CN114166494A - Test system for ventricular assist device - Google Patents

Abstract

The invention provides a test system for a ventricular assist device. The test system for a ventricular assist device includes: a first pipeline; the left heart simulation system comprises a second pipeline, and a left atrium simulation component, a mitral valve simulation valve, a left ventricle simulation component, an aortic valve simulation valve, an aortic simulation component, a first flowmeter and a first resistance valve which are sequentially arranged on the second pipeline; the right heart simulation system comprises a third pipeline, and a right atrium simulation component, a tricuspid valve simulation valve, a right ventricle simulation component, a pulmonary valve simulation valve, a pulmonary artery simulation component and a second resistance valve which are sequentially arranged on the third pipeline; and a switching device for communicating any two of the first, second and third conduits so that the test system for a ventricular assist device has a systemic circulation mode, a right cardiac circulation mode and a full circulation mode. The technical scheme of the invention solves the problem of single function of the in-vitro testing system of the ventricular assist device in the prior art.

Description

Test system for ventricular assist device

Technical Field

The invention relates to the technical field of medical equipment and clinical application research, in particular to a test system for a ventricular assist device.

Background

Heart failure, as the terminal stage of progression of heart disease, is characterized by irreversible, difficult to treat, and high mortality, and heart transplantation is an effective treatment, but many patients have had unfortunate lives due to the shortage of heart donors and difficulty in typing. With the development of artificial heart technology, the hope of a plurality of heart failure patients is brought. The mature development of the artificial heart technology is the ventricular assist device which can be implanted into the heart of a patient through an operation to provide the patient with auxiliary blood circulation support, thereby relieving the heart burden and being beneficial to the recovery of cardiac muscle. This technology is divided into Left Ventricular Assist Devices (LVADs) and Right Ventricular Assist Devices (RVADs), and has become an effective treatment for advanced heart failure.

The artificial heart belongs to a three-level active medical instrument, is related to the life safety of an implanted patient, and has the advantages that the safety, the stability and the effectiveness are all required to be guaranteed powerfully, so that a large amount of verification and test work is particularly important. Meanwhile, as a new technology, the change of physiological state, the adjustment of rotating speed, the balance of blood circulation, the subsequent treatment and the like of a patient after the artificial heart is implanted still contain many unknowns. And reasonable and accurate conclusions can not be obtained from animal experiments due to a plurality of special problems. There is therefore a need for a testing platform that is capable of both testing an artificial heart and providing experience and basis for clinical use.

With the development of artificial heart technology, an in vitro simulation cycle test device comes along, but the simulation test system in the prior art only supports single left ventricle assistance or single systemic circulation, so that abundant and accurate experience and theoretical support cannot be provided for practical clinical application.

Disclosure of Invention

The invention mainly aims to provide a test system for a ventricular assist device, which aims to solve the problem of single function of an in-vitro test system for the ventricular assist device in the prior art.

In order to achieve the above object, the present invention provides a test system for a ventricular assist device, including: the first pipeline is provided with a first port and a second port which are oppositely arranged; the left heart simulation system comprises a second pipeline, and a first one-way valve, a left atrium simulation component, a mitral valve simulation valve, a left ventricle simulation component, an aortic valve simulation valve, an aortic artery simulation component, a first flowmeter and a first resistance valve which are sequentially arranged on the second pipeline, wherein an inlet of the second pipeline is connected with a first port, and an outlet of the second pipeline is connected with a second port; the right heart simulation system comprises a third pipeline, and a second one-way valve, a right atrium simulation assembly, a tricuspid valve, a right ventricle simulation assembly, a pulmonary valve simulation valve, a pulmonary artery simulation assembly and a second resistance valve which are sequentially arranged on the third pipeline, wherein an inlet of the third pipeline is connected with the second port, and an outlet of the third pipeline is connected with the first port; and the switching device is used for communicating any two pipelines of the first pipeline, the second pipeline and the third pipeline so that the test system for the ventricular assist device has a systemic circulation mode that the first pipeline is communicated with the second pipeline, a right cardiac circulation mode that the first pipeline is communicated with the third pipeline and a full circulation mode that the second pipeline is communicated with the third pipeline.

Further, the switching device includes: a first switching valve assembly for communicating any two of the first port, the inlet of the second conduit and the outlet of the third conduit; and the second switching valve assembly is used for communicating any two of the second port and the inlet of the outlet third pipeline of the second pipeline.

Further, the first switching valve assembly comprises a first three-way valve positioned at a connecting node among the first port, the second pipeline and the third pipeline, the first three-way valve is provided with a first liquid inlet, a first liquid outlet and a first liquid inlet and outlet, the first liquid inlet is communicated with an outlet of the third pipeline, the first liquid outlet is communicated with an inlet of the second pipeline, and the first liquid inlet and outlet is communicated with the first port; or the second switching valve component comprises a second three-way valve positioned at a connecting node between the second port, the second pipeline and the third pipeline, the second three-way valve is provided with a second liquid inlet, a second liquid outlet and a second liquid inlet and outlet, the second liquid inlet is communicated with an outlet of the second pipeline, the second liquid outlet is communicated with an inlet of the third pipeline, and the second liquid inlet and outlet is communicated with the second port.

Further, the left heart simulation system also comprises a mitral stenosis valve which is arranged on the second pipeline and can adjust the opening degree, and the mitral stenosis valve is positioned between the mitral simulation valve and the left ventricle simulation assembly; or the left heart simulation system further comprises an aortic stenosis valve which is arranged on the second pipeline and can adjust the opening degree, and the aortic stenosis valve is positioned between the aortic valve simulation valve and the aortic simulation assembly; or the right heart simulation system also comprises a tricuspid stenosis valve which is arranged on the third pipeline and can adjust the opening degree, and the tricuspid stenosis valve is positioned between the tricuspid valve and the right ventricle simulation assembly; or, the right heart simulation system further comprises a pulmonary valve stenosis valve which is arranged on the third pipeline and can adjust the opening degree, and the pulmonary valve stenosis valve is positioned between the pulmonary valve simulation valve and the pulmonary artery simulation assembly.

Furthermore, the left heart simulation system also comprises a first branch and a mitral valve closing incomplete valve which is arranged on the first branch and can adjust the opening degree, one end of the first branch is communicated with an outlet of the left atrium simulation assembly, and the other end of the first branch is communicated with an inlet of the left ventricle simulation assembly; or the left heart simulation system further comprises a second branch and an aortic valve closing incomplete valve which is arranged on the second branch and can adjust the opening degree, one end of the second branch is communicated with the outlet of the left ventricle simulation assembly, and the other end of the second branch is communicated with the inlet of the aortic simulation assembly; or the right heart simulation system further comprises a third branch and a tricuspid valve closing incomplete valve which is arranged on the third branch and can adjust the opening degree, one end of the third branch is communicated with an outlet of the right atrium simulation assembly, and the other end of the third branch is communicated with an inlet of the right ventricle simulation assembly; or the right heart simulation system further comprises a fourth branch and a pulmonary valve closing incomplete valve which is arranged on the fourth branch and can adjust the opening degree, one end of the fourth branch is communicated with an outlet of the right ventricle simulation assembly, and the other end of the fourth branch is communicated with an inlet of the pulmonary artery simulation assembly.

Furthermore, the left heart simulation system also comprises a first accommodating cavity arranged on the second pipeline, and the first accommodating cavity is communicated with an inlet of the first one-way valve; or the right heart simulation system further comprises a second accommodating cavity arranged on the third pipeline, and the second accommodating cavity is communicated with an inlet of the second one-way valve.

Further, the left ventricle simulation assembly includes: a left ventricular housing defining a first receiving cavity; the left elastic ventricular sac is positioned in the first accommodating cavity, an inlet of the left elastic ventricular sac is communicated with an outlet of the mitral valve simulation valve, an outlet of the left elastic ventricular sac is communicated with an inlet of the aortic valve simulation valve, and the volume of the left elastic ventricular sac is variable; the filling piece is used for extruding the left elastic ventricular sac, and the filling piece is filled between the outer wall surface of the left elastic ventricular sac and the inner wall surface of the first accommodating cavity; the first piston is used for sealing the filling piece and the left elastic ventricular sac in the first accommodating cavity, and the first piston is movably arranged along the central line direction of the first accommodating cavity so as to extrude or release the left elastic ventricular sac.

