2021 Design of Medical Devices Conference
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Published By American Society Of Mechanical Engineers

9780791884812

Author(s):  
David A Ramirez ◽  
Weston Upchurch ◽  
Paul A Iaizzo

Abstract As electroporation therapies become more widely used in the cardiac ablation space, there is a critical need to study the potential effects on surrounding tissues: collateral damage. Here we explored methods to study the effects applying electroporative energies on vascular smooth muscle: i.e., loss of vascular function when exposed to energies needed to induce irreversibly electroporative therapy to the myocardium.


Author(s):  
P. Alex Smith ◽  
Timothy J. Keane ◽  
Stefano Serpelloni ◽  
Stephen G. Ramon ◽  
Francesca Taraballi

Abstract Postoperative adhesions are scar tissue that form between internal organs after surgery, leading to devastating life-long complications. Current adhesion barriers used clinically are solid sheets which can only be applied in open surgeries through large incisions. We have developed a material which can be applied as a liquid in minimally invasive surgeries which transitions into a solid thin film barrier upon contact with warm tissue. However, to be effective, it must be sprayed, and spraying a viscous liquid consistently is challenging. We proposed using a gas dispersant to facilitate aerosolization. In this study, we compared a commercially available nozzle without gas dispersant to a custom 3D printed nozzle with gas dispersant. For comparison, we measured both spray pattern and stiffness of the resulting gel. We found that when sprayed with gas dispersant, the spray pattern covered a larger area, and the resulting gel was stiffer than when sprayed without gas dispersant.


Author(s):  
Samhith Kethireddy Abigail Swamidoss ◽  
Bushra Alghamdi ◽  
Ronald L. Hickman ◽  
Shanina Knighton ◽  
Miriam Pekarek ◽  
...  

Abstract Independent living care for polypharmacy patients can be complicated in those situations with medications that are pro re nata (PRN, “as needed”). Such medication regimen may involve multiple dosing whereby specific drug contraindications might be easily overlooked by hospice and palliative care patients, or by those isolated and not in regular contact with care providers. The goal of this paper is to describe the development steps and current design of a system providing medication decision support for isolated patients. With an increased number of patients living alone or isolated - a situation exacerbated during the COVID19 pandemic – polypharmacy patients may be challenged when PRN (as needed) medications confound what might ordinarily be a routine medication schedule. Central to our medication management system design is the so-called “conversational agent” that when integrated with a natural language processing front- end and classification tree algorithm provide a dynamic framework for patient self-management of medications. Research on “patient need” revealed patients were more likely to embrace the system if the system were autonomous, secure, and not cloud-based.


Author(s):  
Deana McDonagh ◽  
Kayla Arquines ◽  
Elizabeth T. Hsiao-Wecksler ◽  
Mahshid Mansouri ◽  
Girish Krishnan ◽  
...  

Abstract User-centered design relies upon the appreciation that assistive technology device solutions need to include the functional and supra-functional (e.g., emotional, social, cultural) needs of users. Developing solutions without basing decision-making on both quantitative (functional) and qualitative (supra-functional) needs can lead to imbalanced devices, services, and/or environments. Satisfying both functional and supra-functional needs is the foundation of user-centered design, which in itself relies upon empathic understanding of the person that one is aiming to serve. This paper presents a study of the lived experiences of people living with Amyotrophic Lateral Sclerosis, their caregivers, and members of the healthcare management team from a human-centered perspective in the pursuit of pain points, deeper understanding of the emotional needs, and revelation of opportunities for improving quality of life and human experience through more user-centered design. We focus on user-centered design-thinking research tools (e.g., mood boards, journey maps, personas) to (a) understand the authentic experience of the individual in their vernacular and their terminology, and (b) to support a data rich conversation that focuses upon both functional and supra-functional needs to highlight opportunities for design interventions).


Author(s):  
Smruti Mahapatra ◽  
Tarana Parvez Kaovasia ◽  
Sufia Ainechi ◽  
Ana Ainechi ◽  
Molly Acord ◽  
...  

Abstract Standard diagnostic ultrasound imaging procedures heavily rely on a sonographer for image acquisition. Given the ultrasound probe is manually manipulated by the sonographer, there is a potential for noise artifacts like blurry acquired images caused by involuntary hand movements. Certain surgical procedures can also cause patients to exhibit involuntary “jumping” movements while on the operating table leading to further deterioration in ultrasound image quality. In this study, we attempt to mitigate these problems by fabricating a 3D-printed ultrasound probe holder. Due to the lightweight nature of the device, it can attach to surgical retractors without influencing the functionality of the retractor. Therefore, the 3D printed probe holder not only reduces relative motion between the probe and the patient, but also reduce the need for a sonographer during complex surgeries.


