CN117982791A - Full-cardiac cycle ventricular assist system and use method thereof - Google Patents

Abstract

The invention discloses a full cardiac cycle ventricular assist system and a use method thereof, comprising the following steps: an external auxiliary module, an internal auxiliary module and a control module; the in-vivo assistance module includes: an AIH orthotopic balloon for assisting in systole and diastole outside the heart, and an IABP counterpulsation balloon for assisting in heart pumping; a plurality of AIH (advanced integrated advanced) normal-beat balloons are arranged on the outer surface of the heart according to a heart function area, an IABP counterpulsation balloon is arranged at the root of a descending aorta, an external auxiliary module is controlled by a control module, and when the heart is relaxed and contracted, the AIH normal-beat balloon and the IABP counterpulsation balloon are inflated and exhausted correspondingly and periodically synchronously, the AIH normal-beat balloon can directly provide systolic and diastolic power for heart of heart failure, the IABP counterpulsation balloon can counterpulse in the aorta, the heart blood circulation is improved, the heart function of heart failure is greatly replaced, the blood pumping capacity of the heart is improved, and the best auxiliary effect is achieved for the recovery effect of heart function.

Description

Full-cardiac cycle ventricular assist system and use method thereof

Technical Field

The invention relates to the technical field of medical equipment, in particular to a full cardiac cycle ventricular assist system and a using method thereof.

Background

Heart failure (hereinafter abbreviated heart failure) is the ultimate destination of most cardiovascular diseases, a common, high medical expenditure and potentially fatal disease. There are generally two ways in the prior art for solving the problem of heart failure: the first is medication and the second is ventricular assist device. But the effect of drug therapy is extremely limited from the present point of view.

In the prior art, ventricular assist devices are devices that increase the function of the heart of heart failure patients. The heart pump is divided into a ventricular blood pump and a heart power pump. Ventricular blood pumps have been used in the clinic for over 40 years, with the pump of blood drawn from the apex of the heart directly into the main artery to supply the whole body, with the heart itself either partially deactivated or completely deactivated, which can easily cause complications and secondary damage due to the need for direct contact with blood, with limited effectiveness in improving heart failure and restoring heart function. The appearance of the existing device heart muffler (HEART SLEEVE) of the heart power pump cannot be completely matched with the appearance of an actual heart, the combination part is easy to be in an overtightening or suspending state, the heart becomes approximate to a triangle after the pericardial pump (AdjuCor-BEAT) is used for a long time, the structural function of an annular inside the heart is further changed, most of heart valves of a heart failure patient are problematic, if mechanical valve replacement is carried out, the pericardial pump can cause peripheral valve leakage, after heart failure is improved, the heart size can be changed, the existing device cannot be changed along with the change of the heart, when the heart cannot be attached, equipment can deviate, the auxiliary heart part of the equipment can be changed, and the function of the heart can be interfered.

Accordingly, there is a need for an improvement over the deficiencies in the prior art to address the above-described issues.

Disclosure of Invention

The invention overcomes the defects of the prior art and provides a full cardiac cycle ventricular assist system and a using method thereof.

In order to achieve the above purpose, the invention adopts the following technical scheme: a full cardiac cycle ventricular assist system and method of use thereof, comprising: an external auxiliary module, an internal auxiliary module and a control module;

The in-vivo assistance module includes: an AIH orthotopic balloon for assisting in systole and diastole outside the heart, and an IABP counterpulsation balloon for assisting in heart pumping;

The extracorporeal auxiliary module comprises: an AIH high pressure chamber, an IABP high pressure chamber and a negative pressure chamber; a first electromagnetic valve and a first safety disc are sequentially connected between the AIH high-pressure cavity and the AIH normal-pressure saccule, and a first air pump is arranged at the input end of the AIH high-pressure cavity; a second electromagnetic valve and a second safety disk are sequentially connected between the IABP high-pressure cavity and the IABP counterpulsation saccule, and a second air pump is arranged at the input end of the IABP high-pressure cavity; a third air pump is arranged between the output end of the negative pressure cavity and the input end of the AIH high-pressure cavity, and a fourth air pump is arranged between the output end of the negative pressure cavity and the input end of the IABP high-pressure cavity;

The control module includes: the system comprises a main control board for manually operating and controlling the external auxiliary module, an AI electrocardio control board for automatically operating and controlling the external auxiliary module AI, and a battery for providing a power supply of the full heart cycle ventricular auxiliary system.

