A device and method for intrarenal dialysis pressurized ultrafiltration

Abstract

This application discloses a pressurized ultrafiltration device and method for nephrology dialysis, relating to the field of hemodialysis technology. It includes a body, a blood loop, a dialysate loop, and a dialyzer. The dialyzer is installed inside the body. Both the blood loop and the dialysate loop are connected to the dialyzer. The device also includes a pumping system connected to the blood loop and the dialysate loop. The pumping system includes at least a first pumping unit and a second pumping unit. The blood loop is at least partially embedded within the first and second pumping units, causing the first and second pumping units to compress the blood loop. Both the first and second pumping units have a pumping state and a compensation state. The device features a synergistic design incorporating dual-pump complementary compression, parallel branching, adjustable rollers and elastic buffers, electromagnetic ejection compensation, magnetically controlled oscillation fine-tuning, and modular drive and sensor-based closed-loop control.

Description

Technical Field

[0001] This application relates to the field of hemodialysis technology, specifically to a pressurized ultrafiltration device and method for nephrology dialysis. Background Technology

[0002] In pressurized dialysis, peristaltic pumps are used to achieve unidirectional fluid delivery by periodically squeezing an elastic pump tubing with rollers. The fluid only contacts the inner wall of the pump tubing. Because there are no mechanical parts directly contacting the delivery medium, the pump tubing is easy to replace, and it has self-priming capability, it has become a commonly used blood and dialysate delivery device in dialysis systems. However, existing single-peristaltic pump solutions have revealed several shortcomings in clinical and engineering applications that urgently need to be addressed.

[0003] First, the discrete squeezing and releasing of the rollers causes periodic changes in the pump chamber volume, resulting in significant flow pulsation, which in turn affects the ultrafiltration accuracy and the stability of the dialysate ratio. Secondly, the rebound of the hose at the moment of release may cause a sudden increase in local volume, forming a short-term negative pressure or back suction phenomenon. This not only increases the risk of air bubble backflow and contamination, but may also generate high shear or negative pressure peaks in the local area, leading to mechanical damage to blood cells or hemolysis. In addition, the compatibility of pump tubing materials and issues with disinfection residues may also affect the safety of blood components and microorganisms.

[0004] Existing improvement approaches include increasing the number of rollers to reduce pulsation, adding damping or compliant chambers to the circuit to smooth the waveform, employing parallel or series multi-pump structures, and attempting to counteract pulsation through phase control. However, these solutions have limitations in practical applications: multi-roller designs are limited by mechanical complexity and cost; damping chambers, while suppressing some pulsation, introduce dead space and potential blood stagnation; and parallel or series pumps, without precise phase control, may superimpose pressure waves or generate more complex negative pressure peaks in the intermediate segment, increasing the risk of hemolysis and thrombosis. More importantly, existing technologies generally lack a holistic solution that organically combines mechanical structure optimization, pump head phase control, and closed-loop pressure / flow feedback algorithms, and there is insufficient systematic in vitro and clinical validation of the effects of improvement measures on hematological indicators (such as hemolysis rate, platelet activation, and coagulation parameters).

[0005] Therefore, there remains a need for an integrated engineering and control technology that can significantly reduce flow pulsation and instantaneous negative pressure peaks, extend pump tubing life, reduce the risk of blood damage, and facilitate clinical maintenance. Summary of the Invention

[0006] In view of this, the embodiments of this application aim to provide a pressurized ultrafiltration device and method for nephrology dialysis, which can reduce flow pulsation and instantaneous negative pressure peaks, extend pump tube life, and reduce the risk of blood damage.

[0007] To achieve the above objectives, the first aspect of this application provides: a pressurized ultrafiltration device for nephrology dialysis, comprising a body, a blood loop, a dialysate loop, and a dialyzer, wherein the dialyzer is installed inside the body, and both the blood loop and the dialysate loop are connected to the dialyzer, further comprising: A pumping system connected to the blood loop and the dialysate loop, the pumping system comprising at least a first pumping unit and a second pumping unit, both of which are connected to the blood loop.

