Sterile diaphragm pump for organ perfusion

Abstract

The invention discloses a sterile diaphragm pump for organ perfusion, and belongs to the technical field of liquid pumps, the diaphragm pump comprises: a cylindrical central pump body for mounting other components; the two double-diaphragm assemblies are symmetrically installed on the two sides of the central pump body and used for achieving fluid conveying; the double-diaphragm assembly comprises a diaphragm body, a fixing ring and a sealing ring assembly; a plurality of micro grooves at equal intervals are formed between the inner side wall and the outer side wall of the sealing groove of the fixing ring in the circumferential direction; the cross section of each micro groove is in a parabola shape, the width from the inner side edge to the outer side edge of each micro groove is gradually reduced, and the depth from the inner side to the outer side of each micro groove is gradually reduced; the inlet and outlet connecting pipe assemblies are installed at the two ends of the diaphragm assembly and used for liquid input and output; the supporting mechanism is installed at the bottom of the pump body and used for adjusting the level of the pump body. According to the scheme, the local strain level of the sealing ring can be reduced while the sealing performance is guaranteed.

Description

Technical Field

[0001] The present application relates to the field of liquid pumps, and in particular 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 will increase by 5.8-8.4 degrees (Shore A scale) compared to the room temperature state, so that the actual contact stress between the sealing ring and the sealing groove exceeds the design value. At the same time, the flow rate needs to be adjusted in a wide range of 0.5-1200 ml / min during the perfusion process, which requires the diaphragm pump to maintain stable sealing performance at different speeds. When the flow rate is adjusted to a lower level (less than 1 ml / min), the reciprocating frequency of the pump body drops to 0.6-0.8 times / min, and the sealing ring is in a static compression state for a long time, which is easy to cause permanent compression deformation; under high flow conditions (greater than 1000 ml / min), the reciprocating frequency can reach 86-92 times / min, and the sealing ring will be repeatedly subjected to high-frequency shear loads. In addition, organ perfusion fluid contains a variety of amino acids, electrolytes and nutrients, and the pH value usually fluctuates in the range of 7.35-7.45. These media will have a certain degree of penetration and potential chemical effects on the sealing material. The traditional single material formula is difficult to simultaneously meet multiple requirements such as low-temperature elasticity, fatigue resistance, and chemical corrosion resistance.

[0003] During the perfusion process, in order to simulate the physiological environment of the human body, the perfusion pressure needs to be pulsated and adjusted within the range of 60-120 mmHg, and the pressure change cycle is usually 0.8-1.0 seconds. This rapid pressure fluctuation will produce transient stress concentration in the sealing contact area, and cause drastic changes in the local lubrication state. The traditional smooth sealing groove wall cannot maintain a stable fluid lubrication film under this working condition, and the strain energy of the circular cross-section sealing ring cannot be quickly released and redistributed, causing the stress state of the sealing area to be disordered. In addition, the organ perfusion device often needs to work continuously for 24-72 hours, and no sealing failure can occur during this period. In such a long period of continuous operation, the deformation accumulation and fatigue damage in the conventional sealing structure will gradually appear, especially in low temperature environments, the self-recovery ability of the sealing material will be significantly reduced, 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, a technical solution is urgently needed to reduce the local strain level of the sealing ring while ensuring the sealing performance. Summary of the invention

[0005] In order to solve the deficiencies of the prior art, the present application discloses a sterile diaphragm pump for organ perfusion. The present application solves the technical problems of the prior art such as disordered stress state in the sealing area.

[0006] The embodiment of the present application discloses a sterile diaphragm pump for organ perfusion, comprising: a central pump body, which is cylindrical and used to install 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 comprises 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 reinforcement layer and an outer protective layer, and the fixing ring is connected to the central pump body by bolts; wherein, a plurality of equally spaced micro grooves are arranged circumferentially between the inner wall and the outer wall of the sealing groove of the fixing ring; 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; an inlet and outlet pipe assembly, the inlet and outlet pipe assembly is installed at both ends of the diaphragm assembly for the input and output of liquid; a support mechanism, the support mechanism is installed at the bottom of the pump body for adjusting the level of the pump body.

