Double-gas-path gas source system, double-gas-path heart assisting system and using method

Abstract

The invention discloses a double-gas-path gas source system, a double-gas-path heart assisting system and a using method. The double-air-path heart assisting system comprises a pressure generating mechanism which alternately generates positive pressure and negative pressure when working; the first auxiliary device comprises first driven equipment and a first piping pipeline, a pipe body at the farthest end of the first piping pipeline is provided with an inflow channel and an outflow channel, and the first driven equipment is located in the pipe body of the first piping pipeline and corresponds to the outflow channel in position; the second auxiliary device comprises second driven equipment and a second piping pipeline communicated with the second driven equipment; the pressure generating mechanism enables the second driven device to repeatedly expand and contract through the second piping. The detection device is used for acquiring the pressure in the cardiac chamber and the pressure in the aorta; and the control mechanism is used for controlling the pressure generation mechanism to respectively drive the first driven equipment and the second driven equipment according to the corresponding time sequence in a cycle control period according to the pressure signal sent by the detection device.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a dual-gas-circuit gas source system, and a dual-gas-circuit heart assist system using the dual-gas-circuit gas source system and a use method thereof. Background Art

[0002] Intra-aortic balloon pump (IABP) is a mechanical circulatory assist device, commonly used in acute coronary syndrome of heart disease and cardiac surgery to help the heart perform effective pumping function, relieve cardiac load, and protect the heart and organs. The intra-aortic balloon pump assists the heart in pumping blood by inserting an inflatable balloon into the aorta. The balloon is mainly placed in the ascending aorta and is inflated and deflated synchronously with the compression of an external pump. During the diastole of the heart, the balloon is inflated, which increases the diastolic pressure in the aorta, thereby increasing the blood flow and oxygen supply in the coronary arteries; during the systole of the heart, the balloon is deflated quickly, reducing the pressure in the aorta, reducing the afterload of the heart, and thus reducing the oxygen consumption of the myocardium.

[0003] A percutaneous ventricular assist device (pVAD) is a temporary cardiac assist device for patients with heart failure. pVAD is usually used for patients who are waiting for a heart transplant or whose heart function is severely impaired due to an acute cardiac event. The working principle of pVAD is: a catheter is inserted into the left or right ventricle of the heart through a surgical procedure, and the other end of the catheter is connected to an external blood pump. The blood pump collects blood from the corresponding ventricle of the heart through the catheter, and the collected blood is sent to the aorta (in the case of LVAD) or the lungs (in the case of RVAD) through the mechanical action of the pump. In this way, the blood pump helps the heart pump blood to the required parts of the body. pVAD helps patients with acute heart failure to enhance the heart's pumping function in the short term by increasing blood flow, enhancing blood perfusion, reducing myocardial oxygen consumption, and effectively reducing cardiac preload.

[0004] From the above introduction, it can be seen that the use of IABP for assistance can reduce cardiac afterload and improve coronary perfusion; while the use of PVAD catheter for assistance can reduce cardiac preload, reduce ventricular wall tension, and reduce myocardial oxygen consumption. At present, both IABP and PVAD catheters are used separately in clinical practice. In order to achieve the auxiliary effect of reducing cardiac preload and afterload at the same time, two devices are required and the equipment must be adjusted separately. Due to the dynamic changes of the cardiac cycle, medical staff need to make corresponding adjustments to the two devices separately, which is very cumbersome.

[0005] Providing an auxiliary system that can assist both the preload and afterload of the heart at the same time and has simplified operation has become a difficult problem in research in the industry. Summary of the invention

[0006] The object of the present invention is to provide a dual-gas-circuit cardiac assist system, which can provide an air-circuit system for realizing simultaneous assistance of two devices, and simplify the operation of the assist system through timing control.

[0007] In order to achieve the above objectives, one aspect of the present invention provides a dual-gas-circuit heart assist system, comprising:

[0008] A pressure generating mechanism that generates positive and negative pressure alternately during operation;

[0009] The first auxiliary device comprises a first driven device and a first piping pipeline, wherein the farthest end of the first piping pipeline is provided with an inflow channel and an outflow channel, and the first driven device is arranged in the tube body of the first piping pipeline and corresponds to the position of the outflow channel; the pressure generating mechanism alternately applies negative pressure and positive pressure to the first piping pipeline so that the first driven device switches between blocking the outflow channel and blocking the first piping pipeline;

[0010] The second auxiliary device comprises a second driven device for assisting the heart in pumping blood and a second piping pipeline connected to the second driven device; the pressure generating mechanism causes the second driven device to repeatedly expand and contract through the second piping pipeline;

[0011] A detection device for obtaining intraventricular pressure and intraaortic pressure;

[0012] The control mechanism is communicatively connected with the detection device, the first auxiliary device, the second auxiliary device and the pressure generating mechanism. The first piping pipeline and the second piping pipeline are both connected to the pressure generating mechanism. The control mechanism controls the pressure generating mechanism to drive the first driven device and the second driven device respectively according to the corresponding timing within a cyclic control period based on the pressure signal sent by the detection device.

[0013] In one embodiment, the detection device includes a first pressure sensor and a second pressure sensor; the first pressure sensor is arranged at the farthest end of the first piping pipeline and can extend into the ventricle along the farthest end of the first piping pipeline; the second pressure sensor is arranged on the second piping pipeline, and after the position of the second piping pipeline is fixed, the position of the second pressure sensor is located in the aorta.

[0014] In one embodiment, the pressure generating mechanism includes a positive pressure generating device and a negative pressure generating device; a first valve group is arranged on the first piping pipeline, the first valve group includes a first positive pressure valve connected to the positive pressure generating device and a first negative pressure valve connected to the negative pressure generating device, and the control mechanism controls the first valve group so that the pressure generating device alternately applies positive pressure and negative pressure to the first driven device; a second valve group is arranged on the second piping pipeline, the second valve group includes a second positive pressure valve connected to the positive pressure generating device and a second negative pressure valve connected to the negative pressure generating device, and the control mechanism controls the second valve group so that the pressure generating device alternately applies positive pressure and negative pressure to the second driving device so that the second driving device repeatedly expands and contracts; and the control mechanism sends control instructions to the first valve group and the second valve group respectively at different timings.

