Intelligent bionic heart with novel structure and operation method thereof

Abstract

The application discloses a novel structure of intelligent bionic heart and a running method thereof, and belongs to the technical field of medical instruments. The intelligent bionic heart comprises a left ventricle, a right ventricle, a power system, a blood volume regulating system and an intelligent control system, and the blood volume regulating system is used for adjusting the start-stop position of a push-pull plate in the power system to the left and right ventricles. When the intelligent control system detects that the pressure change or the flow change of the left and right ventricles is required to be regulated due to the unbalanced blood pumping amount of the left and right ventricles caused by the power system in the conventional initial operation, the blood volume regulating system controls the start-stop operation position of the push-pull plate in the power system to deviate to the direction of the ventricle with more blood supply in the left and right ventricles, so as to change the structural shape of the left and right ventricles during blood pumping, reduce the diameter of the blood outflow position of the ventricle with more blood supply, and reduce the blood pumping amount of the ventricle with more blood supply.

Description

Technical Field

[0001] This application belongs to the field of medical device technology, specifically relating to a novel intelligent bionic heart structure and its operating method. Background Technology

[0002] According to the World Health Organization's "Global Burden of Disease" report, heart disease has become the leading cause of death worldwide, with approximately 17 million people dying from various heart conditions each year. Of these, about 20% die from heart failure, and the only treatment for heart failure is a heart transplant. However, less than 1% of patients receive a transplant each year, leaving approximately 3 million patients (99%) to die while waiting for a transplant. Therefore, developing artificial hearts with higher reliability, safety, and practicality is a top priority for medical professionals worldwide.

[0003] Artificial hearts, mechanical hearts, and bionic hearts generally refer to devices that partially or completely replace the human heart's pumping function using mechanical or biomechanical means. The history of human research and utilization of artificial hearts began in the mid-20th century. While artificial mechanical pumping devices have made significant breakthroughs and progress over the decades, most artificial hearts currently on the market suffer from fatal problems such as large size, short lifespan, and thrombus formation. Furthermore, imbalances in blood supply between the left and right ventricles can lead to various diseases and multiple organ failure after implantation. This is the main reason why the safety of existing artificial hearts is so severely compromised and cannot be widely adopted. Therefore, there is an urgent need to find more effective and reliable technological solutions. Summary of the Invention

[0004] The purpose of this application is to provide a novel intelligent bionic heart structure and its operation method, which can effectively and reliably solve the major problem of insufficient safety performance of existing bionic hearts.

[0005] In a first aspect, embodiments of this application provide a novel intelligent bionic heart structure, which includes: a shell, a left ventricle, a right ventricle, an ingress valve, an egress valve, an artificial blood vessel, a power system, an intelligent control system, sensors, and a blood volume regulation system;

[0006] The left and right ventricles are located on the left and right sides of the shell, respectively. 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 artificial 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 human aorta, the pulmonary aorta, the left atrial incision, and the right atrial incision, respectively.

[0007] Each end of the power system is connected to a push-pull plate. One push-pull plate is fitted to the left ventricle, and the other push-pull plate is fitted to the right ventricle. The power system drives the push-pull plates to reciprocate linearly. When the push-pull plate moves towards the left ventricle, it pushes the left ventricle to pump out blood, while the right ventricle at the other end expands its volume and draws in blood. When the push-pull plate moves towards the right ventricle, it pushes the right ventricle to pump out blood, 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, thus promoting blood circulation in the human body.

[0008] The blood volume regulation system is used to adjust the start and end positions of the push-pull plate in the power system as it moves towards the left and right ventricles. The start and end positions of the push-pull plate in the power system include a normal operating position and an adjustment operating position, and the start and end positions of the normal operating position and the adjustment operating position are different. When adjustment is needed, the blood volume regulation system controls the start and end positions of the push-pull plate in the power system to shift towards the ventricle with a higher blood supply in the left and right ventricles, i.e., shift to the adjustment operating position, and can shift up to the end point of the adjustment operating position as needed. This changes the structural shape of the left and right ventricles during pumping, reduces the diameter of the blood outlet from the ventricle with a higher blood supply, and reduces the amount of blood pumped out by the ventricle with a higher blood supply. When adjustment is not needed, the blood volume regulation system controls the push-pull plate in the power system to gradually return from the adjustment operating position to the normal operating position, or only partially return to the normal operating position as needed, so that the blood supply to the left and right ventricles can reach a balance between supply and demand for a long time.

[0009] Optionally, the blood volume regulation system includes a position driver, a control program, and flow-limiting protrusions. The flow-limiting protrusions are located at the blood outflow positions of the left and right ventricles. The control program is used to drive the position driver. The two flow-limiting protrusions are corresponding to certain structural parts of the two push-pull plates in the power system. When the flow-limiting protrusions and the corresponding structural parts of the two push-pull plates meet, they interlock and engage.

[0010] When the intelligent control system detects an imbalance in blood supply between the left and right ventricles and requires adjustment, including when it is set to a fixed adjustment based on the body's blood supply and demand, it instructs the position driver to control the stroke of the push-pull plate in the power system to change from the normal operating position to the adjustment operating position, that is, to shift from the normal operating position toward the ventricle with a larger blood supply.

[0011] After the push-pull plate shifts from its normal operating position to its adjusted operating position, the diameter of the ventricular blood outflow position in the direction of the shift becomes smaller. Furthermore, at the end of the process of pushing the ventricle, a portion of the push-pull plate's structure interlocks with the corresponding flow-limiting protrusion. This interlocking action closes or partially closes the ventricular blood outflow position, preventing the remaining blood from being pumped out or partially preventing it from being pumped out, thus reducing the amount of blood pumped out by the ventricle. Conversely, because the push-pull plate's starting and ending positions have shifted, at the end of the process of pushing the ventricle, the push-pull plate and any part thereof do not interlock with the flow-limiting protrusion. The ventricular blood outflow position does not close, the diameter does not decrease, and the amount of blood pumped out does not decrease. Thus, although only one power system drives both ventricles, the amount of blood pumped out by the left and right ventricles can be different when needed. Through continuous monitoring and the aforementioned intermittent or constant adjustments, the pumping volume of the left and right ventricles is kept balanced over a long period of time. Although theoretically the pumping volume of the left and right ventricles is the same in the normal operating position, it varies from person to person or from the pressure of the left and right ventricles during pumping. In practical applications, there will be slight differences in the pumping volume of the left and right ventricles each time, which is why it is necessary to monitor and adjust the blood volume at any time.

[0012] Optionally, the intelligent control system includes at least a circuit board and chip, software program and sensor. The intelligent control system is used to detect the user's body index through the sensor. The sensor is a multi-purpose sensor. The body index includes at least: body movement speed and body temperature.