In a preferred embodiment of the present invention, the first safety disk and the second safety disk are hollow ellipses, and pneumatic membranes are circumferentially fixed at the middle parts of the first safety disk and the second safety disk.

In a preferred embodiment of the present invention, the pneumatic membrane is made of a shape memory polymer material.

In a preferred embodiment of the present invention, one end of each of the first electromagnetic valve and the second electromagnetic valve is connected to an input end of the negative pressure chamber.

In a preferred embodiment of the present invention, a first pressure sensor is disposed between the first safety disk and the AIH counterpulsation balloon and between the second safety disk and the IABP counterpulsation balloon, a second pressure sensor is disposed between the third air pump and the AIH high-pressure chamber and between the fourth air pump and the IABP high-pressure chamber, and a third pressure sensor is disposed between the first electromagnetic valve and the negative pressure chamber and between the second electromagnetic valve and the negative pressure chamber.

In a preferred embodiment of the present invention, the AI electrocardio control panel is electrically connected with the main control panel and the battery in sequence; the main control board, the AI electrocardio control board and the battery are respectively and electrically connected with the first electromagnetic valve, the second electromagnetic valve, the first air pump, the second air pump, the third air pump, the fourth air pump, the first pressure sensor, the second pressure sensor and the third pressure sensor.

In a preferred embodiment of the present invention, the method further comprises: the helium bottle is provided with a constant volume device arranged at the gas transmission end of the helium bottle; one end of the fixed container is connected with a pipeline between the first safety disk and the AIH normal pulsation balloon and connected with a pipeline between the second safety disk and the IABP counterpulsation balloon, and the fixed container is electrically connected with the battery.

The invention provides a using method of a full cardiac cycle ventricular assist system, which comprises the following steps:

S1, installing an IABP counterpulsation saccule to a descending aorta, and acquiring electrocardio and blood flow dynamic parameters in the descending aorta;

S2, according to the parameters obtained in the S1, the inflation and exhaust pressure of the IABP counterpulsation balloon is regulated, the IABP counterpulsation balloon is inflated and exhausted by using an external auxiliary module, and the IABP counterpulsation balloon is inflated during diastole and exhausted during systole, so that periodic synchronization is completed;

S3, installing a plurality of AIH orthotopic balloons on the outer surface of the heart according to the positions of different functional areas according to the difference of the functional areas of the heart;

S4, according to the parameters obtained in the S1, the inflation and exhaust pressure of the AIH normal-pulsation balloon are adjusted, the AIH normal-pulsation balloon is inflated and exhausted by utilizing an external auxiliary module, and the AIH normal-pulsation balloon is exhausted during diastole and inflated during systole, so that periodic synchronization is completed;

S5, using an external auxiliary module to perform corresponding inflation and deflation on the IABP counterpulsation saccule and the AIH counterpulsation saccule during diastole and systole, so as to achieve the purpose of assisting the heart function.

In a preferred embodiment of the present invention, in the step S2, the inflating process of the IABP counterpulsation balloon is as follows: controlling a second air pump to convey air into the IABP high-pressure cavity, opening the opening and closing degree of a second electromagnetic valve through the required air pressure, wherein the circulation direction of the second electromagnetic valve is from the IABP high-pressure cavity to a second safety disk, the air enters the second safety disk, and meanwhile, a pneumatic film in the second safety disk is deformed and attached to one side of the second safety disk under the action of the air pressure, so that the air between the second safety disk and the IABP counterpulsation saccule is filled into the IABP counterpulsation saccule to complete the inflation process;

The exhaust process of the IABP counterpulsation saccule comprises the following steps: changing the circulation direction of the second electromagnetic valve into a second safety disk to a negative pressure cavity, simultaneously starting a fourth air pump, and completing an exhaust process between the second safety disk and the IABP counterpulsation balloon by sucking the gas inside the IABP counterpulsation balloon by deforming and attaching the pneumatic membrane inside the second safety disk to the other side of the second safety disk through the negative pressure formed by the gas.