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

[0008] In a 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, a middle reinforcement layer and an outer protective layer, and the fixing ring is connected to the central pump body by bolts.

[0009] In a 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, and a sealing groove structure is provided inside the fixing ring.

[0010] In a possible implementation, the inlet and outlet pipe assembly includes a liquid inlet pipe, a liquid outlet pipe and a connecting flange, a one-way valve assembly is provided in the liquid inlet pipe and the liquid outlet pipe, and the connecting flange is fixed by bolts.

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

[0012] In a possible implementation, a pneumatic system is provided on both sides of the central pump body, and the pneumatic system includes an air inlet interface, an exhaust interface and an air circuit control mechanism, and the air inlet interface and the exhaust interface are in the form of standard connectors.

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

[0014] In a possible implementation, a plurality of inverted conical microcavities are evenly arranged along the circumferential direction on the contact surface between the fixing ring and the sealing ring assembly; the opening of the inverted conical microcavity is arranged on the surface layer of the contact surface; and an angle inclined toward 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 above, the embodiment of the present application can achieve uniform distribution of contact stress while maintaining the original installation space by setting a microgroove array with specific parameters in the sealing groove and combining the sealing ring design with an asymmetric compound curve section. The parabolic cross-section of the microgroove and the accurately calculated depth gradient can disclose a controllable strain energy release space during the deformation of the sealing ring. The design of the asymmetric compound curve section reduces the local strain level of the sealing ring while ensuring the sealing performance through the synergistic effect of the inner arc segment, the middle transition segment and the outer compression segment, so that the sealing ring obtains more stable mechanical properties, especially exhibiting excellent compression permanent deformation characteristics in a wide temperature range. The setting of the annular microcavity 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, suppresses the fluid dynamic 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 embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0017] Figure 1 A side structural diagram of a diaphragm pump disclosed in an embodiment of the present application; Figure 2 It is a front view structural diagram of a diaphragm pump disclosed in an embodiment of the present application; Figure 3A top view of a diaphragm pump disclosed in an embodiment of the present application; Figure 4 A stress simulation comparison diagram of a sealing structure disclosed in an embodiment of the present application.

[0018] Figure numerals: 10, central pump body; 20, double diaphragm assembly; 30, inlet and outlet 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, air path control mechanism. DETAILED DESCRIPTION

[0019] Various exemplary embodiments of the present disclosure will now be described in detail with reference to the accompanying drawings. It should be noted that the relative arrangement of components and steps, numerical expressions and numerical values ​​set forth in these embodiments do not limit the scope of the present disclosure unless otherwise specifically stated.

[0020] Those skilled in the art can understand that the terms "first", "second" and the like 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 represent the necessary logical order between them. It should also be understood that in the embodiments of the present disclosure, "multiple" can refer to two or more, and "at least one" can 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, in the absence of explicit limitation or contrary revelation given in the context, it can generally be understood as one or more. In addition, the term "and / or" in the present disclosure is only a description of the association relationship of the associated objects, indicating that there can be three relationships, for example, A and / or B can represent: A exists alone, A and B exist at the same time, and B exists alone. In addition, the character " / " in the present disclosure generally indicates that the associated objects before and after are an "or" relationship. It should also be understood that the description of each embodiment in the present disclosure emphasizes the differences between the embodiments, and the same or similar parts can refer to each other. For the sake of brevity, they will not be repeated one by one.

[0021] At the same time, it should be understood that, for ease of description, the sizes of the various parts shown in the drawings are not drawn according to the actual proportional relationship. The following description of at least one exemplary embodiment is actually only illustrative and is by no means intended to limit the present disclosure and its application or use. The techniques, methods and devices known to ordinary technicians in the relevant fields may not be discussed in detail, but where appropriate, the techniques, methods and devices should be considered part of the specification. It should be noted that similar numbers and letters represent similar items in the following drawings, so once an item is defined in one drawing, it does not need to be further discussed in subsequent drawings.

