Disposable sterile connector used in non-sterile environment

By designing a sterile connector including connectors, protective covers, pull blocks and barrier membranes, the problem that hose connection cannot be guaranteed to be sterile in a non-sterile environment is solved, and sterility in a non-sterile environment is achieved The connection is isolated from the microorganisms, ensuring the sterile state in the hose after connection.

CN222277807UActive Publication Date: 2024-12-31JIANGSU BAITAI PHARM EQUIP TECH CO LTD
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Patent Information

Application Number
CN202420487449.4
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-03-12
Publication Date
2024-12-31
Estimated Expiration
2034-03-12

AI Technical Summary

Technical Problem

During the production stage of biopharmaceutical companies, when connecting hoses in a non-sterile environment, it is impossible to ensure that the hoses are sterile after connection. The risk of bacteria infection caused by failure of traditional connectors in a sterile environment.

Method used

Design a disposable sterile connector for use in non-sterile environments, including connectors, protective covers, pull blocks and barrier membranes, and achieve sterile connections in non-sterile environments through snap connections and elastic parts. And isolate microorganisms through a composite membrane to prevent contamination of the inner cavity of the joint cover.

Benefits of technology

A sterile connection is achieved in a non-sterile environment to ensure that the hose is sterile after connection, effectively isolate microorganisms, prevent contamination of the cavity of the joint cover, and ensure sterile isolation.

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Abstract

The disposable sterile connector used in the non-sterile environment comprises a connector piece, a protective cover, a pull block and a barrier film, the connector piece is connected with the protective cover in a buckled mode, the connector piece is provided with a fluid channel, one end of the fluid channel is provided with a pipeline connector, the other end of the fluid channel is a butt joint face, and a round hole is formed in the middle of the butt joint face and used for containing a sealing ring. The sealing ring partially protrudes out of the butt joint face, a lower groove is formed in one side of the butt joint face, the pull block is connected with the lower groove in a clamped mode, part of the pull block is exposed to the outer side of the connector piece, and the barrier film is arranged in a folded mode and comprises a first barrier face and a second barrier face. When the sterile connector is used, the protective cover and the connector piece are detached in a clamping mode, the protective cover is taken down, the two sterile connectors with the protective covers detached are in butt joint in a buckling mode, the pull block is clenched and pulled out in the indicating direction to remove the barrier film, operation is completed, and the sterile connector can achieve sterile connection in a non-sterile environment.
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Description

Technical Field

[0001] The utility model relates to the technical field of biomedical auxiliary processes, in particular to a disposable sterile connector used in a non-sterile environment. Background Art

[0002] During the production phase of biopharmaceutical companies, sensitive liquids are often transferred between equipment or containers. At this time, a hose is considered to connect the two containers for transfer out and transfer in. Before the transfer, the two containers are generally separated, and the hoses extending from the two containers need to be connected. Such hose connections mostly need to be made in a non-sterile environment.

[0003] Traditional connectors require sterilization of the environment and the surfaces of both connectors before docking to ensure that the hose is sterile after docking, and there is still a certain chance of operation failure leading to contamination. This type of connector cannot ensure the sterility of the hose after connection when docked in a non-sterile environment. Utility Model Content

[0004] In view of the above situation, it is necessary to provide a disposable sterile connector for use in a non-sterile environment to address the problem in the prior art that docking in a non-sterile environment cannot ensure the sterility of the hose after connection.

[0005] A disposable sterile connector for use in a non-sterile environment, comprising a connector, a protective cover, a pull block and a barrier film, wherein the connector is snap-connected to the protective cover, the connector is provided with a fluid channel, one end of the fluid channel is provided with a docking joint, and the other end is a docking surface, a circular hole is provided in the middle of the docking surface for accommodating a sealing ring, the sealing ring partially protrudes from the docking surface, a lower groove is provided on one side of the docking surface, the pull block is snap-connected to the lower groove, a portion of the pull block is exposed on the outside of the connector, the barrier film is folded, the barrier film comprises a first barrier surface and a second barrier surface, the first barrier surface is pressed by the lower surface of the protective cover, the second barrier surface is fitted with the docking surface, and one end of the first barrier surface is fixedly connected to the pull block.

