Dual-limb gas source system, dual-limb cardiac assist system, and methods of use

Abstract

The application discloses a double-gas-path air source system, a double-gas-path heart auxiliary system and a use method. The double-gas-path heart auxiliary system comprises a pressure generating mechanism, a first auxiliary device, a second auxiliary device, a detection device and a control mechanism. The pressure generating mechanism alternately generates positive pressure and negative pressure during work. The first auxiliary device comprises a first driven device and a first pipe line, and a tube body at the farthest end of the first pipe line is provided with an inflow and an outflow. The first driven device is located in the tube body of the first pipe line and corresponds to the position of the outflow. The second auxiliary device comprises a second driven device and a second pipe line in communication with the second driven device. The pressure generating mechanism makes the second driven device repeatedly expand and contract through the second pipe line. The detection device is used for acquiring the intraventricular pressure and the intra-aortic pressure. The control mechanism controls the pressure generating mechanism to drive the first driven device and the second driven device 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] This invention relates to the field of medical devices, specifically to a dual-airflow gas source system, and a dual-airflow cardiac assist system using the dual-airflow gas source system and its usage method. Background Technology

[0002] An intra-aortic balloon pump (IABP) is a mechanical circulatory assist device commonly used in acute coronary syndrome and cardiac surgery to help the heart pump blood more effectively, reduce cardiac workload, and protect the heart and other organs. The IABP assists the heart in pumping blood by inserting an inflatable balloon into the aorta. This balloon is primarily placed in the ascending aorta and inflates and deflates synchronously with an external pump. During diastole, the balloon inflates, increasing diastolic pressure in the aorta, thereby increasing coronary blood flow and oxygen supply. During systole, the balloon rapidly deflates, reducing pressure in the aorta, decreasing cardiac afterload, and thus reducing myocardial oxygen consumption.

[0003] A percutaneous ventricular assist device (pVAD) is a temporary cardiac assist device used for patients with heart failure. pVADs are typically used for patients awaiting heart transplantation or whose heart function has been severely impaired due to an acute cardiac event. The pVAD works by surgically inserting a catheter into either the left or right ventricle of the heart. The other end of the catheter is connected to an external blood pump. The pump collects blood from the corresponding ventricle through the catheter, and the collected blood is then mechanically pumped to the aorta (in the case of a left ventricular assist device) or the lungs (in the case of a right ventricular assist device). In this way, the pump helps the heart deliver blood to the parts of the body that need it. By increasing blood flow, enhancing blood perfusion, and reducing myocardial oxygen consumption, pVADs effectively reduce cardiac preload and help improve cardiac pumping function in patients with acute heart failure in the short term.

[0004] As described above, using an IABP (Intra-aortic balloon pump) can reduce cardiac afterload and improve coronary perfusion; while using a PVAD (Positive Ventilation Adsorption) catheter can reduce cardiac preload, decrease ventricular wall tension, and reduce myocardial oxygen consumption. Currently, both IABP and PVAD catheters are used clinically alone. To achieve the effect of simultaneously reducing cardiac preload and afterload, two devices are required, each with its own adjustments. Due to the dynamic changes in the cardiac cycle, medical staff need to make corresponding adjustments to both devices separately, making the operation very cumbersome.

[0005] Developing an assistive system that can simultaneously assist cardiac preload and afterload while simplifying operation has become a challenging research problem in the industry. Summary of the Invention

[0006] The purpose of this invention is to provide a dual-airway cardiac assist system that can provide an airway system that enables simultaneous assistance from two devices, and to simplify the operation of the assist system through timing control.

[0007] To achieve the above objectives, one aspect of the present invention provides a dual-circuit cardiac assist system, comprising:

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

[0009] The first auxiliary device includes a first driven device and a first piping system. The pipe body at the farthest end of the first piping system has an inflow channel and an outflow channel. The first driven device is disposed inside the pipe body of the first piping system and corresponds to the position of the outflow channel. The pressure generating mechanism alternately applies negative pressure and positive pressure to the first piping system to switch between blocking the outflow channel and blocking the first piping system.

[0010] The second auxiliary device includes a second driven device for assisting cardiac pumping and a second piping line connected to the second driven device; the pressure generating mechanism causes the second driven device to repeatedly expand and contract through the second piping line.

