2019 Design of Medical Devices Conference
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86
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Published By American Society Of Mechanical Engineers

9780791841037

Author(s):  
Po-Chih Lee ◽  
Arthur G. Erdman ◽  
Charles Ledonio ◽  
David Polly

In this study, we focus on validating the accuracy of the previously developed software, which reconstructs thoracic rib cage and thoracic volume in 3D. This software is applied in spine deformity patients to help doctors monitor and follow spine curvature and the thoracic volume variation. Five users were recruited to perform usability testing for the developed software. The usability testing shows that the performance of the thoracic volume reconstruction via our software meets the criterion set by the American Thoracic Society, which recommends an acceptable error of ±3% for the respiratory measurement. In addition, the user operation results were analyzed through a two-way analysis of variance (ANOVA), without replication, statistical method. The outcome indicates the reconstruction accuracy of the software is satisfactory. In the reproducibility study, the result shows that the performance of the developed software is superior to previous literature and the reconstruction is clinically relevant.


Author(s):  
Esther Foo ◽  
Heidi Woelfle ◽  
Brad Holschuh

This paper investigates the tradeoffs between design variables important for the development of a mobility support soft exoskeleton for horizontal shoulder adduction. The soft exoskeleton utilizes discreet shape memory alloy (SMA) spring actuators to generate the required torque to move the arm segment, while preserving the qualities of a soft, wearable garment solution. A pilot benchtop test involving varying power input, actuator anchor position, actuator orientation, and added weight, was investigated to evaluate their effects against the degree of motion the soft exoskeleton allows. The results show that the power input, actuator anchor position, and simulated limb weight each affect the ultimate horizontal adduction angle the exoskeleton is able to induce. Further, the project highlights a crucial point in regard to the tradeoffs between functionality and wearability: when actuator orientation was investigated, we found a decrement in functionality (as measured by maximum achievable horizontal adduction angle) when the actuators were constrained close to the body. This shows that when aiming to improve the hypothetical system’s wearability/usability, the effective torque that can be generated is reduced. Together these findings demonstrate important design considerations while developing a wearable, soft exoskeleton system that is capable of effectively supporting movement of the body while maintaining the comfort and discreetness of a regular garment.


Author(s):  
Rachel Popkin ◽  
Fluvio Lobo ◽  
Jack Stubbs

Stethoscopes are ubiquitous across the healthcare system. For the most part, stethoscopes do not represent a financial burden, mostly throughout the developed world. Further reducing the cost of stethoscopes has both humanitarian and prophylactic goals. The Glia project pioneered the concept of 3D printing stethoscopes for war or poverty-stricken regions of the world. Cross-contamination concerns have led researchers and manufacturers to develop single-use stethoscopes. Our aim is to develop a fully printed, multi-material, functional stethoscope to alleviate these concerns. Our team also seeks to establish a framework for the on-demand manufacturing of medical devices to reduce costs associated with shipping, distribution, and inventory.


Author(s):  
Bethany Juhnke ◽  
Susan A. Novotny ◽  
Jennifer C. Laine ◽  
Ferenc Toth ◽  
Arthur Erdman

Legg-Calvé-Perthes disease (LCPD) is a painful pediatric hip condition caused by an idiopathic disruption of blood flow to the femoral head. The bone subsequently becomes necrotic and fragile. This can result in significant femoral head deformity, leading to pain and early degeneration of the hip. Severity of avascular involvement of the femoral head correlates with long-term outcomes, including hip arthritis and replacement. Preclinical models present extreme cases of the disease and do not represent the spectrum of LCPD seen clinically. A virtual model was developed to explore advancing the preclinical model through new methods of visualizing the data. Overall, three opportunities to advance the preclinical model and our understanding of LCPD are presented.


Author(s):  
Eric Nickel ◽  
Gregory Voss ◽  
Andrew Hansen ◽  
Sara Koehler-McNicholas

A novel ankle-foot prosthesis with adjustable range-of-motion limits was developed to support implementation of gradual training protocols in the physical therapy of new amputees. Stakeholder interviews drove design requirements that guided the development. Our first prototype did not pass structural strength testing, but with minor revisions to some components, our second prototype was able to pass structural strength testing to the P6 load level (125kg user) of the ISO 10328 standard for prosthetic feet. The system is ready for laboratory testing with prosthesis users and clinicians to generate further insight for future design iterations.


