Wholly implantable non-natural heart for humans

Abstract

A wholly implantable non-natural heart for humans is a double pump configuration provided with two auricles and two ventricles. Both the said auricles and ventricles are driven by solenoid actuators interacting with high energy magnets; the auricles and ventricles which are hollow chambers are provided with one-way valves in the usual manner, for the purpose of effectively and rhythmically moving blood to and from the said chambers; power generation for driving said solenoid actuators, as well as an electronic control unit is accomplished by a power generating module which could be a simple battery, a miniature spring-driven generator, a mems generator or a redundant self-sustaining generator or a combination of all of the above; the self-sustaining generator has been proposed and designed to power this present artificial heart and will be presented in a separate patent application in the near future as a follow up to this present one; the aforementioned electronic control unit is preferably configured to amplify the signals from the power generating unit as well as utilizing input/output signals from temperature and pressure sensors embedded in the heart to vary contractile force and frequency of beats, based on bodily requirements, thereby mimicking some functions of the natural heart; the electronic unit is also preferably provided with a translator chip that converts signals from the cardiac/vargus trunks (sympathetic and parasympathetic nerves) via electrodes into clear electric currents for varying actuator outputs; the heart would be implanted in the normal position in the chest, atop the diaphragm, while the electronic control unit and the power generation module would preferably be implanted behind the breastbone and lower abdomen respectively; all components of the present invention are amenable to current mass production techniques and miniaturization for the purpose of fitting into individuals of various sizes; as is clearly shown in FIG. 1, this present invention is an integral three-tiered configuration constituted of pumping unit I, the power generating unit II and the controller III. Also, as aforementioned, additional signals from the embedded temperature and pressure sensors, as well as nerve connecting electrodes are used to manipulate instantaneous outputs. The said electrodes are in the form of cuffs and are to be implanted on the vargus nerves (sympathetic and parasympathetic); Texas Instruments (TI) manufactures reliable operational and instrumentation amplifiers which can detect condition, and amplify nerve signals. The VCO in the controller uses the signals to manipulate instantaneous outputs of the actuating solenoids.

1 ). A wholly implantable non-natural heart system for humans constituted of a pumping unit, a power supply module and a controller, said pumping unit having two auricles and two ventricles, provided with one way valves for the purpose of controllably moving blood into and from the circulation system; said valves being of single and tri-leaflet designs; said valves being passively manipulated by blood pressures in said auricles and ventricles resulting from compression and relaxation of the chambers of aforesaid auricles and ventricles by the moving diaphragms of solenoid actuators; said solenoid actuators being supplied with electrical power from the aforementioned power generating module and aforementioned electronic controller; said controller utilizing signals from embedded temperature and pressure transducers, mechanical overpressure switch, as well as nerve input signals emanating from the vargus trunk and retrieved via cuff electrodes, to manipulate instantaneous cardiac outputs; aforesaid temperature and pressure transducers preferably being of the probe and diaphragm types; aforesaid moving diaphragms of aforesaid solenoid actuators being driven by high energy flat type magnets interacting with electromagnet stators; said diaphragms provided with yieldable annular surrounds for the purpose of permitting axial motions in a pistonic manner, such that rhythmic opening and closing of said valves moves blood into the pulsating units of both Pulmonic and Aortic systems; said pulsating units acting to enhance the overall efficiency of the pumping action by recoil; reliable coupling of system member components being effected by means of an I beam type chassis provided with matching holes for the purpose of accepting tubular valve mounting bodies embedded in the mass of heart material; said valve mounting bodies being rigidly coupled to aforementioned valves; said valves in turn, rigidly coupled to the housing of aforementioned pulsating units; aforementioned Aortic pulsating unit being provided with aforementioned mechanical overpressure switch; said mechanical switch being of either of a cantilever or axial travel type; said overpressure switch acting to introduce great electrical resistance via resistors in the controlling circuit, thereby effectively modifying dangerous excessive pressure gradients if and when they may occur; movement of blood to and from the lungs is accomplished via lung vessels attached to rigid coupling plates that are bonded to the left auricle such that their oxygen rich blood empties into the said left auricle; a second auricle coupling plate is bonded to the right auricle and firmly connects a vena cava system to said right auricle; left and right heart halves are bondably attached to thin coupling flanges for reinforcement; furthermore, strengthening of said heart halves is effected by means of an adhesive backed belt radially bonded in the North-South direction. 
   
