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

Autor: Schiemer JF; Department of General, Visceral and Transplant Surgery, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany., Merchel D; Wilddesign GmbH & Co. KG, Gelsenkirchen, Germany., Stumm K; Department of General, Visceral and Transplant Surgery, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.; Translational Animal Research Center, University Medical Center of the Johannes Gutenberg-University, Mainz, Germany., Hoffmann KP; Department of Biomedical Engineering, Fraunhofer Institute for Biomedical Engineering, St. Ingbert, Germany., Baumgart J; Translational Animal Research Center, University Medical Center of the Johannes Gutenberg-University, Mainz, Germany., Kneist W; Department of General, Visceral and Transplant Surgery, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.; Department of General and Visceral Surgery, St. Georg Hospital Eisenach, Eisenach, Germany.
Jazyk: angličtina
Zdroj: Journal of medical engineering & technology [J Med Eng Technol] 2020 Apr; Vol. 44 (3), pp. 108-113. Date of Electronic Publication: 2020 May 05.
DOI: 10.1080/03091902.2020.1742394
Abstrakt: 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.
Databáze: MEDLINE
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