Further, the left elastic ventricular sac is of a cylindrical structure, the cylindrical structure comprises a first sac section and a second sac section which are communicated, the inner diameter of the first sac section is larger than that of the second sac section, the inner diameter of the first sac section is gradually increased along the direction far away from the second sac section, the first sac section is communicated with an outlet of the mitral valve simulation valve, and the second sac section is communicated with an inlet of the aortic valve simulation valve.

Further, the left elastic ventricular sac is made of elastic materials such as silica gel, rubber or latex.

Further, the mitral valve simulator comprises: the elastic structure is provided with a mounting cavity and an opening communicated with the mounting cavity on one side, and a first through hole communicated with the mounting cavity is formed in the other side of the elastic structure, and the aperture of the first through hole is smaller than the inner diameter of the mounting cavity; one-way circulation structure is located elastic construction's opposite side, and one-way circulation structure has the second through-hole that can open and shut ground set up, second through-hole and first through-hole intercommunication, and the second through-hole has liquid from the open position that the left atrium simulates subassembly to the left ventricle and simulates the closed position that subassembly flows to the left atrium from the left ventricle, in order to realize the one-way flow of liquid.

Further, the mitral valve simulator also includes a support structure for supporting the resilient structure, the support structure being located within the mounting cavity and the support structure defining a plurality of flow passages in communication with the opening.

Further, one-way circulation structure is including being used for enclosing into two protruding muscle of second through-hole, and at least one side of protruding muscle is equipped with the inclined plane, and the protruding muscle has relative first end and the second end that sets up, and the first end of two protruding muscle all is connected with elastic construction, and the second end of two protruding muscle is close to each other or keeps away from to make the second through-hole close or open, hold by first end to second, and the inclined plane is close to the central line of second through-hole gradually.

Further, the left atrium simulation assembly comprises: a left atrial housing defining a second containment chamber and a first inlet and a first outlet in communication with the second containment chamber, the first inlet in communication with the outlet of the first one-way valve and the first outlet in communication with the inlet of the mitral valve simulation valve; and the second piston is connected with the left atrial shell in a sealing way, and is movably arranged along the central line direction of the second accommodating cavity.

By applying the technical scheme of the invention, the first pipeline, the left heart simulation system, the right heart simulation system and the switching device are arranged, any two pipelines of the first pipeline, the second pipeline and the third pipeline are communicated through the switching device, so that the test system for the ventricular assist device has a body circulation mode, a right heart circulation mode and a full circulation mode for simulating human blood, and the test system for the ventricular assist device can be switched among the three modes.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this application, illustrate embodiments of the invention and, together with the description, serve to explain the invention and not to limit the invention. In the drawings:

FIG. 1 illustrates a schematic structural diagram of a testing system for a ventricular assist device in accordance with an embodiment of the present invention;

FIG. 2 shows a schematic diagram of the structure of the left elastic ventricular sac of the testing system for a ventricular assist device of FIG. 1;

FIG. 3 illustrates a schematic structural view of a mitral valve simulator of the testing system for a ventricular assist device of FIG. 1;

FIG. 4 shows a schematic structural view of a support structure of the mitral valve simulation valve of FIG. 3;

FIG. 5 shows a schematic diagram of the resilient structure of the mitral valve simulator of FIG. 3;

FIG. 6 is a schematic diagram of the structure of the aorta simulation assembly of the testing system for ventricular assist devices of FIG. 1;

fig. 7 is a schematic connection diagram of the host computer, the control system, the communication system and the acquisition system of the testing system for the ventricular assist device according to the embodiment of the invention;

FIG. 8 shows a left elastic ventricular sac pressure-volume graph of an embodiment of the present invention; and

FIG. 9 shows an aortic conduit-volume graph of an embodiment of the present invention.

Wherein the figures include the following reference numerals:

1. a first switching valve assembly; 2. a first accommodating cavity; 3. a first water drain valve; 4. a first check valve; 6. an aorta simulation component; 7. a first pressure sensor; 8. a first flow meter; 9. a first resistance valve; 10. a second switching valve assembly; 11. a second water drain valve; 12. a second accommodating cavity; 13. a second one-way valve; 15. a pulmonary artery simulation component; 16. a second resistance valve; 17. a left atrium simulation assembly; 18. a second pressure sensor; 19. a directional proportional valve; 20. a mitral valve simulator valve; 21. a mitral stenosis valve; 22. mitral valve incompetence; 23. a left ventricle simulation component; 24. a left elastic ventricular sac; 241. a first bladder section; 242. a second bladder section; 25. an aortic valve simulation valve; 26. an aortic valve stenosis valve; 27. aortic valve-closing incompletion valve; 28. a left ventricular assist device; 29. a second flow meter; 32. a right atrium simulation component; 33. a tricuspid valve simulation valve; 34. a right ventricle simulation component; 35. a pulmonary valve simulation valve; 36. a right heart assist device; 37. a third flow meter; 40. a switching device; 43. a first liquid inlet; 44. a first liquid outlet; 45. a first liquid inlet and outlet; 46. a second liquid inlet; 47. a second liquid outlet; 48. a second liquid inlet and outlet; 50. a first pipeline; 53. a second pipeline; 54. a third pipeline; 61. the tricuspid stenosis valve; 62. a pulmonary valve stenosis valve; 63. tricuspid valve incompetence valve; 64. the pulmonary valve closes the incomplete valve; 71. a first accommodating chamber; 72. a first piston; 73. an elastic structure; 75. a one-way flow structure; 76. a second through hole; 77. a support structure; 78. a flow channel; 79. a rib is protruded; 80. an inclined surface; 81. a second accommodating chamber; 82. a second piston.

Detailed Description

It should be noted that the embodiments and features of the embodiments in the present application may be combined with each other without conflict. The present invention will be described in detail below with reference to the embodiments with reference to the attached drawings.

The test system for the ventricular assist device known by the inventor uses a rigid structure for simulation, for example, organic glass is used as a ventricular cavity to simulate the heartbeat through the motion of a voice coil motor, so that the systolic and diastolic phases of the heart myocardium of the natural heart cannot be reasonably simulated, and the isovolumetric contraction and the isovolumetric diastolic phases are not generated. The artery pipeline adopts a common silica gel hose, so that the artery pipeline can not simulate the tension of the blood vessel of the human body, which is far away from the actual application of the human body. The valve is also mostly applied by adopting a mechanical one-way valve, and the problems of vibration, liquid leakage, deformation and the like can be caused. And the test system is also unable to simulate valve-like conditions that most patients have.

Accordingly, as shown in FIG. 1, embodiments of the present invention provide a testing system for a ventricular assist device. The testing system for a ventricular assist device includes afirst conduit 50, a left heart simulation system, a right heart simulation system, and aswitching device 40. Wherein the first pipeline 50 has a first port and a second port arranged oppositely; the left heart simulation system comprises a second pipeline 53, and a first one-way valve 4, a left atrium simulation component 17, a mitral valve simulation valve 20, a left ventricle simulation component 23, an aortic valve simulation valve 25, an aortic simulation component 6, a first flow meter 8 and a first resistance valve 9 which are sequentially arranged on the second pipeline 53, wherein an inlet of the second pipeline 53 is connected with a first port, and an outlet of the second pipeline 53 is connected with a second port; the right heart simulation system comprises a third pipeline 54, and a second one-way valve 13, a right atrium simulation assembly 32, a tricuspid valve 33, a right ventricle simulation assembly 34, a pulmonary valve simulation valve 35, a pulmonary artery simulation assembly 15 and a second resistance valve 16 which are sequentially arranged on the third pipeline 54, wherein an inlet of the third pipeline 54 is connected with the second port, and an outlet of the third pipeline 54 is connected with the first port; the switching device 40 is configured to communicate any two of the first, second, and third lines 50, 53, and 54, so that the ventricular assist device test system has a systemic circulation mode in which the first line 50 communicates with the second line 53, a right cardiac circulation mode in which the first line 50 communicates with the third line 54, and a full circulation mode in which the second line 53 communicates with the third line 54.

In the above technical solution, by providing thefirst pipeline 50, the left heart simulation system, the right heart simulation system, and theswitching device 40, and by communicating any two of thefirst pipeline 50, thesecond pipeline 53, and thethird pipeline 54 through the switchingdevice 40, the testing system for a ventricular assist device has a systemic circulation mode, a right heart circulation mode, and a total circulation mode for simulating human blood, and the testing system for a ventricular assist device can also be switched among the above three modes, so that the testing system can simulate the testing environment of the left heart blood circulation, the right heart blood circulation, and the systemic circulation for the ventricular assist device in vitro, thereby solving the problem of single function of the extracorporeal testing system for a ventricular assist device in the prior art.