[0013] The intelligent control system sets the initial number of runs of the power system based on the user's height, weight, and body mass index. It also adjusts the number of runs of the power system in real time based on the user's body movement speed and body temperature changes during use, thereby adjusting the pumping frequency of the left and right ventricles to adapt to different blood supply needs under different conditions.

[0014] Optionally, the power system includes a power motor, a telescopic component, a push-pull plate, and a power guide slide rod. There are two push-pull plates, which are respectively connected to both ends of the telescopic component. The power motor and the telescopic component drive the push-pull plate to reciprocate linearly to push the left and right ventricles to pump out and draw in blood. The function of the power guide slide rod is to ensure that the power motor runs in a stable linear direction. The deviation of the push-pull plate's running position is caused by the deviation of the telescopic component's running position.

[0015] Optionally, the intelligent bionic heart also includes a power supply system, which includes a built-in battery, a built-in receiving power coil, an external battery, and an external transmitting power coil. The built-in receiving power coil can be implanted subcutaneously and is electrically connected to the built-in battery and the intelligent control system. The external transmitting power coil is correspondingly arranged inside and outside the human body to supply power to the devices inside the human body. The external battery can be integrated with an 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 power coil to supply power to the human body.

[0016] Optionally, the intelligent bionic heart also includes a communication system, which includes a built-in communication module, an external communication module, and an external early warning device. Both the communication system and the power supply system are electrically connected to the intelligent control system, and the connection between the built-in and external parts of the communication system and the power supply system is wireless.

[0017] Optionally, the left ventricle, the right ventricle, the artificial blood vessel, the ingress valve, and the egress valve—all components that come into contact with blood—should be made of biocompatible materials. The surfaces of all components in the intelligent bionic heart that come into contact with blood can still be coated with biocompatible materials.

[0018] Optionally, the intelligent bionic heart further includes a support frame and a locking ring. The support frame is used to fix the power system; the locking ring is used to fix and connect the tube opening to the artificial blood vessel, the ingress valve, and the egress valve, and to fix and connect the shell, the left ventricle, and the right ventricle in combination.

[0019] Optionally, the housing is a multi-component assembly. After the internal components are installed, the multiple components are combined by snap rings or welding to form a sealed whole. Alternatively, the housing is a complete housing with an opening, and the opening is sealed with a back cover after the internal components are installed.

[0020] Secondly, embodiments of this application provide a novel intelligent bionic heart structure and its operating method. The operating method of the intelligent bionic heart is applied to the intelligent bionic heart described in the first aspect, and the operating method includes:

[0021] It acquires information on the operation of the intelligent bionic heart and various movements and functions of the user's body;

[0022] Based on the intelligent bionic heart operating information of the novel structure and the user's various movements and operating information, the system provides prompts and controls the operating status of the power system and blood volume regulation system.

[0023] In this embodiment, the intelligent control system detects the blood supply to the left and right ventricles by acquiring the pushing force of the push-pull plate. When the intelligent control system determines that the blood supply to the left and right ventricles is unbalanced, it controls the blood volume adjustment system. The blood volume adjustment system adjusts the start and end positions of the push-pull plate during operation to shift towards the ventricle with a higher blood supply, thereby changing the structural shape of the left and right ventricles during pumping, reducing the diameter of the blood outlet of the ventricle with a higher blood supply, and reducing the amount of blood pumped out by the ventricle with a higher blood supply. This balances the blood supply to the left and right ventricles, preventing the intelligent bionic heart from experiencing an imbalance in blood supply to the left and right ventricles during use, thus enhancing the safety of this application.

[0024] Meanwhile, the technology disclosed in this application utilizes the interaction between the power system itself and part of the shell to regulate the balance of blood pumping volume between the left and right ventricles. Compared with existing technologies, it reduces many components. Its technology is novel and unique, with an advanced structure, smaller size, stronger practicality, and better performance and operability. Attached Figure Description

[0025] Figure 1 A schematic diagram of the internal structure of the intelligent bionic heart and the movement of the push-pull plate toward the right ventricle, as provided in the embodiments of this application;

[0026] Figure 2 A schematic diagram of the internal structure of the intelligent bionic heart and the movement of the push-pull plate toward the left ventricle, as provided in the embodiments of this application;

[0027] Figure 3 This is a schematic diagram showing the push-pull plate after it has shifted towards the right ventricle and after it has pushed the right ventricle, as provided in the embodiments of this application.

[0028] Figure 4 This is a schematic diagram showing the push-pull plate after it has shifted towards the right ventricle and after it has pushed against the left ventricle, as provided in the embodiments of this application.

[0029] Figure 5 This is a schematic diagram showing the push-pull plate after it has shifted towards the left ventricle and after it has pushed against the left ventricle, as provided in the embodiments of this application.

[0030] Figure 6 This is a schematic diagram showing the push-pull plate after it has shifted towards the left ventricle and after it has pushed against the right ventricle, as provided in the embodiments of this application.

[0031] Figure 7 A schematic cross-sectional view of the internal structure of the intelligent bionic heart provided in the embodiments of this application;

[0032] Figure 8 An exploded view of the intelligent bionic heart shell of the novel structure provided in this application embodiment;

[0033] Figure 9 A schematic diagram of the assembled intelligent bionic heart shell structure provided in the embodiments of this application;

[0034] Figure 10 A schematic diagram of the combination of the intelligent bionic heart diaphragm and shell provided in the embodiments of this application;

[0035] Figure 11 A schematic diagram of the novel intelligent bionic heart capsule component provided in the embodiments of this application;

[0036] Figure 12 A schematic diagram illustrating the relationship between the components of the novel intelligent bionic heart structure provided in this application embodiment;

[0037] Figure 13 A schematic diagram of the intelligent bionic heart power system with the novel structure provided in this application embodiment, showing its normal operation to the left;

[0038] Figure 14 A schematic diagram of the intelligent bionic heart power system with the novel structure provided in this application embodiment, showing normal operation to the right;

[0039] Figure 15 A schematic diagram of the top orifice and blood vessel of the left and right ventricles provided in the embodiments of this application;

[0040] Figure 16 A schematic diagram of the built-in power receiving coil provided in an embodiment of this application;

[0041] Figure 17 This is a schematic diagram of an external component integration module provided in an embodiment of this application;

[0042] Figure 18 This is a schematic diagram of a vest worn according to an embodiment of this application;

[0043] Figure 19 A schematic diagram showing the front (back) view of the novel intelligent bionic heart structure provided in the embodiments of this application;

[0044] Figure 20 A side view of the novel intelligent bionic heart structure provided in the embodiments of this application;

[0045] Figure 21 A schematic diagram illustrating the overall appearance of the novel intelligent bionic heart structure provided in this application embodiment.

