The EPIRET3 system can be successfully implanted and explanted in patients with blindness and RP. The surgical steps are feasible, and the postoperative follow-up disclosed an acceptable range of adverse events.
In industrial-scale biotechnological processes, the active control of the pH-value combined with the controlled feeding of substrate solutions (fed-batch) is the standard strategy to cultivate both prokaryotic and eukaryotic cells. On the contrary, for small-scale cultivations, much simpler batch experiments with no process control are performed. This lack of process control often hinders researchers to scale-up and scale-down fermentation experiments, because the microbial metabolism and thereby the growth and production kinetics drastically changes depending on the cultivation strategy applied. While small-scale batches are typically performed highly parallel and in high throughput, large-scale cultivations demand sophisticated equipment for process control which is in most cases costly and difficult to handle. Currently, there is no technical system on the market that realizes simple process control in high throughput. The novel concept of a microfermentation system described in this work combines a fiber-optic online-monitoring device for microtiter plates (MTPs)--the BioLector technology--together with microfluidic control of cultivation processes in volumes below 1 mL. In the microfluidic chip, a micropump is integrated to realize distinct substrate flow rates during fed-batch cultivation in microscale. Hence, a cultivation system with several distinct advantages could be established: (1) high information output on a microscale; (2) many experiments can be performed in parallel and be automated using MTPs; (3) this system is user-friendly and can easily be transferred to a disposable single-use system. This article elucidates this new concept and illustrates applications in fermentations of Escherichia coli under pH-controlled and fed-batch conditions in shaken MTPs.
This paper describes the reactive RF-powered sputter deposition of iridium oxide (IrOx) to be used as the active stimulation layer in functional medical implants. Using an approach based on generic curves, the amount of oxygen gettered by the film is determined for various carrier gas flows and pumping speeds. It is shown that under certain conditions the getter effect peaks in the shape of a plateau when increasing the oxygen supply to the chamber. Films deposited along this curve show strong differences in electrochemical behaviour. At the beginning of the plateau, stable films with high electrochemical activity are deposited, and impedance measurements link the increase in charge delivery to a higher active surface area. On depositing at the far side of the plateau, the maximum deposition rate is recorded; however, unstable films are formed. These films predominantly contain unstable iridium oxide species, with iridium atoms in higher valence states. Protein adsorption, as is known to occur at implanted electrodes, was tested on some samples, and does not deteriorate the IrOx characteristics.
Objective. The restoration of vision in blind patients suffering from degenerative retinal diseases like retinitis pigmentosa may be obtained by local electrical stimulation with retinal implants. In this study, a very large electrode array for retinal stimulation (VLARS) was introduced and tested regarding its safety in implantation and biocompatibility. Further, the array’s stimulation capabilities were tested in an acute setting. Approach. The polyimide-based implants have a diameter of 12 mm, cover approximately 110 mm2 of the retinal surface and carrying 250 iridium oxide coated gold electrodes. The implantation surgery was established in cadaveric porcine eyes. To analyze biocompatibility, ten rabbits were implanted with the VLARS device, and observed for 12 weeks using slit lamp examination, fundus photography, optical coherence tomography (OCT) as well as ultrasound imaging. After enucleation, histological examinations were performed. In acute stimulation experiments, electrodes recorded cortical field potentials upon retinal stimulation in the visual cortex in rabbits. Main results. Implantation studies in rabbits showed that the implantation surgery is safe but difficult. Retinal detachment induced by retinal tears was observed in five animals in varying severity. In five cases, corneal edema reduced the quality of the follow-up examinations. Findings in OCT-imaging and funduscopy suggested that peripheral fixation was insufficient in various animals. Results of the acute stimulation demonstrated the array’s ability to elicit cortical responses. Significance. Overall, it was possible to implant very large epiretinal arrays. On retinal stimulation with the VLARS responses in the visual cortex were recorded. The VLARS device offers the opportunity to restore a much larger field of visual perception when compared to current available retinal implants.
This paper presents a novel fully implantable wireless sensor system intended for long-term monitoring of hypertension patients, designed for implantation into the femoral artery with computed tomography angiography. It consists of a pressure sensor and a telemetric unit, which is wirelessly connected to an extracorporeal readout station for energy supply and data recording. The system measures intraarterial pressure at a sampling rate of 30 Hz and an accuracy of ±1.0 mmHg over a range of 30-300 mmHg, while consuming up to 300 μW. A special peel-away sheath introducer set was developed to support the implantation procedure. The system delivered stable measurements in initial animal trials in sheep, with results being in good agreement with reference sensor systems.
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