The evolution of ventriculoperitoneal shunt valves and why they fail.

This paper reviews the historical progression of ventriculoperitoneal shunt valve designs with the goal of providing an understanding of their functionality and failure mechanisms. While shunting is the predominant treatment for hydrocephalus, the statistics of overall shunt failure remain high, and valve failure is responsible for a significant percentage of revision surgeries. Therefore, this review spans valve evolution from an engineering perspective with an emphasis on discussing potential failure mechanisms and patient specific valve selection.

Investigation of stent retriever removal forces in an experimental model of acute ischemic stroke.

Introduction: Mechanical thrombectomy becomes more complex when the occlusion occurs in a tortuous cerebral anatomy, increasing the puncture to reperfusion time and the number of attempts for clot removal. Therefore, an understanding of stent retriever performance in these locations is necessary to increase the efficiency and safety of the procedure. An investigation into the effects of occlusion site tortuosity, blood clot hematocrit, and device geometry was conducted to identify their individual influence on stent retriever removal forces.

Investigation of cardiopulmonary bypass parameters on embolus transport in a patient-specific aorta.

Neurological complexities resulting from surgery requiring cardiopulmonary bypass (CPB) remain a major concern, encompassing a spectrum of complications including thromboembolic stroke and various cognitive impairments. Surgical manipulation during CPB is considered the primary cause of these neurological complications. This study addresses the overall lack of knowledge concerning CPB hemodynamics within the aorta, employing a combined experimental-computational modeling approach, featuring computational fluid dynamics simulations validated with an in vitro CPB flow loop under steady conditions.

Experimental evaluation of the plunger technique: A method of cyclic manual aspiration thrombectomy for treatment of acute ischemic stroke.

Background: Mechanical thrombectomy via direct aspiration is a rapid treatment for acute ischemic stroke. This method often results in the partial ingestion of the clot or "corking" of the catheter tip. Cyclic aspiration may take advantage of the mechanical properties of the clot, resulting in greater clot ingestion and overall procedure success.

Analysis of frictional forces in experimental models of stent retriever mechanical thrombectomy.

Acute ischemic stroke (AIS) and mechanical thrombectomy (MT) are commonly studied in vitro using cerebral artery models made of nonbiological materials. However, these models often report higher recanalization rates than those observed clinically, suggesting a discrepancy between experimental models and clinical settings. We believe this may be partly due to the frictional interactions between blood clots, stent retrievers (SRs), and the vessel walls.

Effect of Hematocrit and Elevated Beat Rate on the 12cc Penn State Pediatric Ventricular Assist Device.

Congenital heart disease affects approximately 40,000 infants annually in the United States with 25% requiring invasive treatment. Due to limited number of donor hearts and treatment options available for children, pediatric ventricular assist devices (PVADs) are used as a bridge to transplant. The 12cc pneumatic Penn State PVAD is optimized to prevent platelet adhesion and thrombus formation at patient nominal conditions; however, children demonstrate variable blood hematocrit and elevated heart rates.

A MALDI Mass Spectrometry Imaging Sample Preparation Method for Venous Thrombosis with Initial Lipid Characterization of Lab-Made and Murine Clots.

Venous thromboembolism (VTE) and its complications affect over 900,000 people in the U.S. annually, with a third of cases resulting in fatality.

The influence of blood composition and loading frequency on the behavior of embolus analogs.

In cases of acute ischemic stroke (AIS), mechanical thrombectomy (MT) can be used to directly remove lodged thromboemboli. Despite improvements in patient outcomes, one of the key factors affecting MT success is the mechanical properties of the occlusive thrombus. Therefore, the goal of this study was to investigate the viscoelastic properties of embolus analogs (EAs) and determine the influence of EA hematocrit and loading frequency.

Computational Investigation of Anastomosis Options of a Right-Heart Pump to Patient Specific Pulmonary Arteries.

Patients with Fontan circulation have increased risk of heart failure, but are not always candidates for heart transplant, leading to the development of the subpulmonic Penn State Fontan Circulation Assist Device. The aim of this study was to use patient-specific computational fluid dynamics simulations to evaluate anastomosis options for implanting this device. Simulations were performed of the pre-surgical anatomy as well as four surgical options: a T-junction and three Y-grafts.

Computational Modeling of the Penn State Fontan Circulation Assist Device.

To address the increasing number of failing Fontan patients, Penn State University and the Penn State Hershey Medical Center are developing a centrifugal blood pump for long-term mechanical support. Computational fluid dynamics (CFD) modeling of the Penn State Fontan Circulatory Assist Device (FCAD) was performed to understand hemodynamics within the pump and its potential for hemolysis and thrombosis. CFD velocity and pressure results were first validated against experimental data and found to be within the standard deviations of the velocities and within 5% of the pressures.

The effects of non-Newtonian blood modeling and pulsatility on hemodynamics in the food and drug administration's benchmark nozzle model.

Background: Computational fluid dynamics (CFD) is an important tool for predicting cardiovascular device performance. The FDA developed a benchmark nozzle model in which experimental and CFD data were compared, however, the studies were limited by steady flows and Newtonian models.

Objective: Newtonian and non-Newtonian blood models will be compared under steady and pulsatile flows to evaluate their influence on hemodynamics in the FDA nozzle.

