Electrically Small Circularly Polarized UWB Intraocular Antenna System for Retinal Prosthesis.

OBJECTIVE: This paper presents the design of an electrically small circularly polarized (CP) 3 × 3 mm2 antenna system as an intraocular unit for retinal prosthesis application. METHODS: The system is operating in ISM and ultra-wideband (UWB) bands to target high programmability of retina stimulation and recording, respectively. The electrical dimensions, including the ground plane, are λ0/41 × λ0/41 × λ0/191. Physical limitations of the antenna are discussed based on Hansen and Collin's limitations. The proposed wire patch antenna exhibits wideband characteristics by combining multiple modes of the patch antenna in the presence of an interface PCB circuit. RESULTS: By loading polyimide encapsulated patch with stubs, dominant TM010 mode is combined with the higher order modes TM020-TM070 to exhibit wide -10 dB impedance bandwidth of 2-11 GHz. Annular rings and shorting pins in the ground plane provide CP radiation at 2.45, 5.8, and 8 GHz with 3-dB axial-ratio bandwidth of 0.3, 0.16, and 1.2 GHz, and far-field left hand circularly polarized (LHCP) gain of -18.4, -7.6, and -4.7 dBic, respectively, in broadside direction. A biocompatible antenna system is designed using Ansys HFSS in the presence of a detailed multilayer canonical eye model. Additionally, it is examined in an anatomical HFSS head model. Near and far-field electric field distribution is studied along with peak 1-g average specific absorption rate (SAR) calculations. CONCLUSION: The proposed antenna is fabricated, and the performance, including coupled power from an external antenna, is measured in a custom made eye model including head phantom. A reasonable agreement is obtained between simulated and measured results. SIGNIFICANCE: To generate an artificial vision, image perception capability could be improved with implantable UWB communication systems that feature particularly high data-rate and small size.

Rapid diagnosis of Leishmania infection with a portable loopmediated isothermal amplification device.

L. donovani is an intracellular protozoan parasite, that causes visceral leishmaniasis (VL), and consequently, post-kala azar dermal leishmaniasis (PKDL). Diagnosis and treatment of leishmaniasis is crucial for decreasing its transmission. Various diagnostic techniques like microscopy, enzyme-linked immunosorbent assays (ELISA) and PCR-based methods are used to detect leishmaniasis infection. More recently, loop-mediated isothermal amplification (LAMP) assay has emerged as an ideal diagnostic measure for leishmaniasis, primarily due to its accuracy, speed and simplicity. However, point-of-care diagnosis is still not been tested with the LAMP assay. We have developed a portable LAMP device for the monitoring of Leishmania infection. The LAMP assay performed using our device can detect and amplify as little as 100 femtograms of L. donovani DNA. In a preliminary study, we have shown that the device can also amplify L. donovani DNA present in VL and PKDL patient samples with high sensitivity (100%), specificity (98%) and accuracy (99%), and can be used both for diagnostic and prognostic analysis. To our knowledge, this is the first report to describe the development and application of a portable LAMP device which has the potential to evolve as a point-of-care diagnostic and prognostic tool for Leishmania infections in future.

Novel Diagnostics for Kaposi Sarcoma and Other Skin Diseases in Resource-Limited Settings.

In resource-limited settings, point-of-care diagnostic devices have the potential to reduce diagnostic delays and improve epidemiologic surveillance of dermatologic conditions. We outline novel-point-of care diagnostics that have recently been developed for dermatologic conditions that primarily affect patients living in resource-limited settings, namely, Kaposi sarcoma, cutaneous leishmaniasis, leprosy, Buruli ulcer, yaws, onchocerciasis, and lymphatic filariasis. All of the technologies described in this article are prototypes, and some have undergone field testing. These devices still require validation in real-world settings and effective pricing to have a major impact on dermatologic care in resource-limited settings.

Drug Formulation Impact on Prefilled Syringe Functionality and Autoinjector Performance.