[0046] Explanation of reference numerals in the attached figures:

[0047] 1-A, Right side shell; 1-B, Left side shell; 1-C, Middle shell; 2-A, Left ventricular diaphragm; 2-B, Right ventricular diaphragm; 3-A, Left ventricle; 3-B, Right ventricle; 4-A, Left ventricular push-pull plate; 4-B, Right ventricular push-pull plate; 5, Power motor; 6, Telescopic component; 7, Support frame; 8, Internal circuit board and chip; 9, Internal battery; 10, Right ventricular outflow vessel; 11, Right ventricular inflow vessel; 12, Left ventricular outflow vessel; 13, Left ventricular inflow vessel; 14-A, Right ventricular outflow valve; 14-B, Right ventricular inflow valve; 15-A, Left ventricular outflow valve; 15-B, Left ventricular inflow valve 16. Membrane; 17-A. Connecting buckle between blood vessel and shell port; 17-B. Connecting buckle between right shell and middle shell; 18-A. Connecting buckle between left shell and middle shell; 18-B. Flow limiting protrusion at left ventricular blood outflow position; 19. Power guide slide bar; 20-A. Left ventricular soft capsule; 20-B. Right ventricular soft capsule; 21. Built-in receiving power coil; 22. External transmitting power coil; 23. External warning device; 24. External circuit board and chip; 25. External battery; 26. Outer vest; 27. Vest zipper; 28. Vest pocket; 29. ​​Pocket zipper. Detailed Implementation

[0048] The technical solutions of the embodiments of this application will be clearly described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this application. All other embodiments obtained by those skilled in the art based on the embodiments of this application are within the scope of protection of this application.

[0049] The terms "first," "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 use of 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, a 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.

[0050] In the description of this application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., indicating the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, 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, and therefore should not be construed as a limitation of this application.

[0051] In the description of this application, it should be noted that, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; 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 between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0052] In the description of this application, 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.

[0053] Please see Figures 1 to 21 This application provides a novel intelligent bionic heart structure, comprising: a shell, a left ventricle 3-A, a right ventricle 3-B, an ingress valve, an egress valve, an artificial blood vessel, a power system, an intelligent control system, sensors, and a blood volume regulation system;

[0054] The left ventricle 3-A and right ventricle 3-B are located on the left and right sides inside the shell, respectively. Both the left ventricle 3-A and right ventricle 3-B have two openings, with inlet and outlet valves respectively located at the openings. There are four artificial blood vessels, one end of which is connected to the four openings of the left ventricle 3-A and right ventricle 3-B, and the other end is connected to the human aorta, pulmonary aorta, left atrial incision, and right atrial incision, respectively.

[0055] Please see further. Figure 1 and Figure 2 The shell consists of three parts: the left shell 1-B, the right shell 1-A, and the middle shell 1-C. The left ventricle 3-A is located inside the right shell 1-A, and the right ventricle 3-B is located inside the left shell 1-B.

[0056] The ventricle can be formed in various ways. In one embodiment, please refer to [reference needed]. Figure 1 , Figure 2 and Figure 7 The intelligent bionic heart includes a left ventricular diaphragm 2-A and a right ventricular diaphragm 2-B. The left ventricular diaphragm 2-A is mounted on the right shell 1-A, and the cavity formed between the left ventricular diaphragm 2-A and the right shell 1-A is the left ventricle 3-A. Similarly, the right ventricular diaphragm 2-B is mounted on the left shell 1-B, and the cavity formed between the right ventricular diaphragm 2-B and the left shell 1-B is the right ventricle 3-B.

[0057] In another embodiment, please refer to [reference needed]. Figure 1 , Figure 2 , Figure 10 and Figure 11 The intelligent bionic heart includes a left ventricular soft capsule 20-A and a right ventricular soft capsule 20-B. The left ventricular soft capsule 20-A is installed and closely attached to the right shell 1-A, and the right ventricular soft capsule 20-B is installed and closely attached to the left shell 1-B. The left ventricular soft capsule 20-A itself constitutes the left ventricle 3-A, and the right ventricular soft capsule 20-B itself constitutes the right ventricle 3-B.

[0058] Please refer to the above. Figure 1 , Figure 2 and Figure 15 Two openings are provided on both the left ventricle 3-A and the right ventricle 3-B for connecting artificial blood vessels. The inlet valves include the left ventricle inlet valve 15-B and the right ventricle inlet valve 14-B, and the outlet valves include the left ventricle outlet valve 15-A and the right ventricle outlet valve 14-A. Specifically, the two openings on the left ventricle 3-A are used to install the left ventricle inlet vessel 13 and the left ventricle outlet vessel 12, respectively, to connect the left ventricular common artery and the left ventricular common pulmonary vein. The left ventricle outlet valve 15-A is installed at the opening corresponding to the left ventricle outlet vessel 12, and the left ventricle inlet valve 15-B is installed at the opening corresponding to the left ventricle inlet vessel 13. Two openings are made on the right ventricle to install the right ventricular outflow vessel 10 and the right ventricular inflow vessel 11, respectively, to connect the right ventricular common vein and the right ventricular pulmonary aorta. The right ventricular inflow vessel 11 is equipped with a right ventricular inflow valve 14-B at the opening, and the right ventricular outflow vessel 10 is equipped with a right ventricular outflow valve 14-A at the opening.

[0059] See also Figure 1 , Figure 2The power system has two push-pull plates connected to each end. One push-pull plate is attached to the left ventricle 3-A, and the other is attached to the right ventricle 3-B. The power system drives the push-pull plates to move in a reciprocating linear motion. When the push-pull plate moves towards the left ventricle 3-A, it pushes the left ventricle 3-A to pump out blood, while the right ventricle 3-B expands its volume and draws in blood. When the push-pull plate moves towards the right ventricle 3-B, it pushes the right ventricle 3-B to pump out blood, while the left ventricle 3-A expands its volume and draws in blood. The power system's cyclical motion causes the left ventricle 3-A and right ventricle 3-B to continuously draw in and pump out blood, thus promoting blood circulation in the human body.

[0060] The push-pull plates include a left ventricular push-pull plate 4-A and a right ventricular push-pull plate 4-B. It should be noted that in this embodiment, the left ventricular push-pull plate 4-A is attached to the left ventricular diaphragm 2-A, meaning that the left ventricular push-pull plate 4-A and the left ventricular diaphragm 2-A are tightly attached together, but they are not fixedly connected. Similarly, the right ventricular push-pull plate 4-B is attached to the right ventricular diaphragm 2-B, but they are not fixedly connected to each other. However, in other embodiments, they may be fixedly connected, which will not be elaborated here.

