Spinal cord stimulation is one of the oldest and most established neuromodulation therapies. However, today, clinicians need to choose between bulky paddle-type devices, requiring invasive surgery under general anesthetic, and percutaneous lead–type devices, which can be implanted via simple needle puncture under local anesthetic but offer clinical drawbacks when compared with paddle devices. By applying photo- and soft lithography fabrication, we have developed a device that features thin, flexible electronics and integrated fluidic channels. This device can be rolled up into the shape of a standard percutaneous needle then implanted on the site of interest before being expanded in situ, unfurling into its paddle-type conformation. The device and implantation procedure have been validated in vitro and on human cadaver models. This device paves the way for shape-changing bioelectronic devices that offer a large footprint for sensing or stimulation but are implanted in patients percutaneously in a minimally invasive fashion.
Fluidics are enabling new possibilities in bioelectronic medicine and research.
Implantable electronic medical devices are used in functional mapping of the brain before surgery and to deliver neuromodulation for the treatment of neurological and neuropsychiatric disorders. Their electrode arrays are assembled by hand, and this leads to bulky form factors with limited flexibility and low electrode counts. Thin film implants, made using microfabrication techniques, are emerging as an attractive alternative, as they offer dramatically improved conformability and enable high density recording and stimulation. A major limitation of these devices, however, is that they are invisible to fluoroscopy, the most common method used to monitor the insertion of implantable electrodes. Here, the development of mechanically flexible X-ray markers using bismuth-and barium-infused elastomers is reported. Their X-ray attenuation properties in human cadavers are explored and it is shown that they are biocompatible in cell cultures. It is further shown that they do not distort magnetic resonance imaging images and their integration with thin film implants is demonstrated. This work removes a key barrier for the adoption of thin film implants in brain mapping and in neuromodulation.
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