Evaluation of Pigment Distribution and Depth Analysis Methods for Decorative Soft Contact Lenses.

OBJECTIVES: This study evaluates pigment component distribution and depth in decorative soft contact lenses (DSCLs) using a variety of analytical methods. METHODS: We sampled 18 DSCLs using optical microscopy, optical coherence tomography analysis, Z-stack analysis, X-ray photoelectron spectroscopy (XPS), scanning electron microscopy/energy-dispersive X-ray spectroscopy (SEM/EDX), and time-of-flight secondary ion mass spectrometry (TOF-SIMS) to evaluate the distribution and depth of pigment components. RESULTS: Pigment distribution in DSCLs was easily observed with optical methods including Z-stack analysis. X-ray photoelectron spectroscopy, SEM/EDX, and TOF-SIMS were used to evaluate the level of pigment exposure on the lens surface and the results showed significant differences between the methods. Pigment components were detected in 16 samples by SEM/EDX, but not by XPS. Pigment components were only detected in eight samples using TOF-SIMS. CONCLUSIONS: It may be necessary to show that a nanometer-thick monomolecular film does not exist on the surface of DSCLs, to demonstrate the exposure of a pigment particle. Taking into account the principle behind each of the measurement methods and the resolution and sensitivity of each of the analytical methods compared, TOF-SIMS may be the most appropriate method to accurately judge pigment exposure on DSCLs. The Z-stack method may be useful for estimating the depth of pigment components in DSCLs.

Japanese Regulatory Considerations for Interoperability of Medical Devices.

With the rapid technological innovations of the Internet of Things (IoT), the situation surrounding medical devices and medical systems has been changing. Interoperable medical devices-medical devices capable of interoperating in a clinically significant way with other medical devices-have been developed, and interoperable medical systems consisting of two or more interconnected interoperable medical devices are being used in clinical settings. However, general points that need to be considered to ensure safe and effective interoperability have yet to be fully established in Japan. A research project (FY2019-FY2021) to discuss issues associated with ensuring safe and effective interoperability was commissioned by the Japan Agency for Medical Research and Development. A pivotal aspect identified in that project is how to manage the sharing of data and information among interoperable medical devices from different manufacturers. Characteristics and timestamps of data and information need to be exchanged between interoperable medical devices. Risks associated with interoperable devices should be managed in a manner appropriate to the characteristics and the intended use of the interoperable medical devices. In this review, we summarize the aspects of data and information that this study group judged were important to consider for ensuring safety and effective interoperability.

In vitro evaluation of delamination resistance of PEEK and CFR-PEEK.

Poly-ether-ether-ketone (PEEK) and carbon fiber reinforced PEEK as orthopedic implant materials exhibit excellent material properties. Although delamination of PEEK materials has been reported in knee joint wear research, the delamination resistance behavior remains unclear. In this study, the delamination resistance of PEEK materials was investigated; these materials were compared to ultra-high molecular weight polyethylene (UHMWPE). The results of a ball-on-flat type delamination test indicated that the PEEK materials underwent delamination considerably earlier than UHMWPE, and the contact area of the PEEK materials was smaller than that of UHMWPE. Moreover, the indentation modulus, hardness, and coefficient of friction were higher for PEEK materials than for UHMWPE. The reduced tendency of PEEK materials to undergo deformation to mitigate stress concentration at low conformity contact conditions contributed to their inferior delamination resistance compared to that of UHMWPE. The delamination resistance of the PEEK materials was equivalent to that of degraded UHMWPE, which highlights the risk of delamination of PEEK implants in a clinical context. Consequently, when using PEEK materials as an implant component loaded at a low conformity contact condition, the material selection and component design must be carefully considered. Overall, the results of this study can help guide the future development of PEEK-based implants.

A trial to visualize perforators images from CTA with a tablet device: experience of operating on minipigs.

A reliable method for precise perforator mapping can be extremely valuable in perforator flap surgery. In this study, we attempted to map perforator location using 3-dimensional computed tomography angiography (CTA), a newly developed application, and a tablet device. Preliminary examinations to test the device were conducted in mini-pigs. We used 5 female mini-pigs. Preoperative imaging of the vasculature was undertaken with CTA in the prone position, following Iopamidol (200 ml) injection via the internal jugular vein. Prior to the examination, we placed round markers on the backs of the mini-pigs. To assess accuracy, we compared the perforator positions acquired with an optical position measurement device with the perforator positions acquired with the tablet device. Furthermore, we compared the perforator positions with the tablet navigation device, which we measured directly. We measured 12 perforators with the optical position measurement device. The mean difference was 10 mm (minimum, 2 mm; maximum, 20 mm). We measured these perforators with the tablet navigation device. The mean difference was 5.4 mm (minimum, 0 mm; maximum, 20 mm). The perforator flaps were elevated safely. The perforator flaps could be elevated safely using our device, as the mean difference was only 10 mm, which is acceptable for navigating perforator flap operations. Pig backs are triangular in shape; therefore, we were unable to place markers on the contralateral side. Thus, for clinical applications of the device, we should determine the ideal marker locations.

In Vitro Measurement of Contact Pressure Applied to a Model Vessel Wall during Balloon Dilation by Using a Film-Type Sensor.

