Sterile diaphragm pump for organ perfusion

Abstract

The present application discloses a sterile diaphragm pump for organ perfusion, belonging to the technical field of liquid pumps. The diaphragm pump includes: a central pump body, which is cylindrical and used for installing other components; a double diaphragm assembly, two of which are symmetrically installed on both sides of the central pump body for realizing fluid transportation; the double diaphragm assembly includes a diaphragm body, a fixing ring and a sealing ring assembly; a plurality of equally spaced micro-grooves are arranged circumferentially between the inner side wall and the outer side wall of the sealing groove of the fixing ring; the cross-section of the micro-groove is parabolic, the width from the inner edge to the outer edge of the micro-groove is decreasing, and the depth from the inner side to the outer side of the micro-groove is decreasing; an inlet and outlet connecting pipe assembly, installed at both ends of the diaphragm assembly for liquid input and output; a support mechanism, which is installed at the bottom of the pump body for adjusting the level of the pump body. Through the solution of the present application, it is possible to reduce the local strain level of the sealing ring while ensuring the sealing performance.

Description

Technical Field

[0001] This application relates to the field of liquid pumps, and particularly to a sterile diaphragm pump for organ perfusion. Background Art

[0002] In the application scenario of organ perfusion, the sealing structure of the sterile diaphragm pump faces more stringent technical requirements. The temperature of the organ perfusion fluid needs to be precisely controlled within the range of 4 - 6 degrees Celsius, which causes the sealing system to work in a low-temperature environment for a long time. In this temperature range, the elastic modulus of the traditional circular cross-section sealing ring will increase significantly, and the hardness value increases by 5.8 - 8.4 degrees (Shore A scale) compared to the room temperature state, resulting in the actual contact stress between the sealing ring and the sealing groove exceeding the design value. At the same time, during the perfusion process, the flow rate needs to be adjusted within a wide range of 0.5 - 1200 ml / min, which requires the diaphragm pump to maintain stable sealing performance at different rotational speeds. When the flow rate is adjusted to a low level (less than 1 ml / min), the reciprocating motion frequency of the pump body drops to 0.6 - 0.8 times per minute, and the sealing ring is in a static compression state for a long time, which is prone to compression permanent deformation; while in the high-flow condition (more than 1000 ml / min), the reciprocating frequency can reach 86 - 92 times per minute, and the sealing ring will be repeatedly affected by high-frequency shear loads. In addition, the organ perfusion fluid contains various amino acids, electrolytes, and nutrients, and the pH value usually fluctuates within the range of 7.35 - 7.45. These media will have a certain penetration and potential chemical effect on the sealing material, and the traditional single-material formula is difficult to meet multiple requirements such as low-temperature elasticity, fatigue resistance, and chemical corrosion resistance at the same time.

[0003] During the perfusion process, in order to simulate the human physiological environment, the perfusion pressure needs to be pulsatingly adjusted within the range of 60 - 120 mmHg, and the pressure change period is usually 0.8 - 1.0 seconds. This rapid pressure fluctuation will generate transient stress concentration in the sealing contact area and cause a drastic change in the local lubrication state at the same time. The traditional smooth sealing groove wall surface cannot maintain a stable fluid lubricating film under this working condition, and the strain energy of the circular cross-section sealing ring cannot be quickly released and redistributed, resulting in a disordered stress state in the sealing area. In addition, the organ perfusion device often needs to work continuously for 24 - 72 hours without any sealing failure. During such a long continuous operation, the deformation accumulation and fatigue damage in the conventional sealing structure will gradually appear. Especially in a low-temperature environment, the self-recovery ability of the sealing material significantly decreases, and permanent deformation is more likely to occur. These technical difficulties make it difficult for the traditional double-channel sealing structure to meet the special requirements of organ perfusion applications.

[0004] Therefore, there is an urgent need for a technical solution that can reduce the local strain level of the sealing ring while ensuring the sealing performance. Summary of the Invention

[0005] To address the deficiencies of the prior art, an embodiment of the present application discloses a sterile diaphragm pump for organ perfusion. The present application solves technical problems such as the disorder of the stress state in the sealing area of the prior art.

