Novel totally implantable trans-ventricular and cross-valvular cannular pump with rolling bearings and purge system for recovery therapy.

In the early 1990s, Yamazaki et al. developed a partly intra-ventricular pump, which was inserted into the left ventricle via the apex and then into the aorta through the aortic valve. The pump delivered blood flow directly from the left ventricle to the aorta, like a natural heart, and needed no inflow and outflow connecting tubes; it could be weaned off after the left ventricle had been recovered. The shortcomings were that the driving DC motor remained outside of the ventricle, causing an anatomic space problem, and the sealing and bearing were not appropriate for a durable device. Recently, a totally implantable trans-ventricular pump has been developed in the authors' laboratory. The device has a motor and a pump entirely contained within one cannula. The motor has a motor coil with iron core and a rotor with four-pole magnet; the pump has an impeller and an outflow guide vane. The motor part is 60 mm in length and 13 mm in diameter; the pump part is 55 mm in length and 11 mm in diameter. The total length of the device is therefore 115 mm. The total weight of the device is 53 g. The motor uses rolling bearing with eight needles on each side of the rotor magnets. A special purge system is devised for the infusion of saline mixed with heparin through bearing to the pump inlet (30 - 50 cc per hour). Thus neither mechanical wear nor thrombus formation along the bearing will occur. In haemodynamic testing, the pump can produce a flow of 4 l min-1 with 60 mmHg pressure increase, at a pump rotating speed of 12,500 rpm. At zero flow rate, corresponding to the diastolic period of the heart, the pump can maintain aortic blood pressure over 80 mmHg at the same rotating speed. This novel pump can be quickly inserted in an emergency and easily removed after recovery of natural heart. It will be useful for patients with acute left ventricular failure.

World-smallest LVAD with 27 g weight, 21 mm OD and 5 l min-1 flow with 50 mmHg pressure increase.

To investigate the feasibility of a long-term left ventricular assist device (LVAD) placed in the aortic valve annulus, an implantable aortic valve pump (21 mm outer diameter, weighing 27 g) was developed. The device consists of a central rotor and a stator. The rotor assembly incorporates driven magnets and an impeller. The stator assembly has a motor coil with an iron core and outflow guide vanes. The device is to be implanted identically to an aortic valve replacement, occupying no additional anatomic space. The pump delivers the blood directly from left ventricle to the aortic root, like a natural ventricle, therefore causing less physiologic disturbance to the natural circulation. Neither connecting conduits nor 'bypass' circuits are necessary. The pump is designed to cycle between a peak flow and zero net flow to approximate systole and diastole. Bench testing indicates that the pump can produce a blood flow of 5 l min(-1) with 50 mmHg pressure increase at 17,500 rpm. At zero net flow rate, the pump can maintain a diastole aortic pressure against 80 mmHg at the same rotating speed.

World-first implantable aortic valvo-pump (IAVP) with sufficient haemodynamic capacity.

For better anatomic and physiologic fitting, a novel implantable aortic valvo-pump (IAVP) has been developed. A valvo-pump is a micro axial flow impeller pump, which has the same dimensions and function, as well as the same location, of a valve. Therefore, IAVP needs no inlet and outlet tubes, no additional anatomic occupation, and has less physiologic disturbance to natural circulation compared with the traditional bypass left ventricular assist device (LVAD). The device has a stator and a rotor. The stator consists of a motor coil with an iron core and an outflow guide vane; the rotor includes driven magnets and impeller. There is neither bearing nor strut in both the pump and the motor. In order to reduce the attractive force between the rotor and the stator, so as to enhance the durability of the performance, the rotor magnets were minimized without reducing the driving torque and efficiency of the motor. The impeller vane was designed according to a three-dimensional and analytical method, for preventing stasis and turbulence. The largest outer diameter is 24.7 mm and the length at this point is 12.4 mm. The total weight is 40 g (including the rotor of 11 g). The consumed power is 7 W (14 V x 0.5 A) at 15 000 rpm. This rotating speed stays unchanged during haemodynamic testing together with a pulsatile centrifugal pump, which imitates a failing ventricle. The maximal flow cross IAVP reaches over 10 l min(-1) and the pressure head at 0 l min(-1) can be as large as 80 mmHg. At flow rate of 4 - 8 l min(-1), IAVP enlarges the flow c. 1 l min(-1) and meanwhile increases the pressure about 10 mmHg. The pressure pulsatility generated by the pulsatile centrifugal pump remains 40 mmHg after passing IAVP. By first animal experimental trial the device was sewed in aortic position of an 80 kg pig without harm to adjacent tissue and organs. IAVP promises to be a viable alternative to natural donor heart for heart transplantation in the future.

Evaluation of an extraaortic counterpulsation device in severe cardiac failure.

