System for testing the hemodynamic performance of artificial hearts in a body-lung double circulation simulation

Abstract

This invention provides a systemic-pulmonary dual-circulation simulation system for testing the hemodynamic performance of an artificial heart. It includes a cardiovascular silicone model, a ventricular pulsation device, a controller, a data acquisition device, a fluid reservoir, and an artificial heart. The cardiovascular silicone model, ventricular pulsation device, and fluid reservoir are connected in series to form a blood circulation loop. The cardiovascular silicone model includes systemic and pulmonary circulation loops; the ventricular pulsation device has an internal electric cylinder that drives a piston to reciprocate via a push rod, causing fluid flow in the blood circulation loop; the controller controls the movement of the ventricular pulsation device to simulate blood flow with physiological pulsatile flow characteristics; the data acquisition device collects pressure and flow rate data at different locations on the cardiovascular silicone model. This invention can not only completely simulate the blood flow patterns of the human cardiovascular system but also be used to test the impact of artificial heart implantation on the hemodynamic performance of the human cardiovascular system under different physiological conditions, contributing to the development and research of artificial hearts.

Description

Technical Field

[0001] This invention relates to a system for simulating a dual-circulation system of the body and lungs, and more specifically, to a system for testing the hemodynamic performance of an artificial heart using a dual-circulation model. This invention belongs to the field of medical device testing technology. Background Technology

[0002] As a Class III active medical device, hemodynamics is a key indicator for determining whether the performance of an artificial heart meets clinical requirements, especially its impact on the patient's existing cardiovascular system after implantation, primarily manifested in changes in blood pressure and flow rate. To test and observe the coupling relationship between the hemodynamic performance of an artificial heart and the human cardiovascular system, a cardiovascular circulation simulation system is needed to test its hemodynamic performance.

[0003] Currently, most existing cardiovascular circulation simulation systems for testing use regular-shaped containers such as cylinders or squares to simulate human ventricles or atria. This method can only simulate the volume of the heart structure, but ignores the actual internal structural features of each part of the heart. On the other hand, most existing testing systems only simulate the left atrium-left ventricle-aortic circuit (i.e., the systemic circulation system), lacking the simulation of the right ventricle-right atrium-pulmonary artery circuit (i.e., the pulmonary circulation system). As a result, the cardiovascular circulation model system composed of the circulatory system is incomplete, and the testing of the hemodynamic performance of the artificial heart is limited and one-sided, resulting in unscientific test results. Summary of the Invention

[0004] For the reasons stated above, the purpose of this invention is to provide a systemic-pulmonary dual-circulation simulation system for testing the hemodynamic performance of an artificial heart. This system not only completely simulates the systemic and pulmonary dual-circulation loops of the human cardiovascular system, but also provides a pulsatile blood flow environment that conforms to human physiological characteristics. This facilitates the testing and observation of the hemodynamics of the artificial heart coupled with the cardiovascular system, providing a comprehensive experimental basis for the development of artificial hearts.

[0005] To achieve the above objectives, the present invention adopts the following technical solution: a system for simulating the hemodynamic performance of an artificial heart with a dual circulation of the body and lungs, comprising a cardiovascular silicone model, a ventricular pulsation device, a controller, a data acquisition device, a reservoir, and an artificial heart;

[0006] The cardiovascular silicone model, the ventricular pulsation device, and the reservoir are connected in series to form a blood circulation loop of the integrated lung dual circulation simulation system. The simulated blood flows unidirectionally along the outlet of the reservoir, the first pipe, the ventricular pulsation device, the second pipe, the cardiovascular silicone model, the third pipe, and the inlet of the reservoir.

[0007] The cardiovascular silicone model includes a systemic circulation circuit and a pulmonary circulation circuit;

[0008] The inlet and outlet of the artificial heart are respectively connected to the apex of the left ventricle and the ascending aorta of the cardiovascular silicone model;

[0009] The controller is electrically connected to the ventricular pulsation device and drives the ventricular pulsation device to work, extracting the liquid from the reservoir and allowing the liquid to flow in the blood circulation loop.

