Control host with filtering structure and intravascular balloon system

Abstract

The invention relates to the technical field of medical instruments, discloses a control host with a filtering structure and an intravascular balloon system, and aims to eliminate bubbles possibly existing in a balloon catheter and prevent the bubbles from entering the body of a patient during an operation. The control host comprises a power device for controlling fluid to flow, a control valve capable of controlling whether the fluid flows in a pipeline or not, a filtering structure for preventing bubbles from entering a balloon catheter, a fluid communicating pipeline for a fluid medium and / or blood to flow, a fluid pressure sensor, a microprocessor, a liquid storage structure and the like; and the balloon catheter can be inserted into a blood vessel and enables the balloon at the far end to expand through the control host. According to the control host and the intravascular balloon system, bubbles possibly existing in a balloon catheter cavity can be eliminated, and the risk of a patient in the operation process is reduced.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and in particular to a system capable of performing partial or complete vascular occlusion. Background Technology

[0002] Cardiovascular disease accounts for 30.9% of global deaths, and currently only one in ten people recover from cardiac arrest. It causes more deaths than any other disease in industrialized countries, and accounts for three-quarters of non-communicable deaths in developing countries. In the United States, there are approximately 350,000 cases of cardiac arrest, both in and out of hospitals. The sheer number of patients and the poor prognosis necessitate targeted treatments that are immediate and easy to administer.

[0003] Resuscitation balloon occlusion (REBOA) is a surgical procedure that typically involves percutaneously inserting a balloon catheter device into a blood vessel, which is then inflated to control bleeding. Over the past decade, REBOA has been increasingly used to improve hemodynamic stability by increasing systolic blood pressure, while controlling life-threatening bleeding before and / or during explicit surgical or endovascular interventional procedures.

[0004] The concept of REBOA was first reported in 1954 in wounded soldiers with traumatic trunk bleeding. In the 1970s, transaxillary balloon occlusion was described for treating ruptured aortic aneurysms. Currently, this technique can be used percutaneously and is supplied in kits, including femoral artery access, a REBOA balloon catheter device, and fixation materials. Many catheters are available for REBOA devices, including the 4-French COBRA-OS, 7-French ER-REBOA, and pREBOA-PRO (or 12-14-French Coda) balloon catheters. Aortic blood flow occlusion can only be performed using compliant balloons, primarily because non-compliant balloons pose a high risk of vascular injury, such as aortic dissection rupture, upon inflation within the aorta. All REBOA balloon catheter devices contain a compliant balloon assembly with an inflatable diameter of approximately 9-40 mm. The choice of REBOA device depends on the specific clinical scenario (i.e., determining the appropriate balloon assembly size based on the target aortic segment) and operator preference. The femoral artery approach can be performed using the method most familiar to the surgeon, including femoral artery puncture by palpation or percutaneous puncture under ultrasound guidance using minimally invasive techniques.

[0005] Resuscitation balloon occlusion (REBOA) can be used to treat a variety of clinical conditions, including uncontrolled traumatic hemorrhage, postpartum hemorrhage, placenta accreta spectrum disorder (PAS), out-of-hospital cardiac arrest requiring cardiopulmonary resuscitation (CPR), and non-traumatic intraperitoneal hemorrhage, and is usually performed in non-surgical settings.

[0006] Current technologies require fluoroscopic guidance for handling traumatic bleeding, non-traumatic bleeding, traumatic cardiac arrest, and non-traumatic cardiac arrest. Large fluoroscopic instruments are overly complex to operate, and in time-sensitive emergencies, using fluoroscopy, CT, or MR scans for endovascular catheter insertion is too time-consuming and not the best option. Therefore, there is a growing demand for portable REBOA operating systems. These portable devices allow users without extensive specialized training to operate REBOA in both hospital and non-hospital settings. This allows not only resident specialists but also non-medical personnel or those with only basic medical knowledge to operate the system.

[0007] The problems with existing technologies are as follows: First, existing systems lack effective filtration structures in the media lumen and corresponding tubing of the balloon catheter, which may affect the normal operation of the balloon. Second, the process of eliminating air bubbles in traditional balloon systems is cumbersome and the effect is uncontrollable, the results of bubble elimination are not reliable, and it may affect the use of the balloon catheter during the operation, increasing the risk to the patient during the operation and seriously affecting the safety of the operation.

[0008] Purpose of the invention: By incorporating a filter structure capable of eliminating air bubbles within the main unit of the balloon catheter control system, this invention significantly reduces the risk of air embolism caused by air bubbles. Furthermore, placing the filter structure within the fluid pipeline makes operation more reliable and improves defoaming efficiency. Summary of the Invention

[0009] Embodiments of the present invention provide a control host with a filtration structure and an intravascular balloon system, primarily addressing the technical problem in existing intravascular balloon systems where air bubbles may exist within the balloon catheter during use. These air bubbles may enter the patient's body during surgery, increasing the risk and affecting surgical safety. The technical solution described in this invention effectively eliminates air bubbles that may be present within the balloon catheter lumen, preventing air bubbles from entering the patient's body during surgery, significantly reducing the risk during surgery, and improving the safety and reliability of the intravascular balloon system.