[0015] In one embodiment, the first piping line is further provided with a third pressure sensor capable of detecting the pressure of the first piping line and a first safety valve capable of connecting the first piping line to the outside of the pipeline in sequence in the pipe section between the first driven device and the first valve group.

[0016] In one embodiment, the second driven device includes an IABP counterpulsation balloon, and a safety disk is connected between the IABP counterpulsation balloon and the second valve assembly;

[0017] The first side of the safety disk is used to communicate with the IABP counterpulsation balloon and is detachably connected, and the second side is connected to the first valve group. The first side of the safety disk is connected to the helium tank; the safety disk applies the positive pressure and negative pressure output by the pressure generating mechanism to the IABP counterpulsation balloon to expand or contract the IABP counterpulsation balloon.

[0018] In one embodiment, a three-way catheter is further arranged between the IABP counterpulsation balloon and the safety disk; the first tube port of the three-way catheter is connected to the IABP counterpulsation balloon, the second tube port is connected to the second side of the safety disk; and the third tube port is connected to the negative pressure generating device.

[0019] In one embodiment, a fourth safety valve is provided on the pipeline between the third pipe opening and the negative pressure generating device.

[0020] In one embodiment, the first side of the safety disk is also connected to an air supply pipeline.

[0021] According to another aspect of the present application, a method for using the dual gas circuit heart assist system is provided, which specifically comprises the following steps:

[0022] S1, delivering the inflow channel of the first piping line in the first auxiliary device to the left ventricle, with the outflow channel outlet located at the aortic arch; delivering the second driven device to the vicinity of the aortic arch and below the outflow channel outlet; the below refers to the direction in which the outflow channel outlet is away from the aortic arch;

[0023] S2. Obtaining blood flow dynamic parameters in the left ventricle and aorta according to the detection device; and inferring the closing time of the aortic valve and determining the diastolic period and ejection time of the left ventricle according to the obtained parameters;

[0024] S3, when the closure of the aortic valve is detected, the diastolic period of the left ventricle is divided into a first time period and a second time period, in the first time period, the control mechanism controls the second driven device to expand, and controls the first auxiliary device to eject blood into the aorta; in the second time period, the second driven device in the second auxiliary device is controlled to continue to expand, and controls the first auxiliary device to gradually absorb blood from the left ventricle to reduce the cardiac preload;

[0025] S4. At a predetermined time before the moment of left ventricular ejection, the second driven device is controlled to contract, and the first driven device continues to absorb blood from the left ventricle to reduce the left ventricular after-ejection load.

[0026] According to another aspect of the present application, a dual-gas-circuit gas source system is also provided, comprising:

[0027] A pressure generating mechanism that generates positive and negative pressure alternately during operation;

[0028] a first piping pipeline, wherein the pipe body at the farthest end of the first piping pipeline is provided with an inflow channel and an outflow channel, and a first driven device is arranged in the pipe body of the first piping pipeline at a position corresponding to the outlet of the outflow channel; the pressure generating mechanism alternately applies negative pressure and positive pressure to the first piping pipeline so that the first driven device switches between blocking the outflow channel and blocking the first piping pipeline;

[0029] a second piping line connected to the pressure generating mechanism and used to transmit the alternating positive and negative pressures generated by the pressure generating mechanism;

[0030] A detection device for obtaining intraventricular pressure and intraaortic pressure;

[0031] The control mechanism is communicatively connected with the detection device, the first piping line, the second piping line and the pressure generating mechanism. The control mechanism controls the pressure generating mechanism to drive the position switching of the first driven device according to the corresponding timing within a cyclic control period based on the pressure signal sent by the detection device, and to deliver alternating positive and negative pressures to the second piping line.

[0032] According to another aspect of the present application, a method for using the dual gas path gas source system is provided, comprising the following steps:

[0033] S1, selecting a pVAD conduit whose first driven device is an eccentric valve plate as a first piping pipeline, and connecting the first piping pipeline to the pressure generating mechanism;

[0034] S2, selecting an aortic balloon pump IABP with a safety disc structure as the second piping pipeline; the aortic balloon pump is connected to the pressure generating mechanism;

[0035] S3. The control mechanism controls the pressure generating mechanism to connect only the first piping line within a cycle control period according to the pressure signal sent by the detection device, so as to control the position switching of the first driven device.

[0036] Compared with the prior art, the dual-gas-path gas source device and the heart assist system using the same have the following beneficial effects:

[0037] 1. The same pressure generating device is used to supply pressure to the first auxiliary device and the second auxiliary device, and the first auxiliary device and the second auxiliary device are respectively controlled in timing by a control mechanism to achieve simultaneous assistance to the preload and afterload of the heart within a predetermined cycle, thereby improving the blood supply to the heart.

[0038] 2. The use of the same pressure generating device can further simplify the structure of the auxiliary system. At the same time, the two auxiliary devices are coupled to one control system for coordinated control, which is easier to operate than parallel control of two control systems. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 A schematic diagram of the principle of a dual-gas-circuit heart assist system according to an embodiment of the present application is shown;

[0040] Figure 2 is a schematic structural diagram of a pVAD catheter according to an embodiment;

[0041] Figure 3 is a cross-sectional view of a rotary bidirectional valve located at the front end of a single-lumen catheter according to an embodiment;

[0042] Figure 4 for Figure 3 A second state diagram of the rotary two-way valve shown;

[0043] Figure 5 for Figure 4 The force direction diagram of the rotating bidirectional valve is shown in .

[0044] Figure 6is a cross-sectional view of a balloon catheter according to an embodiment of the present application;

[0045] Figure 7 It is a timing control diagram of a control mechanism according to an embodiment.

