Balloon system and method of driving

Abstract

The application relates to the technical field of medical equipment, in particular to an aortic balloon stable inflation and deflation system and a driving method. The system comprises a balloon module, a gas power module, a gas driving module, a safety disc module and a helium inflation and deflation module; the controllable valve in the gas power module can adjust the opening degree; when the valve is maintained at a preset target opening degree, the gas pressure can be stabilized; dynamic adjustment of the valve allows the system to maintain constant gas flow and pressure under different operating states, thereby reducing pressure fluctuations caused by sudden changes in gas flow; the safety disc module transmits the gas pressure through reciprocating movement of an internal diaphragm; the diaphragm can provide buffering under high-pressure and low-pressure states, thereby effectively reducing the instantaneous fluctuation of the gas. The system can improve the stability of the system gas pressure, thereby helping to solve the problem of inflation and deflation gas flow pressure fluctuation, and providing stable and reliable auxiliary medical effect.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a balloon system and driving method. Background Technology

[0002] An intra-aortic balloon pump (IAB) is a pneumatic system that controls a specially designed balloon catheter within an aorta. Controlled electronically and pneumatically, the balloon inflates during diastole and deflates during systole, increasing diastolic blood pressure and decreasing systolic blood pressure in the aorta. This increases coronary blood supply and reduces cardiac afterload. The IAB is currently the most commonly used left ventricular mechanical assist device in clinical practice for providing pneumatic assistance to failing or weakened hearts. Introduced over 50 years ago, IAB has been proven to improve hemodynamic parameters and myocardial oxygen delivery in patients with myocardial ischemia and cardiogenic shock. The intra-aortic balloon (IAB) catheter is used in patients with left ventricular failure to enhance the heart's pumping action. The catheter is approximately 1 meter long and has an inflatable and deflated balloon at the distal end. Typically, the catheter is inserted through the femoral artery and moved to the descending thoracic aorta, ensuring the balloon is positioned 2-3 cm below the left subclavian artery and above the renal artery. The gas extension tube used to inflate and deflate the balloon is connected to an external pump at its proximal end. By monitoring the patient's ECG or central aortic pressure, the patient's cardiac rhythm is identified, triggering synchronized counterpulsation of the balloon. Overall, the balloon inflates during diastole to increase diastolic pressure, thereby increasing coronary artery (coronary artery) blood flow perfusion; in the early stages of systole, the balloon deflates rapidly to reduce cardiac afterload.

[0003] In related technologies, a dual-headed diaphragm pump is typically used as the power source. One end of the pump provides negative pressure and is connected to a negative pressure tank to form a negative pressure source, while the other end provides positive pressure and is connected to a positive pressure tank to form a positive pressure source. A solenoid valve is connected to the inlet side of the safety disc, and a solenoid valve is also connected to the inlet side of the safety disc. The safety disc has a relatively large-diameter lumen and a flexible diaphragm. The outlet side of the safety disc is connected to an intra-aortic balloon, which has a small-diameter lumen and an extension tube. The balloon catheter is surgically inserted into the patient's aorta. The volume between the outlet side of the safety disc and the balloon is completely filled with helium. In such devices, the negative pressure source, positive pressure source, safety disc, and various valves constitute a reusable inflation / deflation device. During the inflation cycle, the solenoid valve connected to the positive pressure source is opened, and positive pressure gas enters the safety disc, pushing the flexible diaphragm rapidly towards the outlet side, forcing helium to shuttle into and expand the balloon. During the deflation cycle, the solenoid valve connected to the positive pressure source is closed, and the solenoid valve connected to the negative pressure source is opened, drawing out the gas from the inlet side of the safety disc. The flexible diaphragm is quickly pulled back to the inlet side, causing the helium gas inside the balloon to shuttle to the outlet side of the safety disc, and the balloon contracts.

[0004] However, current methods for controlling balloon inflation and deflation have the following technical problems:

[0005] The existing inflation and deflation devices have large fluctuations in airflow pressure, making them difficult to stabilize and control, and thus require optimization. Summary of the Invention

[0006] Therefore, it is necessary to provide a stable inflation / deflation system and driving method for a balloon pump that can achieve stable inflation / deflation control and improve the auxiliary gain effect of the balloon pump.

[0007] This application provides a balloon stabilization inflation / deflation system from a first aspect, comprising:

[0008] A balloon module, located at the intervention site of the target patient, is used to inflate or deflate under the control of the system to achieve auxiliary medical purposes;

[0009] A gas power module is used to provide the gas source power required by the system. The gas pipeline in the gas power module is equipped with several controllable valves. The opening degree of the controllable valves is adjustable. When the controllable valves are maintained at a preset target opening degree, the gas pressure of the gas power module remains stable.

[0010] A gas-driven module, connected to the gas power module, is located in the output pipeline of the gas power module and is used to control the input and output of the gas power module to control the expansion and contraction of the balloon module.

[0011] A safety disc module is located between the gas drive module and the balloon module. The safety disc module is used to transmit gas pressure through the reciprocating motion of the internal diaphragm to control the expansion and contraction of the balloon module.

[0012] A helium filling and extraction module is located between the safety disc module and the balloon module, and is used to fill or extract helium into the gas pipeline to control the periodic operation of the balloon module.

[0013] In one embodiment, the security disk module includes:

[0014] Air-end membrane housing, used to store and protect air-end gas;

[0015] Helium end membrane shell, used for storing and protecting helium;

[0016] A flexible diaphragm is disposed between the air-end membrane shell and the helium-end membrane shell to isolate the air-end gas from the helium gas. The flexible diaphragm deforms in response to changes in pressure.

[0017] In one embodiment, the gas power module includes:

[0018] A dual-head diaphragm pump, a negative pressure tank, and a positive pressure tank are provided. The dual-head diaphragm pump is used to draw in or expel gas from the atmospheric environment to provide chamber pressure. The dual-head diaphragm pump includes a negative pressure pump head and a positive pressure pump head. The negative pressure pump head and the positive pressure pump head are independently controlled. The negative pressure pump head is connected to the negative pressure tank to provide a negative pressure source, and the positive pressure pump head is connected to the positive pressure tank to provide a positive pressure source.

