Blood supply and demand balance adjustment method and system of total artificial heart, and total artificial heart

Abstract

The application provides a blood supply and demand balance adjustment method and system of a total artificial heart and the total artificial heart, and belongs to the technical field of medical devices. The blood supply and demand balance adjustment method of the total artificial heart obtains the real-time blood supply and demand balance index of the total artificial heart, compares the blood supply and demand balance index with the blood supply and demand balance index threshold obtained and set in advance, and obtains the blood supply information of the total artificial heart to the human body. In the case that the blood supply information of the total artificial heart to the human body shows that the blood supply of the left ventricle of the total artificial heart and the right ventricle of the total artificial heart to the human body is unbalanced, the running speed of one of the left and right ventricles is changed based on the correlation between the running speed of the power system and the blood pumping capacity of the ventricle, and the blood pumping capacity of the left and right ventricles is also changed, so that the blood supply of the left and right ventricles can be accurately adjusted in real time to achieve balance.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a method, system and total artificial heart for regulating blood supply and demand balance. Background Technology

[0002] The heart is the body's engine, continuously pumping blood to every corner of the body. If we calculate based on an average heart rate of 70 beats per minute and a lifespan of 80 years, the heart beats nearly 3 billion times in a lifetime.

[0003] However, when certain congenital heart diseases or cardiomyopathies progress to their end-stage, and the heart's pumping function gradually fails, it is medically termed "heart failure." When a user experiences symptoms such as shortness of breath and wheezing at rest, it is classified as stage IV heart failure, also known as end-stage heart failure. According to the latest global epidemiological survey, there are approximately 17 million heart failure patients worldwide, and about 3 million end-stage heart failure patients require heart transplants annually. However, due to a severe shortage of donor organs, only about 5,000 heart transplants can be performed globally each year. The remaining 99% or more die while waiting for a transplant. Therefore, developing artificial hearts with higher safety, durability, and universality is a top priority for medical professionals worldwide.

[0004] While global research teams have made significant breakthroughs in the development of total artificial hearts (TACs), existing TACs still suffer from numerous major problems, including large size, short lifespan, susceptibility to thrombosis, and low survival rates and lifespans. For example, although TACs are designed to pump blood in the left and right ventricles at the same rate during manufacturing, individual differences and changes in body position during operation can lead to variations in pumping volume between the left and right ventricles. This imbalance can cause blood stasis in some organs and insufficient blood supply to others, potentially resulting in multiple diseases, multiple organ failure, and death. This is the main reason for the significant safety deficiencies of current TACs and their limited widespread adoption. Therefore, there is an urgent need to find a more effective, reliable, and precise technical method to balance the blood supply and demand between the left and right ventricles over a long period of time, in order to solve the major problem of the imbalance between the blood supply and demand between the left and right ventricles in a total artificial heart. Summary of the Invention

[0005] This application provides a method for regulating the blood supply and demand balance of a total artificial heart and a total artificial heart, in order to solve the major problems of unbalanced blood supply and demand in the left and right ventricles and insufficient safety performance of existing total artificial hearts.

[0006] In a first aspect, embodiments of this application provide a method for regulating the blood supply and demand balance of a total artificial heart. The method is applied to a blood supply and demand balance regulation system for a total artificial heart. The blood supply and demand balance regulation system for a total artificial heart includes an intelligent system, a power system, a left ventricle, and a right ventricle. The intelligent system is electrically connected to the power system. The blood supply and demand balance regulation method of the total artificial heart includes: The intelligent system acquires a preset blood supply and demand balance index threshold and acquires the correlation between the operating speed of the power system and the blood supply to the ventricles. The correlation between the operating speed of the power system and the blood supply to the ventricles includes: changing the operating speed of either the left or right ventricle will also change the blood supply to the left or right ventricle. The blood supply and demand balance index threshold includes at least one of the following: a preset blood pressure or flow rate value for the left atrium or pulmonary vein; a preset blood pressure or flow rate value for the right atrium or superior and inferior vena cava; a preset blood pressure or flow rate value for the left ventricle or aorta; and a preset blood pressure or flow rate value for the right ventricle or pulmonary artery. The intelligent system controls the real-time detection and acquisition of the blood supply and demand balance index of the total artificial heart. The blood supply and demand balance index includes at least one of the following: real-time detected blood pressure or flow rate of the left atrium or pulmonary vein; real-time detected blood pressure or flow rate of the right atrium or superior and inferior vena cava; real-time detected blood pressure or flow rate of the left ventricle or aorta; and real-time detected blood pressure or flow rate of the right ventricle or pulmonary artery. Based on the blood supply and demand balance index threshold, the blood supply and demand balance index is compared with the blood supply and demand balance index to determine the blood supply information of the total artificial heart to the human body; When the blood supply information of the total artificial heart shows an imbalance in the blood supply from the left ventricle and the right ventricle of the total artificial heart to the human body, the operating speed of the power system for the left ventricle or the right ventricle of the total artificial heart is changed based on the correlation between the operating speed of the power system and the ventricular blood supply. The intelligent system is controlled to detect and acquire the blood supply and demand balance index of the total artificial heart at the current moment in real time; Based on the blood supply and demand balance index of the total artificial heart at the current moment, compared with the blood supply and demand balance index threshold, the blood supply information of the total artificial heart to the human body at the current moment is determined. Based on the blood supply information to the human body at the current moment, a target operation is performed, wherein the target operation includes: When the blood supply information of the total artificial heart to the human body at the current moment shows that the blood supply from the left ventricle and the right ventricle of the total artificial heart to the human body is balanced, the operating speed and blood supply of the power system to the left ventricle and the right ventricle of the total artificial heart become consistent. If the blood supply information of the total artificial heart to the human body at the current moment shows an imbalance in the blood supply from the left ventricle and the right ventricle of the total artificial heart to the human body, the operating speed and blood supply of the power system to the left ventricle or the right ventricle of the total artificial heart will be changed based on the correlation between the operating speed of the power system and the ventricular pumping volume. Based on the correlation between the operating speed of the power system and the ventricular blood supply, changing the operating speed of the power system for the left ventricle or the right ventricle of the total artificial heart includes: When the blood supply to the left and right ventricles of the total artificial heart is unbalanced, the operating speed of the power system for the right ventricle of the total artificial heart is changed while the operating speed of the power system for the left ventricle remains constant; or, the operating speed of the power system for the left ventricle of the total artificial heart is changed while the operating speed of the power system for the right ventricle remains constant, until the blood supply and demand of the left and right ventricles reach equilibrium.