[0046] Reference numerals:

[0047] 100-pressure generating mechanism; 110-positive pressure generating device; 111-positive pressure tank; 120-negative pressure generating device; 121-negative pressure tank; 130-compressor pump; 200-first auxiliary device; 210-first driven device; 211-first positive pressure valve; 212-first negative pressure valve; 220-first valve group; 230-third pressure sensor; 240-first safety valve; 300-second auxiliary device; 310-second driven device; 311-second positive pressure valve; 312-second negative pressure valve; 313-rotor Turn the two-way valve; 314-extracorporeal membrane pump; 320-second valve group; 330-safety disk; 331-first side; 332-second side; 340-fourth pressure sensor; 370-three-way catheter; 380-fourth safety valve; 400-air supply pipeline; 410-gas tank; 420-gas supply tank; 430-sixth safety valve; 440-fifth pressure sensor; 10-valve body; 11-outlet; 16-first opening; 17-second opening; 18-circulation channel; 20-eccentric valve plate; 22-air bag; 30-catheter. DETAILED DESCRIPTION

[0048] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present invention, so the present invention is not limited by the specific implementation disclosed below.

[0049] It should be clear that the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in the field without creative work are within the scope of protection of the present application.

[0050] The terms used in the embodiments of the present application are only for the purpose of describing specific embodiments, and are not intended to limit the present application. The singular forms "a", "said" and "the" used in the embodiments of the present application and the appended claims are also intended to include plural forms, unless the context clearly indicates other meanings.

[0051] The orientation or position relationship indicated by the terms "bottom", "top", "lower", "inside", "outside", etc. is based on the orientation or position relationship shown in the drawings and is only for the convenience of describing the present invention and simplifying the description. It does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0052] Unless otherwise clearly specified and limited, the terms "connected" and "connection" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be directly connected, or indirectly connected through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0053] As used in this specification, the singular forms "a", "an", and "the" include plural referents unless the context clearly indicates otherwise. The terms "first", "second", and "third" are used for descriptive purposes only and are not to be understood as indicating or implying relative importance. The term "or" is generally used in a sense including "and / or" unless the context clearly indicates otherwise.

[0054] Figure 1 FIG. 1 shows a schematic diagram of the principle of a dual-gas-circuit heart assist system according to an embodiment of the present application. Figure 1 The dual-gas-circuit heart assist system includes a pressure generating mechanism 100, a first assisting device 200, a second assisting device 300, a detection device and a control mechanism, wherein the detection device and the control mechanism are not shown in the figure.

[0055] The pressure generating mechanism 100 is used to generate positive pressure and negative pressure alternately during operation. Figure 1 In one embodiment shown in FIG. 1 , the pressure generating mechanism 100 includes a compressor pump 130, a negative pressure tank 121 and a positive pressure tank 111. In one embodiment, the compressor pump 130 includes a negative pressure chamber and a positive pressure chamber, and both the negative pressure chamber and the positive pressure chamber are filled with gas. When the pressure generating mechanism 100 needs to output negative pressure, the compressor pump 130 sucks the gas in the negative pressure tank 121 into the negative pressure chamber, and a negative pressure is formed in the negative pressure tank 121; when the negative pressure tank 121 is connected to the pipeline or driving device connected to it, the pressure of the pipeline and the driving device is adjusted to the preset negative pressure. When the pressure generating mechanism 100 needs to output positive pressure, the positive pressure chamber of the compressor pump 130 injects gas into the positive pressure tank 111, and the pressure in the positive pressure tank 111 increases; when the positive pressure tank 111 is connected to the pipeline or driving device connected to it, the pressure of the pipeline and the driving device is adjusted to the preset positive pressure.

[0056] It should be noted that the present application does not impose any specific restrictions on the structure of the pressure generating mechanism 100, and any device that can alternately generate positive pressure and negative pressure falls within the protection scope of the present application.

[0057] The first auxiliary device 200 includes a first driven device 210 and a first piping line. The farthest end of the first piping line is provided with an inflow channel and an outflow channel, and the first driven device 210 is arranged in the tube body of the first piping line and corresponds to the position of the outflow channel; the pressure generating mechanism 100 alternately applies negative pressure and positive pressure to the first piping line to switch the first driven device 210 between blocking the outflow channel and blocking the first piping line. When performing cardiac assistance, the farthest end of the first piping line extends into the ventricle, and the nearest end of the first piping line is connected to a blood pump / diaphragm pump that can store blood. When the pressure generating mechanism 100 applies negative pressure to the first piping pipeline, the first driven device 210 blocks the outflow duct, and the blood in the ventricle flows into the blood pump / diaphragm pump through the first piping pipeline; when the pressure generating mechanism 100 alternately changes to positive pressure, the first driven device 210 blocks the first piping pipeline, at which time the blood pump / diaphragm pump is connected to the outflow duct, and through positive pressure, the blood in the blood pump / diaphragm pump is sent to the aorta (in the case of LVAD) or the lungs (in the case of RVAD). In this way, the blood pump / diaphragm pump helps the heart pump blood to the required parts of the body. It can be seen that the first auxiliary device can effectively reduce the preload of the heart by increasing blood flow, enhancing blood perfusion, and reducing myocardial oxygen consumption.

[0058] The second auxiliary device 300 includes a second driven device 310 for assisting the heart to pump blood and a second piping pipeline connected to the second driven device 310; the pressure generating mechanism 100 repeatedly expands and contracts the second driven device 310 through the second piping pipeline. The second driven device 310 is located at the ascending aorta and below the first driven device 210 when performing cardiac assistance. The below mentioned here refers to the side of the aorta away from the heart and the aortic arch. In some embodiments of the present application, the second driven device 310 adopts an inflatable balloon structure. The second driven device 310 is mainly placed in the ascending aorta, and is inflated and deflated synchronously with the pressure generating mechanism 100. During the diastole of the heart, the second driven device 310 is inflated, which increases the diastolic pressure in the aorta and increases the blood flow and oxygen supply of the coronary artery; during the systole of the heart, the second driven device 310 is deflated quickly, which reduces the pressure in the aorta, reduces the afterload of the heart, and thus reduces the oxygen consumption of the myocardium.

