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Center for Research & Breakthroughs (R&B)

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Center for Research & Breakthroughs (R&B)
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R&B Advanced Cardiovascular Research

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Introduction

Cardiovascular diseases are one of the main reasons behind deaths according to recent reports. Approximately, 92.1 million American adults have at least one type of cardiovascular disease [1]. 30% of adults with an existing cardiovascular condition suffer from heart disease. For the last century, cardiovascular diseases have been considered the main cause of death in the United States. Depending on the severity and type of the condition, treatment or countermeasure options may vary. Altering lifestyle habits, such as weight control, increasing physical activity, quitting the consumption of tobacco products, moderating alcohol intake, and decreasing saturated fat and sodium in the diet, are shown to be beneficial to improving cardiovascular health. Moreover, assistive medication for high blood pressure or high cholesterol is also beneficial. For people who have been diagnosed with severe conditions, lifestyle changes, and assistive medication may not be enough. Heart transplantation could be considered the best possible treatment. Yet, the ratio of available heart donors to people on the transplantation waitlist is not promising [2]. The World Health Organization’s “Atlas of Heart Disease and Stroke [3]” foresees a grim future for the World’s population. One of the predictions of the report is that by 2030 globally 32.5 % of all deaths would be caused by cardiovascular diseases. The report also plants hope by stating that cardiovascular diseases could be prevented considering research conducted for the last 50 years. Therefore, there is an imminent need for the development of new treatments for cardiovascular diseases and the development and testing of proposed future treatments. The development of a novel Cardiovascular Performance Benchmark platform (CPSP) would be a perfect candidate to meet the requirements of such a need.

Goal

The goal of this research is to empower the development of technologies and simulation models supporting health and medical research through computational science, engineering, bioscience, and health science research. This innovative hands-on cardiovascular performance benchmark simulation platform provides transformative research and learning process that enables the integration of knowledge, methods, and expertise from different disciplines through convergence research across diverse perspectives.

Equipping the Healthcare Industry to Achieve Innovative Design Breakthrough

We will test the hypothesis using the following specific aims as shown in Figure 1: (01) 3D printing customized specialized biocompatible, silicone-based heart valve manufacturing. (02) Silicone heart valve testing using the MCL system for functionality and performance. (03) Integrating a validated heart valve with the cardiovascular performance simulation platform (CPSP) to create a design and monitoring tool can lead to better and more physiologically accurate research and development efforts.

01. Design and Development of a 3D Printing Machine to Manufacture Customized Silicone Heart Valve

Heart valve diseases, such as aortic stenosis, are considered a common illness in the US, resulting in hundreds of thousands of heart valve replacement operations. In severe cases, either mechanical or prosthetic heart valves are used to replace the damaged heart valve. Current heart valve solutions are costly and labor-intensive for fabrication, have relatively short life spans, and include animal-derived tissue (bioprosthetic) or metallic elements that require immunosuppression or anti-thrombogenic drugs, which have significant undesirable side effects. Moreover, the replacement valves presently used are circular and may not fit perfectly into the patient's aorta, which is different for each patient. Additive manufacturing (AM) is becoming increasingly capable of redefining the manufacturing landscape. A high-accuracy, reliable, and capable 3D printing machine for manufacturing customized heart valves is designed and built (see Fig. 2).
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Fig.2 3D silicone printing machine final product (Ertas et al., 2023).

3D Printing of Silicone Heart Valve: A Major Breakthrough

Researchers studying additive manufacturing are very interested in new materials and procedures suitable for 3D printing applications [4, 5]. Custom-made heart valves can be created as functional implants for patients by precisely recreating the geometry of the aortic root region using 3D scanning technology, computer-aided design, and 3D printing. 

Since silicone is known to be biocompatible, it is a good contender to be utilized as the material for heart valve fabrication. Despite being biocompatible, silicone heart valve components are not currently intended for use in human tissue. They will initially function as a model to replicate the actions of bioprosthetic valves. 3D-printed silicone heart valves may eventually be modified for use as implantable artificial heart valves [6].

However, there are difficulties with 3D printing silicone. Silicone is an elastomer, and unlike thermoplastics, which can melt and then solidify again, silicone cannot be melted once it has solidified. Furthermore, silicone is difficult to cure in its pure state.

Despite numerous difficult challenges with silicone printing, our research team has successfully manufactured a 3D-printed silicon heart valve, which is a breakthrough in regenerative medicine and gives hope to those who suffer from heart problems (please watch the above video).

02. Mock Circulation Loops (MCL) to Test Heart Valve Functionality

As shown in Figure 3, mock circulation loops are closed-loop piping systems whose sole purpose is to regenerate physiological circulatory parameters. MCLs consist of compliance chambers, resistance valves, artificial heart valves or flip valves, and more importantly, a pump to act as actuators mimicking the ventricles. The use of expandable sacs, pneumatically actuated chambers, and an artificial heart could be found as examples of a pump for an MCL.
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Fig. 3 Prototyped MCL system (adapted from Baturalp and Ertas, 2015).

03 Cardiovascular Performance Simulation Platform (CPSP)

CPSP will consist of a multistage computational model and an experimental setup for not only validation of the computational counterpart, but also serving as a test bed for cardiovascular assistance devices. General stages of the computational part of CPSP could be listed as follows (see Figure 4): finite element analysis to identify mechanical deformation characteristics of the left ventricular simulator, fluid-structure interaction model to predict cardiac output and flow through valves, and computational fluid dynamics model to monitor flow from aorta to left atrium, excluding pulmonary flow.
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Fig. 4 Proposed Cardiovascular Performance Simulation Platform. (adapted from Gulbulak and Ertas, 2019).

