Patent Publication Number: US-2021186685-A1

Title: Single circular convex magnet leaflet disc with an opposing upper and lower magnetic field and electronic semiconductor sensor prosthetic heart valve that can communicate from the heart to the brain

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This is the continuation of the application previously filed on Dec. 18, 2019, U.S. Provisional No. 62/950,208, and Oct. 30, 2019, U.S. Provisional No. 62/928,032, Magnetic Opposing Artificial Heart Valve which expands and to expressly claim and to apply and set the validity of utility patent. 
    
    
     TECHNICAL FIELD 
     The present invention relates to a single circular convex magnet leaflet with an opposing upper and lower magnetic field and electronic semiconductor sensor artificial heart valve. More specifically, the present invention relates to a prosthetic single magnetic leaflet disc opposing magnetic main housing frame and electronic semiconductor sensory artificial heart valve for medical use to provide the input and response of the heart to the brain and receive signals from the brain to the heart. This magnetic opposing with sensory can be used for replacing the native bicuspid valve or tricuspid valve of the human heart. 
     BACKGROUND OF THE INVENTION 
     Currently the artificial heart valve is divided into two kinds. First, the bioprosthetic heart valve that uses animal tissue such as bovine tissue, Porcine tissue or homograft tissue. Second, is the mechanical prosthetic heart valve such as Caged-Ball, Starr-Edwards et al. Tilting-Disc, Bjork-Shirley et. al, and the most successful bi-leaflet mechanical artificial heart valve from St. Jude. They are all built to help people to overcome a defective native heart valve ultimately designed to save lives. 
     However, the bioprosthetic heart valve is highly susceptible to deterioration caused by the patient&#39;s own immune system, because the immune system is designed to attack all foreign substances. Therefore, sometimes the bioprosthetic heart valve can be destroyed by bacteria that, invades patients&#39; bodies because of the lack of protection from their own immune system. Likewise, the mechanical artificial heart valve will have a high risk of thrombogenicity and homolysis; therefore, a patient must take lifelong medication. Moreover, replacing the artificial heart valve from bioprosthetic valve or prosthetic valve is only solving temporary mechanical issue of the heart but the, blood clot, the feedback from chordate tendineae or SA node as well as future know of specific myocardial tissue would not be connected, response and cooperate with brain for long term problem. 
     Accordingly, there is a need for an artificial heart valve that will not rupture the blood cells and that will communicate with the brain and that respond to natural emotion such as respond to the SA node, the AV node, the pacemaker and the sympathetic and parasympathetic nervous system. 
     FIELD OF THE INVENTION 
     It is a single circular convex magnet leaflet with an opposing magnet and semiconductor sensor prosthetic human heart valve that helps pumps blood in one-way direction acting more like the function of the natural human heart; because this invention is designed to improve their quality of life by interconnection of heart to brain communication, furthermore, minimize friction and reduce medication intake. 
     SUMMARY OF INVENTION 
     The single circular convex magnet leaflet prosthetic heart valve has opposing upper and lower magnetic fields with a semiconductor sensory that aims to solve hemolysis and coagulation problems from a heart valve transplant. This invention uses a single convex leaflet magnet valve. The convex shape helps fluid flow down hydrodynamically and is constructed concave disc that helps fluid flow smoothly. The main housing frame can be constructed of magnetic or nonmagnetic material. If the main housing frame is made of nonmagnetic material then adding an upper center magnet disc to oppose the single circular convex leaflet valve helps reduce the hard impact of single leaflet valve to the main housing frame, result lessening the number of shattered blood cells. The main circular shaft single hole guides the single circular convex magnet leaflet disc that slides up and down producing a soft friction. Adding the rear magnet to the rear of the shaft and helps stabilize the upright position of valve preventing an unexpected blackout when a patient moves or stands up. This artificial heart valve has an electronic semiconductor sensor that sends signals to the brain. Sensor might connect to the SA node, the AV node, the vagus nerve and/or the sympathetic and parasympathetic nervous system. The rear end of the main central shaft has two coils. Coil  1  will receive signals from braingate that processes from the semiconductor sensor and coil  1  pulls the single circular convex magnet leaflet disc down to open and lets blood flow into the other chamber or pushing the concave disc up to close. Its main function is to control bradycardia and tachycardia. Coil  2  is located in the inner rear end center of the opposing rear magnet disc. Coil  2  job is to receive signals from brain to hold the valve open a little longer after coil  1  has initiated its signal. It is control by the computer module, braingate, and microprocessor. Coil  2  is further guaranteeing to control of tachycardia as well as, bradycardia. 