[0061] Combination Figure 1 and Figure 13 In the illustrated state, the power system drives the right ventricular push-pull plate 4-B towards the right ventricle 3-B. The right ventricular push-pull plate 4-B pushes the right ventricle 3-B, causing the right ventricle 3-B to pump blood out. Simultaneously, because the size of the enclosed space remains constant, for every volume of blood squeezed out of the right ventricle 3-B, the left ventricle 3-A is stretched and expanded by the same amount, causing the left ventricle 3-A to draw in an equal amount of blood.

[0062] Combined Figure 2 and Figure 14 In the illustrated state, similarly, the power system drives the left ventricular push-pull plate 4-A towards the left ventricle 3-A. The left ventricular push-pull plate 4-A compresses the left ventricle 3-A, causing the left ventricle 3-A to pump blood out. Similarly, because the size of the enclosed space remains constant, for every volume of space squeezed out of the left ventricle 3-A, the right ventricle 3-B is pulled open, expanding to a volume equal to that squeezed out of the left ventricle 3-A, causing the right ventricle 3-B to draw in blood.

[0063] The power system performs reciprocating linear motion in the left-right direction, enabling the intelligent bionic heart to... Figure 1 , Figure 13 The state shown and Figure 2 , Figure 14The system continuously switches between states, namely, the state of "left ventricle 3-A drawing in blood and right ventricle 3-B pumping out blood" and the state of "left ventricle 3-A pumping out blood and right ventricle 3-B drawing in blood," thus realizing the circulation of blood in the human body.

[0064] It should be noted that the above Figure 1 , Figure 2 , Figure 13 and Figure 14 The diagram shows the power system in normal operation. In specific applications, due to differences in the human body, its movement state, and the closure of the inlet and outlet valves, the amount of blood pumped out and drawn in will vary. Therefore, this application features a unique blood volume regulation system.

[0065] The blood volume regulation system is used to adjust the start and end positions of the push-pull plate in the power system to move towards the left ventricle 3-A and right ventricle 3-B. The start and end positions of the push-pull plate in the power system include a normal operating position and an adjustable operating position. The start and end positions of the normal operating position and the adjustable operating position are different. When the power system is in the normal operating position, when the intelligent control system detects an imbalance in blood supply and demand by monitoring pressure or flow changes in the left ventricle 3-A and right ventricle 3-B during blood pumping, the blood volume regulation system controls the start and end positions of the push-pull plate in the power system to supply blood to the left ventricle 3-A and right ventricle 3-B. The direction of the ventricle with excessive blood supply is shifted, and it can shift up to the end point of the adjustment operation position as needed. This changes the structural shape of the left ventricle 3-A and right ventricle 3-B when pumping blood, reduces the diameter of the blood outlet of the ventricle with excessive blood supply, and reduces the amount of blood pumped out by the ventricle with excessive blood supply. When the intelligent control system detects that the blood supply and demand of the human body have reached a balance, the blood volume adjustment system controls the push-pull plate in the power system to return from the adjustment operation position to the normal operation position, or moves it partially towards the normal operation position as needed, so that the blood pumping volume of the left ventricle 3-A and right ventricle 3-B reaches a balance between supply and demand for a long time.

[0066] It should be noted that during the process of the push-pull plate in the power system pressing the left ventricle 3-A or right ventricle 3-B, the pushing force of the push-pull plate is consistent with the pressure inside the left ventricle 3-A or right ventricle 3-B. Therefore, by acquiring the pushing force of the push-pull plate, the intelligent control system can obtain the pressure inside the ventricle, thereby knowing the pressure change of the left ventricle 3-A or right ventricle 3-B. Based on the pressure change, the pumping volume of the ventricle can be determined. For example, if the pushing force of the push-pull plate when pressing the left ventricle 3-A is greater than the pushing force when pressing the right ventricle 3-B, it means that during this process, the pressure inside the left ventricle 3-A is greater than the pressure inside the right ventricle 3-B. This also means that during this process, the amount of blood pumped by the left ventricle 3-A is greater than the amount of blood pumped by the right ventricle 3-B, indicating an imbalance in the blood supply and demand between the left ventricle 3-A and right ventricle 3-B.

[0067] See further Figures 1 to 6 ,like Figure 3 As shown, when the blood supply to right ventricle 3-B is greater than that to left ventricle 3-A, the adjustment position moves closer to right ventricle 3-B. The intelligent control system controls the blood volume adjustment system, which shifts the start and end positions of the adjustment push-pull plate from the normal operating position to the adjustment position, i.e., towards right ventricle 3-B, to reduce the diameter of the blood outflow from right ventricle 3-B and decrease the amount of blood pumped by right ventricle 3-B; that is, from... Figure 3 , Figure 4 As can be seen, the diameter of the right ventricular blood outflow position corresponding to the right ventricular push-pull plate 4-B is significantly different from that of the left ventricular blood outflow position, especially at the end of ventricular pumping. If the diameter of the right ventricular outflow position is closed or partially closed, while the diameter of the left ventricular outflow position is still open, this will lead to a difference in the amount of blood pumped by the left and right ventricles at the end of pumping.

[0068] Similarly, such as Figure 5 As shown, when the blood supply to the left ventricle 3-A is greater than that to the right ventricle 3-B, the adjustment position is moved closer to the right ventricle 3-B. The intelligent control system controls the blood volume adjustment system, which adjusts the start and end positions of the push-pull plate from the normal operating position to the adjustment position, that is, towards the left ventricle 3-A, so as to reduce the diameter of the blood outflow position of the left ventricle 3-A and reduce the pumping volume of the left ventricle 3-A.

[0069] It should be noted that the sensors can continuously monitor the blood supply to the left ventricle 3-A and right ventricle 3-B and upload this data to the intelligent control system. When the sensors provide pressure or flow through the monitoring points at the four ports of the left ventricle 3-A and right ventricle 3-B, and the intelligent control system calculates and detects that the blood supply to the left ventricle 3-A and right ventricle 3-B has reached equilibrium, the blood volume regulation system controls the push-pull plate in the power system to return to its normal operating position. Alternatively, as needed, based on the accumulated experience data from previous adjustments, it may only partially return to the start and end positions of normal operation, ensuring that the pumping volume of the left ventricle 3-A and right ventricle 3-B remains in balance for an extended period.

[0070] In the intelligent bionic heart of this application embodiment, the intelligent control system detects the blood supply to the left ventricle 3-A and right ventricle 3-B by acquiring the pushing force of the push-pull plate. When the intelligent control system determines that the blood supply to the left ventricle 3-A and right ventricle 3-B is unbalanced, the intelligent control system controls the blood volume adjustment system. The blood volume adjustment system adjusts the start and end positions of the push-pull plate during operation to shift towards the ventricle with a higher blood supply to the left ventricle 3-A and right ventricle 3-B. This changes the structural shape of the left ventricle 3-A and right ventricle 3-B during pumping, reduces the diameter of the blood outlet of the ventricle with a higher blood supply, and reduces the amount of blood pumped out by the ventricle with a higher blood supply. This makes the blood supply to the left ventricle 3-A and right ventricle 3-B balanced, preventing the intelligent bionic heart from experiencing an unbalanced blood supply to the left ventricle 3-A and right ventricle 3-B during use, thus making this application safer.