04. Development of Left Ventricular Assistance Devices (LVAD)

The design of cardiovascular assistance devices (LVADs) has not reached perfection and is yet to even deliver on its initial promises. The complex and sensitive nature of working conditions of cardiovascular assistance devices is the main reason for their decelerated progress. However, for the majority of people worldwide, future treatments appear to be the only practical choice for destination therapy. The proposed research will have an impact on the direction of the development of new solutions for cardiovascular diseases and will be a focal point for medical doctors, engineers, and scientists by creating a transdisciplinary research effort. Mock Circulation Loops (MCLs) play an essential role not only in vitro testing (not in a body) and the development of LVADs and heart valves but also in other circulation-related devices, such as total artificial hearts, artificial lungs, vascular grafts, and bioreactors for tissue-engineered heart valves.

The results of this study will be a stepping stone for researchers all around the globe who have been working on a better understanding of cardiovascular diseases and effective long-term cardiovascular treatments by means of either clinical, computational, or experimental methods. CPSP will accelerate the mentioned research efforts by offering a benchmark strategy that will be as physiologically accurate as possible.

References

  1. Benjamin, E. J., et al., “Heart Disease and Stroke Statistics—2017 Update: A Report From the American Heart Association.” Circulation 135, no. 10 (2017): e146–e603. doi:10.1161/CIR.0000000000000485, Available at http://circ.ahajournals.org/lookup/doi/10.1161/CIR.0000000000000485

  2. Califano, S., Pagani, F. D., and Malani, P. N. “Left Ventricular Assist Device-Associated Infections.” Infectious Disease Clinics of North America 26, no. 1 (2012): 77–87. doi:10.1016/j.idc.2011.09.008, Available at http://www.ncbi.nlm.nih.gov/pubmed/22284377

  3. “WHO | The Atlas of Heart Disease and Stroke.” WHO (2010): Available at http://www.who.int/cardiovascular_diseases/resources/atlas/en/

  4. Radu, M.; Iuliana, M.B., Laurentiu, C.C.; Razvan, E., Alexandru, P., Andrei, T.C., Gabriela, S., Elisa, P., and Teodor, B. (2021). In Vitro Physical-Chemical Behaviour Assessment of 3D-Printed CoCrMo Alloy for Orthopaedic Implants. Metals, 11(6), 857; https://doi.org/10.3390/met11060857

  5. Khaja M.; Syed, H.M., Wadea, A., Hisham A., and Abdul S. (2021). Feasibility Study of the Cranial Implant Fabricated without Supports in Electron Beam Melting. Metals, 2021, 11(3), 496; https://doi.org/10.3390/met11030496

  6. Coulter, F. B., Schaffner, M., Faber, J. A., Rafsanjani, A., Smith, R., Appa, H., Zilla, P., Bezuidenhout, D., Studart, A. R. (2019). Bioinspired Heart Valve Prosthesis Made by Silicone Additive Manufacturing. Matter, Vol.1, Issue 1, 2019, pp. 266-279.

     

Related Published Articles

Ertas, A., Erik Farley-Talamantes, H. Saker, A. Rajan, C. Lamb, D. Flores, B. Norton. Innovative Approach to Design and Development of a 3D Silicone Printing Machine Using Transdisciplinary Integrated Design Tools. Transdisciplinary Journal of Engineering & Science, Vol. 14, pp. 19-63, 2023.

Gulbulak, U., Gecgel, O., and Ertas, A. A Deep Learning Framework to Approximate the Geometric Orifice and Coaptation Area of Polymeric Heart Valves Under Time-Varying Transvalvular Pressure. Journal of the Mechanical Behavior of Biomedical Materials, 2021, 117:104371. doi: 10.1016/j.jmbbm.2021.104371.

Gulbulak, U., Ertas, A., Pavelka, T., Baturalp, T. The Effect of Fundamental Curves on Geometric Orifice Area of Polymeric Bioprosthetic Heart Valves.  Journal of the Mechanical Behavior of Biomedical Materials, 112, 104039. https://doi.org/10.1016/j.jmbbm.2020.104039.

Gulbulak, U., Ertas, A. Finite Element Driven Design Domain Identification of a Beating Left Ventricular Simulator. Bioengineering, 2019, 6, 83; doi:10.3390/bioengineering6030083

Gulbulak U., and Ertas, A., and Students from Additive Manufacturing class. Boosting Just-in-Time Supply Chain Innovation through Additive Manufacturing: A Transdisciplinary Educational Experience. Transdisciplinary Journal of Engineering & Science, Vol. 10, pp. 199-223, 2019. doi: 10.22545/2020/00137

Pavelka, T., Gulbulak, U., Baturalp, T., Ertas, A. Performance Evaluation of a Mock Circulation Loop with Bioprosthetic Heart Valves and a Beating Left Ventricle Simulator. Rice University, Houston, Texas, "Gold Coast Undergraduate Research Symposium," National, peer-reviewed/refereed. (2019).

Baturalp, T. B., Ertas, A. State of the Art Mock Circulation Loop and a Proposed Novel Design (pp. 23-29, 2015). Proceedings of the International Conference on Biomedical Engineering and Science (BIOENG'15).

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