The Effect of Different Sterilization Methods on Polypropylene Syringes
This presents the influence of gamma irradiation on Pharmacopeia specifications, mechanical and flow parameters of polypropylene (PP) syringes. There has been significant progress in the terminal sterilization of single-use, disposable medical devices with gamma radiation sterilization due to the growing awareness of toxic residues during the ethylene oxide (EtO) sterilization. PP is a widely used polymer for the production of syringes because of its excellent mechanical and thermal properties and has expanded continuously over the last decade. Although 25 kGy was generally recommended for the gamma radiation sterilization...
Source: Journal of Medical Devices, Transactions of the ASME - April 5, 2018 Category: Medical Devices Source Type: research

A Novel In Vitro Testing Approach for the Next Generation of Transvenous Cardiac Leads: Buckling Behavior
This study further investigates the effect of boundary conditions on buckling loads at the lead tip of different transvenous cardiac leads achieved using different variations of our initial physiologically relevant test method. The goals of the test are to create the maximum buckling load with high repeatability and the simplest possible design. A buckling test was performed to capture maximum buckling load using three leads of each model (five currently available cardiac lead models) and were tested in each of six test setups. The buckling test methodology had a substantial effect on the load-displacement profiles, regard...
Source: Journal of Medical Devices, Transactions of the ASME - April 2, 2018 Category: Medical Devices Source Type: research

A Precision System for Computed Tomography-Guided Needle Placement in the Thorax and Abdomen —Technical Design and Performance Analysis
The objective of this work is to present its technical design and analyze its performance in terms of placement error in air. The individual contributions to the placement error of a fiducial marker based system-to-CT registration system, a two degrees-of-freedom (2DOFs) drive system to aim the NG, and a structural link between NG and CT table were experimentally determined, in addition to the placement error of the overall system. An error contribution of 0.81  ± 0.34 mm was determined for the registration system,<1.2  mm and<3.3  mm for the drive system, and 0.35 mm and 0.43 mm for two load cases of ...
Source: Journal of Medical Devices, Transactions of the ASME - April 2, 2018 Category: Medical Devices Source Type: research

Numerical and Experimental Simulations of the Wireless Energy Transmission and Harvesting by a Camera Pill
This paper investigates the energy transmitted to and harvested by a camera pill traveling along the gastrointestinal (GI) tract. It focuses on the transmitted electromagnetic (EM) energy in the frequency range of 0.18 to 2450  MHz and compares it to the mechanical energy due to the motion of the pill and the force exerted from the intestine in its peristalsis onto the pill, and the electrochemical energy due to the change ofpH along the path of the pill. A comprehensive multilayer EM power transmission model is constructed and implemented in a numerical code, including power attenuation through each layer and multirefle...
Source: Journal of Medical Devices, Transactions of the ASME - March 19, 2018 Category: Medical Devices Source Type: research

Magnetic Chest Tube Positioning System
Tube thoracostomy (TT) insertion can serve as a life-saving adjunct for thoracic trauma. Unfortunately, suboptimal positioning using the open, standard of care technique is associated with complications resulting in impaired TT function. Using a porcine model, we aimed to determine whether a magnetic chest tube positioning system (MCTPS) could be utilized to direct the intrathoracic TT position. Using recently deceased cross-bred domestic swine, we performed TT using our MCTPS and the standard of care open technique. The operator held one magnet outside of the thorax. The second magnet was positioned at the distal aspect o...
Source: Journal of Medical Devices, Transactions of the ASME - March 3, 2018 Category: Medical Devices Source Type: research

LesionAir: An Automated, Low-Cost Vision-Based Skin Cancer Diagnostic Tool
Current techniques for diagnosing skin cancer lack specificity and sensitivity, resulting in unnecessary biopsies and missed diagnoses. Automating tissue palpation and morphology quantification will result in a repeatable, objective process. LesionAir is a low-cost skin cancer diagnostic tool that measures the full-field compliance of tissue by applying a vacuum force and measuring the precise deflection using structured light three-dimensional (3D) reconstruction. The technology was tested in a benchtop setting on phantom skin and in a small clinical study. LesionAir has been shown to measure deflection with a 0.085  mm...
Source: Journal of Medical Devices, Transactions of the ASME - March 3, 2018 Category: Medical Devices Source Type: research