[0022] In order to make the purpose, technical solution and advantages of the embodiments of the present application clearer, the technical solution in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0023] It should be understood that the systems shown in the figures are exemplary and non-restrictive. This means that the system architecture involved 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 related concepts and relationships, and does not exclude other forms of architecture. Therefore, when interpreting the architecture in the picture, it should be understood that the model is flexible and diverse, and its purpose is to disclose an exemplary description rather than a restrictive provision on a specific form.

[0024] like Figure 1-3 As shown, the embodiment of the present application discloses an aseptic pneumatic diaphragm pump, which is composed of a central pump body 10, a double diaphragm assembly 20, an inlet and outlet pipe assembly 30 and a support mechanism 40. Specifically, the pneumatic diaphragm pump adopts a symmetrical double diaphragm structure, which is mainly composed of a central pump body module, diaphragm assemblies on both sides, an inlet and outlet pipe system and a matching pneumatic drive device. The pump body is cylindrical as a whole, with drive air chambers symmetrically arranged on both sides and a fluid chamber in the middle.

[0025] Among them, the central pump body 10 is cylindrical and is used to install other components; two double diaphragm assemblies 20 are symmetrically installed on both sides of the central pump body 10 for realizing fluid transportation; the inlet and outlet pipe assemblies 30 are installed at both ends of the diaphragm assembly 20 for liquid input and output; the support mechanism 40 is installed at the bottom of the pump body for adjusting the level of the pump body.

[0026] The central pump body 10 adopts an integrated structure of medical grade stainless steel, and fixing bolt holes are evenly arranged on the outer periphery of the pump body for installing the diaphragm assembly. The pump body adopts an integrated design 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, and the whole is cylindrical with a wall thickness of about 2.8 mm, which has sufficient mechanical strength to withstand the working pressure. The outer shell surface is precision machined, and the surface roughness Ra≤0.4 microns to ensure good hygienic performance.

[0027] The diaphragm assembly 20 includes a diaphragm body 21, a fixing ring 22 and a sealing ring assembly 23. Two groups of diaphragm assemblies 20 are symmetrically installed on both sides of the central pump body 10. The diaphragm body 21 adopts a multi-layer composite structure design, including an inner medical-grade diaphragm sheet, an intermediate reinforcement layer and an outer protective layer. Preferably, each side of the double-layer diaphragm assembly is equipped with a group 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) diaphragm with a thickness of 0.38 mm; the middle layer is a reinforced 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 fastened to the central pump body 10 by bolts, and a special sealing groove structure is provided inside to cooperate with the sealing ring assembly 23 to achieve reliable sealing.

[0028] In one embodiment, the sealing ring assembly 23 adopts a double-pass sealing design, and the main sealing ring and the auxiliary sealing ring are made of different materials, and the sealing effect during the working process is ensured by a reasonable pre-compression rate. The sealing groove of the fixing ring 22 is precisely processed to ensure that the deformation of the sealing ring is within an appropriate range. Preferably, the edge of the diaphragm adopts a double-pass sealing ring structure; the main sealing ring is made of fluororubber with a cross-sectional diameter of 3.55 mm; the auxiliary sealing ring is made of EPDM with a cross-sectional diameter of 2.65 mm; the sealing groove depths are 3.75 mm and 2.85 mm respectively; the assembly pre-compression rate is 15.8%.

[0029] Furthermore, in order to improve the aseptic sealing effect of the sealing ring assembly 23, a progressive composite sealing structure can be used. First, a gradient-changing micro-groove array is set in the original sealing groove, and 156 equally spaced micro-grooves are arranged circumferentially. The width of each micro-groove is a gradual structure from the inside to the outside, with an inside width of 0.28 mm and an outside width of 0.21 mm. The depth gradually decreases from 0.12 mm on the inside to 0.06 mm on the outside. The cross section of the micro-groove adopts a parabolic 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).

[0030] 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.

[0031] 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.

[0032] 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.

[0033] 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.

[0034] An annular microcavity array is arranged in the contact area between the fixing ring 22 and the sealing ring assembly 23. 286 microcavities are evenly arranged along the circumference, each microcavity has an opening diameter of 0.14 mm, a depth of 0.23 mm, and an inverted cone shape with a cone angle of 16.8 degrees. The central axis of the microcavity is at an angle of 72.4 degrees to the horizontal plane, pointing in the direction of the medium cavity. When the sealing ring is deformed under pressure, these microcavities can accommodate part of the deformation volume and form a local pressure gradient.