[0007] Secondly, embodiments of this application also provide a blood supply and demand balance regulation system for a total artificial heart. The blood supply and demand balance regulation system is used to execute the blood supply and demand balance regulation method for a total artificial heart described in the first aspect. The power system is a linear motor power system, which includes a linear motor, a push-pull rod, and a push plate. The linear motor is connected to the push-pull rod, and the push-pull rod is connected to the push plate. The power system operates in a reciprocating linear motion so that its push plate pushes the left and right ventricles to pump out and draw in blood.

[0008] Optionally, the blood supply and demand balance regulation system further includes: a shell, a left ventricular diaphragm, a right ventricular diaphragm, an ingress valve, an egress valve, and blood vessels; The left and right ventricular diaphragms are located at the left and right ends of the shell, respectively, and are combined with the shells at the left and right ends to form the left and right ventricles. Each of the left and right ventricles has two openings, and the inlet valve and the outlet valve are respectively located at the openings. There are four blood vessels, one end of which is connected to the four openings of the left and right ventricles, and the other end is connected to the aorta, pulmonary artery, left atrial incision, and right atrial incision, respectively. The power system has two push plates, left and right. One push plate is attached to the diaphragm of the left ventricle, and the other push plate is attached to the diaphragm of the right ventricle. When the push plate moves towards the left ventricle, it pushes the diaphragm of the left ventricle to pump out blood from the left ventricle, while the right ventricle at the other end expands its volume and draws in blood. When the push plate moves towards the right ventricle, it pushes the diaphragm of the right ventricle to pump out blood from the right ventricle, while the left ventricle at the other end expands its volume and draws in blood. The power system operates in a cyclical manner, so that the left and right ventricles continuously draw in and pump out blood, realizing human blood circulation.

[0009] Optionally, the power system is a rotary motor power system, which includes a magnetic levitation motor, a housing, and blood vessels. There are two magnetic levitation motors, which are respectively arranged on the left and right sides of the housing, forming left and right ventricles. There are four blood vessels, one end of which is connected to the inlet and outlet of the left and right ventricles, respectively, and the other end is connected to the aorta, pulmonary artery, left atrial incision, and right atrial incision, respectively.

[0010] Optionally, during operation, the two magnetic levitation motors of the power system rotate, drawing blood from the left and right atria through two ventricular vessels, and then pumping it into the aorta and pulmonary artery through the left and right ventricles, respectively, thus achieving human blood circulation.

[0011] Optionally, the intelligent system further includes a circuit board, sensors, a power supply system, a communication system, and program software, wherein the circuit board is connected to the sensors, the power supply system, and the communication system.

[0012] Optionally, the power supply system includes a built-in battery, a built-in receiving coil and an external battery, an external circuit board and chip, and an external transmitting coil. The built-in receiving coil is used for subcutaneous implantation and is electrically connected to the built-in battery and the intelligent system. The external transmitting coil is correspondingly set inside and outside the human body to supply power to the device inside the body. The external battery can be integrated with the external circuit board and chip into a module and placed in a pocket of a vest or belt worn outside the human body, and connected to the external transmitting coil to supply power to the human body. The power supply system is not limited to wireless power supply, but can also use a wired connection to connect internal and external power sources and devices.

[0013] Optionally, the communication system includes a built-in communication module, an external communication module, an external display, and an early warning device. Both the communication system and the power supply system are electrically connected to the intelligent system. The connection between the built-in and external parts of the communication system is wireless. The communication system is not limited to wireless connection; it can also use a wired connection to connect internal and external communication devices.

[0014] Optionally, the surfaces of the components that come into contact with blood and the human body, such as the left ventricle, the right ventricle, the artificial blood vessel, the ingress valve, the egress valve, and the magnetic levitation motor, are made of biocompatible materials.

[0015] Thirdly, embodiments of this application also provide a total artificial heart, which is used to perform the blood supply and demand balance regulation method of the total artificial heart shown in the first aspect, and the total artificial heart includes the blood supply and demand balance regulation system of the total artificial heart shown in the second aspect.

[0016] In the technical solution provided in this application embodiment, by acquiring the real-time blood supply and demand balance index of the total artificial heart and comparing it with a pre-acquired and set blood supply and demand balance index threshold, the blood supply information of the total artificial heart to the human body can be obtained. When the blood supply information of the total artificial heart shows an imbalance in the blood supply from the left and right ventricles, the pumping speed of the power system to one of the left and right ventricles is changed in real time based on the correlation between the operating speed of the power system and the ventricular pumping volume, thereby increasing or decreasing the blood supply to that ventricle and ensuring that the blood supply to the left and right ventricles is accurately balanced in real time. Through the method provided in this application embodiment, when an imbalance in the blood supply to the left and right ventricles occurs during the use of the total artificial heart, real-time adjustment can be performed as quickly as possible, allowing the blood supply to the left and right ventricles of the total artificial heart to be restored to balance in a timely manner, thereby improving the safety of the total artificial heart. Meanwhile, based on the correlation between the operating speed of the power system and the blood pumping volume of the ventricles, the balance of blood pumping volume between the left and right ventricles is adjusted in real time. Compared with existing technologies, its technology is novel and unique, with advanced structure, smaller size, stronger durability, and better performance and operability. Attached Figure Description

[0017] To more clearly illustrate the technical solutions of the embodiments of this application, the drawings used in the description of the embodiments of this application will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0018] Figure 1 One of the schematic diagrams illustrating the blood supply and demand balance regulation method in a total artificial heart; Figure 2 The second schematic diagram of the blood supply and demand balance regulation method in a total artificial heart; Figure 3 This is one of the schematic diagrams illustrating the operation of a fully artificial heart; Figure 4This is the second schematic diagram of the operation of a fully artificial heart; Figure 5 This is one of the schematic diagrams illustrating the operational status of a fully artificial heart power system; Figure 6 The second schematic diagram of the operation status of a fully artificial heart power system; Figure 7 A schematic diagram showing the combination of the left ventricular diaphragm and the left shell to form the left ventricle; Figure 8 A schematic diagram showing the combination of the right ventricular diaphragm and the right shell to form the right ventricle; Figure 9 A schematic diagram showing the combination of the left and right ventricular shells and the intermediate shell; Figure 10 A schematic diagram of the apical orifices and blood vessels of the left and right ventricles; Figure 11 for Figure 1 A schematic diagram of the center section; Figure 12 A schematic diagram showing the overall appearance of a fully artificial heart; Figure 13 This is a schematic diagram of another structure of a fully artificial heart; Figure 14 This is a schematic cross-sectional view of another structure of a total artificial heart. Figure 15 This is a schematic diagram of the built-in power receiving coil; Figure 16 This is a schematic diagram of an external component integration module; Figure 17 This is a diagram illustrating how to wear a vest.