[0006] In the utility model, two sterile connectors need to be docked and used together to form a disposable sterile connector. First, the protective cover and the connector are removed, and the protective cover is taken off. The two sterile connectors with the protective covers removed are docked by snapping. At this time, the parts of the two pull blocks exposed on the outside of the connector are on the same side. Two fingers are used to pinch and pull the pull block outward from the lower groove. At the same time, the pull block also pulls the barrier membrane outward. The two partially raised sealing rings abut against each other, and the docking surfaces of the two connectors are docked with each other. A complete channel is formed on the docking of the fluid channels. Therefore, the utility model can be used to achieve sterile connection in a non-sterile environment.

[0007] Furthermore, in the disposable sterile connector used in a non-sterile environment, the connector also includes a first snap-on female component and a first snap-on male component, the first snap-on female component and the first snap-on male component are arranged on both sides of the docking surface, the lower groove is provided with a through groove, an elastic component is arranged in the through groove, one end of the elastic component is fixed to one side of the through groove, and a convex portion extends from the other end of the elastic component, the convex portion is suspended in the through groove so that the convex portion can move up and down in the through groove, the convex portion extends upward in the vertical direction into the pull block, and a snap-on groove is provided on one side of the lower groove.

[0008] In the utility model, a single sterile connector, a first snap female component and a first snap male component are snapped together with a protective cover, and two sterile connectors need to be snapped together to form a disposable sterile connector. A single protrusion can prevent a single pull block from being directly pulled out by mistake, because the protrusion only extends into the first through hole. After the two connectors are snapped together, the fixed boss squeezes the protrusion to disengage it from the first through hole. The range of movement of the protrusion is the depth of the first through hole, and the through groove is extended into an arc shape in the direction away from the lower groove. While increasing the downward pressure range of the protrusion, the stress at the connection between the elastic member and the through groove can also be reduced.

[0009] Furthermore, in the disposable sterile connector for use in a non-sterile environment, the pull block includes a fixed end and a handle end, a strip hole matching the width of the barrier membrane is provided on one side of the fixed end, a fixed boss and a first through hole are provided on the side of the strip hole away from the handle end, the opening size of the first through hole is sufficient to accommodate the fixed boss, the first through hole is matched with the convex portion, a snap-in groove edge is provided on the outer side of the fixed end, the snap-in groove edge is matched with the snap-in groove, and a handle is provided on one side of the handle end.

[0010] In the utility model, a single sterile connector, the convex portion extends into the first through hole, the edge of the snap-in groove is snap-fitted with the snap-in groove, and the pull block is fixed to the connector. When two sterile connectors are docked and used in coordination, after the first snap female component and the first snap male component are snap-fitted with each other, the fixed boss just passes through the first through hole to squeeze the convex portion to make it move up and down and thus away from the first through hole. Two fingers clamp the handle to drive the entire pull block to move along the edge of the snap-in groove. When it is away from the edge of the snap-in groove, the pull block is separated from the connector.

[0011] Furthermore, in the disposable sterile connector used in a non-sterile environment, the barrier membrane also includes a first bending surface and a second bending surface extending from both ends of the first barrier surface, the two ends of the second bending surface are respectively connected to the first barrier surface and the second barrier surface, the first bending surface passes through the strip hole and forms a first extension surface in a direction away from the first barrier surface, a second through hole and a third through hole are respectively provided on one side of the first barrier surface, the second through hole is adapted to the convex portion, the third through hole is adapted to the fixed boss, the fixed boss extends out of the barrier membrane in a vertical direction and extends to the protective cover and is partially exposed, and the first extension surface is hot-melt fixed to the bottom of the pull block.

[0012] In the utility model, the third through hole is penetrated by the fixed boss, the second bent surface is fully covered with the joint piece, the first extended surface is hot-melt fixed to the bottom of the pull block, and the second barrier surface is respectively adhered to the docking surface and the sealing ring and hot-melt fixed to the docking surface, so that the docking surface is in a completely sealed environment of the barrier film. When the pull block drives the barrier film away from the docking piece, the second bent surface connected to the first barrier surface is continuously unfolded in the direction of being pulled out, so that the second barrier surface is also disengaged from the docking surface, and finally the handle is guaranteed to pull out the barrier film completely.

