Pre-charging and exhausting system and pre-charging and exhausting method for blood purification

Abstract

The invention relates to a pre-charging and exhausting system for blood purification and a pre-charging and exhausting method, and belongs to the technical field of blood purification. The pre-charging and exhausting system for blood purification comprises a first clamp, a blood pump, a blood purifier and a second clamp which are sequentially arranged in the blood flowing direction and connected through a circulating pipeline, and further comprises an infusion apparatus, a pulse clamp, a vacuum pump and a high-frequency vibrator, and the infusion apparatus is used for conveying pre-charging liquid and is connected with the circulating pipeline between the first clamp and the blood pump through an infusion tube; the pulse clamp is arranged on the infusion tube and is configured to be periodically opened and closed so as to produce pressure pulses in the circulating pipeline; the vacuum pump is communicated with an inner cavity of the blood purifier; and the high-frequency vibrator is connected with the blood purifier. The invention aims to improve the discharge effect and discharge efficiency of gas in the blood purifier in the pre-inflation and exhaust link before the formal start of blood purification treatment, shorten the preparation time of the blood purification treatment, improve the anticoagulation effect of the blood purification treatment, and reduce the adverse effect caused by blood coagulation of the blood purifier.

Description

Technical Field

[0001] This invention relates to a pre-filling and venting system and method for blood purification, belonging to the field of blood purification technology. Background Technology

[0002] A pre-filled degassing system for blood purification is a medical device that removes metabolic waste, toxins, excess water, and inflammatory mediators from the blood through extracorporeal circulation, thereby replacing or assisting the function of organs such as the kidneys. Its core component is the blood purifier, and it is widely used in the treatment of critical illnesses such as liver and kidney failure, sepsis, autoimmune diseases, and poisoning. For example, a wearable artificial kidney device with filtration perfusion type disclosed in patent authorization announcement number CN222033206U and announcement date of 20241122 indirectly removes metabolic waste and toxins from the blood through the ultrafiltrate perfusion device of the ultrafiltrate purification section, which simplifies the treatment process and increases the portability of the artificial kidney device.

[0003] In traditional clinical procedures for blood purification therapy, the pre-filling and venting phase is time-consuming and inefficient, extending the preparation time for the procedure. Furthermore, the traditional manual tapping method for venting is ineffective, easily leading to residual gas in the blood purifier and circulation tubing due to incomplete pre-filling. Residual gas can cause premature clotting in the blood purifier and circulation tubing, shortening treatment time, affecting treatment efficacy, and increasing medical costs. Frequent clotting depletes blood components, leading to anemia, thrombocytopenia, and loss of clotting factors, often requiring blood transfusions and increasing the likelihood of transfusion-related complications.

[0004] To overcome the above-mentioned shortcomings, this application provides a pre-filling and venting system and method for blood purification. The system includes a heater, pulse clamp, vibrator, and vacuum pump. It utilizes the principles of pre-filling liquid heating, water hammer effect, high-frequency vibration, and vacuum treatment to promote the exhaust of gas from the blood purifier during the pre-filling stage, thereby improving the venting efficiency and effectiveness of the pre-filling process, increasing clinical work efficiency, reducing complications, and lowering medical costs. Summary of the Invention

[0005] To address the problems of gas residue and coagulation caused by incomplete pre-filling of blood purifiers in the prior art, this application provides a pre-filling and venting system and method for blood purification. Through structures such as heaters, pulse clamps, vibrators, and vacuum pumps, it utilizes principles such as pre-filling fluid heating, water hammer effect, high-frequency vibration, and vacuum treatment to promote gas expulsion from the blood purifier during the pre-filling stage. This improves the venting efficiency and effectiveness of the pre-filling process, enhances clinical work efficiency, reduces complications, and lowers medical costs.

[0006] An embodiment of the first aspect of this application provides a pre-filling and venting system for blood purification. The pre-filling and venting system for blood purification includes a first clamp, a blood pump, a blood purifier, and a second clamp, which are sequentially arranged along the blood flow direction and connected by a circulation pipeline. It also includes an infusion set, a pulse clamp, a vacuum pump, and a high-frequency vibrator. The infusion set is used to deliver pre-filling fluid and is connected to the circulation pipeline between the first clamp and the blood pump through an infusion tube. The pulse clamp is disposed on the infusion tube and is configured to periodically open and close to generate pressure pulses in the circulation pipeline. The vacuum pump is connected to the inner cavity of the blood purifier, and the high-frequency vibrator is connected to the blood purifier.