[0035] It should be understood that in actual application environments, the traditional double-pass 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 wall of the sealing groove is uneven, resulting in local stress concentration; the friction heat generated by the sealing ring during the reciprocating motion cannot be effectively diffused, causing the local temperature of the sealing ring to rise, causing material performance degradation; the circular cross-section sealing ring has an uneven strain energy distribution in the pre-compression state, and lacks an effective strain energy release mechanism, resulting in a significant reduction in the service life of the sealing ring; the smooth wall of the sealing groove will have an unstable fluid lubrication film thickness during high-speed reciprocating motion, affecting the reliability of the seal; the sealing ring with a single material formula exhibits significant performance fluctuations over a wide temperature range (-45 to 180 degrees Celsius), especially when the temperature changes drastically, the elastic modulus and compression permanent deformation 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 in actual work, resulting in over-compression or under-compression in some areas. Based on the above technical problems, conventional sealing structures are difficult to meet the strict requirements of medical-grade pneumatic diaphragm pumps on sealing stability during long-term operation.

[0036] By setting a micro-groove array with specific parameters in the sealing groove and combining it with the sealing ring design of asymmetric compound curved cross-section, the uniform distribution of contact stress can be achieved while maintaining the original installation space. The parabolic cross-section of the micro-groove and the accurately calculated depth gradient can disclose a controllable strain energy release space during the deformation of the sealing ring. The design of the asymmetric compound curved cross-section reduces the local strain level of the sealing ring while ensuring the sealing performance through the synergistic effect of the inner arc section, the middle transition section and the outer compression section. The improved material formula and vulcanization process enable the sealing ring to obtain more stable mechanical properties, especially excellent compression permanent deformation characteristics in a wide temperature range. The setting of the annular microcavity 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 fluid dynamic 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, which significantly improves 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.

[0037] The inlet and outlet pipe assembly 30 includes a liquid inlet pipe 31, a liquid outlet pipe 32 and a connecting flange 33, and adopts a sanitary quick-release joint design, which is closely matched 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 one-way flow of the fluid.

[0038] 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 matched with the valve seat to ensure good sealing performance and sensitive action characteristics. The design of the valve assembly is easy to disassemble and clean, meeting hygiene requirements.

[0039] 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, which can adjust the levelness of the pump body according to the installation environment to ensure the smooth operation of the equipment. The support point is provided with a shock absorbing device to effectively reduce the operating vibration.

[0040] In one embodiment, the adjusting device adopts a thread locking structure to ensure that the adjusted position is stable and reliable. The shock absorbing device is made of medical grade materials and has good shock absorbing effect and durability.

[0041] The pneumatic system includes an air inlet interface 51, an exhaust interface 52 and an air circuit control mechanism 53. The air inlet and exhaust interfaces are in the form of standard joints, which is convenient for air circuit connection. The air circuit control mechanism is integrated on both sides of the central pump body, and the reasonable distribution of compressed air is achieved through precise air channels to drive the diaphragm to reciprocate. Preferably, the air inlet interface of the pneumatic drive chamber arranged symmetrically on both sides adopts a standard G1 / 4 thread, and the exhaust interface adopts a quick-connect connector with an outer diameter of 8 mm, and the air chamber working pressure range is 0.2-0.6MPa.

[0042] When the present invention is working, compressed air enters the air circuit control mechanism 53 through the air inlet interface 51, and enters the diaphragm chambers on both sides alternately 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 liquid through the liquid inlet pipe 31; at the same time, the right side is exhausted, the diaphragm returns to its position, and the liquid is pushed out from the liquid outlet pipe 32. By alternately filling and exhausting the left and right air chambers, the diaphragm is driven to reciprocate, realizing continuous and stable liquid transportation.