Specifically, in the embodiment of the present invention, when the testing system for a ventricular assist device is in the systemic circulation mode, thefirst pipeline 50 is communicated with thesecond pipeline 53, thefirst pipeline 50 is not communicated with thethird pipeline 54, and thesecond pipeline 53 is not communicated with thethird pipeline 54, so that the condition that human blood flows from the leftatrium simulation module 17, through the leftventricle simulation module 23, the aorta simulation module 6 and thefirst resistance valve 9, and finally flows back to the leftatrium simulation module 17 can be simulated.

Specifically, in the embodiment of the present invention, when the testing system for an auxiliary ventricular device is in the right heart circulation mode, thefirst conduit 50 is communicated with thethird conduit 54, thesecond conduit 53 is not communicated with thethird conduit 54, and thefirst conduit 50 is not communicated with thesecond conduit 53, so as to simulate the situation that human blood flows from the rightatrium simulation module 32, through the rightventricular simulation module 34, the pulmonaryartery simulation module 15 and thesecond resistance valve 16, and finally flows back to the rightatrium simulation module 32.

Specifically, in the embodiment of the present invention, when the testing system for ventricular assist devices is in the full circulation mode, thesecond pipeline 53 is communicated with thethird pipeline 54, thefirst pipeline 50 is not communicated with thethird pipeline 54, and thefirst pipeline 50 is not communicated with thesecond pipeline 53, so as to simulate the situation that human blood flows from the leftatrium simulation module 17, through the leftventricle simulation module 23, the aorta simulation module 6, thefirst resistance valve 9, the rightatrium simulation module 32, the rightventricle simulation module 34, the pulmonaryartery simulation module 15 and thesecond resistance valve 16, finally flows back to the rightatrium simulation module 32, and finally flows back to the leftatrium simulation module 17.

Preferably, in the embodiment of the present invention, thefirst resistance valve 9 and thesecond resistance valve 16 are each solenoid valves with adjustable opening degrees, so as to simulate the resistance of the human blood circulation. Preferably, the maximum Cv value of thefirst resistance valve 9 is 3.5; the maximum Cv value of thesecond resistance valve 16 is 6.5, the control signals of the second resistance valve and the second resistance valve are 4mA-20mA, and the power supply voltage is 12V-24V.

Further, the blood condition of the body circulation and the pulmonary circulation can be simulated by adjusting the opening degree of thefirst resistance valve 9 and thesecond resistance valve 16.

Preferably, in the embodiment of the present invention, the first flow meter 8 is an ultrasonic flow sensor, and the output signal is 4mA to 20mA for the real-time flow.

As shown in fig. 6, in the embodiment of the present invention, the aorta simulation module 6 and the pulmonaryartery simulation module 15 are each a tube made of an elastic material. Preferably, the soft silica gel is made, so that the aorta simulation component 6 and the pulmonaryartery simulation component 15 can perform contraction and relaxation along with the heart pulsation and pressure change, and the capacitive change of human artery and vein vessels is simulated to a great extent, so that the compliance characteristics of the aorta simulation component 6 and the pulmonaryartery simulation component 15 conform to the physiological environment of a human body.

Preferably, in order to reduce the influence of external inertia, the embodiment of the present invention adopts silicone tubes with uniformly distributed elasticity as the aortic and pulmonary artery pipelines, and fig. 9 shows the aortic pipeline-volume curve graph obtained by the test system for the ventricular assist device according to the embodiment of the present invention, and as can be seen from the comparison between the curve in the graph and the volume curve of the human artery pipeline, the compatibility of the pipeline and the human artery blood vessel is basically consistent.

Preferably, in the embodiment of the present invention, the testing system for ventricular assist devices further includes two first pressure sensors 7 respectively disposed on the aortic simulation module 6 and the pulmonaryartery simulation module 15, so that the pressure in the aortic and pulmonary artery pipelines can be detected.

As shown in fig. 1, in an embodiment of the present invention, the switchingdevice 40 includes a first switching valve assembly 1 and a secondswitching valve assembly 10. Wherein the first switching valve assembly 1 is used to communicate any two of the first port, the inlet of thesecond line 53 and the outlet of thethird line 54; the secondswitching valve assembly 10 is used to communicate any two of the second port, the outlet of thesecond conduit 53, and the inlet of thethird conduit 54.

With the above arrangement, any two of the first, second, andthird lines 50, 53, and 54 can be made to communicate with each other, so that the ventricular assist device test system can be made to have a systemic circulation mode in which thefirst line 50 and thesecond line 53 communicate with each other, a right cardiac circulation mode in which thefirst line 50 and thethird line 54 communicate with each other, and a full circulation mode in which thesecond line 53 and thethird line 54 communicate with each other, and the ventricular assist device test system can be switched among the three modes to provide a ventricular assist device with the three-mode test environments.

As shown in fig. 1, in the embodiment of the present invention, the first switching valve assembly 1 includes a first three-way valve at a connection node between the first port, thesecond pipeline 53 and thethird pipeline 54, the first three-way valve has a firstliquid inlet 43, a first liquid outlet 44 and a first liquid inlet andoutlet 45, the firstliquid inlet 43 is communicated with an outlet of thethird pipeline 54, the first liquid outlet 44 is communicated with an inlet of thesecond pipeline 53, and the first liquid inlet andoutlet 45 is communicated with the first port.

In the above-described embodiment, any two of the firstliquid inlet 43, the first liquid outlet 44, and the first liquid inlet/outlet 45 of the first three-way valve are opened, and the remaining one port is closed, so that any two of thefirst line 50, thesecond line 53, and thethird line 54 are communicated with each other, whereby the ventricular assist device test system has a body circulation mode, a right heart circulation mode, and a full circulation mode. Therefore, the testing system can simulate the testing environment of left heart blood circulation, right heart blood circulation and systemic circulation for the ventricular assist device in vitro, and the problem of functional singleness of the in-vitro testing system for the ventricular assist device in the prior art is solved.

Specifically, in the embodiment of the present invention, when the test system for a ventricular assist device is in the body circulation mode, the first liquid outlet 44 is communicated with the first liquid inlet andoutlet 45, the firstliquid inlet 43 is not communicated with the first liquid inlet andoutlet 45, and the firstliquid inlet 43 is not communicated with the first liquid outlet 44.

Specifically, in the embodiment of the present invention, when the testing system for an ventricular assist device is in the right cardiac circulation mode, the firstliquid inlet 43 is communicated with the first liquid inlet/outlet 45, the first liquid outlet 44 is not communicated with the first liquid inlet/outlet 45, and the firstliquid inlet 43 is not communicated with the first liquid outlet 44.

Specifically, in the embodiment of the present invention, when the testing system for a ventricular assist device is in the full circulation mode, the firstliquid inlet 43 is communicated with the first liquid outlet 44, the firstliquid inlet 43 is not communicated with the first liquid inlet/outlet 45, and the first liquid outlet 44 is not communicated with the first liquid inlet/outlet 45.

Of course, in an alternative embodiment not shown in the drawings, the first switching valve assembly 1 may be three two-way valves, and the three two-way valves are respectively disposed on the first, second andthird pipelines 50, 53 and 54, so that any two of the first, second andthird pipelines 50, 53 and 54 can be communicated by controlling the opening and closing of the three two-way valves.

In the embodiment of the present invention shown in fig. 1, the secondswitching valve assembly 10 comprises a second three-way valve located at the connection point between the second port, thesecond pipeline 53 and thethird pipeline 54, the second three-way valve having asecond inlet 46, asecond outlet 47 and a second inlet andoutlet 48, thesecond inlet 46 communicating with the outlet of thesecond pipeline 53, thesecond outlet 47 communicating with the inlet of thethird pipeline 54, and the second inlet andoutlet 48 communicating with the second port.

In the above-described embodiment, any two of the secondliquid inlet port 46, the secondliquid outlet port 47, and the second liquid inlet/outlet port 48 of the second three-way valve are opened, and the remaining one port is closed, so that any two of thefirst line 50, thesecond line 53, and thethird line 54 are communicated with each other, whereby the ventricular assist device test system has a body circulation mode, a right heart circulation mode, and a full circulation mode. Therefore, the testing system can simulate the testing environment of left heart blood circulation, right heart blood circulation and systemic circulation for the ventricular assist device in vitro, and the problem of functional singleness of the in-vitro testing system for the ventricular assist device in the prior art is solved.