[0008] The blood loop is at least partially embedded within the first pumping unit and the second pumping unit, such that the first pumping unit and the second pumping unit compress the blood loop. Both the first pumping unit and the second pumping unit have a pumping state and a compensation state. The first pumping unit and the second pumping unit are configured to move in a complementary manner, such that at any given time, when the first pumping unit is in the pumping state, the second pumping unit is in the compensation state, and when the second pumping unit is in the pumping state, the first pumping unit is in the compensation state.

[0009] Furthermore, the blood loop includes an outflow vessel, a first passage, a second passage, a connecting tube, and a return vessel. The first passage and the second passage are connected in parallel between the outflow vessel and the connecting tube, and both the connecting tube and the return vessel are connected to the dialyzer. The first passage is pressed into the first pumping unit, the second passage is pressed into the second pumping unit, and the pumping system is provided with a driving component to drive the first pumping unit and the second pumping unit to rotate.

[0010] Furthermore, the first pumping unit includes: A first pump body is installed inside the machine body, and a first cover plate is provided on the outside of the first pump body, which is snapped into the first pump body; A first pump core is installed in the first pump body and is rotatable relative to the first pump body. The first pump core is connected to the drive assembly. The first roller is connected to the inner side of the first pump core, and the first roller can rotate relative to the first pump core; The first protective plate is embedded in the first pump body, and the inner side of the first protective plate forms a first pumping channel. The first passage is pressed into the first pumping channel and contacts the first protective plate and the first roller.

[0011] Furthermore, the second pumping unit includes: A second pump body is installed inside the machine body. A second cover plate is provided on the outside of the second pump body. The second cover plate is snapped into the second pump body. The second pump body can slide relative to the machine body. The second pump core is embedded in the second pump body and can rotate relative to the second pump body. The second pump core is connected to the drive assembly. The second roller is connected to the inner side of the second pump core, and the second roller can rotate relative to the second pump core; The second guard plate is embedded in the second pump body. The inner side of the second guard plate forms a second pumping channel. The second channel is pressed into the second pumping channel and contacts the second guard plate and the second roller.

[0012] Furthermore, the first pump core has a guide groove so that the first roller shaft is connected to the guide groove and can slide along the guide groove. An elastic element is provided between the first pump core and the first roller, the elastic element including: A retaining ring is coaxial with the first pump core and embedded inside the first pump core; A top frame is slidably disposed inside the first pump core, and the first roller is shaft-connected to the top frame and can rotate relative to the top frame; A slot is formed at least at the contact portion between the retaining ring and the top frame. The retaining ring extends to the outside of the first pump core, and the rotation of the retaining ring can change the ejection distance to the top frame.

[0013] Furthermore, the second pump body is provided with an ejector that can extend and retract toward the second pump core, the ejector comprising: The electromagnetic component is located within the second pump body; An ejector frame is connected to a portion of an electromagnetic assembly, enabling the electromagnetic assembly to change the extension distance of the ejector frame through magnetic force variations. The contact is located at the end of the ejector frame facing the second pump core. The contact contacts the second guard plate, which is elastically configured.

[0014] Furthermore, the first pump core includes a rotating part and an oscillating part, the oscillating part being axially connected to the rotating part, and the oscillating part being able to oscillate relative to the rotating part within a range of 0°-5° to change the position of the oscillating part relative to the rotating part; The cover plate is equipped with an active magnetic plate on its inner side, and the swing part is embedded in a passive magnetic plate on its inner side. The active magnetic plate and the passive magnetic plate work together to change the swing angle of the swing part.

[0015] Furthermore, the compression gap of the blood loop in the pumping state of the first pumping unit or the second pumping unit is smaller than the compression gap of the blood loop in the compensation state.

[0016] Furthermore, the drive assembly includes a drive source, a drive disk, a first output shaft, and a second output shaft. The drive source is connected to the drive disk. The first output shaft and the second output shaft extend from inside the drive disk to outside the drive disk. The first output shaft is connected to a first pumping unit, and the second output shaft is connected to a second pumping unit.

