A regeneration device for lipid adsorption materials

Abstract

This invention relates to the field of medical blood purification equipment technology, and discloses a lipid adsorption material regeneration device, including a main body, a rotary switching module, an adsorption column module, a dynamic pressure balancing system, a fluid pipeline system, and a main controller. The rotary switching module drives the adsorption column module to switch between three stations: treatment, regeneration, and balancing preparation. The adsorption column module is filled with pH-responsive hydrogel material to achieve adsorption and regeneration functions. The dynamic pressure balancing system forms a magnetic circuit through a magnetic piston and electromagnetic drive components in a bypass pipe, which senses and adjusts the pressure inside the column in real time. The fluid pipeline system controls the connection of input and output connectors via an electric push rod to achieve fluid switching. The main controller integrates data from multiple sensors, including pressure, pH, and optical sensors, to intelligently terminate the regeneration process. This invention achieves in-situ online regeneration of the adsorption material, continuous uninterrupted treatment, and precise closed-loop control, improving treatment efficiency and safety, and significantly reducing consumable costs.

Description

Technical Field

[0001] This invention relates to the field of medical blood purification equipment technology, and in particular to a blood lipid adsorption material regeneration treatment device. Background Technology

[0002] Lipid purification is an important treatment for hyperlipidemia, and adsorption chromatography is widely used due to its high efficiency and selectivity. However, existing lipid adsorption devices mostly use disposable adsorption columns or offline regeneration modes, which have significant drawbacks: First, the regeneration process requires interruption of treatment, disassembly of the adsorption column for chemical cleaning, which is cumbersome and inefficient; second, offline regeneration often uses harsh conditions such as strong acids, strong alkalis, or organic solvents, posing risks of toxic reagent residues and cross-contamination; third, the adsorption material cannot be reused, resulting in high costs per treatment; and fourth, the lack of real-time monitoring and intelligent control means that regeneration quality relies on human experience, leading to poor consistency.

[0003] Therefore, there is an urgent need in this field for an intelligent device that can realize online, safe, and efficient regeneration of adsorbent materials and support continuous treatment. Summary of the Invention

[0004] The purpose of this invention is to address the shortcomings of existing technologies by proposing a blood lipid adsorption material regeneration treatment device.

[0005] To achieve the above objectives, the present invention adopts the following technical solution: a blood lipid adsorption material regeneration treatment device, comprising:

[0006] The main body of the device includes a base, a detection chamber and a display. The detection chamber is fixedly installed on the upper side of the base, the display is installed on the upper side of the detection chamber, and a placement window is provided on the front side of the detection chamber.

[0007] The rotary switching module includes a rotary tray rotatably installed in the detection chamber, a detachable support bracket, and a servo motor set in the base. The support bracket is snapped onto the rotary tray, and the servo motor drives the rotary tray to rotate in increments.

[0008] An adsorption column module is clamped and fixed on the support bracket, and the cavity of the adsorption column module is filled with pH-responsive adsorption material.

[0009] The dynamic pressure balancing system includes a bypass tube fixed to the side wall of the adsorption column module, a magnetic piston slidably disposed in the bypass tube, and an electromagnetic drive assembly disposed in the detection chamber. When the electromagnetic drive assembly is energized, it generates a controllable magnetic attraction or magnetic repulsion force, driving the magnetic piston to reciprocate within the bypass tube.

[0010] The fluid pipeline system includes multiple input connectors and multiple output connectors. Each of the multiple input connectors and multiple output connectors is equipped with a solenoid valve for controlling the on / off state. Electric push rods are fixedly installed on the upper and lower sides of the detection chamber. The electric push rods drive the input connectors or output connectors to extend or retract, so that the input connectors and output connectors are respectively connected to the upper and lower ends of the adsorption column module.

[0011] The main controller is located inside the base and is electrically connected to the servo motor, solenoid valve, electromagnetic drive assembly, and electric push rod.

[0012] Preferably, an upper sieve plate and a lower sieve plate are fixedly installed at the upper and lower ends of the adsorption column module, respectively, and an isolation screen is fixedly installed inside the adsorption column module. The isolation screen divides the inner cavity of the adsorption column module into an upper chamber and a lower chamber, and the pH-responsive adsorption material is filled in the lower chamber.