[0006] An embodiment of the present application discloses a sterile diaphragm pump for organ perfusion, comprising: a central pump body, which is cylindrical and used for installing other components; a double diaphragm assembly, with two double diaphragm assemblies symmetrically installed on both sides of the central pump body for fluid delivery; the double diaphragm assembly includes a diaphragm body, a fixing ring, and a sealing ring assembly. The diaphragm body adopts a multi-layer composite structure, including an inner diaphragm sheet, an intermediate reinforcing layer, and an outer protective layer. The fixing ring is connected to the central pump body by bolts; wherein, a plurality of equally spaced micro-grooves are circumferentially arranged between the inner side wall and the outer side wall of the sealing groove of the fixing ring; the cross-section of the micro-groove is parabolic, the width from the inner edge to the outer edge of the micro-groove decreases, and the depth from the inner side to the outer side of the micro-groove decreases; an inlet and outlet pipe connection assembly, which is installed at both ends of the diaphragm assembly for liquid input and output; a support mechanism, which is installed at the bottom of the pump body for adjusting the level of the pump body.

[0007] In one possible implementation, the central pump body adopts a medical-grade stainless steel integrated structure, with fixing bolt holes evenly arranged on the outer periphery of the central pump body, and the outer surface of the central pump body is precision machined.

[0008] In one possible implementation, the double diaphragm assembly includes a diaphragm body, a fixing ring, and a sealing ring assembly. The diaphragm body adopts a multi-layer composite structure, including an inner diaphragm sheet, an intermediate reinforcing layer, and an outer protective layer. The fixing ring is connected to the central pump body by bolts.

[0009] In one possible implementation, the sealing ring assembly includes a main sealing ring and a secondary sealing ring. The main sealing ring and the secondary sealing ring are made of different materials in cooperation, and a sealing groove structure is provided inside the fixing ring.

[0010] In one possible implementation, the inlet and outlet pipe connection assembly includes an inlet pipe, an outlet pipe, and a connecting flange. Check valve assemblies are provided inside the inlet pipe and the outlet pipe, and the connecting flange is fixed by bolts.

[0011] In one possible implementation, the support mechanism includes a bottom plate and a multi-point support assembly. The multi-point support assembly is provided with an adjusting device, and the adjusting device adopts a threaded locking structure.

[0012] In one possible implementation, pneumatic systems are provided on both sides of the central pump body. The pneumatic systems include an air inlet interface, an air exhaust interface, and an air path control mechanism. The air inlet interface and the air exhaust interface are in the form of standard connectors.

[0013] In one possible implementation, one end of the main sealing ring is provided with an inner arc section in an eccentric arc shape; one end of the inner arc section is connected to an outer pressing section in an elliptical arc shape through a cubic curve transition section; the outer pressing section is inclined at a preset angle; the center of the inner arc section is offset relative to the center line.

[0014] In one possible implementation, a plurality of inverted conical microcavities are uniformly arranged along the circumference on the contact surface between the fixing ring and the sealing ring assembly; the openings of the inverted conical microcavities are arranged on the surface layer of the contact surface; an included angle inclined towards the medium cavity is formed between the axis of the inverted conical microcavity and the horizontal plane.

[0015] In a sterile diaphragm pump for organ perfusion disclosed as above, in the embodiment of the present application, by arranging a microgroove array with specific parameters in the sealing groove and combining with the design of a sealing ring with an asymmetric composite curve section, the uniform distribution of contact stress can be realized on the premise of maintaining the original installation space. The parabolic-like cross-section and precisely calculated depth gradient of the microgrooves can disclose a controllable strain energy release space during the deformation process of the sealing ring. The design of the asymmetric composite curve section, through the synergistic effect of the inner arc section, the intermediate transition section, and the outer pressing section, reduces the local strain level of the sealing ring while ensuring the sealing performance, enabling the sealing ring to obtain more stable mechanical properties, especially showing excellent compression set characteristics in a wide temperature range. The setting of the annular microcavity array not only discloses a strain energy release channel but also forms a favorable pressure distribution in the sealing contact area through specific geometric parameters. The reverse design of the spiral groove effectively improves the lubrication state, suppresses the hydrodynamic effect during high-speed reciprocating motion, and improves the overall reliability of the sealing system. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present application. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0017] Figure 1 It is a side view structural diagram of a diaphragm pump disclosed in an embodiment of the present application;

[0018] Figure 2 It is a front view structural diagram of a diaphragm pump disclosed in an embodiment of the present application;

[0019] Figure 3 The top view structure diagram of a diaphragm pump disclosed in an embodiment of the present application;

[0020] Figure 4 The stress simulation comparison diagram of a sealing structure disclosed in an embodiment of the present application.

