CN216746724U - Test system for ventricular assist device - Google Patents

Abstract

The utility model provides a test system for 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 assembly, a tricuspid valve simulation 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; 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 utility model the problem of the external test system's of ventricle auxiliary device function singleness among the prior art has been solved.

Description

Test system for ventricular assist device

Technical Field

The utility model relates to a medical instrument and clinical application research technical field particularly, relate to a test system for 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.

SUMMERY OF THE UTILITY MODEL

A primary object of the present invention is to provide a testing system for ventricular assist device to solve the problem of single function of the external testing system for 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, comprising: 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.

Use the technical scheme of the utility model, through setting up first pipeline, left side heart analog system, right heart analog system and auto-change over device, and make first pipeline through auto-change over device, two arbitrary pipelines in second pipeline and the third pipeline intercommunication, so that test system for the ventricular assist device has the systemic circulation mode of simulation human blood, right heart circulation mode and complete cycle mode, and test system for the ventricular assist device can also switch between above-mentioned three mode, and thus, test system can be in vitro for the left heart blood circulation of ventricular assist device simulation, right heart blood circulation and systemic circulation's test environment, thereby solve the problem of the ventricular assist device in vitro test system's among the prior art function singleness.

Drawings

The accompanying drawings, which form a part of the present application, are included to provide a further understanding of the invention, and are incorporated in and constitute a part of this specification, 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 shows a schematic structural diagram of a testing system for a ventricular assist device according to 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 upper computer, the control system, the communication system, and the acquisition system of the testing system for a ventricular assist device according to an embodiment of the present invention;

fig. 8 illustrates a left elastic ventricular sac pressure-volume graph in accordance with 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 accompanying drawings in conjunction with embodiments.

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 test system for a ventricular assist device includes a first conduit 50, a left heart simulation system, a right heart simulation system, and a switching 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 the first pipeline 50, the left heart simulation system, the right heart simulation system, and the switching device 40, and by communicating any two of the first pipeline 50, the second pipeline 53, and the third pipeline 54 through the switching device 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 the ventricular assist device is in the body circulation mode, the first pipeline 50 is communicated with the second pipeline 53, the first pipeline 50 is not communicated with the third pipeline 54, and the second pipeline 53 is not communicated with the third pipeline 54, so that it is possible to simulate the situation that the human blood flows through the left ventricular simulation module 23, the aorta simulation module 6 and the first resistance valve 9 from the left atrial simulation module 17, and finally flows back to the left atrial simulation module 17.

Specifically, in the embodiment of the present invention, when the testing system for the ventricular assist device is in the right heart circulation mode, the first pipeline 50 is communicated with the third pipeline 54, the second pipeline 53 is not communicated with the third pipeline 54, and the first pipeline 50 is not communicated with the second pipeline 53, so that it is possible to simulate the situation that the human blood flows from the right atrium simulation module 32, through the right ventricular simulation module 34, the pulmonary artery simulation module 15, and the second resistance valve 16, and finally flows back to the right atrium simulation module 32.

Specifically, in the embodiment of the present invention, when the testing system for the ventricular assist device is in the full circulation mode, the second pipeline 53 and the third pipeline 54 are communicated, the first pipeline 50 and the third pipeline 54 are not communicated, the first pipeline 50 and the second pipeline 53 are not communicated, so that it can be simulated that the human blood flows from the left atrium simulation module 17 through the left ventricle simulation module 23, the aorta simulation module 6, the first resistance valve 9, the right atrium simulation module 32, the right ventricle simulation module 34, the pulmonary artery simulation module 15 and the second resistance valve 16, and finally flows back to the right atrium simulation module 32, and finally flows back to the left atrium simulation module 17.

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

Further, the blood condition when the body circulation and the pulmonary circulation resistance change can be simulated by adjusting the opening degree of the first resistance valve 9 and the second 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 real-time flow.

As shown in fig. 6, in the embodiment of the present invention, the aorta simulation module 6 and the pulmonary artery simulation module 15 are both made of elastic material. Preferably, the soft silica gel is made, so that the aorta simulation component 6 and the pulmonary artery 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 pulmonary artery 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 the silicone tube with uniformly distributed elasticity as the aorta and the pulmonary artery pipeline, fig. 9 shows that the test system for the ventricular assist device according to the embodiment of the present invention is used to test the aorta pipeline-volume curve graph, and as can be seen from the comparison between the curve in the graph and the volume curve of the human artery pipeline, the pipeline has substantially the same capacitance with the human artery blood vessel.

