total artificial heart device ( 1 ) mainly consists of internal apparatus ( 2 ), external apparatus ( 3 ) and adapter ( 4 ) fragments . total artificial heart device ( 1 ) is composed of the left ventricle engine ( 1 . 1 ), the right ventricle engine ( 1 . 2 ), left atrium entrance way ( 1 . 3 ), right atrium inflow tract ( 1 . 4 ), aortic outflow tract ( 1 . 5 ), and pulmonary arterial outflow tract ( 1 . 6 ), aortic valve ( 1 . 7 ), and pulmonary valve ( 1 . 8 ), spacer apparatus ( 1 . 9 ) of parts . interior apparatus ( 2 ) the internal control system ( 2 . 1 ), the internal battery ( 2 . 2 ), internal power transfer apparatus ( 2 . 3 ), the protective sheath ( 2 . 4 ), the electrical power cord ( 2 . 5 ), microprocessor ( 2 . 6 ), blood pressure sensor ( 2 . 7 ), blood flow rate sensor ( 2 . 8 ) and the motor driver circuit ( 2 . 9 ) fragments . external apparatus ( 3 ) consist of the external control unit ( 3 . 1 ), external battery ( 3 . 2 ), the external power transfer apparatus ( 3 . 3 ), touch screen ( 3 . 4 ) and the light and the buzzer ( 3 . 5 ) parts . the engine designs of our heart assist devices , mentioned in the national patent applications we had done before with the reference numbers tr2012 / 00951 , tr2012 / 07222 , tr2012 / 09878 , tr2012 / 15023 and the patent applications we had applied under the patent cooperation treaty regulations with the reference number pct / tr2012 / 00055 , have also been employed in the engine designs of the total artificial heart . direct drive technology is now replacing the conventional engine and transmission systems . various screws , belt systems , gear boxes and mechanical interfaces are removed in the direct drive technology systems , and these have increased the efficiency , accuracy and performance of the system . moreover , they are easy to designs , and it is impossible to realize all of them with conventional drive systems . to name a few benefits of this technology ; productivity has increased ( engine power is not wasted by friction ), lifetime has extended ( having fewer moving parts ), noise and vibration have decreased , they have more rapid and precise positioning and high torque capabilities . all of these elements determining the overall performance of the system create a unity . this technology has been employed in our total artificial heart device ( 1 ). total artificial heart device ( 1 ) includes neither a left ( 1 . 1 ) and a right ventricular engine ( 1 . 2 ) nor the intermediate elements and a rotor with a pivot pin . the left ventricle engine ( 1 . 1 ) and the right ventricle engine ( 1 . 2 ) have the ability to transmit the power from the rotor to the system directly without any connecting link components . there will be design options of various sizes ( pediatric and even neonatal models ) of the precise engines with long life that will not wear out over time . there are high sensitivity of blood pressure and blood flow rate sensors ( 2 . 8 ) in the left ventricular engine ( 1 . 1 ) and the right ventricle motor ( 1 . 2 ) of our total artificial heart device ( 1 ), and these sensors ( 2 . 8 ) provide feedback to the microprocessor ( 2 . 6 ). this state is required for the optimum performance of the total artificial heart device ( 1 ). since the magnetic bearings provide rotation to the rotor without friction , there will be no wear out or component aging , and this will enhance the long life of the total artificial heart ( 1 ). a healthy human heart has a pulsatile blood flow with the contraction and relaxation of the ventricles ( systole and diastole ). the perfusion provided with pulsatile blood flow has hemodynamic significant advantages when compared with non - pulsatile perfusion . pulsatile blood flow is a physiological blood flow pattern in a healthy person . pulsatile blood flow in the patient &# 39 ; s bloodstream means an additional of energy transfer into the micro - circulation , and this extra kinetic energy helps red blood cells transport to capillary vessels . thus , it increases capillary circulation , helps lymph circulation , and ultimately , it has a positive effect on the cell metabolism . a good total artificial heart device ( 1 ) should ensure pulsatile blood flow with natural intermittents to the human body as it has accustomed to . in our device , the left ventricle engine ( 1 . 1 ) and the right ventricle engine ( 1 . 2 ) run making stop - and - go , and they start during the systole and stop during the diastole period . systolic and diastolic interval time is constantly changing in a healthy subject . the duration of systole is the contraction time of the heart ( systolic ejection time ). the blood flow is adjusted according to the needs of the body by extending or shortening the period . systolic ejection time intervals increase when blood flow is required to increase , and systolic ejection time intervals decrease when it is necessary to reduce blood flow . this is provided by the heart &# 39 ; s own natural sinus rhythm . as our invention will run with ecg signals synchronously , it will keep up with the sinus rhythm of the heart , and systolic time will extend or shorten continuously according to the requirement of blood flow . microprocessor will undertake this job in the patients , whose heart conduction system damaged or out of work , with the help of software which contains similar algorithms . moreover , the software includes algorithms that will initiate the microprocessor immediately when a technical problem occurs in the records of the ecg signal . a one - way valve in the aorta outflow tract ( 1 . 5 ) and the pulmonary arterial outflow tract ( 1 . 