Ultrasonic actuating blood pump-oxygenator integrated device

Abstract

The invention discloses an ultrasonic actuating blood pump-oxygenator integrated device. The ultrasonic actuating blood pump-oxygenator integrated device comprises an ultrasonic actuating blood pump and an oxygenation module, the ultrasonic actuating blood pump comprises a device base, a linear ultrasonic motor module and a blood cavity which are assembled from bottom to top. The linear ultrasonic motor module comprises a rotor, a stator and a base; the blood cavity is connected with the push rod and is used for accommodating blood; the oxygenation module is internally provided with an orthogonally-stacked hollow fiber membrane, is used for blood oxygenation, takes an ultrasonic motor as a driving core, realizes stable and adjustable flow output by utilizing the characteristics of quick response and high-precision control of the ultrasonic motor, and constructs a multi-dimensional interaction interface of blood and gas through the three-dimensional flow channel design of the orthogonally-stacked hollow fiber membrane, so that the blood oxygenation is realized. And the diffusion and convection effects in the gas-liquid exchange process are obviously enhanced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to an ultrasonic-actuated blood pump-oxygenator integrated device and an ECMO system. Background Art

[0002] Extracorporeal Membrane Oxygenation (ECMO) is an advanced extracorporeal life support technology, which is widely used in the treatment of patients with acute circulatory and / or respiratory failure who are ineffective with conventional life support measures. The core components of the ECMO system include a blood pump and an oxygenator. The blood pump is responsible for introducing the patient's venous blood into the oxygenator. After gas exchange in the oxygenator, the blood is re-infused into the patient's arterial system through the circulation pipeline. However, the current extracorporeal membrane oxygenation system has a large number of components and complex pipeline connections, which not only increases the possibility of errors and omissions during the operation process, but also increases the risks of blood damage and thrombosis. Therefore, optimizing the component design and pipeline layout of the ECMO system is one of the key directions to improve the safety and effectiveness of its clinical application.

[0003] To improve the safety and operability of ECMO, researchers have been working on developing more integrated and miniaturized ECMO devices to simplify the device structure and tubing connections, reducing operation complexity and the risk of complications. Researchers such as RUEDGER KOPP designed a highly integrated extracorporeal membrane oxygenator (HEXMO), which integrates the oxygenator and the rotary blood pump within a single housing to reduce the priming volume and simplify device management (Kopp, R. et al. (2011) ‘A Miniaturized Extracorporeal Membrane Oxygenator with Integrated Rotary Blood Pump: Preclinical In Vivo Testing’, ASAIO journal (1992), 57(3), pp. 158–163.). HEXMO combines a hollow fiber membrane surface of approximately 0.9 square meters with an integrated rotary blood pump in a compact housing, achieving miniaturization and integration of the device. This design significantly reduces the priming volume of the system to only 125 milliliters, thereby reducing blood product consumption. However, the system also faced some challenges in experiments. For example, there were malfunctions in the magnetic coupling part of the device, and there may be defects in the design of the electromagnetic motor coupler, resulting in its inability to withstand long-term or high-intensity loads during actual operation. In addition, there is a risk of thrombosis in the blood pump outlet part, which is related to the complex flow channel design inside the device, reducing hemodynamic performance and causing slow or stagnant flow regions to form at the inlet and outlet of the blood. Researchers such as Ralf Borchardt designed a new type of integrated pulsatile pump oxygenator, specifically designed for neonatal and pediatric extracorporeal membrane oxygenation (ECMO) systems (Borchardt, R. et al. (2010) ‘Description of a Flow Optimized Oxygenator With Integrated Pulsatile Pump’, Artificial organs, 34(11), pp. 904–910.). This device integrates the pump and the oxygenator in one device by embedding multiple thin-walled silicone tubes in the hollow fiber bundle and using pneumatic pressure to drive the contraction and expansion of these silicone tubes to achieve the pump function. This design simplifies the complexity of the system, and the blood flow channel is also simpler, but the pneumatic system relies on a stable gas source and precise pressure control. In practical applications, instability of the gas source or deviation of pressure control may cause irregular contraction and expansion of the silicone tubes, thereby affecting the normal operation of the pump and the stability of blood flow.Researchers such as Alexander Billioli designed an integrated extracorporeal membrane lung life support system in CN 111658864A. By integrating the blood pump and the membrane lung gas exchanger into one unit, the overall structure of the device is compact. However, such an integrated design may lead to higher device maintenance difficulty and a relatively complex internal structure. If a certain component is damaged, it may be necessary to replace the entire device, increasing the maintenance cost. At the same time, the patent relies on a centrifugal impeller to drive blood flow. Due to the inherent hydrodynamic characteristics of the centrifugal pump (mainly tangential flow) and the lack of a flow guiding structure or an active regulation mechanism, it is difficult to achieve precise regulation of the blood flow state. The annular or wound gas exchange membrane layout may form local turbulence or bypass channels due to fluid resistance, and combined with the gravity guiding effect of the blood inlet and outlet, the actual blood flow direction is prone to deviate from the preset axial path, resulting in uneven contact between the blood and the gas exchange membrane, and the oxygenation efficiency is difficult to reach the theoretical expectation. Researchers such as Yang Ming designed an artificial pump-lung assist device with a linear ultrasonic motor as the driving source in CN 113425930A. This device can adjust the thickness of the blood side boundary of the hollow fiber membrane layer by layer by controlling the micron-level displacement accuracy of the linear ultrasonic motor, so that each layer of blood can be fully oxygenated. The blood inlet is located in front of the hollow fiber membrane, and blood oxygenation is completed simultaneously during the introduction process. Due to the gravity sedimentation effect and the fluid impedance of the fiber membrane array during the perfusion process, such a design may cause deterioration of laminar flow stability, resulting in limited accuracy of blood dynamic regulation. At the same time, the blood discharge process will contact the hollow fiber membrane again, increasing the risk of mechanical damage to blood cells.