   
       2 ). A wholly implantable non-natural heart capable of communicating with the body and nervous system via embedded electrodes connecting sympathetic and parasympathetic trunks and utilizing the acquired signals to manipulate frequency and contractile force of pumping instantaneously according to  claim 1 . 
   
   
       3 ). A wholly implantable non-natural heart employing temperature and pressure sensors, in addition to sympathetic and parasympathetic connecting nerve electrodes to aid in manipulating frequency and contractile force of pumping. 
   
   
       4 ). A wholly implantable non-natural heart according to  claim 1  having a power generating module which can be implanted in the lower abdomen so that if need be, it can easily and safely, surgically, be removed and replaced without interfering with the heart or controller or other upper body tissues and structures such as the lungs, thereby increasing the speed of healing of an access incision. 
   
   
       5 ). A wholly implantable non-natural heart employing electronically controlled solenoid actuators to compress four (4) heart chambers, thereby causing passive cardiac valves to open and close rhythmically in accordance with incoming signals from an electronic controller. 
   
   
       6 ). A wholly implantable non-natural heart according to  claim 1  in which the pumping unit can be implanted in its natural position above the diaphragm, and the controller, behind the breastbone and the power module in the lower abdomen, such that each can be removed and replaced during a surgical operation if need be, without affecting the others. 
   
   
       7 ). A wholly implantable non-natural heart according to  claim 1  having an aortic pulsating unit which pulses (recoils) with each beat, thereby substantially improving the efficiency of the system. 
   
   
       8 ). A wholly implantable non-natural heart according to  claim 1  having a pulmonary pulsating unit which pulses (recoils) with each beat, thereby substantially improving the efficiency of the system. 
   
   
       9 ). A wholly implantable non-natural heart according to  claim 1  for humans having a light and strong chassis member that permits the integral coupling of all the major components of the system owing to the fact that it is essentially an I-beam structure. 
   
   
       10 ). A wholly implantable non-natural heart for humans having tri-leaflet ejection valves employing hybrid construction, aided by metal and fabric reinforcing inserts and silicone rubber encapsulation, resulting in high strength and lightness, such that said valves can be opened by minimal ventricular systolic pressures while able to withstand continuous maximal auricle closure pressures over a long period of time. 
   
   
       11 .) A wholly implantable non-natural heart for humans having mono-leaflet receiving valves employing hybrid construction, aided by metal and fabric reinforcing inserts and silicone rubber encapsulation, resulting in high strength and lightness, such that said valves can be opened by minimal auricle pressures while being able to withstand continuous maximal ventricular closure pressures over a long period of time. 
   
   
       12 ). A wholly implantable non-natural heart for humans employing solenoid actuators interacting with flat, high energy permanent magnets to effect rhythmic compressions of the four chambers of the heart; aforesaid solenoids preferably employing aluminum wire for increased heat dissipation; said magnets being rigidly bonded to movable diaphragms provided with integral yieldable surrounds to permit minimal resistance to axial motions as said magnets repel away from the confronting cores of aforesaid solenoids; said cores being preferably made of sheet iron; venting of warm air from and suction of cool air into the solenoids' chambers being accomplished via holes on mounting or coupling plates for the ventricles and as mall duct for the auricles. 
   
   
       13 ). A wholly implantable non-natural heart for humans designed with all blood contacting internal surfaces able to effect laminar flow by being rounded and/or smoothened out, such that the tendency to form clots is substantially reduced. 
   