[0017] The second aspect of this application provides: a nephrological dialysis method, comprising the following steps: Connect the disposable dialyzer to the blood loop and dialysate loop according to the markings on the machine interface. Install and clamp the first pumping unit and the second pumping unit. Complete the infusion and continuously remove air bubbles until the air bubble test is qualified. Confirm that the pumped section of the blood tubing is correctly embedded in the first pumping unit and the second pumping unit and achieves mechanical coaxiality and sealing. The flow, pressure, bubble, displacement, and angle sensors are self-tested and calibrated sequentially. The extrusion gap mapping is calibrated under no-load or low-flow conditions. The electromagnetic ejection stroke and the angle response of the swing part are calibrated and the calibration data is recorded to establish the mapping relationship between the measurement and the actuator. The controller sets the initial phase difference and target blood flow of the two pump units based on the complementary squeezing principle, and gradually accelerates to the target speed using a segmented rate. At the same time, the flow and pressure curves are monitored in real time, and the system enters steady-state operation after confirming that there are no abnormalities. During steady-state operation, the system reads sensor signals such as flow rate, pressure and bubbles in real time. The controller dynamically adjusts the drive phase, retainer position or electromagnetic ejection current according to the preset control law to maintain the target flow rate and pressure curve, and distributes the flow rate among parallel paths according to the strategy or switches redundant paths in case of failure.

[0018] Through a collaborative design that incorporates dual-pump complementary compression, parallel branching, adjustable rollers and elastic buffers, electromagnetic ejection compensation, magnetically controlled oscillation fine adjustment, and modular drive and sensor-based closed-loop control, continuous and low-pulsation blood delivery, rapid and precise transient compensation and ultrafiltration control, and highly biocompatible gentle pumping are achieved. It also features a redundant and quickly replaceable disposable tubing design, online monitoring and automatic bypass protection, significantly reducing shear peak and hemolysis risk, improving ultrafiltration accuracy and blood flow stability, and facilitating maintenance and clinical safety management, thereby comprehensively improving dialysis efficacy, patient safety and equipment reliability.

[0019] Other features and advantages of this application will be set forth in the following description, and in part will be apparent from the description, or may be learned by practicing the application. The objectives and other advantages of this application may be realized and obtained by means of the structures particularly pointed out in the written description and the accompanying drawings. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the organism structure of this application; Figure 2 This is a schematic diagram of the internal structure of the organism in this application; Figure 3 This is a schematic diagram of the dialyzer connection loop of this application; Figure 4 This is a schematic diagram of the blood circulation loop in this application; Figure 5 This is a schematic diagram of the pumping system of this application; Figure 6 This is a plan view of the internal structure of the first pumping unit of this application; Figure 7 This is a schematic diagram of the first pump core of this application; Figure 8 This is a plan view of the internal structure of the first pump core in this application; Figure 9 This is a schematic diagram of the elastic element structure of this application; Figure 10 This is a schematic diagram of the active magnetic plate of this application; Figure 11 This is a schematic diagram of the second pump body structure of this application; Figure 12 This is a schematic diagram of the second pump core of this application; Figure 13 This is a schematic diagram of the ejector structure of this application.

[0021] In the diagram: 100 body, 200 blood loop, 300 dialysate loop, 400 dialyzer, 500 pumping system; 51 First pumping unit, 52 Second pumping unit, 53 Drive assembly, 54 Elastic element, 55 Ejector; 21 Outgoing blood vessel, 22 First access route, 23 Second access route, 24 Connecting tube, 25 Return blood vessel; 511 First pump body, 512 First cover plate, 513 First pump core, 514 First roller, 515 First guard plate, 516 First pumping channel; 521 Second pump body, 522 Second cover plate, 523 Second pump core, 524 Second roller, 525 Second guard plate, 526 Second pumping channel; 541 guide groove, 542 retaining ring, 543 top frame, 544 retaining groove; 551 Electromagnetic assembly, 552 Ejector frame, 553 Contact; 10 Rotating part, 20 Swinging part, 30 Active magnetic plate, 40 Passive magnetic plate; 531 Driver source, 532 Driver disk, 533 First output shaft, 534 Second output shaft. Detailed Implementation

[0022] The embodiments of the technical solution of this application will now be described in detail with reference to the accompanying drawings. These embodiments are only used to more clearly illustrate the technical solution of this application and are therefore merely examples, and should not be used to limit the scope of protection of this application.

[0023] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of this application. The terms “comprising” and “having”, and any variations thereof, are intended to cover non-exclusive inclusion.