[0004] In the field of integrated blood pump-oxygenator, the existing technologies generally face core challenges such as insufficient dynamic performance of the drive system, limited accuracy of blood flow regulation, and high complexity of device maintenance. Due to problems such as long mechanical transmission chains and inertial lag in traditional drive schemes, it is difficult to achieve precise hemodynamic control and is prone to causing the risk of blood damage; while complex flow channel designs are prone to forming turbulence and stagnant zones, further exacerbating thrombus formation and oxygenation efficiency decay. In contrast, ultrasonic motor drive shows significant advantages in this field. Its excellent control accuracy and fast response characteristics enable it to precisely adjust the blood flow state and meet the complex needs of different patients. The compact design of the ultrasonic motor not only reduces the volume and weight of the device, but also improves the portability and flexibility of the system, making it more convenient in clinical applications. In addition, its low-noise characteristics can effectively alleviate the environmental stress response during the treatment of critically ill patients, which has important clinical value for improving the quality of life of patients. Summary of the Invention

[0005] In view of the above-mentioned defects of the prior art, the technical problem to be solved by the present invention is the problem that the drive components of the existing pump-oxygenator integrated device have complex transmission coupling, the system is unstable, and it is difficult to precisely regulate the blood flow state (such as the output flow waveform, etc.).

[0006] To achieve the above object, the present invention provides an integrated device of an ultrasonic-actuated blood pump and an oxygenator, comprising an ultrasonic-actuated blood pump and an oxygenation module; the ultrasonic-actuated blood pump includes a device base, a linear ultrasonic motor module, and a blood chamber assembled from bottom to top;

[0007] The linear ultrasonic motor module includes a mover, a stator, and a linear ultrasonic motor base; the linear ultrasonic motor base is used to fix the linear ultrasonic motor module;

[0008] The blood chamber is connected to the push rod, periodically changes the volume of the blood chamber, and is used to hold blood;

[0009] The oxygenation module is internally provided with orthogonally stacked hollow fiber membranes for blood oxygenation.

[0010] The present invention uses a linear ultrasonic motor as the driving core, utilizes its characteristics of fast response and high-precision control to achieve stable and adjustable flow output, and constructs a multi-dimensional interaction interface between blood and gas through the three-dimensional flow channel design of orthogonally stacked fiber membranes, significantly strengthening the diffusion and convection effects in the gas-liquid exchange process.