   
       14 ). A wholly implantable non-natural heart for humans capable of communicating with the body and nervous system via embedded electrodes connecting sympathetic and parasympathetic trunks and utilizing the acquired signals to manipulate frequency and contractile force of pumping instantaneously, according to  claim 3 . 
   
   
       15 ). A wholly implantable non-natural heart according to  claim 1  having an aortic system provided with a pulsating system, on overpressure mechanical switch, as well as embedded temperature and pressure transducers that continuously monitor said variables and supply obtained information to the electronic controller for the purpose of manipulating pumping action. 
   
   
       16 ). A wholly implantable non-natural heart for humans having a light and strong auricle's coupling flange according to  claim 1  which aids said auricles resist torsional divergence presented by unbalanced actuator outputs from the left and right sides. 
   
   
       17 ). A wholly implantable non-natural heart for humans having a light and strong ventricle's coupling flange according to  claim 1  which aids said ventricles resist torsional divergence presented by unbalanced actuator outputs from the left and right sides. 
   
   
       18 ). A wholly implantable non-natural heart for humans according to  claim 1  in which the method of coupling the aortic pulsating units' housing to its valve mounting body presents an effective blood seal between the left auricle and left ventricle thereon. 
   
   
       19 ). A wholly implantable non-natural heart for humans according to  claim 1  in which the method of coupling the pulmonic pulsating units' housing to its valve mounting body presents an effective blood seal between the right auricle and right ventricle thereon. 
   
   
       20 ). A wholly implantable non-natural heart for humans according to  claim 1  in which the method of coupling the receiving valves to their respective valve mounting bodies presents in each case, an effective blood seal between the auricles and ventricles thereon. 
   
   
       21 ). A wholly implantable non-natural heart for humans according to  claim 1  having yieldable surrounds for the actuating diaphragms which are filled with a heat absorbing material such as polybalting or other non-fibre glass material for the purpose of absorbing some heat generated by the actuating solenoids. 
   
   
       22 ). A wholly implantable non-natural heart for humans having metal inserts embedded in heart material for the purpose of retaining screws attaching coupling plates to the outer body of the heart, according to  claim 20  or  claim 1 . 
   
   
       23 ). A wholly implantable non-natural heart for humans according to  claim 1  having a wire harness provided with quick disconnect type plugs leading to a control module such that said control module can be easily and quickly removed and replaced if need be, after access has been gained surgically. 
   
   
       24 ). A wholly implantable non-natural heart for humans according to  claim 1  having a compact vena cava system in which flows from superior and inferior are separated by a wall but combine just before emptying into the right auricle for increased efficiency; said dividing wall provided with smoothly curved surfaces that aid laminar flow. 
   
   
       25 ). A wholly implantable non-natural heart for humans according to  claim 1  provided with movable diaphragm solenoid actuators; said diaphragm driven by either moving magnets (MM) or moving coils (MC). 
   
   
       26 ). A wholly implantable non-natural heart for humans according to  claim 1  employing moving magnets for the actuators; said magnets being of several possible shapes as embodiments of the present invention, notably oval, round, race track or square configurations. 
   
   
       27 ). A wholly implantable non-natural heart for humans according to  claim 1  provided with pulsating units for the great Pulmonic and Aortic vessels, the components of said great vessels and said pulsating units are held firmly together by a combination of bonding agents and flat and round wire type tension spring clamps; said flat wire clamps having rounded edges to negate damage to blood vessels. 
   
   
       28 ). A wholly implantable non-natural heart for humans according to  claim 27 , provided with pulsating units for the great Pulmonic and Aortic vessels for the purpose of increasing the efficiency of the system; said pulsating units composed of a highly stretchable membrane having a resilient foam backing so as to mimic natural arterial behavior during pumping. 
   
   
       29 ). A wholly implantable non-natural heart for humans according to  claim 1  having a mechanical overpressure switch embedded within the Aortic pulsating unit such that excessive and dangerous arterial pressures cause the stretchable membrane and foam backing to movably close the switch contacts, thereby introducing electronic countermeasures in the form of voltage/current reduction and increased resistance of the signals emanating via the controller and reaching the solenoid actuators, hence resulting in a reduction of said excessive pressures. 
   