[0011] A detection device used to acquire intracardiac intraventricular pressure and aortic intravascular pressure;

[0012] The control mechanism is communicatively connected to the detection device, the first auxiliary device, the second auxiliary device, and the pressure generating mechanism. The first piping and the second piping 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 in a corresponding timing sequence within a cyclic control cycle according to 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 located at the farthest end of the first piping line and can extend to the ventricle along with the farthest end of the first piping line; the second pressure sensor is located on the second piping line, and after the position of the second piping line 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 configured on the first piping line, the first valve group including 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 to cause the pressure generating device to alternately apply positive and negative pressure to the first driven device; a second valve group is configured on the second piping line, the second valve group including 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 cause the pressure generating device to alternately apply positive and negative pressure to the second driven device to cause the second driven device to repeatedly expand and contract; and the control mechanism sends control commands to the first valve group and the second valve group respectively at different times.

[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 in the section between the first driven device and the first valve group, and a first safety valve capable of connecting the first piping line to the outside of the pipeline.

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

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

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

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

[0021] According to another aspect of this application, a method of using the above-mentioned dual-circuit cardiac assist system is also provided, specifically including the following steps:

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

[0023] S2. Obtain hemodynamic parameters in the left ventricle and aorta using the detection device; and infer the closing time of the aortic valve and determine the diastolic and ejection times of the left ventricle based on the obtained parameters.

[0024] S3. Upon detecting that the aortic valve is closed, the diastolic phase 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 the first auxiliary device is controlled to gradually draw blood from the left ventricle to reduce cardiac preload.

[0025] S4. At a predetermined time before the left ventricular ejection time, control the second driven device to contract, while the first driven device continuously draws blood from the left ventricle to reduce the afterload of the left ventricle.

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

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

[0028] The first piping system has an inflow channel and an outflow channel at its farthest end. A first driven device is installed inside the first piping system 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 system to switch between blocking the outflow channel and blocking the first piping system.

[0029] The second piping line is connected to the pressure generating mechanism and is used to transmit the alternating positive and negative pressure generated by the pressure generating mechanism.

[0030] A detection device used to acquire intracardiac intraventricular pressure and aortic intravascular pressure;

[0031] The control mechanism is communicatively connected to the detection device, the first piping, the second piping, 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 sequence within a cyclic control cycle, and to deliver alternating positive and negative pressure to the second piping, based on the pressure signal sent by the detection device.

[0032] According to another aspect of this application, a method of using the above-mentioned dual-gas-path gas source system is also provided, comprising the following steps:

[0033] S1. Select the pVAD conduit with the eccentric valve plate as the first driven device as the first piping line, and connect the first piping line to the pressure generating mechanism.

[0034] S2. Select an aortic balloon pump (IABP) with a safety disc structure as the second piping line; connect the aortic balloon pump to the pressure generating mechanism.

[0035] S3. The control mechanism controls the pressure generating mechanism to connect only the first piping line in one cycle of control based on the pressure signal sent by the detection device, thereby controlling the position switching of the first driven device.

[0036] Compared with the prior art, the dual-air-path gas source device and the cardiac assist system using the gas source device described in this invention have the following advantages:

[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 controlled in sequence by the control mechanism to simultaneously assist the preload and afterload of the heart within a predetermined cycle, thereby improving the blood supply to the heart.

[0038] 2. Using the same pressure generating device simplifies the structure of the auxiliary system. At the same time, the two auxiliary devices are coupled into a single control system for coordinated control, which makes operation simpler compared to parallel control by two separate control systems. Attached Figure Description

[0039] Figure 1 A schematic diagram illustrating the principle of a dual-airway cardiac assist system according to an embodiment of this application is shown;

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

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

[0042] Figure 4 for Figure 3 The diagram shows the second state of the rotary bidirectional valve.

[0043] Figure 5 for Figure 4 The diagram shows the force direction of the rotary two-way valve.

