Design Of Cardiovascular Devices Research Articles

Tailoring crystallinity for hemocompatible and durable PEEK cardiovascular implants

Polymers have the potential to replace metallic or bioprosthetic heart valve components due to superior durability and inertness while allowing for native tissue-like flexibility. Despite these appealing properties, certain polymers such as polyetheretherketone (PEEK) have issues with hemocompatibility, which have previously been addressed through assorted complex processes. In this paper, we explore the enhancement of PEEK hemocompatibility with polymer crystallinity. Amorphous, semi-crystalline and crystalline PEEK are investigated in addition to a highly crystalline carbon fiber (CF)/PEEK composite material (CFPEEK). The functional group density of the PEEK samples is determined, showing that higher crystallinity results in increased amount of surface carbonyl functional groups. The increase of crystallinity (and negatively charged groups) appears to cause significant reductions in platelet adhesion (33 vs. 1.5 % surface coverage), hemolysis (1.55 vs. 0.75 %∙cm−2), and thrombin generation rate (4840 vs. 1585 mU/mL/min/cm2). In combination with the hemocompatibility study, mechanical characterization demonstrates that tailoring crystallinity is a simple and effective method to control both hemocompatibility and mechanical performance of PEEK. Furthermore, the results display that CFPEEK composite performed very well in all categories due to its enhanced crystallinity and complete carbon encapsulation, allowing the unique properties of CFPEEK to empower new concepts in cardiovascular device design.

Why Polyurethanes Have Been Used in the Manufacture and Design of Cardiovascular Devices: A Systematic Review.

We conducted a systematic review in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement to ascertain why polyurethanes (PUs) have been used in the manufacture and design of cardiovascular devices. A complete database search was performed with PubMed, Scopus, and Web of Science as the information sources. The search period ranged from 1 January 2005 to 31 December 2019. We recovered 1552 articles in the first stage. After the duplicate selection and extraction procedures, a total of 21 papers were included in the analysis. We concluded that polyurethanes are being applied in medical devices because they have the capability to tolerate contractile forces that originate during the cardiac cycle without undergoing plastic deformation or failure, and the capability to imitate the behaviors of different tissues. Studies have reported that polyurethanes cause severe problems when applied in blood-contacting devices that are implanted for long periods. However, the chemical compositions and surface characteristics of polyurethanes can be modified to improve their mechanical properties, blood compatibility, and endothelial cell adhesion, and to reduce their protein adhesion. These modifications enable the use of polyurethanes in the manufacture and design of cardiovascular devices.

Comprehensive In Vitro Study of the Flow Past Two Transcatheter Aortic Valves: Comparison with a Severe Stenotic Case.

We investigate the flow past two transcatheter aortic valves (TAVs) and one severely calcified valve in an anatomically realistic aorta geometry to evaluate the ability of the TAVs to establish a healthier aortic flow compared to a diseased case. Velocity measurements of pulsatile flow are carried out using the 3D-particle tracking velocimetry technique. We present a novel approach based on the Smagorinsky model to assess the important subvoxel-scale (here smaller than 750 [Formula: see text]m) shear stress contribution that is usually unavailable in experiments. Both TAV models feature a small retrograde flow of about 5% of the stroke volume and a lower number of coherent vortical structures. Turbulence past the TAVs is strongly suppressed as evidenced by the lower levels of turbulent kinetic energy even though the newer generation TAV performs better than the old one. Also lysis indices are substantially reduced in both models. The new generation TAV displays a slightly higher risk for thrombogenicity due to longer exposure times. We anticipate that our new approach to include turbulence and shear stress related quantities may help to validate the design of cardiovascular devices.

A Review of Integrin-Mediated Endothelial Cell Phenotype in the Design of Cardiovascular Devices.