   
       30 ). A wholly implantable non-natural heart for humans according to  claim 15  having an overpressure switch, a temperature transducer and a pressure transducer; said temperature and pressure transducers being standard commercially available microprobe and diaphragm types respectively; said temperature and pressure transducers rigidly positioned on the aortic arch such that the aforesaid temperature probe penetrates into the Aorta and remains in constant contact with the blood; aforesaid pressure transducer extending into the Aorta as well, but shrouded by heart material such that it has no direct contact with the blood; aforementioned overpressure mechanical switch provided with a spring loaded axially moving contact rigidly welded to a curved stop arm for contacting aforementioned stretchable membrane; aforesaid switch also being provided with mounting flanges having mounting holes for rigidly mounting the unit to the housing of aforementioned Aortic pulsating unit by means of screws. 
   
   
       31 ). A wholly implantable non-natural heart for humans according to  claim 1  provided with receiving valves which close on compression of the ventricular chambers; positioning and assembly of said receiving valves within the heart simplified by an access hole presented by cut off flaps on top of each auricle such that after the aforesaid valves have been successfully mounted, the holes are precisely closed by bonding and/or stitching, such that a perfect seal is presented each time; beveling of said cut off flaps providing an increased surface area for bonding. 
   
   
       32 ). A wholly implantable non-natural heart for humans according to  claims 27  or  28  having Pulmonic and Aortic pulsating units; said pulsating units having component housings provided with upper necks for attaching to the great vessels externally by means of bonding agents and clamps; inner surfaces of said upper necks of said pulsating units having the stretchable membranes bondably attached thereon, as well as being held firmly by flat tension clamps, such that a curved portion of the inner surfaces of aforesaid upper housing necks are in continuous contact with the blood and are preferably highly polished and/or coated with anticoagulants to prevent clotting of blood. 
   
   
       33 ). A wholly implantable non-natural heart for humans according to  claim 1  having tri-leaflet ejection valves which screw unto the lower edges of their respective pulsating unit housings, thereby forming single integral units. 
   
   
       34 ). A wholly implantable non-natural heart for humans according to  claim 1  provided with auricle coupling plates, ventricle coupling plates, auricles' coupling flange, ventricles' coupling flange, a valve mounting body assembly and an I-beam shaped chassis all of which are preferably made of high strength aluminum alloys or other high strength and light composite materials; combined total weight of said component members capable of being greatly reduced without compromising strength by punching holes in the appropriate places, as well as by Inking. 
   
   
       35 ). A wholly implantable non-natural heart for humans according to  claim 1  provided with single leaflet receiving valves whose maximum diaphragm excursion on opening is determined by an angled stop piece having a silicone encapsulation so as to present damping factor at bottoming as well as preventing diaphragm members from exceeding elastic limits. 
   
   
       36 ). A wholly implantable non-natural heart for humans according to  claim 1  provided with single leaflet receiving valves having diaphragm edge lip bulges of silicone deposit for the purpose of enhancing damping factor on closure, thereby reducing the tendency to damage large blood vessels during large ventricular contractile force closures of said diaphragms during ejections. 
   
   
       37 ). A wholly implantable non-natural heart for humans according to  claim 1  having single leaflet receiving valves preferably provided with perforated metal inserts and reinforcing fibres in cloth form, for the purpose of improving performance and reliability over a long period of time. 
   
   
       38 ). A wholly implantable non-natural heart for humans according to  claim 1  provided with tri-leaflet ejection valves whose maximum individual leaflet's excursion on opening is determined by an angled stop piece having a silicone encapsulation so as to present damping factor aat bottoming, as well as preventing diaphragm member components from exceeding their elastic limits. 
   