[0071] Optionally, such as Figures 3 to 7 As shown, the blood volume regulation system includes a position driver, a control program, and flow-limiting protrusions. The flow-limiting protrusions are located at the blood outflow positions of the left and right ventricles and at sensors. The control program drives the position driver and executes and controls the starting and ending position offset or the amount of offset of the push-pull plates in the power system according to the data collected by the sensors. At the same time, a flow-limiting protrusion is provided at the blood outflow positions of the left ventricle 3-A and the right ventricle 3-B in the housing. The two flow-limiting protrusions correspond to the two push-pull plates, and the partial structures of the flow-limiting protrusions and the corresponding push-pull plates interlock and engage when they meet.

[0072] When the intelligent control system detects an imbalance in blood volume between the left and right ventricles 3-B pumps and needs adjustment, it instructs the position actuator and controls the push-pull plate in the power system to deviate from its normal operating position via sensors, shifting it towards the ventricle with the greater blood supply.

[0073] After the push-pull plate deviates from its normal operating position, the diameter of the ventricular blood outflow position in the direction of the deviated push-pull plate will become smaller. At the end of the process of pushing the ventricle, the push-pull plate and the corresponding flow-limiting protrusion will interlock. After interlocking, the diameter of the blood outflow position of the corresponding ventricle will be closed or partially closed, so that the remaining blood in the ventricle at the end of the pumping process cannot be pumped out or partially cannot be pumped out, thereby reducing the amount of blood pumped out by the ventricle. In the opposite direction, because the starting and ending positions of the push-pull plate have deviated, the push-pull plate will not interlock with the flow-limiting protrusion at the end of the process of pushing the ventricle. The blood outflow position of the ventricle will not be closed, the diameter will not become smaller, and the amount of blood pumped out will not decrease. In this way, although only one power system drives the operation of the left and right ventricles, the amount of blood pumped out by the left and right ventricles can be different when needed. Through continuous monitoring and the aforementioned intermittent or constant adjustments, the pumping volume of the left and right ventricles is kept in balance for an extended period.

[0074] It should also be noted that the amount of blood remaining in the ventricle that cannot be pumped out is extremely small, such as only about 1 milliliter (with a difference of 1 milliliter each time, 60 milliliters per minute, and 200 milliliters in three minutes). This 1 milliliter of remaining blood each time can be temporarily stored in the soft membrane (sac) around the ventricle, and then merge with the next blood to be drawn in, and so on in a cycle.

[0075] like Figures 3 to 7 As shown, a right ventricular blood outflow limiting protrusion 18-B is provided at the right ventricular blood outflow position, and a left ventricular blood outflow limiting protrusion 18-A is provided at the left ventricular blood outflow position 3-A. The position actuator is a control program used to execute the control program for the stroke position of the push-pull plate. Sensors are used to acquire stroke information of the push-pull plate movement. The intelligent control system can accurately control the offset distance of the push-pull plate through the position actuator and sensors.

[0076] When the intelligent control system analyzes the thrust of the push-pull plate and detects that the pumping volume of right ventricle 3-B is greater than that of left ventricle 3-A, the intelligent control system instructs the position actuator. The position actuator executes the control program and, in conjunction with sensors, controls the stroke of the push-pull plate in the power system to shift towards right ventricle 3-B. Please see further details. Figure 3During the movement of the right ventricular push-pull plate 4-B towards the right ventricular 3-B, due to the shift in its starting and ending positions, the right ventricular push-pull plate 4-B eventually enters the right ventricular blood outflow limiting protrusion 18-B, interlocking with it. This blocks the blood outflow orifice of the right ventricular 3-B, reducing or completely closing the orifice. Consequently, only a portion of the remaining blood in the right ventricular 3-B can be pumped out, or it cannot be pumped out at all, thus reducing the amount of blood pumped by the right ventricular 3-B. Please refer to further details. Figure 4 After the push-pull plate shifts towards the right ventricle 3-B, during the movement of the left ventricle push-pull plate 4-A towards the left ventricle 3-A, the left ventricle push-pull plate 4-A, even at its closest position to the left ventricle 3-A, still maintains a certain distance from the flow-limiting protrusion 18-A at the left ventricle's blood outflow position. This will not affect the diameter of the blood outflow position of the left ventricle 3-A, and therefore will not affect the pumping volume of the left ventricle 3-A.

[0077] Similarly, when the intelligent control system detects that the pumping volume of the left ventricle 3-A is greater than that of the right ventricle 3-B by analyzing the thrust of the push-pull plate, the intelligent control system instructs the position actuator. The position actuator executes the control program and, in conjunction with sensors, controls the stroke of the push-pull plate in the power system to shift towards the left ventricle 3-A. Please see further details. Figure 5 During the movement of the left ventricular push-pull plate 4-A towards the left ventricular 3-A, due to the shift in the starting and ending positions of the left ventricular push-pull plate 4-A, it eventually enters the left ventricular blood outflow limiting protrusion 18-A, interlocking with it. This blocks the blood outflow from the left ventricular 3-A, reducing or completely closing the opening. Consequently, only a portion of the remaining blood in the left ventricular 3-A can be pumped out, or it cannot be pumped out at all, thus reducing the amount of blood pumped by the left ventricular 3-A. Please refer to further details. Figure 6 After the push-pull plate shifts towards the left ventricle 3-A, during the movement of the right ventricle push-pull plate 4-B towards the right ventricle 3-B, the right ventricle push-pull plate 4-B, even at its closest position to the right ventricle 3-B, still maintains a certain distance from the flow-limiting protrusion 18-B at the right ventricle's blood outflow position. This will not affect the diameter of the blood outflow position of the right ventricle 3-B, and therefore will not affect the pumping volume of the right ventricle 3-B.

[0078] In this embodiment, by setting a flow-limiting protrusion within the housing and controlling the operating position of the push-pull plate using a position driver combined with a sensor, the push-pull plate can be staggered with the flow-limiting protrusion corresponding to the ventricle with a larger blood pumping volume. This reduces the diameter of the blood outlet of the ventricle with a larger blood pumping volume, thereby reducing its pumping volume. The structure is simple and does not require additional structures within the bionic heart or an increase in its size.