[0019] In one embodiment, the gas power module includes:

[0020] A silencer is installed in the gas pipeline of the gas power module to reduce noise in the gas pipeline.

[0021] In one embodiment, the controllable valve includes:

[0022] An internal spring is provided in the valve. The compression of the internal spring is adjustable. When the compression force of the internal spring is balanced with the pressure of the negative pressure tank or the positive pressure tank in the gas power module, the valve core of the controllable valve is maintained at the target opening degree.

[0023] In one embodiment, the gas power module further includes:

[0024] A back pressure valve, located in the negative pressure tank or the positive pressure tank, is used to discharge excess gas from the negative pressure tank or the positive pressure tank;

[0025] A safety valve is installed in the negative pressure tank or the positive pressure tank to monitor the internal pressure of the negative pressure tank or the positive pressure tank, and to automatically release the gas in the negative pressure tank or the positive pressure tank when the internal pressure exceeds a preset pressure threshold.

[0026] In one embodiment, the gas-driven module includes:

[0027] A negative pressure control branch is connected to the negative pressure tank and is used to control the gas flow in the negative pressure pipeline connected to the negative pressure tank.

[0028] A positive pressure control branch is connected to the positive pressure tank and is used to control the gas flow in the positive pressure pipeline connected to the positive pressure tank.

[0029] In one embodiment, the gas-driven module further includes:

[0030] A branch pressure monitoring unit is located in the drive branch of the gas drive module and is used to monitor the gas pressure in the drive branch.

[0031] In one embodiment, the helium filling and pumping module includes:

[0032] Storage unit for storing helium gas required by the system;

[0033] An output control unit is located in the output pipeline of the helium filling and pumping module, and is used to realize the output and input control of the helium filling and pumping module.

[0034] In a second aspect, this application provides a method for stable inflation / deflation of a balloon, the method being implemented based on a stable inflation / deflation system for a balloon as described in any one of the first aspects, the method comprising the following steps:

[0035] In response to the startup of the target device, the control gas power module establishes a positive and negative pressure environment and completes helium replacement preparation;

[0036] Acquire feature monitoring information of the target object, including electrocardiogram monitoring data, blood pressure monitoring data, and environmental monitoring data, and control the target device to perform periodic inflation and deflation cycles based on the feature monitoring information;

[0037] In response to an abnormality in the characteristics of the target object, the target device is adjusted to maintain a stable positive and negative pressure environment.

[0038] The aforementioned balloon stable inflation / deflation system, derived from the technical features in the claims, can achieve the following beneficial effects to address the technical problems raised in the background art:

[0039] A balloon system includes a balloon module, a gas power module, a gas drive module, a safety disc module, and a helium inflation / deflation module. The balloon module is positioned at the intervention site of the target patient and is used to inflate or deflate under the control of the system to achieve auxiliary medical purposes. The gas power module provides the gas source power required by the system. The gas pipeline in the gas power module is equipped with several controllable valves, the opening degree of which is adjustable. When the controllable valves are maintained at a preset target opening degree, the gas pressure in the gas power module remains stable. The gas drive module is connected to the gas power module and located in the output pipeline of the gas power module, used to control the input and output of the gas power module to control the inflation and deflation of the balloon module. The safety disc module is located between the gas drive module and the balloon module, and is used to transmit gas pressure through the reciprocating motion of an internal diaphragm to control the inflation and deflation of the balloon module. The helium inflation / deflation module is located between the safety disc module and the balloon module, used to fill or deplete helium into the gas pipeline to control the periodic operation of the balloon module. In implementation, the controllable valve in the gas power module has an adjustable opening. When the valve is maintained at a preset target opening, it can stabilize the gas pressure. The dynamic adjustment of the valve allows the system to maintain a constant gas flow and pressure under different operating conditions, thereby reducing pressure fluctuations caused by sudden changes in airflow. The safety disc module transmits gas pressure through the reciprocating motion of an internal diaphragm. The diaphragm can provide buffering under high and low pressure conditions, thereby effectively reducing instantaneous gas fluctuations. In this way, the inflation and deflation gas flow pressure within the system can be maintained during the process of fully driving the balloon with gas, which helps to improve the stability of the system's gas pressure and thus helps to solve the problem of inflation and deflation gas flow pressure fluctuations, providing a stable and reliable auxiliary medical effect. Attached Figure Description

[0040] To more clearly illustrate the technical solutions in the embodiments of this application or the conventional technology, the drawings used in the description of the embodiments or the conventional technology will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0041] Figure 1 This is a schematic diagram of the system structure of a balloon stable inflation / deflation system according to an embodiment of this application;

[0042] Figure 2 This is a schematic diagram showing the position of the flexible diaphragm in the safety disk module and the direction of gas flow during inflation and deflation in one embodiment of this application.

[0043] Figure 3This is a schematic diagram showing the correspondence between the actuation sequence of solenoid valves SV2 and SV3 and the balloon pressure waveform in one embodiment of this application;

[0044] Figure 4 This is a schematic flowchart of a balloon stable inflation / deflation driving method according to an embodiment of this application.

[0045] Explanation of reference numerals in the attached diagram: 100, gas power module; 200, gas drive module; 300, safety disc module; 400, helium filling and pumping module; 500, balloon module. Detailed Implementation

[0046] To facilitate understanding of this application, a more complete description will be provided below with reference to the accompanying drawings, which illustrate embodiments of the present application. However, the present application can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided so that the disclosure of this application will be thorough and complete.

[0047] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0048] It is understood that the terms "first," "second," etc., used herein may be used to describe various elements, but these elements are not limited by these terms. These terms are only used to distinguish one element from another. For example, without departing from the scope of this application, a first resistor may be referred to as a second resistor, and similarly, a second resistor may be referred to as a first resistor. Both the first resistor and the second resistor are resistors, but they are not the same resistor.