[0021] Reference numerals: 10, central pump body; 20, double diaphragm assembly; 30, inlet and outlet connection pipe assembly; 40, support mechanism; 21, diaphragm body; 22, fixing ring; 23, sealing ring assembly; 31, liquid inlet pipe; 32, liquid outlet pipe; 33, connecting flange; 41, bottom plate; 42, multi-point support assembly; 51, air inlet interface; 52, exhaust interface; 53, gas path control mechanism. Detailed implementation manners

[0022] Now, various exemplary embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. It should be noted that: Unless otherwise specifically stated, the relative arrangements of components and steps, numerical expressions, and values set forth in these embodiments do not limit the scope of the present disclosure.

[0023] Those skilled in the art can understand that the terms "first", "second", etc. in the embodiments of the present disclosure are only used to distinguish different steps, devices, or modules, etc., and neither represent any specific technical meaning nor indicate an inevitable logical order between them. It should also be understood that in the embodiments of the present disclosure, "a plurality of" may refer to two or more, and "at least one" may refer to one, two, or more. It should also be understood that for any component, data, or structure mentioned in the embodiments of the present disclosure, unless specifically defined or otherwise indicated by the context, it is generally understood to be one or more. In addition, the term "and / or" in the present disclosure is only a description of the association relationship of associated objects, indicating that three relationships may exist. For example, A and / or B may represent: A exists alone, A and B exist simultaneously, and B exists alone. In addition, the character " / " in the present disclosure generally represents an "or" relationship between the associated objects before and after. It should also be understood that the present disclosure emphasizes the differences between various embodiments, and the same or similar parts can be referred to each other. For the sake of brevity, they will not be described in detail one by one.

[0024] Meanwhile, it should be understood that, for the convenience of description, the sizes of the various parts shown in the drawings are not drawn according to actual proportional relationships. The following description of at least one exemplary embodiment is actually merely illustrative and in no way restricts the present disclosure, its application, or use. Technologies, methods, and devices known to those of ordinary skill in the relevant art may not be discussed in detail, but where appropriate, the said technologies, methods, and devices should be regarded as part of the specification. It should be noted that like reference numerals and letters denote like items in the following drawings, and thus, once an item is defined in one drawing, it does not need to be further discussed in subsequent drawings.

[0025] To make the objectives, technical solutions, and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are some, but not all, of the embodiments of the present application. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present application without creative efforts shall fall within the scope of protection of the present application.

[0026] It should be understood that the system shown in the figure is exemplary rather than restrictive. This means that the involved system architecture is not limited to a specific form or design but is presented as an example. In other words, the architecture shown in the figure can be regarded as a way of expression to clearly describe relevant concepts and relationships and does not exclude other forms of architecture. Therefore, when interpreting the architecture in the said figures, it should be understood that the model has flexibility and diversity, and its purpose is to disclose an exemplary description rather than a restrictive regulation of a specific form.

[0027] As Figures 1-3 shown, an embodiment of the present application discloses a sterile pneumatic diaphragm pump, which is composed of a central pump body 10, a double diaphragm assembly 20, an inlet and outlet pipe connection assembly 30, and a support mechanism 40. Specifically, this pneumatic diaphragm pump adopts a symmetric double diaphragm structure and mainly consists of a central pump body module, diaphragm assemblies on both sides, an inlet and outlet pipe system, and a supporting pneumatic drive device. The pump body is overall cylindrical, with drive air chambers symmetrically arranged on both sides and a fluid chamber in the middle.

[0028] Among them, the central pump body 10 is cylindrical and is used to install other components; the two double diaphragm assemblies 20 are symmetrically installed on both sides of the central pump body 10 and are used to achieve fluid transportation; the inlet and outlet pipe connection assembly 30 is installed at both ends of the diaphragm assembly 20 and is used for the input and output of liquid; the support mechanism 40 is installed at the bottom of the pump body and is used to adjust the level of the pump body.

[0029] The central pump body 10 is made of medical-grade stainless steel in an integrated structure. Fixed bolt holes are evenly arranged on the periphery of the pump body for installing the diaphragm assembly. The pump body is designed integrally to ensure the sealing performance and stability of the overall structure. In one embodiment, the outer shell of the central pump body 10 is made of medical-grade stainless steel material, is in a cylindrical shape as a whole, has a wall thickness of about 2.8 mm, and has sufficient mechanical strength to withstand the working pressure. The surface of the outer shell is precision machined, and the surface roughness Ra ≤ 0.4 μm to ensure good hygienic performance.