Author(s):  
Pradipta Biswas ◽  
Sakura Sikander ◽  
Pankaj Kulkarni ◽  
Sang-Eun Song

Cartilage plays an important role in reducing mechanical stress and assist with smooth limb movement. Osteoarthritis is the degeneration of articular cartilage and bone. This osteochondral region is difficult to heal because of its dissimilar healing capability, so osteochondral transplantation is the most common method to resolve this issue. Post-traumatic osteoarthritis develops after a joint injury and can damage the cartilage and accelerate its wear and tear. Mosaicplasty is the most widely used method involving transplantation of small cylindrical bone cartilage plugs to fill up the affected region. The success of harvesting a larger and complex shaped graft to replace the damaged osteochondral area lies in effective extraction of the cartilage-bone graft from the donor site. Currently, no method exists to perform this procedure for autologous transplantation due to the complexity involved to extract graft without damaging the donor site. In this paper, we propose a novel graft removal mechanism to harvest a personalized autologous graft of virtually any shape and size. Our method involves drilling a profile similar to the effected region on the donor site and slicing off the desired cartilage-bone graft from its root to harvest it. We developed a new graft removal mechanism capable of inserting a flexible saw parallel to the transverse plane and slice the graft parallel to the coronal plane to extract a donor graft for autografting procedures.


Author(s):  
Alicia De Hoyos Reyes

Current chemotherapy delivery methods and CSF sampling in leukemia pediatric patients represents a challenge with multiple associated risks creating the need for a more efficient technique. The proposed design of a novel intrathecal device was submitted to computer simulation analysis finding promising results regarding the fluid behavior inside the port and the structural performance of the components.


Author(s):  
J. Walter Lee ◽  
Esther Foo ◽  
Simon Ozbek ◽  
Brad Holschuh

Strategically-applied compression on the body has been shown to elicit positive affect by creating feelings of calmness/relaxation. Although compression-based therapies are widely used in Occupational Therapy as a clinical intervention, current compression garment solutions suffer from various functional and usability issues and the spatial distribution between different commercially-available solutions vary widely. Currently, little is known about the specific location(s), intensity, and duration of pressure on the body that should be targeted in order to improve physical or mental well-being. With the hopes of contributing to more empirically-based compression garment designs in the future, this work reports a pilot investigation of the subjective user experiences when compression is applied on varying body locations.


Author(s):  
CurtisLee Thornton ◽  
JungHun Choi

This paper explores the ability to measure the impedance of a system consisting of the biological system of the patient combined with the mechanical system of the hot snare and, given a specified impedance threshold value, turn off the firing of an electrosurgical device before serious injury occurs. In electrosurgery, the tissue damage is caused by the thermal energy generated from the resistance in the cells. An impedance feedback control system is designed and tested to minimize the effects of too much thermal damage. This design is based on measuring the impedance of the system and implementing a microcontroller to coordinate the activity and to interrupt the electrosurgical device preventing further firing. The feedback control system was proven to automatically stop the electrosurgical device for three given impedance values of 500Ω, 750Ω, and 1000Ω with an accuracy of ±5Ω. The auto-stop system is able to measure and fire at 5.4 times a second with a duty cycle of 41%. This successfully minimizes the thermal injury sustained from electrosurgery.


Author(s):  
Tom Viker ◽  
Jim Stice

Cerebrospinal fluid shunts for the treatment of hydrocephalus fail at a rate of 40% within the first year. The importance of this problem is supported by one institution’s analysis of neurosurgical 30-day readmissions with CSF shunt failure only second to brain tumor readmissions. Hospital shunt related costs have been estimated at $1.4 to $2 billion annually. The majority of these costs are attributable to shunt failures based on the number of revisions out of the total numbers of annual shunt procedures. The technical innovation of this project is a low cost, low risk and easy to implement CSF shunt design change compatible with current protocols. The proposed product is an innovative distal catheter to minimize the need for revision surgery due to obstruction (also referred to as occlusion). This is accomplished with a dual lumen catheter (current distal catheters are single lumen) consisting of a primary lumen and a secondary lumen providing redundant functionality in the event ofprimary lumen occlusion thereby eliminating the need for surgical shunt revision. 40% of shunts fail within the year after implant and distal catheter obstruction accounts for up to 24% of failures. Though less prevalent than proximal catheter occlusion, incidence of distal catheter occlusion is significant and improved reliability would reduce costs and improve patient outcomes by lowering the number of revisions.


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