[0049] It is understood that the term "connection" in the following embodiments should be understood as "electrical connection," "communication connection," etc., if the connected circuits, modules, units, etc., have electrical signal or data transmission with each other.

[0050] It is understandable that "at least one" refers to one or more, and "multiple" refers to two or more. "At least a part of an element" refers to part or all of an element.

[0051] When used herein, the singular forms of “a,” “an,” and “the” may also include the plural forms unless the context clearly indicates otherwise. It should also be understood that the terms “comprising / including” or “having,” etc., specify the presence of the stated features, wholes, steps, operations, components, parts, or combinations thereof, but do not preclude the possibility of the presence or addition of one or more other features, wholes, steps, operations, components, parts, or combinations thereof. Meanwhile, the term “and / or” as used in this specification includes any and all combinations of the associated listed items.

[0052] This application is based on the inventor's understanding and research on the following issues, specifically:

[0053] In related technologies, a dual-headed diaphragm pump is typically used as the power source. One end of the pump provides negative pressure and is connected to a negative pressure tank to form a negative pressure source, while the other end provides positive pressure and is connected to a positive pressure tank to form a positive pressure source. A solenoid valve is connected to the inlet side of the safety disc, and a solenoid valve is also connected to the inlet side of the safety disc. The safety disc has a relatively large-diameter lumen and a flexible diaphragm. The outlet side of the safety disc is connected to an intra-aortic balloon, which has a small-diameter lumen and an extension tube. The balloon catheter is surgically inserted into the patient's aorta. The volume between the outlet side of the safety disc and the balloon is completely filled with helium. In such devices, the negative pressure source, positive pressure source, safety disc, and various valves constitute a reusable inflation / deflation device. During the inflation cycle, the solenoid valve connected to the positive pressure source is opened, and positive pressure gas enters the safety disc, pushing the flexible diaphragm rapidly towards the outlet side, forcing helium to shuttle into and expand the balloon. During the deflation cycle, the solenoid valve connected to the positive pressure source is closed, and the solenoid valve connected to the negative pressure source is opened, drawing out the gas from the inlet side of the safety disc. The flexible diaphragm is quickly pulled back to the inlet side, causing the helium gas inside the balloon to shuttle to the outlet side of the safety disc, and the balloon contracts.

[0054] However, current methods for controlling balloon inflation and deflation have the following technical problems:

[0055] The existing inflation and deflation devices have large fluctuations in airflow pressure, making them difficult to stabilize and control, and thus require optimization.

[0056] Based on this, embodiments of this application provide a balloon stable inflation / deflation system, which can, as Figure 1 As shown, it includes: a balloon module, a gas power module, a gas drive module, a safety disc module, and a helium filling and pumping module.

[0057] The balloon module is located at the intervention site of the target patient and is used to inflate or contract under the control of the system to achieve auxiliary medical purposes.

[0058] The gas power module is used to provide the gas source power required by the system. The gas pipeline in the gas power module is equipped with several controllable valves. The opening degree of the controllable valves is adjustable. When the controllable valves are maintained at a preset target opening degree, the gas pressure of the gas power module remains stable.

[0059] For example, the gas power module can provide gas power to the system. By setting several controllable valves in the module, the opening degree of the controllable valves can be adjusted to maintain a stable preset gas pressure. In one embodiment, the controllable valve can be a controllable valve whose opening degree is controlled based on spring compression, such as a back pressure valve. Specifically, when gas enters the back pressure valve, it generates upward pressure on the internal diaphragm or valve core. If the gas pressure is greater than the set value, the spring is compressed, the diaphragm or valve core is pushed up, and the fluid flows out through the valve; if the gas pressure is lower than the set value, the spring force will prevent the diaphragm or valve core from opening, thereby creating back pressure and causing the inlet pressure to rise until the set pressure is reached before the valve opens. In another embodiment, the controllable valve can be a controllable valve whose opening degree is precisely controlled based on electrical signals, such as a solenoid valve or a piezoelectric valve. Relatedly, a pressure sensor can be installed in the pipeline to monitor gas pressure. Based on the feedback signal from the pressure sensor, the opening of the controllable valve can be dynamically adjusted under system control. This allows the gas pressure to be dynamically maintained within the target pressure range during the system's inflation and deflation processes, reducing the possibility of pressure fluctuations. In another embodiment, the valve can be configured as a proportional solenoid valve, changing the valve opening by adjusting the input current or voltage to achieve continuous flow regulation. Alternatively, the valve can be configured as a pulse solenoid valve, controlling the valve's opening and closing frequency via pulse signals to indirectly regulate the flow rate. The gas drive module is connected to the gas power module and located in the output pipeline of the gas power module. It controls the input and output of the gas power module to control the expansion and contraction of the balloon module.

[0060] The safety disc module is located between the gas drive module and the balloon module. The safety disc module is used to transmit gas pressure through the reciprocating motion of the internal diaphragm to control the expansion and contraction of the balloon module.

[0061] For example, the safety disc module may include an internal diaphragm that transmits gas pressure between the two sides. In implementation, the reciprocating motion of the internal diaphragm transmits pressure changes within the system. During inflation, the internal diaphragm moves closer to the balloon, uniformly transmitting gas pressure to the balloon, causing it to inflate. During deflation, the internal diaphragm moves further away from the balloon, smoothly expelling gas from the balloon, causing it to contract. During inflation and deflation, the flexible diaphragm evenly distributes pressure changes within the tubing, resulting in smoother overall gas pressure changes. This reduces gas pressure fluctuations and enhances the stability of the system's inflation and deflation. The elastic properties of the internal diaphragm also allow the safety disc module to absorb instantaneous changes in gas pressure, preventing sudden pressure changes from affecting the balloon. Furthermore, the safety disc module further buffers pressure fluctuations through the elastic deformation of the internal diaphragm, enhancing the stability of the gas pressure transmitted to the balloon. Specifically, the diaphragm can be made of a highly elastic, corrosion-resistant, flexible membrane material.