A valveless, single-orifice polyurethane ventricle with a maximum stroke volume of 60 mL was implanted on the brachiocephalic artery just above the aortic arch in sheep (n = 14) to act as an extraaortic counterpulsation device. In parallel, an intraaortic balloon was placed in the descending thoracic aorta. Both devices were pneumatically driven with an intraaortic balloon pump console that was gated by the electrocardiogram to provide aortic diastolic augmentation at a stroke volume of 40 mL. To compare the efficacy of counterpulsation for each device during severe cardiac failure, biventricular block was induced by continuous infusion of esmolol (100 to 600 micrograms.kg-1.min-1), titrated to reduce aortic flow and pressure to less than 75% of baseline. Pulsatile coronary and aortic flows were recorded with ultrasonic flow probes placed around their respective vessels. Aortic root and left ventricular pressures were recorded using micromanometers. The enhancement of hemodynamic variables for both devices were compared for optimal timing conditions, which were defined as inflation set just before the dicrotic notch and deflation bordering on isovolumetric systole. The extraaortic counterpulsation device was able to significantly augment aortic and coronary flows while simultaneously decreasing left ventricular tension time index and aortic end-diastolic pressure (p less than 0.02). The intraarotic balloon pump was able to significantly reduce only tension time index (p less than 0.002) to a lesser extent that the extraaortic counterpulsation device. All analysis was performed with the paired-samples t test. The extraaortic counterpulsation device greatly improves the myocardial oxygen supply-consumption ratio of the left ventricle by increasing diastolic coronary flow and reducing left ventricular wall tension during systole.(ABSTRACT TRUNCATED AT 250 WORDS)

The development of a valveless cardiac assist device attached to the ventricular apex.

Konstantinov et al, in October, 1991, published a novel way to bridge a patient for heart transplantation. They proposed to cut off both ventricles high under the atrioventricular groove, leaving the atria, aorta, and pulmonary artery and their valves intact and to attach pneumatically driven, valveless pulsating pouches to assist the heart until a donor could be found. The removal of the ventricles just below the atrioventricular groove is called the "high cut"; it, however, destroys the chordae tendineae rendering the mitral and tricuspid valves insufficient. These have to be replaced by tissue inflow valves. We chose to cut off the ventricles at a lower level (the "low cut") to leave the papillary muscles on both sides intact, thereby saving the integrity of the mitral and tricuspid valves. Pulsating pouches were made to fit the heart at this lower level. They can be easily connected to the remaining heart after a specially disigned cuff has been sutured over the ventricular stumps. The pouches were pumped during the systole of the natural heart, but the myocardium may have to be electrically stimulated during systole to prevent undue distension. If the turgor is too weak to prevent distension, a sleeve over the ventricles is provided. To find the best location for these pouches, human cadaver implantations were done and the pre peritoneal cavity was found to be the most suitable. In vitro testing to determine how much flow could be pumped was done by attaching the pouches to fresh pig hearts and connecting them to a double sided mock circulation.(ABSTRACT TRUNCATED AT 250 WORDS)

A computer controlled pulsatile pump: preliminary study.

A Stepper Motor Driven Reciprocating Pump (SDRP) can replace roller pumps and rotary pumps for cardio pulmonary bypass, hemodialysis and regional perfusion. The blood pumping ventricles are basically the same as ventricles used for air driven artificial hearts and ventricular assist devices. The electric stepper motor uses a flexible linkage belt to produce a reciprocating movement, which pushes a hard sphere into the diaphragm of the blood ventricles. The SDRP generates pulsatile flow and has a small priming volume. The preset power level of the motor driver limits the maximum potential outflow pressure, so the driver acts as a safety device. A double pump can be made by connecting two fluid pumping chambers to opposing sides of the motor base. Each pump generates pulsatile flow. Pressure and flow studies with water were undertaken. Preliminary blood studies showed low hemolysis, even when circulating a small amount of blood up to 16 hours.

Elastomeric valves, a new design.

The convex bileaflet valve replaces the flat biflap inflow valve designed by Long Sheng Yu and the tricusp semilunair outflow valve. One reason is easier manufacturing. Convex bileaflet valves are developed for the 11, 20, 40, 70 and 140cc ventricles. Testing included curves (Cardiac Output versus Venous Pressure, Cardiac Output versus Heart rate), flow visualization studies, paint and bloodbag studies. The curves and flow visualization were done by connecting ventricles to one of our standard mock circulations. Paint and bloodbag studies were done by connecting the hearts to a bloodbag, but the bag was filled with water for the paint studies. The curves show high cardiac output, even with pumping at high heart rates (150 BPM+). The flow visualization shows a good stream through the sinus Valsalvae. No stagnating flow is visible. The bloodbag studies which provoke thrombosis show it on the edges of the heart valves, and little in the groove between the valve and the sinus Valsalvae. Heparninzation prevents the thrombosis. Results of our tests were good. The convex bileaflet valve seems to have good future.

Molded double lumen silicone skin button for drivelines to an artificial heart.

