Differential combination T mixer for LNP preparation

Abstract

The utility model discloses a differential combination T mixer for LNP preparation, which belongs to the field of micro-fluidic mixers for small-scale test, pilot-scale test amplification and production of LNP preparation and comprises a central connecting module, a connecting bolt and a liquid inlet and outlet module. According to the differential combination T mixer, the pipe diameter sizes and lengths of three different flow paths can be configured according to the flow velocity of a two-phase solution and the total flow velocity, compared with a traditional T mixer, the standby pressure of the whole system can be reduced, and the production speed and efficiency are improved; in the step-by-step amplification process, liquid inlet and outlet modules are flexibly switched, the Reynolds coefficient or standby pressure of each flow path is kept unchanged, and rapid LNP linear amplification is achieved. And more flexible selection can be carried out according to batch, flow velocity, repeated use or not and the like, the whole body can be made of metal materials (such as stainless steel, titanium alloy, hastelloy and the like) or plastic materials (PEEK, PTFE and the like), and different production requirements can be flexibly met.

Description

TECHNICAL FIELD

[0001] The utility model relates to LNP preparation small -scale, pilot -scale and production use micro -fluidic mixer field, especially a difference combination T mixer for LNP preparation. BACKGROUND

[0002] At present, the small -scale test of LNP preparation adopts micro -fluidic channel (tes l a, nexgen structure) mixer, and the small -scale mixer material is mostly plastic (such as COC etc.). And the T-mi xer (junct i on, connector) is adopted by many listed production product companies, and the material is mostly stainless steel, and the inner diameter and length of the three flow paths are all the same size.

[0003] The micro -fluidic mixer used in the small -scale test of LNP preparation has small aperture and complex internal structure, so that the standby pressure generated by the system pump is large, and the application on the high flow rate large -scale LNP preparation cannot be realized. It cannot realize effective and rapid amplification. The internal structure is also fixed, and the flexibility is poor.

[0004] The T-mi xer for production, the internal aperture of the three pipes of T is consistent, and in order to obtain LNP with particle size, PDI and encapsulation rate meeting the requirements, the three apertures and lengths of the T-mi xer used in the current listed products are fixed (and in order to prepare LNP with small enough particle size, the inner diameter size of the three channels is less than 1mm), the flow rate is high, the standby pressure is large, the single pump pressure is limited, and the flow rate cannot be increased, which limits the flow rate of the single pump system, and leads to the production mode of LNP prepared by using multiple pump systems + multiple mixers in parallel (sca l e-out). First, the performance difference between the parallel preparation pumps or the abnormality of a certain pump or pump group will lead to poor sample uniformity or failure of the whole batch of samples. Secondly, the control required by the multiple pump system + multiple mixer production is more complex, and there are more process risk points or quality control points, so that the overall complexity of production is improved, and the risk of production error or failure is greatly improved. UTILITY MODEL CONTENTS

[0005] The utility model discloses a difference combination T mixer for LNP preparation. The technical scheme of the utility model for realizing the above-mentioned purpose is as follows: a difference combination T mixer for LNP preparation, comprising a center connecting module, connecting bolts and inlet and outlet liquid modules, characterized in that the inlet and outlet liquid modules are respectively located on the upper, left and right three surfaces of the center connecting module, the connecting bolts pass through the inlet and outlet liquid modules and are connected with the inlet and outlet liquid modules and the center connecting module through thread engagement, and the inlet and outlet liquid modules are connected through the connecting bolts.

[0006] The center connecting module comprises a center block, three pipeline channels and connecting holes, the center block is internally provided with three pipeline channels, the three pipeline channels are in T shape, the center block is provided with connecting holes on the side surface, and the connecting holes are respectively located on both sides of the three pipeline channels and are connected with connecting bolts through thread engagement;

[0007] The inlet and outlet module comprises a first-stage superposition block, a second-stage superposition block, flow channels, through holes and superposition holes, the first-stage superposition block is internally provided with flow channels, the second-stage superposition block is internally provided with flow channels, the flow channels are located at the positions consistent with the positions of the pipe openings of the three pipeline channels, the protrusions on the first-stage superposition block are inserted into the center connecting module, the first-stage superposition block is provided with through holes, the second-stage superposition block is provided with through holes, the connecting bolts pass through the through holes and are connected with the through holes through thread engagement, and the superposition holes are located on the first-stage superposition block and the second-stage superposition block and are connected with the connecting bolts through thread engagement.

[0008] Further, the center connecting module and the inlet and outlet module are provided with embedded sealing rings, the embedded sealing rings are fixedly installed at the pipe openings of the three pipeline channels and the end portions of the flow channels.