In a preferred embodiment of the present invention, in the step S4, the inflation process of the AIH orthotopic balloon is as follows: the method comprises the steps of controlling a first air pump to convey air into an AIH high-pressure cavity, opening the opening and closing degree of a first electromagnetic valve through required air pressure, enabling the circulation direction of the first electromagnetic valve to be from the AIH high-pressure cavity to a first safety disc, enabling the air to enter the first safety disc, enabling a pneumatic membrane in the first safety disc to deform and attach to one side of the first safety disc under the action of the air pressure, and further enabling air between the first safety disc and an AIH normal pulsation saccule to be filled into the AIH normal pulsation saccule to complete the inflation process;

The air exhausting process of the AIH orthotopic balloon comprises the following steps: the circulation direction of the first electromagnetic valve is changed into a first safety disk to the negative pressure cavity, the third air pump is started simultaneously, the negative pressure formed by the inside of the negative pressure cavity is used for enabling the pneumatic membrane inside the first safety disk to deform and attach to the other side of the first safety disk through the negative pressure formed by the air, and then the air inside the AIH positive pulsation balloon is sucked back to the space between the first safety disk and the AIH positive pulsation balloon to complete the exhaust process.

The invention solves the defects existing in the background technology, and has the following beneficial effects:

(1) The invention provides a ventricular assist system in full cardiac cycle and a use method thereof, wherein a plurality of AIH (advanced integrated advanced) normal-beat balloons are arranged on the outer surface of a heart according to a heart function area, an IABP counterpulsation balloon is arranged at the root of a descending aorta, an external assist module is controlled by a control module, and when the heart is relaxed and contracted, the AIH normal-beat balloon and the IABP counterpulsation balloon are simultaneously inflated and exhausted correspondingly and periodically synchronously, the AIH normal-beat balloon can directly provide contraction and relaxation power for heart in heart failure, the IABP counterpulsation balloon can counterpulse in the aorta to improve the blood circulation of the heart, thereby greatly replacing the heart failure function, improving the blood pumping capacity of the heart and achieving the best assist effect on the recovery effect of the heart function.

(2) According to the invention, the external auxiliary air paths of the AIH normal-pulsation saccule and the IABP counterpulsation saccule are combined, the time phases of inflation and exhaust of the AIH normal-pulsation saccule and the IABP counterpulsation saccule are opposite when the heart is in diastole and contraction, and are synchronous with the systole and diastole rhythms of the heart, and according to the movement of the left ventricle wall and the blood flow dynamic parameters in the left ventricle, the external auxiliary module is used for adjusting the corresponding systole pressure of the heart, realizing the adaptive application effect on the pressure when the heart contracts, and carrying out counterpulsation in the descending aorta, thereby achieving the purpose of assisting the heart function and obviously reducing the afterload of the left ventricle.

(3) In clinical practice of heart failure, when the ventricular assist system assists the contractility of the heart in the full cardiac cycle, the IABP counterpulsation saccule and the external assist module are firstly applied, the external assist module is utilized to provide the effects of inflation and exhaust in the descending aorta, a certain pressure support is given to blood flow in the aorta, the load of the heart is lightened, the blood circulation of the heart is promoted, the coronary artery perfusion is increased, the myocardial blood supply is improved, the safety of the operation is ensured, the AIH counterpulsation saccule is introduced after that, and the external assist air path is combined, so that the feasibility is improved.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are required to be used in the embodiments or the description of the prior art will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments described in the present invention, and other drawings can be obtained according to these drawings without inventive effort for a person skilled in the art;

FIG. 1 is a schematic diagram of a full heart cycle ventricular assist system in accordance with a preferred embodiment of the present invention;

In the figure: 1. AIH pacing balloon; 2. an IABP counterpulsation balloon; 3. AIH high pressure chamber; 31. a first electromagnetic valve; 32. a first security disk; 311. a first air pump; 4. an IABP high pressure chamber; 41. a second electromagnetic valve; 42. a second security disk; 411. a second air pump; 5. a negative pressure chamber; 51. a third air pump; 52. a fourth air pump; 6. a main control board; 61. AI electrocardiograph control board; 62. a battery; 7. a first pressure sensor; 71. a second pressure sensor; 72. a third pressure sensor; 8. a helium cylinder; 81. and (5) setting a container.

