Reliability of Neural Implants-Effective Method for Cleaning and Surface Preparation of Ceramics.

Neural implants provide effective treatment and diagnosis options for diseases where pharmaceutical therapies are missing or ineffective. These active implantable medical devices (AIMDs) are designed to remain implanted and functional over decades. A key factor for achieving reliability and longevity are cleaning procedures used during manufacturing to prevent failures associated with contaminations. The Implantable Devices Group (IDG) at University College London (UCL) pioneered an approach which involved a cocktail of reagents described as "Leslie's soup". This process proved to be successful but no extensive evaluation of this method and the cocktail's ingredients have been reported so far. Our study addressed this gap by a comprehensive analysis of the efficacy of this cleaning method. Surface analysis techniques complemented adhesion strengths methods to identify residues of contaminants like welding flux, solder residues or grease during typical assembly processes. Quantitative data prove the suitability of "Leslie's soup" for cleaning of ceramic components during active implant assembly when residual ionic contaminations were removed by further treatment with isopropanol and deionised water. Solder and flux contaminations were removed without further mechanical cleaning. The adhesive strength of screen-printed metalisation layers increased from 12.50 ± 3.83 MPa without initial cleaning to 21.71 ± 1.85 MPa. We conclude that cleaning procedures during manufacturing of AIMDs, especially the understanding of applicability and limitations, is of central importance for their reliable and longevity.

Neural Implants Without Electronics: A Proof-of-Concept Study on a Human Skin Model.

Objective: Chronic neural implants require energy and signal supply. The objective of this work was to evaluate a multichannel transcutaneous coupling approach in an ex vivo split-concept study, which minimizes the invasiveness of such an implant by externalizing the processing electronics. Methods: Herein, the experimental work focused on the transcutaneous energy and signal transmission. The performance was discussed with widely evaluated concepts of neural interfaces in the literature. Results: The performance of the transcutaneous coupling approach increased with higher channel count and higher electrode pitches. Electrical crosstalk among channels was present, but acceptable for the stimulation of peripheral nerves. Conclusions: Transcutaneous coupling with extracorporeal transmitting arrays and subcutaneous counterparts provide a promising alternative to the inductive concept particularly when a fully integration of the system in a prosthetic shaft is intended. The relocation of the electronics can potentially prevent pressure sores, improve accessibility for maintenance and increase lifetime of the implant.

Paradigms for restoration of somatosensory feedback via stimulation of the peripheral nervous system.

The somatosensory system contributes substantially to the integration of multiple sensor modalities into perception. Tactile sensations, proprioception and even temperature perception are integrated to perceive embodiment of our limbs. Damage of somatosensory networks can severely affect the execution of daily life activities. Peripheral injuries are optimally corrected via direct interfacing of the peripheral nerves. Recent advances in implantable devices, stimulation paradigms, and biomimetic sensors enabled the restoration of natural sensations after amputation of the limb. The refinement of stimulation patterns to deliver natural feedback that can be interpreted intuitively such to prescind from long-learning sessions is crucial to function restoration. For this review, we collected state-of-the-art knowledge on the evolution of stimulation paradigms from single fiber stimulation to the eliciting of multisensory sensations. Data from the literature are structured into six sections: (a) physiology of the somatosensory system; (b) stimulation of single fibers; (c) restoral of multisensory percepts; (d) closure of the control loop in hand prostheses; (e) sensory restoration and the sense of embodiment, and (f) methodologies to assess stimulation outcomes. Full functional recovery demands further research on multisensory integration and brain plasticity, which will bring new paradigms for intuitive sensory feedback in the next generation of limb prostheses.

A polymer-metal two step sealing concept for hermetic neural implant packages.

In this paper, we introduce a technique for double-sealed ceramic packages for the long-term protection of implanted electronics against body fluids. A sequential sealing procedure consisting of a first step, during which the package is sealed with epoxy, protecting the implant electronics from aggressive flux fumes. These result from the application of the actual moisture barrier which is a metal seal applied in a second step by soft soldering. Epoxy sealing is carried out in helium atmosphere for later fine leak testing. The solder seal is applied on the laboratory bench. After the first sealing step, a satisfactory barrier for moisture is already achieved with values for helium leakage of usually LHe = 6·10(-8) mbar 1 s(-1). After solder sealing, a very low leakage rate of LHe ≤ 1·10(-12) mbar 1 s(-1) was found, which was the lower detection limit of the measurement setup, suggesting excellent hermeticity and hence moisture barrier. Presuming an implant package volume of V ≥ 0.5 cm(3), the time to reach a critical humidity of p = 5000 ppm H2O inside the package will be longer than any anticipated average life of human patients.