     Last, let&#39;s look at the C-clamp. The biofabric cuff is wrapped around the C-clamp making it easy for surgeons to attach it to a patients heart tissue (U.S. Pat. No. 6,007,577 Vanney et. al. and U.S. Pat. No. 6,045,576 Starr et al.) The surgeon first secures and installs the C-clamp to a patient&#39;s heart tissue regardless of the direction of blood flow. This main critical C-clamp  FIG. 4, 100  can be enlarge C-clamp diameter. This make is possible for cardiologists to easily exchange or flip the prosthetic artificial heart valve (up to down or down to up) if needed to correct the direction of the blood flow. 
     This will eliminate most errors so surgeons won&#39;t have to uninstall and reinstall the entire unit. This decrease of redoing the artificial heart valve will save time and could mean the difference between life and death to many patients in the operation room. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       To further clarify the above drawings,  FIG. 12A-12B  the main housing frame embodiment  20  is a unit, while  114   a  and  114   b  is the axially magnetized field. Likewise,  FIG. 13  the single circular convex leaflet top view  14   a  is a unit while  19  is the edge of the  14   a  embodiment divided into  19   a  and  19   b  is the axial magnetized field. The objects shown in the figures can be compared to current prosthetic artificial heart valves. Clearly the description can be expanded more to understand the single circular convex leaflet magnet opposing magnet functions shown in  FIG. 14C  the real concept characters refer to all parts throughout magnet opposing magnet: 
         FIG. 1  The top view surface looking into the single circular convex magnet leaflet disc magnetic opposing the magnet and include C-damp sensory. 
         FIG. 2  Images of prosthetic heart valve housing with C-clamp, showing from the rear images of the magnet opposing magnet and sensory artificial mechanical heart valve. 
         FIG. 3  A perspective has three prosthetic artificial magnet opposing magnet heart valves implanted to human heart. The aorta heart valve is in behind so it is not shown. Arrow is indicating of blood flowing. 
         FIG. 4  Illustrates a complete standing upright position of the single circular convex magnet leaflet artificial heart valve with C-clamp on it. 
         FIG. 5  Shows a rear view, slightly tilted, of  FIG. 2  to show the three dimensions and a more clarified side view. 
         FIG. 6  Illustrates a standing upright position of a barebone housing frame of this artificial heart valve with no c-clamp, no shaft and no single magnet leaflet disc on it. 
         FIG. 7  Shows a quarter view that how the c-clamp fits into groove of the main housing frame. 
         FIG. 8A  Illustrates a cutting view showing the entire right half of the prosthetic artificial heart valve. The valve is in closing position. 
         FIG. 8B  Is a cutting view showing the entire right half of the prosthetic artificial heart valve. The valve is in opening position. 
         FIG. 9  Deployed position cutting view of the entire right half of the artificial heart valve with 2 semiconductor sensors inside of 23 on top, 2 magnet coils sensor on bottom. 
         FIG. 10  Cutting view of the entire right half of the magnetic opposing magnet artificial heart valve disc, showing 19 magnet opposing 18 magnet. 
         FIG. 11  Cutting view of the entire right half of the artificial heart valve. It shows the total assembly of the single circular convex magnet opposing magnetic concave rear view disc, the sensors, the shaft, the magnet coils etc. 
         FIG. 12A-12B  Shows the cutting haft of single convex leaflet magnet and opposing magnet on the magnet housing frame. Shows the upper ring  114  proximal inflow-end diameter is slightly smaller than the lower ring  115  distal outflow-end diameter. 
         FIG. 13  Cut view of the single circular convex  14   a  magnet disc upper view and concave  14   b  bottom view. 
         FIG. 14A  The complete circle  14   a  convex leaflet magnetic disc upper view while  14   b  concave in the bottom view.  14  is the hole. 
         FIG. 14B  Shows the simple axially magnetized magnet vs diametrically magnetized magnet. N and S are nonspecific relating to the invention of a single circular leaflet magnet disc. It is just for demo of axially different than diametrically magnet. 
         FIG. 14C  Shows the natural force of the magnet is that like, poles repel like poles. 