[0024] In the description of the embodiments of this application, the technical terms "first," "second," "third," etc., are used only to distinguish different objects and should not be construed as indicating or implying relative importance or implicitly specifying the number, specific order, or primary and secondary relationship of the indicated technical features. In the description of the embodiments of this application, "multiple" means two or more, unless otherwise explicitly defined.

[0025] In this document, the term "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0026] In the description of the embodiments of this application, unless otherwise expressly specified and limited, technical terms such as "installation" and "connection" 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. For those skilled in the art, the specific meaning of the above terms in the embodiments of this application can be understood according to the specific circumstances.

[0027] First, the discrete squeezing and releasing of the rollers causes periodic changes in the pump chamber volume, resulting in significant flow pulsation, which in turn affects the ultrafiltration accuracy and the stability of the dialysate ratio. Secondly, the rebound of the hose at the moment of release may cause a sudden increase in local volume, forming a short-term negative pressure or back suction phenomenon. This not only increases the risk of air bubble backflow and contamination, but may also generate high shear or negative pressure peaks in the local area, leading to mechanical damage to blood cells or hemolysis. In addition, the compatibility of pump tubing materials and issues with disinfection residues may also affect the safety of blood components and microorganisms.

[0028] To address the aforementioned problems, this application provides a pressurized ultrafiltration device for nephrology dialysis, see reference. Figure 1-13 As shown, it includes a body 100, a blood loop 200, and a dialysate loop 300. A dialyzer 400 is installed inside the body 100, and the blood loop 200 and the dialysate loop 300 are respectively connected to the dialyzer 400.

[0029] In this system, a pumping system 500 is provided in the blood loop 200 to realize the peristaltic pumping of blood. The pumping system 500 consists of a first pumping unit 51 and a second pumping unit 52. The pumped section of the blood loop 200 is at least partially embedded in the first pumping unit 51 and the second pumping unit 52, so that the two pumping units can propel blood by squeezing the tubing.

[0030] Both the first pumping unit 51 and the second pumping unit 52 are equipped with pumping mode and compensation mode, and they work alternately in a complementary manner during operation: The side in the pumping state uses a smaller compression gap to achieve propulsion, while the side in the compensation state uses a larger compression gap to reduce resistance. In the pumping state, the pumping unit achieves sealed compression of the blood loop 200. In the compensation state, the compression of the blood loop 200 by the pumping unit has gaps, allowing blood to flow through the gaps.

[0031] The dialysis system is equipped with flow, pressure and bubble detection sensors, over-limit protection and automatic bypass logic. Blood contact parts use disposable or sterilizable modular tubing, and the part embedded in the pump body is designed with a quick-disassembly structure to ensure aseptic replacement.

[0032] By setting different compression gaps between pumping and compensation states and operating in complementary phases, continuous, low-pulsation blood delivery is achieved, significantly reducing the risk of instantaneous shear peaks and blood cell damage. At the same time, it facilitates online compensation and safety protection, improving blood flow stability and clinical safety during dialysis.

[0033] In some embodiments, the blood loop 200 includes an outflow vessel 21, a first passage 22, a second passage 23, a connecting tube 24, and a return vessel 25. The outflow vessel 21 is connected in parallel to the connecting tube 24 via the first passage 22 and the second passage 23. Both the connecting tube 24 and the return vessel 25 are connected to the dialyzer 400.

[0034] The first passage 22 is pumped into the first pumping unit 51, and the second passage 23 is pumped into the second pumping unit 52. The pumping system 500 is equipped with a drive assembly 53. The drive assembly 53 uses a single drive source 531 with a drive disk 532 to distribute power to the first output shaft 533 and the second output shaft 534. Alternatively, dual servo independent drives can be used to achieve more flexible phase and rate control. The passage interface uses standardized quick-connect couplings for one-time pipeline replacement or partial maintenance. The controller supports setting the flow distribution strategy for the two passages and switching the redundant passage in case of failure.

[0035] The parallel branch structure facilitates flow distribution and redundancy protection, improves system fault tolerance and maintenance convenience, and the selectability of the drive mode enables the system to ensure synchronization and achieve independent adjustment when needed, thereby enhancing process adaptability.