[0043] Specifically, the working process of the diaphragm pump can be divided into the following stages. 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 is exhausted at the same time, and the diaphragm returns to its original position under the action of elasticity; the right chamber forms a negative pressure, and the liquid is sucked in through the inlet check valve; the left outlet check valve is closed to prevent backflow. Discharge stage: the right air chamber is inflated, pushing the right diaphragm to move to the left; the left air chamber is exhausted, and the diaphragm returns; 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 transport. Reciprocating: The left and right air chambers are alternately inflated and exhausted, driving the diaphragm to reciprocate; the air path switching timing is controlled by the solenoid valve; forming a continuous liquid transport process.

[0044] During the liquid delivery process, the multi-layer composite diaphragm structure ensures good mechanical strength and chemical stability, and the double-channel sealing design effectively prevents medium leakage. The flow channel is optimized through fluid dynamics to ensure delivery efficiency and stability. The central fluid chamber and the flow channel system coordinate to ensure the continuity of fluid delivery.

[0045] The present invention adopts a modular design concept, and key components can be independently disassembled and maintained. The replacement operation of the diaphragm assembly 20 is simple, and the sealing ring assembly 23 adopts standard specifications, which is convenient for maintenance and replacement. Regular maintenance mainly checks the integrity of the diaphragm, the status of the sealing ring and the action of the one-way valve. The embodiment of the present application adopts multiple sealing measures to ensure aseptic performance. Diaphragm seal: The outer ring adopts a boss extrusion sealing structure, the sealing surface roughness Ra≤0.2 microns, and the sealing ring adopts a pre-compression design with a deformation of 0.62 mm. Axial sealing: A step groove sealing structure is adopted, the cross-sectional shape of the sealing ring is D-type, and the assembly clearance is controlled in the range of 0.08-0.12 mm. Dynamic sealing: The diaphragm relies on its own elasticity to maintain sealing during movement, and the edge is fixed by a multi-point uniformly distributed clamping method, and the clamping force is precisely controlled by the bolt preload.

[0046] In terms of cleaning and disinfection, the present invention adopts an in-situ cleaning and sterilization design, and all liquid contact surfaces can be completely cleaned and sterilized. Through effective diaphragm isolation, the driving gas and the conveying medium are completely isolated, meeting the sterility requirements of medical devices. In the working state, the equipment runs smoothly with little vibration, which is suitable for long-term stable operation in the medical environment.

[0047] Figure 4 This is a stress simulation comparison diagram of a sealing structure disclosed in the embodiment of this application. The simulation analysis of the stress distribution of the sealing structure uses actual engineering parameters for modeling and calculation, and combines the specific dimensions and process parameters in the original text to conduct an in-depth analysis of the stress state of the sealing system. The left figure shows the overall stress distribution of the main sealing ring in the pre-compression state, while the right figure focuses on the local stress characteristics of the microcavity array area.

[0048] In terms of stress distribution of the main seal ring, based on the original parameters that the main seal ring is made of fluororubber and has a cross-sectional diameter of 3.55 mm, the stress state under the non-uniform pre-compression scheme was simulated and analyzed. By dividing the circumference into 24 equal areas, applying a pre-compression rate of 16.8% in the odd-numbered areas and a pre-compression rate of 14.6% in the even-numbered areas, an alternating basic stress field is formed. This design corresponds to the clamping torque control (15.6-16.2 Nm) performed by a precision screw mechanism during the actual assembly process.

[0049] On this basis, the model integrates the influence of 156 equally spaced micro grooves. The width of each micro groove gradually changes from 0.28 mm on the inside to 0.21 mm on the outside, and the depth gradually changes from 0.12 mm on the inside to 0.06 mm on the outside. It can be observed from the stress cloud map that this gradual structure produces a continuous stress transition zone in the radial direction, effectively avoiding sudden stress changes. The parabolic cross section of the micro groove (in accordance with the equation y=0.126-0.068(x / 0.286) 2.42 ) makes the stress present a smooth distribution feature in the groove area.

[0050] The right figure focuses on the stress distribution characteristics of the microcavity array area. Based on the 286 annular microcavity parameters 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 was simulated and analyzed. The central axis of each microcavity maintains an angle of 72.4 degrees with the horizontal plane, pointing in the direction of the medium cavity. It can be clearly seen from the stress cloud map that the microcavity structure forms a regular stress distribution network under pressure, which discloses an effective stress release path for the deformation of the sealing ring.

