Design of a Magnetic Resonance Imaging Guided Magnetically Actuated Steerable Catheter
This paper presents design optimization of a magnetic resonance imaging (MRI) actuated steerable catheter for atrial fibrillation ablation in the left atrium. The catheter prototype, built over polymer tubing, is embedded with current-carrying electromagnetic coils. The prototype can be deflected to a desired location by controlling the currents passing through the coils. The design objective is to develop a prototype that can successfully accomplish the ablation task. To complete the tasks, the catheter needs to be capable of reaching a set of desired targets selected by a physician on the chamber and keeping a stable con...
Source: Journal of Medical Devices, Transactions of the ASME - May 3, 2017 Category: Medical Equipment Source Type: research

Hemodynamic Profile of Two Aortic Endografts Accounting for Their Postimplantation Position
Endovascular aneurysm repair (EVAR) is a clinically effective technique for treating anatomically eligible abdominal aortic aneurysms (AAAs), involving the deployment of an endograft (EG) that is designed to prevent blood leakage in the aneurysmal sac. While most EGs have equivalent operating principles, the hemodynamic environment established by different EGs is not necessarily the same. So, to unveil the post-EVAR hemodynamic properties, we need an EG-specific computational approach that currently lacks from the literature. Endurant and Excluder are two EGs with similar pre-installation designs. We assumed that the flow ...
Source: Journal of Medical Devices, Transactions of the ASME - May 3, 2017 Category: Medical Equipment Source Type: research

Finite Element Stent Modeling for the Postoperative Analysis of Transcatheter Aortic Valve Implantation
This study evaluates element size selection and quantitatively investigates the choice of a linear elastic constitutive model for the Nitinol stent under physiological loading conditions. It is shown that this simplification leads to reliable results and enables a huge reduction in computation time. Further, the procedure used to compensate for noisy postoperative CT data is tested by adding artificial noise. It is concluded that for physiologically relevant loading ranges, the procedure yields convergent results and successfully eliminates the influence of the noise. (Source: Journal of Medical Devices, Transactions of the ASME)
Source: Journal of Medical Devices, Transactions of the ASME - May 3, 2017 Category: Medical Equipment Source Type: research

The Role of Simulation in the Design of a Semi-Enclosed Tubular Embolus Retrieval
A numerical analysis of a semi-enclosed tubular mechanical embolus retrieval device (MERD) for the treatment of acute ischemic stroke (AIS) is presented. In this research, the finite element analysis (FEA) methodology is used to evaluate mechanical performance and provide suggestions for optimizing the geometric design. A MERD fabricated from nickel –titanium alloy (Nitinol) tubing is simulated and analyzed under complex in vivo loading conditions involving shape-setting, crimping, deployment, and embolus retrieval. As a result, the peak strain of the shape-setting procedure is proved to be safe for the device pattern. H...
Source: Journal of Medical Devices, Transactions of the ASME - May 3, 2017 Category: Medical Equipment Source Type: research

Special Issue: Cardiovascular Device Development and Safety Assessment Using Computational Modeling and Experimental Approaches
Cardiovascular devices interact with a complex physiologic environment that can severely challenge device performance and longevity. These challenges include biocompatibility issues such as hemolysis and thrombosis, changing contact conditions during each heartbeat, high-cycle fatigue-to-fracture, the need to accommodate the highly variable geometric, material, and hemodynamic environment encountered in the target population, and many other design and performance concerns. Simultaneously, cardiovascular devices are expected to deliver improved therapeutic benefits with each new product release. Thus, the cardiovascular dev...
Source: Journal of Medical Devices, Transactions of the ASME - May 3, 2017 Category: Medical Equipment Source Type: research

Innovative Design of an Automatic Acupoint Catgut-Embedding Instrument
Acupoint catgut-embedding (ACE) therapy is a type of acupuncture surgery that combines concepts of traditional Chinese medicine with modern medical instruments. The therapy involves using a hypodermic needle and an acupuncture needle to embed 1-cm long catgut segments in an acupoint, enabling the catgut to perform long-term stimulation of the acupoint and achieve the effects of acupuncture treatment. Each therapy process requires numerous repetitions of the same steps, and each needle set can only be used to embed one catgut segment. Additionally, doctors must perform this surgical procedure by hand; no automatic auxiliary...
Source: Journal of Medical Devices, Transactions of the ASME - January 25, 2017 Category: Medical Equipment Source Type: research

Development of Aspiration-Assisted End-Cut Coaxial Biopsy Needles
Needle biopsy procedures, such as fine-needle aspiration and core needle biopsy, are used to extract tissue samples for diagnosis, and collection of larger samples allows for more accurate diagnosis of cancers. The combination of lower needle insertion force, less needle deflection, and reduced friction between the tissue and needle surface also leads to a more efficient biopsy procedure. In this research, a new end-cut-type coaxial needle with a modified aspiration mechanism has been developed to extract large tissue with minimal damage. The study shows that the clearance between the inner stylette and external needle and...
Source: Journal of Medical Devices, Transactions of the ASME - January 25, 2017 Category: Medical Equipment Source Type: research