6 ), and an artificial aortic valve ( 1 . 7 ) on aorta , and an artificial pulmonary valve on the pulmonary artery ( 1 . 8 ) are available . these valves open fully during the systole and close during diastole to prevent back flowing of the blood . artificial aortic and pulmonary valves have artificial joints apparatus that are easily removable , and they can be removed and fitted easily on demand one by one or the other or both . if the patient &# 39 ; s own aortic and pulmonary valves of heart are healthy and functioning properly , artificial aortic and / or pulmonary heart valves will be removed , and while artificial heart is being positioned in its place without damaging these valves so that the system can use the patient &# 39 ; s own natural heart valves . total artificial heart device ( 1 ) has the parts to be attached to the patient such as the left atrium entrance way ( 1 . 3 ), the right atrium entrance way ( 1 . 4 ), aortic outflow tract ( 1 . 5 ), and pulmonary arterial outflow tract ( 1 . 6 ). the connection will be achieved by placing it into the lining of the heart instead of a portion of the heart &# 39 ; s ventricles extracted from patients with open - heart surgery . not all of the heart but only a part of the ventricles of the heart is removed during surgery , and atriums , sinus node , atrioventricular node conduction pathways of the heart are not disturbed . internal control system ( 2 . 1 ) receives the data of the aorta and pulmonary artery blood pressure and blood flow from the blood pressure sensors ( 2 . 7 ) and blood flow sensors ( 2 . 8 ), and processes them in real - time with the help of microprocessor , suitable software and algorithms . the speed of the motors per minute in the left ventricle ( 1 . 1 ) and the right ventricle ( 1 . 2 ) and / or duration of systole are adjusted according to the data obtained from these sensors and algorithm . when the blood pressure goes up above a certain limit , the engine slows down and / or systolic time intervals shortens , and when the blood pressure falls below a certain limit , the engine accelerates and extends the systolic time intervals , thus the formation of normal pulsatile blood flow closest to the heart &# 39 ; s is provided . as the total artificial heart device ( 1 ) can be produced in small volumes , it can be applied to all patients , including pediatric and newborn babies . the device has two batteries ; an internal battery ( 2 . 2 ) and an external battery ( 3 . 2 ). the apparatus ( 3 ) in which external battery ( 3 . 2 ) is located can be recharged with its own adapter ( 4 ). external apparatus ( 3 ) has three separate parts each of which have different functions . the first equipment is a rechargeable lithium - ion battery . this external battery ( 3 . 2 ) is an electrical energy store that provides the necessary energy . the second equipment is the internal battery ( 2 . 2 ) that is power transmission apparatus ( 3 . 3 ). the third is the external control unit ( 3 . 1 ). the external control unit ( 3 . 1 ), continuously updates the vital data such as the charge status of the internal battery ( 2 . 2 ), blood pressure , blood flow and heart rate in real time thanks to a remote control system , and shows on the touch screen ( 3 . 4 ) when prompted . thus , one side of external apparatus ( 3 ) is made up of the touch screen ( 3 . 4 ) of the control unit ( 3 . 1 ) and the other side is the induction surface of external power transmission apparatus ( 3 . 3 ). internal battery ( 2 . 2 ) and the internal control system ( 2 . 1 ) are placed into a protective cover ( 2 . 4 ) both as integrated ( monolithic ). the cover is made of a biocompatible material . internal control unit ( 2 . 1 ) settings can be changed from the touch screen ( 3 . 4 ) of the external control unit ( 3 . 1 ) after the authorized user &# 39 ; s input . the power from the external battery ( 3 . 2 ) is transmitted to the internal battery ( 2 . 2 ) located under the skin with the help of a wireless technology . this transmission is achieved through induction current , and there is an internal power transmission apparatus in the a system placed under the skin by a cardiac surgeon , and an external power transmission apparatus on the other is outside of it . induction current produced by the external apparatus is picked up by the internal apparatus , and is converted to alternating current , and then it is stored into the battery being converted into the direct current . internal battery ( 2 . 2 ) and the external battery ( 3 . 2 ) are formed when the lithium - ion battery cells are linked together . lithium - ion batteries include lithium and polymer chemicals in their structures , and today they are widely used in the model aircraft , navigation devices , mp3 players and mobile phones . lithium - ion batteries are made up of cells . the nominal voltage of each cell is 3 . 7 volts , and these cells can produce batteries whose values increase at 3 . 7 volt and its folds with serial or parallel connections . although lithium - ion batteries are quite lighter than nicd and nimh batteries , they can store more energy , and have also longer battery life . there is a microprocessor ( 2 . 6 ) in the internal control unit ( 2 . 1 ), and its system settings can be reset from the touch screen ( 3 . 4 ) of the external control unit ( 3 . 1 ) after the authorized user &# 39 ; s input . the left ventricle engine ( 1 . 1 ) and the right ventricle engine ( 1 . 2 ) are brushless motors . synchronous , servo or asynchronous motor types can be employed . as it is known , a microprocessor is required to run these advanced brushless motors . the microprocessor in the internal control unit ( 2 . 