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.

Development of an Alveolar Transbronchial Catheter for Concurrent Fiber Optics-Based Imaging and Fluid Delivery
We describe the rationale, development, and validation in ex vivo ovine lung to near clinical readiness of a triple lumen bronchoscopy catheter that allows concurrent imaging and fluid delivery, with the aim of clinical use to deliver multiple fluorescent compounds to image alveolar pathology. Using this device, we were able to produce high-quality images of bacterial infiltrates in ex vivo ovine lung within 60  s of instilling a single microdose of (<100 mcg) imaging agent. This has many advantages for future clinical usage over the current state of the art. (Source: Journal of Medical Devices, Transactions of the ASME)
Source: Journal of Medical Devices, Transactions of the ASME - July 24, 2018 Category: Medical Devices Source Type: research

Novel Miniature Tip Design for Enhancing Dexterity in Minimally Invasive Surgery
Even though technological advances have increased the application area of minimally invasive surgery (MIS), there are still hurdles to allow for widespread adoption for more complex procedures. The development of steerable instruments, in which the surgeon can alter the tip orientation, has increased the application area of MIS, but they are bulky, which limits their ability to navigate through narrow environments, and complex, which complicates miniaturization. Furthermore, they do not allow for navigating through complex anatomies. In an effort to improve the dexterity of the MIS instruments, while minimizing the outer d...
Source: Journal of Medical Devices, Transactions of the ASME - July 24, 2018 Category: Medical Devices Source Type: research

A Specimen Extraction Instrument Based on Braided Fiber Tube for Natural Orifice Translumenal Endoscopic Surgery
Natural orifice translumenal endoscopic surgery (NOTES) has offered significant advantages of less pain, reduced recovery time, and minimized scar after operation, demonstrating a promising development prospect. However, the large-size specimen extraction remains challenging for NOTES, due to the narrow space of the human natural orifices. To address such difficulties, a specimen extraction method that utilizes the braided fiber tube (BFT) structure with excellent retractility to accommodate and bind the bulky specimen has been proposed. Based on the theory of helical spring, the geometric model and the mechanical model of...
Source: Journal of Medical Devices, Transactions of the ASME - July 24, 2018 Category: Medical Devices Source Type: research

The Role of Impulse, Tissue Stretching, and Tip Geometry for Tissue Penetration of Polymer Needles
Polymer needles for medical injections offer a range of opportunities like compatibility with magnetic resonance scanning and simultaneous delivery of more than one drug. However, the lower stiffness property of polymers compared to steel is a challenge for penetration. This paper explores strategies for higher penetration success, which include impulse insertion, tissue stretching, and different tip geometries. The strategies are experimentally examined using three layers of nitrile rubber gloves and sticking glue to create an artificial skin model. It is demonstrated that polymer needles have higher penetration rates whe...
Source: Journal of Medical Devices, Transactions of the ASME - July 24, 2018 Category: Medical Devices Source Type: research

Vibration-Assisted Slicing of Soft Tissue for Biopsy Procedures
In this study, the BP procedure is investigated in detail. First, the steady cutting motion of the BP is analyzed. Then, the superimposition of several vibrational motions onto the rotary motion of the BP is investigated. Analytical models, based on a fracture mechanics approach, are adopted to predict the cutting forces. Experimental studies are performed on phantom tissue, usually adopted in medical investigations. The results demonstrate that the application of rotary vibrational motions determines the increase of the force and penetration depth necessary to fracture soft tissue, while the implementation of axial vibrat...
Source: Journal of Medical Devices, Transactions of the ASME - July 24, 2018 Category: Medical Devices Source Type: research

Creating a Small Anchor to Eliminate Large Knots in Mesh and Tape Suture
Wide mesh or tape sutures are used to close high-tension wounds such as in hernia or tendon repair. However, wide sutures produce large knots that are susceptible to increased palpability, infection, and foreign body response. To prevent such adverse events, we developed a small suture anchor to replace wide suture knots. The suture anchor was iteratively developed using three-dimensional (3D) design software and produced via 3D printing. Anchor prototypes underwent monotonic, cyclic fatigue, and stress-life testing in a benchtop soft tissue suture model. Results were compared to a standard of care knot and alternative sut...
Source: Journal of Medical Devices, Transactions of the ASME - July 13, 2018 Category: Medical Devices Source Type: research

Children and Adults With Rare Diseases Need Innovative Medical Devices
This study is the first to comprehensively evaluate their medical device needs via a survey of physicians. The study sought to identify and document the presumed unmet diagnostic and therapeutic device needs for RD management; clarify the magnitude of the potential unmet need; and generate meaningful data to inform medical device stakeholders. A cross-sectional nonprobability survey was conducted. The study population was drawn from the membership files of four groups: FDA Medical Devices Advisory Committee, Pediatric Advisory Committee, Pediatric Device Consortia, and National Institutes of Health (NIH) Rare Diseases Clin...
Source: Journal of Medical Devices, Transactions of the ASME - July 13, 2018 Category: Medical Devices Source Type: research

Engineering Evaluation of the Performance of an Automatic Peripheral Oxygen Controller Using a Neonatal Respiratory Model
Premature infants often require respiratory support with a varying concentration of the fraction of inspired oxygen FiO2 to keep the arterial oxygen saturation typically measured using a peripheral sensor (SpO2) within the desired range to avoid both hypoxia and hyperoxia. The widespread practice for controlling the fraction of inspired oxygen is by manual adjustment. Automatic control of the oxygen to assist care providers is desired. A novel closed-loop respiratory support device with dynamic adaptability is evaluated nonclinically by using a neonatal respiratory response model. The device demonstrated the ability to imp...
Source: Journal of Medical Devices, Transactions of the ASME - July 13, 2018 Category: Medical Devices Source Type: research

