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

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
• gastrointestinal motility
• motility disorders
• implants
• experimental

Acknowledgements

We thank Nadine Baumgart and Jana Dickmann (Translational Animal Research Centre [TARC], University Medical Centre of the Johannes Gutenberg-University Mainz, Germany) for commitment and support. We also appreciate the support of Hubert Stein (Intuitive Surgical, Sunnyvale, CA, USA) and the team of “Medizin im Grünen” (Wendisch Rietz, Germany).

Disclosure statement

Jonas F. Schiemer, Karen Stumm, Klaus-Peter Hoffmann, Jan Baumgart, and Werner Kneist have no conflicts of interest or financial ties to disclose. Dana Merchel is an employee of Wild Design GmbH & Co. KG.

Additional information

Funding

This work was supported by the Federal Ministry of Education and Research (BMBF), Germany [grant number 16SV7638].