[0013] The upper chamber of the adsorption column module is filled with a high-capacity adsorption material, which is composed of macroporous adsorption resin with a particle diameter ranging from 50 micrometers to 100 micrometers. The pore size of the isolation screen is smaller than the minimum particle diameter of the pH-responsive adsorption material and the high-capacity adsorption material.

[0014] Preferably, the electromagnetic drive assembly includes a first magnetic yoke sleeve and an electromagnetic coil fixedly installed inside the first magnetic yoke sleeve; a second magnetic yoke sleeve is fixedly installed on the outer side of the bypass pipe; when the adsorption column module is in the working position, the end faces of the first magnetic yoke sleeve and the second magnetic yoke sleeve are arranged opposite each other to form a magnetic circuit for guiding the magnetic field.

[0015] Preferably, the pH-responsive adsorbent material is composed of a pH-responsive hydrogel, the diameter of its coated microspheres ranges from 50 micrometers to 80 micrometers, a safety filter membrane is provided at the connection between the bypass tube and the inner cavity of the adsorption column module, the pore size of the safety filter membrane is smaller than the minimum particle diameter of the pH-responsive adsorbent material, and an elastic membrane is fixedly installed inside the bypass tube.

[0016] Preferably, the rotary switching module has three workstations, corresponding to the treatment workstation, regeneration workstation, and balance preparation workstation, respectively. Each of the three workstations is equipped with one of the adsorption column modules, and the inner walls of the detection chamber located at the treatment workstation and the regeneration workstation are equipped with electromagnetic drive components.

[0017] The number of input connectors and output connectors are three in total. Each of the three output connectors is fixedly equipped with a detection module. The detection module includes an online pH sensor for monitoring the effluent, an optical sensor for monitoring the optical properties of the effluent, and a temperature sensor for monitoring the liquid temperature.

[0018] The upper and lower sides of the detection chamber are respectively provided with a first connecting ring and a second connecting ring. The three input connectors are threadedly installed on the first connecting ring, and the three output connectors are threadedly installed on the second connecting ring. The first connecting ring is fixedly connected to the telescopic end of the upper electric push rod, and the second connecting ring is fixedly connected to the telescopic end of the lower electric push rod.

[0019] Preferably, the main controller is configured to automatically terminate the regeneration process by controlling the opening and closing of the solenoid valve based on the pressure data fed back by the electromagnetic drive component, the pH data fed back by the online pH sensor, and the optical data fed back by the optical sensor.

[0020] Preferably, the support bracket includes a chassis and a cover plate. The surface of the chassis has a slot, and the adsorption column module is placed in the slot. The cover plate is bolted to the upper end of the chassis and presses the adsorption column module. The bottom of the chassis has a hexagonal protrusion. The upper surface of the rotating tray has a positioning groove that matches the hexagonal protrusion. The top of the detection chamber is threaded with a positioning knob, and the bottom end of the positioning knob is inserted into the groove at the upper end of the bolt.

[0021] The present invention has the following beneficial effects:

[0022] 1. The lipid adsorption material regeneration device proposed in this invention uses pH-responsive hydrogel as the functional material. Its working mechanism is based on the volume phase change principle of polymer network: at physiological pH (~7.4), the material network shrinks, exposing ligands (such as phenylboronic acid groups), and efficiently adsorbs lipid molecules (such as LDL) through hydrophobic interactions and hydrogen bonds, with an adsorption capacity of more than 1500 mg / g; when a mild weakly acidic regeneration solution (such as citrate buffer at pH 5.0-6.0) is injected, the carboxyl groups on the hydrogel molecular chain are protonated, the electrostatic repulsion is weakened, the network collapses and releases the adsorbed lipid molecules;

[0023] The regeneration trigger signal (weak pH change) and the regeneration medium (biocompatible buffer) are safe for blood components, and the regeneration solution has good biocompatibility, avoiding the risk of toxicity. This fundamentally solves the risk of toxic reagents leaking into the blood, making it possible to achieve safe, in-situ online regeneration inside the treatment device. The swelling / shrinkage of the hydrogel is a physicochemical change with a fast response speed, which can achieve the elution of blood lipids and shorten the regeneration cycle.

[0024] 2. The lipid adsorption material regeneration device proposed in this invention applies a precise and controllable magnetic force to the magnetic piston through an electromagnetic drive component during the lipid adsorption process. This force is converted into a stable pressure on the liquid inside the column, optimizing the plasma flow field, preventing the "channeling" effect, and ensuring that the adsorbent is fully utilized, thereby improving the adsorption efficiency and capacity of a single treatment.

