Yachimski, P, Landewee, CA, Campisano, F et al. (2 more authors) (2020) The waterjet necrosectomy device for endoscopic management of pancreatic necrosis: design, development, and preclinical testing (with videos). Gastrointestinal Endoscopy, 92 (3). pp. 770-775. ISSN 0016-5107
Abstract
Background and Aims: Endoscopic intervention has emerged as a first-line option for management of symptomatic pancreatic necrosis, yet endoscopic debridement is limited by the lack of dedicated endoscopic tools intended for this purpose. The objectives of this study were to design and build a prototype necrosectomy device compatible for use with a flexible endoscope and capable of selective tissue fragmentation, and to test the prototype in benchtop and porcine models.
Methods: A novel prototype, named the waterjet necrosectomy device (WAND), was designed and developed, consisting of a single-use disposable endoscopic waterjet instrument capable of waterjet selection and independent tip articulation while fitting through a 2.8-mm working channel of a standard adult upper GI endoscope. Benchtop, ex vivo, and in vivo (porcine) testing was performed in the initial stages of investigation.
Results: The WAND was capable of delivering a continuous waterjet force with a surface pressure of 0.72 bar at a flow rate of 0.37 L/minute. In phase 1 of testing, the WAND was able to achieve complete fragmentation of gelatin as a surrogate for pancreatic necrosis in benchtop testing. In phase 2 of testing, the WAND was able to achieve complete fragmentation of freshly explanted human pancreatic necrosis. In phase 3 of testing for safety in fresh necropsy swine, use of the WAND resulted in no significant tissue trauma, even when irrigation was applied at closer proximity and for more extended duration than would be anticipated in clinical use.
Conclusion: The WAND prototype delivers irrigation capable of fragmenting necrotic debris ex vivo and avoiding trauma to healthy nontarget tissue. Planning is underway for first-in-human studies to assess the efficacy and safety of the WAND for endoscopic pancreatic necrosectomy.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2020 by the American Society for Gastrointestinal Endoscopy. This is an author produced version of an article published in Gastrointestinal Endoscopy. Uploaded in accordance with the publisher's self-archiving policy. |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Engineering & Physical Sciences (Leeds) > School of Electronic & Electrical Engineering (Leeds) > Robotics, Autonomous Systems & Sensing (Leeds) |
Funding Information: | Funder Grant number Royal Society wm150122 National Institute of Health - NIH (PHS) 6R01EB018992 |
Depositing User: | Symplectic Publications |
Date Deposited: | 20 May 2020 13:07 |
Last Modified: | 28 Jun 2022 14:27 |
Status: | Published |
Publisher: | Elsevier |
Identification Number: | 10.1016/j.gie.2020.04.024 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:160237 |