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

J Med Eng Technol. 2020 Apr;44(3):108-113. doi: 10.1080/03091902.2020.1742394. Epub 2020 May 5.

Abstract

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.

Keywords: Robotic surgical procedures; experimental; gastrointestinal motility; implants; motility disorders.

MeSH terms

  • Animals
  • Equipment Design
  • Gastrointestinal Tract*
  • Minimally Invasive Surgical Procedures / instrumentation*
  • Plastics
  • Printing, Three-Dimensional
  • Prostheses and Implants
  • Robotic Surgical Procedures / instrumentation*
  • Swine
  • Translational Medical Research

Substances

  • Plastics