[0059] The detection device is used to obtain the intraventricular pressure and the intra-aortic pressure. In the embodiment of the present application, the detection device located in the left ventricle includes but is not limited to one or more pressure sensors, and the detection device located in the aorta includes but is not limited to one or more sensors. The detection device can be coupled to the first auxiliary device 200 and the second auxiliary device 300 and follow the first auxiliary device 200 and the second auxiliary device 300 to the preset position, or it can be fixed at the preset position by other independent equipment. The present application does not specifically limit the structure and installation method of the detection device. Any structure that can detect the intra-ventricular pressure and the intra-aortic pressure and the corresponding installation method fall within the protection scope of the present application.

[0060] The control mechanism is communicatively connected with the detection device, the first auxiliary device 200, the second auxiliary device 300 and the pressure generating mechanism 100. The first piping pipeline and the second piping pipeline are both connected to the pressure generating mechanism 100. The control mechanism controls the pressure generating mechanism 100 to drive the first driven device 210 and the second driven device 310 respectively according to the corresponding timing within one control cycle according to the pressure signal sent by the detection device.

[0061] A method for using the dual-gas-circuit cardiac assist system is described in detail below. The method specifically includes the following steps:

[0062] S1. Extend the farthest end of the first piping in the first auxiliary device 200 to the ventricle, and the inflow channel is transported to the left ventricle along the first piping, and the outflow channel outlet is located at the aortic arch. Transport the second driven device 310 in the second auxiliary device 300 to the vicinity of the aortic arch and below the outflow channel outlet. Below refers to the direction in which the outflow channel outlet is away from the heart and the aortic arch.

[0063] S2. Obtain the blood flow dynamic parameters in the left ventricle and aorta according to the detection device; and infer the closing time of the aortic valve and determine the diastolic period and ejection time of the left ventricle according to the obtained parameters.

[0064] S3. When the closure of the aortic valve is detected, the diastolic period of the left ventricle is divided into a first time period and a second time period. In the first time period, the control mechanism controls the first auxiliary device 200 to eject blood into the aorta to reduce the preload of the heart. In the second time period, the control mechanism controls the second driven device 310 in the second auxiliary device 300 to expand and approximately block the aortic segment below the aortic arch to increase the diastolic pressure in the aorta and increase the blood flow and oxygen supply of the coronary artery. In the diastolic period of the left ventricle, the first auxiliary device 200 and the second auxiliary device 300 reduce the preload of the heart according to the sequence of the first time period and the second time period.

[0065] S4. At a predetermined time before the moment of left ventricular ejection, the second driven device 310 is controlled to contract. After the detection device detects that the pressure in the aorta is reduced to a preset value, the control mechanism controls the first driven device 210 to absorb blood from the left ventricle to reduce the left ventricular after-ejection load.

[0066] In one embodiment of the above-mentioned dual-circuit heart assist system, the detection device includes a first pressure sensor and a second pressure sensor. The first pressure sensor is arranged at the farthest end of the first piping pipeline and can extend to the ventricle with the farthest end of the first piping pipeline. In this embodiment, the first pressure sensor reaches the ventricle by coupling on the first piping pipeline and following the farthest end of the first piping pipeline. The number of first pressure sensors includes but is not limited to one. When the number of first pressure sensors is multiple, the position of their arrangement can be arranged according to actual needs, and is not specifically limited in this embodiment. In one embodiment, the second pressure sensor is coupled to the second piping pipeline and can move with the movement of the second piping pipeline. After the position of the second piping pipeline is fixed, the position of the second pressure sensor is located in the aorta. In some embodiments, the number of second pressure sensors includes but is not limited to one. When the number of second pressure sensors is multiple, the position of their arrangement can be arranged according to actual needs, and is not specifically limited in this embodiment.

[0067] In one embodiment, the pressure generating mechanism 100 includes a positive pressure generating device 110 and a negative pressure generating device 120. Figure 1 The compressor pump 130 and the positive pressure tank 111 constitute the positive pressure generating device 110. The compressor pump 130 and the negative pressure tank 121 constitute the negative pressure generating device 120. A first valve group 220 is arranged on the first piping pipeline. The first valve group 220 includes a first positive pressure valve 211 connected to the positive pressure generating device and a first negative pressure valve 212 connected to the negative pressure generating device. The control mechanism controls the first valve group 220 so that the pressure generating device alternately applies positive pressure and negative pressure to the first driven device 210.

[0068] A second valve group 320 is arranged on the second piping pipeline, and the second valve group 320 includes a second positive pressure valve 311 connected to the positive pressure generating device and a second negative pressure valve 312 connected to the negative pressure generating device. The control mechanism controls the second valve group 320 so that the pressure generating device alternately applies positive pressure and negative pressure to the second driven device 310 to repeatedly expand and contract.

[0069] The control mechanism controls the opening and closing of the positive pressure valve and the negative pressure valve in the first valve group 220 and the second valve group 320 respectively to enable the first auxiliary device 200 and the second auxiliary device 300 to perform corresponding auxiliary operations at different time sequences.

[0070] In the above-mentioned method of using the dual-circuit cardiac assist system, the method in which the control mechanism controls the first assist device 200 and the second assist device 300 respectively at different time sequences is specifically as follows:

[0071] First, the blood flow dynamic parameters in the left ventricle and aorta are obtained by the detection device, and the closing time of the aortic valve is inferred based on the obtained parameters, and the diastolic period and ejection time of the left ventricle are determined. The diastolic period of the left ventricle is divided into a first time period and a second time period.

[0072] When it is detected that the aortic valve is closed and the diastolic period of the left ventricle is in the first time period, the control mechanism controls the first positive pressure valve 211 in the first valve group 220 to open and the first negative pressure valve 212 to close, controls the second positive pressure valve 311 in the second valve group 320 to open and the second negative pressure valve 312 to close, and the second driven device 310 in the second auxiliary device 300 expands to approximately block the aortic segment below the aortic arch. The first auxiliary device 200 ejects blood into the aorta, reduces the preload of the heart, increases the diastolic pressure in the aorta, and increases the blood flow and oxygen supply in the coronary artery. In the second time period, the first positive pressure valve 211 is closed and the first negative pressure valve 212 is opened, the first driven device 210 presents negative pressure and causes the first auxiliary device 200 to gradually absorb blood from the left ventricle. The second positive pressure valve 311 is in an open state and the second negative pressure valve 312 is closed, and the second driven device 310 expands and continues to approximately block the aortic segment below the aortic arch.