[0011] Further, in the linear ultrasonic motor module, a linear displacement is generated by driving the push rod with the mover; the push rod is connected to the mover through a conical-thread composite coupling structure to achieve gapless transmission, driving the push plate to periodically contract and relax, and pushing the blood to flow between the blood chamber and the oxygenation module.

[0012] The present invention uses a linear ultrasonic motor as the direct driving unit of the blood pumping device, and realizes the gapless transmission connection between the driving unit and the push plate assembly through a conical-thread composite coupling structure.

[0013] Further, the conical-thread composite coupling structure includes a conical-thread composite coupling head at the top of the mover and a conical-thread composite joint rod at the bottom of the push rod, which are coupled to form a precision transmission interface;

[0014] The mover is driven by the high-frequency vibration of piezoelectric materials.

[0015] Based on the high-precision driving characteristics of the linear ultrasonic motor, the dynamic regulation of the blood flow pattern is realized through its high-precision displacement analysis ability. The unique precision actuation mechanism of the ultrasonic motor can directly couple hemodynamic parameters, and under the direct drive architecture without intermediate transmission loss, accurately generate complex blood flow patterns that meet physiological requirements, enabling the blood to form a controlled progressive oxygenation process within the oxygenation module body.

[0016] Further, the linear ultrasonic motor module further includes a protective housing of the linear ultrasonic motor module;

[0017] The bottom of the protective housing of the linear ultrasonic motor module is provided with fixed holes in an annular array to achieve clearance fit with the device base;

[0018] The top of the protective housing of the linear ultrasonic motor module is provided with a notch and corresponding threaded holes for installing a linear bearing to ensure the coaxiality of the movement of the mover;

[0019] The top of the protective housing of the linear ultrasonic motor module is integrated with a male elastic buckle to achieve elastic connection and fixation requirements with the blood chamber.

[0020] Further, the top of the blood chamber adopts a top-open design, and forms a self-sealing interface through the interlock with the female elastic buckle outside the oxygenation module;

[0021] A blood inlet is arranged on the side of the blood chamber.

[0022] Further, the hollow fiber membranes of the oxygenation module are arranged in a right-angle staggered and stacked manner to form a multi-dimensional interaction network;

[0023] The edge of the membrane layer of the hollow fiber membrane is structurally encapsulated by a biocompatible polyether ether ketone fixing frame, and the hollow fiber membrane is accurately positioned through a dovetail-elastic buckle composite anchoring mechanism at the top;

[0024] A blood outlet is arranged above the oxygenation module.

[0025] In the existing pump-oxygenator integrated device, the blood flow path is relatively complex. It is difficult to ensure that the actual blood flow path is the same as the expected one under such a complex flow path, thus affecting the actual oxygenation efficiency. In addition, the complex flow path design is prone to form turbulence and stagnant areas, further exacerbating thrombus formation and the attenuation of oxygenation efficiency. The present invention designs an axial blood oxygenation flow path and constructs an orthogonally stacked hollow fiber membrane group, thereby realizing an efficient vertical uniform oxygenation mechanism to ensure a more uniform and efficient blood oxygenation process. At the same time, the simple axial blood flow path can better cooperate with the precise motion control of the linear ultrasonic motor, improve the control accuracy, and further enhance the performance of the entire system.

[0026] Driven by the linear ultrasonic motor, the push plate pushes the blood to form a uniform laminar flow, making it axially pass through the orthogonally arranged hollow fiber membrane layers layer by layer - these membrane layers are stacked in a right-angle staggered manner to form a multi-dimensional interaction network. This structure makes the gas diffusion path form a three-dimensional intersection with the blood flow direction, synergistically strengthening the convection and diffusion effects and significantly improving the oxygenation efficiency. At the same time, the gradient flow resistance generated by the orthogonal membrane layers combined with the precise motion control of the linear ultrasonic motor can accurately adjust the blood flow velocity, oxygenation time, and shear stress.

[0027] The technical solution provided by the present invention promotes uniform blood oxygenation, improves the oxygenation efficiency, and at the same time reduces blood damage and blood stagnant areas.