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

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

[0046] Figure label:

[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 assembly; 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-Rotating... 314-Bidirectional valve; 320-Extracorporeal membrane pump; 330-Second valve assembly; 331-First side; 332-Second side; 340-Fourth pressure sensor; 370-Three-way conduit; 380-Fourth safety valve; 400-Make-up gas line; 410-Gas tank; 420-Make-up gas tank; 430-Sixth safety valve; 440-Fifth pressure sensor; 10-Valve body; 11-Outlet; 16-First opening; 17-Second opening; 18-Flow channel; 20-Eccentric valve plate; 22-Airbag; 30-Conduit. Detailed Implementation

[0048] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0049] It should be understood that the described embodiments are merely some, not all, of the embodiments in this application. All other embodiments obtained by those skilled in the art based on the embodiments in this application without inventive effort are within the scope of protection of this application.

[0050] The terminology used in the embodiments of this application is for the purpose of describing particular embodiments only and is not intended to be limiting of this application. The singular forms “a,” “the,” and “the” used in the embodiments of this application and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise.

[0051] The terms “bottom,” “top,” “lower,” “inner,” and “outer,” etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting the present invention.

[0052] Unless otherwise explicitly specified and limited, the terms "connected" and "linked" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0053] As used herein, the singular forms “a,” “an,” and “the” include plural objects unless otherwise expressly stated. The terms “first,” “second,” and “third” are used for descriptive purposes only and should not be construed as indicating or implying relative importance. The term “or” is generally used to include the meaning of “and / or” unless otherwise expressly stated.

[0054] Figure 1 A schematic diagram illustrating the principle of a dual-circuit cardiac assist system according to an embodiment of this application is shown. See also Figure 1 The dual-pathway cardiac assist system includes a pressure generating mechanism 100, a first assist device 200, a second assist device 300, a detection device, and a control mechanism. The detection device and control mechanism are not shown in the figure.

[0055] The pressure generating mechanism 100 is used to alternately generate positive and negative pressure during operation. See also Figure 1 In one embodiment shown, 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, both filled with gas. When the pressure generating mechanism 100 needs to output negative pressure, the compressor pump 130 draws gas from the negative pressure tank 121 into the negative pressure chamber, creating a negative pressure within the negative pressure tank 121. When the negative pressure tank 121 is connected to a pipeline or driving device, the pressure in the pipeline and driving device is adjusted to a 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, increasing the pressure within the positive pressure tank 111. When the positive pressure tank 111 is connected to a pipeline or driving device, the pressure in the pipeline and driving device is adjusted to a preset positive pressure.

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

[0057] The first auxiliary device 200 includes a first driven device 210 and a first piping system. The distal end of the first piping system has an inflow channel and an outflow channel. The first driven device 210 is disposed within the first piping system and corresponds to the position of the outflow channel. A pressure generating mechanism 100 alternately applies negative and positive pressure to the first piping system to switch between blocking the outflow channel and blocking the first piping system. During cardiac assistance, the distal end of the first piping system extends into the ventricle, and the proximal end of the first piping system is connected to a blood pump / diaphragm pump capable of storing blood. When the pressure generating mechanism 100 applies negative pressure to the first piping, the first driven device 210 blocks the outflow channel, and blood in the ventricles flows into the blood pump / diaphragm pump through the first piping. When the pressure generating mechanism 100 alternates to positive pressure, the first driven device 210 blocks the first piping, at which point the blood pump / diaphragm pump is connected to the outflow channel, and through the 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 parts of the body that need it. It can be seen that the first auxiliary device can effectively reduce cardiac preload 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 cardiac pumping and a second piping line connected to the second driven device 310. The pressure generating mechanism 100 repeatedly inflates and contracts the second driven device 310 through the second piping line. When assisting cardiac function, the second driven device 310 is positioned in the ascending aorta, below the first driven device 210. Here, "below" refers to the side of the aorta furthest from the heart and aortic arch. In some embodiments of this application, the second driven device 310 employs an inflatable balloon structure. The second driven device 310 is primarily placed in the ascending aorta and inflates and deflates synchronously with the pressure generating mechanism 100. During diastole, the second driven device 310 inflates, increasing diastolic pressure in the aorta and enhancing coronary blood flow and oxygen supply. During systole, the second driven device 310 rapidly deflates, reducing pressure in the aorta, lowering cardiac afterload, and thus reducing myocardial oxygen consumption.

[0059] The detection device is used to acquire intraventricular pressure and intraaortic pressure. In the embodiments of this 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 a preset position, or it can be fixedly installed at the preset position by other independent devices. This application does not specifically limit the structure and installation method of the detection device. Any structure that can detect intraventricular pressure and intraaortic pressure, as well as the corresponding installation method, falls within the protection scope of this application.