[0073] In the time period before the left ventricle ejection, the control mechanism controls the first negative pressure valve 212 in the first valve group 220 to remain open, the first positive pressure valve 211 to close, the first driven device 210 presents negative pressure and continues to make the first auxiliary device 200 draw blood from the left ventricle. At the same time, the second negative pressure valve 312 in the second valve group 320 is controlled to open and the second positive pressure valve 311 to close, correspondingly the second driven device 310 contracts, the pressure in the aorta is reduced, and the ejection afterload can be reduced.

[0074] In one embodiment, the first piping line is also provided with a third pressure sensor 230 capable of detecting the pressure of the first piping line and a first safety valve 240 capable of connecting the first piping line to the outside of the line in sequence in the pipe section between the first driven device 210 and the first valve group 220. The third pressure sensor 230 is used to detect the pressure in the first piping line, and the first safety valve 240 is used to connect the first piping line to the external atmospheric pressure. Since the first piping line is connected to the first driven device 210, when the pressure in the first piping line is detected to be abnormal, the first safety valve 240 can quickly release the gas in the first piping line to the atmosphere, thereby releasing the pressure in the first driven device 210, and the first driven device 210 is in the original working state.

[0075] In one embodiment, the second driven device 310 comprises an IABP counterpulsation balloon, see Figure 1 . A safety disk 330 is connected between the IABP counterpulsation balloon and the second valve group 320. The first side 331 of the safety disk 330 is used to communicate with the IABP counterpulsation balloon and can be detachably connected, the second side 332 is connected to the first valve group 220, and the first side 331 of the safety disk 330 is connected to the helium tank; the safety disk 330 applies the positive pressure and negative pressure output by the pressure generating mechanism 100 to the IABP counterpulsation balloon to expand or contract the IABP counterpulsation balloon. The safety disk 330 can apply the rated volume of gas and the positive pressure and negative pressure output by the pressure generating device to the IABP counterpulsation balloon to expand or contract the IABP counterpulsation balloon. In this process, the pressure generating device controls the alternating time of positive pressure and negative pressure, can adjust the pressure of the positive pressure, and continuously and stably ensure the pressure output and safe filling volume. By controlling the alternating time of the second positive pressure valve 311 and the second negative pressure valve 312, the expansion and contraction of the IABP counterpulsation balloon can be controlled, and the IABP counterpulsation balloon can be prevented from being subjected to pressure of a continued expansion trend after expansion is completed, thereby ensuring the safety of the IABP counterpulsation balloon.

[0076] In one embodiment, a fourth pressure sensor 340 is provided between the safety disk 330 and the first valve group 220 to monitor the pressure of the first piping line. When the fourth pressure sensor 340 detects that the pressure of the line between the safety disk 330 and the second valve group 320 is abnormal, a monitoring signal is sent to the control mechanism, and the control mechanism can control the valve structure or other structure provided on the first piping line accordingly, so that the pressure on the second side of the safety disk 330 is the same as the atmospheric pressure.

[0077] In one embodiment, a three-way catheter 370 is further provided between the IABP counterpulsation balloon and the safety disk 330. The first tube port of the three-way catheter 370 is connected to the IABP counterpulsation balloon, the second tube port is connected to the second side of the safety disk 330, and the third tube port is connected to the negative pressure generating device 120. The first tube port and the third tube port of the three-way catheter 370 are connected, so that the IABP counterpulsation balloon is directly connected to the negative pressure generating device 120. When the IABP counterpulsation balloon fails or the second piping line fails, the negative pressure of the negative pressure generating device 120 can quickly deflate the IABP counterpulsation balloon, thereby preventing the IABP counterpulsation balloon from being in an expanded state and affecting the pressure in the aorta.

[0078] In one embodiment, a fourth safety valve 380 is provided on the pipeline between the third pipe port and the negative pressure generating device 120. The fourth safety valve 380 is a normally closed solenoid valve, and the fourth safety valve 380 is provided to control the connection between the IABP counterpulsation balloon and the negative pressure generating device 120. The fourth safety valve 380 is used to connect the air pressure in the pipeline with the atmospheric pressure when a fault occurs in the second piping pipeline, so as to ensure that the balloon is restored to its original state and avoid negative effects on the patient.

[0079] In one embodiment, the first side 331 of the safety disk 330 is also connected to a gas supply line 400. Figure 1 In the illustrated embodiment, the gas supply pipeline 400 includes a helium tank 410, a gas supply tank 420, a sixth safety valve 430, and a fifth pressure sensor 440. The pressure on the first side 331 of the safety disk 330 is detected by the fifth pressure sensor 440. When the pressure is insufficient or does not meet the set requirements, the gas in the helium tank 410 can be adjusted to adjust the pressure on the first side 331 of the safety disk 330 by adjusting the opening of the sixth safety valve 430. When the gas in the helium tank 410 is exhausted or insufficient, the pressure on the first side 331 of the safety disk 330 can also be adjusted by the gas supply tank 420.

[0080] The scheme and working principle of the dual-circuit heart assist system are further explained below by taking the first assist device 200 as a pVAD catheter and the second assist device 300 as an aortic balloon counterpulsation pump as an example.

[0081] One embodiment of the pVAD catheter in the present application may be a single-lumen catheter. Figure 2 : is a schematic diagram of the structure of a pVAD catheter according to an embodiment. The single-lumen catheter has a rotating two-way valve 313 integrated at the front end of the catheter, and the distal end of the catheter is connected to an additional extracorporeal membrane pump 314. The working principle of the single-lumen catheter is as follows: the working process is triggered by the heart rhythm like the IABP. When the heart is in the systolic phase, blood is sucked into the extracorporeal membrane pump from the left ventricle through the catheter tip and lumen; in the diastolic phase, the extracorporeal membrane pump discharges the blood through the catheter, then opens the valve at the front end of the catheter, and delivers the blood to the ascending aorta through the side flow outlet. The closing of the aortic valve and the opening of the catheter valve maintain synchronous pulsation to ensure that the function of the aortic valve is not impaired.