[0079] It should be noted that in the normal operating position, the pumping volume of the left and right ventricles is equal each time. However, in practical applications, if the pumping volume of the left and right ventricles does not need to be equal according to human needs, the operating position of the push-pull plate can be always set to the adjustment operating position. In this way, the pumping volume of the left and right ventricles will always be unequal, and there is no need to adjust it by detection during operation. Instead, it can be set to a fixed adjustment in advance. For example, if the pumping volume required by the left ventricle is greater than that of the right ventricle, the start and end operating positions of the push-pull plate can be shifted towards the right ventricle to the adjustment operating position in advance and kept fixed in the adjustment operating position to continuously reduce the pumping volume of the right ventricle.

[0080] Optionally, the intelligent control system includes at least a circuit board and chip, software program, and a sensor, which is a body index sensor, and the software program includes high-precision algorithms and a large amount of experimental data. The intelligent control system is used to detect the user's body index through the body index sensor, and the body index includes at least: body movement speed and body temperature.

[0081] It should be noted that the body index sensor has various functions and models, which are installed inside and outside the housing and at the four ports of this application as needed, and are all electrically connected to the intelligent control system.

[0082] The intelligent control system is used to set the initial number of times the power system runs based on the user's height, weight, and body mass index. It also adjusts the number of times the power system runs in real time based on changes in the user's body movement speed and body temperature after use. In other words, it adjusts the number of times the left ventricle 3-A and right ventricle 3-B pump blood to adapt to the blood supply of the human body under different conditions, including when the body temperature rises due to illness or when breathing becomes rapid.

[0083] For example, a 50 kg adult woman or a 60 kg adult man, at rest, with the heart pumping blood 60 times per minute and each pumping 70 ml of blood, approximately 4200 ml of blood is pumped out of the heart and delivered to various parts of the body per minute. The initial operating frequency of the extension component 6 of the power motor 5, which drives the power system, is 60 times per minute. Of course, the amount of blood pumped by the heart per minute varies for individuals of different weights; the greater the weight, the greater the amount of blood pumped per minute. These settings can be configured during surgery. For example, for a male, the initial pumping frequency is 60 times per minute for a weight of 60 kg, 70 times per minute for a weight of 70 kg, 80 times per minute for a weight of 80 kg, and 90 times per minute for a weight of 90 kg or more. This application designs a pump that delivers 70 ml of blood per pump. When the intelligent control system senses an increase in body temperature or physical activity through sensors, it instructs the motor 5 to either accelerate (gradually increasing from an initial 60 pumps to a maximum of 100 pumps, or from an initial 90 pumps to a maximum of 130 pumps) or slow down (gradually decreasing from a maximum of 100 or 130 pumps to 60 or 90 pumps) to simulate the rhythm and function of the human heart. Furthermore, a single product model addresses the compatibility issue for male and female patients of different weights, making the intelligent bionic heart of this embodiment more suitable for the needs of diverse patients.

[0084] Optionally, the power system includes a power motor 5, a telescopic component 6, a push-pull plate, and a power guide slide rod 19. The power motor 5 is a linear motor that drives the telescopic component 6 to reciprocate in a linear motion to compress the left ventricle 3-A and the right ventricle 3-B. The power guide slide rod 19 is used to ensure that the power motor runs in a stable linear motion. The offset of the push-pull plate's running position is caused by the offset of the telescopic component 6's running position.

[0085] Please refer to the above. Figure 1 , Figure 2 , Figure 7 , Figure 13 and Figure 14 The power system includes a power motor 5, a telescopic component 6, and left ventricular push-pull plates 4-A and 4-B. The power motor 5 is slidably connected to the telescopic component 6, and the power motor 5 drives the telescopic component 6 to perform reciprocating linear motion in the left-right direction.

[0086] In an optional embodiment, the power system further includes a power guide slide rod 19, and a telescopic member 6 is disposed between the two power guide slide rods 19. The telescopic member 6 connects the two power guide slide rods 19, and the power guide slide rods 19 can cooperate with the slide rail to ensure the direction of movement. This can prevent the telescopic member 6 from shifting position during movement and ensure the operational stability of the power system in the intelligent bionic heart of this application embodiment.

[0087] The two ends of the telescopic component 6 of the power system are connected to the left ventricular push-pull plate 4-A and the right ventricular push-pull plate 4-B, respectively. It should be noted that in specific applications, if the telescopic component 6 can achieve stable reciprocating linear operation, the power guide slide rod 19 can also be omitted.

[0088] like Figure 1 and Figure 13 In the indicated state, the power motor 5 drives the telescopic component 6 of the power system to move towards the right ventricle 3-B. The right ventricle push-pull plate 4-B compresses the right ventricle 3-B, causing the right ventricle 3-B to pump blood out. At the same time, because the size of the sealed space remains unchanged, the left ventricle 3-A is "stretched" by the left ventricle push-pull plate 4-A, expanding its volume and causing the left ventricle 3-A to draw in blood.

[0089] like Figure 2 and Figure 14 In the illustrated state, similarly, the power motor 5 drives the telescopic component 6 of the power system to move towards the left ventricle 3-A, and the left ventricle push-pull plate 4-A compresses the left ventricle 3-A, causing the left ventricle 3-A to pump blood out. At the same time, because the size of the sealed space remains unchanged, the right ventricle 3-B is "stretched" by the right ventricle push-pull plate 4-B, expanding its volume, causing the right ventricle 3-B to draw in blood.

[0090] The power motor 5 drives the telescopic component 6 of the power system to reciprocate linearly in the left and right directions, enabling the intelligent bionic heart to... Figure 1 , Figure 13 The state shown and Figure 2 , Figure 14 The system continuously switches between states, namely, the state of "left ventricle 3-A drawing in blood and right ventricle 3-B pumping out blood" and the state of "left ventricle 3-A pumping out blood and right ventricle 3-B drawing in blood," thus realizing the circulation of blood in the human body.

[0091] It should be further explained that the offset of the push-pull plate's operating position is actually caused by the offset of the telescopic component 6's operating position. Because the push-pull plate is fixedly connected to the telescopic component 6 in the power system, and the telescopic component 6 is a suspended sliding connection in the power motor, its stroke start and end positions can be adjusted.

[0092] Optionally, the intelligent bionic heart also includes a power supply system, which includes a built-in battery 9, a built-in receiving power coil 21, an external battery 25, and an external transmitting power coil 22. The built-in receiving power coil 21 can be implanted subcutaneously and is electrically connected to the built-in battery 9 and the intelligent control system. The external transmitting power coil 22 is correspondingly set inside and outside the human body to supply power to the devices inside the human body. The external battery 25 can be integrated with the external circuit board and chip 24 into a module and placed in the pocket of the vest 26 or belt worn outside the human body, and connected to the external transmitting power coil 22 to supply power to the human body; however, the external battery can still be used separately without integration, so as to facilitate replacement and charging.