Novel Design and Validation of a Micro Instrument in an Ear Grommet Insertion Device
An automated surgical device, the ventilator tube applicator (VTA), enables a grommet insertion surgery for patients with otitis media with effusion (OME) to be completed in a short time automatically and precisely, eliminating the use of general anesthesia (GA) typically required in such procedure. However, its current design limits the usefulness of the device as it is restricted by the properties of the tympanic membrane (TM), such as angle, thickness, and strength. Therefore, a novel design was conceptualized and the insertion control algorithm was improved to overcome the current challenges of the VTA. This innovative...
Source: Journal of Medical Devices, Transactions of the ASME - July 13, 2018 Category: Medical Devices Source Type: research

Custom-Fit Three-Dimensional-Printed BiPAP Mask to Improve Compliance in Patients Requiring Long-Term Noninvasive Ventilatory Support
Noninvasive ventilator support using bi-level positive airway pressure/continuous positive airway pressure (BiPAP/CPAP) is commonly utilized for chronic medical conditions like sleep apnea and neuromuscular disorders like amyotrophic lateral sclerosis (ALS) that lead to weakness of respiratory muscles. Generic masks come in standard sizes and are often perceived by patients as being uncomfortable, ill-fitting, and leaky. A significant number of patients are unable to tolerate the masks and eventually stop using their devices. The goal of this project is to develop custom-fit masks to increase comfort, decrease air leakage,...
Source: Journal of Medical Devices, Transactions of the ASME - July 13, 2018 Category: Medical Devices Source Type: research

Optimization of an Endoscopic Radiofrequency Ablation Electrode
Radiofrequency ablation (RFA) is an increasingly used, minimally invasive, cancer treatment modality for patients who are unwilling or unable to undergo a major resective surgery. There is a need for RFA electrodes that generate thermal ablation zones that closely match the geometry of typical tumors, especially for endoscopic ultrasound-guided (EUS) RFA. In this paper, the procedure for optimization of an RFA electrode is presented. First, a novel compliant electrode design is proposed. Next, a thermal ablation model is developed to predict the ablation zone produced by an RFA electrode in biological tissue. Then, a multi...
Source: Journal of Medical Devices, Transactions of the ASME - July 13, 2018 Category: Medical Devices Source Type: research

A Coronally Clutching Ankle to Improve Amputee Balance on Coronally Uneven and Unpredictable Terrain
To improve the balance of individuals with lower limb amputation on coronally uneven terrain, a coronally clutching ankle (CCA) was developed to actively adapt through ±15 deg of free coronal foot rotation during the first ∼60 ms of initial contact. Three individuals with lower limb amputations were fit with the CCA and walked across an instrumented walkway with a middle step that was either flush, 15 deg inverted, or 15 deg everted. An opaque latex mem brane was placed over the middle step, making the coronally uneven terrain unpredictable. Compared to participants' clinically prescribed prosthesis, the CCA exh...
Source: Journal of Medical Devices, Transactions of the ASME - July 13, 2018 Category: Medical Devices Source Type: research

Optimizing Design With Extensive Simulation Data: A Case Study of Designing a Vacuum-Assisted Biopsy Tool
Design by Dragging (DBD) [1] is a virtual design tool, which displays three-dimensional (3D) visualizations of many simulation results obtained by sampling a large design space and ties this visual display together with a new user interface. The design space is explored through mouse-based interactions performed directly on top of the 3D data visualizations. Our previous study [1] introduced the realization ofDBD with a simplistic example of biopsy needle design under a static bending force. This paper considers a realistic problem of designing a vacuum-assisted biopsy (VAB) needle that brings in more technical challenges ...
Source: Journal of Medical Devices, Transactions of the ASME - May 4, 2018 Category: Medical Devices Source Type: research

Endoscopic Closure of Large Defects With a Novel Clipping Device and a 4S-Modified Roeder Slipknot
Endoscopic closure is an essential procedure in gastrointestinal (GI) surgery, but currently it is difficult to close large defects endoscopically because of the lack of an appropriate device. Previously, we developed an endoscopic clipping device that has multifiring function and is equipped with an independent clamp. The goal of this study is to provide a new closure method with this device and 4S-modified Roeder (4SMR) slipknot. The feasibility of the closure method is examined by deploying two clips during one insertion onto the 4SMR slipknot to close a 5  cm full-thickness linear defect of an ex vivo porcine stomach...
Source: Journal of Medical Devices, Transactions of the ASME - April 25, 2018 Category: Medical Devices Source Type: research

Design and Evaluation of a Novel Rotatable One-Element Snake Bone for NOTES
The distal head of the natural orifice transluminal endoscopic surgery (NOTES) platform commonly uses the structure of a snake bone, which cannot rotate, and the manufacturing is often time-consuming. A novel rotatable, one-element snake bone for NOTES is proposed. This paper first describes the movement mechanism and actuation. The new structure, which is composed of hinge pairs for bending and track-sled rings for rotation, was designed to reach a 90  deg bending angle and 62 deg rotational angle. The workspace of the snake bone was derived using screw theory and was simulated onmatlab. The relationship between the a...
Source: Journal of Medical Devices, Transactions of the ASME - April 18, 2018 Category: Medical Devices Source Type: research