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.

An Approach for Generating an Average Bone Template With Semantic Parameters
To facilitate the design of the serialized implants and to satisfy the requirements of the population, a novel method is put forward for constructing an average bone model (ABM) with semantic parameters as a template. First, the ABM is created from the existing bone models, among which each bone has an equal contribution to the ABM. Second, combined with medical semantics, some characteristic points and semantic parameters are defined on the ABM, and then, parameter values for each bone can be automatically obtained through its registration and deformation to the ABM. Finally, an average bone template (ABT) is constructed ...
Source: Journal of Medical Devices, Transactions of the ASME - June 27, 2017 Category: Medical Devices Source Type: research

Influence of a Commercial Antithrombotic Filter on the Caval Blood Flow During Neutra and Valsalva Maneuver
Anticoagulants are the treatment of choice for pulmonary embolism. When these fail or are contraindicated, vena cava filters are effective devices for preventing clots from the legs from migrating to the lung. Many uncertainties exist when a filter is inserted, especially during physiological activity such as normal breathing and the Valsalva maneuver. These activities are often connected with filter migration and vena cava damage due to the various related vein geometrical configurations. In this work, we analyzed the response of the vena cava during normal breathing and Valsalva maneuver, for a healthy vena cava and afte...
Source: Journal of Medical Devices, Transactions of the ASME - June 27, 2017 Category: Medical Devices Source Type: research

Continuous, Real-Time, Noninvasive Hemodynamic Cardiac Doppler Monitoring With a Novel Hands-Free Device: A Feasibility Study Compared to Standard Echo
This study sought to determine the feasibility of using noninvasive cardiac hemodynamics (NICHE), a new noninvasive Doppler-based device, to monitor real-time, simultaneous tissue and blood-flow Doppler measurements in a clinical setting, and to obtain preliminary performance data compared to a commercially available system. Doppler-based measurements have been shown to correlate well with invasive hemodynamic data and diastolic function, but their use in clinical applications has been limited by various technical issues. The NICHE device was developed to obtain simultaneous tissue and blood-flow Doppler measurements autom...
Source: Journal of Medical Devices, Transactions of the ASME - June 27, 2017 Category: Medical Devices Source Type: research

The Role of Computational Modeling and Simulation in the Total Product Life Cycle of Peripheral Vascular Devices
The total product life cycle (TPLC) of medical devices has been defined by four stages: discovery and ideation, regulatory decision, product launch, and postmarket monitoring. Manufacturers of medical devices intended for use in the peripheral vasculature, such as stents, inferior vena cava (IVC) filters, and stent-grafts, mainly use computational modeling and simulation (CM&S) to aid device development and design optimization, supplement bench testing for regulatory decisions, and assess postmarket changes or failures. For example, computational solid mechanics and fluid dynamics enable the investigation of design limitat...
Source: Journal of Medical Devices, Transactions of the ASME - May 3, 2017 Category: Medical Equipment Source Type: research

Automated Real-Time Processing of Single Lead Electrocardiogram for Simultaneous Heart Rate and Respiratory Rate Monitoring
In this article, the design and development of a real-time heart rate (HR) and respiratory rate (RR) monitoring device is reported. The proposed device is designed to impose minimum data acquisition hazards on the subject. In standard bedside monitors, HR and RR are derived from electrocardiogram (ECG) and respiration signals, respectively, and different electrodes are required for capturing the 12-lead ECG and respiration via a chest belt, which is cumbersome for patients and healthcare providers. Respiration signal has an impact on ECG due to anatomical proximity of the heart and lung, and ECG is modulated by respiration...
Source: Journal of Medical Devices, Transactions of the ASME - May 3, 2017 Category: Medical Equipment Source Type: research

Data Communication Pathway for Sensing Guidewire at Proximal Side: A Review
As the connection at the proximal tip plays an important role for sensing guidewires, we compared various sensing guidewires with regard to their proximal connectors. The strengths and weaknesses of each are discussed and recommendations for future development are provided. A literature search limited to the English language for the time period from the 1960s to the 2010s has been performed on the USPTO database, Espacenet, and Web of Science. The results have been categorized on the basis of the connector design. A comprehensive overview and classification of proximal connectors for sensing guidewires used for cardiovascu...
Source: Journal of Medical Devices, Transactions of the ASME - May 3, 2017 Category: Medical Equipment Source Type: research

Computational Modeling of the Mechanical Performance of a Magnesium Stent Undergoing Uniform and Pitting Corrosion in a Remodeling Artery
Coronary stents made from degradable biomaterials such as magnesium alloy are an emerging technology in the treatment of coronary artery disease. Biodegradable stents provide mechanical support to the artery during the initial scaffolding period after which the artery will have remodeled. The subsequent resorption of the stent biomaterial by the body has potential to reduce the risk associated with long-term placement of these devices, such as in-stent restenosis, late stent thrombosis, and fatigue fracture. Computational modeling such as finite-element analysis has proven to be an extremely useful tool in the continued de...
Source: Journal of Medical Devices, Transactions of the ASME - May 3, 2017 Category: Medical Equipment Source Type: research

