Abstract
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.
Highlights
Spinal cord stimulation (SCS) is one of the most established neuromodulation therapies in clinical use
This is achieved by designing a fully rollable device from thin film electronics, which can be inserted via a percutaneous needle, and actuated with air pressure once implanted to transform into its functional, paddle-like orientation (Fig. 1A)
The packaging approach relied on concentric tubing, with the entire device enclosed in a polyimide tube, called the introducer
Summary
Spinal cord stimulation (SCS) is one of the most established neuromodulation therapies in clinical use. The first use of SCS was for the treatment of pain conditions, notably intractable back pain, but is used to treat pain located in the legs, back, and chest, e.g., angina [2]. It is estimated by the Centers for Disease Control and Prevention that, today, up to 8% of the U.S population suffer from intractable back pain, that is, debilitating pain that is not responding to treatment by conventional methods such as nonsteroidal anti-inflammatory drugs or opioid drugs. A linear electrode produces a spherical electric field of which only the part aimed toward the spinal cord is effective, leading to a reduced energy efficiency and limiting the capacity for a more targeted therapy [8]
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