[0013] Furthermore, in the disposable sterile connector used in a non-sterile environment, the protective cover includes a platform portion, and a first handle and a second handle are respectively provided on both sides of the platform portion, and a second snap-on female component and a second snap-on male component are respectively provided at the lower ends of the first handle and the second handle, and the first snap-on female component is respectively adapted to the first snap-on male component and the second snap-on male component, and the first snap-on male component is adapted to the second snap-on female component.

[0014] In the utility model, the second snap female component and the second snap male component can be disengaged from the first snap female component and the first snap male component through the first handle and the second handle respectively, thereby separating the protective cover from the connector. A disposable sterile connector is required to be formed, and the two sets of first snap female components and first snap male components are respectively correspondingly connected.

[0015] Furthermore, in the disposable sterile connector used in a non-sterile environment, one end of the platform portion partially extends downward to form a second extension surface to fit and cover the second bending surface, and the other end of the platform portion partially extends downward to form a third extension surface to cover the first barrier surface and the first bending surface, and a fourth through hole is provided on one side of the platform portion, and the fourth through hole is adapted to the fixed boss.

[0016] In the utility model, the second extension surface is completely fitted with the outer side of the joint member, and the fixing boss extends toward the fourth through hole.

[0017] Furthermore, the disposable sterile connector used in a non-sterile environment includes the barrier film being a composite film.

[0018] In the utility model, the barrier film is a composite film, and when the protective cover is removed, microorganisms are effectively isolated in a daily environment, and contamination of the inner cavity of the joint cover is prevented, thereby achieving aseptic isolation. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 It is a schematic diagram of the overall structure of the sterile connector in the first embodiment of the utility model.

[0020] Figure 2 It is an overall exploded schematic diagram of the aseptic connector in the first embodiment of the utility model.

[0021] Figure 3 It is a schematic diagram of the butt joint structure of two connectors in the first embodiment of the utility model.

[0022] Reference numerals:

[0023] 1. Connector; 11. Butt joint surface; 12. First female clamping part; 13. First male clamping part; 14. Sealing ring; 15. Lower groove; 151. Protrusion; 152. Through groove; 153. Clamping groove; 16. Butt joint;

[0024] 2. Protective cover; 21. Platform; 211. Second extension surface; 212. Third extension surface; 22. Fourth through hole; 23. First handle; 231. Second buckle male component; 24. Second handle; 241. Second buckle female component;

[0025] 3. barrier film; 31. first barrier surface; 311. second through hole; 312. third through hole; 32. first bending surface; 321. first extension surface; 33. second bending surface; 34. second barrier surface;

[0026] 4. Pull block; 41. Handle end; 411. Handle; 42. Fixed end; 421. Strip hole; 422. First through hole; 423. Fixed boss; 424. Clamping groove edge. DETAILED DESCRIPTION

[0027] In order to facilitate the understanding of the present invention, the present invention will be described more fully below with reference to the relevant drawings. The drawings provide embodiments of the present invention. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing this embodiment is to make the disclosure of the present invention more thorough and comprehensive.

[0028] It should be noted that when an element is referred to as being "fixed to" another element, it may be directly on the other element or there may be a central element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are for illustrative purposes only.

[0029] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by technicians in the technical field of the present invention. The terms used herein in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more related listed items. In addition, the various embodiments of the present invention, the features in the embodiments, and the features of the embodiments can be freely combined without obvious conflicts or contradictions.

[0030] like Figure 1 and Figure 2 As shown, a disposable sterile connector for use in a non-sterile environment includes a connector 1, a protective cover 2, a barrier film 3 and a pull block 4. The connector 1 is snap-connected with the protective cover 2. The connector 1 is provided with a fluid channel. A docking joint 16 is provided at one end of the fluid channel, and the other end is a docking surface 11. A circular hole is provided in the middle of the docking surface 11 for accommodating a sealing ring 14. A first snap-on female component 12 and a first snap-on male component 13 are provided on both sides of the docking surface 11. A lower groove 15 is provided on one side of the docking surface 11. The lower groove 15 is provided with a through groove 152. An elastic component is provided in the through groove 152. One end of the elastic component is fixed to one side of the through groove 152. A convex portion 151 extends from the other end of the elastic component. The convex portion 151 is suspended in the through groove 152 so that the convex portion 151 can move up and down in the through groove 152. A snap-on groove 153 is provided on one side of the lower groove 15.