[0030] The diaphragm assembly 20 includes a diaphragm body 21, a fixing ring 22 and a seal ring assembly 23. Two sets of diaphragm assemblies 20 are symmetrically installed on both sides of the central pump body 10. The diaphragm body 21 is designed with a multi-layer composite structure, including an inner layer of medical-grade diaphragm sheet, a middle reinforcing layer and an outer protective layer. Preferably, each side of the double-layer diaphragm assembly is configured with a set of diaphragms made of medical-grade elastic material, the diaphragm diameter is 168.5 mm, and the effective deformation stroke is 12.6 mm. The diaphragm adopts a multi-layer composite structure: the inner layer is a polytetrafluoroethylene (PTFE) film with a thickness of 0.38 mm; the middle layer is a reinforcing fiber layer to disclose mechanical strength; the outer layer is an ethylene propylene diene monomer (EPDM) protective layer with a thickness of 0.42 mm. The fixing ring 22 is fixedly connected to the central pump body 10 by bolts, and a special sealing groove structure is provided inside to cooperate with the seal ring assembly 23 to achieve reliable sealing.

[0031] In one embodiment, the seal ring assembly 23 adopts a double-seal design. The main seal ring and the secondary seal ring are made of different materials and cooperate with each other to ensure the sealing effect during the working process through a reasonable pre-compression rate. The sealing groove of the fixing ring 22 is precision machined to ensure that the deformation amount of the seal ring is within a suitable range. Preferably, the edge of the diaphragm adopts a double-seal ring structure; the main seal ring is made of fluororubber with a cross-sectional diameter of 3.55 mm; the secondary seal ring is made of EPDM with a cross-sectional diameter of 2.65 mm; the depths of the sealing grooves are 3.75 mm and 2.85 mm respectively; the assembly pre-compression rate is 15.8%.

[0032] Furthermore, in order to improve the aseptic sealing effect of the seal ring assembly 23, a progressive composite sealing structure can be adopted. First, a micro-groove array with a gradient change is arranged in the original sealing groove. 156 equally spaced micro-grooves are arranged circumferentially. The width of each micro-groove has a gradually changing structure from the inner side to the outer side, the inner width is 0.28 mm, the outer width is 0.21 mm, and the depth gradually decreases from 0.12 mm on the inner side to 0.06 mm on the outer side. The cross-section of the micro-groove adopts a parabolic-like shape, and its contour curve conforms to the equation y = 0.126 - 0.068(x / 0.286)^2.42, where x represents the distance from the inner edge (mm) and y represents the groove depth (mm).

[0033] On the basis of the micro-grooves, the cross-sectional shape of the main sealing ring is optimized from the original circular shape to an asymmetric composite curve structure. The composite curve consists of an inner arc segment, an intermediate transition segment, and an outer clamping segment. The radius of the inner arc segment is 1.42 mm, and the center of the circle is offset by 0.18 mm; the intermediate transition segment adopts a cubic spline curve, and the coordinates of its control points are (0,0), (0.642,0.324), (1.246,0.526), ​​(1.864,0.608), respectively, in millimeters; the outer clamping segment adopts an elliptical arc, with a major axis of 1.98 mm, a minor axis of 1.64 mm, and an inclination angle of 7.2 degrees. The sealing ring material still uses fluororubber that meets the USP Class VI standard, but by improving the formula, the fluorine content is increased by 8.6% on the basis of the original formula, and 1.8% of medical-grade nano-silica filler is added. The vulcanization temperature is adjusted to 156 degrees Celsius, and the time is controlled at 16 minutes.

[0034] The secondary sealing ring adopts a variable-section multi-step structure, with four sealing steps arranged along the circumference of the ring. The first step is 0.38 mm high and 0.52 mm wide; the second step is 0.28 mm high and 0.44 mm wide; the third step is 0.21 mm high and 0.36 mm wide; the fourth step is 0.14 mm high and 0.28 mm wide. The transition fillet radius between steps is 0.06 mm. The secondary sealing ring still uses EPDM material that meets USP Class VI and ISO 10993 standards, but 3.6% of medical-grade silicone modifiers are added to the formula to improve its stability in the range of -40 to 150 degrees Celsius.

[0035] The pre-compression rate of the sealing ring assembly adopts a non-uniform distribution scheme. The circumference is divided into 24 equal areas, and the pre-compression rate of the odd-numbered area is set to 16.8%, and the pre-compression rate of the even-numbered area is set to 14.6%. Precise control is achieved through a special assembly tool. 24 groups of independently adjustable clamping blocks are set on the tool. The stroke of each clamping block is adjusted by a precision screw mechanism. The screw lead is 0.75 mm, and the adjustment dial division value is 0.01 mm. The clamping torque is applied by a torque wrench. For M8 bolts, the applied torque range is 15.6-16.2 Nm.