[0025] During the regeneration of the adsorbent material, when the pH-responsive hydrogel expands and pushes the magnetic piston, it changes the magnetic resistance of the magnetic circuit formed by the first magnetic yoke sleeve, the second magnetic yoke sleeve, and the air gap between them. This change is reflected very sensitively as a change in the inductance parameter of the electromagnetic coil. By monitoring this electrical signal, the main controller can calculate the actual pressure inside the column in real time with high precision. Combined with pH and optical sensor data, the main controller can establish a multi-parameter model, accurately determine the regeneration endpoint, and realize automatic termination of regeneration as needed. This effectively avoids insufficient regeneration or excessive consumption of reagents and ensures the consistency of regeneration quality.

[0026] 3. The lipid adsorption material regeneration device proposed in this invention, when the pH-responsive hydrogel of the lower layer expands, the resulting expansion force is transmitted upward to the upper high-capacity adsorption material layer through liquid hydraulic pressure and flexible isolation screen, causing micro-strain on the adsorbent particles of the upper layer, which may change their pore structure and adsorption site conformation, weakening their binding force with lipid molecules. This synergistic effect can effectively promote the desorption of lipids deeply adsorbed in the high-capacity adsorption material layer, which is an effect that is difficult to achieve by relying solely on chemical eluent, thereby significantly improving the overall regeneration efficiency and load recovery rate of the entire adsorption column.

[0027] 4. The lipid adsorption material regeneration device proposed in this invention enables parallel treatment and regeneration through station switching, eliminating treatment interruptions and increasing treatment throughput (the amount of plasma processed per unit time). Online regeneration and reuse of adsorption materials transform expensive consumable costs into equipment depreciation, significantly reducing the cost per treatment and making advanced therapies more accessible. Personalized adsorption column modules eliminate cross-infection. Automation and intelligent monitoring reduce operational complexity and the risk of human error. Modular design simplifies loading and replacement, greatly improving the ease of use and reliability of the equipment. Attached Figure Description

[0028] Figure 1 This is a three-dimensional structural schematic diagram of the lipid adsorption material regeneration treatment device proposed in this invention.

[0029] Figure 2 This is a side cross-sectional view of the detection chamber proposed in this invention.

[0030] Figure 3 This is an exploded view of the support structure proposed in this invention. Figure 1 .

[0031] Figure 4 This is an exploded view of the support structure proposed in this invention. Figure 2 .

[0032] Figure 5 This is a side sectional view of the support structure proposed in this invention.

[0033] Figure 6 This is a top-section structural diagram of the detection chamber proposed in this invention.

[0034] Figure 7 This is a side cross-sectional view of the adsorption column module proposed in this invention.

[0035] Figure 8 This is a graph showing the adsorption / regeneration cycle performance of a pH-responsive hydrogel.

[0036] Figure 9 This is a multi-parameter monitoring curve diagram for the dynamic pressure balance system.

[0037] Figure 10 This is a curve showing the synergistic effect of the pH-responsive hydrogel and macroporous adsorption resin bilayer materials.

[0038] In the picture:

[0039] 101. Base; 102. Testing chamber; 103. Display; 104. Positioning knob;

[0040] 201. Rotating pallet; 202. Support bracket; 203. Servo motor; 204. Chassis; 205. Cover plate; 206. Bolt; 207. Hexagonal protrusion;

[0041] 300. Adsorption column module; 301. Bypass pipe; 302. Magnetic piston; 303. Electromagnetic drive assembly; 304. Upper sieve plate; 305. Lower sieve plate; 306. Isolation screen; 307. Safety filter membrane; 308. Elastic membrane; 309. First magnetic yoke sleeve; 310. Electromagnetic coil; 311. Second magnetic yoke sleeve;

[0042] 401. Input connector; 402. Output connector; 403. Electric actuator; 404. Detection module; 405. First connecting ring; 406. Second connecting ring;

[0043] 501. Treatment station; 502. Regeneration station; 503. Balancing preparation station. Detailed Implementation

[0044] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0045] In the description of this invention, it should be understood that the terms "upper", "lower", "front", "rear", "left", "right", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0046] Example 1

[0047] Reference Figure 1 A blood lipid adsorption material regeneration treatment device includes: a device body, a rotary switching module, an adsorption column module 300, a dynamic pressure balance system, a fluid pipeline system, and a main controller, as detailed below:

[0048] The main body of the device includes a base 101, a detection chamber 102 and a display 103. The detection chamber 102 is fixedly installed on the upper side of the base 101, and the display 103 is installed on the upper side of the detection chamber 102. A placement window is provided on the front side of the detection chamber 102 for loading and unloading the adsorption column module 300.