[0019] Figure label: 1-A, Left ventricular shell; 1-B, Right ventricular shell; 2-A, Left ventricle; 2-B, Right ventricle; 3-A, Ventricular diaphragm; 3-B, Right ventricular diaphragm; 4-A, Left ventricular push-pull plate; 4-B, Right ventricular push-pull plate; 5, Linear motor; 6, Linear motor mounting bracket; 7, Intermediate shell; 8, Connecting clips between shells; 9, Push-pull rod; 10, Right ventricular inlet valve; 11, Right ventricular outlet valve; 12, Right ventricular outlet valve; 13, Right ventricular inlet valve; 14, Left ventricular inlet valve; 15. 16. Left ventricular outflow port; 17. Left ventricular outflow valve; 18. Left ventricular inflow port; 19. Intelligent system; 20. Built-in battery; 21. Built-in receiving power coil; 22. External transmitting power coil; 23. External warning device; 24. External circuit board and chip; 25. External rechargeable battery; 26. Connection buckle between port and blood vessel; 27. Left ventricular inflow vessel; 28. Right ventricular inflow vessel; 29. ​​Right ventricular outflow vessel; 30. Left ventricular outflow vessel; 31. Outer vest; 32. Outer vest zipper; 33. Outer vest pocket; 34A. Another type of fully artificial heart structure: left ventricle; 34B. Another type of fully artificial heart structure: right ventricle; 35A. Another type of fully artificial heart left ventricle shell; 35B. Another type of fully artificial heart right ventricle shell; 36A. Another type of fully artificial heart left ventricle magnetic levitation component; 36B. Another type of fully artificial heart right ventricle magnetic levitation component; 37A. Another type of fully artificial heart left ventricle magnetic levitation component impeller; 37B. Another type of fully artificial heart right ventricle magnetic levitation component impeller. Wheel; 38A, another type of fully artificial heart left ventricle blood vessel inlet interface; 38B, another type of fully artificial heart right ventricle blood vessel inlet interface; 39A, another type of fully artificial heart left ventricle blood vessel outlet interface; 39B, another type of fully artificial heart right ventricle blood vessel outlet interface; 40, another type of fully artificial heart intelligent system; 41, another type of fully artificial heart built-in battery; 42, another type of fully artificial heart magnetic levitation power outer coil; 43, another type of fully artificial heart magnetic levitation power inner coil; 44, another type of fully artificial heart rotary motor central shaft. Detailed Implementation

[0020] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0021] The terms "first," "second," "one of," "second," etc., used in the specification and claims of this application are used to distinguish similar objects and not to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that embodiments of this application can be implemented in orders other than those illustrated or described herein, and the objects distinguished by "first," "second," etc., are generally of the same class and the number of objects is not limited; for example, the first object can be one or more. Furthermore, in the specification and claims, "and / or" indicates at least one of the connected objects, and the character " / " generally indicates that the preceding and following objects are in an "or" relationship.

[0022] In the description of this application, it should be understood that the terms "length", "width", "thickness", "left", "right", "top", "bottom", "inner", "outer", "axial", "radial", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the equipment or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0023] In the description of this application, it should be noted that, unless otherwise expressly specified and limited, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or simply being attached to each other; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0024] In this application description, the "adhesive connection" means that the push-pull plate and the ventricular diaphragm or soft capsule are simply attached together, or the push-pull plate and the ventricular diaphragm or soft capsule can still be fixedly connected. "Current moment" and "real time" have the same meaning.

[0025] This application proposes a method for regulating the blood supply and demand balance of a total artificial heart, which can be applied to the blood supply and demand balance regulation system of a total artificial heart. The blood supply and demand balance regulation system of the total artificial heart includes an intelligent system, a power system, a left ventricle, and a right ventricle. The intelligent system is electrically connected to the power system.

[0026] like Figure 1 As shown, the method for regulating blood supply and demand balance in a total artificial heart includes the following steps: Step 101: The intelligent system obtains the preset blood supply and demand balance index threshold and the correlation between the operating speed of the power system and the ventricular blood supply.

[0027] The following explanations are provided regarding the blood supply and demand balance index threshold and the blood supply and demand balance index: Before and after implanting a total artificial heart, the patient's cardiac condition must be monitored, including the blood pressure or flow rates in the left atrial and pulmonary veins, the right atrial and superior vena cava, the left ventricle and aorta, and the right ventricle and pulmonary artery. These pressure or flow rates over a given time period must be compared with internationally recognized health standards, while also considering the patient's individual circumstances. Through extensive data analysis, values ​​that meet both international health monitoring standards and the patient's specific health condition are determined. These four values ​​are then fixed as the "blood supply and demand balance index thresholds" for these four locations. The "blood supply and demand balance index" refers to the real-time monitoring and acquisition of these four blood pressure or flow rates over a given time period.

[0028] The correlation between the operating speed of the power system and the blood supply to the ventricles: changing the operating speed of either the left or right ventricle will change the blood supply to both ventricles.