[0082] Figure 3 FIG. 1 is a cross-sectional view of a rotating bidirectional valve located at the front end of a single-lumen catheter according to an embodiment. Figure 3 The rotary two-way valve comprises a valve body 10, an eccentric valve disc 20 and guide tubes 30 arranged at both ends of the valve body.

[0083] The valve body 10 has a spatial axial direction, and the first opening 16 and the second opening 17 arranged along the axial direction are provided on both sides of the valve body, and the ends of the two sides of the valve body are sleeved on the conduit 30. The flow channel between the first opening 16 and the second opening 17 and the inner cavity of the conduit 30 together constitute the flow channel 18 of the conduit; the eccentric valve disc 20 is located in the flow channel 18 and is rotatably connected to the valve body 10. The eccentric valve disc 20 blocks the flow channel 18 in the original state, see Figure 3 When the pressure on the first opening 16 side is lower than the pressure on the second opening 17 side, the eccentric valve disc 20 rotates in the first direction to block the outlet 11 and connect the flow channel 18 between the first opening 16 and the second opening 17, see Figure 4 When fluid enters the circulation channel 18 from the first opening 16, the fluid acts on the eccentric valve disc 20, and the eccentric valve disc 20 rotates in the second direction until the circulation channel 18 is blocked. Figure 5 The fluid flows out from the second opening 17 , and the first direction is opposite to the second direction.

[0084] When the single-lumen catheter in the above embodiment is used as the first auxiliary device 200, the distal end of the single-lumen catheter is delivered to the ventricle, and the outlet 11 is located at the aortic arch. When the control mechanism controls the first positive pressure valve 211 in the first valve group 220 to open, the eccentric valve plate 20 in the single-lumen catheter is in Figure 3 In the state shown in FIG. 1 , the extracorporeal membrane pump 314 is connected to the outlet 11 (i.e., the outflow channel), and the extracorporeal membrane pump can eject the blood stored inside it into the aorta through the outlet 11. When the control mechanism controls the first negative pressure valve 212 to open and the first positive pressure valve 211 to close, the eccentric valve plate 20 in the single-lumen catheter is in Figure 4 In the state shown, the single-lumen catheter can draw blood in the left ventricle and store it in the extracorporeal membrane pump 314. It should be noted that the above embodiments are only exemplary, and any pVAD catheter structure that realizes catheter opening and closing through an eccentric valve sheet falls within the protection scope of this application.

[0085] In the embodiment of the present application, the second auxiliary device 300 is an aortic balloon pump IABP, and the corresponding second driven device 310 is an IABP balloon catheter. The balloon catheter has a balloon that expands (inflates) and contracts in accordance with the beating of the heart. The balloon is composed of a cylindrical balloon membrane with a membrane thickness of about 50 to 150 μm. Figure 6 is a cross-sectional view of a balloon catheter according to an embodiment of the present application, see Figure 6 The balloon catheter has a balloon 22 that expands (expands) and contracts in accordance with the beating of the heart. The balloon 22 in the IABP is made of a material with excellent bending fatigue resistance. In the embodiment of the present application, the shape of the balloon membrane in the expanded state is cylindrical, but it is not limited to this and can also be a polygonal cylindrical shape. The outer diameter and length of the balloon 22 are determined by the internal volume of the balloon 22 and the inner diameter of the arterial blood vessel.

[0086] It should be noted that the aortic balloon pump including the balloon catheter in the above-mentioned embodiment is only exemplary, and any IABP device on the market that uses positive and negative pressure to help the heart perform effective blood pumping function, relieve cardiac load, and protect the heart and organs can be used as the second auxiliary device 300 in the embodiment of the present application.

[0087] Taking the first auxiliary device 200 as a pVAD catheter and the second auxiliary device 300 as an aortic balloon pump IABP as an example, an exemplary explanation is given of how the control mechanism controls the pressure generating mechanism 100 to drive the first driven device 210 and the second driven device 310 respectively according to the corresponding timing within a control cycle to assist the left ventricle based on the pressure signal sent by the detection device.

[0088] One implantation method is to implant the pVAD catheter from the carotid artery at the most distal end, with the inflow tract of the pVAD catheter entering the left ventricle and the outflow tract located at the aortic arch; the IABP catheter enters from the femoral artery, with the balloon placed at the aortic arch and below the outflow tract of the pVAD catheter, where below refers to the direction of the outflow tract outlet away from the aortic arch. After the pVAD catheter and IABP are implanted, one of the control methods of the control mechanism is as follows:

[0089] Figure 7 FIG. 1 is a timing control diagram of a control mechanism according to an embodiment. Figure 7 , t0, t0', and t0" are the moments when the aortic valve closes.

[0090] In a cycle from the last aortic valve closure time t0 to the next aortic valve closure time t0': at the aortic valve closure time t0, the left ventricle is in diastole, the control mechanism controls the first positive pressure valve 211 to open, and the eccentric valve plate 20 in the pVAD catheter blocks the flow channel 18. At the same time, the control mechanism controls the second negative pressure valve 312 to open, and the balloon is in a deflated state.

[0091] At time t3, the control mechanism controls the second positive pressure valve 311 to open, and the balloon is inflated until time t4. During the time period t3-t2, the first positive pressure valve 211 of the pVAD catheter is still in an open state, that is, the eccentric valve plate 20 in the pVAD catheter still blocks the circulation channel 18. The balloon is in an inflated state. During this time period, the balloon blocks the aorta, and the blood pump located outside the body of the pVAD catheter ejects the blood stored in the blood pump into the aorta, and the blood ejected into the aorta enters the coronary artery and thus helps the coronary blood supply.

[0092] From time t2, the control mechanism controls the first negative pressure valve 212 to open, and the eccentric valve plate 20 in the pVAD catheter blocks the outflow path, so that the flow channel 18 between the first opening 16 and the second opening 17 is connected. From time t2 to the next aortic valve closure time t0', the first negative pressure valve 212 is in an open state. During the time period t2-t0', the left ventricle is in a contraction state, and at this time, the pVAD draws blood from the left ventricle to reduce the pre-ejection load.