         FIG. 15  Shows C-clamp that fit into the main housing frame of the prosthetic artificial heart valve. 
         FIG. 16  the main central supporting shaft and in the bottom might or might not have magnet coil. It depends on medical need. 
         FIG. 17  Shows the entire single circular convex magnet leaflet disc opposing magnet housing frame and included C-clamp. 
         FIG. 18  Illustrates the operation of this magnet opposing magnet with sensory artificial heart valve and computer module in human heart and/or artificial heart (provisional 62/928,032 Oct. 30, 2019 Kyle Au.) 
         FIG. 19  Pictures showing the image braingate “Cyberkinesis Micro Array” #200 Richard Normann et al. U.S. Pat. No. 5,215,088, Jun. 1, 1993 
     
    
    
     DETAIL DESCRIPTION OF THE PREFERRED EMBODIMENT 
     When people have a defective heart valve, it can be successfully replaced by a bioprosthetic or prosthetic mechanical heart valve. The bioprosthetic heart valve is a valve that is made from porcine tissue, bovine tissue, or homograft tissue. The prosthetic heart valve is a valve that is made from nonliving materials such as stainless steel, titanium, pyrolytic carbon, etc. After an artificial heart valve replacement, all patients must take medications to prevent hemoglobin toxicity because blood cells will be lysis by the clapping and collision of the valve to the housing frame causing hemolysis. Normally, clotting factor proteins are everywhere in our bodies and will protect us from cuts and injuries. In general, all external drugs are toxic. When taking any kind of drug long term such as Warfarin, Eliquis, Nitropress, Dobutrex, or lnocor, etc, either an unmetabolized accumulation of the drugs or metabolized waste of the drugs may remain in a patient&#39;s body. When the blood cells are damaged, their internal substances (enzymes, proteins, lipids, irons, hemoglobin, metalloproteins, and clotting factor in plasma) leak out and become toxic. The body will react and activate it natural clotting factors and increase the risk of stroke. It can even damage the lungs and liver as well as the kidneys. Warfarin, Heparin, and Eliquis are blood thinners and their toxicity and side effects are unavoidable. Patients also must carefully control the intake of certain green vegetables such as broccoli, kale, spinach, and others that might react to the medications. Research speculates that after an artificial heart valve replacement, patients lose control of certain involuntary heart signals to the brain and feedback from the brain to heart. Consequently, a patient&#39;s daily activity is constrained and the quality of life is lessened day by day. 
     My invention, the Single Circular Convex Magnet Leaflet Opposing Magnet with the Semiconductor Sensors and Coils Prosthetic Heart Valve might help patients enjoy a better quality of life. The benefit of my heart valve magnet opposing magnet invention reduces the risk of hemolysis and also provides feedback from the sympathetic and parasympathetic nervous system from the brain to the braingate, which then processes in the microprocessor, and thenceforth, regulates the heart beats through coil  1  and, coil  2 , further reducing drug intake. 
       FIG. 1  This is the top view. It shows the layout parts of the prosthetic single convex magnet leaflet opposing magnet, annulus housing frame. The valve is in closed position. This maintains a one-way flow of fluid.  10  is C-clamp that can be made with an enclosed biofabric suture ring like U.S. Pat. No. 6,045,576 Starr et al., and is sewn into the heart first. This C-clamp is wrapped with biofabric and later hold the main housing frame in place. The view of C-clamp  10  embraces the prosthetic artificial heart valve.  100  are two nonspecific holes on the C-damp that can be widened with a tool to enlarge it diameter, unlocking the main housing frame, and allowing the surgeon to exchange or flip the prosthetic artificial heart valve as needed. The natural, unexpended C-clamp diameter position will automatically hold and lock the main housing prosthetic heart valve in place. The benefit is that the cardiologist won&#39;t have to un-install or re-install the entire artificial heart valve unit because of mistaking the direction of blood flow, thus making it easier to switch and replace a prosthetic heart valve, saving time and the saving lives of patients.  11  is the upper view of the main housing frame and can be made of a magnetic or a nonmagnetic circular inflow. This inner diameter is slightly smaller than that of the outer main housing frame showed in  FIG. 11 , and  FIG. 12 . The inner inflow-end proximal diameter of  20  unit is  114  and the outer outflow-end distal diameter is  115 . The three upper mandrels  12 ,  120  and  121  are connected to the center semiconductor sensor disc  13  and secures the structure of heart valve. The  13  can just be an electronic semiconductor sensor or semiconductor sensor with an outer magnetic disc.  14   a  is the single circular convex leaflet magnet disc valve with the center hole connecting to the main shaft  17  (the main shaft  17  is not show in  FIG. 1 ).  14   a  is the single circular convex leaflet magnet that helps the hydrodynamic flow of blood press down and past disc  14   a , thus, the blood will flow into the chamber below. Images  131 ,  151 , and  221  are the three outlet plugs from the main magnet housing frame that connect, from the semiconductor sensor or magnet coils to the braingate.  130  is the impregnated wire in the mandrel of  121 . 