Given the surging interest in developing prefilled syringe and autoinjector combination products, investment in an early compatibility assessment is critical to prevent unwarranted drug/container closure interactions and avoid potential reformulation during late stages of drug development. In addition to the standard evaluation of drug stability, it is important to consider container closure functionality and overall device performance changes over time because of drug-container closure component interaction. This study elucidated the mechanisms that cause changes in syringe glide force over time and the impact on the injection duration. It was an expansion of the previous work, which indicated that drug formulation variables such as formulation excipients and pH affect syringe functionality over time. The current study described an investigative process for troubleshooting prolonged and variable autoinjector injection time caused by an increased syringe glide force variability over time. This increase in glide force variability stems from two root causes, namely plunger dimensional variation and syringe silicone oil change over time. The results demonstrated (a) the underlying factors of silicone oil change in the presence of drug formulation matrices, (b) accelerated stability of syringe glide force as a good indicator of long-term, real-time stability, and (c) that buffer matrix-filled syringes can be used to predict the syringe functionality and stability of drug product-filled syringes. Based on the experimental findings of a variety of orthogonal characterization techniques including contact angle, interfacial tension, and calculation of Hansen solubility parameters, it is proposed that silicone oil change is caused by formulation excipients and a complex set of phenomena summarized as "wet, wash, and delube" processes.

Finite element model-based evaluation of tissue stress variations to fabricate corrective orthosis in feet with neutral subtalar joint.

BACKGROUND: The subtalar joint position during static stance is a crucial determinant of the peak plantar pressures and forms ideal reference point for any intervention in foot-related problems for leprosy-affected patients. OBJECTIVES: The study pursued the hypothesis through a three-dimensional model that stress will be minimal in the distal joints of the foot when the subtalar joint is in neutral static stance position. STUDY DESIGN: Finite element model. METHODS: The computed tomography images of the feet for five patients suffering from Hansen's disease having no muscle weakness and joint restriction were acquired. The gray intensities corresponding to the bones of the foot from the computed tomography images were three-dimensionally reconstructed. The three-dimensional model of the human foot, incorporating the realistic geometry, and the material properties of the hard tissues were then analyzed using a finite element solver for the stress distribution on bones of the foot. RESULTS: The results demonstrate that the position of the calcaneum in the static stance position does contribute to the varying stress in the foot. CONCLUSION: The stresses in the bones of the foot are minimal while the subtalar is in neutral position; this position will be suitable for foot orthotic fabrication. Clinical relevance The clinicians, therapists, and podiatrists having less engineering skills can quickly assess the patient and get optimal results on the stress associated with the joints of the foot.

Analysis of catheter contact force during atrial fibrillation ablation using the robotic navigation system: results from a randomized study.

PURPOSE: Contact with cardiac tissue is an important determinant of lesion efficacy during atrial fibrillation (AF) ablation. The Sensei X™ robotic navigation system (RNS) (Hansen Medical, Mountain View, CA, USA) has been validated for contact force (CF) sensing expressed in grams (g). The Thermocool® SmartTouch™ catheter enables the measurement of catheter tip CF and direction inside the heart. We aimed to investigate the catheter CF with and without RNS during pulmonary vein isolation (PVI) procedures. METHODS: Eighty patients with symptomatic AF (56 males, age 63 ± 18) were enrolled in this study. Fifty-seven patients had paroxysmal AF and 23 early persistent AF. All procedures were performed with the Thermocool® SmartTouch™ ablation catheter. Forty patients were randomized to perform PVI with the Sensei X™ RNS (group 1), while in the other 40 patients (group 2), PVI was performed without the RNS. RESULTS: AF ablation was performed successfully in all patients without complications, while contact force was kept in the established 10-40 g range. A significantly higher CF was documented on the PVs in group 1 compared to group 2. The 1-year freedom from AF recurrence was higher in group 1 compared to group 2 (90 vs. 65 %, p = 0.04). Moreover, a significant reduction of fluoroscopy time was noted in the RNS group (13 ± 10 vs. 20 ± 10 min, respectively, p = 0.05). CONCLUSIONS: The Sensei X™ RNS permits a significantly higher CF during transcatheter AF ablation with a low rate of AF recurrence at clinical follow-up.

Reduction of plantar pressures in leprosy patients by using custom made shoes and total contact insoles.