[0062] The helium filling and extraction module is located between the safety disc module and the balloon module, and is used to fill or extract helium into the gas pipeline to control the periodic operation of the balloon module.

[0063] By implementing the above-described intra-aortic balloon stable inflation / deflation system, the following beneficial effects can be achieved:

[0064] An intra-aortic balloon stabilization inflation and deflation system includes a balloon module, a gas power module, a gas drive module, a safety disc module, and a helium inflation and deflation module. The system comprises the following components: a balloon module positioned at the intervention site of the target patient, used to inflate or deflate under the control of the system to achieve auxiliary medical purposes; a gas power module providing the necessary gas supply power, with several controllable valves in its gas pipeline, the opening of which is adjustable, maintaining stable gas pressure in the gas power module when the controllable valves are maintained at a preset target opening; a gas drive module connected to the gas power module and located in its output pipeline, used to control the input and output of the gas power module to control the inflation and deflation of the balloon module; a safety disc module positioned between the gas drive module and the balloon module, used to transmit gas pressure through the reciprocating motion of its internal diaphragm to control the inflation and deflation of the balloon module; and a helium inflation / deflation module positioned between the safety disc module and the balloon module, used to fill or deflate helium into the gas pipeline to control the periodic operation of the balloon module. In implementation, the controllable valve in the gas power module has an adjustable opening. When the valve is maintained at a preset target opening, it can stabilize the gas pressure. The dynamic adjustment of the valve allows the system to maintain a constant gas flow and pressure under different operating conditions, thereby reducing pressure fluctuations caused by sudden changes in airflow. The safety disc module transmits gas pressure through the reciprocating motion of an internal diaphragm. The diaphragm can provide buffering under high and low pressure conditions, thereby effectively reducing instantaneous gas fluctuations. In this way, the inflation and deflation gas flow pressure within the system can be maintained during the process of fully driving the balloon with gas, which helps to improve the stability of the system's gas pressure and thus helps to solve the problem of inflation and deflation gas flow pressure fluctuations, providing a stable and reliable auxiliary medical effect.

[0065] In one embodiment, such as Figure 2 As shown, the security disk module includes:

[0066] Air-end membrane housing, used to store and protect air-end gas.

[0067] For example, an air-end diaphragm housing can be used to store and protect air-end gas, thereby maintaining the stability of the air-end gas pressure and flow rate. The air-end diaphragm housing can be a sealing structure made of high-strength, corrosion-resistant materials.

[0068] Helium end membrane shell, used for storing and protecting helium.

[0069] For example, a helium-end diaphragm can be used to store and protect helium, thereby maintaining the helium gas concentration and pressure. The helium-end diaphragm can be a sealed structure made of high-strength, corrosion-resistant materials. The helium-end diaphragm can be symmetrically designed with the air-end diaphragm to enhance the balance of gas transfer.

[0070] A flexible diaphragm is disposed between the air-end membrane shell and the helium-end membrane shell to isolate the air-end gas from the helium gas. The flexible diaphragm deforms in response to changes in pressure.

[0071] For example, the flexible diaphragm can isolate gas and helium at the air end while transmitting gas pressure through deformation. The flexible diaphragm can be a membrane material made of highly elastic, fatigue-resistant materials, such as standard-compliant rubber, silicone, or other polymer materials.

[0072] For example, the safety disc 300 comprises a flexible diaphragm 310, an air-end diaphragm housing 320, and a helium-end diaphragm housing 330. The flexible diaphragm 310 is located between the air-end diaphragm housing 320 and the helium-end diaphragm housing 330, isolating air and helium. The flexible diaphragm is typically made of soft materials such as polyurethane or rubber, allowing it to move rapidly in response to pressure changes and preventing deformation or damage during long-term use. The air-end diaphragm housing 320 is connected to the gas drive module 200, and the helium-end diaphragm housing 330 is connected to the helium filling / evacuation module 400 and the balloon catheter 500. The flexible diaphragm 310 moves periodically with the changes in positive and negative pressure sources applied to the air-end diaphragm housing 320. When the air-side membrane shell 320 is subjected to positive pressure, the diaphragm 310 moves to the rightmost end of the helium-side membrane shell 330, forcing helium into the balloon, which is inflated. When the air-side membrane shell 320 is subjected to negative pressure, the diaphragm 310 moves to the leftmost end of the air-side membrane shell, drawing helium into the safety disc, which is deflated. The output states of the positive and negative pressure sources affect the movement of the diaphragm 310, thus affecting the inflation and deflation states of the balloon, and consequently, the final inflation and deflation pressures. The stable output of the positive and negative pressure sources and the stable variable total volume within the safety disc membrane shell ensure consistent balloon changes in each cycle, improving the stability and safety of intra-aortic balloon counterpulsation therapy.

[0073] In this embodiment, the synergistic effect of the flexible diaphragm, the air end membrane shell, and the helium end membrane shell enables effective gas pressure transmission and flow control, reduces pressure fluctuations caused by gas flow, improves the performance and safety of the intra-aortic balloon pump, and ensures its reliability in medical applications.

[0074] In one embodiment, the gas power module includes:

[0075] A dual-head diaphragm pump, a negative pressure tank, and a positive pressure tank are provided. The dual-head diaphragm pump is used to draw in or expel gas from the atmospheric environment to provide chamber pressure. The dual-head diaphragm pump includes a negative pressure pump head and a positive pressure pump head. The negative pressure pump head and the positive pressure pump head are independently controlled. The negative pressure pump head is connected to the negative pressure tank to provide a negative pressure source, and the positive pressure pump head is connected to the positive pressure tank to provide a positive pressure source.

