Abstract
We propose a wirelessly controlled implantable system for on-demand and pulsatile insulin delivery with a more convenient and safer strategy than currently available strategies. The system is a combined entity of a magnetically driven pump (i.e., an MDP), external control device (i.e., an ECD) and mobile app. The MDP for implantation consists of a plunger, barrel and drug reservoir, where an accurate amount of insulin can be infused in a pulsatile manner only at the time when a magnetic force is applied to actuate the plunger in the barrel. The ECD at the outside body can modulate the MDP actuation with an electromagnet and its control circuit, and this modulation can be wirelessly controlled by the mobile app. As a safety feature, the mobile app is programmed to pre-set the restrictions for the insulin dose and administration schedule to avoid overdose. The system is shown to infuse insulin in a highly reproducible manner, but it does not allow for insulin infusion when the pre-set restrictions are violated. When tested with diabetic rats, the profiles of insulin plasma concentration and blood glucose level are similar to those of animals treated with a subcutaneous injection of the same dose of insulin.
Highlights
In this aspect, implantable devices for insulin infusion have gained extensive attention, where the devices are designed to deliver insulin in a minimally invasive, on-demand manner after one-time implantation[6,7,8,9,10,11]
The communications among the app, external control device (ECD) and magnetically driven pump (MDP) were based on wireless means: the app can deliver the commands to the ECD via Bluetooth and the ECD located at the outside skin operates the implanted MDP via magnetic fields
We developed a wirelessly controlled implantable insulin delivery system (WIIDS), a combined entity of a batteryless, implantable device and its wireless control unit, to propose a more convenient and safer strategy for minimally invasive and on-demand insulin infusion
Summary
Implantable devices for insulin infusion have gained extensive attention, where the devices are designed to deliver insulin in a minimally invasive, on-demand manner after one-time implantation[6,7,8,9,10,11]. Because of the components required, the devices became somewhat large for implantation, and additional major surgery for device replacement was inevitable when the battery died To resolve this issue, we previously introduced a magnetically driven pump (MDP) that could be implanted in the body for on-demand and pulsatile insulin infusion[12]. The communications among the app, ECD and MDP were based on wireless means: the app can deliver the commands to the ECD via Bluetooth and the ECD located at the outside skin operates the implanted MDP via magnetic fields In this way, the delivery profiles of insulin with versatile programming functions could be remotely controlled; the system could provide a point-of-care monitoring strategy with improved patient compliance[15]. At the endpoint of the in vivo experiments, the tissue around the MDP was biopsied and analysed histologically for a safety evaluation
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