[0010] An embodiment of the present invention discloses a control host with a filtration structure for connecting an intravascular balloon catheter to control balloon inflation and deflation, comprising: a first fluid communication conduit for guiding a fluid passage within the control host, the first fluid communication conduit primarily supplying the flow of a medium fluid; a power unit for driving the fluid flow within the fluid communication conduit; a first control valve disposed on the fluid communication conduit for controlling fluid flow; a first sensor disposed on the fluid communication conduit, closer to the proximal end relative to the control valve, the first sensor for monitoring pressure and / or flow rate data and changes in the fluid within the fluid communication conduit; a filtration structure disposed on the fluid communication conduit and located between the control valve and the first sensor, the filtration structure for intercepting or separating air bubbles in the fluid; a microprocessor for receiving signals transmitted by the first sensor and controlling the power unit and the control valve; and a liquid storage structure for storing the medium fluid; wherein the first filtration structure is a filter membrane with selective permeability, allowing liquid to pass through while blocking gas.

[0011] Furthermore, the liquid storage structure is an external liquid storage bag, which is detachably connected to the first fluid communication pipeline of the control host through a pipeline, and is arranged outside the control host.

[0012] Furthermore, the external liquid storage bag also includes a drip-type bubble separator. The drip-type bubble separator is installed on the pipeline between the liquid storage structure and the first control valve. It forms a gas-liquid coexistence space inside, with the top used to collect bubbles and the bottom outlet used to output the defoamed liquid.

[0013] Furthermore, the control host, which has a media chamber, also includes a second fluid communication pipeline that connects to the blood chamber, and a second sensor installed on the pipeline for real-time monitoring of changes in blood pressure and / or flow rate within the blood chamber.

[0014] Furthermore, a second filtration structure is provided on the second fluid communication pipeline corresponding to the blood cavity. The second filtration structure is a filter membrane with selective permeability, which can adapt to the blood flow characteristics and retain free air bubbles while maintaining smooth blood flow.

[0015] Furthermore, in addition to having a medium chamber and an external liquid storage structure, the control host also includes a third fluid communication pipeline connecting to the blood chamber, as well as a third sensor and a third control valve installed on the pipeline. The third sensor is used to monitor changes in blood pressure and / or flow rate in the blood chamber in real time, and the third control valve is installed on the third fluid communication pipeline to control the flow on and off.

[0016] Furthermore, a third filtration structure is provided on the third fluid communication pipeline corresponding to the blood cavity. The third filtration structure is a filter membrane with selective permeation characteristics, which can adapt to the blood flow characteristics and retain free air bubbles while maintaining smooth blood flow.

[0017] Furthermore, the first pressure sensor and / or the second pressure sensor, and / or the third sensor transmit the detected pressure and / or flow rate change signals to the microprocessor in real time. The microprocessor determines and controls the running direction and duration of the power unit, as well as the opening and closing state of the control valve, according to a preset algorithm.

[0018] Furthermore, the balloon catheter has at least one lumen that allows a fluid medium to fill the balloon, while another lumen allows blood to flow through and enables the sensor to monitor changes in blood pressure and / or flow rate.

[0019] Furthermore, the balloon is a compliant or semi-compliant balloon, and the material includes, but is not limited to, one or more of the following: nylon (PA), polyurethane (TPU), and polyether amide block copolymer (PEBAX) mixed in a certain proportion.

[0020] Furthermore, the balloon can expand to a diameter ranging from 10 to 35 mm after receiving different pressures.

[0021] Furthermore, the liquid storage structure can be made of medical polyurethane (TPU), silicone, polyethylene terephthalate (PET), ethylene-vinyl acetate copolymer (EVA), polypropylene (PP), nylon (PA), polyvinyl chloride (PVC), acrylonitrile, butadiene, and styrene terpolymer ABS, or a synthetic polymer covered with a metal layer.

[0022] Furthermore, the fluid communication pipeline includes a first fluid communication pipeline, a second fluid communication pipeline, and a third fluid communication pipeline; Furthermore, the first fluid communication conduit connects the liquid storage structure and the balloon catheter for filling and extracting the fluid medium.

[0023] Furthermore, both the second and third fluid communication lines connect to the blood vessels and transmit changes in blood pressure and / or flow rate to the corresponding sensors, which then convert these changes into electrical signals, enabling the microprocessor to intelligently regulate the control host.

[0024] Furthermore, the material of the fluid communication pipeline can be selected from silicone, polyvinyl chloride (PVC), polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), polypropylene (PP), polyethylene (PE), polyurethane (TPU), etc., one or more of which are mixed in a certain proportion.

[0025] Furthermore, the fluid communication pipeline is preferably a hollow tubular channel, and the specific cross-sectional shape can be circular, elliptical, spindle-shaped, etc., preferably circular.

[0026] Furthermore, the diameter of the fluid communication pipeline is in the range of 2mm to 6.4mm, preferably 3mm.

[0027] Furthermore, the power unit is a power-controlled filling device, which can be composed of a piston pump, a peristaltic pump, or any other type of power-driven pump capable of bidirectional filling and discharging.

[0028] Furthermore, the sensor assembly is located within the control unit and includes: a first sensor for sensing changes in fluid pressure and / or flow rate, and a second and third sensor for sensing changes in blood pressure and / or flow rate. These are respectively connected to the corresponding fluid communication lines.

[0029] Furthermore, the sensor can receive blood pressure and / or flow rate change signals transmitted through the fluid communication tubing and fluid medium pressure and / or flow rate change signals within the balloon, and the pressure and / or flow rate change signals are transmitted to the microprocessor.