       FIG. 2  Is the rear view of the prosthetic heart valve housing with the  10  C-damp embracing the single circular convex magnet opposing magnet with semiconductor sensor.  14   b  shows the single circular concave magnet leaflet and this is the rear view of  14   a  looking into the magnet opposing magnet which shows a one-way flow of fluid in its closed position. The purpose of the concave leaflet is to help the hydrodynamic flow of the systolic pressure, while high pressure from the rear concave valve pushes the leaflet up into closed position.  111  is the rear of the main magnetic or nonmagnetic housing frame. The inner orifice diameter  114  is slightly larger than the inner diameter of the outer orifice  115  so valve  14   a  can slide down to open the valve, this relate to  FIGS. 12A and 12B  of cut side view.  15  is the outer magnetic and inner coil disc in the rear end that holds and secure the three mandrels together.  16 ,  160 , and  161  are the three mandrels that are attached from the main housing frame extending down to secure the prosthetic heart valve.  150 , and  220  indicate the impregnated wires in the  161  mandrels at the rear housing frame. 
       FIG. 3  Is a picture of the heart that has three prosthetic magnet opposing magnet and sensory artificial mechanical heart valves.  FIG. 3  shows that the aorta valve is behind so it is not easy to see the implanted prosthetic artificial heart valve. The arrows indicate the direction of the blood flow. 
       FIG. 4  Is showing an upright position of the single convex magnet leaflet opposing magnet of the main housing frame and sensor heart valve with a general overview of all parts with the C-clamp in place. The image of the prosthetic valve has a single convex magnetic disc. The single circular convex magnetic disc can, slide down to open and let blood flow down and out into the different chambers.  10  is the C-clamp.  11  is the upper main magnet housing frame.  12 ,  120 , and  121  are the three mandrels extending from the main housing frame to unite with  13  the magnet with an electronic semiconductor sensor or just semiconductor sensors disc,  14   a  is the single circular convex magnet leaflet disc.  131 ,  151 , and  221  are the connection outlet sensor plugs that lead to the braingate.  16 ,  160  and  161  are the lower mandrels that extend from main housing frame and hold the prosthetic heart valve secure in the rear part.  15  is the rear magnet and inner contain  21  (not shows in  FIG. 4 ) is the inner coil  2 , this coil helps prevent bradycardia and tachycardia by sending signals to the braingate. 
       FIG. 5  is the rear view of the upper top of the prosthetic single circular convex magnet leaflet and is shown slightly tilted of  FIG. 2 . the singular circular concave magnet leaflet is  14   b ; concave in the rear view.  14  shows the center hole of the singular circular magnet leaflet disc; concave in the upper view. Blood can only flow out. 
       FIG. 6  Shows the general upright position of the main frame with no C-clamp, no single leaflet disc, and no main shaft. It does, however, show that  130  is impregnated inside  121  and this is one of the upper three mandrels, and  130  is connected to  131 , the electronic semiconductor sensor plug outlet. Likewise, wire  150  is impregnated inside  161  and this is one of the rear three mandrels connected to  151 , the outlet coil plug and  21  is coil  2 . It shows wire  220  is impregnated inside  161  and is one of the rear three mandrels connected to  221 , the outlet coil plug and  22  is coil  1 . Coil  1  is inside of the rear main circular main shaft  17  (this main shaft and coil  1  are not show in  FIG. 6 ). 