Preferably, in an embodiment of the present invention, the testing system for ventricular assist device further includes two first pressure sensors 7 respectively disposed on the aortic simulation component 6 and the pulmonary artery simulation component 15, so as to detect the pressure in the aortic pipeline and the pulmonary artery pipeline.

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

With the above arrangement, any two of the first, second, and third 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 the first line 50 and the second line 53 communicate with each other, a right cardiac circulation mode in which the first line 50 and the third line 54 communicate with each other, and a full circulation mode in which the second line 53 and the third 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 located at a connection node between the first port, the second pipeline 53 and the third pipeline 54, the first three-way valve has a first inlet 43, a first outlet 44 and a first liquid inlet and outlet 45, the first inlet 43 is communicated with an outlet of the third pipeline 54, the first outlet 44 is communicated with an inlet of the second pipeline 53, and the first liquid inlet and outlet 45 is communicated with the first port.

In the above-described embodiment, any two of the first liquid 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 the first line 50, the second line 53, and the third 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 testing system for the ventricular assist device is in the body circulation mode, the first liquid outlet 44 and the first liquid inlet and outlet 45 are communicated, the first liquid inlet 43 and the first liquid inlet and outlet 45 are not communicated, and the first liquid inlet 43 and the first liquid outlet 44 are not communicated.

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

Specifically, the utility model discloses an in the embodiment, when testing system for heart room auxiliary device was in the full cycle mode, first inlet 43 and first liquid outlet 44 intercommunication, first inlet 43 and first business turn over liquid mouth 45 do not communicate, and first liquid outlet 44 and first business turn over liquid mouth 45 do not communicate.

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 pipeline 50, the second pipeline 53 and the third pipeline 54, so that any two of the first pipeline 50, the second pipeline 53 and the third pipeline 54 can be communicated by controlling the opening and closing of the three two-way valves.

As shown in fig. 1, in the embodiment of the present invention, the second switching valve assembly 10 includes a second three-way valve located at the connection node between the second port, the second pipeline 53 and the third pipeline 54, the second three-way valve has a second inlet 46, a second outlet 47 and a second liquid inlet and outlet 48, the second inlet 46 is communicated with the outlet of the second pipeline 53, the second outlet 47 is communicated with the inlet of the third pipeline 54, and the second liquid inlet and outlet 48 is communicated with the second port.

In the above-described embodiment, any two of the second liquid inlet 46, the second liquid outlet 47, and the second liquid inlet/outlet 48 of the second three-way valve are opened, and the remaining one of the second liquid inlet and outlet is closed, so that any two of the first pipeline 50, the second pipeline 53, and the third pipeline 54 are communicated, and the test system for a ventricular assist device 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 function 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 testing system for the ventricular assist device is in the body circulation mode, the second inlet 46 and the second liquid inlet/outlet 48 are communicated, the second inlet 46 and the second liquid outlet 47 are not communicated, and the second liquid 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 the ventricular assist device is in the right heart circulation mode, the second liquid outlet 47 and the second liquid inlet/outlet 48 are communicated, the second liquid inlet 46 and the second liquid inlet/outlet 48 are not communicated, and the second liquid inlet 46 and the second liquid outlet 47 are not communicated.

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

Of course, in an alternative embodiment not shown in the drawings, the second switching valve assembly 10 may also be three two-way valves, and the three two-way valves are respectively disposed on the first pipeline 50, the second pipeline 53 and the third pipeline 54, so that any two pipelines of the first pipeline 50, the second pipeline 53 and the third 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, the first three-way valve and the second three-way valve can be manually adjusted, so as to facilitate the tester to 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 simulating system further includes a mitral stenosis valve 21 disposed on the second pipeline 53 and capable of adjusting the opening degree, and the mitral stenosis valve 21 is located between the mitral simulation valve 20 and the left ventricle simulating assembly 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 the mitral stenosis valve 21, 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 left heart simulation system further includes an aortic stenosis valve 26 disposed on the second pipeline 53 and capable of adjusting the opening degree, and the aortic stenosis valve 26 is located between the aortic valve simulation valve 25 and the aortic simulation module 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.