[0076] In this embodiment, the gas power module consists of a dual-head diaphragm pump, a negative pressure tank, and a positive pressure tank. The dual-head diaphragm pump helps to achieve independent filling and discharging control, and the flexible diaphragm facilitates pressure transmission, which helps to filter instantaneous pressure changes and enhances smoothness.

[0077] In one embodiment, the gas power module includes:

[0078] A silencer is installed in the gas pipeline of the gas power module to reduce noise in the gas pipeline.

[0079] For example, the silencer can be installed in the gas pipeline of the gas power module. The gas pipeline may include an inlet pipeline and an outlet pipeline, and may include a main pipeline and branch pipelines. The silencer can be implemented based on various silencer architectures, including sound-absorbing material type silencers, expansion cavity type silencers, resonant type silencers, labyrinth type silencers, and combined type silencers, etc. In specific implementations, the specific structural proportions and layout can be set by technical personnel.

[0080] In this embodiment, a silencer is installed in the gas pipeline. The silencer helps reduce noise, suppress turbulence generated during gas flow, and enhance the stability of gas pressure maintenance. Specifically, the silencer can smooth the gas flow path and reduce turbulence through sound-absorbing materials, expansion cavities, resonant cavities, or labyrinth structures. With reduced turbulence, the gas flow in the pipeline is smoother, and gas pressure fluctuations are weakened. This stable airflow helps maintain gas pressure stability and reduces the impact of sudden pressure changes on the system. Secondly, the silencer can absorb the sound wave energy generated during gas flow through sound-absorbing structures or resonant cavities, reducing the interference of sound waves on gas flow. After the sound wave energy is absorbed, the gas flow in the pipeline becomes more stable, further suppressing gas pressure fluctuations. Thirdly, the silencer can cause sound waves to reflect multiple times and cancel each other out through expansion cavities or labyrinth structures, reducing the impact of sound waves on gas flow. After sound wave reflection and cancellation, the gas flow is more stable, and gas pressure fluctuations are significantly reduced. Fourthly, the silencer can also reduce the resistance and energy loss of gas flow by optimizing the gas flow path. The optimized gas flow path makes the airflow more stable and further reduces air pressure fluctuations.

[0081] In one embodiment, the controllable valve includes:

[0082] An internal spring is provided in the valve. The compression of the internal spring is adjustable. When the compression force of the internal spring is balanced with the pressure of the negative pressure tank or the positive pressure tank in the gas power module, the valve core of the controllable valve is maintained at the target opening degree.

[0083] In this embodiment, the core component of the controllable valve is an internal spring with adjustable compression. Adjusting the internal spring helps to maintain pressure for different needs and enhances the flexibility of the system.

[0084] In one embodiment, such as Figure 3 As shown, the gas power module also includes:

[0085] A back pressure valve, located in the negative pressure tank or the positive pressure tank, is used to discharge excess gas from the negative pressure tank or the positive pressure tank;

[0086] A safety valve is installed in the negative pressure tank or the positive pressure tank to monitor the internal pressure of the negative pressure tank or the positive pressure tank, and to automatically release the gas in the negative pressure tank or the positive pressure tank when the internal pressure exceeds a preset pressure threshold.

[0087] For example, the power source of the gas power module 100 is a dual-head diaphragm pump 110. The pump heads (111 and 112) of the dual-head pump each have an air inlet (111a and 112a) and an air outlet (111b and 112b). The air outlet 111b of the pump head 111 is connected to the main air inlet 121 of the positive pressure tank 120. The air inlet 111a of the pump head 111 is connected to port 113a of a three-way connector 113. Port 113b of the connector is connected to the atmospheric environment 114. Port 113c of the connector is connected to port 2 of the solenoid valve SV1. Port 1 of the solenoid valve SV1 is connected to the main branch 210 of the gas drive module 200. The solenoid valve SV1 is a two-position normally closed valve that controls the opening and closing of the air inlet 111a of the pump head 111 and the main branch 210. The air inlet 112a of pump head 112 is connected to the main air outlet 131 of negative pressure tank 130, and the air outlet 112b of pump head 112 is connected to silencer SM3, discharging gas into the environment. Therefore, according to the above air path connection method, pump head 111 draws air from the atmosphere and pumps it into positive pressure tank 120, generating a positive pressure source; hence, pump head 111 can be called a positive pressure pump head. Pump head 112 draws gas from negative pressure tank 130 and discharges it into the environment, generating a negative pressure source; hence, pump head 112 can be called a negative pressure pump head. The dual-head diaphragm pump 110 is connected to positive pressure tank 120, negative pressure tank 130, and three-way connector 113 using a plastic flexible hose; the material can be PU, PVC, or nylon, etc. The main outlet 123 of the positive pressure tank is connected to port 1 of the solenoid valve SV2 of the gas drive module 200, and the main inlet 132 of the negative pressure tank 130 is connected to port 2 of the solenoid valve SV3 of the gas drive module 200. Due to the pulsation of the diaphragm pump, a silencer SM1 is installed at the main inlet 121 inside the positive pressure tank 120 to effectively reduce noise and suppress turbulence generated during gas flow.

[0088] In one embodiment, the gas power module further includes a positive pressure control branch 140 and a negative pressure control branch 150, which help to assist in the gas charging and discharging control of the system. The positive pressure control branch 140 is connected to the positive pressure tank 120 through the auxiliary gas outlet 122 of the positive pressure tank 120, and is used to control the gas flow in the positive pressure pipeline connected to the positive pressure tank 120; the negative pressure control branch 150 is connected to the negative pressure tank 130 through the first auxiliary gas inlet 133 of the negative pressure tank, and is used to control the gas flow in the negative pressure pipeline connected to the negative pressure tank 130.