Sustained biomaterial thromboresistance has long been a goal and challenge in blood-contacting device design. Endothelialization is one of the most successful strategies to achieve long-term thromboresistance of blood-contacting devices, with the endothelial cell layer providing dynamic hemostatic regulation. It is well established that endothelial cell behavior is influenced by interactions with the underlying extracellular matrix (ECM). Numerous researchers have sought to exploit these interactions to generate improved blood-contacting devices by investigating the expression of hemostatic regulators in endothelial cells on various ECM coatings. The ability to select substrates that promote endothelial cell-mediated thromboresistance is crucial to advancing material design strategies to improve cardiovascular device outcomes. This review provides an overview of endothelial cell regulation of hemostasis, the major components found within the cardiovascular basal lamina, and the interactions of endothelial cells with prominent ECM components of the basement membrane. A summary of ECM-mimetic strategies used in cardiovascular devices is provided with a focus on the effects of key adhesion modalities on endothelial cell regulators of hemostasis.

Patient-Specific Atrial Hemodynamics of a Double Lumen Neonatal Cannula in Correct Caval Position.

Clinical success of pediatric veno‐venous (VV) extracorporeal membrane oxygenation (ECMO) is associated with the double lumen cannula cardiovascular device design as well as its anatomic orientation in the atrium. The positions of cannula ports with respect to the vena cavae and the tricuspid valve are believed to play a significant role on device hemodynamics. Despite various improvements in ECMO catheters, especially for the neonatal and congenital heart patients, it is still challenging to select a catalogue size that would fit to most patients optimally. In effect, the local unfavorable blood flow characteristics of the cannula would translate to an overall loss of efficiency of the ECMO circuit. In this study, the complex flow regime of a neonatal double lumen cannula, positioned in a patient‐specific right atrium, is presented for the first time in literature. A pulsatile computational fluid dynamics (CFD) solver that is validated for cardiovascular device flow regimes was used to perform the detailed flow, oxygenated blood transport, and site‐specific blood damage analysis using an integrated cannula and right atrium model. A standard 13Fr double lumen cannula was scanned using micro‐CT, reconstructed and simulated under physiologic flow conditions. User defined scalar transport equations allowed the quantification of the mixing and convection of oxygenated and deoxygenated blood as well as blood residence times and hemolysis build‐up. Site‐specific CFD analysis provided key insight into the hemodynamic challenges encountered in cannula design and the associated intra‐atrial flow patterns. Due to neonatal flow conditions, an ultra high velocity infusion jet emanated from the infusion port and created a zone of major recirculation in the atrium. This flow regime influenced the delivery of the oxygenated blood to the tricuspid valve. Elevated velocities and complex gradients resulted in higher wall shear stresses (WSS) particularly at the infusion port having the highest value followed by the aspiration hole closest to the drainage port. Our results show that, in a cannula that is perfectly oriented in the atrium, almost 38% of the oxygenated blood is lost to the atrial circulation while only half of the blood from inferior vena cava (IVC) can reach to the tricuspid valve. As such, approximately 6% of venous blood from superior vena cava (SVC) can be delivered to tricuspid. High values of hemolysis index were observed with blood damage encountered around infusion hole (0.025%). These results warrant further improvements in the cannula design to achieve optimal performance of ECMO and better patient outcomes.

Nanomatrix Coated Stent Enhances Endothelialization but Reduces Platelet, Smooth Muscle Cell, and Monocyte Adhesion under Physiologic Conditions.

Cardiovascular disease is presently the number one cause of death worldwide. Current stents used to treat cardiovascular disease have a litany of unacceptable shortcomings: adverse clinical events including restenosis, neointimal hyperplasia, thrombosis, inflammation, and poor re-endothelialization. We have developed a biocompatible, multifunctional, peptide amphiphile-based nanomatrix coating for stents. In this study, we evaluated the ability of the nanomatrix coated stent to simultaneously address the issues facing current stents under physiological flow conditions in vitro. We found that the nanomatrix coated stent could increase endothelial cell migration, adhesion, and proliferation (potential for re-endothelialization), discourage smooth muscle cell migration and adhesion (potential to reduce neointimal hyperplasia and restenosis), and decrease both platelet activation and adhesion (potential to prevent thrombosis) as well as monocyte adhesion (potential to attenuate inflammatory responses) under physiological flow conditions in vitro. These promising results demonstrate the potential clinical utility of this nanomatrix stent coating, and highlight the importance of biocompatibility, multifunctionality, and bioactivity in cardiovascular device design.