[0009] Further, the inlet and outlet module is provided with a recess, the recess is arranged on the inlet and outlet module and is located in correspondence with the through holes.

[0010] Further, the center connecting module is in the shape of a cube.

[0011] Further, the sharp edges of the center connecting module and the inlet and outlet module are chamfered.

[0012] Beneficial effects:

[0013] The utility model provides a difference combination T mixer for LNP preparation has the following beneficial effect, the device passes through its structure design, when preparing LNP, first utilize connecting bolt and install three first -level superposition piece respectively in the upper, left, right three sides of center connection module, the protruding portion on the first -level superposition piece is inserted in the center connection module, and the connecting bolt is passed through the through -hole on the first -level superposition piece and is connected with the through -hole and the connecting hole on the center block and is engaged to connect the first -level superposition piece with the center connection module, according to the actual flow rate difference of three -way liquid, the inlet and outlet liquid module with corresponding aperture's flow channel is matched, wherein the pipeline of high flow rate pipeline channel matches the flow channel with big inner diameter, the pipeline of low flow rate pipeline channel matches the flow channel with small inner diameter, the pressure of the fluid generated in each pipeline of three pipeline channels is basically identical, and the pressure of the high flow rate pipeline does not appear too high, and the requirement of pump system hardware can be reduced, so that the overall preparation flow rate and batch can be improved.

[0014] When the pipeline length required by the preparation process needs to be adjusted, the connecting bolt is screwed into the through-hole on the second -level superposition block and is engaged with the superposition hole on the first -level superposition block on the side surface of the center connection module, so that the inlet and outlet liquid modules are stacked with each other, the length and direction of the flow channel are adjusted, and the length of the pipeline can match different preparation process requirements.

[0015] When preparing, the liquid is fed from the flow channel in the two inlet and outlet liquid modules, the liquid is mixed in the middle of the three pipeline channels of the center connection module, and the mixed liquid flows out from the flow channel of another inlet and outlet liquid module, and the preparation is completed.

[0016] The flexible switching of the inlet and outlet liquid modules covers a wider LNP preparation flow rate and batch, and can be used for small -scale LNP preparation and LNP high -flow production amplification, and can be used for small -batch LNP sample production (such as personalized tumor vaccine) and can be used for rapid preparation of large -batch samples (such as preventive vaccine, which can respond and cope with infectious diseases faster) ;

[0017] The center connecting module and the liquid inlet and outlet module can adopt metal materials such as stainless steel, titanium alloy, Hastelloy, etc. (but not limited to), and can also adopt plastic materials such as PEEK and PTFE (but not limited to), which can flexibly match various different production requirements. The metal materials can be subjected to dry heat sterilization, and the PEEK and PTFE can be subjected to irradiation sterilization. The selection can be more flexible according to batch, flow rate, and whether to be reused or not. BRIEF DESCRIPTION OF DRAWINGS

[0018] Figure 1 is a structural schematic view of a differential combination T mixer for LNP preparation according to the utility model;

[0019] Figure 2 is an exploded structural schematic view of a differential combination T mixer for LNP preparation according to the utility model;

[0020] Figure 3 is a structural schematic view of a center connecting module according to the utility model;

[0021] Figure 4 is a front structural schematic view of a first-stage superposition block according to the utility model;

[0022] Figure 5 is a structural schematic view of a second-stage superposition block according to the utility model;

[0023] Figure 6 is a back structural schematic view of a first-stage superposition block according to the utility model;

[0024] Figure 7 is a sectional view of a three-pipeline channel and a flow channel according to the utility model;

[0025] Figure 8 is a sectional view of a connecting bolt according to the utility model.

[0026] In the figure, 1 is a center connecting module; 2 is a connecting bolt; 3 is a liquid inlet and outlet module; 4 is an embedded sealing ring; 5 is a groove; 10 is a center block; 11 is a three-pipeline channel; 12 is a connecting hole; 30 is a first-stage superposition block; 301 is a second-stage superposition block; 31 is a flow channel; 32 is a through hole; and 33 is a superposition hole. DETAILED DESCRIPTION

[0027] The technical solutions in the embodiments of the utility model will be clearly and completely described below with reference to the drawings in the embodiments of the utility model. Obviously, the described embodiments are only part of the embodiments of the utility model, rather than all the embodiments. Based on the embodiments in the utility model, all other embodiments obtained by those skilled in the art without creative labor fall within the protection scope of the utility model.