[0089] The main branch of the positive pressure control circuit 140 connects to the inlet of the back pressure valve BPV1. By adjusting the compression of the spring inside the valve, the gas pressure in the positive pressure tank 120 is balanced with the spring's compression force, and the valve core is at a certain opening. The outlet of the back pressure valve BPV1 connects to the silencer SM6 to release excess gas from the positive pressure tank, thus stabilizing the pressure in the positive pressure tank. The compression of one spring corresponds to the stable pressure of one positive pressure tank. In this device, the pressure in the positive pressure tank is generally stabilized at 400 mmHg ± 10 mmHg. Another branch of the positive pressure control circuit 140 connects to the safety valve RV1. When the pressure inside the tank exceeds the preset pressure of 465 mmHg (9 psi) of the safety valve, the gas inside the tank is automatically released to the atmosphere, providing overpressure protection.

[0090] The first auxiliary air inlet 133 of the negative pressure tank is connected to the negative pressure control branch 150. The main branch of the negative pressure control branch 150 is connected to the air outlet of the back pressure valve BPV2. The air inlet of the back pressure valve BPV2 is connected to the silencer SM2 to replenish the necessary gas. Generally, adjusting the compression of the spring inside the valve, as in the positive pressure control branch 140, cannot successfully adjust the negative pressure value of the negative pressure tank 130 because the atmospheric pressure of the incoming air is insufficient to effectively overcome the compression force of the spring. Therefore, it is necessary to connect the breather hole of BPV2 to the main branch, using the negative pressure suction of the negative pressure tank to balance the compression force of the spring. This allows the valve core to be at a certain opening, replenishing the necessary gas into the negative pressure tank and achieving the effect of stabilizing the negative pressure of the tank. The compression of one spring corresponds to the stable negative pressure of one negative pressure tank. In this device, the pressure of the negative pressure tank is generally stabilized at -390 mmHg ± 10 mmHg. In addition, a solenoid valve SV4 is connected between the breather port of the back pressure valve BPV2 and the main branch. This solenoid valve SV4 is a two-position, three-position normally open valve. Ports 1 and 2 are normally open, maintaining communication between the breather port of BPV2 and the negative pressure tank 130. Port 3 is connected to the silencer SM5. When the solenoid valve SV4 is energized, ports 2 and 3 are connected, disconnecting the breather port of the back pressure valve BPV2 from the negative pressure tank 130. Therefore, the back pressure valve BPV2 cannot be opened by atmospheric pressure alone, and the negative pressure tank 130 will be continuously evacuated by the negative pressure pump head 112. The ultimate negative pressure is determined by the capacity of the negative pressure pump head 112 itself. The second auxiliary air inlet 134 of the negative pressure tank is connected to the inflation module 400. The ultimate negative pressure can be used to replace the air in the balloon catheter 500 with helium. Therefore, the negative pressure control branch 150 has an adjustable and stable negative pressure function (including the ultimate negative pressure value). In addition, a pressure sensor PT3 is connected to the main branch of the negative pressure control branch 150 to monitor the negative pressure of the negative pressure tank 130. A silencer SM2 is installed at the main air inlet 132 inside the negative pressure tank 130, which can also effectively reduce noise and suppress turbulence generated during gas flow.

[0091] In this embodiment, a safety valve is installed in the gas power module. This safety valve helps protect the gas power module from overpressure, enhancing system safety. Specifically, when the gas pressure in the gas power module exceeds a preset safety threshold, the safety valve automatically opens, releasing excess gas to prevent further pressure increases. By automatically releasing excess gas, the safety valve prevents the system pressure from exceeding the safety threshold, reducing the possibility of equipment damage or system malfunction due to overpressure. Furthermore, the automatic response mechanism of the safety valve improves system reliability, ensuring timely intervention in case of abnormal pressure, thus preventing accidents.

[0092] In one embodiment, the gas-driven module further includes:

[0093] A branch pressure monitoring unit is located in the drive branch of the gas drive module and is used to monitor the gas pressure in the drive branch.

[0094] For example, the main branch 210 of the gas drive module 200 can be connected to the safety disc 300 and also to port 1 of the solenoid valve SV1. Solenoid valve SV2 is installed on branch 220, and solenoid valve SV3 is installed on branch 230. Both solenoid valves are two-position, two-normally closed valves. Port 1 of solenoid valve SV2 is connected to the positive pressure tank 120, controlling the connection between the positive pressure tank 120 and the safety disc 300; port 2 of solenoid valve SV3 is connected to the negative pressure tank 130, controlling the connection between the negative pressure tank 130 and the safety disc 300. A three-position, two-normally open solenoid valve SV5 is connected in series on the main branch 210. Port 1 is connected to the main branch, port 2 is connected to a pressure sensor PT2, and port 3 is connected to an air filter PF1, leading to the atmospheric environment. When solenoid valve SV5 is de-energized, ports 1 and 2 remain open, and pressure sensor PT2 monitors pressure changes in the main branch for real-time monitoring. When solenoid valve SV5 is energized, ports 2 and 3 are connected, and pressure sensor PT2 detects the local atmospheric pressure for calculating the absolute pressure and dead volume of the balloon catheter. Including a branch pressure monitoring unit in the system helps monitor the branch pressure in the drive branch, improving the efficiency of branch control and thus enhancing the overall stability of the system.

[0095] In one embodiment, the balloon system further includes an auxiliary depressurization module, which includes a solenoid valve SV1. The solenoid valve is used to assist the negative pressure pump head 112 in venting air when the patient has a high heart rate or high fever, in order to adapt to the shortening of the balloon inflation and deflation cycle.

[0096] In one embodiment, the helium filling and pumping module includes:

[0097] Storage unit for storing helium gas required by the system;

[0098] An output control unit is located in the output pipeline of the helium filling and pumping module, and is used to realize the output and input control of the helium filling and pumping module.