[0007] In some embodiments, the pre-fill venting system for blood purification further includes a heater disposed in the heating section of the infusion tubing, the heating section being located between the infusion set and the pulse clamp.

[0008] In some embodiments, the heater consists of a plurality of heating wires wrapped around the outer wall of the heating section.

[0009] In some embodiments, the heater further includes a thermally conductive insulating layer disposed on the outer wall of the heating section and covering the heating wire.

[0010] In some embodiments, the heater further includes a wrapping layer disposed on the outer wall of the heating section, which covers a thermally conductive and insulating layer.

[0011] In some embodiments, the heating temperature of the heater does not exceed 60°C.

[0012] In some embodiments, the pre-fill venting system for blood purification further includes a temperature detector disposed between the heater and the pulse clamp for detecting the temperature of the pre-fill fluid after heating.

[0013] In some embodiments, the high-frequency vibrator includes a variable-frequency voltage vibrator.

[0014] In some embodiments, the high-frequency vibrator further includes an ultrasonic device, which includes two working bodies respectively disposed on both sides of the blood purifier.

[0015] In some embodiments, the pre-charge venting system for blood purification further includes an inlet trap and an outlet trap, the inlet trap being disposed between the blood pump and the vacuum pump, and the outlet trap being disposed between the blood purifier and the second clamp.

[0016] An embodiment of the second aspect of this application provides a pre-filling and venting method, applied to a pre-filling and venting system for blood purification in any of the above embodiments, the method comprising: S101, clamp the first clamp, the second clamp and the pulse clamp, start the infusion set, and pre-fill the pulse clamp with fluid; S102, start the vacuum pump to evacuate the blood purifier and circulation tubing; S103, open the pulse clamp to allow the pre-filled fluid to perfuse the blood purifier and circulation tubing; S104 controls the pulse clamp to periodically close and open, turning the continuous liquid flow in the circulation pipeline into a pulsed liquid flow to flush the blood purifier. S105, activate the high-frequency vibrator to drive the blood purifier to vibrate at high frequency.

[0017] In some embodiments, the pre-fill venting system for blood purification further includes a heater disposed in the heating section of the infusion tubing, the heating section being located between the infusion set and the pulse clamp; Step S101 further includes: starting the heater, the pre-filled fluid flowing out of the infusion set is heated by the heater, and the heated pre-filled fluid flows to the pulse clamp.

[0018] In some embodiments, the pre-fill venting system for blood purification further includes a bubble detector disposed between the second clamp and the hemodialyzer; After step S105, the method further includes: activating the bubble monitor; if the bubble monitor detects no bubbles in the pre-filling fluid flowing through it within a preset time, it is determined that the pre-filling is complete, and the blood purification system switches from the pre-filling mode to the treatment mode. After the treatment mode is activated, blood purification treatment begins.

[0019] In this embodiment, during the pre-filling stage, when assisting the blood purifier and circulation tubing in venting, the heater and infusion set are first activated to allow the pre-filling fluid to flow towards the heater for heating, reducing its viscosity. The heated pre-filling fluid then flows to the pulse clamp. Next, the vacuum pump is activated to evacuate the circulation tubing and blood purifier between the first clamp and the pulse clamp. Then, the first clamp and the pulse clamp are opened, allowing the heated pre-filling fluid to fill the circulation tubing. The pulse clamp is then driven to open and close periodically, converting the continuous flow into a pulsed flow, flushing the blood purifier. Simultaneously, a high-frequency vibrator is activated to vibrate the blood purifier. At this point, heating, pulsation, and vibration work simultaneously and synergistically to achieve optimal venting, significantly improving the pre-filling venting efficiency and quality of blood purification, shortening the pre-filling venting time, reducing gas residue, and enhancing the anticoagulant effect.