A New Concept of Needle-Free Jet Injector by the Impact Driven Method
In this study, from the prototype of the IDM jet injector, a maximum jet veloci ty of 400 m/s and impact peak pressure of 68 MPa can be obtained. It is clear that the IDM jet injector provides a double pulsed liquid jet, which is a major advantage over the commercial jet injector. Because, the first pulse gives a shorter erosion stage, and then, immediately the second pulse follows and provides a better penetration, wider lateral dispersion, and considerably less back splash. Hence, lower pain level and higher delivery efficiency should be achieved. It can be concluded that the IDM concept is highly feasible for implem...
Source: Journal of Medical Devices, Transactions of the ASME - January 25, 2017 Category: Medical Equipment Source Type: research

pneu RIP TM : A Novel Respiratory Inductance Plethysmography Monitor
Objective pulmonary function (PF) evaluation is essential for the diagnosis, monitoring, and management of many pediatric respiratory diseases as seen in the emergency room, intensive care, and outpatient settings. In this paper, the development and testing of a new noninvasive PF instrument, pneuRIPTM, which utilizes respiratory inductance plethysmography (RIP) are discussed. The pneuRIPTM hardware includes a small circuit board that connects to the RIP bands and measures and wirelessly transmits the band inductance data to any designated wirelessly connected tablet. The software provides indices of respiratory work prese...
Source: Journal of Medical Devices, Transactions of the ASME - January 24, 2017 Category: Medical Equipment Source Type: research

Novel Solutions Applied in Transseptal Puncture: A Systematic Review
Access to the left atrium is required for several minimally invasive cardiac interventions in the left heart. For this purpose, transseptal puncture (TSP) technique is often performed, perforating the atrial septum under fluoroscopic or/and ultrasound imaging guidance. Although this approach has been used for many years, complications/failures are not uncommon mainly in patients with abnormal atrial anatomy and repeated TSP. Thus, this study presents an overview of methods and techniques that have been proposed to increase the safety and feasibility of the TSP. A systematic review of literature was conducted through the an...
Source: Journal of Medical Devices, Transactions of the ASME - January 24, 2017 Category: Medical Equipment Source Type: research

Particulate Release From Nanoparticle-Loaded Shape Memory Polymer Foams
This study demonstrates that particulate numbers and sizes in SMP foams are in compliance with limits stated by the most relevant standard and guidance documents. Particulates were quantified in SMP foams as made, postreticulation, and after incorporating nanoparticles intended to increase material toughness and improve radiopacity. When concentrated particulate treatments were administered to fibroblasts, they exhibited high cell viability (100%). These results demonstrate that the SMP foams do not induce an unacceptable level of risk to potential vascular occlusion devices due to particulate generation. (Source: Journal ...
Source: Journal of Medical Devices, Transactions of the ASME - January 16, 2017 Category: Medical Equipment Source Type: research

Hydraulic Robotic Surgical Tool Changing Manipulator
Natural orifice transluminal endoscopic surgery (NOTES) is a surgical technique to perform “scarless” abdominal operations. Robotic technology has been exploited to improve NOTES and circumvent its limitations. Lack of a multitasking platform is a major limitation. Manual tool exchange can be time consuming and may lead to complications such as bleeding. Previous multifunctional manip ulator designs use electric motors. These designs are bulky, slow, and expensive. This paper presents design, prototyping, and testing of a hydraulic robotic tool changing manipulator. The manipulator is small, fast, low-cost, and capable...
Source: Journal of Medical Devices, Transactions of the ASME - January 16, 2017 Category: Medical Equipment Source Type: research

Toward Medical Devices With Integrated Mechanisms, Sensors, and Actuators Via Printed-Circuit MEMS
Recent advances in medical robotics have initiated a transition from rigid serial manipulators to flexible or continuum robots capable of navigating to confined anatomy within the body. A desire for further procedure minimization is a key accelerator for the development of these flexible systems where the end goal is to provide access to the previously inaccessible anatomical workspaces and enable new minimally invasive surgical (MIS) procedures. While sophisticated navigation and control capabilities have been demonstrated for such systems, existing manufacturing approaches have limited the capabilities of millimeter-scal...
Source: Journal of Medical Devices, Transactions of the ASME - January 11, 2017 Category: Medical Equipment Source Type: research

Novel Device For Removal of Blot Clot Obstructions in Drainage Tubes
Medical drains frequently become obstructed requiring removal or re-intervention. Currently, there is no widely accepted practice for maintaining drain patency. A simple device to remove obstructions from medical drains may have significant benefit. We manufactured a prototype drain clot extractor (DCE) for extracting obstructions. Fresh nonanticoagulated swine blood was instilled within drainage tubes of 16, 20, and 32 French (n  = 2 for each size) to generate a 4 cm blood clot. The operator was then equipped with a 0.035 in. guidewire (GW) and given 2.5 min to attempt removal while blinded. Similarly, the operato...
Source: Journal of Medical Devices, Transactions of the ASME - December 21, 2016 Category: Medical Equipment Source Type: research

Design, Analysis, and Optimization of an Acute Stroke Gait Rehabilitation Device
Stroke is one of the leading causes of adult physical disability, and rehabilitation and hospitalization costs for stroke are among the highest for all injuries. Current rehabilitation techniques are labor intensive and time consuming for therapists and difficult to perform effectively. Research suggests that starting rehabilitation during the acute or subacute stage of recovery results in better outcomes than therapy delivered in the chronic stage. To improve the gait rehabilitation process, robot-assisted gait rehabilitation has gained much interest over the past years. However, many robot-assisted rehabilitation devices...
Source: Journal of Medical Devices, Transactions of the ASME - December 21, 2016 Category: Medical Equipment Source Type: research