[0036] Fine spiral grooves are made on the walls on both sides of the sealing groove. The pitch of the spiral groove is 0.38 mm, the groove depth is 0.04 mm, and the groove width is 0.06 mm. The rotation direction of the spiral groove is opposite to the working direction of the pump body, that is, when the pump body runs forward, the sealing ring produces reverse pressure distribution under the action of the fine spiral groove. The cross-section of the spiral groove adopts an asymmetric triangle, in which the bevel angle on the side facing the working medium is 62.4 degrees, and the bevel angle on the side away from the working medium is 43.6 degrees.

[0037] In the contact area between the fixed ring 22 and the sealing ring assembly 23, an annular microcavity array is provided. 286 microcavities are evenly arranged circumferentially. The opening diameter of each microcavity is 0.14 mm, and the depth is 0.23 mm. The cavity is in an inverted conical shape with a cone angle of 16.8 degrees. The central axis of the microcavity forms an angle of 72.4 degrees with the horizontal plane and points in the direction of the dielectric cavity. When the sealing ring is compressed and deformed, these microcavities can accommodate part of the deformation volume and at the same time form a local pressure gradient.

[0038] It should be understood that in the actual application environment, the traditional double-channel circular cross-section sealing ring structure has several key technical bottlenecks: Under high-frequency reciprocating motion, the contact stress distribution between the circular cross-section sealing ring and the sealing groove wall surface is uneven, resulting in local stress concentration; The frictional heat generated by the sealing ring during reciprocating motion cannot be effectively dissipated, causing the local temperature of the sealing ring to rise and leading to material property attenuation; In the pre-compressed state, the strain energy distribution of the circular cross-section sealing ring is uneven, and there is a lack of an effective strain energy release mechanism, resulting in a significant reduction in the service life of the sealing ring; The smooth wall surface of the sealing groove will show an unstable phenomenon of the fluid lubricating film thickness during high-speed reciprocating motion, affecting the sealing reliability; The sealing ring with a single material formula shows significant performance fluctuations in a wide temperature range (-45 to 180 degrees Celsius). Especially when the temperature changes drastically, the elastic modulus and compression set rate of the sealing ring will change significantly, affecting the sealing effect; The traditional uniform pre-compression method does not take into account the stress distribution law of the sealing ring during actual operation, resulting in over-compression or under-compression in some areas. Based on the above technical problems, the conventional sealing structure is difficult to meet the strict requirements for sealing stability of medical-grade pneumatic diaphragm pumps during long-term operation.

[0039] By setting a micro-groove array with specific parameters in the sealing groove and combining it with the design of a sealing ring with an asymmetric composite curve section, the uniform distribution of contact stress can be achieved while maintaining the original installation space. The parabolic-like cross-section and precisely calculated depth gradient of the micro-grooves can disclose a controllable strain energy release space during the deformation process of the sealing ring. The design of the asymmetric composite curve section, through the synergistic effect of the inner arc section, the middle transition section, and the outer pressing section, reduces the local strain level of the sealing ring while ensuring the sealing performance. The improved material formula and vulcanization process enable the sealing ring to obtain more stable mechanical properties, especially showing excellent compression set characteristics in a wide temperature range. The setting of the annular micro-cavity array not only discloses the strain energy release channel but also forms a favorable pressure distribution in the sealing contact area through specific geometric parameters. The reverse design of the spiral groove effectively improves the lubrication state and suppresses the hydrodynamic effect during high-speed reciprocating motion. The precise control of the non-uniform pre-compression rate matches the actual working stress distribution of the sealing ring, significantly improving the overall reliability of the sealing system. This multi-level composite sealing structure innovation synergistically solves the technical limitations of traditional sealing structures from multiple dimensions such as materials, structures, and processes.

[0040] The inlet and outlet pipe assembly 30 includes an inlet pipe 31, an outlet pipe 32, and a connecting flange 33, which adopts a hygienic quick-connect joint design and closely fits with the axial flow channel of the diaphragm body 21. The connecting flange 33 is reliably fixed by bolts, and the sealing surface is specially treated. The one-way valve assembly is integrated in the inlet and outlet pipelines to ensure the unidirectional flow of the fluid.

[0041] In one embodiment, the one-way valve assembly adopts a ball valve structure. The valve ball is made of wear-resistant material and is precisely fitted with the valve seat to ensure good sealing performance and sensitive action characteristics. The design of the valve assembly is convenient for disassembly, cleaning, and meets the hygienic requirements.

