Intra-aortic and intra-ventricular cardiac assist devices are well known in the art. These devices are generally used to reduce the heart's work load after insult or surgery. They may also be used to increase blood flow from the left ventricle of the heart into the aorta in cases of insufficient cardiac output due, for example, to acute or chronic heart ailments or to interference with normal cardiac function during surgery.
One of the best-known and most widely-used intra-aortic pump systems is the Intra-Aortic Balloon Pump (IABP), comprising a catheter, having an inflatable balloon at its distal end, which is inserted through an artery into the aorta. The balloon is then alternately inflated and deflated by an external pump drive, so as to alternately block and unblock blood flow through the aorta, in synchrony with the beating of the heart, in order to assist the left ventricle in propelling blood into the arterial system. The IABP, however, provides only limited augmentation of the heart's natural, unassisted output, and is not adequate for overcoming heart failure.
U.S. Pat. No. 4,014,317, which is incorporated herein by reference, describes a cardiocirculatory assist cannula with a balloon pump and cardiac pacing electrode. The cannula is inserted percutaneously through the aorta so that its distal end is inside the left ventricle of the heart. During systole, inlet valves on the cannula inside the left ventricle open, and the contraction of the ventricle forces blood to flow into the cannula. Then, during diastole, the blood flows out, into the aorta, through one or more outlet valves along the cannula downstream from the inlet valve. A gas-filled balloon, similar in function to the IABP described above, is connected to the cannula downstream of the outlet valves. The balloon is typically inflated during diastole and deflated during systole, to assist in perfusion of the coronary arteries. The cannula has a small stroke volume, however, and relies on the contractile force of the heart to pump the blood. It is therefore of limited usefulness in augmenting the blood output of a weakened or failing heart.
U.S. Pat. No. 4,906,229, which is also incorporated herein by reference, describes a high-frequency transvalvular axisymmetric blood pump. The pump includes a small internal volume, which may be alternately expanded and reduced by pneumatic or hydraulic pressure which is exerted via a flexible membrane radially surrounding the volume. The volume has intake and outlet ends, with one-way axial valves at both of the ends, so that blood can flow only from the heart into the aorta. The pump is connected via the one-way intake valve to a cannula, which is inserted into the left ventricle of the heart through the aortic valve. When the internal volume is expanded, blood flows into the pump from the ventricle. The volume is then reduced, and the blood is ejected into the aorta through the outlet end. This pump is designed to operate at a frequency of 600 to 1,000 cycles per minute. Since the stroke volume of the pump is typically only about 3-5 cc, these high cycle rates are needed in order to provide adequate perfusion.
In the Hemopump Cardiac Assist System, distributed by Johnson & Johnson Interventional Systems, a cannula containing a special, miniature rotor pump mechanism is inserted into the aorta. The pump is driven by a drive unit outside the body, to pump blood continuously from the aorta into the rest of the arterial system, thereby supplementing the heart's natural output rate. A system of this type is similarly described in U.S. Pat. No. 5,092,844, which is incorporated herein by reference. While continuous-flow devices are useful for short-term augmentation of cardiac output, it is believed that pulsatile pumps provide more effective long-term support, since they approximate more closely the natural pump action of the heart.