Integrating a novel shape memory polymer into surgical meshes decreases placement time in laparoscopic surgery: an in vitro and acute in vivo study.

About 600,000 hernia repair surgeries are performed each year; recently, the use of laparoscopic minimally invasive techniques has become increasingly popular in these operations. Use of surgical mesh in hernia repair has shown lower recurrence rates compared to other repair methods. However in many procedures, placement of surgical mesh can be challenging and even complicate the procedure, potentially leading to lengthy operating times. Various techniques have been attempted to improve mesh placement, including use of specialized systems to orient the mesh into a specific shape, with limited success and acceptance. In this study, a programmed novel Shape Memory Polymer (SMP) was integrated into commercially available polyester surgical meshes to add automatic unrolling and tissue conforming functionalities, while preserving the intrinsic structural properties of the original surgical mesh. Tensile testing and Dynamic Mechanical Analysis was performed on four different SMP formulas to identify appropriate mechanical properties for surgical mesh integration. In vitro testing involved monitoring the time required for a modified surgical mesh to deploy in a 37°C water bath. An acute porcine model was used to test the in vivo unrolling of SMP integrated surgical meshes. The SMP-integrated surgical meshes produced an automated, temperature activated, controlled deployment of surgical mesh on the order of several seconds, via laparoscopy in the animal model. Results indicate surgical mesh modified with SMP is capable of laparoscopic deployment in vivo, activated by body temperature. This suggests a reduction in surgical operating time and improved mesh placement characteristics is possible with SMP-integrated surgical meshes.

An artificial right ventricle for failing fontan: in vitro and computational study.

BACKGROUND: The aim of this study is to develop a destination low-pressure artificial right ventricle (ARV) to correct the impaired hemodynamics in the failing Fontan circulation. METHODS: An in vitro model circuit of the Fontan circulation was created to reproduce the hemodynamics of the failing Fontan and test ARV performance under various central venous pressures (CVP) and flows. A novel geometry of the extracardiac conduit was designed to adapt to the need of the pump. The ARV was a low-pressure axial flow pump designed to produce a low suction inflow pressure and moderate outflow increase. With the power off, the passive forward gradient across the propeller is 2 mm Hg at 4.5 L/min. The ARV would require 4 watts at a rotation of 5000 rpm. To examine the shear loading on the red blood cells, virtual particles were injected upstream of the ARV inducer and tracked by computerized modeling. RESULTS: The effect of the ARV on the failing Fontan was studied at various CVP pressures and flows, and under constant values of lung resistances and left atrial pressure set respectively to 2.5 Woods Units and 7 mm Hg. The CVP pressures decreased respectively from 25, 22.5, 20, 17.5, 15, and 10 mm Hg to a minimal value of 2 to 5 mm Hg with a pump speed varying from 1700 to 4500 rpm. The pulmonary artery pressures increased moderately between 12.5 and 25 mm Hg at 4500 rpm. Cardiac output at 4500 rpm was increased by an average gain of 2 L/min. The average blood damage index was 0.92%, far below the 5% value considered to cause hemolysis. The flow structure produced by the pump was suitable. CONCLUSIONS: The performance of this novel low-pressure ARV was satisfactory, showing good decrease of CVP pressures, a moderate increase of pulmonary artery pressures, adequate increase of cardiac output, and minimal hemolysis. The use of a mock Fontan model circuit facilitates device prototyping and design to a far greater extent than can be achieved using animal studies, and is an essential first step for rapid design iteration of a novel ARV device. The next steps are the manufacturing of this device, including an electromagnetic engine, a regulatory system, and further testing the device in a survival animal experiment.

Initial experience with the development and numerical and in vitro studies of a novel low-pressure artificial right ventricle for pediatric Fontan patients.

The Fontan operation, an efficient palliative surgery, is performed for patients with single-ventricle pathologies. The total cavopulmonary connection is a preferred Fontan procedure in which the superior and inferior vena cava are connected to the left and right pulmonary artery. The overall goal of this work is to develop an artificial right ventricle that can be introduced into the inferior vena cava, which would act to reverse the deleterious hemodynamics in post-Fontan patients. We present the initial design and computational analysis of a micro-axial pump, designed with the particular hemodynamics of Fontan physiology in mind. Preliminary in vitro data on a prototype pump are also presented. Computational studies showed that the new design can deliver a variety of advantageous operating conditions, including decreased venous pressure through proximal suction, increased pressure rise across the pump, increased pulmonary flows, and minimal changes in superior vena cava pressures. In vitro studies on a scaled prototype showed trends similar to those seen computationally. We conclude that a micro-axial flow pump can be designed to operate efficiently within the low-pressure, low-flow environment of cavopulmonary flows. The results provide encouragement to pursue this design to for in vitro studies and animal studies.