[0049] Rotary switching module, such as Figure 2 As shown, it includes a rotating tray 201 rotatably mounted inside the testing chamber 102, a detachable support bracket 202, and a servo motor 203 disposed within the base 101. The support bracket 202 is snapped onto the rotating tray 201, and the servo motor 203 drives the rotating tray 201 to rotate in 120° increments. (Reference) Figure 6 The rotary switching module has three workstations, corresponding to treatment workstation 501, regeneration workstation 502 and balance preparation workstation 503 respectively. Each of the three workstations is equipped with an adsorption column module 300.

[0050] Among them, reference Figure 3 , Figure 4 The support bracket 202 includes a chassis 204 and a cover plate 205. The surface of the chassis 204 has a slot, and the adsorption column module 300 is placed in the slot. The cover plate 205 is installed on the upper end of the chassis 204 by bolts 206 and presses the adsorption column module 300. The bottom of the chassis 204 is provided with a hexagonal protrusion 207. The upper surface of the rotating tray 201 is provided with a positioning groove that matches the hexagonal protrusion 207. The top of the detection chamber 102 is threaded with a positioning knob 104. The bottom end of the positioning knob 104 is inserted into the groove at the upper end of the bolt 206 to limit the position of the support bracket 202.

[0051] The adsorption column module 300 is clamped and fixed on the support bracket 202. The upper and lower ends of the adsorption column module 300 are respectively fixedly installed with an upper sieve plate 304 and a lower sieve plate 305. The upper sieve plate 304 and the lower sieve plate 305 are made of 316L stainless steel with a pore size of 5μm. The chamber of the adsorption column module 300 is filled with pH-responsive adsorption material.

[0052] Among them, the pH-responsive adsorbent material is composed of pH-responsive hydrogels, with coating microspheres ranging in diameter from 50 to 80 micrometers. Based on the volume phase transition principle of polymer networks, the pH-responsive hydrogel shrinks at physiological pH (~7.4), exposing ligands (such as phenylboronic acid groups), and efficiently adsorbs blood lipid molecules (such as LDL) through hydrophobic interactions and hydrogen bonds, achieving an adsorption capacity of up to 150 μL. mg / g or higher; when injected with a mild, weakly acidic regeneration solution (such as citrate buffer at pH 5.0-6.0), the carboxyl groups on the hydrogel molecular chain are protonated, the electrostatic repulsion is weakened, the network collapses and releases the adsorbed blood lipid molecules (desorption rate >94%), the swelling equilibrium time is about 2-5 hours, the response is relatively fast, and the regeneration solution has good biocompatibility, avoiding toxicity risks. For details, please refer to the following reference: Du Xiangxiang, Chen Enzhao, Ding Songqi. Preparation and swelling properties of pH and glucose sensitive Poly(4-VPBA-co-AA) hydrogels [J]. Journal of Pingdingshan University, 2021, 36(05):38-42.

[0053] The dynamic pressure balancing system includes a bypass pipe 301 fixed to the side wall of the adsorption column module 300, a magnetic piston 302 slidably disposed in the bypass pipe 301, and an electromagnetic drive assembly 303 disposed in the detection chamber 102. A safety filter membrane 307 is disposed at the connection between the bypass pipe 301 and the inner cavity of the adsorption column module 300. The safety filter membrane 307 is made of polyethersulfone and has a pore size of 5μm. The pore size of the safety filter membrane 307 is smaller than the minimum particle diameter of the pH-responsive adsorption material. An elastic membrane 308 is fixedly installed inside the bypass pipe 301. The elastic membrane 308 is made of silicone rubber and is used for sealing and buffering.