Experimental Hemodynamics Within the Penn State Fontan Circulatory Assist Device.

For children born with a single functional ventricle, the Fontan operation bypasses the right ventricle by forming a four-way total cavopulmonary connection and adapts the existing ventricle for the systemic circulation. However, upon reaching adulthood, many Fontan patients exhibit low cardiac output and elevated venous pressure, eventually requiring a heart transplantation. Despite efforts in developing a new device or using an existing device for failing Fontan support, there is still no Food and Drug Administration-approved device for subpulmonary support.

Hydrodynamics in Acute Ischemic Stroke Catheters Under Static and Cyclic Aspiration Conditions.

Purpose: Previous studies have suggested improved recanalization efficiency by using cyclic aspiration as opposed to static aspiration for mechanical thrombectomy in the treatment of acute ischemic stroke (AIS). However, there has not been an investigation into which parameters optimize this theoretical approach. Therefore, this study was designed to investigate the application of static and cyclic pressure in AIS aspiration catheters.

Computational modeling of the Food and Drug Administration's benchmark centrifugal blood pump.

In order to simulate hemodynamics within centrifugal blood pumps and to predict pump hemolysis, CFD simulations must be thoroughly validated against experimental data. They must also account for and accurately model the specific working fluid in the pump, whether that is a blood-analog solution to match an experimental PIV study or animal blood in a hemolysis experiment. Therefore, the Food and Drug Administration (FDA) benchmark centrifugal blood pump and its database of experimental PIV and hemolysis data were used to thoroughly validate CFD simulations of the same blood pump.

Development of a computational model for acute ischemic stroke recanalization through cyclic aspiration.

Acute ischemic stroke (AIS), the result of embolic occlusion of a cerebral artery, is responsible for 87% of the 6.5 million stroke-related deaths each year. Despite improvements from first-generation thrombectomy devices for treating AIS, 80% of eligible stroke patients will either die or suffer a major disability.

Inter-Laboratory Characterization of the Velocity Field in the FDA Blood Pump Model Using Particle Image Velocimetry (PIV).

Purpose: A credible computational fluid dynamics (CFD) model can play a meaningful role in evaluating the safety and performance of medical devices. A key step towards establishing model credibility is to first validate CFD models with benchmark experimental datasets to minimize model-form errors before applying the credibility assessment process to more complex medical devices. However, validation studies to establish benchmark datasets can be cost prohibitive and difficult to perform.

Characterizing the HeartMate II Left Ventricular Assist Device Outflow Using Particle Image Velocimetry.

Ventricular assist devices (VADs) are implanted in patients with a diseased ventricle to maintain peripheral perfusion as a bridge-to-transplant or as destination therapy. However, some patients with continuous flow VADs (e.g.

Asynchronous Pumping of a Pulsatile Ventricular Assist Device in a Pediatric Anastomosis Model.

Background: Both pulsatile and continuous flow ventricular assist devices are being developed for pediatric congenital heart defect patients. Pulsatile devices are often operated asynchronously with the heart in either an "automatic" or a fixed beat rate mode. However, most studies have only investigated synchronized ejection.

FDA Benchmark Medical Device Flow Models for CFD Validation.

Computational fluid dynamics (CFD) is increasingly being used to develop blood-contacting medical devices. However, the lack of standardized methods for validating CFD simulations and blood damage predictions limits its use in the safety evaluation of devices. Through a U.

Analysis of Transitional and Turbulent Flow Through the FDA Benchmark Nozzle Model Using Laser Doppler Velocimetry.

Transitional and turbulent flow through a simplified medical device model is analyzed as part of the FDA's Critical Path Initiative, designed to improve the process of bringing medical products to market. Computational predictions are often used in the development of devices and reliable in vitro data is needed to validate computational results, particularly estimations of the Reynolds stresses that could play a role in damaging blood elements. The high spatial resolution of laser Doppler velocimetry (LDV) is used to collect two component velocity data within the FDA benchmark nozzle model.

Continuous and Pulsatile Pediatric Ventricular Assist Device Hemodynamics with a Viscoelastic Blood Model.

To investigate the effects of pulsatile and continuous pediatric ventricular assist (PVAD) flow and pediatric blood viscoelasticity on hemodynamics in a pediatric aortic graft model. Hemodynamic parameters of pulsatility, along with velocity and wall shear stress (WSS), are analyzed and compared between Newtonian and viscoelastic blood models at a range of physiological pediatric hematocrits using computational fluid dynamics. Both pulsatile and continuous PVAD flow lead to a decrease in pulsatility (surplus hemodynamic energy, ergs/cm(3)) compared to healthy aortic flow but with continuous PVAD pulsatility up to 2.

Hemodynamics in a Pediatric Ascending Aorta Using a Viscoelastic Pediatric Blood Model.

Congenital heart disease is the leading cause of infant death in the United States with over 36,000 newborns affected each year. Despite this growing problem there are few mechanical circulatory support devices designed specifically for pediatric and neonate patients. Previous research has been done investigating pediatric ventricular assist devices (PVADs) assuming blood to be a Newtonian fluid in computational fluid dynamics (CFD) simulations, ignoring its viscoelastic and shear-thinning properties.