As shown in fig. 1, in the embodiment of the present invention, the right heart simulating system further includes a tricuspid stenosis valve 61 disposed on the third pipeline 54 and capable of adjusting the opening degree, and the tricuspid stenosis valve 61 is located between the tricuspid valve simulating valve 33 and the right ventricle 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 the tricuspid 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 pulmonary valve stenosis valve 62 disposed on the third pipeline 54 and capable of adjusting the opening degree, and the pulmonary valve stenosis valve 62 is located between the pulmonary valve simulation valve 35 and the pulmonary artery simulation module 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 pulmonary valve stenosis valve 62, so that the ventricular assist device can be detected under different conditions.

It should be noted that, 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 the patient suffering from mitral stenosis, aortic stenosis, tricuspid stenosis, and pulmonary stenosis, and may simulate one or more of the above diseases.

As shown in fig. 1, in an embodiment of the present invention, the left heart simulating system further includes a first branch and a mitral valve closing incompetence valve 22 disposed on the first branch and capable of adjusting an opening degree, one end of the first branch is communicated with an outlet of the left atrium simulating assembly 17, and the other end of the first branch is communicated with an inlet of the left ventricle 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 the mitral insufficiency valve 22 under the condition of mitral insufficiency, 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 left heart simulating system further includes a second branch and an aortic valve closing incomplete valve 27 disposed on the second branch and capable of adjusting the opening degree, one end of the second branch is communicated with the outlet of the left ventricle simulating assembly 23, and the other end of the second branch is communicated with the inlet of the aortic simulating assembly 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 aortic valve closure valve 27 under the condition of aortic valve closure, so that the ventricular assist device can be detected under different conditions.

As shown in fig. 1, in an embodiment of the present invention, the right ventricle simulation system further includes a third branch and a tricuspid valve closing incompetence valve 63 that is disposed on the third branch and can adjust an opening degree, one end of the third branch is communicated with the outlet of the right atrium simulation module 32, and the other end of the third branch is communicated with the inlet of the right ventricle simulation module 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 tricuspid valve incompetence valve 63 under the condition of tricuspid valve closure, so that the ventricular assist device can be detected under different conditions.

As shown in fig. 1, in an embodiment of the present invention, the right heart simulation system further includes a fourth branch and a pulmonary valve closing incomplete valve 64 disposed on the fourth branch and capable of adjusting the opening degree, one end of the fourth branch is communicated with the outlet of the right ventricle simulation module 34, and the other end of the fourth branch is communicated with the inlet of the pulmonary artery 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 the incomplete 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 suffering from mitral insufficiency, aortic insufficiency, tricuspid insufficiency, and pulmonary insufficiency, and may simulate one or more of the above diseases.

Preferably, in an embodiment of the present invention, the mitral stenosis valve 21, aortic stenosis valve 26, tricuspid stenosis valve 61, pulmonary stenosis valve 62, mitral valve incompletion valve 22, aortic valve incompletion valve 27, tricuspid valve incompletion valve 63, and pulmonary valve incompletion valve 64 are throttle valves or micro-adjustment valves with scales, and the corresponding valvular diseases with different degrees can be simulated by manually adjusting the opening degrees thereof.

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 the second pipeline 53, and the first accommodating chamber 2 is communicated with the 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 plexiglass container.

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

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

Through the arrangement, the pulmonary vein pressure can be adjusted by adjusting the liquid level of the second accommodating 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 second accommodating cavity 12 is a cavity of an open plexiglass container.

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

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

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

In the above technical solution, the left elastic ventricular sac 24 is used to simulate the heart of a human body, and when the first piston 72 pressurizes or depressurizes the first accommodating chamber 71, the filling member located at the periphery of the left elastic ventricular sac 24 extrudes or releases the left elastic ventricular sac 24, so that the left ventricular 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 liquid is filled between the outer wall surface of the left elastic ventricular sac 24 and the inner wall surface of the first accommodating cavity 71, so that when the first piston 72 pressurizes or depressurizes the first accommodating cavity 71, the pressure of the liquid at the periphery of the left elastic ventricular sac 24 will increase or decrease, thereby squeezing or releasing the left elastic ventricular sac 24, and making the left ventricular analog component 23 more fit to the human body.