[0054] like Figure 6 As shown, electromagnetic drive components 303 are installed on the inner walls of the detection chamber 102 at the treatment station 501 and the regeneration station 502. When energized, the electromagnetic drive components 303 generate controllable magnetic attraction or repulsion, driving the magnetic piston 302 to reciprocate within the bypass pipe 301; wherein, as... Figure 7As shown, the electromagnetic drive assembly 303 includes a first magnetic yoke sleeve 309 and an electromagnetic coil 310 fixedly installed inside the first magnetic yoke sleeve 309; a second magnetic yoke sleeve 311 is fixedly installed on the outer side of the bypass pipe 301; when the adsorption column module 300 is located at the working position (treatment position 501, regeneration position 502), the end faces of the first magnetic yoke sleeve 309 and the second magnetic yoke sleeve 311 are arranged opposite each other (gap 1-5mm) to form a low magnetic resistance magnetic circuit for guiding the magnetic field.

[0055] Fluid piping system, reference Figure 1 , Figure 2 It includes three input connectors 401 and three output connectors 402, corresponding to three workstations. Each input connector 401 and output connector 402 is equipped with a solenoid valve to control the on / off state. Electric push rods 403 are fixedly installed on the upper and lower sides of the detection chamber 102. The electric push rods 403 drive the input connectors 401 or output connectors 402 to extend or retract, so that the input connectors 401 and output connectors 402 are respectively connected to the upper and lower ends of the adsorption column module 300. The ends of the input connectors 401 and output connectors 402 are equipped with sealing rings to achieve sealing at the connection point.

[0056] Specifically, the upper and lower sides of the detection chamber 102 are respectively provided with a first connecting ring 405 and a second connecting ring 406. Three input connectors 401 are threadedly installed on the first connecting ring 405, and three output connectors 402 are threadedly installed on the second connecting ring 406. The first connecting ring 405 is fixedly connected to the telescopic end of the upper electric push rod 403, and the second connecting ring 406 is fixedly connected to the telescopic end of the lower electric push rod 403.

[0057] Each output connector 402 is fixedly installed with a detection module 404, which includes an online pH sensor for monitoring the outflow liquid, an optical sensor for monitoring the optical properties of the outflow liquid, and a temperature sensor for monitoring the liquid temperature.

[0058] The main controller, which uses an ARM Cortex-M7 microcontroller, is located inside the base 101. The main controller is electrically connected to the servo motor 203, solenoid valve, electromagnetic drive assembly 303, electric push rod 403, and all sensors. The main controller is configured to automatically terminate the regeneration process by controlling the opening and closing of the solenoid valve based on the pressure data fed back by the electromagnetic drive assembly 303, the pH data fed back by the online pH sensor, and the optical data fed back by the optical sensor.

[0059] In this embodiment, the dynamic pressure balancing system achieves pressure sensing and regulation through the magnetic coupling between the electromagnetic drive component 303 and the magnetic piston 302. Its principle is based on the change in magnetic reluctance of the magnetic circuit: when the pressure inside the adsorption column module 300 increases (such as when the hydrogel expands), it pushes the magnetic piston 302 to move inside the bypass tube 301, which changes the magnetic reluctance of the magnetic circuit formed by the first magnetic yoke sleeve 309, the second magnetic yoke sleeve 311 and the air gap between them. This change is reflected very sensitively as a change in the inductance parameter of the electromagnetic coil 310; the inductance parameter of the electromagnetic coil 310 changes accordingly, and the main controller monitors this inductance change and calculates the pressure inside the adsorption column module 300 in real time.

[0060] During the lipid adsorption process, a precise and controllable magnetic force is applied to the magnetic piston 302 by the electromagnetic drive component 303. This force is converted into a stable pressure on the liquid inside the column, optimizing the plasma flow field, preventing the "channeling" effect, and ensuring that the adsorbent is fully utilized, thereby improving the adsorption efficiency and capacity of a single treatment.

[0061] Working principle:

[0062] Treatment phase: The adsorption column module 300 is located at the treatment station 501. The servo motor 203 drives the rotating tray 201 to position, aligning the support bracket 202 with the station. The electric push rod 403 moves, pushing the input connector 401 and the output connector 402 to connect with the upper and lower ends of the adsorption column module 300. Plasma flows in from the input connector 401, is distributed through the upper sieve plate 304, and passes through the upper and lower chambers (pH-responsive hydrogel). The hydrogel contracts and adsorbs blood lipids at physiological pH (~7.4). After purification, the plasma returns to the patient from the output connector 402. The dynamic pressure balance system monitors the pressure in real time to ensure a stable flow field.