[0010] The data acquisition device includes a pressure sensor and a flow meter installed inside the cardiovascular silicone model to collect the fluid flow rate and pressure inside the cardiovascular silicone model during the test; the data acquisition device transmits the collected data to the controller via wired or wireless means.

[0011] In a preferred embodiment of the present invention, the cardiovascular silicone model is based on human heart image data from CT or MRI scans, and is reconstructed into a three-dimensional complete human heart and blood vessel model using 3D printing software. It is made of transparent flexible material through 3D printing. It includes the left ventricle, left atrium, right ventricle, right atrium, aorta, pulmonary artery, and various arterial and venous branches; the systemic circulation loop formed by the left atrium, left ventricle, and aorta; and the pulmonary circulation loop formed by the right ventricle, right atrium, and pulmonary artery.

[0012] In a preferred embodiment of the present invention, the ventricular pulsation device is composed of a pump head, a pump cylinder, and an electric cylinder connected in sequence; the pump head has an outlet connector and an inlet connector on its exterior; a one-way silicone valve is placed inside the outlet connector and the inlet connector; the outlet connector and the inlet connector are fixed to the pump head by a clamping ring and are connected to the pump cylinder.

[0013] The pump cylinder consists of a transparent cavity, a piston, and a push rod. The front end of the transparent cavity is connected to the pump head, and its rear end is connected to the electric cylinder. The piston is built into the transparent cavity, forming a closed liquid space with the front pump head. The push rod is integrally formed with the piston, and the piston reciprocates within the transparent cavity under the push of the push rod. The surface of the piston is provided with a guide ring groove and a sealing ring groove, and a sealing ring is provided in the sealing ring groove.

[0014] The electric cylinder is equipped with a drive motor, and the output shaft of the drive motor is connected to the push rod through a coupling, driving the piston to perform linear reciprocating motion.

[0015] In a preferred embodiment of the present invention, the controller is electrically connected to the ventricular pulsation device and controls the action of the ventricular pulsation device to simulate the blood flow state with physiological pulsating flow characteristics;

[0016] The controller controls the maximum displacement of the ventricular pulsation device cylinder based on the heart rate, controls the movement cycle of the ventricular pulsation device cylinder based on the heart rate, and controls the forward and backward time of the ventricular pulsation device cylinder based on the systolic-diastolic ratio.

[0017] In a preferred embodiment of the present invention, the data acquisition device includes a pressure sensor and a flow sensor;

[0018] The cardiovascular silicone model is equipped with data acquisition interfaces at the lower limb veins, lower limb arteries, left ventricle, and right ventricle; a pressure sensor and a flow sensor are embedded at each data acquisition interface;

[0019] The pressure sensor and flow sensor transmit the detected data to the controller wirelessly; the controller controls the movement of the electric cylinder based on the data collected by the data acquisition device.

[0020] In a preferred embodiment of the present invention, the installation height of the liquid storage tank is higher than the installation height of the ventricular pulsation device; the design capacity of the liquid storage tank is 4L-5L.

[0021] In a preferred embodiment of the present invention, the electric cylinder is a direct-drive electric cylinder, which has a ball screw inside. The ball screw is connected to the push rod of the pump cylinder through a gear set to drive the piston to reciprocate.

[0022] In a preferred embodiment of the present invention, an exhaust port is provided at the top of the pump head. The exhaust port 213 is connected to the outside through a valve to expel excess air from the blood circulation loop before the body-lung dual circulation simulation system is started.

[0023] In a preferred embodiment of the present invention, a metal protective cover is also fixed outside the transparent cavity.

[0024] Compared with traditional cardiovascular circulation simulation systems used to test the hemodynamic performance of artificial hearts, this invention has the following advantages:

[0025] 1. It fully simulates the human cardiovascular circulatory system.

[0026] This invention acquires images of the internal structure of the heart in individuals of different ages and genders using CT or MRI scans. A complete human cardiovascular model is then reconstructed using 3D software. A cardiovascular silicone model is then fabricated using transparent, flexible material via 3D printing. This model includes the left ventricle, left atrium, right ventricle, right atrium, aorta, pulmonary artery, and various arterial and venous branches, forming a complete systemic and pulmonary circulation dual circuit. This overcomes the limitation of traditional cardiovascular circulation simulation systems that only simulate the systemic circulation circuit consisting of the left atrium, left ventricle, and aorta.