A Practical Measurement of Parkinson's Patients Gait Using Simple Walker-Based Motion Sensing and Data Analysis
We present personal aid for mobility and monitoring (PAMM II), an instrumented walker for Parkinson's disease (PD) patients' gait monitoring. The objective of the walker is to aid in the diagnosis and monitoring of PD progression as well as the effects of clinical treatment and rehabilitation. In contrast to existing devices, the walker is a low-cost solution that is simple to operate and maintain, requiring no adjustments, special usage instructions, or infrastructure. This preliminary study reports on the efficiency, reliability, and accuracy of PAMM II when used to evaluate 22 PD patients and 20 control individuals. All...
Source: Journal of Medical Devices, Transactions of the ASME - February 12, 2018 Category: Medical Devices Source Type: research

A Novel Modular Tonometry-Based Device to Measure Pulse Pressure Waveforms in Radial Artery
The paper presents the development of a new device for measuring continuous pulse pressure waveforms (PPW) from the radial artery via applanation tonometry. The development focuses on improved accuracy, open and affordable design using off-the-shelf components, and greater user control in setting operational and calibration parameters to address user variability. The device design parameters are optimized through a tissue device interaction study based on a computational model. The design incorporates modular components and includes a sensor module for arterial flattening and pressure pick-up, a differential screw mechanis...
Source: Journal of Medical Devices, Transactions of the ASME - January 31, 2018 Category: Medical Devices Source Type: research

Estimation of the Two Degrees-of-Freedom Time-Varying Impedance of the Human Ankle
An understanding of the time-varying mechanical impedance of the ankle during walking is fundamental in the design of active ankle-foot prostheses and lower extremity rehabilitation devices. This paper describes the estimation of the time-varying mechanical impedance of the human ankle in both dorsiflexion –plantarflexion (DP) and inversion–eversion (IE) during walking in a straight line. The impedance was estimated using a two degrees-of-freedom (DOF) vibrating platform and instrumented walkway. The perturbations were applied at eight different axes of rotation combining different amounts of DP a nd IE rotations of fo...
Source: Journal of Medical Devices, Transactions of the ASME - January 30, 2018 Category: Medical Devices Source Type: research

Low-Cost Thermal Shield for Rapid Diagnostic Tests Using Phase Change Materials
The shelf life of point-of-care and rapid diagnostic tests (POC-RDTs) is commonly compromised by abrupt temperature changes during storage, transportation, and use. This situation is especially relevant in tropical regions and resource-constrained settings where cold chain may be unreliable. Here, we report the use of novel and low-cost passive thermal shield (TS) made from laminated phase change material (PCM) to reduce thermal overload in POC-RDTs. Validation of the proposed design was done through numerical simulation and testing of an octadecane shield prototype in contact with a lateral flow immunoassay. The use of ou...
Source: Journal of Medical Devices, Transactions of the ASME - January 30, 2018 Category: Medical Devices Source Type: research

Design of an Eye Speculum With Vibrational Anesthesia for Pain Management 1
(Source: Journal of Medical Devices, Transactions of the ASME)
Source: Journal of Medical Devices, Transactions of the ASME - January 25, 2018 Category: Medical Devices Source Type: research

Development and Testing of an External Fixation Coupling for a Damage Control Orthopedic System 1
(Source: Journal of Medical Devices, Transactions of the ASME)
Source: Journal of Medical Devices, Transactions of the ASME - January 25, 2018 Category: Medical Devices Source Type: research

Design of a Novel Three-Dimensional-Printed Two Degrees-of-Freedom Steerable Electrosurgical Grasper for Minimally Invasive Surgery
In this study, we introduce the first 3D-printed steerable bipolar grasper ( ◻ 5 mm) for use in minimal invasive surgery. The grasper significantly improves dexterity by the addition of two planar joints allowing for ±65 deg for sideways and ±85 deg for up- and downward movement. The joints enable a significantly higher bending stiffness, 4.0 N/mm for joint 1 and 4.4 N/mm for joint 2, than that of currently available steerable instruments. The tip consists of two metallic movable jaws that can be opened and closed with angles up to 170 deg and allows for grasping and coagulating of tissues; reaching tissue temper...
Source: Journal of Medical Devices, Transactions of the ASME - January 10, 2018 Category: Medical Devices Source Type: research

Integrating Cadaver Needle Forces Into a Haptic Robotic Simulator
Accurate force simulation is essential to haptic simulators for surgical training. Factors such as tissue inhomogeneity pose unique challenges for simulating needle forces. To aid in the development of haptic needle insertion simulators, a handheld force sensing syringe was created to measure the motion and forces of needle insertions. Five needle insertions were performed into the neck of a cadaver using the force sensing syringe. Based on these measurements a piecewise exponential needle force characterization, was implemented into a haptic central venous catheterization (CVC) simulator. The haptic simulator was evaluate...
Source: Journal of Medical Devices, Transactions of the ASME - December 5, 2017 Category: Medical Devices Source Type: research