[0028] Further, during the operation of the ultrasonic-actuated blood pump-oxygenator integrated device, the push plate of the linear ultrasonic motor module performs bidirectional precise displacement. During the downward stage, a gradient pressure drop is formed inside the blood chamber through the negative pressure effect, and the blood is spin-filled along the spiral flow path through the blood inlet, forming a blood layer with a uniform thickness on the surface of the push plate. During the upward stage, the push plate vertically presses the blood into the oxygenation module. After the oxygenation process is completed in the orthogonally stacked hollow fiber membranes, the blood is finally discharged through the blood outlet;

[0029] The movement of the push plate simulates the pulsatile blood flow of the heart.

[0030] Further, the device base includes a frustum, an internally threaded hole provided on the circumferential surface, and a circularly arrayed fixing hole.

[0031] Further, the ultrasonic-actuated blood pump-oxygenator integrated device further includes a smart control system used in combination for real-time monitoring and automatic feedback adjustment of the patient's physiological parameters.

[0032] Based on the platform of the linear ultrasonic motor and combined with intelligent control algorithms, the present invention can not only ensure the optimal oxygenation efficiency at the blood-gas exchange interface, but also adaptively adjust the movement trajectory of the push plate according to the patient's real-time physiological indicators, achieving intelligent adaptation of blood flow parameters while maintaining a low shear stress environment. At the same time, the compact packaging design and silent operation characteristics of the linear ultrasonic motor provide an innovative solution with both flexible regulation and efficient oxygenation for extracorporeal life support on the basis of ensuring clinical reliability.

[0033] Further, the assembly of the ultrasonic-actuated blood pump-oxygenator integrated device adopts a bottom-up positioning strategy, including:

[0034] (1) Horizontally place the device base and fix the base of the linear ultrasonic motor;

[0035] (2) Drive the mover to the upper limit of the stroke and then lock it;

[0036] (3) Insert the module housing into the base groove, and pass through the fixing hole with a stud and tighten it;

[0037] (4) Install and fix a linear bearing in the top groove of the housing;

[0038] (5) Connect the blood chamber and the housing by interference fit through an elastic buckle;

[0039] (6) Pass the push rod through the mounting hole at the bottom of the blood chamber, and then screw the conical-thread composite joint rod at the bottom of the push rod into the coupling head at the top of the mover;

[0040] (7) Install the hollow fiber membrane module with a polyether ether ketone fixing frame into the oxygenation module;

[0041] (8) Connect the oxygenation module and the blood chamber through snap engagement;

[0042] (9) Conduct a power-on test to verify the coordination between the mover stroke and the movement of the push plate.

[0043] Existing pump-oxygenator integrated devices adopt an integrated design, which may lead to relatively high equipment maintenance difficulty and complex internal structure. If a certain component is damaged, the entire device may need to be replaced, increasing the maintenance cost. The present invention adopts a modular engineering architecture, and each functional component can be quickly disassembled and assembled through standard interfaces, realizing flexible replacement of components and greatly improving the equipment maintenance efficiency.

[0044] The present invention adopts an elastic coupling mechanism to achieve precise docking between the oxygenation module and the blood chamber. At the joint interface, a biocompatible sealing ring is provided and an interference fit design is used. When the snap is closed, micro-gap compensation is achieved by means of the elastic deformation of the material, thereby forming a leak-free quick-disassembly and quick-assembly interface. In addition, various detachable connection methods are also adopted for other components of the device, such as screw connection, snap connection, etc. The modular architecture design not only facilitates the maintenance and cleaning of the equipment, but also enables the components to be quickly and conveniently disassembled and replaced when needed, improving the equipment maintenance efficiency and significantly reducing the operation and maintenance loss.

[0045] Technical effects

[0046] The present invention is an ultrasonic-actuated blood pump-oxygenator integrated device, which uses a linear ultrasonic motor as the core drive and has high-precision displacement analysis and intelligent control capabilities. It can combine intelligent control algorithms to adaptively adjust blood flow parameters according to the patient's real-time physiological indicators, change the blood flow state, maintain a low shear stress environment, ensure the optimal oxygenation efficiency at the blood-gas exchange interface, and reduce the risk of blood damage. Its orthogonal laminated hollow fiber membrane group design makes the gas diffusion path and the blood flow direction in the outflow channel in a three-dimensional intersection, strengthening convection and diffusion, improving the oxygenation efficiency. At the same time, the simple axial blood flow channel can better cooperate with the precise motion control of the linear ultrasonic motor, improving the control accuracy, further enhancing the effectiveness and safety of the entire system, and effectively meeting the patient treatment needs. The modular split architecture and convenient maintenance design ensure the system integration while improving the clinical applicability and operation and maintenance economy.

