Implantable bioelectronic devices for the simulation of peripheral nerves could be used to treat disorders that are resistant to traditional pharmacological therapies. However, for many nerve targets, this requires invasive surgeries and the implantation of bulky devices (about a few centimetres in at least one dimension). Here we report the design and in vivo proof-of-concept testing of an endovascular wireless and battery-free millimetric implant for the stimulation of specific peripheral nerves that are difficult to reach via traditional surgeries. The device can be delivered through a percutaneous catheter and leverages magnetoelectric materials to receive data and power through tissue via a digitally programmable 1 mm × 0.8 mm system-on-a-chip. Implantation of the device directly on top of the sciatic nerve in rats and near a femoral artery in pigs (with a stimulation lead introduced into a blood vessel through a catheter) allowed for wireless stimulation of the animals’ sciatic and femoral nerves. Minimally invasive magnetoelectric implants may allow for the stimulation of nerves without the need for open surgery or the implantation of battery-powered pulse generators.
This paper presents the first wireless and programmable neural stimulator leveraging magnetoelectric (ME) effects for power and data transfer. Thanks to low tissue absorption, low misalignment sensitivity and high power transfer efficiency, the ME effect enables safe delivery of high power levels (a few milliwatts) at low resonant frequencies (∼250 kHz) to mm-sized implants deep inside the body (30-mm depth). The presented MagNI (Magnetoelectric Neural Implant) consists of a 1.5-mm 2 180-nm CMOS chip, an in-house built 4 × 2 mm ME film, an energy storage capacitor, and on-board electrodes on a flexible polyimide substrate with a total volume of 8.2 mm 3 . The chip with a power consumption of 23.7 µW includes robust system control and data recovery mechanisms under source amplitude variations (1-V variation tolerance). The system delivers fully-programmable bi-phasic current-controlled stimulation with patterns covering 0.05-to-1.5-mA amplitude, 64to-512-µs pulse width and 0-to-200-Hz repetition frequency for neurostimulation.
Objective. Compared to biomedical devices with implanted batteries, wirelessly powered technologies can be longer-lasting, less invasive, safer, and can be miniaturized to access difficult-to-reach areas of the body. Magnetic fields are an attractive wireless power transfer modality for such bioelectronic applications because they suffer negligible absorption and reflection in biological tissues. However, current solutions using magnetic fields for mm sized implants either operate at high frequencies (
>
500 kHz) or require high magnetic field strengths (
>
10 mT), which restricts the amount of power that can be transferred safely through tissue and limits the development of wearable power transmitter systems. Magnetoelectric (ME) materials have recently been shown to provide a wireless power solution for mm-sized neural stimulators. These ME transducers convert low magnitude (
<
1 mT) and low-frequency (∼300 kHz) magnetic fields into electric fields that can power custom integrated circuits or stimulate nearby tissue. Approach. Here we demonstrate a battery-powered wearable magnetic field generator that can power a miniaturized MagnetoElectric-powered Bio ImplanT ‘ME-BIT’ that functions as a neural stimulator. The wearable transmitter weighs less than 0.5 lbs and has an approximate battery life of 37 h. Main results. We demonstrate the ability to power a millimeter-sized prototype ‘ME-BIT’ at a distance of 4 cm with enough energy to electrically stimulate a rat sciatic nerve. We also find that the system performs well under translational misalignment and identify safe operating ranges according to the specific absorption rate limits set by the IEEE Std 95.1-2019. Significance. These results validate the feasibility of a wearable system that can power miniaturized ME implants that can be used for different neuromodulation applications.
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