[0020] In this embodiment, the heater reduces the adhesion of the pre-filled liquid to facilitate subsequent steps. The vacuum pump creates a vacuum, which makes the hidden microbubbles in the blood purifier and circulation tubing visible, expand, and loosen through negative pressure, creating an initial environment conducive to pulse flushing. The pulse clamp generates a strong flush from inside the circulation tubing and uses pulse water hammer force to forcefully remove the loosened bubbles. The high-frequency vibrator applies inertia from the outside and removes residual bubbles in the dead corners of the blood purifier through resonance. The four components work together to perform a quick and efficient venting operation on the blood purifier and circulation tubing, solving the industry pain point of difficult removal of membrane pore microbubbles in high-throughput blood purifiers, reducing complications, and improving the treatment effect and safety of blood purification. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of the pre-filled exhaust system for blood purification in one embodiment of this application.

[0022] Figure 2 This is a schematic diagram of the pre-charge and exhaust method in one embodiment of this application.

[0023] The labels in the attached diagram are as follows: 1-First clamp, 2-Blood pump, 3-Blood purifier, 31-Dialysis fluid supply device, 4-Second clamp, 5-Infusion set, 6-Heater, 7-Pulse clamp, 8-Vacuum pump, 9-High-frequency vibrator, 91-Variable frequency voltage vibrator, 92-Ultrasonic device, 10-Inlet air trap, 11-Outlet air trap, 12-Bubble monitor. Detailed Implementation

[0024] To facilitate understanding of this application, a more complete description will be provided below with reference to the accompanying drawings. Preferred embodiments of this application are shown in the drawings. However, this application can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a thorough and complete understanding of the disclosure of this application.

[0025] 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 in the specification of this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0026] When using the terms “including,” “having,” and “comprising” as described herein, another component may be added unless explicitly qualifying terms such as “only,” “consisting of,” etc. are used. Unless otherwise stated, singular terms may include plural forms and should not be construed as having a quantity of one.

[0027] It should be understood that although the terms “first,” “second,” etc., may be used herein to describe various elements, these elements should not be limited by these terms. These terms are used only to distinguish one element from another. For example, without departing from the scope of this application, a first element may be referred to as a second element, and similarly, a second element may be referred to as a first element.

[0028] It should also be understood that, in interpreting an element, although not explicitly described, the element is interpreted as including a range of error, which should be within the acceptable deviation range of a particular value as determined by a person skilled in the art. For example, "approximately," "about," or "substantially" can mean within one or more standard deviations, without limitation herein.

[0029] Furthermore, the accompanying drawings are not drawn to a 1:1 scale, and the relative dimensions of the components are shown in the drawings only as examples and not necessarily to actual scale.

[0030] This invention provides a pre-filling and venting system and method for blood purification, such as... Figure 1 As shown, the gas discharge operation is carried out through structures such as heater 6, pulse clamp 7, vibrator and vacuum pump 8, which aims to improve the gas discharge effect and efficiency of the pre-filled exhaust system for blood purification, and improve the therapeutic effect and safety of blood purification.

[0031] An embodiment of the first aspect of this application provides a pre-filling and venting system for blood purification. The pre-filling and venting system for blood purification includes a first clamp 1, a blood pump 2, a blood purifier 3, and a second clamp 4, which are arranged sequentially along the blood flow direction and connected by a circulation pipeline. It also includes an infusion set 5, a heater 6, a pulse clamp 7, a vacuum pump 8, and a high-frequency vibrator 9. The infusion set 5 is disposed between the first clamp 1 and the blood pump 2 and has an infusion tube for transmitting pre-filling fluid. The infusion tube has a heating section, and the heating section is provided with a heater 6. The heater is used to heat the pre-filling fluid and reduce its viscosity. The pulse clamp 7 is disposed on the infusion tube, located on the side of the heater 6 away from the infusion set 5, and is configured to periodically open and close to generate pressure pulses in the circulation pipeline. The vacuum pump 8 is connected to the inner cavity of the blood purifier 3, and the high-frequency vibrator 9 is connected to the blood purifier 3.

[0032] In this embodiment, the first clamp 1 acts as a "safety switch" for extracorporeal circulation, automatically clamping the arterial blood circuit to block blood flow and prevent blood loss or air ingress when the blood pump 2 stops or the pressure is abnormal. The blood pump 2 drives stable blood flow by squeezing the tubing through a peristaltic pump; the rotation speed and pump tubing diameter directly affect the blood flow velocity. It has overload shutdown protection to avoid red blood cell damage. The blood purifier 3 is the purification center of the pre-filling and degassing system for blood purification, including a dialyzer and / or perfusion device. When the blood purifier 3 is a dialyzer, it utilizes the semi-permeable membrane principle of the hollow fiber membrane to remove metabolic waste and excess water through diffusion and convection; blood flows inside the fiber, and dialysate flows outside the fiber, achieving efficient substance exchange. For example, the hollow fiber hemodialysis filter, model FX60, manufactured by Dalian Xiyu Trading Co., Ltd., is commonly used in clinical practice. The blood purifier 3 is connected to the dialysate supply device 31. The second clamp 4 is located at the end of the circulation tubing and is linked to the bubble monitoring device. When bubbles are detected during dialysis, it clamps the circulation tubing and stops the blood pump 2 to prevent air embolism.