[0047] The raw materials for manufacturing this device, such as stainless steel, aluminum alloy, medical-grade polycarbonate, etc., have stable supply and controllable costs, which is conducive to large-scale procurement and cost control. The manufacturing process is mature, and mass production can be realized by means of existing machining, injection molding and other technologies. The modular design is conducive to large-scale production and assembly, improving production efficiency and production capacity, reducing unit costs, and enhancing market competitiveness.

[0048] The present invention has broad industrial application prospects in the field of extracorporeal life support. With the popularization of ECMO technology, the market demand for more advanced and reliable life support devices has shown an explosive growth. This device ingeniously integrates the advantages of cutting-edge technologies such as portability, precise intelligent control, etc., and changes the limitations of traditional ECMO devices, which are large in size, complex in operation and difficult to move. Its lightweight and compact design enables medical staff to quickly deploy the device to different departments. Whether it is for long-term life support in the intensive care unit, temporary circulatory assistance in the operating room, or even at the emergency rescue site, it can play a key role. At the same time, the low operation threshold greatly shortens the learning curve of medical staff, allowing non-professional personnel to accurately operate after a short training, effectively improving the treatment efficiency. The intelligent control system realizes the real-time monitoring and automatic feedback adjustment of the patient's physiological parameters, ensuring the refinement and personalization of the treatment process. In addition, the design of this device fully considers the operation and maintenance costs. Its modular split architecture enables the core components to be independently maintained and replaced, reducing the maintenance difficulty and replacement cost, and further enhancing its market competitiveness and industrial feasibility.

[0049] The concept, specific structure and technical effects of the present invention will be further described below in conjunction with the accompanying drawings to fully understand the purpose, features and effects of the present invention. Brief Description of the Drawings

[0050] Figure 1 is a schematic diagram of the external structure of the ultrasonic-actuated blood pump-oxygenator integrated device of a preferred embodiment of the present invention;

[0051] Figure 2 is a schematic diagram of the structure of the ultrasonic-actuated blood pump-oxygenator integrated device of a preferred embodiment of the present invention;

[0052] Figure 3 is a top view of the protective housing of the linear ultrasonic motor module of a preferred embodiment of the present invention;

[0053] Figure 4 is a schematic diagram of the structure of the blood chamber housing of a preferred embodiment of the present invention;

[0054] Figure 5 is a schematic diagram of the structure of the oxygenation module of a preferred embodiment of the present invention;

[0055] Figure 6 is a schematic diagram of the blood flow direction of the ultrasonic-actuated blood pump-oxygenator integrated device in the working state of a preferred embodiment of the present invention.

[0056] Wherein:

[0057] 1 - Device base, 2 - Stud, 3 - Hexagon slotted nut, 4 - Protective housing of linear ultrasonic motor, 5 - Blood chamber, 6 - Gas inlet, 7 - Oxygenation module, 8 - Blood outlet, 9 - Gas outlet, 10 - Blood inlet, 11 - Fixing holes on the circumferential surface of the device base, 12 - Inner circular table of the device base, 13 - Fixing holes for the base of the linear ultrasonic motor, 14 - Flat head screw for fixing the linear ultrasonic motor, 15 - Cone-thread composite coupling head, 16 - Circumferential fixing holes of the protective housing of the linear ultrasonic motor, 17 - Installation groove for linear bearing, 18 - Fixing holes for linear bearing, 19 - Elastic female buckle outside the blood chamber, 20 - Cone-thread composite joint rod, 21 - Push rod, 22 - Push plate, 23 - Elastic female buckle outside the oxygenation module, 24 - Flat head screw for fixing the linear bearing, 25 - Linear bearing, 26 - Rotor of linear ultrasonic motor, 27 - Stator of linear ultrasonic motor, 28 - Base of linear ultrasonic motor, 29 - Fixing holes on the circular table surface of the device base, 30 - Elastic male buckle at the top of the protective housing of the linear ultrasonic motor, 31 - Threaded hole at the top of the protective housing of the linear ultrasonic motor, 32 - Elastic male buckle inside the blood chamber, 33 - Installation hole for the push rod inside the blood chamber, 34 - Fixing frame for fiber membrane, 35 - Hollow fiber membrane. Detailed implementation manners