[0099] For example, the helium inflation / deflation module 400 can be located between the safety disc 300 and the balloon catheter 500. One end of the main balloon inflation / deflation path 410 is connected to the helium end membrane shell 330, and the other end is connected to the balloon catheter 500. A branch path 420 of the helium inflation / deflation module 400 is connected to the negative pressure tank 130. A pressure sensor PT1 is connected to the main path 410 to monitor pressure changes within the balloon catheter. This module has two operating modes: deflation and inflation. When switched to deflation mode, the inflation / deflation module 400 is connected to the negative pressure tank 130, extracting gas from the helium end membrane shell 330, the main path 410, and the balloon catheter 500. When switched to inflation mode, the inflation / deflation module 400 is disconnected from the negative pressure tank 130, filling the space between the helium end membrane shell 330 and the flexible diaphragm 310, the main helium path 410, and the balloon catheter 500 with helium. After several cycles of inflation and deflation, the air in the helium end membrane 330, main channel 410, and balloon catheter 500 can be completely replaced, reaching a pure helium state for balloon inflation and deflation cycles. The user can determine the working status of the balloon by observing the balloon pressure waveform transmitted by the pressure sensor PT1. The intra-aortic balloon catheter 500 can be a balloon catheter 520 consisting of a small-diameter extension tube 510 and a balloon. The extension tube 510 is connected to the main channel 410, delivering helium to or removing helium from the balloon.

[0100] Based on the same inventive concept, this application also provides a method for stable inflation and deflation of an intra-aortic balloon, such as... Figure 4 As shown, it includes:

[0101] In response to the startup of the target device, the control gas power module establishes a positive and negative pressure environment and completes helium replacement preparation;

[0102] Acquire feature monitoring information of the target object, including electrocardiogram monitoring data, blood pressure monitoring data, and environmental monitoring data, and control the target device to perform periodic inflation and deflation cycles based on the feature monitoring information;

[0103] In response to an abnormality in the characteristics of the target object, the target device is adjusted to maintain a stable positive and negative pressure environment.

[0104] Specifically, the workflow of this system to stably drive the inflation and deflation of the balloon can be as follows. The specific values ​​involved in the following examples are all exemplary values ​​and are not intended as a specific feasible implementation.

[0105] First, the balloon catheter 500 was purged with helium:

[0106] Step 1: Start the dual-head diaphragm pump 110. The positive pressure value of the back pressure valve BPV1 stabilizing positive pressure tank 120 is 400mmHg±10mmHg, and the negative pressure value of the back pressure valve BPV2 stabilizing negative pressure tank 130 is -390mmHg±10mmHg.

[0107] Step 2: Open the solenoid valve SV3. The air branch line 230 and the main air line 210 are connected to the negative pressure tank 130, and both are under negative pressure. Under the negative pressure of the negative pressure tank 130, the flexible diaphragm moves rapidly towards the air end membrane shell 310 and adheres to the wall of the membrane shell 310.

[0108] Step 3: Switch solenoid valve SV4, opening port 2 to port 3, disconnecting back pressure valve BPV2, and placing negative pressure tank 130 in extreme negative pressure state. Switch helium filling / evacuation module 400 to evacuation mode. Upon reaching the evacuation stop line, it automatically switches to filling mode, reaches the filling stop line, and then switches back to evacuation mode. This cycle repeats approximately 6 times to complete the helium filling / evacuation process. Ultimately, the air between the helium end membrane shell 330 and the flexible diaphragm 310, the main channel 410, and the balloon catheter 500 is in a pure helium state under a certain negative pressure. This negative pressure is the balloon's deflation pressure, and the balloon is in a deflated state. This negative pressure value is related to the balloon catheter specifications and the local atmospheric pressure. For example, at standard atmospheric pressure of 101.3 kPa, the deflation pressure of a 40L balloon catheter is approximately -100 mmHg. Switch solenoid valve SV4, port 1 to port 2 open, back pressure valve BPV2 opens, stabilizing the negative pressure value of negative pressure tank 130 at -390mmHg±10mmHg. The negative pressure value of the negative pressure tank is lower than the deflation pressure of the balloon catheter, the flexible diaphragm 310 remains in close contact with the air end membrane housing 320, and solenoid valve SV3 is disconnected.

[0109] After completing the above steps, the balloon inflation and deflation cycle begins. The sequence starts with the balloon 500 fully deflated, at a deflation pressure of approximately -100 mmHg. The flexible diaphragm 310 of the safety disc is tightly attached to the air-end membrane shell 320, and solenoid valves SV1, SV2, and SV3 are all closed. During the inflation phase, solenoid valve SV2 briefly opens, allowing positive-pressure air from the positive-pressure tank 120 to instantly enter the air-end membrane shell 320 along the air branch path 220 and the main air path 210. At this point, the air pressure of approximately 400 mmHg ± 10 mmHg pressurizes the flexible diaphragm 310, causing it to move towards the helium-end membrane shell 330 and adhere tightly. The helium gas originally present between the flexible diaphragm 310 and the helium-end membrane shell 330 is instantly introduced into the extension tube 510 under the pressure of positive air, generating an immediate positive pressure. Meanwhile, the distal balloon remains under negative pressure. The helium gas in the extension tube 510 begins to flow into the balloon, causing it to expand and eventually generate an inflation pressure approximately equal to the patient's blood pressure, for example, about 100 mmHg. During the deflation phase, solenoid valve SV2 closes, and solenoid valve SV3 briefly opens. The gas in the main air path 210 and the air-end membrane shell 310 is rapidly drawn away by the negative pressure tank 130. The flexible diaphragm 310 instantly moves towards and adheres to the air-end membrane shell, causing the helium-end membrane shell 330 to instantly become under negative pressure. The distal balloon 520 remains under a positive pressure of 100 mmHg. The helium gas in the balloon flows through the extension tube 510 into the helium-end membrane shell 330, causing the balloon to contract and eventually generate a deflation pressure of approximately -100 mmHg within the balloon. Solenoid valves SV2 and SV3 alternately open and close. Under the influence of a positive or negative pressure source, the flexible diaphragm 310 moves closer to the helium-side membrane shell 330 or the air-side membrane shell 320 within the safety disc, compressing or retracting the helium in the balloon catheter. This achieves the periodic expansion and contraction of the balloon, synchronized with the patient's heart rate (T = 60 / heartrate, unit: seconds). The stable positive pressure of the positive pressure tank and the stable negative pressure of the negative pressure tank ensure stable air flow within the drive module and safety disc, thus guaranteeing stable reciprocating motion of the flexible diaphragm. Consequently, the balloon's inflation and deflation state tends to be stable, and the inherent delay of the pneumatic system tends to be fixed. This facilitates R-wave prediction algorithm control, improving the stability and safety of intra-aortic balloon counterpulsation therapy.