[0093] During the time period of t4-t0', the control mechanism controls the second negative pressure valve 312 to open, and the balloon is in a deflated state, which can reduce the after-ejection load.

[0094] From the above analysis, it can be seen that in the cycle from the closure of the aortic valve to the next closure, the control mechanism controls the exchange control of the eccentric valve leaf and the balloon in the pVAD catheter, which can reduce the front and rear loads at the same time in the same cycle period, thereby improving the blood supply to the heart.

[0095] In summary, the dual-circuit cardiac assist system in the present application uses the same pressure generating device to supply pressure to the first assisting device 200 and the second assisting device 300, and controls the first assisting device 200 and the second assisting device 300 in timing respectively through a control mechanism to achieve simultaneous assisting of the cardiac preload and afterload within a predetermined cycle. The use of the same pressure generating device simplifies the structure of the assisting system, and the two assisting devices are coupled to a control system for coordinated control, which further simplifies the operation compared with the parallel control of two control systems.

[0096] According to another aspect of the present application, a dual-gas-circuit gas source system is also provided, comprising:

[0097] A pressure generating mechanism 100 which generates positive pressure and negative pressure alternately during operation;

[0098] a first piping pipeline, wherein the pipe body at the farthest end of the first piping pipeline is provided with an inflow channel and an outflow channel, and a first driven device 210 is arranged in the pipe body of the first piping pipeline at a position corresponding to the outlet of the outflow channel; the pressure generating mechanism 100 alternately applies negative pressure and positive pressure to the first piping pipeline so that the first driven device 210 switches between blocking the outflow channel and blocking the first piping pipeline;

[0099] a second piping line connected to the pressure generating mechanism 100 and used to transmit the alternating positive pressure and negative pressure generated by the pressure generating mechanism 100;

[0100] A detection device for obtaining intraventricular pressure and intraaortic pressure;

[0101] The control mechanism is communicatively connected with the detection device, the first piping pipeline, the second piping pipeline and the pressure generating mechanism 100. The control mechanism controls the pressure generating mechanism 100 to drive the position switching of the first driven device 210 according to the corresponding timing within a cyclic control period according to the pressure signal sent by the detection device, and to deliver alternating positive and negative pressures to the second piping pipeline.

[0102] The first piping line of the dual-gas source system is used to connect the first driven device 210 such as pVAD, and the second piping line is used to connect the second driven device 310 such as the balloon of the aortic balloon pump. The working principle and control method of how the control mechanism controls the pressure generating mechanism 100 to drive the first driven device 210 and the second driven device 310 according to the corresponding timing in a cycle control period according to the pressure signal sent by the detection device, refer to the relevant content in the exemplary case in the above embodiment, and will not be repeated here.

[0103] According to another aspect of the present application, a method for using the dual gas path gas source system is provided, which specifically includes the following steps:

[0104] S1, selecting a pVAD conduit whose first driven device is an eccentric valve plate as a first piping pipeline, and connecting the first piping pipeline to a pressure generating mechanism;

[0105] S2, selecting an aortic balloon pump IABP with a safety disc structure as the second piping line; connecting the aortic balloon pump to the pressure generating mechanism;

[0106] S3. The control mechanism controls the pressure generating mechanism to connect only the first piping line in one cycle control period according to the pressure signal sent by the detection device, thereby controlling the position switching of the first driven device.

[0107] The dual gas source system in the present application includes two piping lines, one connected to the pVAD catheter and the other connected to the aortic balloon pump IABP. The control mechanism closes the valve structure on the second piping line within a cycle control period, and the IABP is in a closed state, and only the pVAD works.

[0108] In one embodiment of the prior art, a pVAD catheter access port is provided on the IABP, which can be referred to Figure 1The interface with the label number 370. When the pVAD catheter is used for left ventricular assistance, the aortic balloon pump does not work, and the pVAD catheter uses the air source of the aortic balloon pump for corresponding assistance. The balloon in the aortic balloon pump is usually thin. In order to prevent the balloon from being blown up or broken, a safety disk 330 is usually provided in the pipeline of the aortic balloon pump. At the same time, the balloon is directly driven after the pressure is transmitted through the safety disk 330, and the pressure loss is small. Due to the volume of the safety disk 330, the pressure value used by the aortic balloon pump to drive the balloon is relatively small. When the pVAD catheter is connected to the interface 370 of the aortic balloon pump, since the middle part of the pVAD is usually a thinner liquid tube, the liquid flow pressure loss is large, and the required driving pressure is also relatively large. The pressure provided by the aortic balloon pump is limited by the safety disk and the balloon, and is smaller than the driving pressure required by the pVAD catheter. Of the smaller pressure, part is lost to liquid flow, and only the other part is used to promote blood flow into the aorta. This results in less blood flow into the aorta through the pVAD catheter per unit time, and thus a poorer auxiliary effect.

[0109] The dual-air-circuit gas source system in the embodiment of the present application is provided with two piping pipelines, and the pVAD catheter can be directly connected to the gas source (pressure generating mechanism). Since it is no longer restricted by the safety disk and the balloon, the pressure provided to the pVAD catheter by the pressure generating mechanism 100 can take factors such as liquid flow pressure loss into consideration to provide a larger driving pressure. The blood flow rate flowing into the aorta through the pVAD catheter per unit time will be greatly increased, thereby having a better auxiliary effect.

[0110] Obviously, many modifications and variations can be made according to the contents of this specification. This specification selects and specifically describes these embodiments in order to better explain the principles and practical applications of the present invention, so that those skilled in the art can make good use of the present invention. The present invention is limited only by the claims and their full scope and equivalents.