[0058] The following introduces multiple preferred embodiments of the present invention with reference to the accompanying drawings of the specification to make its technical content clearer and easier to understand. The present invention can be embodied in many different forms of embodiments, and the protection scope of the present invention is not limited to the embodiments mentioned in the text.

[0059] In the drawings, components with the same structure are denoted by the same reference numerals, and components with similar structures or functions everywhere are denoted by similar reference numerals. The size and thickness of each component shown in the drawings are arbitrarily shown, and the present invention does not limit the size and thickness of each component. To make the illustration clearer, the thickness of some parts in the drawings is appropriately exaggerated.

[0060] As Figure 1 and Figure 2 shown, the ultrasonic-actuated blood pump-oxygenator integrated device consists of a device base 1, a protective housing 4 of the linear ultrasonic motor module, a blood chamber 5 and an oxygenation module 7 to form a basic structure. The device base 1 serves as a structural foundation to carry the device and achieve electrical signal transmission. The threaded inner holes and the annular array of fixing holes 11 on the circumferential surface of its circular table 12 form a mechanical positioning reference. The linear ultrasonic motor module drives the rotor 26 to generate linear displacement through the high-frequency vibration of piezoelectric materials. The cone-thread composite coupling head 15 at the top of the rotor and the cone-thread composite joint rod 20 at the bottom of the push rod 21 form a precise transmission interface to drive the push plate 22 to realize the periodic contraction and relaxation function of the blood chamber.

[0061] As Figure 3As shown, the protective housing 4 of the linear ultrasonic motor module is positioned by the fixing holes 16 in a bottom annular array in cooperation with the positioning hole system of the device base. After being connected through the through bolts 2, it is fastened with hexagon slotted nuts 3, and split pins can be selectively added to enhance the structural stability. The notch 17 at the top of the housing is used for installing a linear bearing. The threaded hole 31 cooperates with the flat head screw 24 to fix the bearing, and at the same time, an elastic male buckle 30 is provided for an elastic connection with the blood chamber.

[0062] As Figure 4 shown, the blood chamber 5 adopts an open-top design and forms a self-sealing interface through the interlock with the external elastic female buckle 23 of the oxygenation module 7. The push rod 21 forms a motion transfer channel with the mover 26 through the mounting hole 33.

[0063] As Figure 5 shown, the core of the oxygenation module 7 is composed of a cylindrical hollow fiber membrane 35. The edge of the membrane layer is structurally encapsulated by a biocompatible polyether ether ketone fixing frame 34, and the precise positioning of the fiber membrane is completed through a dovetail-elastic buckle composite anchoring mechanism at the top. Through the application of precise mechanical cooperation, this integrated design achieves modular detachable maintenance characteristics while ensuring liquid tightness.

[0064] As Figure 6 shown, in a complete working cycle of the device, the linear ultrasonic motor drives the push plate 22 to perform bidirectional precise displacement: in the downward stage, a gradient pressure drop is formed inside the blood chamber 5 through the negative pressure effect, and the blood completes self-rotation filling along the spiral flow path through the blood inlet 10, and the blood gradually forms a blood layer with a uniform thickness on the surface of the push plate. In the upward stage, the push plate 22 vertically presses the blood into the orthogonally stacked hollow fiber membranes 35. Since the blood is evenly distributed on the push plate, the uniformity of blood oxygenation is ensured when the blood passes through the hollow fiber membranes layer by layer. After the oxygenation process is completed, the blood finally exits through the blood outlet 8 located above the oxygenation module. By adjusting the motion mode of the linear ultrasonic motor, the residence time of the blood between the fiber membranes and the laminar flow pattern are precisely controlled, thereby optimizing the boundary layer thickness of the blood-gas exchange interface and realizing a layer-by-layer and batch-by-batch oxygenation process, thus significantly improving the oxygenation efficiency. In addition, since this device utilizes the precise motion characteristics of the linear ultrasonic motor to precisely adjust the blood flow rate, compared with traditional methods, it can effectively reduce the shear stress of the blood, contribute to protecting the physiological activity of the blood, and reduce the risk of blood damage.