Specifically, in the embodiment of the present invention, when the test system for a ventricular assist device is in the body circulation mode, the secondliquid inlet 46 and the second liquid inlet/outlet 48 are communicated, the secondliquid inlet 46 and the secondliquid outlet 47 are not communicated, and the secondliquid outlet 47 and the second liquid inlet/outlet 48 are not communicated.

Specifically, in the embodiment of the present invention, when the testing system for an ventricular assist device is in the right cardiac circulation mode, the secondliquid outlet 47 is communicated with the second liquid inlet/outlet 48, the secondliquid inlet 46 is not communicated with the second liquid inlet/outlet 48, and the secondliquid inlet 46 is not communicated with the secondliquid outlet 47.

Specifically, in the embodiment of the present invention, when the testing system for a ventricular assist device is in the full circulation mode, the secondliquid inlet 46 and the secondliquid outlet 47 are communicated, the secondliquid inlet 46 and the second liquid inlet/outlet 48 are not communicated, and the secondliquid outlet 47 and the second liquid inlet/outlet 48 are not communicated.

Of course, in an alternative embodiment not shown in the drawings, the secondswitching valve assembly 10 may also be three two-way valves, and the three two-way valves are respectively disposed on thefirst pipeline 50, thesecond pipeline 53 and thethird pipeline 54, so that any two pipelines of thefirst pipeline 50, thesecond pipeline 53 and thethird pipeline 54 can be communicated by controlling the opening and closing of the three two-way valves.

It should be noted that, in the embodiment of the present invention, both the first three-way valve and the second three-way valve can be manually adjusted, so that the tester can conveniently switch the body circulation mode, the right heart circulation mode, and the full circulation mode.

As shown in fig. 1, in the embodiment of the present invention, the left heart simulation system further includes amitral stenosis valve 21 disposed on thesecond pipeline 53 and capable of adjusting the opening degree, and themitral stenosis valve 21 is located between themitral simulation valve 20 and the leftventricle simulation module 23.

Through the arrangement, the blood circulation condition of a patient suffering from the disease of mitral stenosis can be simulated, and the conditions with different degrees of mitral valve opening can be simulated by adjusting the opening degree of themitral stenosis valve 21, so that the ventricular assist device can be detected under different conditions.

In the embodiment of the present invention, as shown in fig. 1, the left heart simulation system further includes an aortic stenosis valve 26 disposed on thesecond conduit 53 and capable of adjusting the opening degree, and the aortic stenosis valve 26 is located between the aorticvalve simulation valve 25 and the aortic simulation assembly 6.

Through the arrangement, the blood circulation condition of a patient suffering from the disease of aortic stenosis can be simulated, and the conditions with different degrees of aortic valve openness can be simulated by adjusting the opening degree of the aortic stenosis valve 26, so that the ventricular assist device can be detected under different conditions.

In an embodiment of the present invention, as shown in fig. 1, the right heart simulating system further includes atricuspid stenosis valve 61 disposed on thethird conduit 54 and capable of adjusting the opening degree, wherein thetricuspid stenosis valve 61 is located between the tricuspidvalve simulating valve 33 and the rightventricle simulating assembly 34.

Through the arrangement, the blood circulation condition of a patient suffering from the tricuspid stenosis can be simulated, and the conditions with different tricuspid valve opening degrees can be simulated by adjusting the opening degree of thetricuspid stenosis valve 61, so that the ventricular assist device can be detected under different conditions.

As shown in fig. 1, in the embodiment of the present invention, the right heart simulation system further includes a pulmonaryvalve stenosis valve 62 disposed on thethird conduit 54 and capable of adjusting the opening degree, and the pulmonaryvalve stenosis valve 62 is located between the pulmonaryvalve simulation valve 35 and the pulmonaryartery simulation assembly 15.

With the above arrangement, the blood circulation condition of the patient suffering from the disease of the pulmonary valve stenosis can be simulated, and the condition with different degrees of opening of the pulmonary valve can be simulated by adjusting the opening degree of the pulmonaryvalve stenosis valve 62, so that the ventricular assist device can be detected under different conditions.

In the embodiment of the present invention, the test system for a ventricular assist device is not limited to the simulation of the type of disease in mitral stenosis, aortic stenosis, tricuspid stenosis, and pulmonary stenosis of a patient, and may simulate one or more of the above diseases.

In the embodiment of the present invention, as shown in fig. 1, the left heart simulating system further includes a first branch and a mitral valveclosure incompetence valve 22 capable of adjusting the degree of opening, the first branch has one end communicating with the outlet of the leftatrium simulating assembly 17 and the other end communicating with the inlet of the leftventricle simulating assembly 23.

By the arrangement, the blood circulation condition of the patient suffering from the disease of mitral insufficiency can be simulated, and the conditions of different degrees of mitral insufficiency can be simulated by adjusting the opening of themitral insufficiency valve 22 under the condition of mitral insufficiency, so that the ventricular assist device can be detected under different conditions.

In the embodiment of the present invention, as shown in fig. 1, the left heart simulation system further includes a second branch and an aortic valve closingnon-complete valve 27 capable of adjusting the opening degree, the second branch is disposed on the second branch, one end of the second branch is communicated with the outlet of the leftventricle simulation module 23, and the other end of the second branch is communicated with the inlet of the aortic simulation module 6.

Through the arrangement, the blood circulation condition of a patient suffering from the disease of incomplete aortic valve closure can be simulated, and different degrees of conditions of aortic valve closure can be simulated by adjusting the opening degree of the incomplete aorticvalve closure valve 27 under the condition of aortic valve closure, so that the ventricular assist device can be detected under different conditions.

In the embodiment of the present invention, as shown in fig. 1, the right heart simulating system further includes a third branch and a tricuspid valve closingincompetence valve 63 capable of adjusting the opening degree, the third branch has one end communicating with the outlet of the rightatrium simulating assembly 32, and the other end communicating with the inlet of the rightventricle simulating assembly 34.

Through the arrangement, the blood circulation condition of a patient suffering from the disease of tricuspid valve insufficiency can be simulated, and different degrees of conditions of tricuspid valve closure can be simulated by adjusting the opening degree of the tricuspidvalve incompetence valve 63 under the condition of tricuspid valve closure, so that the ventricular assist device can be detected under different conditions.

In the embodiment of the present invention, as shown in fig. 1, the right heart simulation system further includes a fourth branch and a pulmonary valve closingnon-full valve 64 capable of adjusting the opening degree, the fourth branch has one end communicating with the outlet of the rightventricle simulation module 34 and the other end communicating with the inlet of the pulmonaryartery simulation module 15.

With the above arrangement, the blood circulation condition of the patient suffering from the disease of incomplete closing of the pulmonary valve can be simulated, and different degrees of conditions of closing of the pulmonary valve can be simulated by adjusting the opening degree of theincomplete closing valve 64 of the pulmonary valve under the condition of closing of the pulmonary valve, so that the ventricular assist device can be detected under different conditions.

In the embodiment of the present invention, the test system for a ventricular assist device is not limited to the simulation of the type of disease in patients with mitral insufficiency, aortic insufficiency, tricuspid insufficiency, and pulmonary insufficiency, and may simulate one or more of the above diseases.

Preferably, in the embodiment of the present invention, themitral stenosis valve 21, the aortic stenosis valve 26, thetricuspid stenosis valve 61, thepulmonary stenosis valve 62, the mitral valve-closingincompetence valve 22, the aortic valve-closingincompetence valve 27, the tricuspid valve-closingincompetence valve 63, and the pulmonary valve-closingincompetence valve 64 are all throttles or micro-adjustment valves with scales, and the opening degrees thereof can be manually adjusted to simulate corresponding valvular diseases with different degrees.

As shown in fig. 1, in the embodiment of the present invention, the left heart simulation system further includes a first accommodating chamber 2 disposed on thesecond pipeline 53, and the first accommodating chamber 2 is communicated with an inlet of the first check valve 4.

Through the setting, the main vein pressure can be adjusted by adjusting the liquid level of the first accommodating cavity 2, so that the change of the flow in the blood circulation process can be simulated to cause the change of the liquid level of the main vein cavity, and the compatibility of the main vein of a human body can be simulated.

Preferably, in the embodiment of the present invention, the first accommodating cavity 2 is a cavity of an open plexiglas container.

Preferably, in the embodiment of the present invention, the left heart simulation system further includes a first water drain valve 3 connected to the first receiving chamber 2, so that when the circulation loop is used and needs to be cleaned, liquid can be drained through the first water drain valve 3.