[0033] In this embodiment, the heating section of the infusion tube is made of PFA (Perfluoroalkoxy Vinyl Ether Copolymer), which has excellent chemical corrosion resistance, high temperature resistance, biocompatibility, high purity, low coefficient of friction, and non-stickiness. This makes the surface of the heating section smooth, less prone to liquid residue, and ensures the purity and efficiency of the delivery. It is widely used in the medical field.

[0034] In this embodiment, before the blood purification pre-filling and venting system is used for treatment, a pre-filling and venting operation is required to improve the treatment effect and safety of blood purification. Before the pre-filling and venting operation, the first clamp 1, the second clamp 4, and the pulse clamp 7 are all in the closed state. The infusion set 5 is used to supply pre-filling fluid. The pre-filling fluid in blood purification is a special liquid used to fill the tubing system before extracorporeal circulation surgery. Its main function is to remove gas from the tubing and ensure the safe conduct of the blood purification process.

[0035] In this embodiment, during the pre-filling stage, when assisting the blood purifier and circulation tubing in venting, the heater 6 and infusion set 5 are first activated to allow the pre-filling fluid to flow to the heater 6 for heating, reducing its viscosity. The heated pre-filling fluid then flows to the pulse clamp 7. Next, the vacuum pump 8 is activated to evacuate the circulation tubing and blood purifier 3 between the first clamp 1 and the pulse clamp 7. Then, the pulse clamp 7 is opened to allow the heated pre-filling fluid to fill the circulation tubing. The pulse clamp 7 is then driven to open and close periodically, changing the continuous flow into a pulsed flow, flushing the blood purifier 3 and circulation tubing. Simultaneously, a high-frequency vibrator is activated to vibrate the blood purifier 3. At this time, heating, pulse, and vibration work simultaneously and synergistically to achieve optimal venting, significantly improving the pre-filling venting efficiency and quality of the blood purification system, shortening the pre-filling venting time, reducing gas residue, and enhancing the anticoagulant effect. After pre-filling venting is completed, the blood purifier 3 enters a standby state and can be switched to treatment mode.

[0036] In this embodiment, the pre-filling fluid is heated by heater 6, which not only serves to keep the patient warm but also to specifically reduce the viscosity and surface tension of the pre-filling fluid. According to fluid mechanics principles, reduced viscosity can significantly reduce the resistance to bubble rise (Stokes' Law) and reduce the surface tension adhesion between bubbles and the membrane wall, thereby increasing the rising and movement speed of microbubbles in the pre-filling fluid. It can also create better fluid conditions for subsequent pulsed flushing and high-frequency vibration, allowing loosened bubbles to be carried away more quickly and improving gas removal efficiency.

[0037] In this embodiment, the vacuum pump 8 is connected to the blood purifier 3 (filter) or the circulation pipeline via a pipeline, and is used to perform vacuum pretreatment on the inner cavity of the blood purifier 3 and the circulation pipeline. Specifically, before the pre-filling liquid enters the circulation pipeline, the first clamp 1, the second clamp 4, and the pulse clamp 7 are closed, making the circulation pipeline a closed pipeline. Then, the vacuum pump 8 is turned on to actively extract most of the free gas in the blood purifier 3 and the circulation pipeline before the pre-filling liquid is injected, actively creating a negative pressure environment to achieve the "evacuation first, filling later" operation. This changes the traditional pre-filling operation's passive gas-driving mode, actively creating a negative pressure environment conducive to the filling of the pre-filling liquid. When the pulse clamp 7 is opened, the pre-charge fluid can enter the circulation pipeline. The pre-charge fluid is "drawn" into the membrane pore by the pressure difference instead of being "forced" in. This reduces the pre-charge time and avoids the gas embolism blockage effect caused by positive pressure pre-charge. It can significantly reduce the burden on subsequent flushing and venting. It can also make the pulse flow generated in the subsequent pulse flushing step cause more intense pressure changes and flow field disturbances, thereby improving the venting effect and venting efficiency.