   
       39 ). A wholly implantable non-natural heart for humans according to  claim 1  provided with tri-leaflet ejection valves having cusp-like leaflet apexes encapsulated with silicone in such a manner that damping factor is effected on closure, resulting in reduced tendency to damage blood vessels while at the same time providing enough hold strength to negate prolapse during peak auricles pressure fluctuations. 
   
   
       40 ). A wholly implantable non-natural heart for humans according to  claim 1  provided with trileaflet ejection valves having cusp-like leaflets whose shape is defined by cusp-shaped perforated metal or plastic (movable) inserts and perforated non-movable plates, as well as woven fabric type reinforcing fibres, for the purpose of improving performance and reliability over a long period of time. 
   
   
       41 ). A wholly implantable non-natural heart for humans according to  claim 1  provided with single leaflet diaphragm receiving valves; said valves having a movable diaphragm ledge which could also be integrally molded with the valve body. 
   
   
       42 ). A wholly implantable non-natural heart for humans according to  claim 1  provided with trileaflet ejection valves having diaphragm mounting ledges which terminate towards the bottom of the valves. 
   
   
       43 ). A wholly implantable non-natural heart for humans according to  claim 1  provided with both single leaflet receiving and tri-leaflet ejection valves; said valves having threaded outer short tubular profiles, for the purpose of rigidly coupling aforesaid receiving valves to insert valve mounting body assemblies and the aforesaid ejection valves to pulsating unit housings for pulmonary and aortic systems. 
   
   
       44 ). A wholly implantable non-natural heart for humans according to  claim 1  having a vena cava blood delivery system having a widened mid-section and a narrowed thickness and provided with an oval connecting tube as a variant of the standard round profile system, for the purpose of handling larger volumes of blood without taking up much more space. 
   
   
       45 ). A wholly implantable non-natural heart for humans according to  claim 1  provided with yieldable surrounds which are integral with the diaphragms of the actuators and the rest of the heart material for each given chamber; said surrounds suitably reinforced by bonding with woven fibre cloth type material such as nylon and the likes. 
   
   
       46 ). A wholly implantable non-natural heart for humans according to  claim 45  provided with reinforced yieldable diaphragm surrounds; said surrounds capable of being several variants such as single or double roll convex, single or double roll convex, single or double V groove, flat annular, design or an integral accordion configuration. 
   
   
       47 ). A wholly implantable non-natural heart for humans according to  claim 1  provided with actuating solenoids interacting high energy disc magnets; governing magnetic orientation of said components is such that only repulsion of the magnets from the solenoids is used to generate dynamic compressive forces for opening the valves and, in the case of the ventricles, to aid in the rapid return of the moving diaphragms to their rest positions in preparation for the next cycle. 
   
   
       48 ). A wholly implantable non-natural heart for humans according to  claim 1  provided with chambers for both auricles and ventricles defined by yieldable surrounds, such that warm air from aforementioned solenoids in the said chambers are vented through small openings tuned in such a manner that enclosed air volume increases with increased diaphragm excursions owing to cooler air suction which presents resistive pneumatic loads that help control and negate violent diaphragm returns to their rest position. 
   
   
       49 ). A wholly implantable non-natural heart for humans according to  claim 1  having blood vessels made of bio-inert material molded of silicone or other suitable material and provided with flared exit mouths for the purpose of attaching by suturing, with natural human body blood vessels with varying diameters; said flared exit mouths preferably made of a woven fabric such as dacron or nylon or such a material as to promote growth of body tissue into it; said exit mouths being either integrally molded with the artificial vessels or attached by stitching and/or bonding with, a suitable bonding agent. 
   
   
       50 ). A wholly implantable non-natural heart for humans according to  claim 1  provided with strengthening means along the seam defining left and right halves of the heart; said strengthening means being in the form of an adhesive backed belt which reduces the risk of separation of the individual chambers from the others owing to the torsional forces produced by the actuators; said heart chamber components such as coupling plates etc. capable of being further strengthened as well as being made biocompatible by encapsulating with a thin coat of silicone sprayed on with a suitable spray equipment or brushed on.