As shown in fig. 1, in the embodiment of the present invention, the right heart simulation system further includes asecond receiving chamber 12 disposed on thethird pipeline 54, and the second receivingchamber 12 is communicated with the inlet of thesecond check valve 13.

Through the arrangement, the pulmonary vein pressure can be adjusted by adjusting the liquid level of the secondaccommodating cavity 12, so that the change of the liquid level of the pulmonary vein cavity caused by the change of the flow in the blood circulation process can be simulated, and the compatibility of the pulmonary vein of a human body can be simulated.

Preferably, in the embodiment of the present invention, the secondaccommodating cavity 12 is a cavity of an open plexiglas container.

Preferably, in the embodiment of the present invention, the right heart simulation system further includes a secondwater drain valve 11 connected to the second receivingchamber 12, so that the liquid can be drained through the secondwater drain valve 11 when the circulation loop needs to be cleaned after being used.

Specifically, in the embodiment of the present invention, the left heart simulation system further includes a first branch, and a left ventricleauxiliary device 28 and asecond flowmeter 29 which are arranged on the first branch, one end of the first branch is communicated with the outlet of the leftventricle simulation assembly 23, and the other end of the first branch is communicated with the inlet of the aorta simulation assembly 6; the right heart simulation system further comprises a second branch, and a right heart assistdevice 36 and athird flow meter 37 which are arranged on the second branch, wherein one end of the second branch is communicated with an outlet of the rightventricle simulation assembly 34, and the other end of the second branch is communicated with an inlet of the pulmonaryartery simulation assembly 15, so that the left ventricle assistdevice 28 and the right heart assistdevice 36 can be tested.

As shown in fig. 1 and 2, in an embodiment of the present invention, the leftventricular simulator assembly 23 includes a left ventricular housing, a leftelastomeric ventricular sac 24, a filler member, and afirst piston 72. Wherein the left ventricular housing defines a first receivingchamber 71; the leftelastic ventricular sac 24 is positioned in the first accommodatingcavity 71, the inlet of the leftelastic ventricular sac 24 is communicated with the outlet of the mitralvalve simulation valve 20, the outlet of the leftelastic ventricular sac 24 is communicated with the inlet of the aorticvalve simulation valve 25, and the volume of the leftelastic ventricular sac 24 is variable; the filling member is used for extruding the leftelastic ventricular sac 24, and the space between the outer wall surface of the leftelastic ventricular sac 24 and the inner wall surface of the first accommodatingcavity 71 is filled with the filling member; thefirst piston 72 is used to enclose the filler and the leftelastic ventricular sac 24 in thefirst accommodation chamber 71, and thefirst piston 72 is movably disposed in the direction of the center line of thefirst accommodation chamber 71 to compress or release the leftelastic ventricular sac 24.

In the above technical solution, the leftelastic ventricular sac 24 is used to simulate the heart of a human body, and when thefirst piston 72 pressurizes or depressurizes the firstaccommodating chamber 71, the filling member located at the periphery of the leftelastic ventricular sac 24 extrudes or releases the leftelastic ventricular sac 24, so that the leftventricular simulation assembly 23 better conforms to the characteristics of the human body, and further the ventricular model better conforms to the reality of the human body.

Preferably, in the embodiment of the present invention, the filling member is a liquid, that is, a space between the outer wall surface of the leftelastic ventricular sac 24 and the inner wall surface of the firstaccommodating chamber 71 is filled with the liquid, so that when thefirst piston 72 pressurizes or depressurizes the firstaccommodating chamber 71, the pressure of the liquid at the periphery of the leftelastic ventricular sac 24 increases or decreases, thereby squeezing or releasing the leftelastic ventricular sac 24, and further conforming the leftventricular simulator assembly 23 to the human body.

Specifically, in the embodiment of the present invention, the pressure rise outside the leftelastic ventricular sac 24 is the contraction process of the ventricle, the fluid in the cardiac sac is ejected and enters the aortic simulation assembly 6 through the aorticvalve simulation valve 25, due to the characteristics of aortic compliance, a part of the fluid is temporarily stored in the aortic simulation assembly 6, and the other part of the fluid enters the secondaccommodating chamber 12 from thefirst resistance valve 9 after the circulation flow rate is measured by the first flow meter 8.

Preferably, in an embodiment of the invention, the left ventricular housing is made of plexiglas.

As shown in fig. 1 and 2, in the embodiment of the present invention, the leftelastic ventricular balloon 24 is a cylindrical structure, and the cylindrical structure includes afirst balloon segment 241 and asecond balloon segment 242 which are communicated with each other, the inner diameter of thefirst balloon segment 241 is larger than that of thesecond balloon segment 242, and the inner diameter of thefirst balloon segment 241 is gradually increased along the direction away from thesecond balloon segment 242, wherein thefirst balloon segment 241 is communicated with the outlet of the mitralvalve simulation valve 20, and thesecond balloon segment 242 is communicated with the inlet of the aorticvalve simulation valve 25.

With the above arrangement, the leftelastic ventricular sac 24 can simulate the true shape of the ventricle of the human body, thereby making the leftventricular simulation module 23 more realistic with the human body.

Preferably, in the embodiment of the present invention, the leftelastic ventricular sac 24 is made of an elastic material such as silicone rubber, rubber or latex. More preferably, the leftelastomeric ventricular sac 24 is injection molded from silicone rubber of varying hardness. Thus, the leftelastic ventricular sac 24 can simulate the compliance characteristic of the ventricle and act as a limit to the ventricular volume, the stiffness of the ventricle is very small and basically unchanged within the normal operating range of the ventricle, and when the ventricular sac contracts or expands to a certain value, the stiffness of the ventricle is rapidly increased, so that the pressure in the first accommodatingcavity 71 cannot enable the ventricle to continue to contract or expand, and the phenomenon that the ventricular volume is too large or too small is avoided, so that the ventricular model is more consistent with the reality of the human body.

As shown in fig. 2, the opposite ends of the leftelastic ventricular sac 24 are both provided with a connecting flange, that is, one end of thefirst sac section 241 is provided with a connecting flange, one end of thesecond sac section 242 is also provided with a connecting flange, and both the connecting flanges are connected with the inner wall surface of the first accommodatingcavity 71, so that the leftelastic ventricular sac 24 can be more firmly connected with the left ventricular shell.

Specifically, as shown in fig. 1, in the embodiment of the present invention, the leftventricle simulation module 23 simulates the contraction and relaxation processes of the heart in a pneumatic driving manner, the left ventricle housing further defines a third accommodating cavity, the third accommodating cavity and the first accommodatingcavity 71 are respectively located at two opposite sides of thefirst piston 72, the testing system for ventricular assist devices further includes an air compressor for supplying air to the third accommodating cavity and a vacuum pump for exhausting air, and a directionalproportional valve 19 disposed at an inlet of the third accommodating cavity, the directionalproportional valve 19 is respectively communicated with an exhaust port of the vacuum pump, an outlet of the air compressor, and an inlet of the third accommodating cavity, so that the third accommodating cavity can be inflated or exhausted in a reversing manner through the directionalproportional valve 19 to control the movement of thefirst piston 72, thereby controlling the pressure in the first accommodatingcavity 71, and the pressure change in the first accommodatingcavity 71 can squeeze or release the leftelastic ventricle 24, so that the contraction or relaxation of the ventricles can be simulated.

Preferably, in the embodiment of the invention, during inflation, an air compressor is used for inflating compressed air with gauge pressure of 0.5bar so as to realize rapid contraction, and during exhaust, a vacuum pump is used for realizing rapid relaxation at negative pressure of-0.3 bar.

Preferably, in the embodiment of the present invention, the standard rated flow of the directionalproportional valve 19 is 350L/min, the output analog signal is set to be 4mA-20mA, the power supply voltage is 17V-30V, and the highest frequency is 100 Hz.

Preferably, in the embodiment of the invention, the vacuum pump is a primary microcomputer double-head vacuum pump, the model is 1500D, the vacuum degree range reaches 0MPa to-0.093 MPa, the power is 3000W, and the flow rate is 12.8L/min under the condition of-0.08 MPa.

Preferably, in the embodiment of the invention, the maximum pressure of the air compressor is 0.7 MPa.

Preferably, in the embodiment of the invention, in order to control the pressure of the air compressor and the vacuum pump, a vacuum pressure reducing valve is arranged in the gas pipeline, the air is an air F.R.L combined triplet, the pressure range is set to be-100 kPa-1.3kPa, and the maximum flow is 240L/min.