[0038] In this embodiment, the negative pressure environment causes the residual gas in the blood purifier 3 and the circulation tubing to expand, exposing it from micropores and corners, such as residual gas in the dead corners of the hollow fiber lumen and residual gas in the membrane fiber micropores. This makes it easier for the residual gas to be captured and carried by the subsequently flowing pre-filling fluid, thereby removing the gas and improving the therapeutic effect and safety of blood purification. The negative pressure environment also helps the dissolved gas in the pre-filling fluid to precipitate (similar to the principle of "vacuum degassing"), removing dissolved gas in advance during the pre-filling stage and further improving the exhaust effect.

[0039] In this embodiment, the vacuum pump 8 can be a high-precision vacuum pump, such as a rotary vane vacuum pump or a momentum transfer pump (molecular vacuum pump), which can achieve precise control of the vacuum level. This not only achieves effective venting but also avoids excessive negative pressure that could damage the membrane structure or cause the pre-filled liquid to "boil" and generate more bubbles, thus ensuring the safety of the pre-filling venting operation.

[0040] In this embodiment, the pulse clamp 7 can be a conventional controlled, rapid-opening and closing pipe clamp (mechanical clamp), and the opening and closing frequency of the pulse clamp 7 can be controlled by a simple programming program. After the pre-filled liquid is injected into the circulation pipeline after heating, the circulation pipeline is periodically blocked and released by the pulse clamp 7, thereby artificially creating periodic, alternating fast and slow or high and low pressure pulses (pulsed liquid flow) in the circulation pipeline. This introduces an unsteady flow field into the originally stable, continuous, and uniformly sheared circulation pipeline with pre-filled liquid, creating alternating shear force.

[0041] In this embodiment, the rapid action of the pulse clamp 7 can generate a "surge" effect in the pre-filled fluid within the circulation tubing, breaking the laminar boundary layer and producing intense pressure waves and transient high velocities. The peak velocity of the pressure pulse generates transient high shear forces. These transient high velocities and high shear forces effectively flush the inner walls of the membrane fibers of the blood purifier 3 and the circulation tubing, "tearing off" and carrying away the loosened and residual air bubbles after vacuum pretreatment. The unsteady flow field (turbulent flow field) can enhance radial mixing within the circulation tubing, preventing air bubbles from "drifting with the current" in the central streamline, and pushing the air bubbles towards the tubing wall for discharge, thus removing gas and improving the therapeutic effect and safety of blood purification.

[0042] In this embodiment, when the pulse clamp 7 is working, it can also generate pressure wave disturbance in the circulation pipeline with pre-filled liquid. The pressure fluctuation itself will form a small pressure wave in the pre-filled liquid, which will exert an alternating squeezing and expansion effect on the bubbles in the circulation pipeline, destroying their adhesion stability. The loosened bubbles can be carried away more quickly, improving the gas discharge effect.

[0043] In one example, the pulse clamp 7 can be a mechanical clamp with two jaws, with the circulation tubing (including a section of the infusion tubing) located between the two jaws. After pre-filling the circulation tubing with fluid, the pulse clamp 7 is in a normally open state. The jaws can be opened by a micro motor, push rod, or other structure. The micro motor controls the extension and retraction of the push rod, and the extension and retraction part of the push rod is connected to one of the jaws. The controller of the blood purifier 3 can send control waves to the micro motor to control its opening. The controller can release a wave every 3 seconds. Upon receiving the wave, the micro motor starts, driving the push rod to extend once and then retract. The push rod drives the jaws to close, and the pulse clamp 7 closes the circulation tubing for 1 second before reopening, thus achieving a pulse effect.

[0044] In this embodiment, the structure and addition method of the pulse clamp 7 are simple, and it can be easily and conveniently integrated into the existing blood purification system. Therefore, there is no need to add a complex high-speed pump. Only a smart-controlled clamp is used to generate the required pressure fluctuation by cutting off the flow path. It has the advantages of low cost and high reliability.

[0045] In this embodiment, one or more pulse clips 7 can be provided; multiple pulse clips 7 can bypass the blood purifier 3, blood pump 2 and other structures, and be evenly distributed on the circulation pipeline to further improve the exhaust effect and improve the blood purification treatment effect and safety.