[0036] In some embodiments, the first pumping unit 51 includes a first pump body 511, a first pump core 513, a first roller 514, and a first guard plate 515. The first pump body 511 is detachably installed inside the body 100 and is provided with a first cover plate 512 to form a seal on the first pump body 511. The first cover plate 512 is snapped onto the outside of the first pump body 511. The first pump core 513 is located inside the first pump body 511 and is connected to the first output shaft 533. The first output shaft 533 drives the first pump core 513 to rotate. The first guard plate 515 is embedded in the first pump body 511 to form a first pumping channel 516 on one side of the first guard plate 515. During dialysis, the first passage 22 is pressed into the first pumping channel 516 and contacts the first guard plate 515 and the first roller 514. The first roller 514 is rotatably installed on the first pump core 513 facing the first passage 22.

[0037] Furthermore, a guide groove 541 is formed inside the first pump core 513, and the first roller 514 is axially connected to the guide groove 541 and can slide along the guide groove 541 to adapt to different pipe diameters and compression amounts. An elastic element 54 is provided between the pump core and the roller. The elastic element 54 includes a retaining ring 542 coaxial with the first pump core 513, a sliding top frame 543, and a retaining groove 544. The rotation of the retaining ring 542 changes the ejection distance of the top frame 543, thereby adjusting the preload and rebound characteristics of the roller.

[0038] The slot 544 is located in the part of the retaining ring 542 that can contact the top frame 543. When the first passage 22 is pressed into the first pumping flow channel 516, the top frame 543 cannot disengage from the slot 544 to reset the retaining ring 542. When the first passage 22 is removed, the top frame 543 can be pushed out to the maximum extent so that the top frame 543 disengages from the slot 544 and resets the retaining ring 542 and the top frame 543.

[0039] The guide groove 541 of this unit slides and cooperates with the elastic element 54 to achieve buffering and rebound compensation for transient loads. The retaining ring 542 can be calibrated online or offline by manual fine adjustment or motor drive. The contact curve and roller diameter of the first guard plate 515 are designed according to the hose material and hemodynamic requirements to ensure smooth compression and rapid rebound.

[0040] Adjustable pre-compression and buffer rebound capabilities significantly reduce shear stress and hemolysis probability during extrusion. Meanwhile, online calibration enables adaptation to different pipe diameters and flow conditions, meeting high biocompatibility requirements and improving pumping stability and reliability.

[0041] In some embodiments, the second pumping unit 52 includes a second pump body 521, a second pump core 523, a second roller 524, and a second guard plate 525. The second pump body 521 can slide relative to the machine body 100 to cooperate with compensation actions. The structural positions of the second pump core 523, the second roller 524, and the second guard plate 525 are consistent with those of the first pumping unit 51. The second pump core 523 is embedded with the second roller 524 and forms a second pumping flow channel 526 with the second guard plate 525. During dialysis, the first passage 22 is pressed in. The first pumping channel 516 is in contact with the first guard plate 515 and the first roller 514. The second pump body 521 is provided with an ejector 55 that can extend and retract toward the second pump core 523. The ejector 55 includes an electromagnetic component 551, an ejector frame 552 and a contact 553. When the electromagnetic component 551 is energized or de-energized, it changes the magnetic force to extend and retract the ejector frame 552. The contact 553 changes the local compression depth by contacting the elastic second guard plate 525, thereby realizing the switching or fine adjustment of the pumping state and the compensation state under the command of the controller.

[0042] The electromagnetic component 551 is fast-responding, programmable, and easy to integrate into closed-loop control. The ejection stroke and torque are calibrated according to flow / pressure requirements.

[0043] The combination of electromagnetic ejection and pump body sliding enables high-response, precise online compensation and transient flow regulation, which is suitable for clinical conditions that require rapid fine-tuning or high-frequency compensation. It can accurately control instantaneous flow and pressure while ensuring continuous blood transfusion and reduce blood stress fluctuations.

[0044] In some embodiments, the first pump core 513 is provided with a rotating part 10 and an oscillating part 20. The oscillating part 20 is axially connected to the rotating part 10 and can oscillate within the range of 0°–5°. An active magnetic plate 30 is arranged inside the cover plate. A passive magnetic plate 40 is embedded in the oscillating part 20. When the active magnetic plate 30 is energized or the magnetic field is changed, it interacts with the passive magnetic plate 40 to change the oscillation angle in a contactless manner.