[0030] Furthermore, the control valve can respond to the microprocessor's regulation based on the blood pressure and / or flow rate change signals transmitted by the fluid communication pipeline and the pressure and / or flow rate change signals of the fluid in the balloon catheter. The control valve includes a solenoid valve, a ball valve, a clamp valve, or a tube-clamp valve, etc.

[0031] Furthermore, the control host also includes an energy storage structure, which may be a battery, a solar cell, or any other power supply device for providing electricity. A battery is preferred, including but not limited to: lead-acid batteries, nickel-cadmium batteries, nickel-metal hydride batteries, lithium-ion batteries, lithium polymer batteries, lithium iron phosphate batteries, etc.

[0032] Furthermore, embodiments of the present invention also disclose an intravascular balloon system, characterized in that the system comprises: the aforementioned control host and an external balloon catheter; the balloon catheter has a distal inflatable balloon, which has at least one cavity inside, the cavity including a medium cavity and / or a blood cavity; the balloon catheter is connected to the control host through the fluid communication conduit, and is used to realize the inflation, maintenance or periodic deflation of the balloon under the drive of the control host; wherein, the balloon is an occlusive balloon or a pulsatile assist balloon with periodic inflation and deflation function.

[0033] The beneficial effects of this invention are as follows: by setting a filtration structure in the control host, especially by setting a filter membrane in the medium chamber and corresponding pipeline, air bubbles in the fluid medium can be effectively filtered to prevent air bubbles from entering the balloon catheter; by setting an external liquid storage structure and a drip chamber, the effect of removing air bubbles is further enhanced; through the cooperation of a fluid pressure sensor and a microprocessor, intelligent control of the entire system is realized; compared with the prior art, this invention significantly reduces the risks to patients during surgery, improves the safety and reliability of the intravascular balloon system, and provides a safer and more reliable medical device for clinical surgery. Attached Figure Description

[0034] The accompanying drawings are for illustrative purposes only and are not intended to limit the invention. Furthermore, the same reference numerals are used to identify the same parts throughout the drawings. In the drawings:

[0035] Figure 1 Intravascular balloon system

[0036] Figure 2 Anatomical diagram of the control unit

[0037] Figure 3 Example 1 of the control host

[0038] Figure 4 Example 2 of the control host

[0039] Figure 5 Example 3 of the control host

[0040] Figure 6 Example 4 of the control host

[0041] Figure 7 balloon catheter

[0042] Explanation of reference numerals in the attached figures:

[0043] 10: Control unit; 1010: Fluid communication pipeline; 1011: First fluid communication pipeline; 1012: Second fluid communication pipeline; 1013: Third fluid communication pipeline; 1020: Power unit; 1030: Control valve; 1031: First control valve; 1032: Second control valve; 1033: Third control valve; 1040: Pressure sensor; 1041: First pressure sensor; 1042: Second pressure sensor; 1043: Third pressure sensor; 1050: Filtration structure; 1051: First filtration structure; 1052: Second filtration structure; 1053: Third filtration structure; 1060: Microprocessor; 1070: Liquid storage structure; 1080: Energy storage structure; 20: Balloon catheter; 2010: Balloon; 2020: Catheter; 2030: Fluid chamber; 2031: Medium chamber; 2032: Blood chamber. Detailed Implementation

[0044] Exemplary embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

[0045] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also mean including the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a specific order as described or illustrated, unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0046] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0047] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, in addition to those depicted in the figure. For example, if the device in the figure is flipped, then an element described as "below other elements or features" or "below other elements or features" will subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0048] In the description of this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction 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.

[0049] In the field of interventional medical devices, the end of a medical device implanted in the human or animal body that is closer to the operator is generally called the "proximal end," and the end that is farther from the operator is called the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device are defined.

[0050] In one embodiment, a control host 10 with a filtering structure 1050 is provided, such as Figure 3As shown, it includes: a first fluid communication pipe 1011 for guiding the fluid passage within the control host 10, the first fluid communication pipe 1011 mainly supplying the flow of the medium fluid; a power unit 1020 for driving the fluid to flow in the fluid communication pipe 1010; a first control valve 1031 disposed on the first fluid communication pipe 1011 for controlling the flow of fluid; and a first pressure sensor 1041 disposed on the fluid communication pipe 1010, closer to the proximal end relative to the control valve 1030, the first pressure sensor 1041 for monitoring the flow of fluid in the fluid communication pipe 1010. The system includes: pressure data and changes of the fluid within 010; a first filtration structure 1051, disposed on the fluid communication pipe 1010 and located between the control valve 1030 and the pressure sensor 1040, used to intercept or separate air bubbles in the fluid; a microprocessor 1060, used to receive signals transmitted by the pressure sensor 1040 and control the power unit 1020 and the control valve 1030; and a liquid storage structure 1070, used to store the medium fluid; wherein, the first filtration structure 1051 is a filter membrane with selective permeability, allowing liquid to pass through while blocking gas.

