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Advances in Cardiovascular Medical Devices

Wednesday, April 11, 4:00-5:30, Ski-U-Mah, McNamara Alumni Center

Organizer: Paul Iaizzo, University of Minnesota

"A Semi-Stented and Chorded Mitral Valve Prosthesis: Design and Method of Chordal Setting and In Vitro Testing" (DMD2018-6860)
Romilde Kotzé, Department of Chemical Engineering and Biotechnology, University of Cambridge

"Thrombogenicity Testing for Blood-Contacting Medical Devices in an in vitro Human Blood-Loop" (DMD2018-6875)
Yan Chen, Director of Biocompatibility, American Preclinical Services

"Portable Ex Vivo Heart Perfusion Apparatus The Visible Heart® Mobile" (DMD2018-6877)
Mikayle Holm, Biomedical Engineering, University of Minnesota

"Design and Development of a Novel Drug Delivery Catheter for Atherosclerosis" (DMD2018-6869)
Sunandita Sarker, Mechanical Engineering, University of Nebraska-Lincoln

"Design of a Muscle-powered Soft Robotic Bi-VAD for Long-term Circulatory Support" (DMD2018-6835)
Jooli Han, Biomedical Engineering, Carnegie Mellon University

"A Smartphone Stethoscope and Application for Automated Identification of Innocent Still's Murmur" (DMD2018-6905)
Titus John, Sheikh Zayed Institute for Pediatric Surgical Innovation, Children's National Medical Center

"Development and Validation of Numerical Model Simulation for RF Ablation using the Isolator Synergy Clamp" (DMD2018-6949)
Michael Etheridge, Principal Research Scientist/Engineer at AtriCure, Inc.


Session Abstract:

Presentations focused on Cardiovascular Medical Devices were chosen from the 2018 DMD Conference Call for Papers accepted paper submissions. All accepted papers will be published in the Proceedings of the Design of Medical Devices Conference in the ASME Digital Collection, and will also be published as a printed book by ASME Press. Conference registration and presentation of the paper in a conference poster session is required for publication of the paper.


Speaker Bios:

Romilde Kotzé, Department of Chemical Engineering and Biotechnology, University of Cambridge
Romilde Kotzé is a PhD candidate at the Chemical Engineering and Biotechnology Department at the University of Cambridge. She is a medical device designer with industry experience in the design and development of orthopedic and cardiovascular medical devices. She is currently researching mitral valve repair and replacement technologies and focuses on the design of a pediatric growth-adapting valve prosthesis.

Yan Chen, Director of Biocompatibility, American Preclinical Services
Yan Chen, PhD is the Director of Biocompatibility at American Preclinical Services. She received a Ph.D degree in pharmacology from the University of Illinois and has conducted preclinical research and study management for over 16 years. Dr. Chen’s current primary focus is biosafety evaluation of medical devices and method improvement for biocompatibility testing.

Mikayle Holm, Biomedical Engineering, University of Minnesota
Mikayle is a second year PhD student studying biomedical engineering at the University of Minnesota. She works in the Visible Heart Lab researching ways novel cardiac and full body imaging techniques can improve preclinical studies of medical devices. She is excited to pursue a career in cardiac device design and procedural development upon completion of her PhD.

Sunandita Sarker, Mechanical Engineering, University of Nebraska-Lincoln
Sunandita is a second-year Ph.D. student in Mechanical and Materials Engineering department at University of Nebraska-Lincoln. She got her bachelor’s degree from Bangladesh University of Engineering and technology (BUET) on 2015. Currently she is a graduate research assistant at the Terry Research laboratory, working on novel drug delivery systems and swallowable capsule robot.

Jooli Han, Biomedical Engineering, Carnegie Mellon University
Jooli Han is a Ph.D. candidate in the Biomedical Engineering Department at Carnegie Mellon University. She is currently working on development of muscle-powered soft robotic ventricular assist devices that uses endogenous skeletal muscle power to hydraulically actuate non-blood-contacting heart pumps manufactured with soft materials.

Titus John, Sheikh Zayed Institute for Pediatric Surgical Innovation, Children's National Medical Center
Titus John is a research engineer in the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children's National Medical Center. He is currently working on product and algorithm development for analysis of heart murmurs.

Michael Etheridge, Principal Research Scientist/Engineer at AtriCure, Inc.
Michael Etheridge is a Principal Research Scientist/Engineer at AtriCure, Inc., a company that provides innovative epicardial technologies for the treatment of Atrial Fibrillation and related conditions. He is part of the Research and Technology group, focused on early phase technology evaluation and basic science support for the company. Michael is a doctoral graduate of Professor Bischof's Bioheat and Mass Transfer Lab, where he focused on the engineering and science behind thermal medicine, and has previously worked on catheter ablation at Medtronic’s Atrial Fibrillation Solutions.