Specifically, as shown in fig. 1 and 8, in the embodiment of the present invention, the testing system for ventricular assist devices further includes asecond pressure sensor 18 for detecting the pressure of the leftelastic ventricular sac 24, and the third accommodating chamber is formed with a pressure closed-loop control by using the directionalproportional valve 19 and thesecond pressure sensor 18 to achieve precise pressure control, which conforms to the Frangk-training mechanism, and the pressure formula is as follows:

wherein:

P_vventricular pressure (mmHg), the pressure within the leftelastic ventricular sac 24, is measured at pressure points within the sac to measure intracardiac real-time pressure;

V_vis the volume of the ventricle, and is expressed by ml, namely the volume of the first accommodating cavity;

E_max，vmaximum elasticity during ventricular contraction, unit mmHg/ml;

phi (t) is the ventricular activation function; v_u，v、P_0，v、K_E，v、K_E、K_vAre all constant parameters.

In the embodiment of the present invention, in the pressure/volume function, the ratio coefficient K of the volume to the contraction force influence in the Frangk-training mechanism is set_EAnd K_VCan be adjusted by adjusting K_EAnd K_VTo achieve the effect of ventricular volume on ventricular contractility. When it is assumed that the ventricular volume is fully functional, K is set_E＝0，K_V1 is ═ 1; when ventricular contractility is specified, i.e. setting K_EConstant, K_V＝0。

Preferably, in the embodiment of the invention, the range of the pressure sensor selected for the analog blood circulation loop is-20 kPa-40kPa, the output signal is 2mA-20mA, and the power supply voltage is 12V-30V.

It is to be noted that the inventionIn an embodiment, the testing system for ventricular assist devices further comprises a displacement sensor and a foam float located in the first receivingchamber 71, the ventricular volume V_VObtained by a displacement sensor, a magnetic ring of the displacement sensor is placed on a foam floater of the liquid level in the first accommodatingcavity 71, so that the magnetic ring floats up and down along with the change of the liquid level, and the volume V of the ventricle can be calculated_VReal-time changes in time.

Preferably, in the embodiment of the invention, the effective stroke of the displacement sensor is 125mm, a standard magnetic ring with the diameter of 33mm is matched, the output analog current is 4mA-20mA, and the power supply voltage is 24V.

It should be noted that in the embodiment of the present invention, the structure of the rightventricle simulation assembly 34 is the same as that of the leftventricle simulation assembly 23, and the description thereof is omitted.

Fig. 8 shows a pressure-volume curve of the left elastic ventricular sac obtained by a structural test using the leftventricular simulator assembly 23 of the present application, and it can be seen from the above curve that the leftventricular simulator assembly 23 of the present embodiment can maximally simulate the contraction and relaxation of the myocardium of a human heart.

As shown in fig. 3 and 5, in an embodiment of the present invention, the mitralvalve simulation valve 20 includes aresilient structure 73 and a one-way flow structure 75. Wherein, one side of theelastic structure 73 is provided with a mounting cavity and an opening communicated with the mounting cavity, the other side of theelastic structure 73 is provided with a first through hole communicated with the mounting cavity, and the aperture of the first through hole is smaller than the inner diameter of the mounting cavity; the one-way flow structure 75 is located on the other side of theelastic structure 73, the one-way flow structure 75 has a second throughhole 76 that is openably and closably disposed, the second throughhole 76 is communicated with the first through hole, and the second throughhole 76 has an open position where the liquid flows from the leftatrium simulation member 17 to the leftventricle simulation member 23 and a closed position where the liquid is prevented from flowing from the leftventricle simulation member 23 to the leftatrium simulation member 17, so as to realize the one-way flow of the liquid.

With the above arrangement, the blood flowing out of the leftatrium simulation module 17 flows into the mitralvalve simulation valve 20 through the opening, flows out of the mitralvalve simulation valve 20 through the second throughhole 76, and flows into the leftventricle simulation module 23, and the liquid can be prevented from flowing from the leftventricle simulation module 23 to the leftatrium simulation module 17, so that the unidirectional flow of the blood in the body can be simulated; further, theelastic structure 73 has certain elasticity, and can absorb certain pressure impact while satisfying the function of the check valve, so that the problems of leakage, deformation, vibration and the like which easily occur to a mechanical valve can be avoided.

Preferably, in the embodiment of the present invention, theelastic structure 73 is made of silicone, and since the silicone is soft and has a certain elasticity, a certain pressure impact can be absorbed while a single valve function is satisfied.

As shown in fig. 3 and 4, in an embodiment of the invention, themitral valve simulator 20 further comprises asupport structure 77 for supporting theresilient structure 73, thesupport structure 77 being located within the mounting cavity, and thesupport structure 77 defining a plurality offlow passages 78 in communication with the openings.

Through the arrangement, the supportingstructure 77 can support theelastic structure 73, and theelastic structure 73 can be matched with the inner wall surface of the pipeline, so that theelastic structure 73 can be prevented from leaking due to impact deformation of liquid pressure, and the existence of a constant volume period in the working cycle of a ventricle can be further ensured.

In the embodiment of the present invention, as shown in fig. 4, the supportingstructure 77 includes a plurality of supporting rings and connecting ribs for connecting the supporting rings, which are spaced from each other from the inside to the outside, so that the spaces between the supporting rings form theflow passages 78 to facilitate the flow of the liquid.

As shown in fig. 3 and 5, in the embodiment of the present invention, the one-way flow structure 75 includes tworibs 79 for enclosing the second throughhole 76, at least one side of therib 79 is provided with aninclined surface 80, therib 79 has a first end and a second end which are oppositely arranged, the first ends of the tworibs 79 are both connected with theelastic structure 73, the second ends of the tworibs 79 are close to or far away from each other, so that the second throughhole 76 is closed or opened, and theinclined surface 80 is gradually close to the center line of the second throughhole 76 from the first end to the second end.

With the above arrangement, when the inlet pressure of themitral valve simulator 20 is greater than the outlet pressure, the second ends of the tworibs 79 move away from each other to open the second through-hole 76; when the outlet pressure of themitral valve simulator 20 is greater than or equal to the inlet pressure, the second ends of the tworibs 79 will approach each other to close the second throughhole 76 due to the pressure of the outlet and theinclined surface 80 on at least one side of theribs 79, so that the unidirectional flow of blood in the body can be simulated.

It should be noted that, in the embodiment of the present invention, theaortic valve simulator 25, thetricuspid valve simulator 33, and thepulmonary valve simulator 35 are all the same as themitral valve simulator 20 in structure, and are not described herein again.

As shown in FIG. 1, in an embodiment of the present invention, leftatrial simulation assembly 17 includes a left atrial housing and asecond piston 82. Wherein the left atrial housing defines asecond receiving chamber 81 and a first inlet and a first outlet in communication with the second receivingchamber 81, the first inlet being in communication with the outlet of the first one-way valve 4 and the first outlet being in communication with the inlet of the mitralvalve simulation valve 20; thesecond piston 82 is connected to the left atrial casing in a sealing manner, and thesecond piston 82 is disposed movably in the direction of the center line of the secondaccommodating chamber 81.

In the above technical solution, the left atrium of the human body is better simulated by arranging thesecond piston 82, so that the leftatrium simulation assembly 17 better conforms to the human body characteristics, and further the atrium model is more actually conformed to the human body.

Preferably, in an embodiment of the invention, the left atrial housing is made of plexiglass.

It should be noted that in the embodiments of the present invention, since the atrial pressure is low, the elastic bag is not added for the volume limitation.

Preferably, in an embodiment of the present invention, leftatrium simulation module 17 also drivessecond piston 82 pneumatically, and utilizes a proportional directional valve and a pressure transducer to achieve closed loop control of pressure.

It should be noted that in the embodiment of the present invention, the structure of rightatrium simulation module 32 is the same as the structure of leftatrium simulation module 17, and thus, the detailed description thereof is omitted.

In an embodiment of the present invention, as shown in fig. 7, the testing system for ventricular assist devices further comprises a control system, and the first resistance valve 9 (i.e. the solenoid valve in fig. 7) and the second resistance valve 16 (i.e. the solenoid valve in fig. 7) are connected to the control system, so that the control system can control the opening degree of thefirst resistance valve 9 and thesecond resistance valve 16, thereby simulating the blood condition when the resistance of the systemic circulation and the full circulation changes.

