bluuebunny/crossref_metadata_2025_split huggingface dataset:
Human Factors Applications to Mitigate Design Limitations of a Wearable Telemedicine Heart Rate Monitor
Authors: Lowndes Bethany , Finnie Dawn , Hathaway Julie , Ridgeway Jennifer , Vickers-Douglas Kristin , Bruce Charles , Hallbeck Susan 
Published: October 2017

The time required to get a device to market is critical to a successful design, development, and manufacturing process [1]. Achieving status of the first device to market is often a priority for manufacturers and developers. Upon market introduction, it is well known that device performance must meet at least minimum standards in order to provide consumer satisfaction and be a successful product to prevent competitive devices from taking over the market [1]. However, if a design only meets minimum expectations, it may struggle to maintain market control. This demonstrates the tradeoffs of speed-to-market and performance, for which optimization has not been clearly defined [2]. Product performance and usability can be designed in, evaluated and enhanced in order to avoid user errors and achieve optimal profitability.
For medical devices, clinical trials are a key step in preparing to take a device to market. Clinical trials can allow for analyses of the effectiveness of the device in the patient care process. For wearable medical devices, patient usability is crucial to patient adherence and safety since the device will be operated by non-medically trained individuals [3,4]. Without adequate usability, adherence and continuity of care are greatly reduced which will reduce the overall effectiveness of the device [5,6]. Human factors principles can best be incorporated in the design process to improve the usability of medical devices and patient safety [5,6,7], specifically for those used in telemedicine [4] and cardiovascular treatment [3]. The objective of this project was to evaluate a telemedicine heart rate monitoring device for patient usability in order to improve the next device’s performance and lead to greater patient adherence for the current version via an improved user manual.
The Effect of a Lower-Limb Sensory Prosthesis on Balance and Gait in People With Peripheral Neuropathy
Authors: Koehler-McNicholas Sara R. , Danzl Lori , Oddsson Lars 
Published: October 2017

Peripheral neuropathy (PN), commonly caused by diabetes mellitus, is a debilitating condition that currently affects approximately 20 million Americans. Chronic symptoms of PN often involve pain and weakness of the lower limbs, with eventual sensation loss on the plantar surfaces of the feet. According to epidemiological studies, reduced foot sole sensation has been linked to decreased standing stability [1] and an increased risk of falling [2]. Consequently, cost-effective interventions are needed to improve balance and mobility in this population.
A growing body of research suggests that vibrotactile cues delivered to sensate areas of the lower limb may be an effective way to provide information about foot sole pressure to PN patients who experience poor balance control. Indeed, sensory substitution devices that provide vibrotactile feedback have been shown to aid in balance and improve postural control in various patient populations [3–7]. However, none of these technologies have been based on measurements of foot pressure nor have they been used as a balance prosthesis.
The goal of this study was to investigate the effect of a new external lower-limb sensory prosthesis, the Walkasins™, on the balance and gait of individuals with PN who experience balance problems [8]. Walkasins™ consist of two parts: a leg unit and a foot pad (Figure 1). The leg unit wraps around the lower leg of the user and contains electronics for reading foot pad pressure signals, a microprocessor, and four vibrating motors that provide gentle tactile sensory cues to the front, back, medial, and lateral surfaces of the user’s leg. These cues reflect real-time foot pressure information at a location above the ankle where skin sensation is still present. The leg unit has a power button, two status LEDs, and a reset button (not shown in Figure 1). Power is supplied by a rechargeable internal battery. The foot pad is a thin consumable sole insert that can be cut to size and fit into a regular shoe. The foot pad connects to the leg unit through a physical cable. In this study, subjects performed gait and balance assessments with and without the Walkasins™ turned on in order to determine its short-term effects.
Review of Cardiac Pacemaker Lead Designs for Computational Models in a VR Environment
Authors: Tourek Bethany , Orban Dan , Meng Lingyu , Runesha Hakizumwami Birali , Keefe Dan , Erdman Arthur 
Published: October 2017