[0045] The swinging part 20 can change the local contact angle or pre-pressure distribution, and can also create a pump core retention effect by swinging the part 20. That is, when the first pump core 513 and the second pump core 523 rotate synchronously, the swinging angle of the swinging part 20 of one of the pump cores changes. While the first pump core 513 and the second pump core 523 are rotating continuously, the roller will be briefly retained to improve the stability of the compensation.

[0046] Furthermore, by utilizing the oscillating characteristic, when one pump core rotates and experiences a release rebound, the other pump core can avoid negative pressure backflow by stagnating or oscillating in the opposite direction.

[0047] The active magnetic plate 30 is arranged in a ring inside the cover plate. By changing the magnetic force of the active magnetic plate 30, it forms a traction on the swing part 20 in combination with the passive magnetic plate 40.

[0048] The minute angle adjustment of the swing section 20 is used to optimize the contact line between the roller and the guard plate, improve the local flow channel shape, and achieve closed-loop fine adjustment in conjunction with sensor feedback.

[0049] Magnetically controlled oscillation provides wear-free, stepless fine-tuning capabilities, optimizing the extrusion contact pattern without increasing mechanical complexity, reducing local stress concentration, and improving flow control accuracy and equipment lifespan.

[0050] It is understandable that the first pump body 511 and the second pump body 521 have the same structure, and the elastic element 54 provided in the first pump body 511 and the ejector 55 provided in the second pump body 521 can be provided in one pumping unit at the same time, or the elastic element 54 of the first pumping unit 51 and the ejector 55 of the second pumping unit 52 can be interchanged. Moreover, the cooperation structure between the swing part 20 and the rotating part 10 can not only appear in the first pump core 513. Those skilled in the art can make the same adjustment or replacement to the second pump core 523.

[0051] In some embodiments, the drive assembly 53 consists of a drive source 531, a drive disk 532, a first output shaft 533, and a second output shaft 534: the drive source 531 drives the drive disk 532, the drive disk 532 is provided with a differential or phase adjustment mechanism, and the first output shaft 533 and the second output shaft 534 extend from the drive disk 532 to the outside of the body 100 and are respectively connected to the first pumping unit 51 and the second pumping unit 52.

[0052] The drive disc 532 can achieve fixed phase difference or variable phase difference control. The coupling between the output shaft and the pump unit adopts a modular coupling for maintenance and redundant configuration. The drive system is equipped with an encoder and a closed-loop controller to ensure position and speed accuracy.

[0053] The modular drive disc 532 and adjustable phase output shaft ensure the synchronization and controllability of the two pump units, support the precise execution of complementary extrusion strategies, and facilitate maintenance and fault isolation, thereby improving pumping stability and reliability at the system level.

[0054] This application also provides a nephrology dialysis method, the steps of which are as follows: Connect the disposable dialyzer 400, blood loop 200, and dialysate loop 300 to the interface of the machine body 100 according to the markings. Install and tighten the first pump body 511 and the second pump body 521 and their cover plates. Complete the infusion according to the device prompts and continuously remove air bubbles until the air bubble detection is qualified. Confirm that the pumped section of the blood tubing is correctly embedded in the first pumping unit 51 and the second pumping unit 52 and achieves mechanical coaxiality and sealing.

[0055] Sensor and pump unit calibration self-test: The controller sequentially self-tests and calibrates the flow, pressure, bubble and displacement / angle sensors. According to the program, the snap ring 542-extrusion gap mapping is calibrated under no-load or low flow conditions. The electromagnetic ejection stroke and the 20-degree angle response of the swing part are calibrated and the calibration data is recorded to establish the mapping relationship between the measurement and the actuator.

[0056] The controller sets the initial phase difference and target blood flow of the two pump units based on the complementary squeezing principle, and gradually accelerates to the target speed using a segmented rate. At the same time, the flow / pressure curve is monitored in real time, and the system enters steady-state operation after confirming that there are no abnormalities.

[0057] Closed-loop steady-state operation and online fine-tuning: During steady-state operation, the system reads sensor signals such as flow rate, pressure and bubbles in real time. The controller dynamically adjusts the drive phase, the position of the retaining ring 542 or the electromagnetic ejection current according to the preset control law to maintain the target flow rate / pressure curve, and distributes the flow rate between parallel paths according to the strategy or switches redundant paths in case of failure.