[0046] In this embodiment, the pulse frequency, amplitude, and waveform (square wave, sine wave) of the pulse clip 7 can be adjusted according to the structure of different models of blood purifier 3 or the pressure in the circulation pipeline. The selection can be made according to actual needs to achieve personalized exhaust operation to adapt to different treatment plans. This application does not limit this.

[0047] In this embodiment, the high-frequency vibrator 9 is connected to the outer shell of the blood purifier 3, providing continuous, stable, and controllable high-frequency vibration to the blood purifier 3, including vertical and torsional vibration. The vibration energy is directly applied to the body of the blood purifier 3, causing the entire outer shell and its thousands of hollow fibers to vibrate at high frequency. Under high-frequency vibration, the residual gas inside the blood purifier 3 can have greater inertial force, enabling it to overcome the adhesion force to the membrane wall and detach. Furthermore, high-frequency vibration can cause the tiny bubbles inside the blood purifier 3 to collide and merge into larger bubbles, which then rise rapidly due to increased buoyancy, allowing them to be captured and carried by the pre-filled liquid for removal, thus improving the therapeutic effect and safety of blood purification.

[0048] In this embodiment, blood purifiers 3 of different brands and models have their own inherent mechanical resonance frequencies. The vibration frequency of the high-frequency vibrator 9 can be adjusted according to the inherent frequency of the outer shell and internal bundles of the blood purifier 3, so that the vibration frequency is close to its resonance point, thereby improving energy transfer efficiency, causing the membrane fibers to produce large-scale micro-vibrations, and improving the degassing effect.

[0049] In this embodiment, the heater 6 reduces the adhesion of the pre-filled liquid to facilitate subsequent steps. The vacuum pump 8 creates a vacuum, which allows the hidden microbubbles in the blood purifier 3 and circulation tubing to become visible, expand, and loosen through negative pressure, creating an initial environment conducive to pulse flushing. The pulse clamp 7 generates a powerful flush from inside the circulation tubing and uses pulse water hammer force to forcefully remove the loosened bubbles. The high-frequency vibrator 9 applies inertia from the outside and removes residual bubbles in the dead corners of the blood purifier 3 through resonance. The four components work together to perform a quick and efficient venting operation on the blood purifier 3 and circulation tubing, solving the industry pain point of difficult removal of membrane pore microbubbles in high-throughput blood purifiers 3, reducing complications, and improving the treatment effect and safety of blood purification.

[0050] In this embodiment, the heater 6, pulse clamp 7, vacuum pump 8, and high-frequency vibrator 9 can be used as independent accessories or integrated modules. They can be connected to the infusion tube and blood purifier 3 (filter) through standard pipelines, which can significantly improve the efficiency of blood purification treatment. At the same time, there is no need to make complex equipment modifications to the existing pre-filling and degassing system for blood purification. The operation is simple, the applicability is strong, and it has excellent clinical applicability.

[0051] In some embodiments, the heater 6 comprises multiple heating guide wires, which are wrapped around the outer wall of the heating section or embedded in the heating section pipeline, thereby heating the flowing pre-filled liquid. The heating guide wires include metal guide wires (nickel-chromium heating alloy, iron-chromium-aluminum alloy), etched foils, carbon fiber heating wires, etc.

[0052] In some embodiments, the heater 6 further includes a thermally conductive insulating layer disposed on the outer wall of the heating section, covering the heating guide wire, which can improve heating safety. Materials include medical-grade silicone rubber, thermoplastic elastomers, etc.

[0053] In some embodiments, the heater 6 further includes a wrapping layer disposed on the outer wall of the heating section, which covers a thermally conductive and insulating layer to improve heating safety and facilitate cleaning of the heater 6.

[0054] In some embodiments, the heating temperature of heater 6 does not exceed 60°C, which serves as a safe and effective upper temperature limit to ensure that the viscosity of the liquid is reduced without causing protein denaturation or generating too many new bubbles.

[0055] In this embodiment, 35-37°C can be set as the optimal exhaust temperature range. Compared with commonly used room temperature (about 25°C) liquid prefilling, the liquid viscosity can be significantly reduced in this temperature range, but the protein denaturation (if the prefilling liquid contains blood products) or the generation of new microbubbles will not be caused by excessively high temperature (such as >40°C), so as to balance exhaust efficiency and biosafety and ensure the prefilling exhaust effect.