[0027] 2. The ventricular pulsation device of the present invention can simulate pulsatile blood flow with physiological characteristics, and can adjust the stroke volume, heart rate and systolic-diastolic ratio, thereby simulating the blood flow pattern under different physiological conditions. This helps to carry out coupling analysis of artificial heart and cardiovascular system and promotes further optimization of hemodynamics of artificial heart. Attached Figure Description

[0028] Figure 1 This is a schematic diagram of the somatic-lung dual-circulation simulation system used in this invention for testing the hemodynamic performance of an artificial heart;

[0029] Figure 2 This is a schematic diagram of the cardiovascular silicone model structure of the present invention;

[0030] Figure 3 This is a schematic diagram of the ventricular pulsation device of the present invention;

[0031] Figure 4 This is a schematic diagram of the exploded structure of the ventricular pulsation device of the present invention;

[0032] Figure 5 This is a cross-sectional structural diagram of the pump head and pump cylinder assembly of the ventricular pulsation device of the present invention;

[0033] The components include: 1. Cardiovascular silicone model; 11. Left ventricle; 12. Data acquisition interface; 2. Ventricular pulsation device; 21. Pump head; 211. Outlet connector; 212. Inlet connector; 213. Exhaust port; 214. Compression ring; 215. One-way silicone valve; 22. Pump cylinder; 221. Transparent cavity; 222. Piston; 2221. Guide ring groove; 2222. Sealing ring groove; 223. Push rod; 224. Wire groove; 225. Metal protective cover; 23. Electric cylinder; 231. Power terminal and control terminal; 3. Controller; 4. Data acquisition device; 5. Liquid reservoir; 51. First pipe; 52. Second pipe; 53. Third pipe; 6. Artificial heart. Detailed Implementation

[0034] The structure and features of the present invention will now be described in detail with reference to the accompanying drawings and embodiments. It should be noted that various modifications can be made to the embodiments disclosed herein; therefore, the embodiments disclosed in this specification should not be considered as limitations on the present invention, but merely as examples to make the features of the present invention readily apparent.

[0035] like Figure 1As shown, the in vivo-lung dual circulation simulation system for testing the hemodynamic performance of an artificial heart disclosed in this invention includes a cardiovascular silicone model 1, a ventricular pulsation device 2, a controller 3, a data acquisition device 4, a reservoir 5, and an artificial heart 6. The cardiovascular silicone model 1, the ventricular pulsation device 2, and the reservoir 5 are connected in series to form the blood circulation loop of the in vivo-lung dual circulation simulation system. The simulated blood flows unidirectionally along the outlet of the reservoir 5, the first pipe 51, the ventricular pulsation device 2, the second pipe 52, the cardiovascular silicone model 1, the third pipe 53, and the inlet of the reservoir 5. The left ventricle 11 serves as the inlet of the cardiovascular silicone model, and the right ventricle serves as the outlet. To improve the testing effect, the installation height of the reservoir 5 is higher than the installation height of the ventricular pulsation device 2.

[0036] The inlet and outlet of the artificial heart 6 are connected to the apex of the left ventricle and the ascending aorta of the cardiovascular silicone model 1, respectively.

[0037] The controller 3 is electrically connected to the ventricular pulsation device 2, driving the ventricular pulsation device 2 to work, extracting the liquid from the reservoir 5, and allowing the liquid to flow in the blood circulation circuit.

[0038] The data acquisition device 4 includes a pressure sensor and a flow meter installed inside the cardiovascular silicone model 1 to collect the liquid flow rate and pressure inside the cardiovascular silicone model 1 during the test.