[0060] The control mechanism is communicatively connected to the detection device, the first auxiliary device 200, the second auxiliary device 300, and the pressure generating mechanism 100. The first piping and the second piping 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 in a corresponding timing sequence within a control cycle according to the pressure signal sent by the detection device.

[0061] The following describes in detail one method of using the aforementioned dual-circuit cardiac assist system, which specifically includes the following steps:

[0062] S1. The distal end of the first conduit in the first auxiliary device 200 is extended into the ventricle. The inflow tract is delivered to the left ventricle along with the first conduit, and the outflow outlet is located at the aortic arch. The second driven device 310 in the second auxiliary device 300 is delivered to the vicinity of the aortic arch and located below the outflow outlet. "Below" refers to the direction in which the outflow outlet is furthest from the heart and the aortic arch.

[0063] S2. Obtain hemodynamic parameters in the left ventricle and aorta using the detection device; and infer the closing time of the aortic valve and determine the diastolic and ejection times of the left ventricle based on the obtained parameters.

[0064] S3. Upon detecting aortic valve closure, the diastolic phase of the left ventricle is divided into a first time period and a second time period. During the first time period, the control mechanism controls the first auxiliary device 200 to eject blood into the aorta to reduce cardiac preload. During the second time period, the control mechanism controls the second driven device 310 in the second auxiliary device 300 to expand, approximately blocking the aortic segment below the aortic arch, thereby increasing diastolic pressure within the aorta and enhancing coronary blood flow and oxygen supply. During the diastolic phase of the left ventricle, the first auxiliary device 200 and the second auxiliary device 300 reduce cardiac preload according to the sequence of the first and second time periods.

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

[0066] In one embodiment of the aforementioned dual-pathway cardiac assist system, the detection device includes a first pressure sensor and a second pressure sensor. The first pressure sensor is located at the distal end of a first conduit and extends into the ventricle along with the distal end of the first conduit. In this embodiment, the first pressure sensor is coupled to the first conduit and reaches the ventricle by following the distal end of the first conduit. The number of first pressure sensors includes, but is not limited to, one. When there are multiple first pressure sensors, their arrangement can be determined according to actual needs, and this embodiment does not impose a specific limitation. In one embodiment, the second pressure sensor is coupled to a second conduit and can move with the movement of the second conduit. After the position of the second conduit is fixed, the position of the second pressure sensor is located within the aorta. In some embodiments, the number of second pressure sensors includes, but is not limited to, one. When there are multiple second pressure sensors, their arrangement can be determined according to actual needs, and this embodiment does not impose a specific limitation.

[0067] In one embodiment, the pressure generating mechanism 100 includes a positive pressure generating device 110 and a negative pressure generating device 120. See also... Figure 1 The compressor pump 130 and the positive pressure tank 111 constitute a positive pressure generating device 110. The compressor pump 130 and the negative pressure tank 121 constitute a negative pressure generating device 120. A first valve group 220 is provided on the first piping line. 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 to cause the pressure generating device to alternately apply positive and negative pressure to the first driven device 210.

[0068] The second piping is equipped with a second valve group 320, which includes a second positive pressure valve 311 connected to a positive pressure generating device and a second negative pressure valve 312 connected to a negative pressure generating device. The control mechanism controls the second valve group 320 to make the pressure generating device alternately apply positive and negative pressure to the second driven device 310 so that the second driven device 310 repeatedly expands and contracts.

[0069] The control mechanism enables the first auxiliary device 200 and the second auxiliary device 300 to perform corresponding auxiliary operations at different times by controlling 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.

[0070] In the above-mentioned method of using the dual-circuit cardiac assist system, the specific method by which the control mechanism controls the first auxiliary device 200 and the second auxiliary device 300 at different times is as follows:

[0071] First, hemodynamic parameters within the left ventricle and aorta are acquired using a detection device. Based on these parameters, the aortic valve closure time, the diastolic phase of the left ventricle, and the ejection time are determined. The diastolic phase of the left ventricle is then divided into a first time period and a second time period.