[0051] In this embodiment, the first filter structure 1051 is disposed in the first fluid communication pipeline 1011, i.e., the pipeline for the flow of fluid medium, and is located between the control valve 1030 and the pressure sensor 1040. The first filter structure 1051 is generally a filter membrane, made of materials such as PES, PVDF, PTFE, and CA, and has a uniform microporous structure with a pore size ranging from 0.1 to 0.5 μm. The filter membrane is connected within the pipeline, and the connection method can be snap-fit, adhesive, or welded, effectively blocking microbubbles in the fluid medium and ensuring that the fluid medium injected into the balloon catheter 20 is bubble-free. Furthermore, since the filter membrane is located after the sensor, the filtering of bubbles does not affect the pressure monitoring by the first pressure sensor 1041.

[0052] The power unit 1020 is a power pump device capable of changing the suction direction. In this embodiment, a peristaltic pump structure is adopted to achieve the suction function. The peristaltic pump includes components such as a pump head, rotor, rollers, and compression tubing. The pump head has good corrosion resistance and mechanical strength; multiple rollers are evenly distributed on the rotor, and the rollers are made of polyurethane material, possessing appropriate hardness and elasticity. When the peristaltic pump is working, the rotor drives the rollers to rotate, and the rollers sequentially compress the tubing, forming a peristaltic wave that propels the liquid towards the direction of the conduit 2020. The suction function of the peristaltic pump is achieved by changing the rotor's rotation direction, enabling precise control of the liquid flow rate and direction to meet the needs of different stages during surgery.

[0053] The sensors can be of various types, such as pressure sensors 1040, level sensors, and flow sensors. These sensors transmit the detected information to the microprocessor 1060 of the control host 10 via data transmission cables. The built-in algorithm program of the microprocessor 1060 can perform real-time analysis and judgment on the received sensor data, control the start and stop of the power unit 1020 and speed regulation, and simultaneously control the opening and closing status of various control valves 1030 in the pipeline, thereby realizing automated operation and safety protection of the equipment.

[0054] The working principle of the entire control host 10 is as follows:

[0055] The control unit 10 is connected to the media chamber 2031 of the balloon catheter 20 via a first fluid communication pipe 1011. The reservoir structure 1070 is pre-filled with filling medium (such as physiological saline, contrast agent, or a certain concentration of anticoagulant), and is sequentially connected to the power unit 1020, the first control valve 1031, the first filtration structure 1051 (filtration membrane), and the first sensor via pipes, finally connecting to the media chamber 2031 of the balloon catheter 20 to form a closed media circulation loop. In the initial state, all control valves 1030 are closed, the power unit 1020 is stopped, and the microprocessor 1060 is in standby mode. When the pre-flushing program is started, the microprocessor 1060 controls the first control valve 1031 corresponding to the media chamber 2031 to open, and simultaneously starts the power unit 1020 to run, driving the medium in the reservoir bag to flow sequentially through the first filtration structure 1051 (filtration membrane) and the first sensor, finally connecting to the media chamber 2031 of the balloon catheter 20 and being injected into the balloon 2010. After pre-rinsing, the microprocessor 1060 controls the power unit 1020 to reverse, drawing the balloon catheter 20 and residual liquid in the tubing back into the storage structure 1070. During formal inflation, the microprocessor 1060 controls the first control valve 1031 to remain open, and the power unit 1020 delivers the medium to the balloon 2010. During this process, air bubbles in the fluid are intercepted or separated by the first filter structure 1051, and bubble-free medium is injected into the balloon 2010, causing it to inflate to the target pressure. When deflating the balloon 2010, the microprocessor 1060 opens the first control valve 1031 and starts the power unit 1020 to reverse, drawing the medium from the balloon 2010 back into the storage structure 1070. The returned medium passes through the first filter structure 1051 (filter membrane) again to prevent the formation of new air bubbles due to negative pressure.

[0056] In yet another embodiment, a control host 10 with a filtering structure 1050 is provided, such as Figure 4As shown, the system includes: a first fluid communication pipeline 1011, a power unit 1020, a first control valve 1031, a first sensor, a first filtration structure 1051, a microprocessor 1060, and a liquid storage structure 1070, which is an external liquid storage bag. This bag is detachably connected to the first fluid communication pipeline 1011 of the control host 10 via a pipeline and is located outside the control host 10. The first filtration structure 1051 is a filter membrane with selective permeability, allowing liquid to pass through while blocking gas. The filtration structure 1050 also includes a drip-type bubble separator. The drip-type separator is located on the pipeline between the liquid storage structure 1070 and the first control valve 1031, forming a gas-liquid coexistence space inside. The top is used to collect bubbles, and the bottom outlet is used to output the defoamed liquid.

[0057] In this embodiment, the liquid storage structure 1070 is externally connected to the main unit via a dedicated connecting pipe. This external design allows the liquid storage structure 1070 to be selected with different capacity specifications according to actual needs, while also facilitating replacement and maintenance. The container of the liquid storage structure 1070 is made of transparent or semi-transparent material, making it easy to observe the liquid level and state. The dripper is located below the liquid storage structure 1070 and includes an inlet, a bubble separation chamber, and an outlet. After the liquid flows from the liquid storage structure 1070 into the inlet of the dripper, it is naturally lifted by gravity and a special flow channel design within the bubble separation chamber, and then discharged from the vent at the top. The bubble separation chamber has a multi-layer separation structure, increasing the liquid flow path and improving bubble separation efficiency. The outlet of the dripper is connected to the liquid input terminal of the control host 10, ensuring that the liquid entering the control host 10 has been thoroughly de-bubbled. In a preferred embodiment, the dripper may also be equipped with a bubble detection sensor to monitor the bubble content in the liquid in real time. When the bubble content exceeds a preset threshold, the system will automatically adjust the liquid flow rate or start an additional debubbling program.

