Search Results (4)

The multicomponent injection molding of liquid silicone rubbers (LSR) with thermoplastics, such as polybutylene terephthalate (PBT) or polyamide (PA), is a state-of-the-art technique and is used in the manufacturing process for many components in the automotive industry and in the field of sanitary engineering. Standard thermoplastics, such as acrylonitrile butadiene styrene (ABS), cannot be bonded with silicone rubbers in injection molding because of their low heat deflection temperature. In this study, we investigated ABS grades approved for medical applications to show how dynamic mold heating and various pretreatment methods for thermoplastic surfaces can be used to produce ABS-LSR test specimens. In addition, such components’ sterilization effect on the adhesive bond will be shown. Full article

The gold standard for the partial restoration of sensorineural hearing loss is cochlear implant surgery, which restores patients’ speech comprehension. The remaining limitations, e.g., music perception, are partly due to a gap between cochlear implant electrodes and the auditory nerve cells in the modiolus of the inner ear. Reducing this gap will most likely lead to improved cochlear implant performance. To achieve this, a bending or curling mechanism in the electrode array is discussed. We propose a silicone rubber–hydrogel actuator where the hydrogel forms a percolating network in the dorsal silicone rubber compartment of the electrode array to exert bending forces at low volume swelling ratios. A material study of suitable polymers (medical-grade PDMS and hydrogels), including parametrized bending curvature measurements, is presented. The curvature radii measured meet the anatomical needs for positioning electrodes very closely to the modiolus. Besides stage-one biocompatibility according to ISO 10993-5, we also developed and validated a simplified mathematical model for designing hydrogel-actuated CI with modiolar hugging functionality. Full article

The ingress of body fluids or their constituents is one of the main causes of failure of active implantable medical devices (AIMDs). Progressive delamination takes its origin at the junctions where exposed electrodes and conductive pathways enter the implant interior. The description of this interface is considered challenging because electrochemically-diffusively coupled processes are involved. Furthermore, standard tests and specimens, with clearly defined 3-phase boundaries (body fluid-metal-polymer), are lacking. We focus on polymers as substrate and encapsulation and present a simple method to fabricate reliable test specimens with defined boundaries. By using silicone rubber as standard material in active implant encapsulation in combination with a metal surface, a corrosion-triggered delamination process was observed that can be universalised towards typical AIMD electrode materials. Copper was used instead of medical grade platinum since surface energies are comparable but corrosion occurs faster. The finding is that two processes are superimposed there: First, diffusion-limited chemical reactions at interfaces that undermine the layer adhesion. The second process is the influx of ions and body fluid components that leave the aqueous phase and migrate through the rubber to internal interfaces. The latter observation is new for active implants. Our mathematical description with a Stefan-model coupled to volume diffusion reproduces the experimental data in good agreement and lends itself to further generalisation. Full article

Current personalized treatment of neurological diseases is limited by availability of appropriate manufacturing methods suitable for long term sensors for neural electrical activities in the brain. An additive manufacturing process for polymer-based biocompatible neural sensors for chronic application towards individualized implants is here presented. To process thermal crosslinking polymers, the developed extrusion process enables, in combination with an infrared (IR)-Laser, accelerated curing directly after passing the outlet of the nozzle. As a result, no additional curing steps are necessary during the build-up. Furthermore, the minimal structure size can be achieved using the laser and, in combination with the extrusion parameters, provide structural resolutions desired. Active implant components fabricated using biocompatible materials for both conductive pathways and insulating cladding keep their biocompatible properties even after the additive manufacturing process. In addition, first characterization of the electric properties in terms of impedance towards application in neural tissues are shown. The printing toolkit developed enables processing of low-viscous, flexible polymeric thermal curing materials for fabrication of individualized neural implants. Full article