Detailed Description

The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention, but the present invention may be practiced in other ways than those described herein, and therefore the scope of the present invention is not limited to the specific embodiments disclosed below.

In the description of the present application, it should be understood that the terms "center", "longitudinal", "lateral", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. indicate orientations or positional relationships based on the drawings, are merely for convenience in describing the present application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the scope of the present application. Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first", "a second", etc. may include one or more of the feature, either explicitly or implicitly. In the description of the application, unless otherwise indicated, the meaning of "a plurality" is two or more.

In the description of the present application, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present application can be understood by those of ordinary skill in the art in a specific case.

As shown in fig. 1, a full cardiac cycle ventricular assist system comprising: an external auxiliary module, an internal auxiliary module and a control module.

The in-vivo assistance module includes: an AIH orthotopic balloon 1 for assisting in systole and diastole outside the heart, and an IABP counterpulsation balloon 2 for assisting in heart pumping.

The AIH orthotopic balloon 1 is designed into different armor pieces according to the different sizes, shapes and surface curvatures of different parts of the heart by using an armor shell, and can be finally perfectly matched with the heart; the armor shell is made of medical plastic, titanium alloy and polyurethane composite materials, a plurality of tunnel parts at the apex of the heart are single pieces, and 6-10 pieces of heart parts are divided into sectors with different sizes and shapes; the AIH orthotopic balloon 1 is made of polyurethane material, has the length of 5cm-10cm, the diameter of 2cm and the thickness of 6-10 mu m, and is formed by arranging 6-8 balloons according to the positions of the armor sheets on the surface of the heart; simultaneously, the pipeline of the AIH normal pulsation saccule 1 uniformly penetrates out of a tunnel at the apex of the armor shell and is connected with an external auxiliary module; the IABP counterpulsation balloon 2 has three specifications which are completely the same as the specifications of the current clinical IABP balloon and are not described in detail; the pipeline of the IABP counterpulsation saccule 2 is connected with an external auxiliary module.

The extracorporeal auxiliary module includes: an AIH high pressure chamber 3, an IABP high pressure chamber 4 and a negative pressure chamber 5; a first electromagnetic valve 31 and a first safety disk 32 are sequentially connected between the AIH high-pressure cavity 3 and the AIH normal-pulsation saccule 1, and a first air pump 311 is arranged at the input end of the AIH high-pressure cavity 3; a second electromagnetic valve 41 and a second safety disk 42 are sequentially connected between the IABP high-pressure cavity 4 and the IABP counterpulsation saccule 2, and a second air pump 411 is arranged at the input end of the IABP high-pressure cavity 4; a third air pump 51 is arranged between the output end of the negative pressure cavity 5 and the input end of the AIH high pressure cavity 3, and a fourth air pump 52 is arranged between the output end of the negative pressure cavity 5 and the input end of the IABP high pressure cavity 4.

The first and second safety discs 32 and 42 are hollow oval, the middle parts of the first and second safety discs 32 and 42 are circumferentially fixed with pneumatic membranes, the pneumatic membranes are made of shape memory polymer materials, preferably shape memory polymer composite materials (SMPC), the initial state of the pneumatic membranes is located in the middle part of the first or second safety discs 32 and 42, when the pneumatic membranes are inflated, the pneumatic membranes are attached to one side of the first or second safety discs 32 and 42 under the action of gas pressure, gas is filled into the AIH positive pacing balloon 1 or IABP counterpulsation balloon 2, and when the pneumatic membranes are exhausted, the pneumatic membranes are attached to the other side of the first or second safety discs 32 or 42 under the action of gas negative pressure, and the gas in the AIH positive pacing balloon 1 or IABP counterpulsation balloon 2 is exhausted.

One end of each of the first solenoid valve 31 and the second solenoid valve 41 is connected to the input end of the negative pressure chamber 5.

The flow direction of the first solenoid valve 31 may be switched between the AIH high pressure chamber 3 to the first safety disk 32 or the first safety disk 32 to the negative pressure chamber 5; the flow direction of the second solenoid valve 31 can be switched between the IABP high pressure chamber 4 to the second safety disk 42 or the second safety disk 42 to the negative pressure chamber 5.