[0072] When aortic valve closure is detected and the left ventricle is in diastole during 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, and controls the second positive pressure valve 311 in the second valve group 320 to open and the second negative pressure valve 312 to close. The second driven device 310 in the second auxiliary device 300 expands, approximately blocking the aortic segment below the aortic arch. The first auxiliary device 200 ejects blood into the aorta, reducing cardiac preload, increasing diastolic pressure in the aorta, and increasing coronary blood flow and oxygen supply. During the second time period, the first positive pressure valve 211 closes and the first negative pressure valve 212 opens. The first driven device 210 presents negative pressure and gradually draws blood from the left ventricle. The second positive pressure valve 311 is open and the second negative pressure valve 312 is closed. The second driven device 310 expands and continues to approximately block the aortic segment below the aortic arch.

[0073] During the period prior to left ventricular ejection, the control mechanism keeps the first negative pressure valve 212 in the first valve group 220 open and the first positive pressure valve 211 closed. The first driven device 210 presents negative pressure and continuously draws blood from the left ventricle through the first auxiliary device 200. Simultaneously, the control mechanism opens the second negative pressure valve 312 and closes the second positive pressure valve 311 in the second valve group 320. Correspondingly, the second driven device 310 contracts, reducing the pressure in the aorta and thus reducing the afterload of blood ejection.

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

[0075] In one embodiment, the second driven device 310 includes an IABP counterpulsation balloon, see [link to relevant documentation]. Figure 1 A safety disc 330 connects the IABP counterpulsation balloon to the second valve assembly 320. The first side 331 of the safety disc 330 is detachably connected to the IABP counterpulsation balloon, and the second side 332 is connected to the first valve assembly 220. The first side 331 of the safety disc 330 is connected to the helium tank. The safety disc 330 applies the positive and negative pressure output from the pressure generating mechanism 100 to the IABP counterpulsation balloon to cause it to expand or contract. The safety disc 330 can apply the rated volume of gas and the positive and negative pressure output from the pressure generating device to the IABP counterpulsation balloon to cause it to expand or contract. During this process, the pressure generating device controls the alternation time of the positive and negative pressures, and can adjust the magnitude of the positive pressure to continuously and stably ensure pressure output and a safe inflation volume. By controlling the alternation 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 pressure of the IABP counterpulsation balloon continuing to expand after expansion can be avoided, thereby ensuring the safety of the IABP counterpulsation balloon.

[0076] In one embodiment, a fourth pressure sensor 340 is provided between the safety disc 330 and the first valve group 220 to monitor the pressure of the first piping. When the fourth pressure sensor 340 detects an abnormality in the piping pressure between the safety disc 330 and the second valve group 320, it sends a monitoring signal to the control mechanism. The control mechanism can then control the valve structure or other structures installed on the first piping to ensure that the pressure on the second side of the safety disc 330 is the same as atmospheric pressure.

[0077] In one embodiment, a three-way catheter 370 is further provided between the IABP counterpulsation balloon and the safety disc 330. The first port of the three-way catheter 370 is connected to the IABP counterpulsation balloon, the second port is connected to the second side of the safety disc 330, and the third port is connected to the negative pressure generating device 120. The connection between the first and third ports of the three-way catheter 370 allows the IABP counterpulsation balloon to be directly connected to the negative pressure generating device 120. When the IABP counterpulsation balloon malfunctions or the second tubing malfunctions, the negative pressure from the negative pressure generating device 120 can cause the IABP counterpulsation balloon to collapse quickly, preventing the IABP counterpulsation balloon from remaining in an inflated state and affecting the pressure within the aorta.

[0078] In one embodiment, a fourth safety valve 380 is installed on the pipeline between the third port and the negative pressure generating device 120. The fourth safety valve 380 is a normally closed solenoid valve, and its installation controls the connection between the IABP counterpulsation balloon and the negative pressure generating device 120. The function of the fourth safety valve 380 is to connect the air pressure in the pipeline to atmospheric pressure in the event of a malfunction in the second piping, ensuring the balloon returns to its original state and preventing adverse effects on the patient.

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

[0080] The following section will further explain the scheme and working principle of the dual-path cardiac assist system by taking the first auxiliary device 200 as a pVAD catheter and the second auxiliary device 300 as an aortic balloon counterpulsation pump as an example.