[0058] The required net fluid removal rate is calculated based on the set ultrafiltration rate, and ultrafiltration control is performed during operation. When transient pressure or load disturbance is detected, the controller triggers the electromagnetic ejector 55 for fine adjustment or triggers the oscillating part 20 for retention / reverse action to avoid negative pressure backflow and maintain continuous flow. At the same time, the flow distribution is adjusted as needed between parallel channels to ensure ultrafiltration accuracy and hemodynamic stability.

[0059] The above embodiments are merely illustrative of the technical solutions of this application and are not intended to limit it. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. These modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this application, and all should be covered within the scope of this application. In particular, as long as there is no structural conflict, the various technical features mentioned in the embodiments can be combined in any way. This application is not limited to the specific embodiments disclosed herein.

Claims

1. A pressurized ultrafiltration device for nephrology dialysis, comprising a body (100), a blood loop (200), a dialysate loop (300), and a dialyzer (400), wherein the dialyzer (400) is installed inside the body (100), and both the blood loop (200) and the dialysate loop (300) are connected to the dialyzer (400), characterized in that, Also includes: A pumping system (500) is connected to the blood loop (200) and the dialysate loop (300). The pumping system (500) includes at least a first pumping unit (51) and a second pumping unit (52), both of which are connected to the blood loop (200). The blood loop (200) is at least partially embedded in the first pumping unit (51) and the second pumping unit (52) so that the first pumping unit (51) and the second pumping unit (52) squeeze the blood loop (200). The first pumping unit (51) and the second pumping unit (52) each have a pumping state and a compensation state. The first pumping unit (51) and the second pumping unit (52) are configured to move in a complementary manner, such that at any time when the first pumping unit (51) is in the pumping state, the second pumping unit (52) is in the compensation state, and when the second pumping unit (52) is in the pumping state, the first pumping unit (51) is in the compensation state.

2. The pressurized ultrafiltration device for nephrology dialysis according to claim 1, characterized in that, The blood loop (200) includes an outflow vessel (21), a first passage (22), a second passage (23), a connecting tube (24), and a return vessel (25). The first passage (22) and the second passage (23) are connected in parallel to the outflow vessel (21) and the connecting tube (24), and both the connecting tube (24) and the return vessel (25) are connected to the dialyzer (400). The first passage (22) is pressed into the first pumping unit (51), the second passage (23) is pressed into the second pumping unit (52), and the pumping system (500) is provided with a drive component (53) to drive the first pumping unit (51) and the second pumping unit (52) to rotate.

3. The pressurized ultrafiltration device for nephrology dialysis according to claim 2, characterized in that, The first pumping unit (51) includes: The first pump body (511) is installed inside the body (100), and a first cover plate (512) is provided on the outside of the first pump body (511). The first cover plate (512) is snapped into the first pump body (511). The first pump core (513) is installed inside the first pump body (511) and can rotate relative to the first pump body (511). The first pump core (513) is connected to the drive assembly (53). The first roller (514) is axially connected to the inner side of the first pump core (513), and the first roller (514) can rotate relative to the first pump core (513). The first guard plate (515) is embedded in the first pump body (511). The first pumping channel (516) is formed on the inner side of the first guard plate (515). The first passage (22) is pressed into the first pumping channel (516) and contacts the first guard plate (515) and the first roller (514).

4. A pressurized ultrafiltration device for nephrology dialysis according to claim 2, characterized in that, The second pumping unit (52) includes: The second pump body (521) is installed inside the body (100). A second cover plate (522) is provided on the outside of the second pump body (521). The second cover plate (522) is snapped into the second pump body (521). The second pump body (521) can slide relative to the body (100). The second pump core (523) is embedded in the second pump body (521) and can rotate relative to the second pump body (521). The second pump core (523) is connected to the drive assembly (53). The second roller (524) is axially connected to the inner side of the second pump core (523), and the second roller (524) can rotate relative to the second pump core (523); The second guard plate (525) is embedded in the second pump body (521). The second pumping channel (526) is formed on the inner side of the second guard plate (525). The second passage (23) is pressed into the second pumping channel (526) and contacts the second guard plate (525) and the second roller (524).