A first pressure sensor 7 is arranged between the first safety disk 32 and the AIH positive pacing balloon 1 and between the second safety disk 42 and the IABP counterpulsation balloon 2, a second pressure sensor 71 is arranged between the third air pump 51 and the AIH high-pressure chamber 3 and between the fourth air pump 52 and the IABP high-pressure chamber 4, and a third pressure sensor 72 is arranged between the first electromagnetic valve 31 and the negative pressure chamber 5 and between the second electromagnetic valve 41 and the negative pressure chamber 5.

By means of the first pressure sensor 7, the gas pressure between the first safety disk 32 and the AIH counterpulsation balloon 1 or between the second safety disk 42 and the IABP counterpulsation balloon 2 can be detected; the second pressure sensor 7 can detect the gas pressure of the first safety disk 32 or the second safety disk 42 flowing back to the negative pressure cavity 5; the third pressure sensor 72 detects the pressure of the gas inputted into the AIH high pressure chamber by the third air pump 51 or the IABP high pressure chamber 4 by the fourth air pump 54; thus, the accurate delivery of the gas flow rate can be performed according to the degree of inflation or deflation required for the AIH pacing balloon 1 or the IABP counterpulsation balloon 2.

The control module comprises: the main control board 6 for manually controlling the external auxiliary module, the AI electrocardio control board 61 for automatically controlling the external auxiliary module AI, and the battery 62 for providing the power supply of the ventricular auxiliary system in the whole cardiac cycle.

Note that, the AI electrocardiograph control board 61 is electrically connected with the main control board 6 and the battery 62 in sequence; the main control board 6, the AI electrocardio control board 61 and the battery 62 are respectively and electrically connected with the first electromagnetic valve 31, the second electromagnetic valve 41, the first air pump 311, the second air pump 411, the third air pump 51, the fourth air pump 52, the first pressure sensor 7, the second pressure sensor 71 and the third pressure sensor 72; the first solenoid valve 31, the second solenoid valve 41, the first air pump 311, the second air pump 411, the third air pump 51, the fourth air pump 52, the first pressure sensor 7, the second pressure sensor 71, or the third pressure sensor 72 can be manually operated by the main control board 6, and the AI heart control board 61 can be opened to automatically operate according to a set program.

A full cardiac cycle ventricular assist system, further comprising: a helium bottle 8 and a constant volume container 81 arranged at the gas delivery end of the helium bottle 8; one end of the constant volume container 81 is connected to the tubing between the first safety disk 32 and the AIH pacing balloon 1 and to the tubing between the second safety disk 42 and the IABP counterpulsation balloon 2, and the constant volume container 81 is electrically connected to the battery 62.

The gas between the first safety disk 32 and the AIH pacing balloon 1 and the second safety disk 42 and the IABP counterpulsation balloon 2 are helium (inert gas); helium can be provided between the first safety disk 32 and the AIH normal pulsation balloon 1 or between the second safety disk 42 and the IABP counterpulsation balloon 2 by using the helium bottle 8, and the pressure and flow rate of the gas can be controlled or regulated by arranging the constant container 81, so that the gas can be ensured to be output from the helium bottle 8 at constant pressure and flow rate, and the safety during use is improved.

A method of using a full cardiac cycle ventricular assist system, comprising the steps of:

S1, installing an IABP counterpulsation saccule 2 to a descending aorta, and acquiring electrocardio and blood flow dynamic parameters in the descending aorta;

s2, according to the parameters obtained in the S1, the inflation and exhaust pressure of the IABP counterpulsation sacculus 2 is regulated, the IABP counterpulsation sacculus 2 is inflated and exhausted by utilizing an external auxiliary module, and the IABP counterpulsation sacculus 2 is inflated during diastole and exhausted during systole, so that the periodic synchronization is completed;

S3, installing a plurality of AIH orthotopic balloons 1 on the outer surface of the heart according to the positions of different functional areas according to the difference of the functional areas of the heart;

S4, according to the parameters obtained in the S1, the inflation and exhaust pressure of the AIH normal-pulsation balloon 1 are regulated, the AIH normal-pulsation balloon 1 is inflated and exhausted by utilizing an external auxiliary module, and the AIH normal-pulsation balloon is exhausted during diastole and inflated during systole, so that periodic synchronization is completed;

S5, using an external auxiliary module, and simultaneously carrying out corresponding inflation and deflation on the IABP counterpulsation saccule 2 and the AIH counterpulsation saccule 1 during diastole and systole, so as to achieve the purpose of assisting heart functions.

