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Optimized Magnetically Docked Ingestible Capsules for Non-Invasive Refilling of Implantable Devices

2024

Article

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Automated drug delivery systems (ADDS) improve chronic disease management by enhancing adherence and reducing patient burden, particularly in conditions like type 1 diabetes, through intraperitoneal insulin delivery. However, periodic invasive refilling of the reservoir is needed in such a class of implantable devices. In previous work, an implantable ADDS with a capsule docking system is introduced for non-invasive reservoir refilling. Yet, it encounters reliability issues in manufacturing, sealing, and docking design and lacks evidence on intestinal tissue compression effects and chronic in vivo data. This work proposes an optimization of the different components featuring this ADDS. The ingestible capsule is designed, developed, and tested following ISO 13485, exhibiting high insulin stability and optimal sealing for six days in harsh gastrointestinal-like conditions. A magnetic docking system is optimized, ensuring reliable and stable capsule docking at a clinically relevant distance of 5.92 mm. Histological tests on human intestinal tissues confirm safe capsule compression during docking. Bench tests demonstrate that the integrated mechatronic system effectively docks capsules at various peristalsis-mimicking velocities. A six-week in vivo test on porcine models demonstrates chronic safety and provides hints on fibrotic reactions. These results pave the way for the further evolution of implantable ADDS.

Author(s): Hind Al-Haddad and Daniele Guarnera and Izadyar Tamadon and Lorenzo Arrico and Giulia Ballardini and Francesco Mariottini and Alessio Cucini and Simone Ricciardi and Fabio Vistoli and Maria Isabella Rotondo and Daniela Campani and Xuyang Ren and Gastone Ciuti and Benjamin Terry and Veronica Iacovacci and Leonardo Ricott
Journal: Advanced Intelligent Systems
Number (issue): 2400125
Pages: 1--21
Year: 2024
Month: July

Department(s): Haptic Intelligence
Bibtex Type: Article (article)
Paper Type: Journal

DOI: 10.1002/aisy.202400125
State: Published

BibTex

@article{Al-Haddad24-AIS-Capsules,
  title = {Optimized Magnetically Docked Ingestible Capsules for Non-Invasive Refilling of Implantable Devices},
  author = {Al-Haddad, Hind and Guarnera, Daniele and Tamadon, Izadyar and Arrico, Lorenzo and Ballardini, Giulia and Mariottini, Francesco and Cucini, Alessio and Ricciardi, Simone and Vistoli, Fabio and Rotondo, Maria Isabella and Campani, Daniela and Ren, Xuyang and Ciuti, Gastone and Terry, Benjamin and Iacovacci, Veronica and Ricott, Leonardo},
  journal = {Advanced Intelligent Systems},
  number = {2400125},
  pages = {1--21},
  month = jul,
  year = {2024},
  doi = {10.1002/aisy.202400125},
  month_numeric = {7}
}