[0065] The assembly of the device provided by the present invention adopts a modular bottom-up positioning strategy: First, place the device base 1 on a horizontal reference plane, and complete the rigid connection between the linear ultrasonic motor base 28 and the frustum 12 through flat head screws 14; after powering on to drive the mover 26 to the upper limit of the stroke and then powering off to lock it, then embed the module housing 4 into the base groove, use the stud 2 to pass through the coaxially calibrated fixing holes 16 / 11, and cooperate with the hexagon slotted nut 3 to achieve circumferential restraint, and ensure that the top groove 17 of the housing is coaxial with the mover 26; then install the linear bearing 25 into the groove 17 and fix it with flat head screws 24, and complete the liquid-tight connection between the blood cavity and the housing through the interference fit of the elastic snap fasteners 19 / 30; then screw the conical-thread composite joint rod 20 at the bottom of the push rod 21 into the coupling head 15 at the top of the mover to form a zero-clearance transmission interface; finally, place the hollow fiber membrane module 35 integrated with the polyether ether ketone fixed frame 34 into the oxygenation module 7, and achieve the mechanical seal between the oxygenation module and the blood cavity through the engagement of the snap fasteners 32 / 23. This design supports rapid maintenance, and only needs to decouple the snap fasteners 23 / 32 and the elastic snap fasteners 19 / 30 to separate the oxygenation module and the blood cavity, meeting the requirements of non-destructive disassembly, cleaning and consumable replacement in clinical scenarios, and improving the operation efficiency while ensuring the sealing performance.

[0066] The device of the present invention uses a linear ultrasonic motor as the driving core, utilizes its characteristics of rapid response and high-precision control to achieve stable and adjustable flow output, and constructs a multi-dimensional interaction interface between blood and gas through the three-dimensional flow channel design of the orthogonal laminated fiber membrane, significantly enhancing the diffusion and convection effects in the gas-liquid exchange process. The device can dynamically adjust the blood flow state by combining intelligent control algorithms to further optimize the oxygenation efficiency, or can also achieve real-time adaptation of blood flow parameters to the physiological needs of patients while maintaining a low shear stress environment through real-time control.

[0067] At the engineering design level, the device adopts a modular split architecture: the driving unit and the functional module are quickly separated through a highly reliable interface, supporting independent maintenance and replacement of core components; the hollow fiber membrane assembly adopts a guiding and positioning structure design to ensure the geometric accuracy and sealing integrity during the disassembly and assembly process; the special coating treatment on the inner wall of the flow channel effectively inhibits the adhesion of biological contamination. This design concept endows the device with higher clinical applicability and operation and maintenance economy while ensuring the system integration.

[0068] The preferred specific embodiments of the present invention have been described in detail above. It should be understood that those of ordinary skill in the art can make many modifications and variations according to the concept of the present invention without creative labor. Therefore, all technical solutions that can be obtained by those skilled in the art in the technical field of the present invention based on the concept of the present invention through logical analysis, reasoning or limited experiments on the basis of the prior art should be within the protection scope determined by the claims.

Claims

1. An ultrasonically actuated blood pump-oxygenator integrated device, characterized in that: include: Ultrasound-actuated blood pump and oxygenation module; The ultrasonically actuated blood pump comprises a device base, a linear ultrasonic motor module and a blood chamber assembled from bottom to top; The linear ultrasonic motor module comprises a mover, a stator and a base; The blood chamber is connected to the push rod to periodically change the volume of the blood chamber to drive the blood; The oxygenation module has built-in orthogonally stacked hollow fiber membranes for blood oxygenation to achieve the function of an oxygenator.

