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Technical Brief

Endoscopic Closure of Large Defects With a Novel Clipping Device and a 4S-Modified Roeder Slipknot

[+] Author and Article Information
Shuchen Ge

School of Medical Instrument and Food Engineering,
University of Shanghai for Science and Technology,
Shanghai 200093, China;
Earl. E. Bakken Medical Devices Center,
University of Minnesota,
Minneapolis, MN 55455

Liaoyuan Ai

School of Medical Instrument and Food Engineering,
University of Shanghai for Science and Technology,
Shanghai 200093, China

Arthur G. Erdman

Earl. E. Bakken Medical Devices Center,
University of Minnesota,
Minneapolis, MN 55455

Chengli Song

School of Medical Instrument and Food Engineering,
University of Shanghai for Science and Technology,
Shanghai 200093, China
e-mail: csong@usst.edu.cn

1Corresponding author.

Manuscript received October 30, 2017; final manuscript received January 25, 2018; published online April 25, 2018. Editor: William Durfee.

J. Med. Devices 12(2), 024501 (Apr 25, 2018) (5 pages) Paper No: MED-17-1339; doi: 10.1115/1.4039753 History: Received October 30, 2017; Revised January 25, 2018

Endoscopic closure is an essential procedure in gastrointestinal (GI) surgery, but currently it is difficult to close large defects endoscopically because of the lack of an appropriate device. Previously, we developed an endoscopic clipping device that has multifiring function and is equipped with an independent clamp. The goal of this study is to provide a new closure method with this device and 4S-modified Roeder (4SMR) slipknot. The feasibility of the closure method is examined by deploying two clips during one insertion onto the 4SMR slipknot to close a 5 cm full-thickness linear defect of an ex vivo porcine stomach from the center. Mechanical strengths of clip-knot closure and the slipknot as regards to tensioning forces are also evaluated. Specifically, the mechanical strength of the 4SMR slipknot is verified by mean peak forces to failure, while the knot is tensioning by 2.5, 5, 7.5, and 10 N force (n = 20 for each group), respectively. Experimental results indicate the clip-slipknot closure can withstand a distracting force of 6.3 ± 5.6 N. Tensioning force has a great influence on the mechanical strength of slipknot, with the mean peak force (tensioning force) being 7.1± 6.5, 16.3 ± 9.3, 18.9 ± 10.4, and 24.2 ± 12.0 N, respectively. The proposed closure method can be used for large defects. Tensioning force higher than 5 N is suitable to ensure a stronger 4SMR slipknot.

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Figures

Grahic Jump Location
Fig. 1

Design and main dimensions of device: (a) the loop of slipknot is caught by clamp of clipping device and (b) two clips with barbed fins

Grahic Jump Location
Fig. 2

Deployment of a clip with novel clipping device: (a) positioning and adjusting the clamp toward to tissue, (b) closing the clamp thus squeezing the tissue, (c) keeping the clamp in a closed position and the clip is advanced, with the clip and barbed fins penetrating the tissue and the distal segment of clip bending inward, and (d) the clamp is released to complete a deployment, leaving the clips clamping the tissue

Grahic Jump Location
Fig. 3

Knot tying of 4SMR slipknot: (a) making a single throw, (b) wrapping the free end of suture four times over the top of the loop, (c) making a half-hitch by passing the free end of the suture from anterior to posterior, (d) making a square knot by passing the free end of suture from posterior to anterior, and (e) flatting out the knot by pulling both ends toward operator

Grahic Jump Location
Fig. 4

Schematic view of endoscopic closure with two clips and a 4SMR knot: (a) clamp is opened, (b) grasping one side of defect with clamp, (c) loop of slipknot is anchored onto tissue with one clip, (d) approximating the opposite side of defect by clamp, (e) placing a second clip with loop, (f) pushing the knot toward clips by using clamp, (g) tensioning the knot by pulling back free end of knot by hand, with anchored end holding by the clamp, and (h) string is cut to complete the closure

Grahic Jump Location
Fig. 5

Procedure view of the clip-slipknot closure (the endoscopic view is shown in small windows): (a) a clip is deployed to one side of defect, anchoring the loop of the slipknot, (b) a second clip is deployed to another side the defect in the same way, (c) the slipknot is tensioned by using the clamp of the clipping device, and (d) the closure is completed by cutting the string from the anchored end of the slipknot

Grahic Jump Location
Fig. 6

Strength measurements of the clip-slipknot closure and the 4SMR slipknot: (a) the tensiometer was used to measure the mechanical strength of the clip-slipknot closure, (b) the closure site cracked under distracting loads, and (c) the loop of 4SMR slipknot was fixed by hooks of the tensiometer

Grahic Jump Location
Fig. 7

Peak force to failure of 4SMR slipknot of four tensioning force groups

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