COMSOL Day: Biomedical Devices
Simulation Software's Role in Inventing, Developing, and Certifying Medical Device Designs
The application of new and innovative biomedical devices has seen an accelerated and even paradigm shift in the last decade or so. COMSOL Day: Biomedical Devices will feature many invited speakers and panelists using simulation to study medical devices.
Join us to discover how new applications, processes, and methods are being developed by startups and established biotech companies. Invited speakers and COMSOL technical staff will discuss the innovation of far less intrusive medical devices that make the medical health and well-being of people increasingly better.
Simulation software's role in developing, optimizing, and applying medical devices has now become an integral part of the reporting criterion required to ascertain a device's operation, efficacy, and safety through mechanisms such as those provided by the FDA. Invited speakers and panelists will discuss this change, along with the general trends and applications of using simulation in the biomedical device industry.
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To start, we will briefly discuss the format of the day and go over the logistics for using GoToWebinar.
Arlen Ward, System Insight Engineering
The invention, development, and application of new and innovative biomedical devices has seen an acceleration in the last decade or so. Discovering new ways, processes, and methods by a plethora of startups and established biotech companies has been complemented by transformations provided by other innovators developing less intrusive and more focused devices to make the medical health and wellbeing of people increasingly better.
Much of this has come about due to modeling practices provided by simulation software, such as COMSOL Multiphysics®, that provides the industry with more efficient ways to discover, develop, and optimize the design and operation of such devices. The integration of simulation software has now reached the stage where it has become an integral part of all reporting mechanisms required to ascertain a device's operation, efficacy, and safety through mechanisms such as those provided by the FDA. This will be discussed during this panel discussion, along with the general trends and applications of using simulation in the biomedical device industry.
Moderators: Nagi Elabassi, Veryst Engineering and Phil Kinnane, COMSOL
- Ismail Guler, Boston Scientific Corporation
- Carlos Corrales, Baxter Healthcare
- William Torres, Exponent
- Arlen Ward, System Insight Engineering
David Gross, MED Institute
Open-bore MRI systems account for approximately 18% of the global MRI installed base, compared to 3 T closed bore, accounting for approximately 19% of the global MRI installed base. The wide patient table, large opening, and open view of these MRI systems are advantageous for imaging pediatric, bariatric, geriatric, and claustrophobic patients. With the parallel growth of open-bore MRI systems and the increased prevalence of patients with implanted medical devices, it is important to consider RF-induced heating of devices in open-bore MRI systems. This presentation will highlight how we use COMSOL Multiphysics® to evaluate RF-induced heating of medical devices for MRI labeling.
Thomas Clavet, EMC3 Consulting
Acoustic waves in the ultrasonic range are widely used in many industries, including MedTech. For instance, echography is a well-known medical imaging technique that is often prescribed to diagnose an illness or health issue.
In addition to diagnostics, ultrasound can also provide a noninvasive way to treat a condition. Focused ultrasound (FUS) devices have become a common choice to kill cancerous tumors in the prostate, breast, pancreas, liver, and brain, but other conditions also take advantage of focused ultrasound, such as neurodegenerative diseases and glaucoma. Research in the field is very important and could lead to disruptive technologies and novel treatments in years to come.
High-intensity focused ultrasound (HIFU) ablation tools are designed to produce a localized elevation of temperature and necrosis of biological tissues. Simulating the acoustics and heat transfer phenomena involved in such tools allows engineers and researchers to select the combination of parameters that will deliver the right amount of energy in the targeted zone and limit the damage to the surrounding healthy tissues. There are numerous parameters, including the size of the transducer that transmits the ultrasound, the frequency of the signal, and the duration of the treatment.
Challenges remain as well, related to the knowledge of acoustics and thermal properties of tissues, and the nonlinear effects that happen at these high frequencies and amplitudes. Thus, there is still a long way to go before having a patient-specific treatment planning simulator, but the COMSOL® software would be a solution of choice to try to reach this goal.
In this presentation, Thomas Clavet from EMC3 Consulting will discuss how HIFU can be produced and key points about how to model this multiphysics problem.
Andres Belalcazar, Consultant
Atrial fibrillation is an arrhythmic disease that often arises from electrical activity conducting between the pulmonary veins and the left atrium of the heart. A therapeutic mainstay using catheter electrodes relies on isolating the pulmonary veins by creating durable lesions on atrial tissue. Heat or electrical fields may be used. With the COMSOL® models presented, a couple of design variations are presented using MRI/CT image sets that illustrate the power of modeling to refine electrical and mechanical design of ablation catheters.
Alireza Kermani, Veryst Engineering
Hemolysis caused by flow-induced mechanical damage to red blood cells is a concern in devices that involve transporting blood. Mathematical models have been proposed to estimate red blood cell damage in blood flow. We used hemolysis mathematical models to evaluate the effect of modifications to the device geometry on blood damage. We used Lagrangian and Eulerian approaches to obtain blood damage estimates based on Ref. 1.
The United States Food and Drug Administration (FDA) initiated benchmark models of typical device flow geometries, including a nozzle (Ref. 2). Multiple laboratories participated and provided experimental velocities, pressure, and hemolysis data to support CFD simulations. We used the FDA nozzle as our benchmark. Our preliminary results show that the simple power law stress relation used in this hemolysis model in both its Lagrangian and Eulerian implementations cannot accurately quantify damage at flow rates of 6L/min, as used in the FDA experiments. However, the models can predict which geometries are more prone to blood damage than others. Therefore, these models can be used to compare hemolysis in different device geometries and assess the effect of slight geometrical modifications.
- Yu, H., Engel, S. 1, Janiga, G., & Thévenin, D. A Review of Hemolysis Prediction Models for Computational Fluid Dynamics. Artif Organs 2017 Jul; 41(7):603-621.
- Grigioni, M., Morbiducci, U., D’Avenio, G., Di Benedetto, G., & Del Gaudio, C. A novel formulation for blood trauma prediction by a modified power- law mathematical model. Biomechanics and Modeling in Mechanobiology 2005, 4(4), 249-260.
- Website. U.S. Food and Drug Administration. https://fdacfd.nci.nih.gov
The Application Builder is included in the COMSOL Multiphysics® software and allows you to transform your models into simulation apps controlled by interfaces appropriate for what is being simulated. This type of tool is unique to COMSOL Multiphysics® and will open up the world of simulation to all engineers, operators of processes, and scientists. This session will demonstrate the use of the Application Builder and how it can fundamentally augment how your organization approaches simulation.
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