[0058] The working principle of the entire control host 10 is as follows:

[0059] The control host 10 is connected to the media chamber 2031 of the balloon catheter 20 via the first fluid communication pipe 1011. The liquid is first stored in the external liquid storage structure 1070, and then flows into the drip chamber below for degassing by gravity or pumping. The degassed liquid is then transported to the control host 10, and then sequentially connected to the power unit 1020, the first control valve 1031, the filter membrane structure 1050, and the first sensor through pipelines, finally connecting to the media chamber 2031 of the balloon catheter 20, forming a closed media circulation loop. In the initial state, all control valves 1030 are closed, the power unit 1020 is stopped, and the microprocessor 1060 is in standby mode. When the filling process is initiated, the microprocessor 1060 controls the opening of the first control valve 1031 corresponding to the media chamber 2031, and simultaneously starts the power unit 1020 to drive the media in the storage bag to flow sequentially through the filter membrane filtration structure 1050 and the first sensor, finally connecting to the media chamber 2031 of the balloon catheter 20 and being injected into the balloon 2010. After filling is completed, the microprocessor 1060 controls the power unit 1020 to run in reverse, drawing the balloon catheter 20 and residual liquid in the pipeline back into the storage structure 1070. The external design of the storage structure 1070 not only improves the modularity of the equipment but also facilitates the replacement of storage devices of different specifications according to different process requirements. The de-aeration function of the dripper ensures the stability of liquid quality, avoids the adverse effects of bubbles on subsequent processes, and improves the overall working efficiency and product quality of the equipment.

[0060] In another embodiment, a control host 10 with a filtration structure 1050 is provided, as shown in FIG5. It includes: a first fluid communication pipe 1011, a power unit 1020, a first control valve 1031, a first sensor, the first filtration structure 1051, a microprocessor 1060, and a liquid storage structure 1070; it also includes a second fluid communication pipe 1012 communicating with a blood chamber 2032, and a second pressure sensor 1042 disposed on the pipe for real-time monitoring of blood pressure changes within the blood chamber 2032. The first filtration structure 1051 is a filter membrane with selective permeability, allowing liquid to pass through while blocking gas. The second fluid communication pipe 1012 corresponding to the blood chamber 2032 is also provided with a second filtration structure 1052, which is a filter membrane with selective permeability, adaptable to blood flow characteristics, and capable of maintaining smooth blood flow while trapping free air bubbles.

[0061] The working principle of the entire control host 10 is as follows:

[0062] The control host 10 is connected to the media chamber 2031 of the balloon catheter 20 through the first fluid communication pipeline 1011. The reservoir structure 1070 is pre-filled with filling medium (such as physiological saline, contrast agent, or a certain concentration of anticoagulant), and is connected in sequence through the pipeline to the power unit 1020, the first control valve 1031, the first filtration structure 1051 (filtration membrane), and the first sensor, and finally connected to the media chamber 2031 of the balloon catheter 20, forming a closed media circulation loop; the blood chamber 2032 passage also connects to the reservoir structure 1070, the power unit 1020, the second control valve 1032, the second filtration structure 1052 (filtration membrane), the second sensor, and finally connected to the blood chamber 2032 of the balloon catheter 20. The connection between the blood chamber 2032 and the reservoir structure 1070 only occurs during the pre-flushing process. When the pre-flushing is complete, the second control valve 1032 closes the passage of the blood chamber 2032, blocking the blood introduced from the blood vessel before the second sensor, which detects the blood pressure at the proximal end of the balloon 2010. When the pre-flushing program is started, the microprocessor 1060 controls the first control valve 1031 corresponding to the media chamber 2031 to open, and simultaneously starts the power unit 1020 to drive the media in the reservoir bag to flow sequentially through the first filtration structure 1051 (filtration membrane) and the first sensor, and finally connect to the media chamber 2031 of the balloon catheter 20 and be injected into the balloon 2010; at the same time, the second control valve 1032 opens, and the media also flows through the second filtration structure 1052 and the second sensor, and finally enters the blood chamber 2032 of the balloon catheter 20. The two filtration structures ensure that there are no air bubbles in the cavity of the balloon catheter 20. After pre-rinsing, the microprocessor 1060 controls the power unit 1020 to reverse, drawing the balloon catheter 20 and residual liquid in the tubing back into the reservoir structure 1070. During formal inflation, the microprocessor 1060 controls the first control valve 1031 to remain open, and the power unit 1020 delivers the medium to the balloon 2010. During this process, air bubbles in the fluid are intercepted or separated by the first filter structure 1051, and bubble-free medium is injected into the balloon 2010, causing it to inflate to the target pressure. However, at this time, the second control valve 1032 is closed, and the blood chamber 2032 is not connected to the reservoir structure 1070. When deflating the balloon 2010, the microprocessor 1060 opens the first control valve 1031 and starts the power unit 1020 to reverse, drawing the medium in the balloon 2010 back into the reservoir structure 1070. The returned medium passes through the first filter structure 1051 (filter membrane) again to prevent the formation of new air bubbles due to negative pressure.

