a porcine model[J] . Gastrointest Endosc, 2005, 61(3): 449-453.
18. DESILETS D J, ROMANELLI J R, EARLE D B, et al. Loop-anchor purse-string versus endoscopic clips for gastric closure: a natural orifice transluminal endoscopic surgery comparison study using burst pressures[J] . Gastrointest Endosc, 2009, 70(6): 1225-1230.
19. RAJU G S, AHMED I, BRINING D, et al. Endoluminal closure of large perforations of colon with clips in a porcine model (with video)[J] . Gastrointest Endosc, 2006, 64(4): 640-646.
20. 刘靖正, 周平红, 姚礼庆, 等.应用金属夹缝合胃壁全层缺损的动物实验[J] .中华胃肠外科杂志, 2012, 15(1):72-75.

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