In the step S1, the installation step of the IABP counterpulsation balloon 2 in the descending aorta is the same as the installation step of a clinical intra-aortic balloon counterpulsation pump (IABP) balloon, and will not be described in detail; and the flexible ultrasonic probe can be arranged on the surface of the heart to monitor the heart function conveniently so as to adjust the parameters in the external auxiliary module.

In step S2, the inflation process of the IABP counterpulsation balloon 2 is: the second air pump 411 is controlled to convey air to the inside of the IABP high-pressure cavity 4, the opening and closing degree of the second electromagnetic valve 41 is opened through the required air pressure, the circulation direction of the second electromagnetic valve 41 is the IABP high-pressure cavity 4 to the second safety disk 42, the air can enter the inside of the second safety disk 42, meanwhile, the air film inside the second safety disk 42 is deformed and attached to one side of the second safety disk 42 under the action of the air pressure, and then the air between the second safety disk 42 and the IABP counterpulsation saccule 2 is filled into the inside of the IABP counterpulsation saccule 2 to complete the inflation process.

The exhaust process of the IABP counterpulsation balloon 2 is as follows: changing the circulation direction of the second electromagnetic valve 41 into the second safety disk 42 to the negative pressure cavity 5, simultaneously starting the fourth air pump 52, and through the negative pressure formed in the negative pressure cavity 5, the pneumatic membrane in the second safety disk 42 deforms and adheres to the other side of the second safety disk 42 through the negative pressure formed by the air, so that the air in the IABP counterpulsation saccule 2 is sucked back to the space between the second safety disk 42 and the IABP counterpulsation saccule 2 to complete the exhaust process.

In the step S3, the AIH orthotopic balloon 1 is mounted as follows: 1. dividing the outer surface of the heart into a plurality of functional areas, and designing different armor sheets which can be perfectly matched with the heart according to the size, shape and surface curvature of the functional areas of the heart; 2. minimally invasive incision is carried out on the left front chest wall by about 5cm, pericardium is incised, and heart is exposed; 3. sleeving and fixing different armor pieces at the bottom of the heart, and arranging a plurality of AIH orthotopic balloons 1 according to the positions of the armor pieces on the surface of the heart; 4. the pipeline of the AIH normal pulsation saccule 1 uniformly penetrates out of the tunnel of the apex part of the armor shell and is connected with the external auxiliary module, so that the installation is completed.

In step S4, the inflation process of the AIH orthotopic balloon 1 is: the first air pump 311 is controlled to convey air to the inside of the AIH high-pressure cavity 3, the opening and closing degree of the first electromagnetic valve 31 is opened through the required air pressure, the circulation direction of the first electromagnetic valve 31 is from the AIH high-pressure cavity 3 to the first safety disk 32, the air can enter the inside of the first safety disk 32, meanwhile, the pneumatic membrane inside the first safety disk 32 deforms and adheres to one side of the first safety disk 32 under the action of the air pressure, and then the air between the first safety disk 32 and the AIH normal pulsation saccule 1 is filled into the inside of the AIH normal pulsation saccule 1 to complete the inflation process.

The air discharge process of the AIH orthotopic balloon 1 is as follows: changing the circulation direction of the first electromagnetic valve 31 into the first safety disk 32 to the negative pressure cavity 5, simultaneously starting the third air pump 51, and through the negative pressure formed in the negative pressure cavity 5, the pneumatic membrane in the first safety disk 32 deforms and adheres to the other side of the first safety disk 32 through the negative pressure formed by the air, so that the air in the AIH positive pulsation balloon 1 is sucked back to the space between the first safety disk 32 and the AIH positive pulsation balloon 1 to complete the exhaust process.

