Characterization of Outer Insulation in Long-Term-Implanted Leads.

Success of pacemakers and implantable cardioverter defibrillators may be limited by premature lead failure. Lead insulation polymers, such as polyurethane (PU) and polydimethylsiloxane (PDMS), are reported to degrade over time in vivo. PU is known to undergo oxidation, whereas PDMS undergoes surface hydrolysis. Previous studies have characterized polymer degradation in vitro, in animals or in short-term human study; however, complex effects of the biochemical and mechanical environment on the lead insulation can only be fully understood by evaluating long-term-implanted leads. Therefore, we established a retrieval program to systematically characterize the chemical and surface changes in 37 of 104 retrieved pacing and defibrillator leads, implanted for ≥5 yr. Fourier transform infrared (FTIR) spectroscopy was used for chemical analysis, and a scanning electron microscope was used for surface degradation evaluation. PDMS leads were investigated for changes in the ratio of Si-O-Si to Si-C peaks, whereas PU degradation was evaluated by changes in ether (C-O-C), carbonyl (C=O), methylene (C-H), and amino (C-N/N-H) peaks. Under SEM, PDMS showed enhanced roughness but no statistical increase in Si-O-Si bonds. PU showed uniform cracking throughout the lead body and statistical changes in each of the oxidation indicative peaks. Overall, both polymers showed surface changes in the physiological environment, but PU was the only material to show chemical changes. This work is a large-scale characterization study on long-term-implanted leads that confirmed PU oxidation but not hydrolysis of PDMS in vivo. It provides important insight for manufacturers when making design improvements and for surgeons when making decisions about lead implantation.

Effects of gamma and e-beam sterilization on the chemical, mechanical and tribological properties of a novel hydrogel.

Hydrogels are known to possess cartilage-like mechanical and lubrication properties; however, hydrogel sterilization is challenging. Cyborgel(™), a proprietary hydrogel, is intended for use as a cartilage replacement implant. This study evaluated the effect of 30-35 kGy e-beam and gamma radiation on the polymer swell ratio, and the mechanical, chemical and tribological behavior of this hydrogel. Three different formulations were mechanically tested, and material parameters were identified using finite element analysis. FTIR spectroscopy was used to investigate chemical changes. Wear test was carried out for 2 million cycles in bovine serum, followed by 2 million cycles in distilled water. No significant difference was found in the swell ratio, mechanical and tribological properties of control hydrogel samples and those exposed to e-beam or gamma radiation; however, chemical spectra of e-beam sterilized samples revealed minor changes, which were absent in unsterilized and gamma sterilized samples.

Percolating bulk heterostructures from neutron reflectometry and small-angle scattering data.

We generate percolating fullerene-polymer bulk heterostructures that are consistent with the experimental characterization of a nanostructure, in particular neutron reflectometry and small-angle neutron scattering data from as-cast and annealed poly(3-hexylthiophene) (P3HT) and [6,6]-phenyl C61-butyric acid methyl ester systems. Transport simulations correlate changes in exciton dissociation efficiency and charge collection efficiency with morphological features including characteristic domain size, fullerene concentration profile, degree of fullerene sequestration, and degree of P3HT crystallization.