用于植入式设备非侵入性填充的优化磁性对接可吞食胶囊

IF 6.8 Q1 AUTOMATION & CONTROL SYSTEMS
Hind Al-Haddad, Daniele Guarnera, Izadyar Tamadon, Lorenzo Arrico, Giulia Ballardini, Francesco Mariottini, Alessio Cucini, Simone Ricciardi, Fabio Vistoli, Maria Isabella Rotondo, Daniela Campani, Xuyang Ren, Gastone Ciuti, Benjamin Terry, Veronica Iacovacci, Leonardo Ricotti
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引用次数: 0

摘要

自动给药系统(ADDS)通过腹腔注射胰岛素,提高了患者的依从性,减轻了患者的负担,从而改善了慢性疾病的管理,尤其是对 1 型糖尿病患者而言。然而,这类植入式设备需要定期对储液器进行侵入性加注。在以前的工作中,曾介绍过一种带有胶囊对接系统的植入式 ADDS,可实现无创储液器再充液。然而,它在制造、密封和对接设计方面遇到了可靠性问题,而且缺乏有关肠道组织压缩效应的证据和慢性体内数据。这项研究提出了对该 ADDS 不同组件的优化方案。按照 ISO 13485 标准设计、开发和测试了可食用胶囊,其胰岛素稳定性高,在类似胃肠道的苛刻条件下可保持六天的最佳密封性。磁性对接系统经过优化,可确保在 5.92 毫米的临床相关距离内可靠、稳定地对接胶囊。对人体肠道组织的组织学测试证实,在对接过程中胶囊的压缩是安全的。工作台测试表明,集成机电一体化系统可在各种蠕动模拟速度下有效对接胶囊。在猪模型上进行的为期六周的体内试验证明了其长期安全性,并提供了有关纤维化反应的提示。这些结果为植入式 ADDS 的进一步发展铺平了道路。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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

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

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.

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CiteScore
1.30
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