Author(s):  
Shonit Nair Sharma ◽  
Devrina Chidambaram ◽  
Gianna Mizzi ◽  
Daniel Rosen ◽  
Kristin Slaughter ◽  
...  

Abstract As a preemptive response to the widespread need for respiratory medical devices developing in the wake of the COVID-19 pandemic, we propose a low-cost incentive spirometer for respiratory rehabilitation in patients with reduced lung function. An incentive spirometer manufactured entirely out of recyclable material, termed “Paperometer,” aims to address the multifaced problem of medical device inaccessibility: high cost, lack of user- or environmental-friendliness, and unavailability to those who need them the most. Operating in accordance with governing physical formulae including Ohm’s law and the Hagen-Poiseuille equation, Paperometer is intended to improve the user’s lung function through repeated use of the device, which facilitates slow, deep breaths of air. Several prototypes were created based on a list of design criteria established through background research and stakeholder interviews. From four initial prototypes, all created predominantly from simple foldable geometries, one design was selected for further iteration. The most promising functional prototype was crafted from recyclable plastic and paper folded into various shapes including a box, tube, and pinwheel. The Paperometer concept stands as an innovative solution to reduce the cost and environmental burden of meeting the demand for medical devices. Once validated, the device may serve as an important tool in combating the ongoing global pandemic.


Author(s):  
Enrique Alvarez Vazquez ◽  
Daniel Ewert ◽  
Dave Jorgenson ◽  
Michael Sand

Abstract This study describes a non-invasive medical device capable of measuring arterial blood pressure (BP) with a combination of inflationary and deflationary procedures. The device uses the pressure cuff pressure signal, arterial skin-surface acoustics, and photoplethysmography (PPG) to make a sensor-fusion estimation of blood pressure readings. We developed an apparatus composed of 1) a modified off-the-shelf oscillometric blood pressure system, 2) a contact microphone with an amplifier, 3) and high-sensitivity pulse oximeter, and its control electronics.


Author(s):  
Jorge A. Vergen ◽  
Tinen L. Iles ◽  
Paul A. Iaizzo

Abstract Mimetic three-dimensional (3D) printing has been shown to enhance presurgical planning and improve patient outcomes. However, data inconsistencies and non-optimized soft tissue data management strategies have impaired efforts to characterize soft tissues and translate biophysical values to 3D printing media durometers and shore values. As a result, finished models are inconsistent and exhibit reduced mimetic qualities. Improving biophysical characterizations of soft tissues, analysis strategies, and consolidation infrastructures are important factors that will improve 3D modeling in a presurgical planning setting. In our ongoing associated studies, both physiologically viable and formalin fixed large mammalian tissues (including human) were assessed using uniaxial and biaxial testing strategies. Biophysical datasets were analyzed using a gated analysis strategy, tailored to data acquisition methods developed within the University of Minnesota Visible Heart® Labs (VHL). A SQL database was then constructed to consolidate analyzed data for future retrieval. This strong preliminary data is a foundation for further development and refinement of future studies. It is our long-term goal that these strategies be improved and adopted to enhance the mimetic qualities of 3D presurgical planning models.


Author(s):  
Moegammad Ameen Bardien ◽  
Sudesh Sivarasu

Abstract Users of body-driven prostheses often abandon their prostheses due to overexertion of their shoulders and a lack of features. The aim of this study was thus to design an electromechanical hand prosthesis that meets the functional and grasping requirements of prosthesis users. To this end, the Self-Actuated Tenim Hand (SATH), a functional electromechanically actuated prosthesis, was developed. The SATH, based on the novel body-driven Tenim Hand, incorporated design refinements that improved on its predecessor’s grasping capabilities. An electromechanical actuator and a wrist supination and pronation mechanism were integrated into the SATH thereby improving its functional capabilities. The Anthropomorphic Hand Assessment Protocol (AHAP) was used as a design validation tool to assess the functional capabilities of the SATH. The SATH performed satisfactorily in AHAP and achieved results that are comparable to scores obtained by a more advanced prosthesis.


Author(s):  
Michael Kopcak ◽  
Kent Wika ◽  
Bridget Portway ◽  
Linnea Lentz ◽  
Angela Brockel ◽  
...  

Abstract The Anatomage Table was originally marketed to medical schools as an anatomical training tool and to hospitals for preoperative planning. When Medtronic employees began to understand the power of the Anatomage Table for product development and data analysis, the uniqueness of how the table was utilized led to its many valuable contributions. The Anatomage Table has significantly reduced product development time with its ability to immediately render anatomical models in a way that allows the development team to evaluate outcomes and react with clear direction. It also reduces cognitive load for the users thereby expediting the interpretive process. The technology has become a tool to enhance research and training outcomes. This paper serves as an example to stimulate the use of this type of technology in similar applications. Hard data originating from controlled studies are not provided in this report due to the technology’s early use at Medtronic and the proprietary nature of the development processes on which the technology was used.


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