[0063] In yet another embodiment, a control host 10 with a filtering structure 1050 is provided, such as Figure 6As shown, the system includes: a fluid communication conduit 1010, a power unit 1020, a first control valve 1031, a first sensor, a first filtration structure 1051, a microprocessor 1060, and a liquid storage structure 1070; it also includes a second fluid communication conduit 1012 connecting to a blood chamber 2032, and a second pressure sensor 1042 disposed on the conduit for real-time monitoring of blood pressure changes within the blood chamber 2032. The first filtration structure 1051 and the second filtration structure 1052 disposed on the second fluid communication conduit 1012 corresponding to the blood chamber 2032 are both selectively permeable membranes, adaptable to blood flow characteristics, capable of maintaining smooth blood flow while trapping free air bubbles. Furthermore, in this embodiment, the liquid storage structure 1070 is an external liquid storage bag, which is detachably connected to the fluid communication pipe 1010 of the control host 10 via a pipeline and is arranged outside the control host 10. A drip-type bubble separator is connected below the external liquid storage bag. The drip-type bubble separator is set on the pipeline between the liquid storage structure 1070 and the control valve 1030, and a gas-liquid coexistence space is formed inside it. The top is used to collect bubbles, and the bottom outlet is used to output the defoamed liquid.

[0064] The working principle of the entire control host 10 is as follows:

[0065] The control host 10 is connected to the media chamber 2031 of the balloon catheter 20 through the first fluid communication pipe 1011. The liquid is first stored in the external liquid storage structure 1070, and then flows into the drip chamber below for degassing by gravity or pumping. The degassed liquid is then transported to the control host 10 and connected in sequence through the pipeline to the power unit 1020, the first control valve 1031, the first filtration structure 1051 (filtration membrane), and the first sensor, and finally connected to the media chamber 2031 of the balloon catheter 20, forming a closed media circulation loop. The blood chamber 2032 passage also connects to the liquid storage structure 1070, the power unit 1021, the second control valve 1032, the second filtration structure 1052 (filtration membrane), and the second sensor, and finally connects to the blood chamber 2032 of the balloon catheter 20. The connection between the blood chamber 2032 and the reservoir structure 1070 only occurs during the pre-flushing process. When the pre-flushing is complete, the second control valve 1032 closes the passage of the blood chamber 2032, blocking the blood introduced from the blood vessel before the second sensor, which detects the blood pressure at the proximal end of the balloon 2010. When the pre-flushing program is started, the microprocessor 1060 controls the first control valve 1031 corresponding to the media chamber 2031 to open, and simultaneously starts the power unit 1020 to drive the media in the reservoir bag to flow sequentially through the first filter structure 1051 (filter membrane) and the first sensor, and finally connect to the media chamber 2031 of the balloon catheter 20 and be injected into the balloon 2010; at the same time, the second control valve 1032 opens, and the media also flows through the second filter structure 1052 and the second sensor, and finally enters the blood chamber 2032 of the balloon catheter 20. The two filter structures 1050 ensure that there are no air bubbles in the cavity of the balloon catheter 20. After pre-rinsing, the microprocessor 1060 controls the power unit 1020 to reverse, drawing the balloon catheter 20 and residual liquid in the tubing back into the reservoir structure 1070. During formal inflation, the microprocessor 1060 controls the first control valve 1031 to remain open, and the power unit 1020 delivers the medium to the balloon 2010. During this process, air bubbles in the fluid are intercepted or separated by the first filter structure 1051, and bubble-free medium is injected into the balloon 2010, causing it to inflate to the target pressure. However, at this time, the second control valve 1032 is closed, and the blood chamber 2032 is not connected to the reservoir structure 1070. When deflating the balloon 2010, the microprocessor 1060 opens the first control valve 1031 and starts the power unit 1020 to reverse, drawing the medium in the balloon 2010 back into the reservoir structure 1070. The returned medium passes through the first filter structure 1051 (filter membrane) again to prevent the formation of new air bubbles due to negative pressure. The external design of the 1070 liquid storage structure not only improves the modularity of the equipment but also facilitates the replacement of different specifications of liquid storage devices according to different process requirements. The de-aeration function of the dripper ensures the stability of liquid quality, avoids the adverse effects of bubbles on subsequent processes, and improves the overall efficiency of the equipment and product quality.

[0066] In a further embodiment, such as Figure 1 As shown, an intravascular balloon system is provided, including a control unit 10 and an external balloon catheter 20. The balloon catheter 20 has a distal inflatable balloon 2010, which has at least one cavity inside, the cavity including a medium cavity 2031 and / or a blood cavity 2032; the balloon catheter 20 is connected to the control unit 10 through the fluid communication conduit 1010, and is used to realize the inflation, maintenance or periodic deflation of the balloon 2010 under the drive of the control unit 10; wherein, the balloon 2010 is an occlusive balloon or a pulsatile assist balloon with periodic inflation and deflation function.

[0067] The balloon catheter 20, as the core component of the system, is made of a flexible polymer material, possessing excellent biocompatibility and mechanical strength. The wall thickness of the balloon catheter 20 is 0.02-0.05 mm, ensuring sufficient strength while maintaining good flexibility during intravascular manipulation. The catheter 2020 contains a media chamber 2031, through which saline or contrast agent can be injected into the balloon 2010, causing it to inflate and expand at a predetermined location. The distal end of the balloon catheter 20 is connected to an inflatable balloon 2010 structure, which is made of polyurethane or nylon and has a preset inflation diameter and pressure threshold.

