Development and initial testing of a permanently implantable centrifugal pump

Area of Science:

• Biomedical Engineering
• Cardiovascular Devices
• Medical Device Development

Background:

• Increasing demand for economical permanent ventricular assist devices (VADs) to manage heart failure.
• Need for miniaturized, implantable blood pumps to improve patient outcomes.
• Limitations of existing VADs in terms of size, thrombogenicity, and cost.

Purpose of the Study:

• To develop and evaluate a miniaturized, permanently implantable centrifugal blood pump (Gyro PI-601) for VAD applications.
• To assess the hydraulic performance, hemocompatibility, and implantability of the novel blood pump.
• To explore the feasibility of using the device as a biventricular assist device.

Main Methods:

• Development of a sealless centrifugal blood pump with magnetic coupling and a double pivot bearing system.
• In vitro testing of hydraulic performance, including flow rate and pressure head at various speeds.
• Evaluation of hemolysis using the normalized index of hemolysis (NIH).
• Preliminary anatomical study for assessing implantability in biventricular bypass configurations.

Main Results:

• The Gyro PI-601 pump achieved 5 L/min at 110 mm Hg and 8 L/min at 150 mm Hg.
• Demonstrated a low normalized index of hemolysis (NIH) of 0.0028 g/100 L at 5 L/min against 100 mm Hg.
• Preliminary studies indicated feasibility for implantation as a biventricular assist device.

Conclusions:

• The miniaturized Gyro PI-601 centrifugal blood pump is a feasible option for permanent VAD implantation.
• The pump's sealless, atraumatic, and antithrombogenic design addresses key challenges in VAD technology.
• The device shows potential for use in biventricular assist applications, offering a novel solution for advanced heart failure treatment.