According to the invention, a plurality of AIH (advanced integrated advanced) counterpulsation balloons 1 are arranged on the outer surface of the heart according to the heart function area, an IABP counterpulsation balloon 2 is arranged at the root of the descending aorta, and an external auxiliary module is controlled by a control module, so that when the heart is relaxed and contracted, the AIH counterpulsation balloons 1 and the IABP counterpulsation balloons 2 are simultaneously inflated and exhausted correspondingly and periodically, the AIH counterpulsation balloons 1 can directly provide contraction and relaxation power for heart of heart failure, the IABP counterpulsation balloons 2 counterpulsation in the aorta can improve the blood circulation of the heart, thereby greatly replacing the heart function of heart failure, improving the heart pumping capacity and achieving the best auxiliary effect on the recovery effect of the heart function.

The external auxiliary air paths of the AIH normal-pulsation saccule and the IABP counterpulsation saccule are combined, the time phases of inflation and exhaust of the AIH normal-pulsation saccule and the IABP counterpulsation saccule are opposite when the heart is in diastole and systole, and are synchronous with the systole and diastole rhythm of the heart, and according to the movement of the left ventricle wall and the blood flow dynamic parameters in the left ventricle, the external auxiliary module is used for adjusting the corresponding systole pressure of the heart, realizing the adaptive application effect on the pressure when the heart contracts, and carrying out counterpulsation in the descending aorta, thereby achieving the purpose of assisting the heart function and obviously reducing the afterload of the left ventricle.

The above-described preferred embodiments according to the present invention are intended to suggest that, from the above description, various changes and modifications can be made by the person skilled in the art without departing from the scope of the technical idea of the present invention. The technical scope of the present invention is not limited to the description, but must be determined according to the scope of claims.

Claims (10)

1. A full-cardiac cycle ventricular assist system, comprising: an external auxiliary module, an internal auxiliary module and a control module;

The in-vivo assistance module includes: an AIH orthotopic balloon for assisting in systole and diastole outside the heart, and an IABP counterpulsation balloon for assisting in heart pumping;

The extracorporeal auxiliary module comprises: an AIH high pressure chamber, an IABP high pressure chamber and a negative pressure chamber; a first electromagnetic valve and a first safety disc are sequentially connected between the AIH high-pressure cavity and the AIH normal-pressure saccule, and a first air pump is arranged at the input end of the AIH high-pressure cavity; a second electromagnetic valve and a second safety disk are sequentially connected between the IABP high-pressure cavity and the IABP counterpulsation saccule, and a second air pump is arranged at the input end of the IABP high-pressure cavity; a third air pump is arranged between the output end of the negative pressure cavity and the input end of the AIH high-pressure cavity, and a fourth air pump is arranged between the output end of the negative pressure cavity and the input end of the IABP high-pressure cavity;

The control module includes: the system comprises a main control board for manually operating and controlling the external auxiliary module, an AI electrocardio control board for automatically operating and controlling the external auxiliary module AI, and a battery for providing a power supply of the full heart cycle ventricular auxiliary system.

2. A full cardiac cycle ventricular assist system as claimed in claim 1 wherein: the first safety disc and the second safety disc are hollow oval, and pneumatic membranes are circumferentially fixed at the middle parts of the first safety disc and the second safety disc.

3. A full cardiac cycle ventricular assist system as claimed in claim 2 wherein: the pneumatic membrane is made of a shape memory polymer material.

4. A full cardiac cycle ventricular assist system as claimed in claim 1 wherein: one end of the first electromagnetic valve and one end of the second electromagnetic valve are connected with the input end of the negative pressure cavity.

5. A full cardiac cycle ventricular assist system as claimed in claim 1 wherein: the first safety disc with between the AIH normal beat sacculus with all be provided with first pressure sensor between the second safety disc with between the IABP counterpulsation sacculus, third air pump with between the AIH high pressure chamber with all be provided with second pressure sensor between the fourth air pump with between the IABP high pressure chamber, first solenoid valve with between the negative pressure chamber with all be provided with third pressure sensor between the second solenoid valve with between the negative pressure chamber.

6. A full cardiac cycle ventricular assist system as claimed in claim 5 wherein: the AI electrocardio control board is electrically connected with the main control board and the battery in sequence; the main control board, the AI electrocardio control board and the battery are respectively and electrically connected with the first electromagnetic valve, the second electromagnetic valve, the first air pump, the second air pump, the third air pump, the fourth air pump, the first pressure sensor, the second pressure sensor and the third pressure sensor.