As shown in fig. 7, in the embodiment of the present invention, the testing system for a ventricular assist device further includes an upper computer, and a communication system and an acquisition system connected to the upper computer, where the communication system and the acquisition system are both connected to the control system (the control system is not directly connected to the upper computer). The pressure sensor, the temperature sensor, the displacement sensor and the flow sensor are all connected with the acquisition system, so that the pressure sensor is used for acquiring the pressure in the ventricular cavity, the atrial cavity, the aorta and the pulmonary artery, the displacement sensor can also be used for acquiring the volume of the ventricular cavity and the atrial cavity, the flow sensor can also be used for acquiring the flow of the ventricular auxiliary device and the aorta, and the flow is acquired and transmitted back to the upper computer system to form a corresponding numerical value or curve for analysis; the air compressor, the vacuum pump and the reversing proportional valve are all connected with the control system, so that the control system can control the valve to act and can also control the action of the air compressor and the vacuum pump, and the beating of the heart can be simulated; the communication system is connected with the heart auxiliary device, so that signals of the heart auxiliary device can be transmitted to the upper computer for processing, and testers can conveniently know test results.

Specifically, in the embodiment of the invention, the communication system and the acquisition system are connected with the control system, the command sent by the upper computer is transmitted to the control system through the communication system, then the control system controls the corresponding hardware equipment, and the result is transmitted back to the upper computer system through the communication system; the acquisition system transmits acquired information to the upper computer and the control system, so that the control system can conveniently control corresponding hardware equipment according to the sensor result and feed back the result. Furthermore, the acquisition system is connected with the control system, so that the acquisition system can transmit acquired signals to the control system, and then the control system controls the vacuum pump, the air compressor, the reversing proportional valve and the electromagnetic valve, thereby realizing closed-loop control of the test system and improving the test precision.

In particular, in embodiments of the present invention, the communication system is coupled to the control system such that the communication system can communicate signals from the ventricular assist device to the control system. The communication system can transmit the information of the artificial heart back to the upper computer and can also transmit the command sent by the upper computer to the artificial heart and control the artificial heart. Meanwhile, the communication system can also send the command of the upper computer to the control system to control the hardware equipment, and simultaneously, the current working parameters of the hardware equipment are transmitted back to the upper computer.

It should be noted that, in the embodiment of the present invention, the upper computer system is based on a Windows operating system, and is programmed by using LabVIEW software developed by national instruments and companies in the united states, so as to implement a human-computer interface function. The LabVIEW program is used for generating application software of a human blood circulation test bed, and an operator can complete the functions of parameter setting, test operation, data processing, command issuing and the like by using the application software. The main interface of the application software is a main functional window of man-machine interaction, and the hardware equipment control, data acquisition and other work are completed according to the main functional window.

In the embodiment of the present invention, the control system connected to the upper computer is a PXI controller, the acquisition system is an NI data acquisition card, and the communication system communicates with the communication system through an ethernet.

It should be noted that, in the embodiment of the present invention, the main power switch needs to be turned on before the experiment starts, the vacuum pump automatically turns on the power at this time, then the air compressor valve is manually turned on, and then the computer enters the software operation interface.

It should be noted that the test system for the ventricular assist device in the embodiment of the present invention not only can greatly simulate the normal human environment, but also can complete the simulation of the left and right heart failure and adjust the degree of the heart failure; the method can also be used for simulating the blood circulation condition in the states of incomplete valve closure, ventricular septal defect, systemic circulation, pulmonary circulation resistance change and the like, evaluating the performance of the artificial heart by recording and analyzing data under various conditions, simulating the physiological state of a patient implanted with the artificial heart and the hemodynamic environment under various diseases, and sufficiently and effectively providing guidance for clinical work.

The following are the simulation of the normal physiological environment of the human body, the simulation of the physiological condition of the heart failure patient, and the simulation of the bi-cardiac assist physiological state by the test system for the ventricular assist device.

Firstly, the invention is used for carrying out a human body normal physiological environment simulation experiment:

electrifying a test system for the ventricular assist device, opening an air source main switch, positioning a pressure reducing valve at the vacuum air source at the outlet of a vacuum pump, setting the pressure to be-40 KPa, positioning the pressure reducing valve at the compressed air source below a test bed, and setting the pressure to be 0.05 Mpa; operating application software of a human body blood circulation test bed; switching to full-cycle mode by means of switching means 40; then the prepared blood simulation liquid is added into the first containing cavity 2, or simultaneously added into the second containingcavity 12, and the adding amount of the simulation blood is based on the standard scale of the capacitive cavity.

The circulation circuit is then emptied of air, a quantity of pure water is added to thefirst housing chamber 71 of the left ventricle and to the housing chamber of the right ventricle, on the basis of the standard scale, and the housing chambers are closed. The mitral valve and the tricuspid valve are closed, and the mitral stenosis valve and the tricuspid stenosis valve are ensured to be in the maximum open state. The aortic and pulmonary stenosis valves are rotated to maximum, leaving the aortic and pulmonary incompetence valves in a closed state.

Finally, setting the normal human body parameter values by operating software includes, but is not limited to, the following: heart rate, myocardial contractility coefficient E, cardiac output, opening of pulmonary circulatory resistance, opening of systemic circulatory resistance, and the like. After parameter setting is completed, an experiment is started, various data such as atrial pressure, ventricular pressure, aortic pressure, pulmonary artery pressure, aortic flow, pulmonary artery flow, anterior and posterior pressures of an artificial heart, a left and right ventricular pressure-volume closed loop curve and the like of the left and right heart can be collected, and data storage and derivation are completed for analysis.

The simulated blood is generally based on a 1:2.3 aqueous glycerol solution, and the viscosity and the characteristics of the fluid are similar to those of human blood.

Secondly, simulating the physiological condition of the heart failure patient by the invention:

the former operation is consistent with the simulation experiment of the normal physiological environment of the human body. Heart failure refers to the failure of the systolic or diastolic function of the heart, and during the occurrence of heart failure, the contractile ability is greatly reduced, which lowers the blood pumping function. The system simulates heart failure by reducing the value of the myocardial contractility coefficient E, and other parameters are unchanged. After the artificial heart is installed, the treatment effect of the heart failure patient can be tested, the change of the physiological state of the patient after the artificial heart is implanted can be simulated, the performance of the blood pump can be tested, and the like, so that the knowledge of the clinical medicine can be provided.

Thirdly, the invention simulates the bixin auxiliary physiological state:

biventricular assist is a research focus of the current medical community, namely, the implantation of artificial hearts in both the left and right heart of a patient to maintain the life of the patient. Most simulated circulation systems either cannot perform the experiment or collect too single data, so the significance is not large. In the invention, after artificial hearts are arranged in the left heart circulation loop and the right heart circulation loop, experimental parameters are set, so that the collection of various parameters can be realized, and the physiological state after the artificial hearts are implanted into the double artificial hearts can be fully simulated.

In addition, the invention can also simulate the physiological state of patients with valvular diseases by adjusting the mitral valve, the tricuspid valve, the aortic valve, the pulmonary valve incompetence valve and the stenotic valve, and the physiological state of the patients with the diseases after being implanted into the artificial heart. Judging the interaction between the implanted artificial heart and the physiology of the patient; simulation of aortic and pulmonary artery compliance changes, simulation of systemic and pulmonary circulatory resistance changes, and simulation of ventricular septal defects can also be performed.

It should be noted that the testing system for ventricular assist devices according to the embodiments of the present invention can cover substantially all of the main physiological features and functions of the human body in the blood circulation process.

From the above description, it can be seen that the above-described embodiments of the present invention achieve the following technical effects: the test system for the ventricular assist device has the advantages that the first pipeline, the left heart simulation system, the right heart simulation system and the switching device are arranged, any two pipelines of the first pipeline, the second pipeline and the third pipeline are communicated through the switching device, so that the test system for the ventricular assist device has a body circulation mode, a right heart circulation mode and a full circulation mode for simulating human blood, and the test system for the ventricular assist device can be switched among the three modes.

The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (13)

1. A testing system for a ventricular assist device, comprising:

a first conduit (50) having first and second oppositely disposed ports;

the left heart simulation system comprises a second pipeline (53), and a first one-way valve (4), a left atrium simulation component (17), a mitral valve simulation valve (20), a left ventricle simulation component (23), an aortic valve simulation valve (25), an aortic simulation component (6), a first flowmeter (8) and a first resistance valve (9) which are sequentially arranged on the second pipeline (53), wherein an inlet of the second pipeline (53) is connected with the first port, and an outlet of the second pipeline (53) is connected with the second port;

the right heart simulation system comprises a third pipeline (54), and a second one-way valve (13), a right atrium simulation assembly (32), a tricuspid valve simulation valve (33), a right ventricle simulation assembly (34), a pulmonary valve simulation valve (35), a pulmonary artery simulation assembly (15) and a second resistance valve (16) which are sequentially arranged on the third pipeline (54), wherein an inlet of the third pipeline (54) is connected with the second port, and an outlet of the third pipeline (54) is connected with the first port;

a switching device (40) for communicating any two of the first, second and third lines (50, 53, 54) to provide the ventricular assist device testing system with a systemic circulation mode in which the first line (50) communicates with the second line (53), a right systemic circulation mode in which the first line (50) communicates with the third line (54), and a full circulation mode in which the second and third lines (53, 54) communicate.