[0093] like Figure 12 As shown, the built-in battery 9, built-in circuit board and chip 8 are respectively set on both sides of the power system to receive external charging power and simultaneously power the various components inside the intelligent bionic heart shell. However, the built-in battery 9, built-in circuit board and chip 8 can also be set outside the shell as needed.

[0094] Please refer to the above. Figure 17 and Figure 18 The external battery 25 and the external power transmitting coil 22 are electrically connected. The power of the external battery 25 is sent to the internal power receiving coil 21 through the external power transmitting coil 22, and then to the internal battery 9.

[0095] like Figure 18 As shown, the outer vest 26 includes a vest zipper 27, a vest pocket 28, and a pocket zipper 29. The external battery 25, external power transmitting coil 22, external circuit board, and chip 24 can be integrated into a small module, installed in the pocket, to maintain a stable connection with the intelligent bionic heart inside the human body for a long time, continuously charging the built-in rechargeable battery to power the components inside the intelligent bionic heart shell. It also has a built-in power receiving coil, which, upon receiving power, can directly power the drive motor 5 through the circuit board and chip.

[0096] Optionally, the intelligent bionic heart also includes a communication system, which includes a built-in communication module, an external communication module, and an external early warning device 23. Both the communication system and the power supply system are electrically connected to the intelligent control system. The connection between the built-in and external parts of the communication system and the power supply system is wireless.

[0097] like Figure 17As shown, the external warning device 23 is integrated with the external battery, external power transmission coil 22, external circuit board, and chip 24 onto the same module, making it easy to carry. The operating information of the intelligent bionic heart is sent to the external warning device 23 via the built-in communication module and the external communication module. When the intelligent bionic heart's operating status is abnormal, the external warning device 23 issues an alarm, reminding the user to check or replace the battery in a timely manner.

[0098] Optionally, the left ventricle 3-A, right ventricle 3-B, artificial blood vessels, ingress valves, and egress valves—all components that come into contact with blood—should be made of biocompatible materials. The surfaces of all components in the intelligent bionic heart that come into contact with blood can still be coated with biocompatible materials.

[0099] Optionally, such as Figure 10 , Figure 11 As shown, the left and right ventricles are in the form of soft capsules. The soft capsule form is used so that the ventricles are formed in one piece using only one material, which is conducive to their compatibility with blood. This can avoid adverse reactions between the intelligent bionic heart and the human body and further improve safety.

[0100] Optionally, the intelligent bionic heart also includes a support frame 7 and a snap ring. The support frame 7 is used to fix the power system; the snap ring is used to fix and connect the tube opening to the artificial blood vessel and the ingress valve and egress valve, as well as to fix and connect the shell to the left ventricle 3-A and the right ventricle 3-B.

[0101] It should be noted that there are multiple models of the locking ring, such as the locking ring 16 connecting the blood vessel to the shell port, the locking ring 17-B connecting the left shell to the middle shell, and the locking ring 17-A connecting the right shell to the middle shell.

[0102] Optionally, the housing is a multi-part assembly. After the internal components are installed, the multiple components are combined using snap-fit ​​rings or welding to form a sealed whole. Alternatively, the housing is a complete housing with an opening, which is sealed with a back cover after the internal components are installed.

[0103] like Figure 1 , Figure 7 As shown, a support frame 7 is provided in the middle of the shell of the intelligent bionic heart, and the power system is installed on the support frame 7.

[0104] like Figure 7 , Figure 8As shown, the housing can be composed of three parts: left, right, and middle. The support frame 7 is located within the middle housing 1-C. After the power system, built-in battery 9, built-in circuit board, and chip 8 are installed onto the support frame 7, the left housing 1-B and the middle housing 1-C are assembled using the connecting buckle 17-B between the left and middle housings. Similarly, the right housing 1-A and the middle housing 1-C are assembled using the connecting buckle 17-A between the right and middle housings. This allows for the following... Figure 9 The state shown is as follows, as it appears from the outside. Figure 19 , Figure 20 , Figure 21 The status shown. Please refer to further details. Figure 1 and Figure 15 The artificial blood vessel is detachably connected to the shell opening via a connecting buckle 16. This connection structure is simple and easy to install and remove, allowing the user to quickly replace it at the hospital when needed.

[0105] In another embodiment, the housing can be a single, integral component with an opening at one end for installing internal components. After installation, the components can be sealed using a rear cover. In this embodiment, the integral structure of the housing facilitates component installation.

[0106] This application also provides a novel intelligent bionic heart structure and its operating method, applied to the aforementioned intelligent bionic heart, the method comprising:

[0107] It acquires information on the operation of the intelligent bionic heart and various movements and functions of the user's body;

[0108] Based on the novel structure of the intelligent bionic heart, the system displays and controls the operation status of the power system and blood volume regulation system by providing operational information and various movements and operation information of the user's body.

[0109] The intelligent bionic heart's operational information includes at least the blood supply information for the left and right ventricles. The intelligent control system, by acquiring and analyzing the thrust of the push-pull plate, can detect the blood supply to the left and right ventricles. When the blood supply to the left and right ventricles is unbalanced, the intelligent control system controls the blood volume regulation system. This system adjusts the start and end positions of the push-pull plate during operation, shifting it towards the ventricle with the higher blood supply. This alters the structural shape of the left and right ventricles during pumping, reducing the diameter of the blood outlet from the ventricle with the higher blood supply, thus decreasing the amount of blood pumped out by the ventricle with the higher blood supply and achieving a balance in the blood supply to the left and right ventricles.

[0110] The intelligent bionic heart's operating information can also include the user's physical movement speed, body temperature, and other indices. Based on these indices, the reciprocating speed of the power system can be adjusted to increase or decrease the number of pumping operations in the left ventricle 3-A and right ventricle 3-B, adapting to the blood supply under different conditions.

[0111] 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 form of each component in the illustrations should be adjusted according to actual needs (unless otherwise specified). For example (but not limited to) the main blood vessel, the inlet, the inlet valve, the outlet valve, the power guide slide rod 19 and its corresponding slide rail, various sensors, circuit boards and chips, the power system motor, etc. For example, the built-in battery, circuit board and chip in the illustration are set inside the housing, but in actual manufacturing, they can also be set outside the housing as needed; for example, the power guide slide rod 19 is set on both sides of the power motor in the illustration, but in actual manufacturing, the power guide slide rod 19 can also be replaced with a "linear self-lubricating bushing" and set around the round shaft of the telescopic part 6 as needed; for example, the push-pull plate and the power motor are separate in the illustration, but in actual manufacturing, one of them can be integrated with the power motor or partially integrated as needed.

