Characterization of thin film Parylene C device curvature and the formation of helices via thermoforming.

In microfabricated biomedical devices, flexible, polymer substrates are becoming increasingly preferred over rigid, silicon substrates because of their ability to conform to biological tissue. Such devices, however, are fabricated in a planar configuration, which results in planar devices that do not closely match the shape of most tissues. Thermoforming, a process which can reshape thermoplastic polymers, can be used to transform flat, thin film, polymer devices with patterned metal features into complex three-dimensional (3D) geometries. This process extends the use of planar microfabrication to achieve 3D shapes which can more closely interface with the body. Common shapes include spheres, which can conform to the shape of the retina; cones, which can be used as a sheath to interface with an insertion stylet; and helices, which can be wrapped around nerves, blood vessels, muscle fibers, or be used as strain relief feature. This work characterizes the curvature of thin film Parylene C devices with patterned metal features built with varying Parylene thicknesses and processing conditions. Device curvature is caused by film stress in each Parylene and metal layer, which is characterized experimentally and by a mathematical model which estimates the effects of device geometry and processing on curvature. Using this characterization, an optimized process to thermoform thin film Parylene C devices with patterned metal features into 0.25 mm diameter helices while preventing cracking in the polymer and metal was developed.

Making a case for endovascular approaches for neural recording and stimulation.

There are many electrode types for recording and stimulating neural tissue, most of which necessitate direct contact with the target tissue. These electrodes range from large, scalp electrodes which are used to non-invasively record averaged, low frequency electrical signals from large areas/volumes of the brain, to penetrating microelectrodes which are implanted directly into neural tissue and interface with one or a few neurons. With the exception of scalp electrodes (which provide very low-resolution recordings), each of these electrodes requires a highly invasive, open brain surgical procedure for implantation, which is accompanied by significant risk to the patient. To mitigate this risk, a minimally invasive endovascular approach can be used. Several types of endovascular electrodes have been developed to be delivered into the blood vessels in the brain via a standard catheterization procedure. In this review, the existing body of research on the development and application of endovascular electrodes is presented. The capabilities of each of these endovascular electrodes is compared to commonly used direct-contact electrodes to demonstrate the relative efficacy of the devices. Potential clinical applications of endovascular recording and stimulation and the advantages of endovascular versus direct-contact approaches are presented.

A comparison of insertion methods for surgical placement of penetrating neural interfaces.

Many implantable electrode arrays exist for the purpose of stimulating or recording electrical activity in brain, spinal, or peripheral nerve tissue, however most of these devices are constructed from materials that are mechanically rigid. A growing body of evidence suggests that the chronic presence of these rigid probes in the neural tissue causes a significant immune response and glial encapsulation of the probes, which in turn leads to gradual increase in distance between the electrodes and surrounding neurons. In recording electrodes, the consequence is the loss of signal quality and, therefore, the inability to collect electrophysiological recordings long term. In stimulation electrodes, higher current injection is required to achieve a comparable response which can lead to tissue and electrode damage. To minimize the impact of the immune response, flexible neural probes constructed with softer materials have been developed. These flexible probes, however, are often not strong enough to be inserted on their own into the tissue, and instead fail via mechanical buckling of the shank under the force of insertion. Several strategies have been developed to allow the insertion of flexible probes while minimizing tissue damage. It is critical to keep these strategies in mind during probe design in order to ensure successful surgical placement. In this review, existing insertion strategies will be presented and evaluated with respect to surgical difficulty, immune response, ability to reach the target tissue, and overall limitations of the technique. Overall, the majority of these insertion techniques have only been evaluated for the insertion of a single probe and do not quantify the accuracy of probe placement. More work needs to be performed to evaluate and optimize insertion methods for accurate placement of devices and for devices with multiple probes.