Precise control of bionic limbs relies on robust decoding of motor commands from nerves or muscles signals and sensory feedback from artificial limbs to the nervous system by interfacing the afferent nerve pathways. Implantable devices for bidirectional communication with bionic limbs have been developed in parallel with research on physiological alterations caused by an amputation. In this perspective article, we question whether increasing our effort on bridging these technologies with a deeper understanding of amputation pathophysiology and human motor control may help to overcome pressing stalls in the next generation of bionic limbs.

Substrates and packages of active implantable medical devices are often fabricated from ceramics like alumina. Screen printed PtAu paste is the state of the art metallization for functional structures. Due to solid state and liquid diffusion of Au during thermal exposure, solder times are limited. Otherwise, metal structures tend to delaminate. Moreover, it was shown that PtAu with solder fails after 37.4 years. We established a thin film metallization on alumina process to overcome these disadvantages. We used sputtered platinum with an underlying adhesion layer made of tungsten-titanium to increase the adhesion strength to the alumina substrate. We avoided using gold in this work due to its high diffusion tendency. All used materials provided relatively low diffusion properties, which increases independency from joining techniques and mechanical longevity during use. Utilizing the Design of Experiment (DoE) methodology, we derived an optimal Pt thickness of 500 nm with 43 nm of WTi as an adhesion promoting layer. After accelerated aging at 150 °C, corresponding to 125 years at body temperature (37 °C), the contact pad adhesion strength was 32.75 MPa ± 7.08 MPa. This exceeded the safety limit of 17 MPa by far, set as recommendation for robust screen-printing metallization processes. Soldering times of up to 120 s did not influence the adhesive strength. The new process reduced the minimum track distance to 50% of screen printing values and is capable to be transferred into rapid prototyping techniques. It helps to make the assembly process independent of the manufacturing person, in order to increase the yield of device fabrication and -most important in implantable device manufacturing-to make it more robust and thereby safer for the patient.

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.

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.

Goal: Transcutaneous coupling scheme for wireless powering and signal in active implants are known for more than a decade. This study aimed to investigate the in vivo behavior of this approach to drive multiple channels of an implanted peripheral nerve interfaces. Methods: The stimulation signals were transmitted through the skin over two contacts to an intracorporeal counterpart which was connected to a cuff electrode with two channels. EMG after stimulation was measured to establish recruitment curves. Results: Limitations of transcutaneous coupling were found in the feasible complexity of the system. High electrical crosstalk in a multi-channel system reduces this approach to low channel applications, such as pain treatment. No significant influence of the pulse width or extracorporeal stimulation amplitude on the electrical crosstalk was observed. Conclusions: The study's findings provide insight into the behavior of the transcutaneous coupling scheme in vivo and highlight the limitations and areas of application. Our results indicate that transcutaneous coupling schemes are a promising alternative approach for wireless powering of implants, as it does not require complex implanted electronics, expensive sophisticated electronics, and hermetic enclosures. Physical constraints, however, limit the use in highly selective nerve stimulation scenarios.

Hermetic and non-hermetic packages of active implantable medical devices are often fabricated of ceramics like alumina. Screen printed PtAu paste is the state of the art metallization for functional structures. Due to solid state and liquid diffusion of Au at thermal exposure, solder times are limited; otherwise metal structures tend to delaminate. Moreover, it was shown that PtAu with solder fails after 37.4 years. We established a thin film metallization on alumina process to overcome these disadvantages. The metallization consists of sputtered platinum with an underlying adhesion layer made of tungsten-titanium to increase the adhesion strength to the alumina substrate. We avoided using gold in this work due to its high diffusion tendency. Instead, the materials in use provide relatively low diffusion properties, which potentially increases the long term mechanical performance and usability during assembly and packaging. Utilizing the Design of Experiment (DoE) methodology, we derived an optimal Pt thickness of 500 nm with 43 nm of WTi as adhesion promoting layer. After accelerated aging at 150 °C, corresponding to 125 years at body temperature (37 °C), the contact pad adhesion strength was with 32.75 MPa ± 7.08 MPa still significantly higher than the safety limit of 17 MPa, following the recommendations for a robust screen-printing metallization process. Moreover, soldering times of up to 120 s did not influence the adhesive strength. The new process reduced the minimum track distance to 50% of screen printing values and is capable of rapid prototyping. It helps to make the assembly process independent of the manufacturing person, to increase the yield of device fabrication and -most important in implantable device manufacturing-to make it more robust and thereby more safe for the patient.