Abstract
Background/purpose
Natural orifice transluminal endoscopic surgery (NOTES) offers the possibility of surgery without visible scars. To overcome the limitations of NOTES, we developed a novel surgical device called the rigid and flexible outer sheath with multi-piercing surgery (MPS).
Methods
This sheath can switch between flexible and rigid modes using a novel “Dragon skin” structure and a negative pneumatic shape-locking mechanism. In addition, it has an integrated bending structure that enables it to flex in four directions at the distal end. The insertion part of the prototype is 575 mm long with a 20 mm outer diameter. The rigid and flexible shaft is separated into two parts. The primary and secondary shape-locking shafts are 300 and 200 mm long, respectively. The two parts of shape-locking shaft can be locked independently, including both being locked simultaneously. In addition, the model was equipped with one 7- and 1.7-mm-diameter, and three 3-mm-diameter working channels. When the sheath approaches the target, the surgeon locks the shape and then easily inserts flexible instruments through the path created by the sheath. In this study, we evaluated the stiffness of the prototype. Furthermore, an in vivo partial gastrectomy experiment was also performed.
Results
The experimental results regarding the shape property suggest that the rigidity of the shaft was considerably increased using this mechanism. An in vivo partial gastrectomy experiment performed using a swine was successfully performed using the outer sheath for assistance. The outer sheath was inserted through a percutaneous route during the in vivo experiment.
Conclusions
The evaluation results show that the advanced outer sheath system has great promise for solving access and stability problems with NOTES.








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Acknowledgments
All the authors have read the manuscript and have approved this submission. Siyang Zuo, Kazuo Iijima, Takahiro Tokumiya, and Ken Masamune declare that they have no conflict of interest.
Conflict of interest
Ken Masamune and Siyang Zuo are researchers of the University of Tokyo and receive research funding from SAMSUNG Yokohama Research Institute (Project #121400000191), which is developing products related to the research described in this paper. Kazuo Iijima and Takahiro Tokumiya are senior researchers of SAMSUNG Yokohama Research Institute and serve on the company’s ER Center ET-1 Team.
Ethical standard
The study design was approved by an ethics review board. All animal studies have been approved by the appropriate ethics committee. All institutional and national guidelines for the care and use of laboratory animals were followed.
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Zuo, S., Iijima, K., Tokumiya, T. et al. Variable stiffness outer sheath with “Dragon skin” structure and negative pneumatic shape-locking mechanism. Int J CARS 9, 857–865 (2014). https://doi.org/10.1007/s11548-014-0981-4
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DOI: https://doi.org/10.1007/s11548-014-0981-4