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A tubular pediatric ventricular assist device. Design considerations and system characteristics
1ABIOMED R&D, Inc., Danvers, Massachusetts 01923, USA.
Insights
A novel tubular ventricular assist device offers a reliable, low-cost solution for critically ill pediatric heart failure patients. This pump provides essential circulatory support as a bridge to transplant or for short-term recovery.
Area of Science:
- Biomedical Engineering
- Pediatric Cardiology
- Medical Device Design
Background:
- Critically ill children with heart failure require advanced circulatory support.
- Existing ventricular assist devices may not be optimal for all pediatric patients.
- A need exists for short-term, reliable, and cost-effective pediatric ventricular assist devices.
Purpose of the Study:
- To present the design and characteristics of a novel tubular ventricular assist device for pediatric use.
- To evaluate the feasibility and performance of this new device in critically ill infants and children.
- To address the clinical need for short-term mechanical circulatory support in pediatric heart failure.
Main Methods:
- Development of a tubular pump with integrated inflow and outflow valves.
- Pneumatic actuation of the inflow valve and pump chamber via a single drive line.
- In vitro and in vivo characterization of a 5 ml stroke volume prototype device.
Main Results:
- The tubular design facilitates simple fabrication, potentially leading to a reliable and low-cost device.
- The prototype pump achieved a flow rate of 0.5 L/min at 100 beats per minute.
- The device demonstrated successful function in both in vitro and in vivo settings, with potential for larger stroke volumes.
Conclusions:
- The presented tubular ventricular assist device is a promising option for short-term mechanical circulatory support in pediatric heart failure.
- Its simple, integrated design offers advantages in fabrication, reliability, and cost.
- Further development and clinical application could significantly benefit critically ill infants and children awaiting heart transplantation or recovery.
Abstract:
A clinical need exists for the short-term use of pediatric ventricular assist device in children and small infants who are critically ill with heart failure unresponsive to pharmacologic support or, in the case of irreversible heart failure, as a bridge to a transplant device. The design considerations and device characteristics of a tubular pump are presented. The device consists of an integrally formed inflow valve, pump chamber, and outflow valve in a tubular construction. This design approach was selected due to its simplicity of fabrication, which can result in a reliable and low cost device. The inflow valve and pump are actuated pneumatically through a single drive line. The outflow valve can be either actively actuated or operated passively. A 5 ml stroke volume device was built and characterized in vitro and in vivo. This pump can generate 0.5 L/min at 100 beats per minute. Larger stroke volume devices can be and have been fabricated using the same principle.