[0063] Regeneration stage: When adsorption is saturated (e.g., by detecting changes in the transmittance of the effluent through an optical sensor), the main controller triggers the servo motor 203 to rotate 120°, moving the adsorption column module 300 to the regeneration station 502. The regeneration solution (pH 5.0 citrate buffer) is injected into the input connector 401 on the upper side of the regeneration station 502. The hydrogel expands and releases blood lipids, which are discharged from the output connector 402 on the lower side of the regeneration station 502. The pH data fed back by the online pH sensor and the optical data fed back by the optical sensor are transmitted to the main controller. The main controller automatically terminates the regeneration process by controlling the opening and closing of the solenoid valve.

[0064] Balance preparation stage: The main controller triggers the servo motor 203 to drive the rotating tray 201 to rotate 120°, so that the adsorption column module 300 moves to the balance preparation station 503. The residual regeneration solution and blood lipids are rinsed with buffer (such as PBS) to restore the physiological pH. After completion, the adsorption column module 300 can rotate back to the treatment station 501 for the next cycle. The whole process is automatically controlled by the main controller to realize continuous treatment.

[0065] Example 2

[0066] Reference Figure 7 Unlike Example 1, an isolation screen 306 is fixedly installed inside the adsorption column module 300. The isolation screen 306 is made of polyurethane with a pore size of 10 μm. The isolation screen 306 divides the inner cavity of the adsorption column module 300 into an upper chamber and a lower chamber. The upper chamber of the adsorption column module 300 is filled with a high-capacity adsorption material, which is composed of macroporous adsorption resin with a particle diameter ranging from 50 micrometers to 100 micrometers. The lower chamber of the adsorption column module 300 is filled with a pH-responsive adsorption material. The pore size of the isolation screen 306 is smaller than the minimum particle diameter of the pH-responsive adsorption material and the high-capacity adsorption material.

[0067] In this embodiment, the high-capacity adsorbent material (such as macroporous adsorbent resin) filling the upper chamber provides an initial high adsorption capacity (up to 2000 mg / g) to rapidly capture most blood lipid molecules, reduce the load on the lower pH-responsive hydrogel, and extend the overall adsorption column life. Its particle diameter (50-100 μm) and pore structure optimize hemodynamics and reduce pressure drop. The high-capacity material can be personalized for patients with high blood lipid levels (e.g., high-capacity resin is selected for patients with high LDL). Customized treatment can be achieved by removing the upper sieve plate 304 and replacing the high-capacity adsorbent material in the upper chamber.

[0068] The lower pH-responsive hydrogel expands during regeneration, and the resulting expansion force is transmitted upward to the upper high-capacity adsorbent material layer through the liquid hydraulic pressure and flexible isolation screen 306. This causes micro-strain on the adsorbent particles in the upper layer, which may change their pore structure and adsorption site conformation, weakening their binding force with blood lipid molecules. This synergistic effect can effectively promote the desorption of blood lipids deeply adsorbed in the high-capacity adsorbent material layer, improving the overall regeneration efficiency and load recovery rate of the entire adsorption column module 300.

[0069] Example 3

[0070] This embodiment aims to verify the adsorption / regeneration performance of the devices in Example 1 and Example 2. The experimental procedures and material synthesis follow the ISO 10993 series of standards for biological evaluation of medical devices and the GB / T16886.4 guideline for in vitro blood compatibility testing.

[0071] Material synthesis: Hydrogel microspheres with diameters of 50-80 μm were prepared by polymerizing 4-vinylphenylboronic acid (4-VPBA) and acrylic acid (AA) as monomers in a molar ratio of 1:4, initiated by ammonium persulfate (APS), and crosslinked by N,N'-methylenebisacrylamide (BIS) at 70 °C for 3 hours.

[0072] Simulated plasma: According to YY / T 0660-2008 Medical Device Blood Compatibility Standard, simulated plasma containing LDL (2.0 mg / mL) was prepared using PBS buffer (pH=7.4);

[0073] Experimental procedure:

[0074] S1. Place the adsorption column module 300 in the treatment station 501 and inject simulated plasma at a flow rate of 2.0 mL / min;

[0075] S2. Detect the LDL concentration of output connector 402 every 5 minutes, and calculate the adsorption capacity (mg / g) using the BCA protein assay method.

[0076] S3. After adsorption saturation, switch to regeneration station 502 and inject regeneration solution (pH=5.0 citrate buffer).