[0042] The support mechanism 40 adopts a stable base structure design, including a bottom plate 41 and a multi-point support assembly 42. The support assembly is provided with an adjustment device that can adjust the level of the pump body according to the installation environment to ensure the stable operation of the equipment. The support points are provided with shock-absorbing devices to effectively reduce the operating vibration.

[0043] In one embodiment, the adjustment device adopts a threaded locking structure to ensure the stable and reliable position after adjustment. The shock-absorbing device is made of medical-grade material and has good shock-absorbing effect and durability.

[0044] The pneumatic system includes an air inlet interface 51, an air exhaust interface 52 and an air path control mechanism 53. The air inlet and exhaust interfaces adopt standard connector forms, facilitating air path connection. The air path control mechanism is integrated on both sides of the central pump body, and realizes the reasonable distribution of compressed air through a precision air path, driving the diaphragm to reciprocate. Preferably, the pneumatic drive chamber air inlet interfaces arranged symmetrically on both sides adopt standard G1 / 4 threads, the exhaust interfaces adopt quick-connect joints with an outer diameter of 8 mm, and the working pressure range of the air chamber is 0.2 - 0.6 MPa.

[0045] When the present invention is working, compressed air enters the air path control mechanism 53 through the air inlet interface 51, and alternately enters the diaphragm chambers on both sides after being controlled. When the left side is inflated, the diaphragm body 21 moves to the right, forming a negative pressure in the right chamber, and sucking in liquid through the liquid inlet pipe 31; at the same time, the right side exhausts air, the diaphragm returns to its original position, and pushes the liquid to be discharged from the liquid outlet pipe 32. Through the alternate inflation and deflation of the left and right air chambers, the diaphragm is driven to reciprocate, realizing continuous and stable liquid transportation.

[0046] Specifically, the working process of this diaphragm pump can be divided into the following stages. Liquid suction stage: The left air chamber is inflated, and the air pressure pushes the left diaphragm to move to the right; the right air chamber exhausts air at the same time, and the diaphragm returns to its original position under the elastic action; a negative pressure is formed in the right chamber, and liquid is sucked in through the inlet check valve; the left outlet check valve is closed to prevent backflow. Liquid discharge stage: The right air chamber is inflated, pushing the right diaphragm to move to the left; the left air chamber exhausts air, and the diaphragm returns to its original position; the right chamber is pressurized, and the liquid is discharged through the outlet check valve; the right inlet check valve is closed to form a one-way transportation. Cycle: The left and right air chambers alternately inflate and deflate, driving the diaphragm to reciprocate; the air path switching timing is controlled by an electromagnetic valve; a continuous liquid transportation process is formed.

[0047] During the liquid transportation process, the multi-layer composite diaphragm structure ensures good mechanical strength and chemical stability, and the double-channel seal design effectively prevents medium leakage. The flow path is optimized by fluid dynamics to ensure the transportation efficiency and stability. The central fluid chamber and the flow path system cooperate coordinately to ensure the continuity of fluid transportation.

[0048] The present invention adopts a modular design concept, and key components can be independently disassembled, assembled and maintained. The replacement operation of the diaphragm assembly 20 is simple, and the sealing ring assembly 23 adopts standard specifications, facilitating maintenance and replacement. Regular maintenance mainly checks the integrity of the diaphragm, the state of the sealing ring and the action of the check valve. The embodiments of this application adopt multiple sealing measures to ensure aseptic performance. Diaphragm seal: The outer ring adopts a boss extrusion seal structure, the surface roughness Ra of the sealing surface ≤ 0.2 microns, and the sealing ring adopts a pre-pressed design with a deformation of 0.62 mm. Axial seal: Adopt a stepped groove seal structure, the cross-sectional shape of the sealing ring is D-shaped, and the assembly gap is controlled in the range of 0.08 - 0.12 mm. Dynamic seal: During the movement of the diaphragm, it maintains the seal by its own elasticity, and the edge fixation adopts a multi-point evenly distributed pressing method, and the pressing force is precisely controlled by the bolt pre-tightening force.

[0049] In terms of cleaning and disinfection, the present invention adopts an in-situ cleaning and sterilization design, and all liquid-contact surfaces can achieve complete cleaning and sterilization. Through effective diaphragm blocking, it is ensured that the driving gas is completely isolated from the conveying medium, meeting the aseptic requirements of medical devices. During the working state, the equipment runs smoothly with little vibration, and is suitable for long-term stable operation in a medical environment.

