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BACKGROUND AND AIM: The PillCam patency capsule (PC) without a radio frequency identification tag was released to preclude retention of the small bowel capsule endoscope (CE) in Japan in 2012. We conducted a multicenter study to determine tag-less PC-related adverse events (AEs). METHODS: We first conducted a retrospective survey using a standardized data collection sheet for the clinical characteristics of PC-related AEs among 1096 patients collected in a prospective survey conducted between January 2013 and May 2014 (Cohort 1). Next, we retrospectively investigated additional AEs that occurred before and after Cohort 1 within the period June 2012 and December 2014 among 1482 patients (Cohort 2). RESULTS: Of the 2578 patients who underwent PC examinations from both cohorts, 74 AEs occurred among 61 patients (2.37%). The main AEs were residual parylene coating in 25 events (0.97%), PC-induced small bowel obstruction, suspicious of impaction, in 23 events (0.89%), and CE retention even after patency confirmation in 10 events (0.39%). Residual parylene coating was significantly associated with Crohn's disease (P < 0.01). Small bowel obstruction was significantly associated with physicians with less than 1 year of experience handling the PC and previous history of postprandial abdominal pain (P < 0.01 and P < 0.03, respectively). CE retention was ascribed to erroneous judgment of PC localization in all cases. CONCLUSIONS: This large-scale multicenter study provides evidence supporting the safety and efficiency of a PC to preclude CE retention. Accurate PC localization in patients without excretion and confirmation of previous history of postprandial abdominal pain before PC examinations is warranted (UMIN000010513).

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Implantable vascular devices are widely used in clinical treatments for various vascular diseases. However, current approved clinical implantable vascular devices generally have high failure rates primarily due to their surface lacking inherent functional endothelium. Here, inspired by the pathological mechanisms of vascular device failure and physiological functions of native endothelium, we developed a new generation of bioactive parylene (poly(p-xylylene))-based conformal coating to address these challenges of the vascular devices. This coating used a polyethylene glycol (PEG) linker to introduce an endothelial progenitor cell (EPC) specific binding ligand LXW7 (cGRGDdvc) onto the vascular devices for preventing platelet adhesion and selectively capturing endogenous EPCs. Also, we confirmed the long-term stability and function of this coating in human serum. Using two vascular disease-related large animal models, a porcine carotid artery interposition model and a porcine carotid artery-jugular vein arteriovenous graft model, we demonstrated that this coating enabled rapid generation of self-renewable "living" endothelium on the blood contacting surface of the expanded polytetrafluoroethylene (ePTFE) grafts after implantation. We expect this easy-to-apply conformal coating will present a promising avenue to engineer surface properties of "off-the-shelf" implantable vascular devices for long-lasting performance in the clinical settings.

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Stabilization techniques for n-doped carbon nanotubes (CNTs) are essential for the practical use of CNT devices. However, none of the reported n-dopants have sufficient robustness in a practical environment. Herein, we report a highly stable technique for fabricating n-doped CNT films. We elucidate the mechanism by which air stability can be achieved by completely covering CNTs with n-dopants to prevent oxidation; consequently, the stability is lost when exposed to scratches or moisture. Therefore, we introduce parylene as a protective layer for n-doped CNTs and achieve air stability for more than 365 d. Moreover, we demonstrate outstanding robust thermo-electric power generation from strong acids, alkalis, and alcohols, which cannot be realized with conventional air-stable n-dopants. The proposed stabilization technique is versatile and can be applied to various n-dopants. Thus, it is expected to be a key technology in the practical application of CNT devices.

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INTRODUCTION: The advent of the penile prosthesis revolutionized the treatment of erectile dysfunction (ED), resulting in near-complete treatment efficacy and high patient satisfaction rates. While several types of penile prosthesis are available, the inflatable penile prosthesis (IPP) is the most commonly used device in the United States. AIMS: To describe the key modifications to IPPs from the two major manufacturers-American Medical Systems (AMS) and Coloplast-since the invention of the IPP, and to relate these changes to improvements in prosthesis function and patient outcomes based on available literature. METHODS: Review and evaluation of the literature between 1973 and present describing modifications in IPP design and the influence of these modifications on IPP durability and patient-related factors. MAIN OUTCOME MEASURES: Data describing the impact of iterative improvements in three-piece IPP design on device function, durability, and patient outcomes. RESULTS: There were progressive improvements in IPP technology from both major manufacturers not only on the durability of the prosthesis but also on patient outcomes, with fewer device failures and lower infection rates. Notable improvements include incorporation of kink-resistant tubing, changes in the weave or addition of shear- and infection-resistant coatings to cylinder layers, pump and tubing connection modifications, the addition of rear tip extenders, and the incorporation of lockout valves to prevent autoinflation. CONCLUSIONS: Numerous incremental modifications to the IPP from both major manufacturers since its invention have increased its durability and improved patient outcomes.

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Simple fabrication, high power-to-weight and power-to-volume ratios, and the ability to operate in open air at low voltage make the ionic electroactive polymer actuators highly attractive for haptic applications. Whenever a direct tactile stimulation of the skin is involved, electrical and chemical insulation as well as a long-term stability of the actuator are required. Because of its inherent physicochemical properties such as high dielectric strength, resistance to solvents, and biological inactivity, Parylene C meets the requirements for making biocompatible actuators. We have studied the displacement and the generated force of Parylene-coated carbon nanotube actuators as well as the encapsulation quality. A 2 µm coating creates an effective electrical insulation of the actuators without altering the blocking force at frequencies from 50 mHz to 1 Hz. Moreover, the generated strain is preserved at higher frequencies (from 0.5 to 5 Hz). We employed a simple mechanical model to explain the relation between the key parameters-flexural stiffness, displacement, and force-for uncoated and coated actuators. In addition, we demonstrated that our Parylene-coated actuators are not damaged by rinsing in liquid media such as 2-propanol or water. In conclusion, our results indicate that Parylene C encapsulated actuators are safe to touch and can be used in contact with human skin and in biomedical applications in direct contact with tissues and physiological fluids.

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This work describes uniform polymer coatings allowing for an adjustment of the orifice dimension of vibrating-mesh nozzles and therefore, size of emerging formulation droplets and dried particles, which is of general interest for diverse spray-drying applications. Chemical vapor deposition of poly(p-xylylene) (PPXN) on aperture templates of the B-90 spray-dryer (orifice diameters: ∼4.0µm) caused a reduction of the opening cross-sections of ∼50%. Thus, a more efficient formulation atomization was observed (finer droplets). Likewise, application of PPXN-coated, rather than plain nozzles, resulted in significantly smaller (particle diameter: 1.3 vs. 3.6µm) and narrower distributed (span: ∼1.4 vs. ∼1.8) sildenafil-loaded poly(lactide-co-glycolide) microparticles. Prediction of the size of spray-dried microparticles using the size results of atomized droplets ("residual core method") was shown to be in agreement with the observed values. Formulations prepared with plain and PPXN-coated nozzles exhibited a sustained sildenafil release profile with mean dissolution times of ∼1.5 and ∼4.0h, respectively. Regardless of the starting aperture template, any desired orifice dimension and therefore, dried particle size could be achieved by generating adequate polymer deposits.

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