Specifically, in the embodiment of the present invention, the pressure rise inside the left elastic ventricular sac 24 is the contraction process of the ventricle, the liquid flow inside the ventricular sac is ejected and enters the aorta simulation module 6 through the aortic valve simulation valve 25, because of the characteristics of the aorta compliance, a part of the liquid is temporarily stored in the aorta simulation module 6, and the other part of the liquid enters the second accommodating chamber 12 from the first resistance valve 9 after the circulation flow is measured by the first flowmeter 8.

Preferably, in an embodiment of the invention, the left ventricle casing is made of plexiglass.

As shown in fig. 1 and 2, in the embodiment of the present invention, the left elastic ventricular sac 24 is a tubular structure, the tubular structure includes a first sac section 241 and a second sac section 242 that are communicated with each other, the inner diameter of the first sac section 241 is larger than the inner diameter of the second sac section 242, and the inner diameter of the first sac section 241 is gradually increased along the direction away from the second sac section 242, wherein the first sac section 241 is communicated with the outlet of the mitral valve simulation valve 20, and the second sac section 242 is communicated with the inlet of the aortic valve simulation valve 25.

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

Preferably, in the embodiment of the present invention, the left elastic ventricular sac 24 is made of an elastic material such as silicone, rubber or latex. More preferably, the left elastomeric ventricular sac 24 is injection molded from silicone rubber of varying hardness. Thus, the left elastic ventricular sac 24 can simulate the compliance characteristic of a ventricle and play a role in limiting the ventricular volume, the rigidity of the ventricular sac is very small and basically unchanged in the normal working range of the ventricle, and when the ventricular sac contracts or expands to a certain value, the rigidity of the ventricular sac is rapidly increased, so that the pressure in the first accommodating cavity 71 cannot enable the ventricular sac to continue to contract or expand, the phenomenon that the ventricular volume is too large or too small is avoided, and the ventricular model is more consistent with the human body actually.

As shown in fig. 2, the opposite ends of the left elastic ventricular sac 24 are both provided with a connecting flange, that is, one end of the first sac section 241 is provided with a connecting flange, one end of the second sac section 242 is also provided with a connecting flange, and the two connecting flanges are connected with the inner wall surface of the first accommodating cavity 71, so that the left elastic ventricular sac 24 can be more tightly connected with the left ventricular housing.

Specifically, as shown in fig. 1, in the embodiment of the present invention, the left ventricle 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 accommodating cavity 71 are respectively located at two opposite sides of the first piston 72, the testing system for ventricular assist device further includes an air compressor for providing air to the third accommodating cavity and a vacuum pump for pumping air, and a directional proportional valve 19 disposed at an inlet of the third accommodating cavity, the directional proportional valve 19 is respectively communicated with a pumping 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 by reversing the directional proportional valve 19 to control the movement of the first piston 72, thereby controlling the pressure in the first accommodating cavity 71, the pressure change in the first accommodating cavity 71 squeezes or releases the left elastic ventricle 24, so that the contraction or relaxation of the ventricles can be simulated.

Preferably, the embodiment of the present invention, when inflating, the air compressor is used to inflate the compressed air with gauge pressure of 0.5bar to realize rapid contraction, and when exhausting, the vacuum pump is used to realize rapid relaxation with negative pressure of-0.3 bar.

Preferably, in the embodiment of the present invention, the standard rated flow of the directional proportional 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 present 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 present invention, the maximum pressure of the air compressor is 0.7 MPa.

Preferably, in the embodiment of the present invention, in order to control the pressure of the air compressor and the vacuum pump, a vacuum pressure reducing valve is installed in the gas pipeline, and the pressure range is set to-100 kPa-1.3kPa for the air f.r.l combined triplet, and the maximum flow rate is 240L/min.