An implantable cardiac pacemaker is used to modify and treat irregular heartbeats [1] and invented in 1958 [2]. Devices have no fixation or fixed to the heart wall. No fixation leads lay in the bottom of heart cavities, while fixed leads have tines (passive) or a helix screw (active) to attach to the heart. Lead geometries and material properties vary between companies, with geometric sizing based primarily on the internal mechanics of the lead.
Finite element analysis (FEA), computational fluid dynamics (CFD) and bench-top simulations are used to evaluate cardiac leads. These simulations analyze only one lead and struggle to compare and test variations in lead designs. Advanced computational resources can run many computer simulations of anatomical environments, however model complexity increases the time to run each simulation.
To address this issue, we present a simplified parameterized design space for cardiac pacemaker leads in the right atrium. This information will be used to run multiple simulations of leads in blood flow, for visualization in a single virtual reality (VR) environment and allow the designer to iterate through many design variations (See Figure 1).
An Open Source Biometric Patient Identification System for Low Resource Setting
Authors: Noko Ofentse , Lashansky Ariel , Beukes Giancarlo , Sivarasu Sudesh 
Published: October 2017

It is estimated that as many as 1.5 billion people globally do not possess any form of identification [1]. Most of these people currently live in Africa and Asia. The lack of identification prevents them from accessing the basic rights and services afforded to them. In healthcare, proof of identity is required to access basic health services, and accurately monitor one’s diagnosis and treatment. This enables health care facilities to provide quality services. Without any identification, governments and development organisations cannot cater to the basic needs of these individuals. This is a key factor in the increased adoption of digital information systems in healthcare. These systems assist with validating patients’ identities. Additionally, these systems store information about patients’ medical history to allow for more effective treatment practices [2]. Digital information systems have proven to be more reliable than paper-based systems currently used in many health facilities in developing countries.
Health service providers are now seeking ways to integrate these systems into their daily operations. Electronic health record systems could potentially solve many problems these facilities face. This includes issues related to data management and patient identification. These systems, when paired with biometric technologies, can remove the need for patients to carry physical identification to gain access to medical services. This would be a great benefit to rural communities. It could also assist with reducing the prevalence of fraud in these communities. Cases where individuals make use of stolen identification cards and multiple identities to access health benefits are known to occur in these areas.
Existing biometric identification solutions are not designed specifically for the rural environment. Therefore, an open source biometric patient identification system was developed. The system was developed specifically for a hospital located in a rural setting. The aim was to leverage off existing technologies, and adapt it accordingly to suit the conditions faced by health service providers in these areas.
The Design and Development of Active Compression Garments for Orthostatic Intolerance
Authors: Duvall Julia , Granberry Rachael , Dunne Lucy E. , Holschuh Brad , Johnson Christopher , Kelly Kevin , Johnson Bruce , Joyner Michael 
Published: October 2017

Current compression garments are often made from a spandex-type elastic material with static levels of compression and can become uncomfortable and difficult to don/doff [1]. This limits their usability, especially for unhealthy or aging populations. The only current alternative to elastic compression stockings are inflatable compression sleeves that are controllable, but highly immobile and must be tethered to an inflation source [2]. Neither design offers a solution that is simultaneously low profile, mobile, and controllable. Here we present the design and development of compression garments with embedded shape-changing materials that can produce controllable compression without the need for a bulky inflation system. This active materials approach enables dynamic control over the degree, timing and location of compression, and allows for graded, synchronized, pulsed, and peristaltic compression patterns, which provide the medical benefit of moving fluid in the body [2]. Such a design combines the best features of both elastic and inflatable compression garments: a slim, low-profile form factor that is easy to don/doff and provides dynamic control.
Shape memory alloy (SMA) coil actuators, as described by Holschuh et al., [3] have the ability to apply compressive forces to the body when paired with passive textiles and wrapped circumferentially around the body. These actuators are engineered to contract when heated, creating controllable forces and displacements that are modulated through an applied current. SMA compression garments (SMA-CG) have important applications, from consumer uses to clinical interventions, including: augmenting venous return for conditions of orthostatic intolerance (e.g., postural orthostatic tachycardia syndrome (POTS)); cardiac rehabilitation in heart failure patients; lymphedema venous insufficiency; reducing deep vein thrombosis (DVT) risk; sports performance; and countermeasures for flight or space flight.
While the potential uses for this technology are broad, the basic design is similar across many conditions. Key research areas include: 1) identifying and addressing design considerations relevant to prototype development of SMA-CG; 2) determining the compression thresholds needed to dynamically oppose orthostatic changes; and 3) evaluating the effectiveness of the prototypes for augmented venous return by synchronizing compression during cardiac diastole. Here, we focus on the first question: design of SMA-CG prototypes.
3D Printing in Medicine: Challenges Beyond Technology
Authors: McDaniel Lauralyn 
Published: October 2017