Objective: As an important evaluation index of vascular damage, the study aims to clarify the value of contact pressure applied to blood vessels and how it changes with respect to balloon pressure during balloon dilation. Methods: The contact pressure was evaluated through an in vitro measurement system using a model tube with almost the same elastic modulus as the blood vessel wall and our film-type pressure sensor. A poly (vinyl alcohol) hydrogel tube with almost the same elastic modulus was fabricated as the model vessel. The film-type sensor was inserted between the balloon catheter and the model vessel, and the balloon was dilated. Results: The contact pressure applied to the blood vessel was less than 10% of the balloon pressure, and the increase in contact pressure was less than 1% of the increase in balloon pressure (8 to 14 atm). Moreover, the contact pressure and its increase were larger in the model with a high elastic modulus. Conclusion: The contact pressure to expand the soft vessel model was not high, and the balloon pressure almost appeared to act on the expansion of the balloon itself. Our experiment using variable stiffness vessel models containing film-type sensors showed that the contact pressure acting on the vessel wall tended to increase as the wall became harder, even when the nominal diameter of the balloon was almost identical to the vessel. Our results can be clinically interpreted: when a vessel is stiff, the high-pressure inflation may rupture it even if its nominal diameter is identical to the diameter of the vessel.

[Evaluation of the Influence of Pharmaceuticals on the Mechanical Properties of Polymeric Medical Devices].

Pharmaceuticals reportedly cause damage to some polymeric medical devices that administer them. Because this phenomenon and its causes still remain unclear, in this study, all the possible combinations of polymeric materials and pharmaceutical ingredients that could cause failures were identified by conducting a comprehensive analysis on a wide variety of such combinations and through verification tests using the products. The results of the simple immersion tests and the reports of clinical failures indicated that the failures were not caused by the lack of chemical resistance of the polymers but by the environmental stress cracking (ESC) induced by a combination of the stress generated in the material and the interaction with a specific chemical. Therefore, we evaluated all combinations that could cause ESC by developing and applying a simple method for testing ESC. Polycarbonate and polyethylene terephthalate were found to be damaged by alkaline solutions and oils and fats, and surfactants solutions. These failures were also confirmed by the verification tests. Results from the stress state verification, fractographic analysis, and other studies confirmed that these failures were caused by ESC. Cytotoxicity owing to the induction of ESC was not detected in any combination. These results indicated that the residual stress generated during the manufacturing process was one of the reasons for the failure of the medical devices. This residual stress can be eliminated by employing additional processes such as annealing, thereby preventing medical device failures induced through interactions with pharmaceutical ingredients.

Development of a data fusion system using color information for real-time intraoperative liver surface measurement.

The goal of our study is to develop a data fusion system, which enables surgeons to easily visualize the inner structures of elastic organs during open surgery. We chose the liver as the focus of this study due to its easily deformable nature and complex vascular structures. To do so, we propose using preoperative data and supplementary intraoperative data. We captured a sequence of liver surface data for the intraoperative data by using trinocular stereo and we applied them to the preoperative 3D model's surface. Then, we modified the model to fit the intraoperative liver condition and portrayed the model's inner structures. With this method, we could establish this system.

Positive intraoperative pleural lavage cytology is a predictive marker of disease recurrence in stage I lung adenocarcinoma.

OBJECTIVES: This study aimed at analysing the relationship between the pleural lavage cytology (PLC) status and clinicopathological characteristics, including the outcome of examined patients and tumour recurrence sites in surgically resected stage I non-small-cell lung carcinoma. METHODS: From April 2002 to August 2012, PLC was performed immediately after thoracotomy in 428 consecutive patients undergoing pulmonary resection for lung cancer. The relationship between clinicopathological characteristics and the PLC status was retrospectively analysed. RESULTS: The frequency of PLC-positive results was 4.4%, and larger tumour size, stage IB and pleural invasion were found more frequently in PLC-positive patients. Patients with a PLC-positive status had significantly worse disease-free survival (DFS) than those with a PLC-negative status (PLC positive versus PLC negative: hazard ratio [HR] = 2.79, 95% confidence interval [CI]: 1.4-5.57, P < 0.004; 5-year DFS: 46.6 vs 76.5%). With regard to the PLC status and histological type, adenocarcinoma was associated with a worse DFS in PLC-positive patients when compared with PLC-negative patients (5-year DFS: 38.1 vs 81.1%, P < 0.001). In multivariate analysis, PLC status remained significantly associated with DFS in patients with a PLC-positive status having an increased risk of recurrence, compared with PLC-negative patients (HR = 2.494, 95% CI: 1.241-5.011, P = 0.01) only in the case of adenocarcinoma. CONCLUSIONS: Our current study showed the clinicopathological characteristics associated with PLC status and demonstrated that PLC status was an independent predictor of increased recurrence in stage I lung adenocarcinoma.

Comparison of control modes of a hand-held robot for laparoscopic surgery.

Teleoperated robots for minimally invasive surgery make surgeons loose direct contact with the patient. We are developing a handheld, dexterous surgical robot that can be controlled with one hand only, while standing at the operating table. The instrument is composed of a master part (the handle) and a slave part (the tip). This work compares the performance of different control modes, i.e. different ways to map the degrees of freedom of the handle to those of the tip. We ask users to drive the tip along complex trajectories in a virtual environment, using the real master to drive a simulated slave, and assess their performance. Results show that, concerning time, users with no training in laparoscopy prefer a direct mapping of position and orientation, like in free hand motion. However, users trained in laparoscopy perform equally fast with our hand-held robot and, concerning precision, make a smaller number of errors.