[0051] The asymmetric compound curve structure (inner arc radius 1.42 mm, center offset 0.18 mm) used in the sealing ring shows unique characteristics in stress distribution. Especially in the middle transition section, the cubic spline curve control point coordinates [(0,0), (0.642,0.324), (1.246,0.526), ​​(1.864,0.608)] make the stress maintain a continuous and smooth change in the transition area. The elliptical arc design (long axis 1.98 mm, short axis 1.64 mm, inclination angle 7.2 degrees) used in the outer clamping section ensures a good fit with the sealing groove.

[0052] The design of the fine spiral groove (pitch 0.38 mm, groove depth 0.04 mm, groove width 0.06 mm) is shown as a series of regular stress fluctuations in the stress distribution diagram. The asymmetric design of the 62.4-degree bevel angle on the side facing the working medium and the 43.6-degree bevel angle on the side away from the working medium produces the expected reverse pressure gradient effect when the pump body is running in the forward direction. This design cooperates with the improved formula of the sealing ring material (increasing the fluorine content by 8.6% and adding 1.8% of medical-grade nano-silica filler) to disclose the necessary dynamic compensation capability while maintaining the sealing performance.

[0053] From the perspective of overall stress distribution, the new sealing structure achieves effective control and reasonable distribution of stress. The microcavity array can not only accommodate the deformation volume when the sealing ring is deformed under pressure, but also enhance the contact quality of the sealing surface through the formation of local stress gradients. With precise assembly technology (such as the use of 24 sets of independently adjustable clamping blocks, a screw lead of 0.75 mm, and an adjustment dial graduation value of 0.01 mm), the sealing structure can maintain a stable and reliable sealing effect in the actual working environment.

[0054] Furthermore, an embodiment of the present application also discloses a device for optimizing a sealing ring, comprising: a processor, a memory, and a system bus; the processor and the memory are connected via the system bus; the memory is used to store one or more programs, and the one or more programs include instructions, which, when executed by the processor, enable the processor to execute any of the above methods.

[0055] It can be known from the description of the above implementation mode that those skilled in the art can clearly understand that all or part of the steps in the above-mentioned embodiment method 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 can be essentially or partly embodied in the form of a software product that contributes to the prior art. The computer software product can be stored in a storage medium such as ROM / RAM, a disk, an optical disk, etc., including several instructions for enabling 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 the various embodiments of the present application or certain parts of the embodiments.

[0056] It should be noted that the various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments, and the same or similar parts between the various embodiments can be referred to each other. For the device disclosed in the embodiment, since it corresponds to the method disclosed in the embodiment, the description is relatively simple, and the relevant parts can be referred to the method part description.

[0057] It should also be noted that, in this article, relational terms such as first and second, etc. 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 terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the sentence "comprise a ..." do not exclude the presence of other identical elements in the process, method, article or device including the elements.

[0058] 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 apparent to those skilled in the art, and the general principles defined herein may 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 conform to 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 of the 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 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 in a parabolic shape, the width of the micro groove from the inner side edge to the outer side edge is arranged in a decreasing manner, and the depth of the micro groove from the inner side to the outer side is arranged in a decreasing manner; 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 sealing ring assembly (23) comprises a main sealing ring and a secondary sealing ring, the main sealing ring and the secondary sealing ring are made of different materials, and a sealing groove structure is provided inside the fixing ring (22).

4. 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.

5. The aseptic diaphragm pump according to claim 4, 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.

6. 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.

7. The aseptic diaphragm pump according to claim 1, characterized in that: in, An eccentric arc-shaped inner arc segment is set 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 through 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.

8. The aseptic diaphragm pump according to claim 1, characterized in that: in, A plurality of inverted cone microcavities are evenly arranged along the circumferential direction on the contact surface between the fixing ring and the sealing ring assembly; the opening of the inverted cone microcavity is arranged on the surface layer of the contact surface; and an angle inclined toward the medium cavity is formed between the axis of the inverted cone microcavity and the horizontal plane.

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