7. A full cardiac cycle ventricular assist system as claimed in claim 1 wherein: further comprises: the helium bottle is provided with a constant volume device arranged at the gas transmission end of the helium bottle; one end of the fixed container is connected with a pipeline between the first safety disk and the AIH normal pulsation balloon and connected with a pipeline between the second safety disk and the IABP counterpulsation balloon, and the fixed container is electrically connected with the battery.

8. A method of using a full cardiac cycle ventricular assist system as claimed in any one of claims 1 to 7, comprising the steps of:

S1, installing an IABP counterpulsation saccule to a descending aorta, and acquiring electrocardio and blood flow dynamic parameters in the descending aorta;

S2, according to the parameters obtained in the S1, the inflation and exhaust pressure of the IABP counterpulsation balloon is regulated, the IABP counterpulsation balloon is inflated and exhausted by using an external auxiliary module, and the IABP counterpulsation balloon is inflated during diastole and exhausted during systole, so that periodic synchronization is completed;

S3, installing a plurality of AIH orthotopic balloons on the outer surface of the heart according to the positions of different functional areas according to the difference of the functional areas of the heart;

S4, according to the parameters obtained in the S1, the inflation and exhaust pressure of the AIH normal-pulsation balloon are adjusted, the AIH normal-pulsation balloon is inflated and exhausted by utilizing an external auxiliary module, and the AIH normal-pulsation balloon is exhausted during diastole and inflated during systole, so that periodic synchronization is completed;

S5, using an external auxiliary module to perform corresponding inflation and deflation on the IABP counterpulsation saccule and the AIH counterpulsation saccule during diastole and systole, so as to achieve the purpose of assisting the heart function.

9. A method of using a full cardiac cycle ventricular assist system as claimed in claim 8 wherein: in the step S2, the inflating process of the IABP counterpulsation balloon is as follows: controlling a second air pump to convey air into the IABP high-pressure cavity, opening the opening and closing degree of a second electromagnetic valve through the required air pressure, wherein the circulation direction of the second electromagnetic valve is from the IABP high-pressure cavity to a second safety disk, the air enters the second safety disk, and meanwhile, a pneumatic film in the second safety disk is deformed and attached to one side of the second safety disk under the action of the air pressure, so that the air between the second safety disk and the IABP counterpulsation saccule is filled into the IABP counterpulsation saccule to complete the inflation process;

The exhaust process of the IABP counterpulsation saccule comprises the following steps: changing the circulation direction of the second electromagnetic valve into a second safety disk to a negative pressure cavity, simultaneously starting a fourth air pump, and completing an exhaust process between the second safety disk and the IABP counterpulsation balloon by sucking the gas inside the IABP counterpulsation balloon by deforming and attaching the pneumatic membrane inside the second safety disk to the other side of the second safety disk through the negative pressure formed by the gas.

10. A method of using a full cardiac cycle ventricular assist system as claimed in claim 8 wherein: in the step S4, the inflation process of the AIH orthotopic balloon is as follows: the method comprises the steps of controlling a first air pump to convey air into an AIH high-pressure cavity, opening the opening and closing degree of a first electromagnetic valve through required air pressure, enabling the circulation direction of the first electromagnetic valve to be from the AIH high-pressure cavity to a first safety disc, enabling the air to enter the first safety disc, enabling a pneumatic membrane in the first safety disc to deform and attach to one side of the first safety disc under the action of the air pressure, and further enabling air between the first safety disc and an AIH normal pulsation saccule to be filled into the AIH normal pulsation saccule to complete the inflation process;

The air exhausting process of the AIH orthotopic balloon comprises the following steps: the circulation direction of the first electromagnetic valve is changed into a first safety disk to the negative pressure cavity, the third air pump is started simultaneously, the negative pressure formed by the inside of the negative pressure cavity is used for enabling the pneumatic membrane inside the first safety disk to deform and attach to the other side of the first safety disk through the negative pressure formed by the air, and then the air inside the AIH positive pulsation balloon is sucked back to the space between the first safety disk and the AIH positive pulsation balloon to complete the exhaust process.