[0029] Specifically, the correlation between the operating speed of the power system and the ventricular pumping volume can include: T SL -T SR If q > 0, then inL >q inR q outL >q outR ; T SL -T SR If q < 0, then inL <q inR q outL <q outR ; T SR -T SL If q > 0, then inR >q inL q outR >q outL ; T SR -T SL If q < 0, then inR <q inL q outR <q outL ; Among them, T SLT represents the operating speed of the power system for the left ventricle of the total artificial heart. SR q represents the operating speed of the power system for the right ventricle of the total artificial heart. inL q represents the blood intake of the left ventricle of the total artificial heart. inR q represents the blood intake of the right ventricle of the total artificial heart. outL q represents the pumping volume of the left ventricle of the total artificial heart. outR This refers to the blood volume pumped by the right ventricle of the total artificial heart.

[0030] Based on the above correlation, it can be concluded that when the operating speed of the power system on the left ventricle is different from that on the right ventricle, it indicates that the blood pumping volume of the left ventricle is different from that of the right ventricle.

[0031] A detailed explanation of the above correlation: Changing the operating speed of the power system for one of the ventricles can increase or decrease the pumping volume of that ventricle, thus regulating the pumping volume of either the left or right ventricle. For example... Figure 3 , Figure 4 , Figure 5 , Figure 6 As shown, its Figure 3 and Figure 5 The corresponding state, Figure 4 and Figure 6 The corresponding states show the states of the power system pushing the left ventricle 2-A and right ventricle 2-B in the blood supply and demand balance regulation system. Each side of the power system is equipped with a push plate, which is attached to the left ventricle 2-A and right ventricle 2-B respectively. The power system is a left-right linkage structure. "If the speed of the push plate to one ventricle is fast and the speed of the push plate to the other ventricle is slow, the speed of the push plate to return to the ventricle with the slower speed will also be slow. The slower the speed of the push plate to return, the longer the blood intake time of the ventricle attached to it will be. The longer the blood intake time, the more blood intake will be, and of course, the more blood will be pumped out; and vice versa."

[0032] Step 102: Control the intelligent system to detect and obtain the blood supply and demand balance index of the total artificial heart in real time.

[0033] In this step, the intelligent system detects the real-time blood supply and demand balance index of the total artificial heart, namely the patient's real-time "left atrial pulmonary vein blood pressure or flow rate, right atrial superior and inferior vena cava blood pressure or flow rate, left ventricle aorta blood pressure or flow rate, and right ventricle pulmonary artery blood pressure or flow rate". These four blood pressure or flow rates can be acquired using sensors (i.e., sensors are placed inside the left atrium or pulmonary vein, right atrium or superior and inferior vena cava, left ventricle or aorta, and right ventricle or pulmonary artery) in specific embodiments, or they can be obtained by measuring changes in current over a period of time during operation.

[0034] Step 103: Based on the blood supply and demand balance index threshold, compare with the blood supply and demand balance index to determine the blood supply information of the total artificial heart to the human body.

[0035] In this step, the real-time blood supply and demand balance index of the total artificial heart is compared with a pre-detected and set blood supply and demand balance index threshold to determine the blood supply information of the total artificial heart to the human body. The blood supply and demand balance index includes at least one of the following: real-time detected blood pressure or flow rate values ​​of the left atrium or pulmonary vein, real-time detected blood pressure or flow rate values ​​of the right atrium or superior and inferior vena cava, real-time detected blood pressure or flow rate values ​​of the left ventricle or aorta, and real-time detected blood pressure or flow rate values ​​of the right ventricle or pulmonary artery. The blood supply and demand balance index threshold also includes at least one of the following: preset blood pressure or flow rate values ​​of the left atrium or pulmonary vein, preset blood pressure or flow rate values ​​of the right atrium or superior and inferior vena cava, preset blood pressure or flow rate values ​​of the left ventricle or aorta, and preset blood pressure or flow rate values ​​of the right ventricle or pulmonary artery.

[0036] It should be noted that in the specific implementation process, the number of blood supply and demand balance index thresholds selected is consistent with the number of blood supply and demand balance indices detected in real time, and the corresponding sites are also consistent. For example, when the real-time detected blood supply and demand balance index is the blood pressure value of the right atrium or superior and inferior vena cava, then the blood supply and demand balance index threshold is also the preset blood pressure value of the right atrium or superior and inferior vena cava; similarly, when the real-time detected blood supply and demand balance index is the blood flow value of the left ventricle or aorta, or the blood flow value of the right ventricle or pulmonary artery, the blood supply and demand balance index threshold is also the preset blood flow value of the left ventricle or aorta, or the preset blood flow value of the right ventricle or pulmonary artery. Furthermore, in the same comparison process, flow values ​​and blood values ​​cannot be mixed; that is, it is not permissible to use flow values ​​for comparison in one site while using pressure values ​​for comparison in another site.

[0037] After comparison, the blood supply information to the human body can show two situations: one is that the blood supply to the human body from the left ventricle 2-A and the right ventricle 2-B of the total artificial heart is unbalanced, and the other is that the blood supply to the human body from the left ventricle 2-A and the right ventricle 2-B of the total artificial heart is balanced.

[0038] Step 104: If the blood supply information of the total artificial heart shows an imbalance in the blood supply from the left ventricle and the right ventricle of the total artificial heart to the human body, the operating speed of the power system for the left ventricle or the right ventricle of the total artificial heart is changed based on the correlation between the operating speed of the power system and the ventricular blood supply.