A strain-based model for mechanical hemolysis based on a coarse-grained red blood cell model.

Mechanical hemolysis is a major concern in the design of cardiovascular devices, such as prosthetic heart valves and ventricular assist devices. The primary cause of mechanical hemolysis is the impact of the device on the local blood flow, which exposes blood elements to non-physiologic conditions. The majority of existing hemolysis models correlate red blood cell (RBC) damage to the imposed fluid shear stress and exposure time. Only recently more realistic, strain-based models have been proposed, where the RBC's response to the imposed hydrodynamic loading is accounted for. In the present work we extend strain-based models by introducing a high-fidelity representation of RBCs, which is based on existing coarse-grained particle dynamics approach. We report a series of numerical experiments in simple shear flows of increasing complexity, to illuminate the basic differences between existing models and establish their accuracy in comparison to the high-fidelity RBC approach. We also consider a practical configuration, where the flow through an artificial heart valve is computed. Our results shed light on the strengths and weaknesses of each approach and identify the key gaps that should be addressed in the development of new models.

In vitro quantification of time dependent thrombus size using magnetic resonance imaging and computational simulations of thrombus surface shear stresses.

Thrombosis and thromboembolization remain large obstacles in the design of cardiovascular devices. In this study, the temporal behavior of thrombus size within a backward-facing step (BFS) model is investigated, as this geometry can mimic the flow separation which has been found to contribute to thrombosis in cardiac devices. Magnetic resonance imaging (MRI) is used to quantify thrombus size and collect topographic data of thrombi formed by circulating bovine blood through a BFS model for times ranging between 10 and 90 min at a constant upstream Reynolds number of 490. Thrombus height, length, exposed surface area, and volume are measured, and asymptotic behavior is observed for each as the blood circulation time is increased. Velocity patterns near, and wall shear stress (WSS) distributions on, the exposed thrombus surfaces are calculated using computational fluid dynamics (CFD). Both the mean and maximum WSS on the exposed thrombus surfaces are much more dependent on thrombus topography than thrombus size, and the best predictors for asymptotic thrombus length and volume are the reattachment length and volume of reversed flow, respectively, from the region of separated flow downstream of the BFS.

Multidisciplinary collaboration as a sustainable research model for device development

The concurrent problems of research sustainability and decreased clinician involvement with medical device development can be jointly addressed through a novel, multidisciplinary solution. The University of Rochester Cardiovascular Device Design Program is a sustainable program in medical device design supported through a collaboration between the Schools of Medicine and Engineering. This article provides a detailed description of the motivation for starting the program, the current structure of the program, the methods of financial sustainability, and the direct impact it intends to have on the national vascular surgery community. The further expansion of this program and encouragement for development of similar programs throughout the country aims to address many of our current challenges in both research funding and device development education.

Chapter 1 Principles of cardiovascular device design

The design of cardiovascular devices is a complex process that is partially, but never completely, illuminated by scientific information and precise specification of the performance wanted of the device. No design satisfies by only accomplishing its intended goal; it must also avoid unintended, unwanted effects, termed in this chapter failure modes. Discussion of these modes is the principal goal of this chapter, which, however, concludes with a discussion of a feasible process of design that can be carried out in the presence of substantial ignorance. Natural components of the cardiovascular system as models for the exploitation of current technology are suggested to be, at least at present, less useful than are precedent artificial systems.