Specifically, as shown in fig. 1 and 8, in an embodiment of the present invention, the testing system for a ventricular assist device further includes a second pressure sensor 18 for detecting the pressure of the left elastic ventricular sac 24, and the third accommodating chamber forms a pressure closed-loop control by using the directional proportional valve 19 and the second pressure sensor 18 to realize an accurate pressure control, which conforms to the Frangk-standing mechanism, and the pressure formula is as follows:

wherein:

P_vis ventricular pressure (mmHg), i.e., the pressure within the left elastic ventricular sac 24, with pressure points within the sac to measure the 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。

It should be noted that, in the embodiment of the present invention, in the pressure/volume function, the ratio coefficient K of the volume influence on the contraction force in the Frangk-training mechanism is set_EAnd K_VCan be adjusted by adjusting K_EAnd K_VTo achieve an 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 present invention, the range of the pressure sensor selected for the analog blood circulation circuit is-20 kPa-40kPa, the output signal is 2mA-20mA, and the power supply voltage is 12V-30V.

It should be noted that, in the embodiment of the present invention, the testing system for ventricular assist device further includes a displacement sensor and a foam float located in the first accommodating cavity 71, and 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 accommodating cavity 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 present invention, the effective stroke of the displacement sensor is 125mm, a standard magnetic ring with a diameter of 33mm is provided, 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 right ventricle simulation module 34 is the same as that of the left ventricle simulation module 23, and the description thereof is omitted here.

Fig. 8 shows a pressure-volume curve of the left elastic ventricular sac obtained by a structural test using the left ventricular simulator assembly 23 of the present application, and it can be seen from the above curve that the left ventricular 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 mitral valve simulator 20 includes a resilient structure 73 and a one-way flow structure 75. Wherein, 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; the one-way flow structure 75 is located on the other side of the elastic structure 73, the one-way flow structure 75 has a second through hole 76 that is openably and closably disposed, the second through hole 76 is communicated with the first through hole, and the second through hole 76 has an open position where the liquid flows from the left atrium simulation member 17 to the left ventricle simulation member 23 and a closed position where the liquid is prevented from flowing from the left ventricle simulation member 23 to the left atrium simulation member 17, so as to realize the one-way flow of the liquid.

With the above arrangement, the blood flowing out of the left atrium simulation module 17 flows into the mitral valve simulation valve 20 through the opening, flows out of the mitral valve simulation valve 20 through the second through hole 76, and flows into the left ventricle simulation module 23, and the liquid can be prevented from flowing from the left ventricle simulation module 23 to the left atrium simulation module 17, so that the unidirectional flow of the blood in the body can be simulated; further, the elastic 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, the elastic structure 73 is made of silica gel, and since the silica gel is soft and has a certain elasticity, it can absorb a certain pressure impact while satisfying the single valve function.

As shown in fig. 3 and 4, in an embodiment of the present invention, 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 passages 78 in communication with the openings.

Through the arrangement, the supporting structure 77 can support the elastic structure 73, and the elastic structure 73 can be matched with the inner wall surface of the pipeline, so that the elastic 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.

As shown in fig. 4, in the embodiment of the present invention, the supporting structure 77 includes a plurality of supporting rings and connecting ribs for connecting the supporting rings, which are arranged at intervals from inside to outside in sequence, so that the flow passage 78 can be formed at the intervals between the supporting rings to facilitate the flow of the liquid.

As shown in fig. 3 and 5, in the embodiment of the present invention, the one-way circulation structure 75 includes two ribs 79 for enclosing the second through hole 76, at least one side of the rib 79 is provided with an inclined surface 80, the rib 79 has a first end and a second end which are oppositely disposed, the first ends of the two ribs 79 are all connected with the elastic structure 73, the second ends of the two ribs 79 are close to or away from each other, so that the second through hole 76 is closed or opened, and the inclined surface 80 is gradually close to the central line of the second through hole 76 from the first end to the second end.

With the above arrangement, when the inlet pressure of the mitral valve simulator 20 is greater than the outlet pressure, the second ends of the two ribs 79 move away from each other to open the second through-hole 76; when the outlet pressure of the mitral valve simulator 20 is greater than or equal to the inlet pressure, the second ends of the two ribs 79 will approach each other to close the second through hole 76 due to the pressure of the outlet and the inclined surface 80 on at least one side of the ribs 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, the aortic valve simulator 25, the tricuspid valve simulator 33, and the pulmonary valve simulator 35 are all the same as the mitral valve simulator 20, and are not described herein again.