Presentation Abstracts:

"A Semi-Stented and Chorded Mitral Valve Prosthesis: Design and Method of Chordal Setting and In Vitro Testing" (DMD2018-6860)
Existing mitral valve prostheses do not mimic the native valve and hence do not preserve annulo-ventricular continuity, which is known to play an important role in mitral and ventricular dynamics. We address these issues through the design of a novel semi-stented and chorded mitral valve that mimics the native mitral annulus, leaflets and chordae function. We also propose a novel and reliable method, with novel instrumentation, to set chordal length. We demonstrate the valve produces appropriate hydrodynamic valve performance.

"Thrombogenicity Testing for Blood-Contacting Medical Devices in an in vitro Human Blood-Loop" (DMD2018-6875)
Thrombogenicity testing is often a requirement for regulatory approval of blood-contacting medical devices. Previously we have successfully developed an in vitro model using minimally heparinized ovine blood which has been successfully used in lieu of the NAVI model in several submissions. This study describes the translation of the methods and materials from the ovine model to one utilizing human blood to enhance the ability to predict clinical outcomes.

"Portable Ex Vivo Heart Perfusion Apparatus The Visible Heart® Mobile" (DMD2018-6877)
The Visible Heart apparatus, developed more than 20 years ago, allows for human hearts to be reanimated outside the body with a clear perfusate for internal functional imaging. Though these methodologies are incredibly valuable in terms of preclinical device research, the machine was not portable, eliminating the ability to do 3D CT imaging. Therefore, a mobile Visible Heart apparatus was built (termed Visible Heart Mobile). This design allows a beating heart to be moved from the Visible Heart Lab to the CT scanner, where it can be imaged with high doses of radiation and unlimited amounts of contrast.

"Design and Development of a Novel Drug Delivery Catheter for Atherosclerosis" (DMD2018-6869)
Atherosclerosis is a chronic progressive cardiovascular disease that results from plaque formation in the major arteries. Identified as an inflammatory disease, it is open to novel anti-inflammatory treatments including local delivery of nano drug carriers. In this research we designed and developed a novel drug delivery catheter and a delivery system for the treatment of atherosclerosis. After computational modelling, we validated the concept in a bench-top test before proceeding to In-vitro experiment.

"Design of a Muscle-powered Soft Robotic Bi-VAD for Long-term Circulatory Support" (DMD2018-6835)
Increased risk of infection associated with the use of percutaneous drivelines and the persistent risk of clot formation at blood-device interfaces remain problematic for mechanical ventricular assist devices (VADs) currently used to treat congestive heart failure patients. Our lab is working to develop a completely self-contained, non-blood-contacting muscle-powered soft robotic biventricular assist device (BiVAD) to solve both these problems. This tether-free ventricular copulsation device represents a potential breakthrough in long-term mechanical circulatory support.

"A Smartphone Stethoscope and Application for Automated Identification of Innocent Still's Murmur" (DMD2018-6905)
Still’s murmur is the most common innocent heart murmur in children. It is also the most commonly misdiagnosed murmur, resulting in a high number of unnecessary referrals to pediatric cardiologist. The purpose of this study was to develop a device and computer algorithm for automated identification of Still’s murmur that may help reduce unnecessary referrals.

"Development and Validation of Numerical Model Simulation for RF Ablation using the Isolator Synergy Clamp" (DMD2018-6949)
Thermal ablation is rapidly becoming a standard of care for the treatment of atrial fibrillation. Here we describe the development of a numerical model to study the performance of the Isolator® SynergyTM Clamp bipolar radiofrequency (RF) device, which features an impedance-based control algorithm. Patient anatomies vary greatly and measured impedance will depend on atrial wall thickness, epicardial fat, electrode-tissue engagement, and structural variations. Further, tissue conductivity (inversely related to impedance) increases as the tissue is heated, leading to a complicated process, where the heat generation depends on the impedance, which in turn is a strong function of temperature. Since tissue impedance and heating drive the device’s performance, a majority of the effort described here focuses on the validation work done to ensure the model is based on an accurate description of the tissue properties and physical response.


Related Cardiovascular Sessions:

Advances in Cardiovascular Medical Devices
Advances in Cardiovascular Structural Devices
Cardiovascular Keynotes

Related Papers Sessions:

Advances in Medical Devices 1
Advances in Medical Devices 2

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