1 ) performs this task . microprocessor engines control in a detailed manner , amplify the signals from the sensors through the amplifier ( amplifier ) circuit , and analyze with the help of the software by means of a suitable algorithm prepared and through the adc ( analog - converter to digital ), and implement in real - time . a microprocessor ( 2 . 6 ) controls synchronized both of the right ventricle engine ( 1 . 2 ) and the left ventricular engines ( 1 . 1 ) per minute ( rotation / minute ) revolution speed led by a software setting . while blood pumps run intermittently , start and stop time intervals occur , and this gives rise to pulsatile blood flow . from a physiological point of view , for example , when a person is in any effort , the human body responds that by increasing pulse rate per minute . a reverse situation occurs at rest , and the number of pulses is at the lowest level . another rule is that the duration of systole increases when the cardiac output increases . conversely , systolic interval decreases when cardiac output decreases . the duration of systole and diastole of a healthy human heart , especially , the systolic ejection time can be measured in milliseconds echocardiographic examinations , and the duration of systole is approximately half of the diastole time . also , the coordination between the systolic and diastolic time intervals of the total artificial heart should be as in a healthy human . thus , the total blood flow is obtained , and as the systolic time intervals increases , the blood flow increases , and when the systolic time intervals decreases , blood flow decreases . only the ventricles of the heart is removed from the patient at the surgery , and the heart &# 39 ; s sinus node and the atrioventricular node and nerve conduction paths will remain and run intact . therefore , the right atrial sinus node will continue to produce ecg signals . when the total artificial heart runs synchronous with the ecg signals , it will act in accordance with the running physiology of a healthy human heart . initially , the systolic period of artificial heart will be half as much as diastolic time , but with the efforts of the patient , ecg signals caused by the sinus node will begin to occur more frequently . microprocessor will respond by extending the duration of systole when the ecg signals become frequent , thus , the blood flow increases as the patient makes efforts . a reverse situation will occur when the patient is at rest . the blood flow passing from the aorta is equal to the flow from the pulmonary artery in a healthy person . that is , the ratio of mean pulmonary blood flow ( qp ) to systemic blood flow ( qs ) always equals to one ( qp / qs = 1 ). microprocessor will always keep the qp / qs = 1 equation uninterrupted after processing the data separately from the blood flow meter on the aorta and pulmonary artery ; if blood flow increases in one the artery , the microprocessor will shorten the duration of systolic blood flow of that blood pump motor , and extend the systolic time interval if blood flow decreases . thus , the microprocessor runs two blood pump motors separately . the surfaces of the left ventricle engine ( 1 . 1 ) and the right ventricle engine ( 1 . 2 ), which may contact with blood and body tissues , will be covered with special materials such as nickel - titanium alloy and porcelain to which human body will not react , and the electrical components will be isolated from the blood . assuming that electric motors get heated while running under high performance , the outer surface of the artificial heart that will be placed into the pericardial cavity will also be insulated . this insulation , as in the steel thermos containers , will be carried out by vacuuming the air in the gaps , and the gaps that cannot be vacuumed will be insulated with porcelain - like materials that have both heat and electrical insulation properties . in addition , the system will operate more stable as both blood pump motor will turn in the opposite directions to each other . the upper and lower speed limits of the heart engines will be determined and set either automatically or manually by the patient &# 39 ; s physician according to the conditions compatible with the patient &# 39 ; s age , weight , and specific health conditions . when a donor &# 39 ; s heart is transplanted to the patient , immunotherapy ( a drug treatment that prevents the rejection of the donor heart by suppressing the immune system ) is administrated , and this drug therapy will be out of question for the patients with total artificial heart transplantation . in addition , some heart diseases may lead to heart failure even in newborn infants , and therefore , artificial heart devices can be produced in all sizes , including newborn infant sizes . when exceptional cardiac malformations occur in cases , prototype molds will be prepared from three - dimensional patient &# 39 ; s heart mr or ct images obtained by imaging and a patient - specific total artificial heart device compatible with the morphological structure of the patient &# 39 ; s heart will be produced if required . since the total artificial heart device is vital for the patient , all software , hardware , apparatus and all functions of the system will have a standby backup , and will have master and apprentice or master / slave configuration , and they will be designed so that when one fails , the other can be activated instantly . in order to prevent the damage of electrical leakage and high temperatures that may arise when total artificial heart device runs , all