[0028] In the description of the utility model, it needs to explain, the term "upper / lower end", "internal", "external" "front end", "rear end", "both ends", "one end", "the other end" and so on indicate the position relation or position relation is based on the position relation or position relation shown in the drawing, only for the convenience of describing the utility model and simplifying the description, and not indicate or imply that the device or element indicated must have a particular orientation, construct and operate with a particular orientation, therefore cannot be understood as the limitation of the utility model. In addition, the term "first", "second" is only for the purpose of description, and cannot be understood as indicating or implying relative importance.

[0029] In the description of the utility model, it needs to explain, unless otherwise expressly provided and limited, the term "installation", "set / set with", "sleeve joint", "connection" and so on, should be broad understanding, for example, "connection", can be fixed connection, can also be detachable connection, or integrally connected;Can be mechanical connection, can also be electrical connection;Can be directly connected, can also be indirectly connected through intermediate medium, can be the communication inside two elements. For ordinary skilled in the art, the specific meaning of the above-mentioned terms in the utility model can be understood according to the specific circumstances.

[0030] Please refer to Figures 1-8 The utility model provides a kind of technical scheme: a difference combination T mixer for LNP preparation, including center connection module 1, connecting bolt 2, inlet and outlet module 3, it is characterized in that, inlet and outlet module 3 are located respectively on the left, right three faces of center connection module 1, connecting bolt 2 passes through inlet and outlet module 3 and is connected with inlet and outlet module 3 and center connection module 1 by thread engagement, inlet and outlet module 3 are connected by connecting bolt 2 between;

[0031] Center connection module 1 includes center block 10, three pipe channels 11 (three directions channel internal diameter is consistent), connecting hole 12, three pipe channels 11 are opened in center block 10, three pipe channels 11 are T-shaped, connecting hole 12 is opened in the side of center block 10, connecting hole 12 is located respectively on both sides of three pipe channels 11 and is connected with connecting bolt 2 by thread engagement;

[0032] The inlet and outlet liquid module 3 comprises a first level superposition block 30, a second level superposition block 301, a flow channel 31, a through hole 32, a superposition hole 33, the first level superposition block 30 has a protruding pipeline part, the flow channel 31 is opened in the first level superposition block 30, the length and the outer diameter of the protruding pipeline part are fixed and matched with the center block 10 and the three-pipeline channel 11, the flow channels 31 of the three first level superposition blocks 30 converge at the center point of the center block 10 after the three first level superposition blocks 30 are inserted into the center block 10, the flow channel 31 is opened in the second level superposition block 301, the position of the flow channel 31 is consistent with the position of the pipe opening of the three-pipeline channel 11, the protruding position on the first level superposition block 30 is inserted into the center connection module 1, the through hole 32 is opened on the first level superposition block 30, the through hole 32 is opened on the second level superposition block 301, the connecting bolt 2 passes through the through hole 32 and is connected with the through hole 32 through thread engagement, and the superposition hole 33 is located on the first level superposition block 30 and the second level superposition block 301 and is connected with the connecting bolt 2 through thread engagement.

[0033] In the utility model, the center connection module 1 and the inlet and outlet liquid module 3 are provided with the embedded sealing ring 4, the embedded sealing ring 4 is fixedly installed at the pipe opening of the three-pipeline channel 11 and the end of the flow channel 31, the embedded sealing ring 4 on the center connection module 1 and the inlet and outlet liquid module 3 improves the sealing property, and prevents liquid from flowing out from the gap.

[0034] In the utility model, the recess 5 is arranged on the inlet and outlet liquid module 3 and corresponds to the through hole 32, the recess 5 at the corresponding position of the through hole 32 makes the upper plane of the connecting bolt 2 lower than the plane of the inlet and outlet liquid module 3 after being screwed, and the close connection between every two inlet and outlet liquid modules 3 is guaranteed.

[0035] In the utility model, the center connection module 1 is a cube, the six faces of the cube-shaped center connection module 1 are all squares, and the size of the inlet and outlet liquid module 3 is more conveniently manufactured.

[0036] In the utility model, the sharp parts of the center connection module 1 and the inlet and outlet liquid module 3 are chamfered, the sharp parts are prevented from hurting the user by mistake, and the safety of the user is protected.

[0037] In the present embodiment: when preparing LNP, first install three first-level superposition blocks 30 on the upper, left and right sides of the center connection module 1 respectively by using connecting bolts 2, the protruding part on the first-level superposition block 30 is inserted into the center connection module 1, the connecting bolt 2 penetrates the through hole 32 on the first-level superposition block 30 and engages with the through hole 32 and the connecting hole 12 on the center block 10 to connect the first-level superposition block 30 and the center connection module 1, according to the actual flow rate of the three liquid, the inlet and outlet liquid module 3 with corresponding pore size is matched, among them, the pipeline with high flow rate matches the flow channel 31 with large inner diameter, the pipeline with low flow rate matches the flow channel 31 with small inner diameter, the pressure generated by the fluid in each pipeline of the three pipeline channels 11 is basically consistent, and there is no restriction of small short board, so that the overall preparation flow rate and batch can be improved. But still can keep its preparation LNP particle size, PDI, encapsulation rate, and structure unchanged. The center connection module 1 and the inlet and outlet liquid module 3 can be selected from metal materials or plastic materials, and various sterilization methods can be used.