[0110] Specifically, when the patient's heart rate exceeds the system's preset value, such as greater than 140 BPM, the balloon inflation / deflation cycle shortens, and correspondingly, the opening time of solenoid valve SV3 also shortens. The negative pressure pump head 112 cannot quickly remove the instantaneously increased gas in the negative pressure tank 130. At this time, the negative pressure value of the negative pressure tank 130 cannot be effectively stabilized at -390 mmHg ± 10 mmHg, resulting in the balloon not fully contracting or unstable pressure during deflation. In this situation, the original solenoid valve SV3 will open, and solenoid valve SV1 will also open. The main air path 210 will connect with the air inlet 111a of the positive pressure pump head 111, assisting in removing the positive pressure gas from the main air path 210 and the air end diaphragm housing 310, thus stabilizing the negative pressure tank 130 at -390 mmHg ± 10 mmHg, ensuring the stability of the negative pressure source and guaranteeing stable balloon contraction. Solenoid valve SV1 can also open once after solenoid valve SV3 has been operating for several cycles. The opening frequency of the solenoid valve SV1 is automatically set by the system based on the actual pressure of the balloon inflation / deflation waveform in the aorta.

[0111] It is understood that the above-mentioned intra-aortic balloon stable inflation / deflation system and driving method can also take other forms, and are not limited to the forms mentioned in the above embodiments, as long as they can achieve the function of stable inflation / deflation control and improve the auxiliary gain effect of the balloon pump.

[0112] In the description of this specification, references to terms such as "some embodiments," "other embodiments," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of this application. In this specification, the illustrative descriptions of the above terms do not necessarily refer to the same embodiments or examples.

[0113] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0114] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of this application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these modifications and improvements all fall within the protection scope of this application. Therefore, the protection scope of this application should be determined by the appended claims.

Claims

1. A balloon system, characterized in that, include: A gas power module is used to provide the gas power required by the system. A gas drive module, connected to the gas power module, controls the shuttle direction of the gas source power; The balloon module is placed at the intervention site of the target patient and expands or contracts under the control of the gas-driven module to achieve auxiliary medical purposes.

2. The balloon system according to claim 1, characterized in that, The gas power module includes: A dual-head diaphragm pump, a negative pressure tank, and a positive pressure tank are provided. The dual-head diaphragm pump is used to draw in or expel gas from the atmospheric environment to provide chamber pressure. The dual-head diaphragm pump includes a negative pressure pump head and a positive pressure pump head. The negative pressure pump head and the positive pressure pump head are independently controlled. The negative pressure pump head is connected to the negative pressure tank to provide a negative pressure source, and the positive pressure pump head is connected to the positive pressure tank to provide a positive pressure source.

3. A balloon system according to claim 2, characterized in that, The gas power module includes: A controllable valve, the opening degree of which is adjustable, and the gas pressure of the gas power module remains stable when the controllable valve is maintained at a preset target opening degree.

4. A balloon system according to claim 3, characterized in that, The controllable valve includes: An internal spring is provided in the valve. The compression of the internal spring is adjustable. When the compression force of the internal spring is balanced with the pressure of the negative pressure tank or the positive pressure tank in the gas power module, the valve core of the controllable valve is maintained at the target opening degree.

5. A balloon system according to claim 2, characterized in that, The gas power module also includes: A back pressure valve, located in the negative pressure tank or the positive pressure tank, is used to discharge excess gas from the negative pressure tank or the positive pressure tank; A safety valve is installed in the negative pressure tank or the positive pressure tank to monitor the internal pressure of the negative pressure tank or the positive pressure tank, and to automatically release the gas in the negative pressure tank or the positive pressure tank when the internal pressure exceeds a preset pressure threshold.

6. A balloon system according to claim 2, characterized in that, The gas-driven module includes: A positive pressure control branch is connected to the negative pressure tank and is used to control the gas flow in the negative pressure pipeline connected to the negative pressure tank; The negative pressure control branch is connected to the positive pressure tank and is used to control the gas flow in the positive pressure pipeline connected to the positive pressure tank.

7. A balloon system according to claim 6, characterized in that, The gas-driven module further includes: A branch pressure monitoring unit is located in the drive branch of the gas drive module and is used to monitor the gas pressure in the drive branch.

8. A balloon system according to claim 1, characterized in that, It also includes a security disk module, which comprises: Air-end membrane housing, used to store and protect air-end gas; Helium end membrane shell, used for storing and protecting helium; A flexible diaphragm is disposed between the air-end membrane shell and the helium-end membrane shell to isolate the air-end gas from the helium gas. The flexible diaphragm deforms in response to changes in pressure.

9. A balloon system according to claim 1, characterized in that, It also includes a helium filling and pumping module, including: Storage unit for storing helium gas required by the system; An output control unit is located in the output pipeline of the helium filling and pumping module, and is used to realize the output and input control of the helium filling and pumping module.

10. A driving method, characterized in that, The method is implemented based on a balloon system as described in any one of claims 1 to 9, comprising: In response to the startup of the target device, the control gas power module establishes a positive and negative pressure environment and completes helium replacement preparation; Acquire feature monitoring information of the target object, including electrocardiogram monitoring data, blood pressure monitoring data, and environmental monitoring data, and control the target device to perform periodic inflation and deflation cycles based on the feature monitoring information; In response to an abnormality in the characteristics of the target object, the target device is adjusted to maintain a stable positive and negative pressure environment.

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