       FIG. 7  Shows the outer frame housing of the artificial mechanical heart valve cut to a quarter portion. The inner frame  10  of the C-clamp is held tight to fit the outer ring of  112 . As indicated,  11  is the upper frame of the single circular convex leaflet magnet opposing magnet housing main frame.  110  is the upper outer and lateral annulus ring.  113  is the bottom lateral inside while  111  is the inner upper side of the artificial housing frame.  111  and  113  fit snugly into the C-clamp indicated  10  and it is the bottom portion of  11 . The C-clamp, in position, will hold the prosthetic magnet opposing magnet heart valve in place. The C-clamp is un-expanded and in locked position. This C-clamp holds the prosthetic artificial heart valve in place. 
       FIG. 8A  Shows the prosthetic single circular convex leaflet magnet opposing magnet with semiconductor sensor heart valve cut in half and views into the internal structure. Convex valve  14   a  slides up, and is shown in closed position. 
       FIG. 8B  Shows the artificial valve cut in half and views into the internal structure. Valve  14   b  is the bottom view of the concave disc showing the valve in open position. 
       FIG. 9  Shows the artificial valve cut in half with, a view of the internal structure. The internal wire indicated  130  is impregnated inside of the upper mandrel of  121 .  23  has two electronic semiconductor sensors and  23  is inside  13 . The inner coil  22  that wraps around the bottom of  17  shaft that help to control bradycardia and tachycardia. The exterior of  13  whether can be made out of either the semiconductor sensors or semiconductor sensors with an outer magnet washer disc. 
       FIG. 10  Shows the artificial valve cut in half with a view of the internal structure. This is the main frame of magnet  20  opposing from  19   a  the single circular convex magnet leaflet disc.  19   b  is opposing to  18 , the magnet in the rear. Notice that if the housing main frame  20  is nonmagnetic then  13  must be magnetic to create the opposing force to  19   a  at the top, either to  13  (or to the three top mandrels might be magnet) for that magnet opposing magnet effect to avoid hemolysis. 
       FIG. 11  Combines  FIG. 8-10 . This acts as magnet opposing magnet sensory unit that sends signals of heart beats from the heart to the braingate, and the braingate might send signals to the microprocessor and the computer module that is connected to the braingate as well as the SA node or the AV node and pacemaker to regulate heartbeat. 
       FIG. 12A  Shows the magnet annulus ring main housing frame proximal diameter of  114  is a little smaller than distal  115  diameter so that the valve can slides up to close or slides down to open.  20  is a unit while divided to  114   a  and  114   b  magnetically field. The magnet annulus ring housing main frame axial magnetized of  114   a  opposes to  19   a  magnetic field of the single circular leaflet magnetic field. 
       FIG. 12B .  190  shows axially magnetized of  19   a  and  19   b  and  190  is the edge of  14   a  and  14   b  a single circular magnet leaflet disc.  FIG. 12B  shows the gap between  115  and  190  is very small. 
       FIG. 13  The convex disc  14   a  cut section shows the upper magnet is convex while the lower is concave creating a fluid dynamic that strengthens the hardness of the disc. This is indicated by  19   a  and  19   b  showing the disc as being axially magnetized; it is either north pole to south pole or south pole to north pole. This will have the opposing affect at the top of the housing and it is arranged to oppose the lower magnet of  18  as well as the opposing magnet on the top of  20   
       FIG. 14A  Shows the complete circular upper disc  14   a , with the central hole  14 . 
       FIG. 14B  Magnet  24  shows an axially magnetized field vs magnet  25  which show a diametrically magnetized field. 
       FIG. 14C  Shows the magnet conception of like pole opposing like pole (show N or S is nonspecific). 
       FIG. 15  Shows the C-clamp. This can combine with the prior art of Vanney et al biofabric cusp to be sewn into the heart first, either the aorta, the mitral valve, or the pulmonic valve. This prosthetic single circular convex leaflet magnet opposing magnet can replace a tricuspid or a bicuspid valve. 
       FIG. 16 . Shaft  17  image is the assembly of the main circular shaft to be connected into the main central artificial heart valve housing. In the rear end there is coil  1  indicated as  22 . It is in the inner of shaft.  22  is connected to the wire  220  inside the  161  mandrel and leads to outlet plug  221 , which send signals to the braingate. 
       FIG. 17  Shows the complete image of the single circular leaflet magnet opposing, magnet with  10  C-clamp and is ready for installation. 
       FIG. 18  Shows the attachment of the magnetic opposing heart valve communicating with the pacemaker  300 , nonspecific.  400  is the newer Metronic pacemaker patented by Micra. It is also receiving and communicating with the braingate and is controlled by a computer module that regulates the heartbeat.