[0056] In some embodiments, the pre-filling and venting system for blood purification also includes a temperature detector disposed between the heater 6 and the pulse clamp 7, for detecting the temperature of the pre-filling fluid after heating. The temperature detector can be a thermistor (such as NTC 10K), platinum resistance thermometer (PT100 / PT1000), etc., which works in conjunction with the heater 6 to form a closed-loop control to prevent the heating temperature from exceeding 60°C and causing overheating, thereby improving heating safety.

[0057] In some embodiments, the high-frequency vibrator 9 includes a variable-frequency voltage vibrator 91. The variable-frequency setting allows it to be adapted to various types of blood purifiers 3 on the market, expanding its applicability. The vibration frequency can be 100 Hz, which can improve the gas removal efficiency in the blood purifier 3 without increasing the wear and tear on the blood purifier 3. The high-frequency vibrator 9 can also be a variable-frequency electromagnetic vibrator. The type and vibration frequency of the high-frequency vibrator 9 can be selected according to actual needs, and this application does not limit this.

[0058] In some embodiments, the high-frequency vibrator 9 further includes an ultrasonic device 92, which comprises two working bodies respectively disposed on both sides of the blood purifier 3. The ultrasonic device 92 vibrates the blood purifier 3 by releasing ultrasonic waves with a frequency of approximately 30,000-50,000 Hz. Adding ultrasonic vibration to mechanical vibration can further increase the gas removal efficiency.

[0059] In some embodiments, the pre-fill venting system for blood purification further includes an inlet trap 10 and an outlet trap 11. The inlet trap 10 is disposed between the blood pump 2 and the vacuum pump 8, and the outlet trap 11 is disposed between the blood purifier 3 and the second clamp 4. The inlet trap 10 and the outlet trap 11 are key safety components of the hemodialysis device, and their main function is to capture and remove gases (such as air) from the blood or dialysate. (etc.) This prevents air bubbles from entering the patient's body and causing serious risks such as air embolism, while ensuring dialysis efficiency and treatment safety. Both operate through physical filtration or negative pressure adsorption principles and can be linked with pressure sensors and alarm systems to form a closed loop of "gas capture-monitoring-alarm," ensuring that the amount of residual gas is controlled within a safe range.

[0060] In this embodiment, the inlet gas trap 10 is used to capture gas mixed in from the infusion site, blood pump, or tubing, preventing gas from entering the perfusion device or blood purifier 3 with the blood, thus preventing air bubbles from clogging the membrane pores, reducing toxin removal efficiency, or causing hemodynamic instability in the patient (such as blood pressure fluctuations or abnormal heart rate). The outlet gas trap 11 is used to capture gas that seeps in from the dialysate side during dialysis (such as... This can prevent dissolved gases from being released due to pressure changes from being reinfused into the patient's venous system with the blood, thus preventing fatal complications such as pulmonary embolism and cerebral embolism.

[0061] An embodiment of the second aspect of this application provides a pre-filling and venting method, applied to a pre-filling and venting system for blood purification in any of the above embodiments. The pre-filling and venting method includes: S101, clamp the first clamp, the second clamp and the pulse clamp, start the infusion set, and pre-fill the pulse clamp with fluid; S102, start the vacuum pump to evacuate the blood purifier and circulation tubing; S103, open the pulse clamp to allow the pre-filled fluid to perfuse the blood purifier and circulation tubing; S104 controls the pulse clamp to periodically close and open, turning the continuous liquid flow in the circulation pipeline into a pulsed liquid flow to flush the blood purifier. S105, activate the high-frequency vibrator to drive the blood purifier to vibrate at high frequency.

[0062] In some embodiments, the pre-fill venting system for blood purification further includes a heater disposed in the heating section of the infusion tubing, the heating section being located between the infusion set and the pulse clamp.

[0063] Step S101 further includes: starting the heater, the pre-filled fluid flowing out of the infusion set is heated by the heater, and the heated pre-filled fluid flows to the pulse clamp.

[0064] In some embodiments, the pre-fill venting system for blood purification further includes a bubble monitor disposed between the second clamp and the hemodialyzer.

