Journal of Medical Devices, Transactions of the ASME Journal of Medical Devices, Transactions of the ASME RSS feedThis is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

A Human Thermoregulation Simulator for Calibrating Water-Perfused Cooling Pad Systems for Therapeutic Hypothermia
The induction of a mild reduction in body core temperature has been demonstrated to provide neuroprotection for patients who have suffered a medical event resulting in ischemia to the brain or vital organs. Temperatures in the range of 32 –34 °C provide the required level of protection and can be produced and maintained by diverse means for periods of days. Rewarming from hypothermia must be conducted slowly to avoid serious adverse consequences and usually is performed under control of the thermal therapeutic device based on a closed-loop feedback strategy based on the patient's core temperature. Given the sensitivit...
Source: Journal of Medical Devices, Transactions of the ASME - June 28, 2017 Category: Medical Devices Source Type: research

Effects of Sterilization on Shape Memory Polyurethane Embolic Foam Devices
Polyurethane shape memory polymer (SMP) foams have been developed for various embolic medical devices due to their unique properties in minimally invasive biomedical applications. These polyurethane materials can be stored in a secondary shape, from which they can recover their primary shape after exposure to an external stimulus, such as heat and water exposure. Tailored actuation temperatures of SMPs provide benefits for minimally invasive biomedical applications, but incur significant challenges for SMP-based medical device sterilization. Most sterilization methods require high temperatures or high humidity to effective...
Source: Journal of Medical Devices, Transactions of the ASME - June 28, 2017 Category: Medical Devices Source Type: research

Individually Controllable Magnetic Cilia: Mixing Application
This paper introduces a new design for individually controlled magnetic artificial cilia for use in fluid devices and specifically intended to improve the mixing in DNA microarray experiments. The design has been implemented using a low-cost prototype that can be fabricated using polydimethylsiloxane (PDMS) and off-the-shelf parts and achieves large cilium deflections (59% of the cilium length). The device's performance is measured via a series of mixing experiments using different actuation patterns inspired by the blinking vortex theory. The experimental results, quantified using the relative standard deviation of the co...
Source: Journal of Medical Devices, Transactions of the ASME - June 27, 2017 Category: Medical Devices Source Type: research

Food and Drug Administration's Humanitarian Device Exemption Marketing Approval Pathway: Insights for Developing Devices for Rare Diseases
The Food and Drug Administration's (FDA) Humanitarian Device Exemption (HDE) is a unique marketing approval pathway for medical devices targeting diseases affecting small (rare) patient populations. In an effort to increase the utilization and success of this pathway, the FDA has analyzed data from HDE approvals from 2007 to 2015 to identify factors that have contributed to a successful HDE marketing application. There were 28 HDE approvals during the analysis period and were based on a broad range of data constituting valid scientific evidence. Most had at least one prospectively conducted clinical trial to support safety...
Source: Journal of Medical Devices, Transactions of the ASME - June 27, 2017 Category: Medical Devices Source Type: research

Cardiovascular Catheter With an Expandable Origami Structure
In this study, geometrical analysis is utilized to optimize the size and shape of the origami structure and MRI scans are taken to confirm the MRI compatibility of the structure. The origami expandable mechanism could also be applied to other medical device designs that require expandable structures. (Source: Journal of Medical Devices, Transactions of the ASME)
Source: Journal of Medical Devices, Transactions of the ASME - June 27, 2017 Category: Medical Devices Source Type: research

Assessment of the Accuracy of Optical Shape Sensing for Needle Tracking Interventions
This study establishes the needle tracking accuracy of FBG needle tracking for image-guided procedures. (Source: Journal of Medical Devices, Transactions of the ASME)
Source: Journal of Medical Devices, Transactions of the ASME - June 27, 2017 Category: Medical Devices Source Type: research

Design and Preliminary Testing of Novel Injection Port Contamination Barrier Devices
Prior studies have linked microbial contamination of intravenous (IV) ports and stopcocks with postoperative infections. Existing technologies to address contamination are not consistently utilized because of the time and effort they require. Herein, novel barrier devices were created that form a protective shell to passively prevent contact between injection sites and practitioner hands or environmental surfaces while still allowing rapid connection of a syringe for injection of medications via an opening in the shell. Prototypes were tested using a grossly contaminated environment and adenosine triphosphate (ATP)-biolumi...
Source: Journal of Medical Devices, Transactions of the ASME - June 27, 2017 Category: Medical Devices Source Type: research

Inverted L-Arm Gripper Compliant Mechanism
This work exploits the advantages of compliant mechanisms (devices that achieve their motion through the deflection of flexible members) to enable the creation of small instruments for minimally invasive surgery (MIS). Using flexures to achieve motion presents challenges, three of which are considered in this work. First, compliant mechanisms generally perform inadequately in compression. Second, for a ±90deg range of motion desired for each jaw, the bending stresses in the flexures are prohibitive considering materials used in current instruments. Third, for cables attached at fixed points on the mechanism, the mechanica...
Source: Journal of Medical Devices, Transactions of the ASME - June 27, 2017 Category: Medical Devices Source Type: research