[0077] S4. The dynamic pressure balance system monitors the relative pressure signal inside the column, the pH value of the effluent, the optical signal, and the concentration of blood lipids eluted throughout the entire process;

[0078] S5. The main controller automatically determines and records the regeneration termination point based on multiple parameters (setting conditions: pressure <25 kPa, pH <5.2, optical signal <0.1);

[0079] S6. Repeat the adsorption-regeneration cycle 20 times to evaluate the material stability;

[0080] S7. Compare the total adsorption capacity and post-cycle load recovery rate of the devices in Example 1 and Example 2.

[0081] Data Analysis:

[0082] Experimental results are as follows Figure 8 As shown, the initial adsorption capacity was 1580 mg / g, which showed a steady decreasing trend with the increase of the number of cycles. After 20 cycles, it remained above 1510 mg / g with a decay rate of <3.8%. The desorption rate fluctuated between 94% and 98% throughout the process. Although there were some fluctuations, it was always above 94%, indicating that the pH-responsive hydrogel has excellent regenerability and stability.

[0083] Dynamic pressure balancing system monitoring data such as Figure 9As shown, after regeneration begins, the relative pressure signal rises rapidly, stabilizing after about 1 hour (approximately 80). The pH value decreases continuously from an initial value of approximately 7.8, eventually stabilizing at 5.5. The optical signal decays rapidly within 1 hour. The lipid elution concentration subsequently decreases. Approximately 2.5 hours into regeneration, the system automatically triggers a "smart termination point" based on preset conditions (at which point the optical signal is close to 0, the pH value is approximately 5.5, and the lipid concentration has decreased to a low level). This design avoids under-regeneration or over-regeneration, complying with the safety and effectiveness requirements of IEC 60601-2-16 for automatic control systems of medical devices.

[0084] like Figure 10 As shown, throughout the entire cycle, the loading recovery rate of the bilayer material (pH-responsive hydrogel + macroporous resin) was consistently higher than that of the monolayer material (pH-responsive hydrogel). Especially in the later stages of the cycle (15-20 cycles), the recovery rate of the bilayer material (approximately 90%) was significantly better than that of the monolayer material (approximately 87%). The "synergistic effect improving stability" indicated by the arrow is clearly demonstrated. This indicates that the bilayer structure effectively mitigates the degradation of material performance and improves the long-term performance of the device through synergistic action. This design meets the requirements of YY / T 0642-2018 for the adsorption performance of adsorbent medical devices.

[0085] The lipid adsorption material regeneration device proposed in this invention enables parallel treatment and regeneration through station switching, eliminating treatment interruptions and increasing treatment throughput (the amount of plasma processed per unit time). Online regeneration and reuse of the adsorption material transforms expensive consumable costs into equipment depreciation, significantly reducing the cost per treatment and making advanced therapies more accessible. A dedicated 300-cell adsorption column module eliminates cross-infection. Automation and intelligent monitoring reduce operational complexity and the risk of human error. Modular design simplifies loading and replacement, greatly improving the ease of use and reliability of the equipment.