around the system will be coated with a biocompatible insulating material that enhances electrical and thermal insulation . one of the properties of total artificial heart device is that when a donor &# 39 ; s heart is found , it makes it possible to remove the artificial heart installed without damaging the anatomical structures surrounding heart . another feature of the total artificial heart device is the spacer ( connector ) that has been developed to help the cardiac surgeon while installing it into the patient . this median apparatus is made of biocompatible material , and it is a spacer ( connector ) compatible with mitral and tricuspid valve inputs and aorta and pulmonary arterial outputs after the removal of both the right and left ventricles of the heart . a surgeon first adapts this spacer ( connector ) to the output and input tracks of the heart with a surgical intervention and sutures it , and after this process , she takes the actual total artificial heart device and fastens it to spacer ( connector ) with a simple mechanical process . after all these , one of the most vital tasks before the artificial heart device operates is to ensure that there is no air embolism . an important task before running the artificial heart is that all the entire interior apparatus , including power transmission apparatus must be located and all connections must be done . when myocardium loses its contractility feature almost completely , artificial heart components can be placed separately into the right and left ventricles without interference the heart muscle . the artificial heart component located in the right ventricle of a heart includes a heart assist device , and takes the blood from the right atrium and passes it into the pulmonary artery . the artificial heart component located in the left ventricle also includes a heart assist device , and it takes the blood from the left atrium and passes it into the aorta . both heart assist devices are controlled by a common microprocessor . as the devices are located into the ventricles , this kind of structure can be called as “ in ventricular heart assist device ” ( intraventricular heart assist device ). in this case , without ventriculotomy , the components of both heart assist devices can be placed into the ventricles through mitral and tricuspid valve caps with a simple atrial incision . thermal insulation will be carried out assuming that total artificial heart device will overheat , and damage the surrounding tissues and organs while running . for this purpose , it contains spaces providing heat insulation with the similar logic as in the air in the thermos containers whose air is vacuumed . thus , the lightest method will be used for the thermal insulation while the patient &# 39 ; s body is not loaded with unnecessary material or metals . while a total artificial heart device is being installed into a patient by a heart surgeon , there will be a spacer ( connector ) ( 1 . 9 ) made of biocompatible material which will make the surgical procedures easy . first , the surgeon will locate this apparatus into the heart and the circulatory system of the patient , and then will install easily the main part of the artificial heart to this apparatus ( 1 . 9 ) mechanically ( by fastening , attaching to each other by means of permanent magnets , or screwing with the help of screws ). the microprocessor ( 2 . 6 ) of artificial heart will produce light and acoustic warnings ( 3 . 5 ) in such cases of emergency as when the internal and external battery charges are within the danger limits of pre - determined limits or there is abnormal increase or decrease in the blood flow rate or blood pressure , and thus , patients and their relatives will be warned beforehand . moreover , when the the data reaches the danger limit , all the people will be informed as it includes a software that sends messages to the patient &# 39 ; s physician , hospital or ambulance service or predetermined addresses . the external control unit ( 3 . 1 ) of the artificial heart includes a clock , a calendar and software that display the current screen values and the coordinates where the patient is . in the event of any negative case , the software will notify the relevant places the pre - determined coordinates where the patient is via sms or e - mail . for this purpose , the system includes a modem that provides wireless internet access . it also includes a software that allows the the patient &# 39 ; s physician to reset the control unit by providing a remote access via the internet being entered by an authorized user . in order not to disturb the patient when its engines start and stop , the outer part of the artificial heart will be coated with a biocompatible silicone - like material that dampens vibrations .
the invention is about a permanent total artificial heart device that is developed for the patients who are at the end - stage heart failure and included in the heart transplantation program , and which is placed into the ventricles of the patient &# 39 ; s heart completely or placed surgically into the space obtained when a piece of ventricle is removed . the device employs “ direct drive technology ,” technically using the advantages of brushless electric motors . special - designed engines require quite little energy for the pulsatile blood flow produced by stopping and starting synchronously with the ecg signals . it is about a permanent total artificial heart device system that will offer high quality of life for many years to the patients as it protects the heart valves and heart conduction system , has wireless charging and longer battery life .