[0039] To fully simulate the systemic and pulmonary circulation circuits of the human cardiovascular system, such as Figure 2 As shown, the cardiovascular silicone model 1 of this invention includes the left ventricle, left atrium, right ventricle, right atrium, aorta, pulmonary artery, and various arterial and venous branches; the systemic circulation loop formed by the left atrium, left ventricle, and aorta; and the pulmonary circulation loop formed by the right ventricle, right atrium, and pulmonary artery. It is based on CT or MRI scan image data of people of different ages and genders, reconstructed using 3D printing software to generate a complete three-dimensional human cardiovascular model, and then fabricated using transparent flexible material through 3D printing. This cardiovascular silicone model can not only completely simulate the systemic and pulmonary dual circulation of the human cardiovascular system, but also provide a pulsatile blood flow environment that conforms to human physiological characteristics.

[0040] like Figure 3 , Figure 4 and Figure 5 As shown, the ventricular pulsation device 2 of the present invention consists of a pump head 21, a pump cylinder 22 and an electric cylinder 23 connected in sequence. The two ends of the pump cylinder 22 are connected to the pump head 21 and the electric cylinder 23 respectively through a flange or threaded connection.

[0041] The pump head 21 has a pagoda-shaped outlet connector 211 and a pagoda-shaped inlet connector 212 externally mounted. A one-way silicone valve 215 is placed inside the outlet connector 211 and inlet connector 212 to prevent liquid backflow. The outlet connector 211 and inlet connector 212 are fixed to the pump head 21 by a clamping ring 214 and are connected to the pump cylinder 22. An exhaust port 213 is provided at the top of the pump head 21. The exhaust port 213 is connected to a three-way valve or a two-way valve to expel excess air from the blood circulation loop of the test system before the dual-circulation simulation system is started, reducing errors in pressure measurement.

[0042] The pump cylinder 22 consists of a transparent cavity 221, a piston 222, and a push rod 223. The front end of the transparent cavity 221 is connected to the pump head 21, and its rear end is connected to the electric cylinder 23. The piston 222 is built into the transparent cavity 221, forming a closed liquid space with the front pump head 21. The push rod 223 is integrally formed with the piston 222. Under the push of the push rod 223, the piston 222 reciprocates within the transparent cavity 221. The surface of the piston 222 is provided with a guide ring groove 2221 and a sealing ring groove 2222. A sealing ring is provided in the sealing ring groove to prevent liquid from leaking out of the electric cylinder 23 during piston movement.

[0043] The electric cylinder 23 houses a drive motor, whose output shaft is connected to the push rod 223 of the pump cylinder 22 via a coupling, driving the piston 222 to perform linear reciprocating motion. The outer wall of the electric cylinder 23 has power terminals and a control terminal 231, which are electrically connected to the controller 3 via wires. The controller 3 controls the movement of the electric cylinder 23 based on three parameters: stroke volume, heart rate, and systolic-diastolic ratio for individuals of different ages and genders. Functionally, it realizes the control of stroke volume, heart rate, and systolic-diastolic ratio of the ventricular pulsation device. Specifically, the controller 3 controls the maximum displacement of the electric cylinder 23 based on the stroke volume, controls the movement cycle of the electric cylinder 23 based on the heart rate, and controls the forward and backward movement time of the electric cylinder 23 based on the systolic-diastolic ratio. Typically, the heart rate range of the ventricular pulsation device 2 can be set to 4-200 bpm, the stroke volume to 0-200 mL / beat, and the diastolic-compression ratio to 30-60%. The forward and backward movements of the electric cylinder 23 simulate the ventricular contraction and relaxation processes, respectively. During each movement, the controller 3 uses pulse signals to adjust the displacement of the electric cylinder 23 to ensure high precision of the movement displacement.

[0044] The controller 3 can be a microprocessor and its peripheral circuits, or it can be a PLC controller. In a preferred embodiment of the present invention, the controller 3 is a PLC controller, and its control signal output terminal is connected to the control terminal 231 of the electric cylinder 23 of the ventricular pulsation device 2 through a wire, controlling the motor in the electric cylinder 23 to move, and then driving the piston 222 to reciprocate through the push rod 223, so that the liquid in the blood circulation loop of the test system flows.

[0045] During the test, parameters such as stroke volume, heart rate, and systolic-diastolic ratio can be set directly through the human-machine interface touch screen of the PLC controller, thereby changing the motion pattern of the electric cylinder 23.