[0086] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A device for regenerating lipid adsorption materials, characterized in that, include: The main body of the device includes a base (101), a detection chamber (102) and a display (103). The detection chamber (102) is fixedly installed on the upper side of the base (101), and the display (103) is installed on the upper side of the detection chamber (102). A placement window is provided on the front side of the detection chamber (102). The rotation switching module includes a rotating tray (201) rotatably installed in the detection chamber (102), a detachable support bracket (202), and a servo motor (203) set in the base (101). The support bracket (202) is snapped onto the rotating tray (201), and the servo motor (203) drives the rotating tray (201) to rotate in increments. An adsorption column module (300) is clamped and fixed on the support bracket (202), and the cavity of the adsorption column module (300) is filled with pH-responsive adsorption material. The dynamic pressure balancing system includes a bypass tube (301) fixed on the side wall of the adsorption column module (300), a magnetic piston (302) slidably disposed in the bypass tube (301), and an electromagnetic drive assembly (303) disposed in the detection chamber (102). The electromagnetic drive assembly (303) generates a controllable magnetic attraction or magnetic repulsion force when energized, driving the magnetic piston (302) to reciprocate within the bypass tube (301). The fluid piping system includes multiple input connectors (401) and multiple output connectors (402). Each of the multiple input connectors (401) and multiple output connectors (402) is equipped with a solenoid valve for controlling the on / off state. An electric push rod (403) is fixedly installed on the upper and lower sides of the detection chamber (102). The electric push rod (403) drives the input connectors (401) or output connectors (402) to extend or retract, so that the input connectors (401) and output connectors (402) are respectively connected to the upper and lower ends of the adsorption column module (300). There are three input connectors (401) and three output connectors (402). Each of the three output connectors (402) is fixedly installed with a detection module (404). The detection module (404) includes an online pH sensor for monitoring the effluent, an optical sensor for monitoring the optical properties of the effluent, and a temperature sensor for monitoring the liquid temperature. The main controller is located inside the base (101) and is electrically connected to the servo motor (203), solenoid valve, electromagnetic drive assembly (303), and electric push rod (403). The upper and lower ends of the adsorption column module (300) are respectively fixedly installed with an upper sieve plate (304) and a lower sieve plate (305). An isolation screen (306) is fixedly installed inside the adsorption column module (300). The isolation screen (306) divides the inner cavity of the adsorption column module (300) into an upper chamber and a lower chamber. The pH-responsive adsorption material is filled in the lower chamber. The upper chamber of the adsorption column module (300) is filled with a high-capacity adsorption material, which is composed of macroporous adsorption resin with a particle diameter ranging from 50 micrometers to 100 micrometers. The pore size of the isolation screen (306) is smaller than the minimum particle diameter of the pH-responsive adsorption material and the high-capacity adsorption material. The electromagnetic drive assembly (303) includes a first magnetic yoke sleeve (309) and an electromagnetic coil (310) fixedly installed inside the first magnetic yoke sleeve (309); a second magnetic yoke sleeve (311) is fixedly fitted on the outside of the bypass pipe (301); when the adsorption column module (300) is in the working position, the end faces of the first magnetic yoke sleeve (309) and the second magnetic yoke sleeve (311) are arranged opposite to each other to form a magnetic circuit for guiding the magnetic field; The pH-responsive adsorbent material is composed of a pH-responsive hydrogel, and the diameter of its coated microspheres ranges from 50 micrometers to 80 micrometers. A safety filter membrane (307) is provided at the connection between the bypass tube (301) and the inner cavity of the adsorption column module (300). The pore size of the safety filter membrane (307) is smaller than the minimum particle diameter of the pH-responsive adsorbent material. An elastic membrane (308) is fixedly installed inside the bypass tube (301).

2. The blood lipid adsorption material regeneration device according to claim 1, characterized in that: The rotating switching module has three workstations, corresponding to the treatment workstation (501), the regeneration workstation (502), and the balance preparation workstation (503), respectively. Each of the three workstations is equipped with an adsorption column module (300). The inner wall of the detection chamber (102) located at the treatment workstation (501) and the regeneration workstation (502) is provided with an electromagnetic drive component (303).

3. The blood lipid adsorption material regeneration device according to claim 2, characterized in that: The detection chamber (102) has a first connecting ring (405) and a second connecting ring (406) movably arranged on its upper and lower sides, respectively. The three input connectors (401) are threaded onto the first connecting ring (405), and the three output connectors (402) are threaded onto the second connecting ring (406). The first connecting ring (405) is fixedly connected to the telescopic end of the upper electric push rod (403), and the second connecting ring (406) is fixedly connected to the telescopic end of the lower electric push rod (403).

4. The blood lipid adsorption material regeneration device according to claim 2, characterized in that: The main controller is configured to automatically terminate the regeneration process by controlling the opening and closing of the solenoid valve based on the pressure data fed back by the electromagnetic drive assembly (303), the pH data fed back by the online pH sensor, and the optical data fed back by the optical sensor.

5. The blood lipid adsorption material regeneration device according to claim 1, characterized in that: The support bracket (202) includes a chassis (204) and a cover plate (205). The surface of the chassis (204) is provided with a slot, and the adsorption column module (300) is placed in the slot. The cover plate (205) is installed on the upper end of the chassis (204) by bolts (206) and presses the adsorption column module (300) tightly. The bottom of the chassis (204) is provided with a hexagonal protrusion (207). The upper surface of the rotating tray (201) is provided with a positioning groove that matches the hexagonal protrusion (207). The top of the detection chamber (102) is threaded with a positioning knob (104), and the bottom end of the positioning knob (104) is inserted into the groove at the upper end of the bolt (206).

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