[0038] When the pipeline length required by the preparation process needs to be adjusted, the connecting bolt 2 is screwed on the through hole 32 on the second-level superposition block 301 and engages with the superposition hole 33 on the first-level superposition block 30 on the side of the center connection module 1, so as to stack the inlet and outlet liquid modules 3 with each other, adjust the length and direction of the flow channel 31, and make the length of the pipeline match the different preparation process requirements. The recess 52 at the corresponding position of the through hole 32 makes the upper plane of the connecting bolt 2 lower than the plane of the inlet and outlet liquid module 3 after the connecting bolt 2 is screwed, so as to ensure the close connection between every two inlet and outlet liquid modules 3.

[0039] When preparing, the liquid flows into the flow channel from the two inlet and outlet liquid modules 3, the liquid converges in the middle of the three pipeline channels 11 of the center connection module 1, the embedded sealing ring 4 on the center connection module 1 and the inlet and outlet liquid module 3 improves the sealing performance to prevent the liquid from flowing out of the gap, and the mixed liquid flows out of the flow channel 31 of the other inlet and outlet liquid module 3, completing the preparation.

[0040] It is to be noted that, in the present document, relational terms such as first and second and the like can be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises", "comprising", or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but can include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element proceeded by "comprises a... " does not, without more constraints, foreclose the existence of additional identical elements in the process, method, article, or apparatus that comprises the element.

[0041] While embodiments of the present application have been shown and described with reference to the figures, it will be understood by those of ordinary skill in the art that various changes, modifications, substitutions and alterations can be made thereto without departing from the spirit and scope of the present application, which should be limited only by the scope of the appended claims and the equivalents thereof.

Claims

1. A differential combination T mixer for LNP preparation, comprising a center connection module (1), a connection bolt (2), an inlet and outlet liquid module (3), characterized in that, The inlet and outlet liquid module (3) is respectively located on the left, right three surfaces of the center connecting module (1), the connecting bolt (2) passes through the inlet and outlet liquid module (3) and is connected with the inlet and outlet liquid module (3) and the center connecting module (1) through thread engagement, and the inlet and outlet liquid modules (3) are connected through the connecting bolt (2); The center connecting module (1) comprises a center block (10), three pipeline channels (11) and connecting holes (12), the center block (10) is internally provided with three pipeline channels (11), the three pipeline channels (11) are in the shape of T, the center block (10) is provided with connecting holes (12) on the side surface, the connecting holes (12) are respectively located on the two sides of the three pipeline channels (11) and are connected with the connecting bolt (2) through thread engagement; The inlet and outlet liquid module (3) comprises a first level superposition block (30), a second level superposition block (301), a flow channel (31), a through hole (32) and a superposition hole (33), the first level superposition block (30) is internally provided with a flow channel (31), the second level superposition block (301) is internally provided with a flow channel (31), the flow channel (31) is located at the position consistent with the pipe opening of the three pipeline channels (11), the protruding position on the first level superposition block (30) is inserted into the center connecting module (1), the first level superposition block (30) is provided with a through hole (32), the second level superposition block (301) is provided with a through hole (32), the connecting bolt (2) passes through the through hole (32) and is connected with the through hole (32) through thread engagement, and the superposition hole (33) is located on the first level superposition block (30) and the second level superposition block (301) and is connected with the connecting bolt (2) through thread engagement.

2. A differential combination T-mixer for LNP preparation according to claim 1, characterized in that, The center connecting module (1) and the inlet and outlet liquid module (3) are provided with embedded sealing rings (4), and the embedded sealing rings (4) are fixedly installed at the pipe openings of the three pipeline channels (11) and the end portions of the flow channels (31).

3. A differential combination T-mixer for LNP preparation according to claim 1, characterized in that, The inlet and outlet liquid module (3) is provided with a groove (5), and the groove (5) is arranged on the inlet and outlet liquid module (3) and corresponds to the through hole (32).

4. The differential combination T-mixer for LNP preparation of claim 1, wherein, The center connecting module (1) is in the shape of a cube.

5. The differential combination T-mixer for LNP preparation of claim 1, wherein, The sharp portions of the center connecting module (1) and the inlet and outlet liquid module (3) are chamfered.

Images