5. A pressurized ultrafiltration device for nephrology dialysis according to claim 3, characterized in that, The first pump core (513) has a guide groove (541) so that the first roller (514) is axially connected to the guide groove (541) and can slide along the guide groove (541). An elastic element (54) is provided between the first pump core (513) and the first roller (514), and the elastic element (54) includes: A retaining ring (542) is coaxial with the first pump core (513) and embedded inside the first pump core (513); The top frame (543) is slidably disposed inside the first pump core (513), and the first roller (514) is shaft-connected to the top frame (543) and can rotate relative to the top frame (543). A slot (544) is provided at least at the contact portion between the retaining ring (542) and the top frame (543). The retaining ring (542) extends to the outside of the first pump core (513), and the rotation of the retaining ring (542) can change the ejection distance to the top frame (543).

6. A pressurized ultrafiltration device for nephrology dialysis according to claim 4, characterized in that, The second pump body (521) is provided with an ejector (55) that can extend and retract toward the second pump core (523), the ejector (55) comprising: The electromagnetic component (551) is located inside the second pump body (521); An ejector frame (552) is connected to a portion of an electromagnetic assembly (551) so that the electromagnetic assembly (551) can change the extension distance of the ejector frame (552) through magnetic force changes. The contact (553) is the end of the ejector (552) facing the second pump core (523), the contact (553) contacts the second guard plate (525), and the second guard plate (525) is elastically configured.

7. A pressurized ultrafiltration device for nephrology dialysis according to claim 3 or 5, characterized in that, The first pump core (513) includes a rotating part (10) and an oscillating part (20). The oscillating part (20) is axially connected to the rotating part (10), and the oscillating part (20) can oscillate relative to the rotating part (10) within 0°-5° to change the position of the oscillating part (20) relative to the rotating part (10). The cover plate is provided with an active magnetic plate (30) on its inner side, and the swing part (20) is embedded in a passive magnetic plate (40) on its inner side. The active magnetic plate (30) and the passive magnetic plate (40) cooperate to change the swing angle of the swing part (20).

8. A pressurized ultrafiltration device for nephrology dialysis according to claim 1, characterized in that, The squeezing gap of the first pumping unit (51) or the second pumping unit (52) on the blood loop (200) in the pumping state is smaller than the squeezing gap of the blood loop (200) in the compensation state.

9. A pressurized ultrafiltration device for nephrology dialysis according to claim 2, characterized in that, The drive assembly (53) includes a drive source (531), a drive disk (532), a first output shaft (533), and a second output shaft (534). The drive source (531) is connected to the drive disk (532). The first output shaft (533) and the second output shaft (534) extend from the inside of the drive disk (532) to the outside of the drive disk (532). The first output shaft (533) is connected to a first pumping unit (51), and the second output shaft (534) is connected to a second pumping unit (52).

10. A nephrology dialysis method, using the nephrology dialysis pressurized ultrafiltration device as described in any one of claims 1-9, characterized in that, The steps are as follows: Connect the disposable dialyzer (400) to the blood loop (200) and dialysate loop (300) according to the markings to the interface of the body (100). Install and clamp the first pumping unit (51) and the second pumping unit (52). Complete the infusion and continuously remove air bubbles until the air bubble detection is qualified. Confirm that the pumped section of the blood loop (200) is correctly embedded in the first pumping unit (51) and the second pumping unit (52) and achieves mechanical coaxiality and sealing. The flow, pressure, bubble, displacement, and angle sensors are self-tested and calibrated sequentially. The extrusion gap mapping is calibrated under no-load or low-flow conditions, and the calibration data is recorded to establish the mapping relationship between the measurement and the actuator. The controller sets the initial phase difference and target blood flow of the two pump units based on the complementary squeezing principle, and gradually accelerates to the target speed using a segmented rate. At the same time, the flow and pressure curves are monitored in real time, and the system enters steady-state operation after confirming that there are no abnormalities. During steady-state operation, the system reads the flow, pressure and bubble sensor signals in real time, maintains the target flow and pressure curves, and distributes the flow among parallel paths according to the strategy or switches redundant paths in case of failure.

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