2. The ultrasonically actuated blood pump-oxygenator integrated device according to claim 1, characterized in that: In the linear ultrasonic motor module, the push rod is driven by the mover to generate linear displacement; the push rod is connected to the mover through a conical surface-thread composite coupling structure to achieve gapless transmission, drive the push plate to contract and relax periodically, and promote blood to flow between the blood cavity and the oxygenation module.

3. The ultrasonically actuated blood pump-oxygenator integrated device according to claim 2, characterized in that: The conical surface-thread composite coupling structure comprises a conical surface-thread composite coupling head at the top of the mover and a conical surface-thread composite coupling rod at the bottom of the push rod, which are coupled to form a precise transmission interface; The mover is driven by high-frequency vibrations of the piezoelectric material.

4. The ultrasonically actuated blood pump-oxygenator integrated device according to claim 1, characterized in that: The linear ultrasonic motor module also includes a linear ultrasonic motor module protective housing; The bottom of the protective housing of the linear ultrasonic motor module is provided with a circular array of fixing holes to achieve the hole matching with the base of the device; The top of the linear ultrasonic motor module protective housing is provided with a notch and a corresponding threaded hole for installing a linear bearing to ensure the coaxiality of the movement of the mover; An elastic male buckle is integrated on the top of the linear ultrasonic motor module protective shell to achieve elastic connection and fixation requirements with the blood cavity.

5. The ultrasonically actuated blood pump-oxygenator integrated device according to claim 1, characterized in that: The top of the blood chamber adopts an open-top design, and forms a self-sealing interface by interlocking with the elastic female buckle outside the oxygenation module; A blood inlet is arranged on the side of the blood chamber.

6. The ultrasonically actuated blood pump-oxygenator integrated device according to claim 1, characterized in that: The hollow fiber membranes of the oxygenation module are stacked and arranged at right angles to form a multi-dimensional interactive network; The membrane edge of the hollow fiber membrane adopts a biocompatible polyetheretherketone fixed frame to achieve structural packaging, and the top is precisely positioned by a dovetail-elastic buckle composite anchoring mechanism; A blood outlet is arranged above the oxygenation module.

7. The ultrasonically actuated blood pump-oxygenator integrated device according to claim 1, characterized in that: During the operation of the ultrasonically actuated blood pump-oxygenator integrated device, the linear ultrasonic motor module drives the push plate to perform bidirectional precision displacement. In the downward stage, a gradient pressure drop is formed inside the blood cavity through the negative pressure effect, and spin filling is completed along the spiral flow channel through the blood inlet, forming a blood layer of uniform thickness on the surface of the push plate. In the upward stage, the push plate presses the blood vertically into the oxygenation module. After the oxygenation process is completed in the orthogonally stacked hollow fiber membranes, the blood is finally discharged through the blood outlet. The movement of the push plate simulates the blood flow caused by heart beating.

8. The ultrasonically actuated blood pump-oxygenator integrated device according to claim 1, characterized in that: The device base comprises a truncated table, threaded inner holes arranged on the circumference and fixing holes in an annular array.

9. The ultrasonically actuated blood pump-oxygenator integrated device according to claim 1, characterized in that: The ultrasonically actuated blood pump-oxygenator integrated device also includes an intelligent control system used in conjunction with the device for real-time monitoring and automatic feedback regulation of the patient's physiological parameters.

10. The ultrasonically actuated blood pump-oxygenator integrated device according to claim 1, characterized in that: The assembly of the ultrasonically actuated blood pump-oxygenator integrated device adopts a bottom-up positioning strategy, including: (1) Place the base of the device horizontally and fix the base of the linear ultrasonic motor; (2) The actuator is driven to the upper limit of the stroke and then locked; (3) Insert the module housing into the base groove, penetrate the fixing holes with studs and tighten them; (4) Install the linear bearing in the groove at the top of the housing and secure it; (5) connecting the blood chamber and the shell by means of an elastic buckle interference fit; (6) Insert the push rod through the mounting hole at the bottom of the blood chamber, and then screw the conical-threaded composite joint rod at the bottom of the push rod into the coupling head at the top of the mover; (7) installing the hollow fiber membrane module with the polyetheretherketone fixing frame into the oxygenation module; (8) connecting the oxygenation module to the blood chamber by snap engagement; (9) Perform a power-on test to verify the coordination between the mover stroke and the push plate movement.

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