2020 Design of Medical Devices Conference
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Published By American Society Of Mechanical Engineers

9780791883549

Author(s):  
Jeong Hun Kim ◽  
Nicholas Theodore ◽  
Rajiv Iyer ◽  
Amir Manbachi ◽  
Richard Um

Abstract Wasted time in the operating room results in higher operating costs and greater post-operative complications. One effective way to reduce operation time is automating basic processes that occur during surgery. Given the rise of smart-home devices, implementation of virtual assistants became a feasible solution in many medical settings. With a consumer smart-home device and off-the-shelf components, we engineered a voice-controlled smart surgical bed that adjusts the bed configuration via a voice input. The resulting device is expected to optimize human resources and reduce surgical site infection by eliminating the need of a traditional touch control mechanism. Future work is needed to develop its proprietary hardware and software, and continuous collaboration with medical personnel to bring this device into market.


Author(s):  
Arash Mahnan ◽  
Jessica Holst-Wolf ◽  
Jürgen Konczak

Abstract Proprioceptive afferents from the ankle joint are essential feedback for maintaining balance. However, there is no widely accepted test or measurement system available for determining the proprioceptive accuracy of the human ankle joint. Here, we present a system with a novel hardware design that applies an established psychometric testing protocol that generates a Just-Noticeable-Difference (JND) threshold as a measure of ankle proprioceptive acuity at the end of testing. To establish the system validity, twelve healthy adult participants completed the assessment. Testing required 25 trials and took approximately 10 minutes to complete. We show exemplar data of the ankle JND threshold and the summary results for all twelve participants. This assessment has the potential to become a tool for clinicians to identify proprioceptive impairment at the ankle and to assess the efficacy of sensorimotor interventions for improving balance in clinical populations.


Author(s):  
Roopam Dey ◽  
Giancarlo Beukes ◽  
Gokul Nair ◽  
Sudesh Sivarasu

Abstract Radiopaque scales have numerous uses in the field of surgery, especially orthopaedic surgery. Scales of this nature can be used to guide surgeons by taking intra-operative measurements, pinpoint insertion points on bones and detect locations of deformations and tumours inside the body. Despite this, these scales are not used widely enough because of its high cost and that there are no widely acceptable ways of developing them from off the shelf materials. This paper details the method of inventing a novel low-cost radiopaque scale using off the shelf materials such as Barium Sulfate and Iodinated Contrast Agent (ICA). The radiopaque scale was manufactured using Perspex® and was filled with the contrast agents. The scales were then scanned using low-dose X-ray machines. The scale filled with Barium was found to be provide a better contrast image suggesting that the Barium to be a better high-contrast agent when compared to iodine and is recommended for use.


Author(s):  
Jorge D. Zhingre Sanchez ◽  
Paul A. Iaizzo

Abstract Tricuspid valve regurgitation is a major clinical issue that continues to attract interest from interventional cardiologists and medical device designers due to its rising prevalence and progressive nature. This disease impact is exacerbated among the aging population, considered as high risk of mortality for open-heart surgical procedures. Furthermore, early intervention for tricuspid regurgitation following left-sided heart procedures continues to increase. Thus, percutaneous or transcatheter interventions have emerged as the new frontier for tricuspid valve therapy. Specifically, tricuspid leaflet plication, or edge-to-edge repair, is a valvular procedure to enhance the coaptation of the leaflets and reduce regurgitation. The current landscape of approved transcatheter devices for leaflet coaptation are exclusive to the mitral valve or being investigated for tricuspid treatment. However, most of these transcatheter systems are designed with high procedure specificities, are expensive, and require extensive procedural training. Hence, there is an opportunity to percutaneously plicate the tricuspid leaflets using commonly available right-heart catheter equipment. This study details a novel transcatheter repair procedure that can plicate the tricuspid valve leaflets solely using current market released catheters and/or surgical equipment. Testing and evaluation of this prototype procedure was performed using Visible Heart® methodologies.


Author(s):  
Avery Smith ◽  
Ada-Rhodes Short

Abstract An accurate understanding of anatomy allows designers and scientists to create medical devices that work well for their market. However, reliable descriptions of vulva vaginal dimensions are not currently available for reference. This literature review attempts to survey the existing data collected on vulva vaginal dimensions and report the findings. We located scholarly journal articles and cross-sectional studies via academic databases and online search engines. To pinpoint the data that would be helpful in dimensional analysis of vulva vaginal measurements, key search terms included: “vulva dimensions”, “vulva measurements”, “vaginal dimensions”, “vaginal measurements”, “labia dimensions”, “labia measurements”, “clitoral dimensions”, “clitoral measurements”, and “vulva cross-sectional study”.


