TY - JOUR
T1 - Preliminary performance of a flexible cap and catheter-based endoscopic suturing system
AU - Moran, Erica A.
AU - Gostout, Christopher J.
AU - Bingener, Juliane
N1 - Funding Information:
DISCLOSURE: The following authors disclosed financial relationships relevant to this publication: E. A. Moran receives research support from the Mayo Foundation. C. J. Gostout is a nonremunerated adviser to Apollo Endosurgery. Both he and the Mayo Foundation maintain an equity position in Apollo Endosurgery. J. Bingener was a consultant for Apollo Endosurgery Inc. This study was funded by Apollo Endosurgery Inc., Austin, Texas.
PY - 2009/6
Y1 - 2009/6
N2 - Background: Translation of natural orifice transluminal endoscopic surgery (NOTES) into clinical applications requires efficient and reliable enterotomy closure. Objective: To evaluate a prototype endoscopic suturing system for enterotomy closure. Design: This study took place in an ex vivo animal laboratory. Isolated porcine stomachs were contained within a plastic molded abdominal torso. The device specifications included a curved needle, end-cap assembly with a side-mounting wire-actuation channel, a needle-exchange assembly that operates within an endoscopic working channel, and a detachable needle tip attached to suture material. Interventions: Mucosal templates (3-cm circular markings) for targeted suture placement were created along the anterior wall of the stomach (cardia, antrum, and body). Device performance and functionality were studied in 3 ways: suture placement, purse-string closure, and edge-to-edge gastrotomy closure. Interrupted and running stitches were placed with the endoscope straight and retroflexed. Simple leak testing was conducted. Results: Sutures could accurately be placed at preset templated markings. Creation of a purse-string gastrotomy closure confirmed the capability to place a set of circumferential full-thickness running sutures during a single endoscopic intubation that resulted in a leak-proof closure. Edge-to-edge full-thickness tissue apposition was accomplished, which provided a water-tight closure of an 18-mm gastrotomy. The device worked consistently, without any problems. Conclusions: This endoscopic suturing device provided accurate placement of full-thickness sutures during a single intubation and permitted satisfactory tissue apposition. Standardized leak testing is needed for further development and evaluation of new devices. The catheter-driven needle actuator and the transfer-component system were intuitive and universally adaptable to any endoscope. This closure device may advance transluminal therapies by offering a secure, efficient method of hollow viscus closure.
AB - Background: Translation of natural orifice transluminal endoscopic surgery (NOTES) into clinical applications requires efficient and reliable enterotomy closure. Objective: To evaluate a prototype endoscopic suturing system for enterotomy closure. Design: This study took place in an ex vivo animal laboratory. Isolated porcine stomachs were contained within a plastic molded abdominal torso. The device specifications included a curved needle, end-cap assembly with a side-mounting wire-actuation channel, a needle-exchange assembly that operates within an endoscopic working channel, and a detachable needle tip attached to suture material. Interventions: Mucosal templates (3-cm circular markings) for targeted suture placement were created along the anterior wall of the stomach (cardia, antrum, and body). Device performance and functionality were studied in 3 ways: suture placement, purse-string closure, and edge-to-edge gastrotomy closure. Interrupted and running stitches were placed with the endoscope straight and retroflexed. Simple leak testing was conducted. Results: Sutures could accurately be placed at preset templated markings. Creation of a purse-string gastrotomy closure confirmed the capability to place a set of circumferential full-thickness running sutures during a single endoscopic intubation that resulted in a leak-proof closure. Edge-to-edge full-thickness tissue apposition was accomplished, which provided a water-tight closure of an 18-mm gastrotomy. The device worked consistently, without any problems. Conclusions: This endoscopic suturing device provided accurate placement of full-thickness sutures during a single intubation and permitted satisfactory tissue apposition. Standardized leak testing is needed for further development and evaluation of new devices. The catheter-driven needle actuator and the transfer-component system were intuitive and universally adaptable to any endoscope. This closure device may advance transluminal therapies by offering a secure, efficient method of hollow viscus closure.
UR - http://www.scopus.com/inward/record.url?scp=65749119193&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=65749119193&partnerID=8YFLogxK
U2 - 10.1016/j.gie.2009.01.032
DO - 10.1016/j.gie.2009.01.032
M3 - Article
C2 - 19481658
AN - SCOPUS:65749119193
SN - 0016-5107
VL - 69
SP - 1375
EP - 1383
JO - Gastrointestinal endoscopy
JF - Gastrointestinal endoscopy
IS - 7
ER -