[0046] The data acquisition device 4 is mainly used to collect the pressure and flow rate of the cardiovascular silicone model 1, and transmits the collected data to the controller 3 via wired or wireless transmission. The controller 3 further controls the movement of the electric cylinder 23 based on the data collected by the data acquisition device 4. The data acquisition device 4 includes a pressure sensor and a flow sensor. Figure 2 As shown, this invention provides data acquisition interfaces 12 at the lower limb veins, lower limb arteries, left ventricle, and right ventricle of the cardiovascular silicone model 1. Pressure sensors and flow sensors are embedded at each data acquisition interface 12 to achieve multi-channel, simultaneous-baseline measurement, comprehensively monitoring the blood flow and pressure conditions of each ventricle, atrium, systemic circulation loop, and pulmonary circulation loop. The pressure and flow sensors wirelessly transmit the detected data to the controller 3 and a remote control terminal.

[0047] In a preferred embodiment of the present invention, both the pressure sensor and the flow meter are disposable medical invasive sensors.

[0048] In a preferred embodiment of the present invention, the electric cylinder 23 is a direct-drive electric cylinder, which has a ball screw inside. This ball screw is connected to the push rod 223 of the pump cylinder 22 via a gear set, converting the rotational motion into linear motion of the push rod 223, thus driving the piston 222 to perform linear reciprocating motion. To ensure that the piston 222 and the push rod 223 perform linear reciprocating motion along the axis of the transparent cavity 221, and to improve the stability of the ventricular pulsation device, such as... Figure 5 As shown, the present invention provides a wire groove 224 on the inner wall of the hole through which the push rod 223 passes at the end of the pump cylinder 22 connected to the electric cylinder 23, so that the push rod 223 can move back and forth along the wire groove.

[0049] In a preferred embodiment of the present invention, the transparent cavity 221 is made of transparent materials such as acrylic or glass, and a metal protective cover 225 is fixed on the outside of the transparent cavity 221 to prevent damage to the transparent cavity 221 during the test.

[0050] In a preferred embodiment of the present invention, the capacity of the liquid storage tank 5 is required to meet the total blood volume requirements of people of different ages and genders, and its designed capacity is 4L-5L.

[0051] This invention, unlike traditional cardiovascular circulation simulation systems, fully simulates the human cardiovascular circulation system. Specifically, this invention's cardiovascular circulation simulation system includes systemic circulation and pulmonary circulation, enabling a complete simulation of the human cardiovascular system and realistically reflecting the hemodynamic impact of artificial heart implantation on the cardiovascular system. Furthermore, this invention also incorporates functions for regulating different physiological states and testing flow and pressure, providing a more comprehensive and scientific assessment of the artificial heart's working status.

[0052] This invention is applicable not only to the hemodynamic performance testing of magnetically levitated artificial hearts, but also to the hemodynamic performance testing of percutaneous interventional artificial hearts, thus having a wide range of applications.

[0053] Finally, it should be noted that the above-described embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit them. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A system for simulating the hemodynamic performance of an artificial heart using a dual-circulation system of the lungs and body, characterized in that: It includes a cardiovascular silicone model, a ventricular pulsation device, a controller, a data acquisition device, a reservoir, and an artificial heart; The cardiovascular silicone model, the ventricular pulsation device, and the reservoir are connected in series to form a blood circulation loop of the integrated lung dual circulation simulation system. The simulated blood flows unidirectionally along the outlet of the reservoir, the first pipe, the ventricular pulsation device, the second pipe, the cardiovascular silicone model, the third pipe, and the inlet of the reservoir. The cardiovascular silicone model includes a systemic circulation circuit and a pulmonary circulation circuit; The inlet and outlet of the artificial heart are respectively connected to the apex of the left ventricle and the ascending aorta of the cardiovascular silicone model; The controller is electrically connected to the ventricular pulsation device and drives the ventricular pulsation device to work, extracting the liquid from the reservoir and allowing the liquid to flow in the blood circulation loop. The data acquisition device includes a pressure sensor and a flow meter installed inside the cardiovascular silicone model to collect the fluid flow rate and pressure inside the cardiovascular silicone model during the test; the data acquisition device transmits the collected data to the controller via wired or wireless means.