2. A testing system for ventricular assist devices as claimed in claim 1, characterized in that the switching device (40) comprises:

a first switching valve assembly (1) for putting any two of the first port, an inlet of the second line (53) and an outlet of the third line (54) into communication;

a second switching valve assembly (10) for communicating any two of the second port, the outlet of the second conduit (53), and the inlet of the third conduit (54).

3. A testing system for ventricular assist devices according to claim 2, characterized in that the first switching valve assembly (1) comprises a first three-way valve at the junction between the first port, the second tubing (53) and the third tubing (54), the first three-way valve having a first inlet port (43), a first outlet port (44) and a first inlet and outlet port (45), the first inlet port (43) communicating with an outlet of the third tubing (54), the first outlet port (44) communicating with an inlet of the second tubing (53), the first inlet and outlet port (45) communicating with the first port; or,

the second switching valve assembly (10) comprises a second three-way valve at a junction between the second port, the second line (53) and the third line (54), the second three-way valve having a second inlet (46), a second outlet (47) and a second inlet and outlet (48), the second inlet (46) communicating with an outlet of the second line (53), the second outlet (47) communicating with an inlet of the third line (54), the second inlet and outlet (48) communicating with the second port.

4. A testing system for ventricular assist devices according to any one of claims 1 to 3, characterized in that the left heart simulating system further comprises a mitral stenosis valve (21) disposed on the second conduit (53) and adjustable in opening, the mitral stenosis valve (21) being located between the mitral valve simulating valve (20) and the left ventricular simulating assembly (23); or,

the left heart simulation system further comprises an aortic stenosis valve (26) which is arranged on the second pipeline (53) and can adjust the opening degree, and the aortic stenosis valve (26) is positioned between the aortic valve simulation valve (25) and the aortic simulation component (6); or,

the right heart simulation system further comprises a tricuspid stenosis valve (61) disposed on the third conduit (54) and adjustable in opening, the tricuspid stenosis valve (61) being located between the tricuspid simulation valve (33) and the right ventricle simulation assembly (34); or,

the right heart simulation system further comprises a pulmonary valve stenosis valve (62) disposed on the third conduit (54) and adjustable in opening, the pulmonary valve stenosis valve (62) being located between the pulmonary valve simulation valve (35) and the pulmonary artery simulation assembly (15).

5. A testing system for ventricular assist devices according to any one of claims 1 to 3, wherein the left ventricular simulator system further comprises a first branch and an adjustable opening mitral valve closure incompetence valve (22) disposed on the first branch, one end of the first branch communicating with an outlet of the left atrial simulator assembly (17), the other end of the first branch communicating with an inlet of the left ventricular simulator assembly (23); or,

the left heart simulation system further comprises a second branch and an aortic valve closing incomplete valve (27) which is arranged on the second branch and can adjust the opening degree, one end of the second branch is communicated with an outlet of the left ventricle simulation assembly (23), and the other end of the second branch is communicated with an inlet of the aortic simulation assembly (6); or,

the right heart simulation system further comprises a third branch and a tricuspid valve closing incompetence valve (63) which is arranged on the third branch and can adjust the opening degree, one end of the third branch is communicated with an outlet of the right atrium simulation assembly (32), and the other end of the third branch is communicated with an inlet of the right ventricle simulation assembly (34); or,

the right heart simulation system further comprises a fourth branch and a pulmonary valve closing incomplete valve (64) which is arranged on the fourth branch and can adjust the opening degree, one end of the fourth branch is communicated with an outlet of the right ventricle simulation assembly (34), and the other end of the fourth branch is communicated with an inlet of the pulmonary artery simulation assembly (15).

6. A testing system for ventricular assist devices according to any one of claims 1 to 3, characterized in that the left heart simulation system further comprises a first housing chamber (2) provided on the second tubing (53), the first housing chamber (2) communicating with the inlet of the first one-way valve (4); or the right heart simulation system further comprises a second accommodating cavity (12) arranged on the third pipeline (54), and the second accommodating cavity (12) is communicated with an inlet of the second one-way valve (13).

7. A testing system for ventricular assist devices according to any one of claims 1 to 3, wherein the left ventricular simulator assembly (23) comprises:

a left ventricular housing defining a first receiving chamber (71);

a left elastomeric ventricular balloon (24) located within the first receiving cavity (71), an inlet of the left elastomeric ventricular balloon (24) communicating with an outlet of the mitral valve simulation valve (20), an outlet of the left elastomeric ventricular balloon (24) communicating with an inlet of the aortic valve simulation valve (25), and a volume of the left elastomeric ventricular balloon (24) being variable;

a filling member for pressing the left elastic ventricular sac (24), the filling member being filled between an outer wall surface of the left elastic ventricular sac (24) and an inner wall surface of the first accommodation chamber (71);

a first piston (72) for enclosing the filling member and the left elastomeric ventricular sac (24) within the first receiving chamber (71), the first piston (72) being movably arranged along a centerline direction of the first receiving chamber (71) to compress or release the left elastomeric ventricular sac (24).

8. A testing system for ventricular assist devices according to claim 7, characterized in that the left elastic ventricular balloon (24) is a cylindrical structure comprising a first balloon segment (241) and a second balloon segment (242) in communication, the first balloon segment (241) having an inner diameter larger than the inner diameter of the second balloon segment (242), the inner diameter of the first balloon segment (241) increasing in a direction away from the second balloon segment (242), wherein the first balloon segment (241) communicates with the outlet of the mitral valve simulation valve (20) and the second balloon segment (242) communicates with the inlet of the aortic valve simulation valve (25).

9. A testing system for ventricular assist devices according to claim 7, characterized in that the left elastic ventricular sac (24) is made of an elastic material such as silicone or rubber or latex.

10. A testing system for ventricular assist devices according to any one of claims 1 to 3, wherein the mitral valve simulator valve (20) comprises:

the elastic structure (73), one side of the elastic structure (73) is provided with an installation cavity and an opening communicated with the installation cavity, the other side of the elastic structure (73) is provided with a first through hole communicated with the installation cavity, and the aperture of the first through hole is smaller than the inner diameter of the installation cavity;

a one-way flow structure (75) located on the other side of the elastic structure (73), the one-way flow structure (75) having a second through hole (76) openably and closably disposed, the second through hole (76) communicating with the first through hole, the second through hole (76) having an open position where liquid flows from the left atrium simulation module (17) to the left ventricle simulation module (23) and a closed position where the liquid is prevented from flowing from the left ventricle simulation module (23) to the left atrium simulation module (17) to achieve one-way flow of the liquid.

11. A testing system for a ventricular assist device according to claim 10, characterized in that the mitral valve simulator (20) further comprises a support structure (77) for supporting the resilient structure (73), the support structure (77) being located within the mounting cavity, and the support structure (77) defining a plurality of flow channels (78) communicating with the openings.

12. A testing system for ventricular assist devices according to claim 10, wherein the one-way flow structure (75) comprises two ribs (79) for enclosing the second through hole (76), at least one side of the ribs (79) is provided with an inclined surface (80), the ribs (79) have a first end and a second end which are oppositely arranged, the first ends of the two ribs (79) are both connected with the elastic structure (73), and the second ends of the two ribs (79) are close to or far away from each other, so that the second through hole (76) is closed or opened, and from the first end to the second end, the inclined surface (80) is gradually close to the center line of the second through hole (76).

13. A testing system for a ventricular assist device according to any one of claims 1 to 3, wherein the left atrial simulation assembly (17) comprises:

a left atrial housing defining a second containment chamber (81) and a first inlet and a first outlet in communication with the second containment chamber (81), the first inlet in communication with the outlet of the first one-way valve (4) and the first outlet in communication with the inlet of the mitral valve simulation valve (20);

and the second piston (82) is connected with the left atrial shell in a sealing mode, and the second piston (82) is movably arranged along the central line direction of the second accommodating cavity (81).

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