[0081] One embodiment of the pVAD catheter in this application can be a single-lumen catheter. Figure 2 The diagram illustrates the structure of a pVAD catheter according to an embodiment. This single-lumen catheter integrates a rotary bidirectional valve 313 at its tip, and its distal end is connected to an additional extracorporeal membrane pump 314. The single-lumen catheter operates as follows: like an IABP, it is triggered by cardiac rhythm. During systole, blood is drawn from the left ventricle through the catheter tip and lumen into the extracorporeal membrane pump; during diastole, the extracorporeal membrane pump expels blood through the catheter, subsequently opening the valve at the catheter tip and delivering blood to the ascending aorta through a lateral outlet. The aortic valve closure and the catheter valve opening maintain synchronized pulsation to ensure that aortic valve function is not impaired.

[0082] Figure 3 This is a cross-sectional view of a rotary bidirectional valve located at the tip of a single-lumen catheter according to one embodiment. See also... Figure 3 The rotary bidirectional valve includes a valve body 10, an eccentric valve plate 20, and conduits 30 disposed at both ends of the valve body.

[0083] The valve body 10 has a spatial axial orientation, with a first opening 16 and a second opening 17 arranged axially on both sides. The ends of the valve body are sleeved on the conduit 30. The flow channel between the first opening 16 and the second opening 17, together with the inner cavity of the conduit 30, constitutes the flow channel 18 of the conduit. An eccentric valve plate 20 is located within the flow channel 18 and rotatably connected to the valve body 10. In its original state, the eccentric valve plate 20 blocks the flow channel 18. (See [reference]). Figure 3 When the pressure on the first opening 16 side is less than the pressure on the second opening 17 side, the eccentric valve plate 20 rotates around 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 [link to relevant documentation]. Figure 4 When fluid enters the flow channel 18 through the first opening 16, the fluid acts on the eccentric valve plate 20, causing the eccentric valve plate 20 to rotate in the second direction until it blocks the flow channel 18. See [link to relevant documentation]. Figure 5 The fluid flows out from the second opening 17, with the first direction being 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 in the aortic arch. When the control mechanism controls the opening of the first positive pressure valve 211 in the first valve group 220, the eccentric valve plate 20 in the single-lumen catheter is in a position... Figure 3 In the state shown, during this process, 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 a state of... Figure 4 As shown, the single-lumen catheter can draw blood from the left ventricle and store it in the extracorporeal membrane pump 314. It should be noted that the above embodiments are merely exemplary, and all pVAD catheter structures that achieve catheter opening and closing through an eccentric valve plate fall within the protection scope of this application.

[0085] In this embodiment, the second auxiliary device 300 is an aortic balloon pump (IABP), and the corresponding second driven device 310 is the IABP's balloon catheter. The balloon catheter has a balloon that expands and contracts in response to the heart's pulsation. The balloon is composed of a cylindrical balloon membrane with a thickness of approximately 50–150 μm. Figure 6 This is a cross-sectional view of a balloon catheter according to an embodiment of this application. See also... Figure 6 The balloon catheter has a balloon 22 that expands and contracts in response to the heart's pumping action. The balloon 22 in the IABP is made of a material with excellent resistance to bending fatigue. In the embodiments of this application, the balloon membrane in the expanded state is cylindrical, but not limited to this; it can also be a polygonal cylindrical shape. The outer diameter and length of the balloon 22 are determined based on the internal volume of the balloon 22 and the inner diameter of the artery.

[0086] It should be noted that the aortic balloon pump including the balloon catheter in the above embodiments is only exemplary. Any IABP device on the market that uses positive and negative pressure to help the heart perform effective blood pumping function, relieve the heart's load, and protect the heart and organs can be used as the second auxiliary device 300 in the embodiments of this 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, this paper exemplifies how the control mechanism controls the pressure generating mechanism 100 to drive the first driven device 210 and the second driven device 310 respectively in a corresponding sequence within a control cycle to assist the left ventricle according to the pressure signal sent by the detection device.

