Translational development and pre-clinical evaluation of prototype gastrointestinal mock-up devices: only robotic placement of plastic?

Background: The aim of this study was to address the vision of wireless theranostic devices distributed along the gastrointestinal (GI) tract by defining design requirements, developing prototype mock-ups, and establishing a minimally invasive surgical approach for the implantation process. Methods:...

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Bibliographic Details
Published in:	Journal of medical engineering & technology Vol. 44; no. 3; pp. 108 - 113
Main Authors:	Schiemer, Jonas F., Merchel, Dana, Stumm, Karen, Hoffmann, Klaus-Peter, Baumgart, Jan, Kneist, Werner
Format:	Journal Article
Language:	English
Published:	England Taylor & Francis 02-04-2020
Subjects:	Animals Equipment Design experimental gastrointestinal motility Gastrointestinal Tract implants Minimally Invasive Surgical Procedures - instrumentation motility disorders Plastics Printing, Three-Dimensional Prostheses and Implants Robotic surgical procedures Robotic Surgical Procedures - instrumentation Swine Translational Medical Research gastrointestinal motility experimental Robotic surgical procedures implants motility disorders
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Summary:	Background: The aim of this study was to address the vision of wireless theranostic devices distributed along the gastrointestinal (GI) tract by defining design requirements, developing prototype mock-ups, and establishing a minimally invasive surgical approach for the implantation process. Methods: Questionnaires for contextual analysis and use case scenarios addressing the technical issues of an implantable GI device, a possible scenario for implantation, preparation and calibration of a device, and therapeutic usage by professionals and patients were completed and discussed by an interdisciplinary team of surgeons, engineers, and product designers. Two acute porcine experiments were conducted with a robotic surgical system under general anaesthesia. Results: A variety of requirements for the design and implantation of implantable devices for modulating GI motility were defined. Five prototype implant mock-ups were three-dimensional (3D)-printed from black polymer material (width 22.32 mm, height 7.66 mm) and successfully implanted on the stomach, duodenum, jejunum, ileum, and colon using the robotic surgical system, without any complications. Conclusions: Our study shows the development and successful pre-clinical evaluation of a reliable device design with a minimally invasive implantation approach. Several stages of device development, including pre-clinical tests, characterisation of clinical requirements, regulatory affairs, and marketing issues should be managed side by side.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0309-1902 1464-522X
DOI:	10.1080/03091902.2020.1742394