Dramatic news headlines imply that the use of additive manufacturing/3D printing in medicine is a brand new way to save and improve lives. The truth is, it’s not so new. Twenty years ago anatomical models were beginning to be used for planning complicated surgeries. In 2000, hearing aid cases were being 3D-printed and within a few years became industry standard. Medical applications have been a leader in taking 3D printing technology far beyond a product development tool. The combination of using medical imaging data to create patient-matched devices and the ability to manufacture structures difficult to produce with traditional technologies is compelling to an industry always looking for ways to innovate.
Surgical uses of 3D printing-centric therapies have a long history beginning with anatomical modeling for bony reconstructive surgery planning[8]. By practicing on a tactile model before surgery surgeons were more prepared and patients received better care. Patient matched implants were a natural extension of this work, leading to truly personalized implants that fit one unique individual[10]. Virtual planning of surgery and guidance using 3D printed, personalized instruments have been applied to many areas of surgery including total joint replacement and craniomaxillofacial reconstruction with great success[9,11]. Further study of the use of models for planning heart and solid organ surgery has lead to increased use in these areas[14]. Finally, hospital-based 3D printing is now of great interest and many institutions are pursuing adding this specialty within individual radiology departments[12,13].
Despite these successful areas of application, widespread use has been fairly slow. Working toward increasing the use of 3D printing in medicine, industry professionals, clinicians, technology developers, and researchers[1] are working together to first identify the challenges and then develop tools and resources to address these challenges.
Medtronic Reveal LINQ™ Devices Provide Better Understanding of Hibernation Physiology in the American Black Bear (Ursus Americanus)
Authors: Iles Tinen L. , Laske Timothy G. , Garshelis David L. , Mattison Lars , Lee Brian , Eisele Val , Gaasedelen Erik , Iaizzo Paul A. 
Published: October 2017

The American black bear (Ursus americanus) has been called a metabolic marvel6. In northern Minnesota, where we have conducted long-term physiological and ecological studies of this species, bears may remain in their winter dens for 6 months or more without eating, drinking, urinating or defecating and yet lose very little muscle mass2. We also found that hibernating black bears elicit asystolic events of over 30 seconds and experience an exaggerated respiratory sinus arrhythmia2. In this previous work we employed Medtronic Reveal® XT devices that required us to visit the den and temporarily extract the bear (under anesthesia) to download the stored data.4 Here we describe Medtronic’s latest generation of Insertable Cardiac Monitor (ICM), the Reveal LINQ™, which enables continuous transmission of data via a relay station from the den site3. Black bear hibernation physiology remains of high interest because of the multiple potential applications to human medicine.
ICMs have been used for nearly two decades by clinicians as a critical diagnostic tool to assess the nature of cardiac arrhythmias in humans. Such devices are primarily implanted subcutaneously to record electrocardiograms. The device size, battery life and transmission capabilities have evolved in recent years. The first devices were relatively large and a programmer was needed to retrieve information during each clinical (or in our case, den visit). These devices were programmed to capture cardiac incidents such as asystolic events, arrhythmias and tachycardias and apply algorithms that ensure proper data collection: e.g. ectopy rejection and p-wave presence algorithms.
The new generation Reveal LINQ was made to telemetrically transmit heart data from human patients, but we needed to develop a system to enable transmission from bear dens, which are remote (cannot easily be checked and adjusted) and are subject to extreme winter weather conditions. Besides the advantage of these devices transmitting data automatically, they are considerably smaller and thus less prone to rejection by the extraordinary immune system of the hibernating bear1.
Toward a Low-Cost Modular Powered Transtibial Prosthesis: Initial Prototype Design and Testing
Authors: Wu Molei , Thapa Saroj , Haque Md Rejwanul , Shen Xiangrong 
Published: October 2017

In human walking, the ankle plays an important role of supplying power needed for the forward motion [1]. However, traditional transtibial (TT, a.k.a. below-knee, BK) prostheses are passive, lacking the ability of generating power output in the prosthetic ankle. Consequently, amputees fitted with such prostheses suffer from multiple issues (asymmetric gait, greater metabolic energy expenditure, etc.).
To address such issues, researchers have explored various technical approaches to develop powered TT prostheses. Hydraulics and pneumatics have been attempted, leveraging the high power density with these actuators (e.g. [2]). Electromagnetic actuators were used more extensively with its technological maturity and convenience in packaging. Typical examples include the multiple prototypes developed by the MIT Biomechatronics Group (e.g., [3]), the SPARKy project, and the Vanderbilt Transtibial Prosthesis.
The TT prostheses mentioned above all include powered ankle joints to provide power for the users’ locomotion. However, cost and complexity are often given lower priority than performance in the development of such devices. Powered TT prosthesis is a typical low-volume product from a commercial perspective, and the resulting high cost is a major hurdle for the large-scale adoption among amputee users. General robotic components (motors, gearsets, etc.), in contrary, are produced in large quantities with relatively low prices. Such contrast is the major inspiration for this work: the goal is to develop a modular powered TT prosthesis based on low-cost commercial robotic components while minimizing the complexity in manufacturing and assembly.
Sit-to-Stand Control of Powered Knee Prostheses
Authors: Wu Molei , Haque Md Rejwanul , Shen Xiangrong 
Published: October 2017