[0039] Based on the correlation between the operating speed of the power system and the ventricular blood supply, the way to change the operating speed of the power system for the left ventricle or the right ventricle of the total artificial heart can be: When the blood supply to the left and right ventricles of the total artificial heart is unbalanced, the operating speed of the power system for the right ventricle is changed while the operating speed for the left ventricle remains constant; or, the operating speed of the power system for the left ventricle is changed while the operating speed for the right ventricle remains constant, until the blood supply and demand of the left and right ventricles reach equilibrium. Specifically, this can be achieved by: When the blood supply from the left ventricle 2-A to the body in a total artificial heart is greater than that from the right ventricle 2-B, increasing the operating speed of the power system on the right ventricle 2-B while keeping the operating speed on the left ventricle 2-A constant, or decreasing the operating speed on the left ventricle 2-A while keeping the operating speed on the right ventricle 2-B constant, increases the blood intake and pumping volume of the right ventricle 2-B. Keeping the operating speed on the left ventricle 2-A constant also increases the blood intake of the left ventricle 2-A. If the blood intake and pumping volume remain constant, adjustments can be made to balance the blood pumping volume of the left and right ventricles. During the adjustment process, the blood supply and demand balance index can be continuously monitored in real time until the detected blood supply and demand balance index is compared with the blood supply and demand balance index threshold. When the blood pressure of the index is the same or close (e.g., the difference is less than 10%), it can be concluded that the blood supply to the body from the left ventricle 2-A and the right ventricle 2-B is in balance, and the adjustment can be stopped. Similarly, reducing the operating speed of the power system on the left ventricle 2-A while keeping the speed on the right ventricle 2-B constant can also reduce the pumping volume of the left ventricle, thus achieving a balance in the blood supply to the body from the left ventricle 2-A and the right ventricle 2-B. When the blood supply from the right ventricle 2-B to the body in a total artificial heart is greater than that from the left ventricle 2-A, increasing the operating speed of the power system on the left ventricle 2-A while keeping the operating speed on the right ventricle 2-B constant, or decreasing the operating speed of the power system on the right ventricle 2-B while keeping the operating speed on the left ventricle 2-A constant, can reduce the pumping volume of the right ventricle. As described above, this can achieve a balance in the blood supply from the left ventricle 2-A and right ventricle 2-B to the body.

[0040] Please see further. Figure 2 The blood supply and demand balance regulation method for a total artificial heart provided in this application embodiment, in such a way... Figure 1 Following steps 101-104 shown, the following steps are also included: Step 105: Control the intelligent system to detect and obtain the blood supply and demand balance index of the total artificial heart at the current moment in real time.

[0041] After step 104, a balance in blood supply to the body from the left ventricle 2-A and right ventricle 2-B can be achieved. Subsequently, the intelligent control system continues to monitor the blood supply and demand balance index of the total artificial heart in real time to determine its operational status.

[0042] Step 106: Based on the blood supply and demand balance index of the total artificial heart at the current moment, compare it with the blood supply and demand balance index threshold to determine the blood supply information of the total artificial heart to the human body at the current moment. Based on the blood supply information to the human body at the current moment, perform a target operation, wherein the target operation includes: When the blood supply information of the total artificial heart to the human body at the current moment shows that the blood supply from the left ventricle and the right ventricle of the total artificial heart to the human body is balanced, the operating speed and blood supply of the power system to the left ventricle and the right ventricle of the total artificial heart become consistent. or, If the current information on the blood supply to the human body from the total artificial heart shows an imbalance in the blood supply from the left ventricle and the right ventricle of the total artificial heart, the operating speed and blood supply of the power system to the left ventricle and the right ventricle of the total artificial heart will be changed based on the correlation between the operating speed of the power system and the blood pumping volume of the ventricle.

[0043] In this step, by comparing the current blood supply and demand balance index of the total artificial heart with the blood supply and demand balance index threshold, the blood supply information of the total artificial heart to the human body at the current moment can be obtained. This information can indicate two scenarios: either the blood supply from left ventricle 2-A and right ventricle 2-B to the human body is balanced, or the blood supply from left ventricle 2-A and right ventricle 2-B to the human body is unbalanced.

[0044] When the blood supply from the left ventricle 2-A and the right ventricle 2-B to the body is balanced at the current moment, the operating speed and blood supply of the control power system to the left and right ventricles of the total artificial heart become consistent. It should be noted that when the operating speed of the left and right ventricles is consistent, the pumping volume of the left and right ventricles is also basically consistent.

[0045] If the blood supply to the human body from the left ventricle 2-A and the right ventricle 2-B is unbalanced at the current moment, the blood supply to the human body from the left ventricle 2-A and the right ventricle 2-B can be balanced again by adjusting the operating speed of the power system for the left ventricle 2-A or the right ventricle 2-B, as included in step 104.

[0046] In this embodiment of the application, by obtaining the real-time blood supply and demand balance index of the total artificial heart and comparing the blood supply and demand balance index with a preset blood supply and demand balance index threshold, the blood supply information of the total artificial heart to the human body can be obtained in real time.

[0047] The method provided in this application allows for immediate and automatic adjustment of the blood supply to the left ventricle 2-A and right ventricle 2-B in the event of an imbalance during the use of a total artificial heart. This ensures that the blood supply to the left ventricle 2-A and right ventricle 2-B remains balanced at all times, thereby improving the safety of the total artificial heart. Furthermore, the real-time automatic adjustment of the blood supply balance between the left ventricle 2-A and right ventricle 2-B is based on the correlation between the operating speed of the power system and the ventricular pumping volume. Compared to existing technologies, this method is novel and unique, with an advanced structure, smaller size, greater operability and durability, and superior and more precise blood supply regulation, resulting in a long-term balanced effect.

[0048] like Figure 3 , Figure 4 , Figure 5 , Figure 6 , Figure 11 As shown in a specific embodiment of this application, the blood supply and demand balance regulation system of the total artificial heart includes a linear motor power system.

[0049] The core of this power system is a linear motor 5, which is connected to two push plates (left ventricular push plate 4-A and right ventricular push plate 4-B) via a push-pull rod 9. The linear motor 5 is securely mounted on a linear motor mounting bracket 6, which is integrally formed with the intermediate housing 7, ensuring operational stability. The power system operates in a reciprocating linear cycle, driving the two push plates to alternately push the left ventricular 2-A and right ventricular 2-B. Understandably, by controlling the operating speed of the linear motor 5, the speed of the reciprocating linear motion of the push-pull rod 9 can be controlled, thereby changing the operating speed of the left ventricular 2-A and right ventricular 2-B. The structure is simple and reliable.

[0050] The shell of the total artificial heart is an assembly, mainly comprising the left ventricular shell 1-A, the right ventricular shell 1-B, and the intermediate shell 7 located in the middle. Figure 7 As shown, the left ventricular diaphragm 3-A combines with the left ventricular shell 1-A to form the left ventricle 2-A; Figure 8 As shown, the right ventricular diaphragm 3-B and the right ventricular shell 1-B combine to form the right ventricle 2-B. The push-pull plates (4-A, 4-B) of each ventricle are respectively attached to the diaphragm (3-A, 3-B) of the corresponding ventricle, that is, they are tightly attached together and can transmit thrust.