Claims

1. A dual-circuit heart assist system, characterized in that: include: A pressure generating mechanism that generates positive and negative pressure alternately during operation; The first auxiliary device comprises a first driven device and a first piping pipeline, wherein the farthest end of the first piping pipeline is provided with an inflow channel and an outflow channel, and the first driven device is arranged in the tube body of the first piping pipeline and corresponds to the position of the outflow channel; the pressure generating mechanism alternately applies negative pressure and positive pressure to the first piping pipeline so that the first driven device switches between blocking the outflow channel and blocking the first piping pipeline; A second auxiliary device, comprising a second driven device for assisting the heart in pumping blood and a second piping line in communication with the second driven device; The pressure generating mechanism causes the second driven device to repeatedly expand and contract through the second piping line; A detection device for obtaining intraventricular pressure and intraaortic pressure; The control mechanism is communicatively connected with the detection device, the first auxiliary device, the second auxiliary device and the pressure generating mechanism. The first piping pipeline and the second piping pipeline are both connected to the pressure generating mechanism. The control mechanism controls the pressure generating mechanism to drive the first driven device and the second driven device respectively according to the corresponding timing within a cyclic control period based on the pressure signal sent by the detection device.

2. The dual-circuit heart assist system according to claim 1, characterized in that: The detection device includes a first pressure sensor and a second pressure sensor; The first pressure sensor is disposed at the most distal end of the first piping pipeline and can extend along the most distal end of the first piping pipeline to the ventricle; The second pressure sensor is disposed on the second piping line. After the position of the second piping line is fixed, the second pressure sensor is located in the aorta.

3. The dual-circuit heart assist system according to claim 1 or 2, characterized in that: The pressure generating mechanism includes a positive pressure generating device and a negative pressure generating device; A first valve group is arranged on the first piping line, the first valve group includes a first positive pressure valve connected to the positive pressure generating device and a first negative pressure valve connected to the negative pressure generating device, and the control mechanism controls the first valve group so that the pressure generating device alternately applies positive pressure and negative pressure to the first driven device; A second valve group is arranged on the second piping line, the second valve group includes a second positive pressure valve connected to the positive pressure generating device and a second negative pressure valve connected to the negative pressure generating device, and the control mechanism controls the second valve group to make the pressure generating device alternately apply positive pressure and negative pressure to the second driven device so that the second driving device repeatedly expands and contracts; And the control mechanism sends control instructions to the first valve group and the second valve group respectively at different time sequences.

4. The dual-circuit heart assist system according to claim 3, characterized in that: The second driven device includes an IABP counterpulsation balloon, and a safety disk is connected between the IABP counterpulsation balloon and the second valve group; The first side of the safety disk is used to communicate with the IABP counterpulsation balloon and is detachably connected, and the second side is connected to the first valve group. The first side of the safety disk is connected to the helium tank; the safety disk applies the positive pressure and negative pressure output by the pressure generating mechanism to the IABP counterpulsation balloon to expand or contract the IABP counterpulsation balloon.

5. The dual-circuit heart assist system according to claim 4, characterized in that: A three-way catheter is also arranged between the IABP counterpulsation balloon and the safety disk; the first tube port of the three-way catheter is connected to the IABP counterpulsation balloon, the second tube port is connected to the second side of the safety disk; and the third tube port is connected to the negative pressure generating device.

6. The dual-circuit heart assist system according to claim 5, characterized in that: A fourth safety valve is arranged on the pipeline between the third pipe opening and the negative pressure generating device.

7. The dual-circuit heart assist system according to claim 4, characterized in that: The first side of the safety disk is also connected to an air supply pipeline.

8. A method for using the dual-circuit heart assist system according to any one of claims 1 to 7, characterized in that: The following steps are involved: S1, delivering the inflow channel of the first piping line in the first auxiliary device to the left ventricle, with the outflow channel outlet located at the aortic arch; delivering the second driven device to the vicinity of the aortic arch and below the outflow channel outlet; the below refers to the direction in which the outflow channel outlet is away from the aortic arch; S2. Obtaining blood flow dynamic parameters in the left ventricle and aorta according to the detection device; and inferring the closing time of the aortic valve and determining the diastolic period and ejection time of the left ventricle according to the obtained parameters; S3, when the closure of the aortic valve is detected, the diastolic period of the left ventricle is divided into a first time period and a second time period, in the first time period, the control mechanism controls the second driven device to expand, and controls the first auxiliary device to eject blood into the aorta; in the second time period, the second driven device in the second auxiliary device is controlled to continue to expand, and controls the first auxiliary device to gradually absorb blood from the left ventricle to reduce the cardiac preload; S4. At a predetermined time before the moment of left ventricular ejection, the second driven device is controlled to contract, and the first driven device continues to absorb blood from the left ventricle to reduce the left ventricular after-ejection load.

9. A dual-gas-circuit gas source system, characterized in that: include: A pressure generating mechanism that generates positive and negative pressure alternately during operation; a first piping pipeline, wherein the pipe body at the farthest end of the first piping pipeline is provided with an inflow channel and an outflow channel, and a first driven device is arranged in the pipe body of the first piping pipeline at a position corresponding to the outlet of the outflow channel; the pressure generating mechanism alternately applies negative pressure and positive pressure to the first piping pipeline so that the first driven device switches between blocking the outflow channel and blocking the first piping pipeline; a second piping line connected to the pressure generating mechanism and used to transmit the alternating positive and negative pressures generated by the pressure generating mechanism; A detection device for obtaining intraventricular pressure and intraaortic pressure; The control mechanism is communicatively connected with the detection device, the first piping line, the second piping line and the pressure generating mechanism. The control mechanism controls the pressure generating mechanism to drive the position switching of the first driven device according to the corresponding timing within a cyclic control period based on the pressure signal sent by the detection device, and to deliver alternating positive and negative pressures to the second piping line.

10. A method for using the dual gas path gas source system according to claim 9, characterized in that: The following steps are involved: S1, selecting a pVAD conduit with an eccentric valve disc as a first driven device as a first piping pipeline, and connecting the first piping pipeline to the pressure generating mechanism; S2, selecting an aortic balloon pump IABP with a safety disc structure as the second piping pipeline; the aortic balloon pump is connected to the pressure generating mechanism; S3. The control mechanism controls the pressure generating mechanism to connect only the first piping line within a cycle control period according to the pressure signal sent by the detection device, so as to control the position switching of the first driven device.

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