2. The system for simulating the hemodynamic performance of an artificial heart using a dual-circulation system of the lungs according to claim 1, characterized in that: The cardiovascular silicone model is based on CT or MRI scans of human heart images. It is reconstructed using 3D printing software to generate a complete three-dimensional human heart and blood vessel model. It is made of transparent and flexible material through 3D printing. It includes the left ventricle, left atrium, right ventricle, right atrium, aorta, pulmonary artery, and various arterial and venous branches; the systemic circulation loop formed by the left atrium, left ventricle, and aorta; and the pulmonary circulation loop formed by the right ventricle, right atrium, and pulmonary artery.

3. The system for testing the hemodynamic performance of an artificial heart using a dual-circulation system of the lungs according to claim 2, characterized in that: The ventricular pulsation device consists of a pump head, a pump cylinder, and an electric cylinder connected in sequence; The pump head is externally equipped with an outlet connector and an inlet connector; a one-way silicone valve is placed inside the outlet connector and the inlet connector; the outlet connector and the inlet connector are fixed to the pump head by a clamping ring and are connected to the pump cylinder. The pump cylinder consists of a transparent cavity, a piston, and a push rod. The front end of the transparent cavity is connected to the pump head, and its rear end is connected to the electric cylinder. The piston is built into the transparent cavity, forming a closed liquid space with the front pump head. The push rod is integrally formed with the piston, and the piston reciprocates within the transparent cavity under the push of the push rod. The surface of the piston is provided with a guide ring groove and a sealing ring groove, and a sealing ring is provided in the sealing ring groove. The electric cylinder is equipped with a drive motor, and the output shaft of the drive motor is connected to the push rod through a coupling, driving the piston to perform linear reciprocating motion.

4. The system for testing the hemodynamic performance of an artificial heart using a dual-circulation system of the lungs according to claim 3, characterized in that: The controller is electrically connected to the ventricular pulsation device and controls the movement of the ventricular pulsation device to simulate the blood flow state with physiological pulsating flow characteristics; The controller controls the maximum displacement of the ventricular pulsation device cylinder based on the heart rate, controls the movement cycle of the ventricular pulsation device cylinder based on the heart rate, and controls the forward and backward time of the ventricular pulsation device cylinder based on the systolic-diastolic ratio.

5. The system for testing the hemodynamic performance of an artificial heart using a dual-circulation system of the lungs according to claim 4, characterized in that: The data acquisition device includes a pressure sensor and a flow sensor; The cardiovascular silicone model is equipped with data acquisition interfaces at the lower limb veins, lower limb arteries, left ventricle, and right ventricle; a pressure sensor and a flow sensor are embedded at each data acquisition interface; The pressure sensor and flow sensor transmit the detected data to the controller wirelessly; the controller controls the movement of the electric cylinder based on the data collected by the data acquisition device.

6. The system for testing the hemodynamic performance of an artificial heart using a dual-circulation system of the lungs according to any one of claims 1-5, characterized in that: The installation height of the liquid storage tank must be higher than the installation height of the ventricular pulsation device; The storage tank is designed to have a capacity of 4L-5L.

7. The system for simulating the hemodynamic performance of an artificial heart using a dual-circulation system of the lungs according to claim 6, characterized in that: The electric cylinder is a direct-drive type, which has a ball screw inside. The ball screw is connected to the push rod of the pump cylinder through a gear set, which drives the piston to reciprocate.

8. The system for testing the hemodynamic performance of an artificial heart using a dual-circulation system of the lungs according to claim 7, characterized in that: An exhaust port 213 is provided at the top of the pump head. The exhaust port 213 is connected to the outside through a valve to expel excess air from the blood circulation loop before the body-lung dual circulation simulation system is started.

9. The system for simulating the hemodynamic performance of an artificial heart using a dual-circulation system of the lungs according to claim 8, characterized in that: A metal protective cover is also fixed to the outside of the transparent cavity.

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