[0051] like Figure 9 As shown, the left and right ventricular shells (1-A, 1-B) are connected to the intermediate shell 7 by shell connecting buckles 8 to form a complete sealed whole.

[0052] like Figure 10 As shown, each ventricle has two openings at its top. The left ventricle 2-A has a left ventricular inlet port 17 and a left ventricular outlet port 15; the right ventricle 2-B has a right ventricular inlet port 10 and a right ventricular outlet port 12. All openings are fitted with valves: a left ventricular inlet valve 14 is located at the left ventricular inlet port 17, and a left ventricular outlet valve 16 is located at the left ventricular outlet port 15; a right ventricular inlet valve 13 is located at the right ventricular inlet port 10, and a right ventricular outlet valve 11 is located at the right ventricular outlet port 12.

[0053] like Figure 12 As shown, during the surgery, the four inlets are connected to the corresponding structures of the human body via artificial blood vessels (left ventricular inlet vessel 26, left ventricular outlet vessel 29, right ventricular inlet vessel 27, and right ventricular outlet vessel 28). Connection points can be secured using connecting clips 25. Specifically, the left ventricular inlet vessel 17 connects to the left atrial incision via an artificial blood vessel, and the left ventricular outlet vessel 15 connects to the aorta via an artificial blood vessel; the right ventricular inlet vessel 10 connects to the right atrial incision via an artificial blood vessel, and the right ventricular outlet vessel 12 connects to the pulmonary artery via an artificial blood vessel.

[0054] like Figure 3 , Figure 5 and Figure 4 , Figure 6 As shown in the corresponding state, its working process is as follows: When the linear motor 5 drives the push-pull rod 9 to move in the direction of the left ventricle 2-A, the left ventricle push-pull plate 4-A pushes the left ventricle diaphragm 3-A, causing the volume of the left ventricle 2-A to decrease and pump out blood; at the same time, due to the equal amount of the sealed space, the volume of the right ventricle 2-B expands, generating negative pressure and drawing in blood.

[0055] When the linear motor 5 drives the push-pull rod 9 to move in the direction of the right ventricle 2-B, the right ventricle push-pull plate 4-B pushes the right ventricle diaphragm 3-B, causing the volume of the right ventricle 2-B to decrease and pump out blood; at the same time, the volume of the left ventricle 2-A increases and draws in blood.

[0056] This cycle repeats continuously, achieving blood circulation in the human body.

[0057] Based on the blood supply and demand balance regulation method described in claim 1, when the intelligent system determines that the blood supply to the left and right ventricles is unbalanced, it adjusts the blood supply by changing the running speed of the linear motor 5 on one side of the ventricle until the balance is restored.

[0058] It should be noted that in this embodiment, the left ventricular push-pull plate 4-A and the left ventricular diaphragm 3-A are attached together, meaning that the left ventricular push-pull plate 4-A and the left ventricular diaphragm 3-A are tightly attached together, but are not fixedly connected. Similarly, the right ventricular push-pull plate 4-B and the right ventricular diaphragm 3-B are also tightly attached together, but are not fixedly connected to each other. However, in other embodiments, they may be fixedly connected, which will not be elaborated here.

[0059] It should also be noted that, for example Figure 13 and Figure 14 As shown, in another embodiment of this application, the power system is a rotary motor power system, specifically adopting a magnetic levitation motor scheme.

[0060] The total artificial heart consists of a left ventricle 34A and a right ventricle 34B, which are respectively enclosed by a structural shell 35A for the left ventricle and a structural shell 35B for the right ventricle. Each ventricle is equipped with a magnetic levitation motor, with 36A being the magnetic levitation component for the left ventricle and 36B being the magnetic levitation component for the right ventricle. Impeller blades (37A, 37B) are also provided on the magnetic levitation components.

[0061] The left ventricle 34A has a left ventricular inlet vessel interface 38A and a left ventricular outlet vessel interface 39A; the right ventricle 34B has a right ventricular inlet vessel interface 38B and a right ventricular outlet vessel interface 39B. The vessel connection method is similar to that of a linear motor system, with one end of each of the four vessels connected to one of the four interfaces, and the other end connected to the aorta, pulmonary artery, left atrial incision, and right atrial incision, respectively.

[0062] The power core of this system consists of a magnetic levitation outer coil 42, a magnetic levitation inner coil 43, magnetic levitation components (36A, 36B), impeller blades (37A, 37B), and a rotating motor central shaft 44. During operation, the two magnetic levitation motors rotate independently, driving the impeller blades to draw blood from the left and right atria through the inlet blood vessels, through the left and right ventricles, and then pumped into the aorta and pulmonary artery through the outlet blood vessels, thereby achieving stable and balanced blood circulation. The blood volume balance regulation method is also based on claim 1, achieved by independently adjusting the rotational speed (i.e., operating speed) of the two magnetic levitation motors through an intelligent system. The specific adjustment and operation methods are the same as or similar to those of linear motors, and will not be elaborated here.

[0063] Because the two ventricles have the same structure Figure 14 The cross-sectional view shows only one ventricle, but those skilled in the art will understand that both ventricles use the same structure.

[0064] The intelligent system 40, built-in battery 41, magnetic levitation power outer coil, magnetic levitation power inner coil, impeller blades, and rotating motor central shaft work together to ensure smooth and balanced blood pumping. The specific connection method of blood vessels is similar to that of the linear motor system and will not be described in detail here.

[0065] Optionally, the intelligent system includes a circuit board, sensors, a power supply system, a communication system, and program software, wherein the circuit board is connected to the sensors, the power supply system, and the communication system.

[0066] Optionally, the power system is electrically connected to the intelligent system. The sensors are of various types. The intelligent system is also used to detect the user's body index through the various types of sensors. The body index includes at least the speed of body movement and the body temperature. Based on the body index, the initial operating speed of the power system for the left and right ventricles can be set.

[0067] Depending on their functional requirements, some of the sensors can be installed inside the housing, while others can be installed outside the housing.