[0050] Figure 4 It is a stress simulation comparison diagram of a sealing structure disclosed in an embodiment of the present application. The simulation analysis of the stress distribution of the sealing structure is modeled and calculated using actual engineering parameters. Combining the specific dimensions and process parameters in the original text, an in-depth analysis of the stress state of the sealing system is carried out. The left figure shows the overall stress distribution of the main sealing ring in the pre-compressed state, and the right figure focuses on the local stress characteristics of the microcavity array area.

[0051] In terms of the stress distribution of the main sealing ring, based on the parameters that the main sealing ring in the original text is made of fluororubber and has a cross-sectional diameter of 3.55 mm, the stress state under the non-uniform pre-compression scheme is simulated and analyzed. By dividing the circumference of the ring into 24 equal parts, a pre-compression rate of 16.8% is applied to the odd-numbered areas and a pre-compression rate of 14.6% is applied to the even-numbered areas, forming an alternating basic stress field. This design corresponds to the pressing torque control (15.6 - 16.2 N·m) carried out through a precision screw mechanism during the actual assembly process.

[0052] On this basis, the influence of 156 equally spaced micro-grooves is integrated into the model. The width of each micro-groove gradually changes from 0.28 mm on the inner side to 0.21 mm on the outer side, and the depth gradually changes from 0.12 mm on the inner side to 0.06 mm on the outer side. It can be observed from the stress nephogram that this gradient structure generates a continuous stress transition zone in the radial direction, effectively avoiding the sudden change of stress. The parabolic cross-section of the micro-groove (conforming to the equation y = 0.126 - 0.068(x / 0.286) 2.42 ) makes the stress show a smooth distribution characteristic in the groove area.

[0053] The right figure focuses on showing the stress distribution characteristics of the microcavity array area. Based on the parameters of 286 annular microcavities set in the previous embodiment (opening diameter 0.14 mm, depth 0.23 mm, inverted cone structure, cone angle 16.8 degrees), the stress state of the local area is simulated and analyzed. The central axis of each microcavity forms an angle of 72.4 degrees with the horizontal plane, pointing towards the medium cavity direction. It can be clearly seen from the stress nephogram that the microcavity structure forms a regular stress distribution network under the compressed state, revealing an effective stress release path for the deformation of the sealing ring.

[0054] The asymmetric composite curve structure adopted by the sealing ring (inner arc segment radius 1.42 mm, center offset 0.18 mm) exhibits unique characteristics in stress distribution. Especially in the middle transition section, the control point coordinates of the cubic spline curve [(0,0), (0.642,0.324), (1.246,0.526), (1.864,0.608)] adopted ensure that the stress changes continuously and smoothly in the transition region. The elliptical arc design adopted for the outer pressing section (major axis 1.98 mm, minor axis 1.64 mm, inclination angle 7.2 degrees) ensures a good fit with the sealing groove.

[0055] The design of the micro - fine spiral groove (pitch 0.38 mm, groove depth 0.04 mm, groove width 0.06 mm) shows a series of regular stress fluctuations in the stress distribution diagram. Among them, the asymmetric design of the 62.4 - degree oblique angle on the working medium side and the 43.6 - degree oblique angle on the side away from the working medium generates the expected reverse pressure gradient effect during the forward operation of the pump body. This design, in combination with the improved formulation of the sealing ring material (increasing the fluorine content by 8.6% and adding 1.8% of medical - grade nano - silica filler), while maintaining the sealing performance, discloses the necessary dynamic compensation ability.

[0056] From the overall stress distribution, the new sealing structure realizes the effective control and reasonable distribution of stress. When the sealing ring is compressed and deformed, the micro - cavity array can not only accommodate the deformed volume, but also enhance the contact quality of the sealing surface by forming a local stress gradient. With precise assembly processes (such as using 24 groups of independently adjustable pressing blocks, screw lead 0.75 mm, and adjustment dial graduation value 0.01 mm), this sealing structure can maintain a stable and reliable sealing effect in the actual working environment.

[0057] Furthermore, the embodiment of the present application also discloses a device for optimizing the sealing ring, including: a processor, a memory, and a system bus; the processor and the memory are connected through the system bus; the memory is used to store one or more programs, and the one or more programs include instructions that, when executed by the processor, cause the processor to execute any of the above - mentioned methods.

[0058] As can be seen from the description of the above embodiments, those skilled in the art can clearly understand that all or part of the steps in the above-described embodiment methods can be implemented by means of software plus a necessary general hardware platform. Based on such an understanding, the technical solution of the present application, in essence, or the part that contributes to the prior art can be embodied in the form of a software product. This computer software product can be stored in a storage medium, such as ROM / RAM, magnetic disk, optical disk, etc., and includes several instructions for causing a computer device (which can be a personal computer, a server, or a network communication device such as a media gateway, etc.) to execute the methods described in various embodiments or certain parts of the embodiments of the present application.