[0112] The above is merely one example of a specific implementation of this application, but the scope of protection of this application is not limited thereto. Any person skilled in the art can easily conceive of various variations or substitutions within the scope of the technical methods disclosed in this application. Any example within the scope disclosed in this technology 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 novel intelligent bionic heart, characterized in that, The novel intelligent bionic heart structure includes: a shell, a left ventricle, a right ventricle, an ingress valve, an egress valve, artificial blood vessels, a power system, an intelligent control system, sensors, and a blood volume regulation system; The left and right ventricles are located on the left and right sides of the shell, respectively. 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 artificial 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 human aorta, the pulmonary aorta, the left atrial incision, and the right atrial incision, respectively. Each end of the power system is connected to a push-pull plate. One push-pull plate is fitted to the left ventricle, and the other push-pull plate is fitted to the right ventricle. The power system drives the push-pull plates to reciprocate linearly. When the push-pull plate moves towards the left ventricle, it pushes the left ventricle to pump out blood, while the right ventricle at the other end expands its volume and draws in blood. When the push-pull plate moves towards the right ventricle, it pushes the right ventricle to pump out blood, 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, thus promoting blood circulation in the human body. The blood volume regulation system is used to adjust the start and end positions of the push-pull plate in the power system as it moves towards the left and right ventricles. The start and end positions of the push-pull plate in the power system include a normal operating position and an adjustment operating position, and the start and end positions of the normal operating position and the adjustment operating position are different. When adjustment is needed, the blood volume regulation system controls the start and end positions of the push-pull plate in the power system to shift towards the ventricle with a higher blood supply in the left and right ventricles, i.e., shift to the adjustment operating position, and can shift up to the end point of the adjustment operating position as needed. This changes the structural shape of the left and right ventricles during pumping, reduces the diameter of the blood outlet from the ventricle with a higher blood supply, and reduces the amount of blood pumped out by the ventricle with a higher blood supply. When adjustment is not needed, the blood volume regulation system controls the push-pull plate in the power system to gradually return from the adjustment operating position to the normal operating position, or only partially return to the normal operating position as needed, so that the blood supply to the left and right ventricles can reach a balance between supply and demand for a long time. The blood volume regulation system includes flow-limiting protrusions, which are positioned at the blood outflow points of the left and right ventricles. Two flow-limiting protrusions correspond to certain structural components of two push-pull plates in the power system. When these protrusions and corresponding components of the push-pull plates meet, they interlock. At the end of the process of pushing and pressing the ventricle with a higher blood supply, a portion of the push-pull plate interlocks with the corresponding flow-limiting protrusion, thus closing or partially closing the blood outflow point of that ventricle.

2. The novel intelligent bionic heart according to claim 1, characterized in that, The blood volume regulation system includes a position driver and a control program; The blood volume regulation system is electrically connected to the intelligent control system, wherein the control program is used to drive the position driver; When the intelligent control system detects that the blood supply to the left and right ventricles is unbalanced and needs to be adjusted, including when it is set to a fixed adjustment according to the blood supply and demand of the human body, it instructs the position driver to control the stroke of the push-pull plate in the power system to change from the normal operating position to the adjustment operating position, that is, to shift from the normal operating position to the ventricle with a larger blood supply. After the push-pull plate shifts from its normal operating position to its adjusted operating position, the diameter of the ventricular blood outflow position in the direction of the shift becomes smaller. This prevents or partially prevents the remaining blood from being pumped out at the end of the ventricular pumping process, thus reducing the amount of blood pumped out by that ventricle. Conversely, because the starting and ending positions of the push-pull plate have shifted, at the end of the process of pushing the ventricle, the push-pull plate and any part thereof will not intersect with the flow-limiting protrusion. The ventricular blood outflow position will not close, the diameter will not decrease, and the amount of blood pumped out will not decrease. In this way, although only one power system drives the left and right ventricles, the amount of blood pumped out by the left and right ventricles can be made different when needed. Through continuous monitoring and such intermittent or continuous back-and-forth adjustments, the effect of maintaining a long-term balance in the blood pumping volume of the left and right ventricles is achieved.

3. The novel intelligent bionic heart according to claim 1, characterized in that, The intelligent control system includes at least a circuit board and chip, software program and sensor. The intelligent control system is used to detect the user's body index through the sensor. The body index includes at least: body movement speed and body temperature. The intelligent control system sets the initial number of runs of the power system based on the user's height, weight, and body mass index. It also adjusts the number of runs of the power system in real time based on the user's body movement speed and body temperature changes during use, thereby adjusting the pumping frequency of the left and right ventricles to adapt to different blood supply needs under different conditions.

4. The novel intelligent bionic heart according to claim 1, characterized in that, The power system includes a power motor, a telescopic component, a push-pull plate, and a power guide slide rod. There are two push-pull plates, which are respectively connected to both ends of the telescopic component. The power motor and the telescopic component drive the push-pull plate to reciprocate linearly to push the left and right ventricles to pump out and draw in blood. The function of the power guide slide rod is to ensure that the power motor runs in a stable linear direction. The deviation of the push-pull plate's running position is caused by the deviation of the telescopic component's running position.

5. The novel intelligent bionic heart according to claim 1, characterized in that, The intelligent bionic heart also includes a power supply system, which includes a built-in battery, a built-in receiving power coil, an external battery, and an external transmitting power coil. The built-in receiving power coil can be implanted subcutaneously and is electrically connected to the built-in battery and the intelligent control system. The external transmitting power coil is correspondingly set inside and outside the human body to supply power to the devices inside the human body. The external battery can be integrated with an 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 power coil to supply power to the human body.

6. The novel intelligent bionic heart according to claim 1, characterized in that, The intelligent bionic heart also includes a communication system, which includes a built-in communication module, an external communication module, and an external early warning device. Both the communication system and the power supply system are electrically connected to the intelligent control system. The connection between the built-in and external parts of the communication system and the power supply system is wireless.

7. The novel intelligent bionic heart according to claim 1, characterized in that, The surfaces of the left ventricle, the right ventricle, the artificial blood vessel, the ingress valve, and the egress valve—all components that come into contact with blood and with the human body—should be made of biocompatible materials. The surfaces of all components in the intelligent bionic heart that come into contact with blood can still be coated with biocompatible materials.

8. The novel intelligent bionic heart according to claim 1, characterized in that, The intelligent bionic heart also includes a support frame and a locking ring. The support frame is used to fix the power system. The locking ring is used to fix and connect the tube opening to the artificial blood vessel, the ingress valve, and the egress valve, as well as to fix and connect the shell, the left ventricle, and the right ventricle together.

9. The novel intelligent bionic heart according to claim 1, characterized in that, The housing is a multi-component assembly. After the internal components are installed, the multiple components are combined by snap rings or welding to form a sealed whole. Alternatively, the housing is a complete housing with an opening, and the opening is sealed with a back cover after the internal components are installed.

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