[0088] One implantation method involves inserting the pVAD catheter distally into the carotid artery. The inflow tract of the pVAD catheter enters the left ventricle, and the outflow tract is located in the aortic arch. The IABP catheter is inserted through the femoral artery, and the balloon is placed in the aortic arch, positioned below the outflow tract of the pVAD catheter. Here, "below" refers to the direction from which the outflow tract exits the aortic arch. After both the pVAD catheter and IABP are implanted, one control method for the control mechanism is as follows:

[0089] Figure 7 This is a timing control diagram of a control mechanism according to an embodiment. See also... Figure 7 t0, t0', and t0" are all times when the aortic valve closes.

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

[0091] At time t3, the control mechanism opens the second positive pressure valve 311, and the balloon is inflated until time t4. During the time interval t3-t2, the first positive pressure valve 211 of the pVAD catheter remains open, meaning the eccentric valve 20 inside the pVAD catheter continues to block the flow channel 18. The balloon remains inflated. During this time interval, the balloon blocks the aorta, and the external blood pump of the pVAD catheter pumps the blood stored in the pump into the aorta. The blood injected into the aorta enters the coronary arteries, thus aiding in coronary blood supply.

[0092] From time t2, the control mechanism opens the first negative pressure valve 212, and the eccentric valve plate 20 inside the pVAD catheter blocks the outflow channel, connecting the flow channel 18 between the first opening 16 and the second opening 17. From time t2 until the next aortic valve closure time t0', the first negative pressure valve 212 remains open. During the time interval t2-t0', the left ventricle is in a contracted state, and the pVAD draws blood from the left ventricle, which can reduce the preload of ejection.

[0093] During the time period 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 post-ejaculation load.

[0094] The above analysis shows that during the cycle from the closure of the aortic valve to the next closure, the control mechanism controls the exchange between the eccentric valve plate and the balloon in the pVAD catheter, which can simultaneously reduce the preload and afterload during the same cycle, thereby improving the blood supply to the heart.

[0095] In summary, the dual-pathway cardiac assist system of this application uses the same pressure generating device to supply pressure to the first assist device 200 and the second assist device 300, and controls the first assist device 200 and the second assist device 300 separately in terms of timing through a control mechanism to simultaneously assist the heart's preload and afterload within a predetermined cycle. Using the same pressure generating device simplifies the structure of the assist system, and coupling the two assist devices into a single control system for coordinated control further simplifies operation compared to parallel control by two separate control systems.

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

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

[0098] The first piping system has an inflow channel and an outflow channel at its farthest end. A first driven device 210 is installed inside the first piping system 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 system to switch between blocking the outflow channel and blocking the first piping system.

[0099] The second piping is connected to the pressure generating mechanism 100 and is used to transmit the alternating positive and negative pressure generated by the pressure generating mechanism 100.

[0100] A detection device used to acquire intracardiac intraventricular pressure and aortic intravascular pressure;

[0101] The control mechanism is communicatively connected to the detection device, the first piping, the second piping, 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 and deliver alternating positive and negative pressure to the second piping according to the pressure signal sent by the detection device in a cyclic control cycle.

[0102] The first piping of the dual-gas-path gas source system is used to connect a first driven device 210, such as a pVAD, and the second piping is used to connect a second driven device 310, such as a balloon of an 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 respectively according to the corresponding timing sequence within a cyclic control cycle, based on the pressure signal sent by the detection device, are detailed in the relevant content of the exemplary case in the above embodiments and will not be repeated here.

[0103] According to another aspect of this application, a method for using the above-mentioned dual-gas-path gas source system is also provided, specifically including the following steps:

[0104] S1. Select the pVAD conduit with the eccentric valve plate as the first driven device as the first piping line, and connect the first piping line to the pressure generating mechanism.

[0105] S2. Select the aortic balloon pump (IABP) with a safety disc structure as the second tubing line; connect 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 of control based on the pressure signal sent by the detection device, thereby controlling the position switching of the first driven equipment.

[0107] The dual-path gas supply system in this application includes two piping lines, one connected to the pVAD catheter and the other connected to the aortic balloon pump (IABP). During one control cycle, the control mechanism closes the valve structure on the second piping line, thus shutting down the IABP and allowing only the pVAD to operate.