Author(s):  
David A. Ramirez ◽  
Mikayle A. Holm ◽  
Andrew Shaffer ◽  
Paul A. Iaizzo

Abstract Implanting Left ventricular assist devices (LVADs) can be life saving therapies that improve life expectancy for the patients that receive it. The target patient population suffer from end-stage heart failure and are therefore susceptible to morbidities arising from a less than ideal surgical implantation. Importantly, the graft that carries the blood from the LVAD pump to the aorta needs to be sized accordingly so as to not cause any compounding complications. The current typical surgical method, is to perform a visual estimation at the time of implantation. This present study proposes a computational tool that utilizes pre-procedural imaging to better calculate the personalized, ideal, LVAD graft length.


Author(s):  
Etse-Oghena Campbell ◽  
Christopher G. Rylander ◽  
Lauren Thaxton ◽  
Marian Yvette Williams-Brown

Abstract The immediate post-partum period offers a convenient time to have an intrauterine device placed because of the co-location of a non-pregnant woman and her clinician; however, this practice is associated with increased expulsion rates of up to 30%, compared with a 3% expulsion rate for interval insertions. This paper presents a device and method to improve intrauterine device delivery and retention in the immediate postpartum period. This initial feasibility study illustrates that it is possible to temporarily tether a commercially available intrauterine device within the uterus of an immediately postpartum baboon. The results indicate this device and method are technically feasible, but further studies will be needed to evaluate safety and efficacy in reducing expulsion rates.


Author(s):  
Mikayle A. Holm ◽  
Alex Deakyne ◽  
Erik Gaasedelen ◽  
Weston Upchurch ◽  
Paul A. Iaizzo

Abstract Atrial fibrillation, a common cardiac arrhythmia, can lead to blood clots in the left atrial appendage (LAA) of the heart, increasing the risk of stroke. Understanding the LAA morphology can indicate the likelihood of a blood clot. Therefore, a classification convolutional neural network was implemented to predict the LAA morphology. Using 2D images of 3D models created from MRI scans of fixed human hearts and a pre-trained network, an 8.7% error rate was achieved. The network can be improved with more data or expanded to classify the LAA from the automatically segmented DICOM datasets and measure the LAA ostia.


Author(s):  
Thomas W. Secord ◽  
Lucas J. Koerner ◽  
Robert J. Kopas

Abstract Transcathether aortic heart valve replacement (TAVR) is a widespread approach to treating patients with severe aortic stenosis. A TAVR implant is ideally positioned to access numerous clinically relevant signals including arterial blood pressure, pulse wave velocity, electrocardiogram (ECG), patient motion, heart rate, respiration, and blood oxygenation. Unlike medical devices such as pacemakers, TAVR implants are purely mechanical structures with no sensing capabilities. In this work, we address this unmet clinical need by incorporating an Inter-Integrated Circuit (I2C) sensor network within a TAVR stent frame and designing sensor modules that can physically connect to the network at various landing zones. To illustrate this approach, we designed and built a sensor circuit board populated with a commercial inertial measurement unit (IMU) that can detect clinically useful metrics including pulse wave velocity at the aortic root. We use two spatially separated accelerometers to measure pulse wave propagation time with a standard deviation of 140 μs, which translates to an uncertainty of the pulse wave velocity of ±0.2 m/s. The sensor modules connect to a customized stent frame containing the necessary I2C conductors. Our data suggest that a fully instrumented TAVR paradigm is feasible using this frame design and modular sensor approach.


Author(s):  
Awaiz Khan ◽  
Edmundo Rubio ◽  
Bradley Icard

Abstract This project sought to develop a method to provide a clinically meaningful, surrogate measure for viscosity that will help analyze complex biofluids. Goals for this project included precise measurements that differentiate a wide variety of standard viscosities, table-top level of size, and ease-of-use. The design utilized a custom 3D-printed analog of a cone and plate viscometer with an attachment for a smartphone to provide gyroscopic data. The device is currently in the stages of final validation and will ultimately be tested in a 40-patient clinical trial intended to assess efficacy of mucolytic therapy in mechanically ventilated patients.


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