Abstract:
A single chamber mechanical heart has a movable vane journaled in the apex of the casing, an inlet port and an outlet port in each side wall of the chamber, and means for mechanically reciprocating the vane to pump blood on either side of the vane. The vane can be electromagnetically positioned using electro magnets or a shaft drive through the chest of the patient. The blood pressure and rate can be controlled by appropriate motion of the vane.

Description:
FIELD OF THE INVENTION 
     The present invention relates to a total artificial mechanical heart for use in replacement of a human heart. In particular, the invention relates to such a device which has a single pumping chamber. 
     BACKGROUND OF THE INVENTION 
     Numerous efforts have been made to replace a defective human heart with a mechanical device which replicates the pumping action of a normal human heart. Canadian published patent applications 2,105,908 and 2,105,935 to Mussivand et al, filed Sep. 10, 1993 both relate to hydraulically actuated mechanical pumps for duplicating blood pumping action of the human heart. A right ventricular assist device is shown in Canadian patent 1,234,953 which utilizes an elliptical chamber with a flexible diaphragm separating a sac for connection to the patient&#39;s blood system and a pressurizing chamber for augmenting the flow of blood from the sac. 
     U.S. Pat. No. 3,734,648 relates to a mechanical heart which injects a driving fluid into one side of a diaphragm dividing a chamber to cause the evacuation of blood from the opposite side of the chamber. The system includes a piston pump and an accumulator for the driving fluid. U.S. Pat. No. 5,578,077 of Nov. 26, 1996 teaches the use of a scroll type pump modified for medical applications. U.S. Pat. No. 5,549,667 teaches an external mechanical heart having blood contacting parts made of Zirconium and alloys thereof. U.S. Pat. No. 4,547,911 of Oct. 22, 1995 relates to an implantable heart pump which runs at a harmonic multiple of a normal heart beat frequency, thereby reducing the pump chamber volume. 
     Thus many inventors have attempted to duplicate the pumping action of the human heart in an implantable mechanical heart. 
     SUMMARY OF THE INVENTION 
     The present invention provides a single chamber mechanical heart which duplicates the function of a human heart with minimum moving mechanical parts, thus providing a simple reliable mechanism suitable for implantation in the chest of a patient in the space formerly occupied by a human heart. In one embodiment, the heart pumping action is powered by an electromagnetically operated diaphragm vane, with electrical connections to an external power source, which controls the pulse rate as well as the volume of blood pumped. In a second embodiment the pump is powered by a mechanical shaft extending through the skin of the patient. This shaft is rotated in an oscillatory fashion causing motion of the diaphragm vane to pump the blood. In this second embodiment, the pulse rate as well as the blood pressure are controlled by external drive mechanisms controlled by sensors connected to the patient. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     In the accompanying drawings, 
     FIG. 1 is a phantom perspective of a first embodiment of the invention, 
     FIG. 2 is a side view of the embodiment of FIG. 1, 
     FIG. 3 is a view of embodiment of FIG. 1 with the top removed to show the diaphragm vane, 
     FIGS. 4 and 5 are side and top views of the vane, 
     FIG. 6 is a phantom perspective of a second embodiment of the invention, 
     FIG. 7 is a side view of the vane of FIG. 6, and 
     FIG. 8 is a side view of the second embodiment. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     With reference to FIG. 1 there is shown a first embodiment of the invention, including a case  13 , a vane  9  and valves  1 , 2 , 3 , 4 . A plurality of electromagnets  11  are energized by a power supply (not shown),via a cable  12  and attract the magnetic end  10  of vane  9  to successive positions along the arc of the casing  13  under control of the power supply. The sequence of energizing the magnets  11  is normally from one end of the array to the other, the rate being determined by the pulse rate to be provided to the patient. The volume of each stroke of the mechanical heart is determined by the distance the vane travels along the arc. Ports  5 , 6 , 7  &amp;  8  are connected to the arteries and veins normally, with blood from the one side of the pump being circulated to the pulmonary system, and blood from the other side of the pump being circulated to the aorta, and to the vena cava whence it is returned to the first side of the pump. 