A one-piece transfer molded double skin button allows two drivelines to pass through the skin and reduces the penetration area by 44%. The use of elastomer HP-100 (Dow Corning) without a reinforcing mesh allows some additional features not possible with hand lay-up techniques. These include "S" curved passages for the lines, double sealing rings within the passages, a sleeve, and a flange, all as one piece of silicone. The sealing rings prevent the leakage of air, create a pocket for a glue seal, and anchor the air line. The sleeve prevents the air lines from putting necrosis-causing pressure on the skin. The flange keeps the button from being pulled out, is covered with Dacron velour, and is a barrier against infection. The shape of the device allows the air lines to be tunneled under the skin and exited parallel to the skin.

History of the Kolff Laboratory turbine driven electrohydraulic artificial heart.

The concept of an electrically powered total artificial heart has been pursued by Dr. Kolff and his associates since the 1960s. Since the 1980s these efforts have been concentrated upon the development of the electrohydraulic total artificial heart, a turbine pump powered by a brushless DC motor. Dr. Kolff realized the benefits of pulsatile flow and device response to Starling's Law, and these concepts have formed the basis of subsequent design decisions. Design iterations have both solved existing problems and exposed new challenges. The current device design is greatly improved over early attempts due to the incorporation of technologies that have recently become available as the result of progress in the fields of materials and electronics and due to the lessons learned over many years of research under the guidance of Dr. Kolff. This article describes, from its inception, the last major research project of Dr. Kolff prior to his retirement. The discussion centers around development, problems and their solutions, and the reasoning for given solutions.

Soft artificial ventricles for infants and adults, with or without a clamshell.

The quick connect system and mechanical disk valves used in total artificial hearts (TAH) are sources of thrombogenesis and blood damage. Our soft TAH, which has no quick connectors, can be squeezed and bent, making it easily implantable, and blood damage is reduced by the use of trileaflet and biflap polyurethane valves. The soft ventricles were made by vacuum forming, after which the pieces were welded together by radiofrequency heat sealing. A rapid clamshell can be pushed and slipped over the soft heart to prevent deformation of the ventricle. Three calves have had the 60 cc soft TAH implanted, both with and without a clamshell. The cardiac outputs were as high as 7 L/min, without a vacuum applied during diastole. Two lambs received the 20 cc TAH (as an acute experiment); it fit and functioned well. One healthy lamb received a 20 cc left ventricular assist device (LVAD) with a pulsating artificial atrium as a survival experiment. The lamb survived for 8 days, after which the device was removed and the lamb returned to the meadow. Thrombosis in the TAH was minimal, and the plasma free hemoglobin values in all the TAH and LVAD experiments were usually lower than 5 mg/dl and often lower than 2 mg/dl.

Concept of a soft, compressible artificial ventricle under evaluation.

This study was designed to compare the relative merits of soft and rigid artificial ventricles. A cascade mock circulation was used to measure cardiac output under different circumstances. The data show that these soft air driven ventricles show a Starling's-like response over a wider range of filling pressures than identical, but rigid, ventricles. Compression of soft ventricles by high intrathoracic pressures was simulated in vitro. Air pressures up to +20 mm Hg did not seriously affect soft ventricles. Cardiac tamponade was simulated by compressing the ventricle in a closed fluid compartment. Tamponade became severe when volume reduction of the ventricle rose to 60 ml. Hemolysis caused by soft and rigid ventricles was tested in a blood bag set-up and was 48-82% higher in the rigid ventricle, depending on the driving conditions. Possibly, this could be explained by the authors' finding that rigid ventricles showed a 20% higher intraventricular dP/dtmax value than soft ventricles. Soft ventricles were implanted in three calves as a total artificial heart (TAH). Implantation without quick connectors was easy because the surgeon could easily fold and compress the ventricles. No physiological complications of softness were observed. Blood damage in the animals was low (less than 5 mg/dl). The authors conclude that soft ventricles show distinct surgical and functional advantages over rigid ventricles.

New polyurethane valves in new soft artificial hearts.

This article describes new bistable valves, and introduces a new soft heart that is easy to implant. Earlier, five polyurethane (PU) valves were implanted in the mitral position in sheep. All five survived for 1 year or more, and the valves, although calcified, were intact. Since the opening resistance was somewhat high, valves that are bistable were developed, which means they may be open or closed. These valves have lower opening resistance, and regurgitation is similar to that of mechanical valves. Eight calves have been implanted with a new, soft total artificial heart (TAH). Seven had bistable leaflet valves; the eighth had mechanical (Bicer) valves in the inflow position. Four of the calves were sacrificed after 22 to 43 days. At autopsy, the number of thromboemboli found, particularly in the kidneys, was low compared with previous experiments. None of these animals received anticoagulants other than the heparin given during heart/lung bypass.

Electrohydraulic-clamshell heart with energy converter inside the compliance reservoir.

Two new ideas on the electrohydraulic actuation of blood pumps have been combined. The first idea was to put the energy converters that propel the hydraulic fluid inside the compliance reservoir instead of having them separate. Compactness of the device and better cooling of the energy converter by the surrounding fluid are two major advantages of this approach. Secondly, we put the pumping membrane inside a clamshell that fits over a soft ventricle (1). The ventricle can be implanted first, after which the shell is slid over it. These two ideas have resulted in devices described in this paper. Preliminary in vitro and in vivo data are presented.