[0068] The balloon catheter 20 can be configured as an occlusion balloon. In this configuration, the balloon 2010's diameter is matched to the inner diameter of the target blood vessel. When inflated, the balloon 2010 completely occludes the vessel lumen, blocking blood flow. The inflation pressure of the occlusion balloon is typically controlled between 8 and 12 atmospheres to ensure that the balloon 2010 adheres tightly to the vessel wall to form an effective occlusion while avoiding excessive pressure on the vessel wall. The occlusion function is primarily used to control bleeding, isolate the lesion area, or create a bloodless environment for other treatment procedures.

[0069] The balloon catheter 20 can also be configured as a periodic deflation balloon, in which case the balloon 2010 has a controllable inflation and deflation cycle. The periodic deflation balloon inflates and deflates at preset time intervals or in conjunction with electrocardiographic fluctuations, creating regular periodic blood flow regulation. This periodic blood flow control helps improve local blood circulation, reduce the risk of thrombosis, and provides intermittent blood flow cessation windows for drug delivery or other treatments.

[0070] exist Figures 1 to 6In the embodiments shown, the liquid storage structure 1070 can be made of medical polyurethane (TPU), silicone, polyethylene terephthalate (PET), ethylene-vinyl acetate copolymer (EVA), polypropylene (PP), nylon (PA), polyvinyl chloride (PVC), acrylonitrile, butadiene, and styrene terpolymer ABS, or a synthetic polymer covered with a metal layer.

[0071] In some preferred embodiments, the control host 10 and intravascular balloon system provided in this application can achieve complete or partial occlusion of the subject's aorta. The process includes introducing a balloon catheter 20 into the subject's blood vessel and advancing the distal balloon 2010 to a specific location in the subject's vascular system. The control host 10 provided in this application can inform the user of the device's usage status and inflate the balloon 2010 to a certain extent to reduce blood flow from that location in the vascular system to a specific part of the body. The balloon catheter 20 has a fluid medium cavity 2031, also known as the medium cavity 2031. The balloon 2010 can be inflated by the fluid medium stored in the reservoir structure 1070, and this cavity is also in contact with a first sensor via a first fluid communication conduit 1011. The first sensor converts the fluid signal into an electrical signal and transmits the electrical signal to a microprocessor 1060.

[0072] Furthermore, the distal end of the balloon catheter 20 has an opening, allowing blood to pass through a blood chamber 2032 within the balloon catheter 20, distinct from the medium chamber 2031 connecting the balloon 2010. This allows blood to pass through this chamber and ultimately contact the second or third sensor via the second fluid communication conduit 1012 or the third fluid communication conduit 1010. The second or third sensor can convert the fluid signal into an electrical signal and transmit the electrical signal to the microprocessor 1060.

[0073] Furthermore, the fluid signal can specifically be a signal indicating fluid pressure and / or fluid flow rate, and the electronic signal can in particular be a digital or analog electronic indication of that pressure or flow rate. The sensor transmits the electrical signal to the microprocessor 1060, which can process the electrical signal and display the corresponding information in a location visible to the operator on the control host 10. The microprocessor 1060 can provide a set of instructions, including: electronic control signals for controlling the power unit 1020 to control whether or not the balloon 2010 is inflated with fluid, and / or for regulating the control valve 1030 to control whether or not the corresponding fluid communication line 1010 is opened or closed.

[0074] Furthermore, the balloon catheter 20 has at least one lumen that allows the balloon 2010 to be filled with a fluid medium, while another lumen allows blood to flow through and enables the sensor to monitor changes in blood pressure and / or flow rate. The balloon 2010 is a compliant or semi-compliant balloon, made of materials including, but not limited to, nylon (PA), polyurethane (TPU), and polyetheramide block copolymer (PEBAX), one or more of these materials mixed in a certain proportion. The balloon 2010 can inflate to a diameter ranging from 10 to 35 mm upon receiving different pressures.

[0075] Furthermore, the liquid storage structure 1070 can be made of medical polyurethane (TPU), silicone, polyethylene terephthalate (PET), ethylene-vinyl acetate copolymer (EVA), polypropylene (PP), nylon (PA), polyvinyl chloride (PVC), acrylonitrile, butadiene, and styrene terpolymer ABS, or a synthetic polymer covered with a metal layer.

[0076] Further, the fluid communication conduit 1010 includes a first fluid communication conduit 1011, a second fluid communication conduit 1012, and a third fluid communication conduit 1013. The first fluid communication conduit 1011 connects the liquid storage structure 1070 and the balloon catheter 20, and is used for filling and extracting fluid media. The second fluid communication conduit 1012 and the third fluid communication conduit 1013 both connect to blood within the blood vessels and transmit changes in blood pressure and / or flow rate to corresponding sensors, further converting them into electrical signals, enabling the microprocessor 1060 to intelligently regulate the control host 10. The fluid communication conduit 1010 can be made of silicone, polyvinyl chloride (PVC), polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), polypropylene (PP), polyethylene (PE), polyurethane (TPU), etc., or a mixture of one or more of these materials in a certain proportion. The fluid communication conduit 1010 is preferably a hollow tubular channel, and its specific cross-sectional shape can be circular, elliptical, spindle-shaped, etc., preferably circular. The diameter of the fluid communication pipe 1010 is in the range of 2mm to 6.4mm, preferably 3mm.