[0068] The initial operating speed corresponds to the pumping rate per minute when the user is in a "low-intensity exercise state." Based on changes in the user's physical activity and body temperature, the power system adjusts the pumping rate of the left and right ventricles in real time, increasing or decreasing the initial operating speed. The initial operating speed is ideally set at 3-5 liters per minute, considering the user's age, gender, height, and weight, to accommodate users of different heights and weights. Furthermore, to adapt to varying pumping volumes during different exercise states, the intelligent system should also consider the user's "physical activity state" and "body temperature." "Low" refers to the amount of blood pumped to the user in real time. The body movement state includes three levels: low-intensity movement (i.e., initial running speed), medium-intensity movement, and high-intensity movement. In specific applications, the blood pumping volume in the medium-intensity movement state should be increased by 10-30% compared to the low-intensity movement state, and the blood pumping volume in the high-intensity movement state should be increased by another 10-30% compared to the medium-intensity movement state. The body temperature should also be adjusted according to the different levels of body movement state. For example, for every degree increase in normal body temperature, the blood pumping volume should increase by one level. However, if both the movement state and body temperature should be increased, only one should be adjusted.

[0069] Please refer to the above. Figure 15 , Figure 16 Optionally, the power supply system includes a built-in battery 19, a built-in receiving coil 20, an external battery 24, an external circuit board and chip 23, and an external transmitting coil 21. The built-in receiving coil 20 can be implanted subcutaneously or placed close to the inner surface of the human body and is electrically connected to the built-in battery 19 and the intelligent system. The external transmitting coil 21 is correspondingly set inside and outside the human body to supply power to the devices inside the human body. The external battery 24 can be integrated with the external circuit board and chip 23 into a module and placed in the pocket of an external vest 30 or belt, and connected to the external transmitting coil 21 to supply power to the human body. The power supply system is not limited to wireless power supply; it can also use a wired connection to connect internal and external power sources and devices.

[0070] The external battery 24 and the external transmitting power coil 21 are electrically connected. The power from the external battery 24 is transmitted to the internal receiving power coil 20 through the external transmitting power coil 21. However, in another embodiment, the external battery may be set separately from the external transmitting power coil. The internal receiving power coil 20 charges the internal battery and can also directly power the motor through the circuit board.

[0071] See Figure 17The outer vest 30 includes an outer vest 30 zipper, an outer vest 30 pocket, and an outer vest 30 pocket zipper. The external battery 24 can be integrated with the external circuit board and chip 23, the external transmitting power coil 21, and the external warning device 22 into a module and placed in the pocket of the outer vest 30 or the waist belt. It can maintain a stable connection with the fully artificial heart inside the human body for a long time and continuously charge the built-in receiving power coil 20 to power the components inside the fully artificial heart shell. After receiving power, the built-in receiving power coil 20 can still directly power the motor through the intelligent system.

[0072] Optionally, the communication system includes a built-in communication module, an external communication module, an external display, and an early warning device. Both the communication system and the power supply system are electrically connected to the intelligent system. The built-in and external parts of the communication and power supply systems are connected wirelessly. The built-in and external communication modules transmit the operating information of the total artificial heart to the external early warning device 22 in real time. When the operating status of the total artificial heart is abnormal, the external early warning device 22 issues an alarm, reminding the user to check or replace the battery in time. Furthermore, the external communication module can wirelessly connect to the intelligent system, allowing for manual intervention or adjustment of various settings and operating parameters of the artificial heart, thus changing its operating status.

[0073] Optionally, the surfaces of components that come into contact with blood, such as left ventricle 2-A, right ventricle 2-B, artificial blood vessels, ingress valves, and egress valves, as well as those that come into contact with the human body, are all made of biocompatible materials. Furthermore, all surfaces of components that come into contact with blood can be coated or layered with biocompatible materials. This avoids adverse reactions between the components of the total artificial heart and human tissues.

[0074] It should be noted that this application can be used in two modes depending on the different conditions of different patients: one mode is to remove and replace the patient's original heart; the other mode is to retain the patient's original heart, connect the left and right ventricular inlet ports of this application to the patient's left and right ventricles respectively, and connect the left and right ventricular outlet ports of this application to the patient's aorta and pulmonary artery respectively. The operation and adjustment methods remain unchanged as described above. However, for the version that retains the patient's original heart, the size of this application only needs to be slightly smaller during manufacturing.

[0075] It should also be noted that the illustrations shown in this application are for ease of understanding only. In actual manufacturing and use, the position, shape, size, proportion, and structural relationship of each component in the illustrations can be adjusted according to actual needs (unless there are specific requirements). For example, the built-in battery, circuit board, and chip in the illustrations are set inside the housing, but they can also be set outside the housing as needed during actual manufacturing.

[0076] The above are merely specific embodiments of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technical methods disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

Claims

1. A method for regulating blood supply and demand balance in a total artificial heart, characterized in that, The blood supply and demand balance regulation method of the total artificial heart is applied to the blood supply and demand balance regulation system of the total artificial heart. The blood supply and demand balance regulation system of the total artificial heart includes an intelligent system, a power system, a left ventricle, and a right ventricle. The intelligent system is electrically connected to the power system. The blood supply and demand balance regulation method of the total artificial heart includes: The intelligent system acquires a preset blood supply and demand balance index threshold and acquires the correlation between the operating speed of the power system and the blood supply to the ventricles. The correlation between the operating speed of the power system and the blood supply to the ventricles includes: changing the operating speed of either the left or right ventricle will also change the blood supply to the left or right ventricle. The blood supply and demand balance index threshold includes at least one of the following: a preset blood pressure or flow rate value for the left atrium or pulmonary vein; a preset blood pressure or flow rate value for the right atrium or superior and inferior vena cava; a preset blood pressure or flow rate value for the left ventricle or aorta; and a preset blood pressure or flow rate value for the right ventricle or pulmonary artery. The intelligent system controls the real-time detection and acquisition of the blood supply and demand balance index of the total artificial heart. The blood supply and demand balance index includes at least one of the following: real-time detected blood pressure or flow rate of the left atrium or pulmonary vein; real-time detected blood pressure or flow rate of the right atrium or superior and inferior vena cava; real-time detected blood pressure or flow rate of the left ventricle or aorta; and real-time detected blood pressure or flow rate of the right ventricle or pulmonary artery. Based on the blood supply and demand balance index threshold, the blood supply and demand balance index is compared with the blood supply and demand balance index to determine the blood supply information of the total artificial heart to the human body; When the blood supply information of the total artificial heart shows an imbalance in the blood supply from the left ventricle and the right ventricle of the total artificial heart to the human body, the operating speed of the power system for the left ventricle or the right ventricle of the total artificial heart is changed based on the correlation between the operating speed of the power system and the ventricular blood supply. The intelligent system is controlled to detect and acquire the blood supply and demand balance index of the total artificial heart at the current moment in real time; Based on the blood supply and demand balance index of the total artificial heart at the current moment, compared with the blood supply and demand balance index threshold, the blood supply information of the total artificial heart to the human body at the current moment is determined. Based on the blood supply information to the human body at the current moment, a target operation is performed, wherein the target operation includes: When the blood supply information of the total artificial heart to the human body at the current moment shows that the blood supply from the left ventricle and the right ventricle of the total artificial heart to the human body is balanced, the operating speed and blood supply of the power system to the left ventricle and the right ventricle of the total artificial heart become consistent. If the blood supply information of the total artificial heart to the human body at the current moment shows an imbalance in the blood supply from the left ventricle and the right ventricle of the total artificial heart to the human body, the operating speed and blood supply of the power system to the left ventricle or the right ventricle of the total artificial heart will be changed based on the correlation between the operating speed of the power system and the ventricular pumping volume. Based on the correlation between the operating speed of the power system and the ventricular blood supply, changing the operating speed of the power system for the left ventricle or the right ventricle of the total artificial heart includes: When the blood supply to the left and right ventricles of the total artificial heart is unbalanced, the operating speed of the power system for the right ventricle of the total artificial heart is changed while the operating speed of the power system for the left ventricle remains constant; or, the operating speed of the power system for the left ventricle of the total artificial heart is changed while the operating speed of the power system for the right ventricle remains constant, until the blood supply and demand of the left and right ventricles reach equilibrium.

