2020, Cao, H., Wu, M.H., Zhou, F., McMeeking, R.M., Ritchie, R.O.

One of the contentious issues associated with the high-cycle fatigue of Nitinol, a nominally equiatomic alloy of nickel and titanium, is the claim that increasing the applied mean strain can increase, or at least have no negative impact, on the fatigue lifetime, in conflict with reported behavior for the vast majority of other metallic materials. To investigate this in further detail, cyclic fatigue tests in bending were carried out on electropolished medical grade Nitinol at 37 °C for lives of up to 400 million cycles of strain involving various levels of the mean strain. A constant life model was developed through statistical analysis of the fatigue data, with 90% reliability at a confidence level of 95% on the effective fatigue strain. Our results show that the constant life diagram, a plot of strain amplitude versus mean strain, is monotonic yet nonlinear for lives of 400 million cycles of fatigue loading. Specifically, we find that in contradiction to the aforementioned claim, the strain amplitude limit at zero mean strain is 0.55% to achieve a 400 million cycle lifetime, at 90% reliability with 95% confidence; however, to achieve the same lifetime, reliability and confidence level in the presence of a 3% or more mean strain, the required strain amplitude limit is decreased by over a factor of three to 0.16%. Moreover, for mean strains from 3% to 7%, the strain amplitude limit that allows a 400 million cycle lifetime, at 90% reliability with 95% confidence, is ~ 0.16%, and essentially independent of mean strain. We conclude that the debatable claim that an increase in the applied mean strain can increase the fatigue life of Nitinol components is not supported by the current data.

2018, Glogener, Paul, Krause, Michael, Katzer, Jens, Schubert, Markus A., Birkholz, Mario, Bellmann, Olaf, Kröger-Koch, Claudia, Hammon, Harald M., Metges, Cornelia C., Welsch, Christine, Ruff, Roman, Hoffmann, Klaus P.

A microelectronic biosensor was subjected to in vivo exposure by implanting it in the vicinity of m. trapezii (Trapezius muscle) from cattle. The implant is intended for the continuous monitoring of glucose levels, and the study aimed at evaluating the biostability of exposed semiconductor surfaces. The sensor chip was a microelectromechanical system (MEMS) prepared using 0.25 µm complementary metal–oxide–semiconductor CMOS/BiCMOS technology. Sensing is based on the principle of affinity viscometry with a sensoric assay, which is separated by a semipermeable membrane from the tissue. Outer dimensions of the otherwise hermetically sealed biosensor system were 39 × 49 × 16 mm. The test system was implanted into cattle in a subcutaneous position without running it. After 17 months, the device was explanted and analyzed by comparing it with unexposed chips and systems. Investigations focused on the MEMS chip using SEM, TEM, and elemental analysis by EDX mapping. The sensor chip turned out to be uncorroded and no diminishing of the topmost passivation layer could be determined, which contrasts remarkably with previous results on CMOS biosensors. The negligible corrosive attack is understood to be a side effect of the semipermeable membrane separating the assay from the tissue. It is concluded that the separation has enabled a prolonged biostability of the chip, which will be of relevance for biosensor implants in general.

2015, Maitz, Manfred F.

Multiple biological, synthetic and hybrid polymers are used for multiple medical applications. A wide range of different polymers is available, and they have further the advantage to be tunable in physical, chemical and biological properties in a wide range to match the requirements of specific applications. This review gives a brief overview about the introduction and developments of polymers in medicine in general, addressing first stable polymers, then polymers with degradability as a first biological function, followed by various other functional and responsive polymers. It is shown up that biomedical polymers comprise not only bulk materials, but also coatings and pharmaceutical nano-carriers for drugs. There is subsequently an overview of the most frequently used polymer classes. The main body of the review then is structured according to the medical applications, where key requirements of the applications and the currently used polymer solutions are indicated.