Improving hydraulic performance of the left atrial assist device using computational fluid dynamics.

Background: The left atrial assist device (LAAD) is a novel continuous-flow pump designed to treat patients with heart failure with preserved ejection fraction, a growing type of heart failure, but with limited device-treatment options. The LAAD is implanted in the mitral plane and pumps blood from the left atrium into the left ventricle. The purpose of this study was to refine the initial design of the LAAD, using results from computational fluid dynamics (CFD) analyses to inform changes that could improve hydraulic performance and flow patterns within the LAAD.

Feasibility of an implantable bioreactor for renal cell therapy using silicon nanopore membranes.

The definitive treatment for end-stage renal disease is kidney transplantation, which remains limited by organ availability and post-transplant complications. Alternatively, an implantable bioartificial kidney could address both problems while enhancing the quality and length of patient life. An implantable bioartificial kidney requires a bioreactor containing renal cells to replicate key native cell functions, such as water and solute reabsorption, and metabolic and endocrinologic functions.

A Critical Comparison of Comparators Used to Demonstrate Credibility of Physics-Based Numerical Spine Models.

The ability of new medical devices and technology to demonstrate safety and effectiveness, and consequently acquire regulatory approval, has been dependent on benchtop, in vitro, and in vivo evidence and experimentation. Regulatory agencies have recently begun accepting computational models and simulations as credible evidence for virtual clinical trials and medical device development. However, it is crucial that any computational model undergo rigorous verification and validation activities to attain credibility for its context of use before it can be accepted for regulatory submission.

Characterization and Development of Universal Ventricular Assist Device: Computational Fluid Dynamics Analysis of Advanced Design.

We are developing a universal, advanced ventricular assist device (AVAD) with automatic pressure regulation suitable for both left and right ventricular support. The primary goal of this computational fluid dynamics (CFD) study was to analyze the biventricular performance of the AVAD across its wide range of operating conditions. An AVAD CFD model was created and validated using in vitro hydraulic performance measurements taken over conditions spanning both left ventricular assist device (LVAD) and right ventricular assist device (RVAD) operation.

Computational Fluid Dynamics Model of Continuous-Flow Total Artificial Heart: Right Pump Impeller Design Changes to Improve Biocompatibility.

Cleveland Clinic is developing a continuous-flow total artificial heart (CFTAH). This novel design operates without valves and is suspended both axially and radially through the balancing of the magnetic and hydrodynamic forces. A series of long-term animal studies with no anticoagulation demonstrated good biocompatibility, without any thromboemboli or infarctions in the organs.

Total Artificial Heart Computational Fluid Dynamics: Modeling of Stator Bore Design Effects on Journal-Bearing Performance.

Cleveland Clinic's continuous-flow total artificial heart (CFTAH) is a double-ended centrifugal blood pump that has a single rotating assembly with an embedded magnet, which is axially and radially suspended by a balance of magnetic and hydrodynamic forces. The key to the radial suspension is a radial offset between the stator bearing bore and the magnet's steel laminations. This offset applies a radial magnetic force, which is balanced by a hydrodynamic force as the rotating assembly moves to a "force-balanced" radial position.

Microfluidic chip for graduated magnetic separation of circulating tumor cells by their epithelial cell adhesion molecule expression and magnetic nanoparticle binding.

The enumeration of circulating tumor cells (CTCs) in the peripheral bloodstream of metastatic cancer patients has contributed to improvements in prognosis and therapeutics. There have been numerous approaches to capture and counting of CTCs. However, CTCs have potential information beyond simple enumeration and hold promise as a liquid biopsy for cancer and a pathway for personalized cancer therapy by detecting the subset of CTCs having the highest metastatic potential.

Assessing Computational Model Credibility Using a Risk-Based Framework: Application to Hemolysis in Centrifugal Blood Pumps.

Medical device manufacturers using computational modeling to support their device designs have traditionally been guided by internally developed modeling best practices. A lack of consensus on the evidentiary bar for model validation has hindered broader acceptance, particularly in regulatory areas. This has motivated the US Food and Drug Administration and the American Society of Mechanical Engineers (ASME), in partnership with medical device companies and software providers, to develop a structured approach for establishing the credibility of computational models for a specific use.

Original article submission: Platelet stress accumulation analysis to predict thrombogenicity of an artificial kidney.

An implantable artificial kidney using a hemofilter constructed from an array of silicon membranes to provide ultrafiltration requires a suitable blood flow path to ensure stable operation in vivo. Two types of flow paths distributing blood to the array of membranes were evaluated: parallel and serpentine. Computational fluid dynamics (CFD) simulations were used to guide the development of the blood flow paths.

Thrombotic Depositions on Right Impeller of Double-Ended Centrifugal Total Artificial Heart In Vivo.

The development of total artificial heart devices is a complex undertaking that includes chronic biocompatibility assessment of the device. It is considered particularly important to assess whether device design and features can be compatible long term in a biological environment. As part of the development program for the Cleveland Clinic continuous-flow total artificial heart (CFTAH), we evaluated the device for signs of thrombosis and biological material deposition in four animals that had achieved the intended 14-, 30-, or 90-day durations in each respective experiment.

The impact of spinal cord nerve roots and denticulate ligaments on cerebrospinal fluid dynamics in the cervical spine.

Cerebrospinal fluid (CSF) dynamics in the spinal subarachnoid space (SSS) have been thought to play an important pathophysiological role in syringomyelia, Chiari I malformation (CM), and a role in intrathecal drug delivery. Yet, the impact that fine anatomical structures, including nerve roots and denticulate ligaments (NRDL), have on SSS CSF dynamics is not clear. In the present study we assessed the impact of NRDL on CSF dynamics in the cervical SSS.

Progress on the design and development of the continuous-flow total artificial heart.

Cleveland Clinic's continuous-flow total artificial heart has one motor and one rotating assembly supported by a hydrodynamic bearing. The right hydraulic output is self regulated by passive axial movement of the rotating assembly to balance itself with the left output. The purpose of this article is to present progress in four areas of development: the automatic speed control system, self-regulation to balance right/left inlet pressures and flows, hemolysis testing using calf blood, and coupled electromagnetics (EMAG) and computational fluid dynamics (CFD) analysis.

In vitro performance of the novel coronary sinus AutoRetroPerfusion Cannula.

Myocardial salvage through coronary sinus intervention has been documented. The AutoRetroPerfusion Cannula is a novel device that is able to perfuse the coronary bed retrogradely through the coronary sinus with arterial blood generated from a peripheral artery with no need for a pump. The cannula consists of a distal end that, once secured in the coronary sinus, opens an umbrella-like membrane to create pressure in the coronary sinus, and at the same time has small channels directed backwards to the right atrium to provide pressure relief.