[0065] After step S105, the method further includes: activating the bubble monitor; if the bubble monitor detects no bubbles in the pre-filling fluid flowing through it within a preset time, it is determined that the pre-filling is complete, and the blood purification system switches from the pre-filling mode to the treatment mode. After the treatment mode is activated, blood purification treatment begins.

[0066] In this embodiment, the heater 6 reduces the adhesion of the pre-filled liquid to facilitate subsequent steps. The vacuum pump 8 creates a vacuum, which allows the hidden microbubbles in the blood purifier 3 and circulation pipeline to become visible, expand, and loosen through negative pressure, creating an initial environment conducive to pulse flushing. The pulse clamp 7 generates a powerful flush from inside the circulation pipeline and uses pulse water hammer force to forcefully remove the loosened bubbles. The high-frequency vibrator 9 applies inertia from the outside and removes residual bubbles in the dead corners of the blood purifier 3 through resonance. The four components work together to perform a quick and efficient venting operation on the blood purification system, solving the industry pain point of difficult removal of membrane pore microbubbles in the high-throughput blood purifier 3, reducing complications, and improving the therapeutic effect and safety of blood purification.

[0067] 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.

[0068] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. 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 all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A pre-filling and degassing system for blood purification, characterized in that, The system includes a first clamp (1), a blood pump (2), a blood purifier (3), and a second clamp (4), which are arranged sequentially along the direction of blood flow and connected by circulation tubing. It also includes: The infusion set (5) is used to deliver pre-filled fluid and is connected to the circulation line between the first clamp (1) and the blood pump (2) via the infusion tube; A pulse clamp (7) is installed on the infusion tube and is configured to open and close periodically to generate pressure pulses in the circulation line; The vacuum pump (8) is connected to the inner cavity of the blood purifier (3); The high-frequency vibrator (9) is connected to the blood purifier (3).

2. The pre-filling and venting system for blood purification according to claim 1, characterized in that, It also includes a heater (6), which is located in the heating section of the infusion tube between the infusion set (5) and the pulse clamp (7).

3. The pre-filling and venting system for blood purification according to claim 2, characterized in that, The heater (6) consists of multiple heating wires, which are wrapped around the outer wall of the heating section.

4. The pre-filling and venting system for blood purification according to claim 2, characterized in that, The heating temperature of the heater (6) shall not exceed 60°C.

5. The pre-filling and venting system for blood purification according to claim 2, characterized in that, It also includes a temperature detector, which is located between the heater (6) and the pulse clamp (7) to detect the temperature of the pre-filled liquid after heating.

6. The pre-filling and venting system for blood purification according to claim 1, characterized in that, The high-frequency vibrator (9) includes the variable frequency voltage vibrator (91).

7. The pre-filling and venting system for blood purification according to claim 6, characterized in that, The high-frequency vibrator (9) also includes an ultrasonic device (92), which includes two working bodies, which are respectively located on both sides of the blood purifier (3).

8. A pre-filling and venting method, applied to the pre-filling and venting system for blood purification as described in any one of claims 1 to 7, characterized in that, The method includes: S101, clamp the first clamp, the second clamp and the pulse clamp, start the infusion set, and pre-fill the pulse clamp with fluid; S102, start the vacuum pump to evacuate the blood purifier and circulation tubing; S103, open the pulse clamp to allow the pre-filled fluid to perfuse the blood purifier and circulation tubing; S104 controls the pulse clamp to periodically close and open, turning the continuous liquid flow in the circulation pipeline into a pulsed liquid flow to flush the blood purifier. S105, activate the high-frequency vibrator to drive the blood purifier to vibrate at high frequency.

9. The pre-charge and venting method according to claim 8, characterized in that, The pre-filling and venting system for blood purification also includes a heater, which is disposed in the heating section of the infusion tubing, located between the infusion set and the pulse clamp; step S101 further includes: When the heater is turned on, the pre-filled fluid flowing out of the infusion set is heated by the heater, and the heated pre-filled fluid flows to the pulse clamp.

10. The pre-charge and venting method according to claim 9, characterized in that, The pre-filling and degassing system for blood purification also includes a bubble detector disposed between the second clamp and the hemodialyzer; after step S105, the method further includes: The bubble monitor is activated. If the bubble monitor detects no bubbles in the pre-filling fluid flowing through it within a preset time, the pre-filling is considered complete. The blood purification system then switches from pre-filling mode to treatment mode, and blood purification treatment begins after the treatment mode is activated.

Images