     By using a single vane to pump both sides of the artificial heart, a simple efficient mechanism is obtained which can effectively replace the human heart. 
     Specifically, port  5  is connected to the Superior Vena Cava, and Inferior Vena Cava, drawing blood from both when the vane  9  is moving away from the port  5 . Port  6  is supplying blood to the Pulmonary Artery, which supplies blood to the lungs. Port  7  is receiving blood from the Pulmonary Vein, and port  8  is connected to the Aorta, taking oxygenated blood to all parts of the body. 
     FIGS. 4 and 5 are respectively a side view and top view of the vane  9 . One end of the vane has bearing means  14  fitted for rotation in depressions in the top and bottom surfaces of the case  13 . Magnet member  10  on the free end of the vane  9  is moved in response to the energization of the array of magnets  11 , by the external power supply. The speed of motion of the vane  9  is regulated by well known current control means in the power supply. 
     The chambers of each side of the vane can be made of a size to accommodate the actual cardiac output of the patient. Once the cardiac output has been determined the artificial heart may then be made to order. Stops  15  in each corner of the case  13  prevent the vane from crushing blood cells against the sides of the case. 
     For a mechanical heart to be implantable in a human chest, it must meet specific requirements; it must not weigh more than about 300 grams, or ¾ pound, it must fit into a chest cavity of approximately 5.5×3×3.5 inches, it must be stable within the chest, it must not crush blood cells, it must not cause blood clotting, it must pump the correct volume of blood at the correct pressure, and it must have a reliable power source. By having a residual amount of blood in the chamber at all times, blood clotting should be prevented, as there will always be a mixing and blood will be mixed and moved on either to the lungs or as oxygenated blood to serve the body. 
     A mechanically driven embodiment of the mechanical heart is shown in FIGS.  6 , 7 ,&amp;  8 . As before, a casing  13  encloses a vane  9  which is attached to a shaft  20  which will extend through the skin of the patient in a housing  25 , and be connected to a reciprocating mechanical drive (not shown). A plate  21  is fastened to the exterior of the case  13 , with pillars  22 , and is connected to the sternum of the patient by screws  26  to stabilize the position of the heart in the chest cavity of the patient. As before blood is pumped by reciprocation of the vane  9  in the cavity  13 . Preferably the comers of the chamber  13  will be rounded, as will the edges of the ports  5 , 6 , 7  &amp;  8 , and some blood should be left in the chamber at the end of each stroke so there will always be a mixing action and blood will be moved on, and not remain in the chamber to clot. 
     Stabilizing the unit to the sternum will not be difficult, since the distance between the pumping unit and the under side of the sternum is small. The top side of the sternum center section is only slightly convex, and the plate  20  could extend over the sides of the sternum onto the cartilage that joins the ribs to the sternum. The screws 26  in the sternum make a rigid connection to the unit  13 . The hole in the chest in the skin will allow the shaft  20  to protrude about ½ inch, above the skin. The hole is of course stabilized in one position by the plate  21  being anchored to the sternum. The skin will heal round the housing  25  to maintain cleanliness. 
     The casing  13  and the plate  21  are solidly joined so that the casing  13  will move in the the chest with movement of the rib cage and the sternum. Coughing will move it around, so there must be a flexible section in the shaft connected to shaft  20 . A simple variable speed electric motor and control can easily be positioned on the body of the patient. 
     The exact position of the stabilizing pillars  22  will depend on the the lie of the person&#39;s heart. Each heart is tailor made to fit the position of the damaged heart it replaces. The cavity created by the removal of the damaged heart must be filled by the mechanical heart and its outer molded shell around the casing  13 . As the mechanical heart must pump about ⅓ of a cup of blood at a time using a single chamber, it will not be very big and will weigh about 300 grams. The volume or cardiac output, the weight and size of the damaged heart can be ascertained and the mechanical heart designed to fit perfectly. In installing the mechanical heart, a heart/lung machine would be attached to the large blood vessels in the leg of the patient. The custom made mechanical heart whether electromagnetically or mechanically driven, would be put in place and set to operate with a heart lung machine still in place, until the mechanical heart takes over the circulation of blood.