Our Technology
CircuLite is working to commercialize a unique proprietary and patented miniature circulatory assist device, called the Synergy Pocket circulatory assist device, designed to expand the treatment options for chronic heart failure patients.
About Synergy
Our approach to treating heart failure is unique in that our device is designed to work in synergy with the patient’s native heart and physiological function. The device works with the patient’s heart to increase total cardiac output and decrease left ventricular end diastolic pressure. This is designed to allow the patient’s heart to rest while relieving the symptoms of heart failure with the intention of improving their quality of life.
In its ultimate embodiment, the Synergy Pocket Circulatory Assist device combines a superficially positioned micro-pump with inflow and outflow cannulae placed with endovascular techniques (Figure 1). Blood is drawn from the Left Atrium via the Inflow Cannula that is connected to the micro-pump which pumps the blood back to the body via the Outflow Graft to the Subclavian Artery.
| Figure 1: Synergy Endovascular Implantation |
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Mode of Action
The Synergy Pocket Circulatory Assist device works in synergy with the patient's native heart function and pumps up to 3 liters of blood per minute (partial circulatory assist) to increase the total cardiac output (blood to body).
The hemodynamic effects of partial circulatory assist were assessed in a computer-based heart failure simulation model which predicts partial circulatory assist of 2 to 3 liter of blood flow per minute1:
• Decreases left ventricular end diastolic pressure by 7 to 10 mm Hg
• Provides significant pressure and volume unloading of the native heart
• Increases net cardiac output by ~ 1 liter of blood flow per minute
The hemodynamic effects of partial circulatory assist have also been reported in a small, single center study. Twenty patients supported on HeartMate™ VE Ventricular Assist Device (VAD), were assessed on full assist (approximately 5 liters of blood flow per minute) and partial assist (approximately 1.6 liters of blood flow per minute) which was achieved by reducing the device’s cycles per minutes setting. The authors concluded that partial circulatory assist2:
• Improved peak VO2 consumption
• Improved myocardial function
Synergy Micro-pump
The Synergy Pocket Circulatory Assist device features a micro-implantable blood pump which can be superficially placed, allowing the system to be placed with endovascular techniques.
The Synergy device micro-pump’s development began in 1999 at the Helmholtz Institute for Biomedical Engineering in Aachen, Germany, one of the world’s leading centers for blood pump technology development. Over these years of development, the Synergy device micro-pump has been refined to be the smallest implantable blood pump and has several unique features that are designed to minimize the risk of thrombus formation and hemolysis.
The Synergy device micro-pump combines axial, centrifugal and orthogonal flow paths with a single-stage impeller that is powered by an integrated brushless micro-electric motor (Figure 2). The micro-pump is the size of a AA battery with an outer body diameter of 14 mm, length of 49 mm, weight of 25 grams (Figure 3) and pumps up to 3 liters of blood per minute.
| Figure 2: Micro-pump blood flow path |
Figure 3: Synergy micro-pump |
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The Synergy device micro-pump design features a unique magnetically and hydrodynamically levitated and stabilized impeller design. The design allows the motor to be sealed thus eliminating blood contact in the motor and the potential of thrombosis formation. The micro-pump also features a proprietary self-washing flow path that minimizes the risk of thrombus formation in or around the impeller.
Synergy Power System
A lightweight, rechargeable dual battery pack system and controller have been designed to control and power the Synergy Pocket Circulatory Assist device (Figure 4). The power system weighs approximately 6 pounds and the dual battery pack will power the system for approximately 8-12 hours. The controller provides the patient with information on the battery status and alerts the patient to any change that needs attention (alarms). The micro-pump is connected to the power system via a Percutaneous Lead that exits the body in the abdominal area. The power system is designed to allow un-tethered (not connected to an electrical outlet) patient mobility and a return to activities of daily living.
| Figure 4: Power System |
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| Since the Synergy Pocket Circulatory Assist device works in conjunction with the patient’s native cardiac flow and function, there is a built in “fail-safe” mechanism in the event of an accidental power disconnect. The patient would be supported by their native cardiac flow (“fail-safe” mechanism) until they are able to restore power. |
1 D. Morley, et al. Journal of Thoracic and Cardiovascular Surgery, 2006; 132:459-463.
2 S. Maybaum, et al. Journal of Heart and Lung Transplant, 2002 Apr; 21(4): 446-54.