OBJECTIVE: The purpose of this study was to observe whether our custom made shoes and total contact insoles can effectively increase the plantar contact areas and reduce peak pressures in patients with leprosy. DESIGN: In the rehabilitation laboratory of a tertiary medical center. Six male and two female leprosy patients were recruited in this study. In this study, parameters related to foot pressures were compared between these patients wearing commercial available soft-lining kung-fu shoes and our custom made shoes with total contact insoles. The custom made shoes were made with larger toe box and were able to accommodate both the foot and the insoles. Custom made total contact insoles were made with the subtalar joints under neutral and non-weight-bearing positions. The insole force measurement system of Novel Pedar-X (Novel, Munich, Germany) was used to measure the plantar forces. The parameters of contact area (cm(2)), peak plantar pressures (kPa), contact time (s), and pressure time integral (kPa s) were measured. RESULTS: There were significant contact area increases in the right and left foot heel areas, left medial arch, and second to fifth toes after wearing the custom made shoes and insoles. There were significant decreases in peak plantar pressures in bilateral heels, left lateral midfoot, bilateral second to fourth metatarsal areas, and left fifth metatarsal head after wearing the custom made shoes and insoles (p<0.05). CONCLUSIONS: Plantar ulceration is a common serious disability in leprosy patients. As a result, footwear and measures able to reduce plantar pressures may be beneficial in preventing plantar ulcers from occurring in these patients. Our custom made shoes and total contact insoles were proven to be effective in increasing contact areas and decreasing peak pressures in plantar surfaces, and may therefore be a feasible treatment option in preventing leprosy patients from developing plantar ulcers.

Current state in tracking and robotic navigation systems for application in endovascular aortic aneurysm repair.

OBJECTIVE: This study reviewed the current developments in manual tracking and robotic navigation technologies for application in endovascular aortic aneurysm repair (EVAR). METHODS: EMBASE and MEDLINE databases were searched for studies reporting manual tracking or robotic navigation systems that are able to manipulate endovascular surgical tools during abdominal or thoracic aortic aneurysm repair. Reports were grouped by the navigation systems and categorized into phantom, animal, and clinical studies. First, the general characteristics of each system were compared. Second, target registration error and deployment error were used to compare the accuracy of the tracking systems. Third, all systems were reviewed for fluoroscopy time (FT), radiation dose, and contrast volumes, if reported, in rigid and nonrigid studies. Fourth, vascular cannulation performance of the systems was compared, studying cannulation time, Imperial College Complex Cannulation Scoring Tool score, and the number of wall hits and catheter movements within rigid studies. RESULTS: Of 721 articles and references found, 18 studies of four different navigation systems were included: the Aurora (Northern Digital, Waterloo, Ontario, Canada) tracking system, the StealthStation (Medtronic Inc, Minneapolis, Minn) tracking system, an ultrasound localization tracking system, and the Sensei (Hansen Medical, Mountain View, Calif) steerable remote-controlled robotic navigation system. The mean tracking accuracy averaged 1 mm for the three manual tracking systems measured in a rigid environment. An increase of target registration error reaching >3 mm was reported when measured in a nonrigid experimental environment or due to external distortion factors. Except within small-animal studies or case studies, no evidence was found on reduction of clinical outcome parameters, such as FT, radiation dose, and contrast volumes, within clinical EVAR. A comparison of vascular cannulation performance in rigid studies revealed that the Sensei robotic system might have an advantage during advanced cannulation compared with standard cannulation within complex cannulations tasks. CONCLUSIONS: This review summarizes the current studies on manual tracking and robotic navigation systems for application in EVAR. The main focus of these systems is improving aortic vessel cannulation, required in complex EVAR, in which the robotic system with the improved steerability is favored over manual tracking systems or conventional cannulation. All reviewed tracking systems still require X-ray for anatomic imaging, stent graft deployment, and device registration. Although the current reviewed endovascular navigation systems have shown their potential in phantom and animal studies, clinical trials are too limited to conclude that these systems can improve EVAR outcomes or that they can systematically reduce FTs, radiation doses, and contrast volumes during (complex) EVAR.

Associated Da Vinci and magellan robotic systems for successful treatment of nutcracker syndrome.

Here, we report the case of a 26-year-old woman suffering from nutcracker syndrome with concurrent disabling pelvic congestion syndrome. She was given the minimally invasive treatment of left renal vein transposition with the Da Vinci(®) robotic system (Intuitive Surgical, Sunnyvale, CA), followed the next day by a gonadal vein and pelvic varicose embolization using a robotic intraluminal navigation with the Magellan™ robotic system (Hansen Medical, Mountain View, CA). The procedure was uneventful, and the patient had good results at 6 months of follow-up, including a patent left renal vein and complete relief of symptoms.