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Waltham, MA, United States

Wu Z.J.,University of Maryland Baltimore County | Gellman B.,Thoratec Corporation | Zhang T.,University of Maryland Baltimore County | Taskin M.E.,University of Maryland Baltimore County | And 2 more authors.
Cardiovascular Engineering and Technology | Year: 2011

The pediatric pump-lung (PediPL) is a miniaturized integrated pediatric pump-oxygenator specifically designed for cardiac or cardiopulmonary support for patients weighing 5-20 kg to allow mobility and extended use for 30 days. The PediPL incorporates a magnetically levitated impeller with uniquely configured hollow fiber membranes (HFMs) into a single unit capable of performing both pumping and gas exchange. A combined computational and experimental study was conducted to characterize the functional and hemocompatibility performances of this newly developed device. The three-dimensional flow features of the PediPL and its hemolytic characteristics were analyzed using computational fluid dynamics based modeling. The oxygen exchange was modeled based on a convection-diffusion-reaction process. The HFMs were modeled as a porous medium which incorporates the flow resistance in the bundle by an added momentum sink term. The pumping function was evaluated for the required range of operating conditions (0.5-2.5 L/min and 1000-3000 rpm). The blood damage potentials were further analyzed in terms of flow and shear stress fields, and the calculations of hemolysis index. In parallel, the hydraulic pump performance, oxygen transfer, and hemolysis level were quantified experimentally. Based on the computational and experimental results, the PediPL is found to be functional to provide necessary oxygen transfer and blood pumping requirements for the pediatric patients. Smooth blood flow characteristics and low blood damage potential were observed in the entire device. The in vitro tests further confirmed that the PediPL can provide adequate blood pumping and oxygen transfer over the range of intended operating conditions with acceptable hemolytic performance. The rated flow rate for oxygenation is 2.5 L/min. The normalized index of hemolysis is 0.065 g/100 L at 1.0 L/min and 3000 rpm. © 2011 Biomedical Engineering Society. Source


Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase II | Award Amount: 1.40M | Year: 2008

DESCRIPTION (provided by applicant): Chronic lung disease remains America's third largest cause of death. Adult respiratory distress syndrome (ARDS) alone afflicts approximately 150,000 patients every year with a mortality rate between 30-70%. Current ther apy for respiratory failure includes mechanical ventilation and extracorporeal membrane oxygenation (ECMO). Mechanical ventilation is effective for short term support, yet the sustained tidal volumes and airway pressures often used may also damage the lung s via barotrauma, volutrauma, and other iatrogenic injuries. While ECMO systems simulate physiological gas exchange, these systems are limited by the complexity of its operation, bleeding, and reduced patient mobility. These factors lead to the need for hi gher than desired priming volumes and membrane surface areas. In order to overcome these limitations, we propose to develop an integrated maglev pump-oxygenator (IMPO), which incorporates durable membranes and magnetically levitated blood pump technology t o produce a highly efficient respiratory support system with low priming volumes. The IMPO is intended to be a self-contained blood pump and blood oxygenator assembly enabling rapid deployment for a patient requiring ECMO or trauma support for 3 to 14 days or longer. In Phase I of the project, we modeled, fabricated and tested a prototype IMPO device and assessed its gas transfer efficiency and biocompatibility in vitro and in vivo. In the current Phase II research, we intend to complete the design and vali dation of the IMPO device, to assess in vivo performance and biocompatibility, and to launch device readiness testing in anticipation of clinical trials. Accordingly, our specific aims include: Specific Aim 1: Design the IMPO system with optimized pump- im peller and fiber configuration to maximize oxygen transfer and biocompatibility. Specific Aim 2. Complete IMPO fabrication and perform in vitro assessment of oxygen transfer and biocompatibility. Specific Aim 3. Demonstrate hemodynamic performance and bioc ompatibility of the IMPO in an animal model. Successful completion of this project will result in the development of a portable pump oxygenator system characterized by improved hemocompatibility and oxygen efficiency. We anticipate that such as system will be capable of providing long term respiratory support (weeks to months) and thus should have significant impact on the reduction of mortality due to severe, acute respiratory disorders.7. Narrative Lung disease is the third largest cause of death in the United States of America, accounting for approximately 1 out of every 7 adult deaths. It is estimated that 30 million Americans are living with chronic lung disease. The current technology for respiratory failure is complex, is associated with multi ple complications and is very costly. The proposed Integrated Membrane Pump Oxygenator (IMPO) is a simple, portable and affordable technology designed to provide a better option for the treatment of these patients with severe, acute potentially reversible respiratory failure.


Trademark
Levitronix | Date: 2007-08-03

rotary pumps for liquids. circulatory assist devices, namely, blood pumps and associated controls for stabilizing blood flow for providing circulatory support during cardiac intervention; percutaneous assist devices, namely, blood pumps, cannulae and associated controls for connection to a circulatory system via cannulae inserted through the skin for stabilizing blood flow and providing circulatory support during cardiac intervention; implantable assist devices, namely, blood pumps and associated controls for implantation in a patient.


Trademark
Thoratec Llc and Levitronix | Date: 2010-11-23

rotary pumps for liquids. circulatory assist devices, namely, blood pumps and associated controls for stabilizing blood flow for providing circulatory support during cardiac intervention; percutaneous assist devices, namely, blood pumps, cannulae and associated controls for connection to a circulatory system via cannulae inserted through the skin for stabilizing blood flow and providing circulatory support during cardiac intervention; implantable assist devices, namely, blood pumps and associated controls for implantation in a patient.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 166.44K | Year: 2003

DESCRIPTION (provided by applicant): This project seeks to address a particular unmet need for mechanical circulatory support in children with heart failure. Pediatric heart patients possess several unique features, such as small body size, reduced blood volume, and altered hemodynamic properties. We have sought to account for these features by developing a miniature, low-cost, centrifugal left ventricular assist device for use as an extracorporeal mechanical support system. Our approach will feature a magnetically levitated, and thus friction-less, rotor/stator configuration, which efficiently generates flow, with minimum hemolysis. The major advantages of the current design are its small and relatively simple extracorporeal design, its ability to efficiently regulate pump output over a large range of flow conditions, and its ease of production. This program's overall goal will be to demonstrate that the hemodynamic performance and degree of biocompatibility for the magnetically levitated, centrifugal pump support is appropriate for children with severe heart failure. We contend that the development of a small, inexpensive pump, which requires a minimal priming volume, and which eliminates seals and bearings, is highly desirable. The specific aims of this proposal are as follows: 1) Design and fabricate a pediatric blood pump and motor. 2) Fabricate the system controller, employing optimized flow regulation and power use. 3) Determine pressure-flow characteristics of the ventricular assist device over the range of cardiac output conditions spanning neonates to young children (0.3 to 1.5 L/min). 4) Determine hemolysis levels over the expected range of cardiac outputs. 5) Perform preliminary in vitro endurance testing for the blood pump. 6) Conduct three short-term (< 24 hours) in vivo experiments to demonstrate hemodynamic performance and biocompatibility, and, thus, suitability, of the device for the intended application. We believe that our technology, which provides effective left ventricular assistance with a small, disposable device, may provide needed benefits to the health of children with severe cardiac disease, while not adding significantly to cost of caring for these patients. If we successfully meet the Phase I goals, we will propose in a Phase II program to refine the mechanical design with respect to manufacturing, optimize the ventricular assist control console (with appropriate safety and alarm systems), and expand the in vivo data to include longer-term animal experiments. This would provide a database to support the use of our device for durations consistent with current clinical practice for short-term mechanical support for children.

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