As shown in FIG. 1, in an embodiment of the present invention, left atrial simulation assembly 17 includes a left atrial housing and a second piston 82. Wherein the left atrial housing defines a second receiving chamber 81 and a first inlet and a first outlet in communication with the second receiving chamber 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 mitral valve simulation valve 20; the second piston 82 is connected to the left atrial casing in a sealing manner, and the second piston 82 is disposed movably in the direction of the center line of the second accommodating chamber 81.

In the above technical solution, the left atrium of the human body is better simulated by arranging the second piston 82, so that the left atrium 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 volume limitation.

Preferably, in an embodiment of the present invention, the left atrium simulation module 17 also drives the second piston 82 by means of pneumatic driving, and uses a proportional directional valve and a pressure sensor to realize a closed loop control of the pressure.

It should be noted that in the embodiment of the present invention, the structure of the right atrium simulation module 32 is the same as the structure of the left atrium simulation module 17, and the description thereof is omitted.

As shown in fig. 7, in an embodiment of the present invention, the testing system for ventricular assist device further includes 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 the first resistance valve 9 and the second resistance valve 16, thereby simulating the blood condition when the resistance of the systemic circulation and the complete circulation changes.

As shown in fig. 7, in an embodiment of the present invention, the testing system for a ventricular assist device further includes an upper computer, a communication system and an acquisition system connected to the upper computer, and both the communication system and the acquisition system are 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 present invention, the communication system and the collection system are connected to the control system, and the command sent by the upper computer is transmitted to the control system through the communication system, and then the control system controls the corresponding hardware device, 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 an embodiment of the present invention, the communication system is connected to the control system, so that the communication system can transmit the signal of 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 adopts LabVIEW software developed by the national instruments and companies of the united states to program, so as to realize the 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 work of hardware equipment control, data acquisition and the like is completed according to the main functional window.

It should be noted that, in the embodiment of the present invention, the control system connected to the upper computer is a PXI controller, and the acquisition system is an NI data acquisition card and the communication system communicates through the ethernet.

It should be noted that, in the embodiment of the utility model, main switch need be opened before the experiment begins, and the vacuum pump is automatic to be opened this moment, and then the manual air compressor machine valve of opening gets into software operation interface through the computer afterwards.

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

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.

One, pass through the utility model discloses carry out human 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 containing cavity 12, and the adding amount of the simulation blood is based on the standard scale of the capacitive cavity.

The air in the circulation circuit is then evacuated, a certain amount of pure water is added in the first housing chamber 71 of the left ventricle and the housing chamber of the right ventricle, based on 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, through the utility model discloses to the simulation of heart failure patient's physiological status:

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, through the utility model discloses to the supplementary physiological state simulation of two hearts:

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. And the utility model discloses after all packing into artificial heart in left heart circulation circuit and right heart circulation circuit, set up the experiment parameter, can realize the collection of above-mentioned various parameters, the physiological state behind the double artificial heart is implanted in abundant simulation.

In addition, the utility model can simulate the physiological state of patients with valvular diseases by adjusting the mitral valve, the tricuspid valve, the aortic valve, the pulmonary valve to close the incompletion valve and the stenosis valve, and the physiological state of the patients with the diseases after the artificial heart is implanted. 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 device according to the embodiment of the present invention can cover all 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-mentioned 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 pipeline (53) and the third pipeline (54), the second three-way valve having a second liquid inlet (46), a second liquid outlet (47) and a second liquid inlet and outlet (48), the second liquid inlet (46) communicating with an outlet of the second pipeline (53), the second liquid outlet (47) communicating with an inlet of the third pipeline (54), the second liquid inlet and outlet (48) communicating with the second port.

4. A testing system for a ventricular assist device according to any one of claims 1 to 3, characterized in that the left heart simulating system further comprises a mitral stenosis valve (21) that is provided on the second conduit (53) and is adjustable in opening, the mitral stenosis valve (21) being located between the mitral simulation valve (20) and the left ventricle 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 elastic ventricular sac (24) located within the first accommodation chamber (71), an inlet of the left elastic ventricular sac (24) being in communication with an outlet of the mitral valve simulation valve (20), an outlet of the left elastic ventricular sac (24) being in communication with an inlet of the aortic valve simulation valve (25), and a volume of the left elastic ventricular sac (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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