Lowering the Barrier of Surgical Endoscopy With a Novel Articulating Retractor
Surgical endoscopy has gained traction over the past several decades as a viable option for therapeutic interventions in the gastrointestinal tract. It utilizes natural orifice access which shortens hospital stay, minimizes patient discomfort, and decreases overall healthcare costs. However, the inability to effectively retract and position target tissue is a significant limitation for these procedures. Current instruments are unable to triangulate and can only be manually withdrawn or advanced through the channels. There is a need to provide better access and control of soft tissue to be able to perform more complex and c...
Source: Journal of Medical Devices, Transactions of the ASME - June 27, 2017 Category: Medical Devices Source Type: research

Therapeutic Equipment for Brain-Hyperthermia Using Convective Spray Cooling
A new type of therapeutic equipment is designed herein, using concepts of convective heat transfer and spray cooling, to treat patients suffering from brain-hyperthermia. The equipment is aimed to provide emergency treatment in order to prevent disability or possible mortality because thermoregulatory system of the patients fails to maintain a homeostasis. The equipment uses noncontact method of forced convection, applied uniformly at body exteriors. The heat exchanger is designed to contain four independent pipe-sections with orifice openings around the body. The cool-air, maintained within ASHRAE ’s thermal comfort bou...
Source: Journal of Medical Devices, Transactions of the ASME - June 27, 2017 Category: Medical Devices Source Type: research

A New Surgical Drill Instrument With Force Sensing and Force Feedback for Robotically Assisted Otologic Surgery
Drilling through bone is a common task during otologic procedures. Currently, the drilling tool is manually held by the surgeon. A robotically assisted surgical drill with force sensing for otologic surgery was developed, and the feasibility of using the da Vinci research kit to hold the drill and provide force feedback for temporal bone drilling was demonstrated in this paper. To accomplish intuitive motion and force feedback, the kinematics and coupling matrices of the slave manipulator were analyzed and a suitable mapping was implemented. Several experiments were completed including trajectory tracking, drill instrument...
Source: Journal of Medical Devices, Transactions of the ASME - June 27, 2017 Category: Medical Devices Source Type: research

Comparative Evaluation of a Positive-Locking Antirotation Mechanism in the Design of Telescopic Nails for Patients in the Growth Phase
The aim of this study is to develop an intramedullary telescopic nail that —in contrast to the current standard—is rotationally stable and firmly anchored in the bone proximally and distally, without containing any extraosseous components that may alter the surrounding soft tissue. Three prototypes for a positive-locking adapted telescopic intramedullary nail (PLATIN) were developed. In a series of biomechanical tests, the prototypes were compared with two Fassier–Duval telescopic nails, which represent the clinical standard. Axial pressure, torsion, and four-point bending measurements were carried out in a materials...
Source: Journal of Medical Devices, Transactions of the ASME - June 27, 2017 Category: Medical Devices Source Type: research

RFID-Based Real-Time Navigation for Interventional Magnetic Resonance Imaging: Development and Evaluation of a Novel Tracking System
The purpose of this study was to evaluate the suitability of a novel radio-frequency identification (RFID)-based tracking system for intraoperative magnetic resonance imaging (MRI). A RFID tracking system was modified to fulfill MRI-compatibility and tested according to ASTM and NEMA. The influence of the RFID tracking system on MRI was analyzed in a phantom study using a half-Fourier acquisition single-shot turbospin echo (HASTE) and true fast imaging with steady-state precession sequence (TrueFISP) sequence. The RFID antenna was gradually moved closer to the isocenter of the MR scanner from 90 to 210  cm to investigate...
Source: Journal of Medical Devices, Transactions of the ASME - June 27, 2017 Category: Medical Devices Source Type: research

Investigations on Multisensor-Based Noninvasive Blood Glucose Measurement System
Noninvasive blood glucose (NIBG) measurement technique has been explored for the last three decades to facilitate diabetes management. Photoplethysmogram (PPG) signal may be used to measure the variations in blood glucose concentration. However, the literature reveals that physiological perturbations such as temperature, skin moisture, and sweat lead to less accurate NIBG measurements. The task of minimizing the effect of these perturbations for accurate measurements is an important research area. Therefore, in the present work, galvanic skin response (GSR) and temperature measurements along with PPG were used to measure b...
Source: Journal of Medical Devices, Transactions of the ASME - June 27, 2017 Category: Medical Devices Source Type: research

Development of a Multimodal Colposcopy for Characterization of Cervical Intraepithelial Neoplasia
To develop and evaluate the clinical application of a multimodal colposcopy combining multispectral reflectance, autofluorescence, and red, green, blue (RGB) imaging for noninvasive characterization of cervical intraepithelial neoplasia (CIN). We developed a multimodal colposcopy system that combined multispectral reflectance, autofluorescence, and RGB imaging for noninvasive characterization of CIN. We studied the optical properties of cervical tissue first; then the imaging system was designed and tested in a clinical trial where comprehensive datasets were acquired and analyzed to differentiate between squamous normal a...
Source: Journal of Medical Devices, Transactions of the ASME - June 27, 2017 Category: Medical Devices Source Type: research