[0108] In one implementation of the prior art, a pVAD catheter inlet is provided on the IABP, as can be referred to... Figure 1The interface is designated 370. When using a pVAD catheter for left ventricular assist, the aortic balloon pump is not operational; the pVAD catheter utilizes the air supply from the aortic balloon pump for assistance. The balloon in an aortic balloon pump is typically thin, and to prevent it from bursting, a safety disc 330 is usually installed in the pump's tubing. The balloon is directly driven after pressure transmission through the safety disc 330, resulting in minimal pressure loss. However, due to the limited volume of the safety disc 330, the pressure required by the aortic balloon pump to drive the balloon is relatively low. When the pVAD catheter is connected to the aortic balloon pump interface 370, the middle section of the pVAD is typically a thin fluid tube, leading to greater pressure loss and requiring a higher driving pressure. The pressure provided by the aortic balloon pump is limited by the safety disc and balloon, which is lower than the driving pressure required by the pVAD catheter. As a result, part of the lower pressure is lost to fluid flow, and only a portion is used to promote blood flow into the aorta. This means that the blood flow into the aorta per unit time through the pVAD catheter is less, and therefore the auxiliary effect is poor.

[0109] The dual-air-path gas source system in this embodiment includes two piping lines. The pVAD catheter can be directly connected to the gas source (pressure generating mechanism). Since it is no longer limited by the safety disc and balloon, the pressure provided by the pressure generating mechanism 100 to the pVAD catheter can take into account factors such as liquid flow pressure loss to provide a larger driving pressure. As a result, the blood flow into the aorta through the pVAD catheter per unit time will increase significantly, thus having a better auxiliary effect.

[0110] Obviously, many modifications and variations can be made based on the content of this specification. These embodiments have been selected and specifically described in this specification to better explain the principles and practical applications of the invention, thereby enabling those skilled in the art to make good use of the invention. The invention is limited only by the claims and their full scope and equivalents.

Claims

1. A dual-circuit cardiac assist system, characterized in that, include: The pressure generating mechanism alternately generates positive and negative pressure during operation; The first auxiliary device includes a first driven device and a first piping system. The pipe body at the farthest end of the first piping system has an inflow channel and an outflow channel. The first driven device is disposed inside the pipe body of the first piping system and corresponds to the position of the outflow channel. The pressure generating mechanism alternately applies negative pressure and positive pressure to the first piping system to switch between blocking the outflow channel and blocking the first piping system. The second auxiliary device includes a second driven device for assisting cardiac pumping and a second piping line connected to the second driven device. The pressure generating mechanism causes the second driven device to repeatedly expand and contract through the second piping. A detection device used to acquire intracardiac intraventricular pressure and aortic intravascular pressure; A control mechanism is communicatively connected to the detection device, the first auxiliary device, the second auxiliary device, and the pressure generating mechanism. Both the first piping line and the second piping line are connected to the pressure generating mechanism. The control method of the control mechanism includes: The hemodynamic parameters of the left ventricle and aorta are obtained by the detection device; and the closing time of the aortic valve and the diastolic and ejection time of the left ventricle are inferred based on the obtained parameters. Upon detection of aortic valve closure, the diastolic phase 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 control mechanism controls the second driven device in the second auxiliary device to continue expanding and controls the first auxiliary device to gradually draw blood from the left ventricle to reduce cardiac preload. At a predetermined time before the left ventricular ejection time, the second driven device is controlled to contract, while the first driven device continuously draws blood from the left ventricle to reduce the afterload of the left ventricle.

2. The dual-airway cardiac 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 located at the farthest end of the first piping line and can extend along the farthest end of the first piping line into the ventricle. The second pressure sensor is installed on the second piping line, and after the position of the second piping line is fixed, the position of the second pressure sensor is located inside the aorta.

3. The dual-airway cardiac 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; The first piping is equipped with a first valve group, which 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. The control mechanism controls the first valve group to cause the pressure generating mechanism to alternately apply positive and negative pressure to the first driven device. The second piping is equipped with a second valve group, which 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. The control mechanism controls the second valve group to cause the pressure generating mechanism to alternately apply positive and negative pressure to the second driven device so that the second driven device repeatedly expands and contracts. The control mechanism sends control commands to the first valve group and the second valve group at different times.

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

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

6. The dual-airway cardiac assist system according to claim 5, characterized in that, A fourth safety valve is installed on the pipeline between the third port and the negative pressure generating device.

7. The dual-airway cardiac assist system according to claim 4, characterized in that, The first side of the safety disc is also connected to an air supply line.

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