2. A blood supply and demand balance regulation system for a fully artificial heart, characterized in that, The blood supply and demand balance regulation system is used to execute the blood supply and demand balance regulation method of the total artificial heart as described in claim 1. The power system is a linear motor power system, which includes a linear motor, a push-pull rod, and a push plate. The linear motor is connected to the push-pull rod, and the push-pull rod is connected to the push plate. The power system reciprocates linearly so that its push plate pushes the left and right ventricles to pump out and draw in blood.

3. The blood supply and demand balance regulation system for a total artificial heart according to claim 2, characterized in that, The blood supply and demand balance regulation system also includes: a shell, a left ventricular diaphragm, a right ventricular diaphragm, an ingress valve, an egress valve, and blood vessels; The left and right ventricular diaphragms are located at the left and right ends of the shell, respectively, and are combined with the shells at the left and right ends to form the left and right ventricles. Each of the left and right ventricles has two openings, and the inlet valve and the outlet valve are respectively located at the openings. There are four blood vessels, one end of which is connected to the four openings of the left and right ventricles, and the other end is connected to the aorta, pulmonary artery, left atrial incision, and right atrial incision, respectively. The power system has two push plates, left and right. One push plate is attached to the diaphragm of the left ventricle, and the other push plate is attached to the diaphragm of the right ventricle. When the push plate moves towards the left ventricle, it pushes the diaphragm of the left ventricle to pump out blood from the left ventricle, while the right ventricle at the other end expands its volume and draws in blood. When the push plate moves towards the right ventricle, it pushes the diaphragm of the right ventricle to pump out blood from the right ventricle, while the left ventricle at the other end expands its volume and draws in blood. The power system operates in a cyclical manner, so that the left and right ventricles continuously draw in and pump out blood, realizing human blood circulation.

4. The blood supply and demand balance regulation system for a total artificial heart according to claim 2, characterized in that, The power system is a rotary motor power system, which includes a magnetic levitation motor, a housing, and blood vessels. There are two magnetic levitation motors, which are respectively located on the left and right sides of the housing, forming the left and right ventricles. There are four blood vessels, one end of which is connected to the inlet and outlet of the left and right ventricles, respectively, and the other end is connected to the aorta, pulmonary artery, left atrial incision, and right atrial incision, respectively.

5. The blood supply and demand balance regulation system for a total artificial heart according to claim 4, characterized in that, During operation, the two magnetic levitation motors of the power system rotate, drawing blood from the left and right atria through two access vessels, and then pumping it into the aorta and pulmonary artery through the left and right ventricles, respectively, thus achieving blood circulation in the human body.

6. The blood supply and demand balance regulation system for a total artificial heart according to claim 2, characterized in that, The intelligent system also includes a circuit board, sensors, a power supply system, a communication system, and program software. The circuit board is connected to the sensors, the power supply system, and the communication system.

7. The blood supply and demand balance regulation system for a total artificial heart according to claim 6, characterized in that, The power supply system includes a built-in battery, a built-in receiving coil, an external battery, an external circuit board and chip, and an external transmitting coil. The built-in receiving coil is used for subcutaneous implantation and is electrically connected to the built-in battery and the intelligent system. The external transmitting coil is correspondingly positioned inside and outside the human body to supply power to the devices inside the body. The external battery can be integrated with the external circuit board and chip into a module and placed in a pocket of a vest or belt worn outside the body, and connected to the external transmitting coil to supply power to the body. The power supply system is not limited to wireless power supply; it can also use a wired connection to connect internal and external power sources and devices.

8. The blood supply and demand balance regulation system for a total artificial heart according to claim 6, characterized in that, The communication system includes a built-in communication module, an external communication module, an external display, and an early warning device. Both the communication system and the power supply system are electrically connected to the intelligent system. The connection between the built-in and external parts of the communication system is wireless. The communication system is not limited to wireless connection; it can also be wired to connect internal and external communication devices.

9. The blood supply and demand balance regulation system for a total artificial heart according to any one of claims 4 to 8, characterized in that, The surfaces of the left ventricle, the right ventricle, the artificial blood vessel, the ingress valve, the egress valve, and the magnetic levitation motor—components that come into contact with blood and the human body—are made of biocompatible materials.

10. A total artificial heart, characterized in that, The total artificial heart is used to perform the blood supply and demand balance regulation method of the total artificial heart as described in claim 1, wherein the total artificial heart includes the blood supply and demand balance regulation system of the total artificial heart as described in any one of claims 2 to 9.

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