Increased Energy Loss Due to Twist and Offset Buckling of the Total Cavopulmonary Connection
In this study, the hemodynamics of severely deformed surgical pathways due to torsional deformation and anastomosis offset are investigated. We designed a mock-up total cavopulmonary connection (TCPC) circuit to replicate the mechanically failed inferior vena cava (IVC) anastomosis morphologies under physiological venous pressure (9, 12, 15  mmHg), in vitro, employing the commonly used conduit materials: Polytetrafluoroethylene (PTFE), Dacron, and porcine pericardium. The sensitivity of hemodynamic performance to torsional deformation for three different twist angles (0 deg, 30 deg, and 60 deg) and three different ...
Source: Journal of Medical Devices, Transactions of the ASME - May 3, 2017 Category: Medical Equipment Source Type: research

Statistical Shape Modeling for Cavopulmonary Assist Device Development: Variability of Vascular Graft Geometry and Implications for Hemodynamics
In this study, we focus on the ex tra cardiac conduit (ECC) vascular graft connecting IVC and pulmonary arteries (PAs) as one possible landing zone for a CPAD and describe its geometric variability in a cohort of 18 patients that had their TCPC realized with a 20 mm vascular graft. We report traditional morphometric parameters and apply statistical shape modeling (SSM) to determine the main contributors of graft shape variability. Such information may prove useful when designing CPADs that are adapted to the challenging anatomical boundaries in Fontan patients. We further compute the anatomical mean 3D graft shape (templ...
Source: Journal of Medical Devices, Transactions of the ASME - May 3, 2017 Category: Medical Equipment Source Type: research

Finite Element Analysis of the Implantation Process of Overlapping Stents
Overlapping stents are widely used in vascular stent surgeries. However, the rate of stent fractures (SF) and in-stent restenosis (ISR) after using overlapping stents is higher than that of single stent implantations. Published studies investigating the nature of overlapping stents rely primarily on medical images, which can only reveal the effect of the surgery without providing insights into how stent overlap influences the implantation process. In this paper, a finite element analysis of the overlapping stent implantation process was performed to study the interaction between overlapping stents. Four different cases, ba...
Source: Journal of Medical Devices, Transactions of the ASME - May 3, 2017 Category: Medical Equipment Source Type: research

Simplified Multistage Computational Approach to Assess the Fatigue Behavior of a Niti Transcatheter Aortic Valve During In Vitro Tests: A Proof-of-Concept Study
In conclusion, the presented methodology provides a tool to support the choice of proper testing conditions for the in vitro assessment of TAV fatigue behavior. (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

Thrombogenicity Testing of Medical Devices in a Minimally Heparinized Ovine Blood Loop
This study describes an in vitro assay that integrates freshly harvested ovine blood containing minimal heparin in a closed pumped loop. To confirm the reproducibility of this assay, control materials were identified that elicited either a positive or a negative thrombogenic response. These controls demonstrated reproducibility in the resulting thrombogenicity scores with median scores of 5 and 0 for the positive and negative controls, respectively, which also demonstrated a significant difference (p   (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

Modeling of Biodegradable Polyesters With Applications to Coronary Stents
The interest in biodegradable polymers for clinical and biomedical engineering applications has seen a dramatic increase in the last 10 years. Recent innovations include bioresorbable polymeric stents (BPS), which are temporary vascular scaffolds designed to restore patency and provide short-term support to a blocked blood vessel, before becoming naturally resorbed over time. BPS offer possibilities to overcome the long-term complications often observed with the permanent metallic stents, well established in the treatment of coronary and peripheral artery disease. From the perspective of designing next generation BPS, the ...
Source: Journal of Medical Devices, Transactions of the ASME - May 3, 2017 Category: Medical Equipment Source Type: research

Computational Modeling and Comparative Tissue Damage Analysis of Angioplasty and Orbital Atherectomy Interventional Procedures
This research was directed toward quantitatively characterizing the effects of arterial mechanical treatment procedures on the stress and strain energy states of the artery wall. Finite element simulations of percutaneous transluminal angioplasty (PTA) and orbital atherectomy (OA) were performed on arterial lesion models with various extents and types of plaque. Stress fields in the artery were calculated and strain energy density was used as an explicit description of potential damage to the artery. The research also included numerical simulations of changes in arterial compliance due to orbital atherectomy. The angioplas...
Source: Journal of Medical Devices, Transactions of the ASME - May 3, 2017 Category: Medical Equipment Source Type: research

Machinability and Optimization of Shrouded Centrifugal Impellers for Implantable Blood Pumps
This paper describes the use of analytical methods to determine machinable centrifugal impeller geometries and the use of computational fluid dynamics (CFD) for predicting the impeller performance. An analytical scheme is described to determine the machinable geometries for a shrouded centrifugal impeller with blades composed of equiangular spirals. The scheme is used to determine the maximum machinable blade angles for impellers with three to nine blades in a case study. Computational fluid dynamics is then used to analyze all the machinable geometries and determine the optimal blade number and angle based on measures of ...
Source: Journal of Medical Devices, Transactions of the ASME - May 3, 2017 Category: Medical Equipment Source Type: research