Standing from a seated position is a common, yet dynamically challenging task. Due to the vertical ascent of the body center of gravity, sit-to-stand (STS) transition requires high torque output from the knee. As a result, STS transition poses a major barrier to the mobility of individuals with lower-limb issues, including the transfemoral (TF, also known as above-knee) amputees. A study showed that unilateral TF amputees suffer from high asymmetry in ground reaction forces (53∼69%) and knee moments (110∼124%), while the asymmetry for healthy controls is less than 7% [1]. Note that, although a powered TF prosthesis (Power Knee™) was used in this study, it generated resistance in the STS and thus produced similar results as the passive devices. The inability of existing prostheses in generating knee torque and regulating the torque delivery in the STS seriously affects the mobility of TF amputees in their daily life.
Motivated by this issue, researchers have developed numerous powered TF prostheses (e.g., Vanderbilt powered TF prostheses [2]). These devices are able to generate torque and power for challenging tasks such as STS transition. Making full use of such capability, however, requires an effective controller. Currently, walking control for powered prostheses has been well established, but STS control is much less investigated. Varol et al. developed a multi-mode TF prosthesis controller, in which STS is treated as a transitional motion between sitting and standing states [2]. However, no details were provided on the rationale of the STS controller structure or the determination of the control parameters.
In this paper, a new prosthesis control approach is presented, which regulates the power and torque delivery in the STS process. Inspired by the biomechanical behavior of the knee in the STS motion, the new controller provides two desired functions (gradual loading of the knee at the beginning, and automatic adjustment of the knee torque according to motion progress) with a single equation. Combined with a simple yet reliable triggering condition, the proposed control approach is able to provide natural STS motion for the powered knee prosthesis users.
Low Friction, Long-Stroke Rolling Diaphragm Cylinder for Passive Hydraulic Rehabilitation Robots
Authors: Hashemi Saeed , Durfee William K. 
Published: October 2017

Hydraulic actuators are commonly used in mechanical systems, and actuator efficiency is one of the most important factors in these systems [1]. The energy loss to overcome friction force makes the actuator less efficient. Wearable rehabilitation robotics is one of the applications of hydraulic actuators. Hydraulic cylinders deliver the power extracted from the external resources and/or less stroke-affected limbs to the more stroke-affected limbs (Fig. 1).
O-ring seal, rolling diaphragm, and gap seal cylinders are three common technologies that have been used in different hydraulic systems for years. O-ring seal actuators use an O-ring seal between the piston and cylinder. Rolling diaphragm actuators have a diaphragm between the cylinder and piston which rolls back and forth. In gap seal cylinders, there is a gap between the piston and cylinder. Since it is a tradeoff between leakage and friction, leakage between the two chambers in these cylinders is tolerated to reduce friction (Fig. 2). One study examined low friction cylinders in a low pressure hydraulic transmission [2]. In this study, rolling diaphragm cylinders were used in the transmission, but the restriction on stroke length of these cylinders is a problem that needs to be solved. Commercial rolling diaphragms are manufactured using compression molding of a sheet rubber and woven fabric [2], a manufacturing method that limits the stroke length to no more than the bore of the cylinder. Rolling diaphragm cylinders with the higher stroke-to-bore ratios could multiply the work per cycle of the system [2]. Furthermore, there are limitations of using short stroke length rolling diaphragm cylinders [3] [4].
A more thorough friction evaluation of various cylinder technologies is needed to determine which technology has the lowest friction and is most appropriate for low pressure hydraulic systems like rehabilitation robots. Developing a low friction, leakage-free cylinder without stroke limitations is needed for small hydraulics.
Using an experimental test, we measured the resistance forces in three types of cylinders: O-ring, gap seal, and rolling diaphragm. The cylinders were tested at low-pressure and with mineral oil to determine the lowest friction cylinder technology. The same friction test was performed in a novel, long-stroke, rolling diaphragm cylinder (LSRD) to compare it in two different thicknesses with commercial actuators.