[0059] It should be noted that the various embodiments in this specification are described in a progressive manner. The key point of each embodiment is to illustrate the differences from other embodiments. For the same or similar parts among the various embodiments, reference can be made to each other. For the devices disclosed in the embodiments, since they correspond to the methods disclosed in the embodiments, the description is relatively simple. For the relevant parts, reference can be made to the description in the method part.

[0060] It should also be noted that in this text, relational terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the term "comprising", "including" or any other variant thereof is intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements not only includes those elements, but also includes other elements not explicitly listed, or further includes elements inherent to such a process, method, article or device. Without further limitation, an element defined by the statement "including a..." does not exclude the existence of another identical element in the process, method, article or device including the said element.

[0061] The above description of the disclosed embodiments enables those skilled in the art to implement or use the present application. Various modifications to these embodiments will be obvious to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present application. Therefore, the present application will not be limited to the embodiments shown herein, but will be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A sterile diaphragm pump for organ perfusion, characterized in that: include: A central pump body (10), which is cylindrical and used for mounting other components; A double diaphragm assembly (20), wherein two double diaphragm assemblies (20) are symmetrically mounted on both sides of a central pump body (10) for achieving fluid delivery; the double diaphragm assembly (20) comprises a diaphragm body (21), a fixing ring (22) and a sealing ring assembly (23); the diaphragm body (21) adopts a multi-layer composite structure, comprising an inner diaphragm sheet, an intermediate reinforcement layer and an outer protective layer; the fixing ring (22) is connected to the central pump body (10) by bolts; wherein a sealing groove structure is provided inside the fixing ring (22); a plurality of equally spaced micro grooves are arranged along the circumferential direction between the inner side wall and the outer side wall of the sealing groove of the fixing ring (22); the cross section of the micro groove is a parabola shape, the width from the inner edge to the outer edge of the micro groove is arranged in a decreasing manner, and the depth from the inner side to the outer side of the micro groove is arranged in a decreasing manner; spiral grooves are made on the wall surfaces on both sides of the sealing groove, the rotation direction of the spiral groove is opposite to the working direction of the pump body, and the cross section of the spiral groove adopts an asymmetric triangle; The sealing ring assembly (23) comprises a main sealing ring and a secondary sealing ring, wherein the main sealing ring and the secondary sealing ring are made of different materials; an eccentric arc-shaped inner arc segment is arranged at one end of the main sealing ring; one end of the inner arc segment is connected to an elliptical arc-shaped outer clamping segment via a cubic curve transition segment; the outer clamping segment is inclined at a preset angle; the center of the inner arc segment is offset relative to the center line; a plurality of inverted cone microcavities are evenly arranged along the circumferential direction on the contact surface between the fixing ring (22) and the sealing ring assembly (23); the opening of the inverted cone microcavity is arranged on the surface layer of the contact surface; an angle inclined toward the medium cavity is formed between the axis of the inverted cone microcavity and the horizontal plane; An inlet and outlet pipe assembly (30), wherein the inlet and outlet pipe assembly (30) is installed at both ends of the diaphragm assembly (20) and is used for input and output of liquid; A support mechanism (40) is installed at the bottom of the pump body and is used to adjust the level of the pump body.

2. The aseptic diaphragm pump according to claim 1, characterized in that: in, The central pump body (10) adopts an integrated structure of medical-grade stainless steel, and fixing bolt holes are evenly arranged on the outer circumference of the central pump body (10), and the outer surface of the central pump body (10) is processed by precision machining.

3. The aseptic diaphragm pump according to claim 1, characterized in that: in, The inlet and outlet pipe assembly (30) comprises a liquid inlet pipe (31), a liquid outlet pipe (32) and a connecting flange (33). One-way valve assemblies are provided in the liquid inlet pipe (31) and the liquid outlet pipe (32), and the connecting flange (33) is fixed by bolts.

4. The aseptic diaphragm pump according to claim 3, characterized in that: in, The support mechanism (40) comprises a base plate (41) and a multi-point support assembly (42); the multi-point support assembly (42) is provided with an adjustment device, and the adjustment device adopts a threaded locking structure.

5. The aseptic diaphragm pump according to claim 1, characterized in that: in, A pneumatic system is provided on both sides of the central pump body (10), the pneumatic system comprising an air intake interface (51), an air exhaust interface (52) and an air circuit control mechanism (53), and the air intake interface (51) and the air exhaust interface (52) are in the form of standard connectors.

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