[0077] Furthermore, the power unit 1020 is a power-controlled filling device, which may consist of a piston pump, a peristaltic pump, or any other type of power-driven pump capable of bidirectional filling and discharging.

[0078] Furthermore, the sensor assembly is located within the control host 10 and includes: a first sensor for sensing changes in fluid pressure and / or flow rate, and a second and third sensor for sensing changes in blood pressure and / or flow rate. These are respectively connected to the corresponding fluid communication lines 1010. The sensors can receive blood pressure and / or flow rate change signals transmitted through the fluid communication lines 1010 and fluid medium pressure and / or flow rate change signals within the balloon 2010. The pressure and / or flow rate change signals are transmitted to the microprocessor 1060.

[0079] Furthermore, the control valve 1030 can respond to the regulation of the microprocessor 1060 based on the blood pressure and / or flow rate change signals transmitted by the fluid communication pipeline 1010 and the pressure and / or flow rate change signals of the fluid in the balloon catheter 20. The control valve 1030 includes a solenoid valve, a ball valve, a clamp valve, or a tube-clamp valve, etc.

[0080] Furthermore, the control host 10 also includes an energy storage structure 1080, which can be a battery, a solar cell, or any other power supply device for providing power. A battery is preferred, including but not limited to: lead-acid batteries, nickel-cadmium batteries, nickel-metal hydride batteries, lithium-ion batteries, lithium polymer batteries, lithium iron phosphate batteries, etc.

[0081] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A control unit with a filtration structure, used to connect to an intravascular balloon catheter to control balloon inflation and deflation, characterized in that, The control host includes: The first fluid communication pipeline is used to guide the fluid passage within the control host, and the first fluid communication pipeline is mainly for the flow of the medium fluid. A power unit for driving fluid to flow in the fluid communication pipeline; A first control valve is installed on the fluid communication pipeline to control the flow of fluid. A first sensor is disposed on the fluid communication pipeline, closer to the proximal end relative to the control valve. The first sensor is used to monitor the pressure and / or flow rate data and changes of the fluid in the fluid communication pipeline. A filter structure is disposed on the fluid communication pipeline and located between the control valve and the first sensor. The filter structure is used to intercept or separate air bubbles in the fluid. A microprocessor is used to receive signals transmitted by the first sensor and control the power unit and the control valve; Liquid storage structure, a structure used to store a medium fluid; The first filtration structure is a filter membrane with selective permeability, which allows liquid to pass through while blocking gas.

2. The control host according to claim 1, characterized in that, The liquid storage structure is an external liquid storage bag, which is detachably connected to the first fluid communication pipeline of the control host through a pipeline, and is arranged outside the control host.

3. The control host according to claim 2, characterized in that, The filtration structure also includes a drip-type bubble separator. The drip is installed on the pipeline between the liquid storage structure and the first control valve. It forms a gas-liquid coexistence space inside, with the top for collecting bubbles and the bottom outlet for outputting the defoamed liquid.

4. The control host according to claim 1, characterized in that, It also includes a second fluid communication conduit connecting to the blood cavity, and a second sensor disposed on the conduit for real-time monitoring of changes in blood pressure and / or flow rate within the blood cavity.

5. The control host according to claim 4, characterized in that, The second fluid communication pipeline corresponding to the blood cavity is also provided with a second filtration structure. The second filtration structure is a filter membrane with selective permeability, which can adapt to the blood flow characteristics and retain free air bubbles while maintaining smooth blood flow.

6. The control host according to claim 3, characterized in that, It also includes a third fluid communication line connecting to the blood cavity, and a third sensor and a third control valve disposed on the line. The third sensor is used to monitor changes in blood pressure and / or flow rate in the blood cavity in real time, and the third control valve is disposed on the third fluid communication line to control the flow on and off.

7. The control host according to claim 6, characterized in that, A third filtration structure is provided on the third fluid communication tube corresponding to the blood cavity. The third filtration structure is a filter membrane with selective permeability, which can adapt to the blood flow characteristics and retain free air bubbles while maintaining smooth blood flow.

8. The control host according to any one of claims 1 to 7, characterized in that, The power unit can achieve bidirectional fluid transport, which can pump the medium to the outside of the control host, or pump it in the opposite direction to recover the fluid. The power unit can be a peristaltic pump.

9. The control host according to any one of claims 1 to 8, characterized in that, The first sensor and / or the second sensor, and / or the third sensor transmit the detected pressure and / or flow signals to the microprocessor in real time. The microprocessor determines and controls the running direction and duration of the power unit, as well as the opening and closing state of the control valve, according to a preset algorithm.

10. An intravascular balloon system, characterized in that, The device includes a control unit as described in any one of claims 1 to 9, and an external balloon catheter; the balloon catheter has a distal inflatable balloon with at least one internal cavity, the cavity including a medium cavity and / or a blood cavity; the balloon catheter is connected to the control unit via the fluid communication conduit, and is used to inflate, maintain, or periodically deflate the balloon under the drive of the control unit; wherein the balloon is an occlusive balloon or a pulsatile balloon with periodic inflation and deflation function.

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