[0031] The protective cover 2 includes a platform portion 21, and a first handle 23 and a second handle 24 are respectively provided on both sides of the platform portion 21. The lower ends of the first handle 23 and the second handle 24 are respectively provided with a second snap-on female component 241 and a second snap-on male component 231. The first snap-on female component 12 is respectively adapted to the first snap-on male component 13 and the second snap-on male component 231, and the first snap-on male component 13 is adapted to the second snap-on female component 241. One end of the platform portion 21 partially extends downward to form a second extension surface 211 to fit and cover the second bending surface 33. The other end of the platform portion 21 partially extends downward to form a third extension surface 212 to cover the first blocking surface 31 and the first bending surface 32. A fourth through hole 22 is provided on one side of the platform portion 21, and the fourth through hole 22 is adapted to the fixing boss 423.

[0032] The barrier film 3 is folded and includes a first barrier surface 31, a second barrier surface 34, and a first bending surface 32 and a second bending surface 33 respectively extending from both ends of the first barrier surface 31. The two ends of the second bending surface 33 are respectively connected to the first barrier surface 31 and the second barrier surface 34. The first bending surface 32 passes through the strip hole and forms a first extension surface 321 in the direction away from the first barrier surface. The first barrier surface 31 is pressed by the lower surface of the protective cover 2, and the second barrier surface 34 is attached to the docking surface 11 and the sealing ring 14 and is fixed to the docking surface 11 by hot melt. The first barrier surface 31 is respectively provided with a second through hole 311 and a third through hole 312, the second through hole 311 is adapted to the convex portion 151, and the third through hole 312 is adapted to the fixed boss 423. The first bending surface 32 passes through the strip hole 421 and forms a first extension surface 321 in the direction away from the first barrier surface 31. The first extension surface 321 is hot melt fixed to the bottom of the pull block 4.

[0033] The pull block 4 includes a fixed end 42 and a handle end 41, and a strip hole 421 adapted to the width of the barrier film 3 is opened on one side of the fixed end 42, and a fixed boss 423 and a first through hole 422 are provided on the side of the strip hole 421 away from the handle end 41, and the first through hole 422 is adapted to the convex portion 151, and a snap-in groove edge 424 is provided on the outer side of the fixed end 42, and the snap-in groove edge 424 is adapted to the snap-in groove 153, and a handle 411 is provided on one side of the handle end 41, and the opening size of the first through hole 422 is sufficient to accommodate the fixed boss 423, and one side of the pull block 4 is exposed on the outside of the connector 1.

[0034] As a single sterile connector, the first female snap-in component 12 and the first male snap-in component 13 are respectively snap-fitted with the second male snap-in component 231 and the second female snap-in component 241, and the second extension surface 211 and the third extension surface 212 are completely fitted with the outer side of the connector 1, and the fixing boss 423 passes through the fourth through hole 22, thereby ensuring that the protective cover 2 is indirectly fixed to the uppermost end of the connector 1, and extends into the first through hole 422 through the convex portion 151, and the snap-fit ​​groove edge 424 is snap-fitted with the snap-fit ​​groove 153, so as to connect the pull block 4 with the connector. The head piece 1 is fixed, the fixing boss 423 passes through the third through hole 312, the first barrier surface 31 is fitted with the second barrier surface 34, the second bending surface 33 ensures that the barrier membrane 3 and the sterile environment of the connector 1 are appropriately extended, the first extension surface 321 is hot-melt fixed to the bottom of the pull block 4 to ensure that the handle 411 can completely pull out the barrier membrane 3, the second barrier surface 34 is respectively fitted with the docking surface 11 and the sealing ring 14 and hot-melt fixed to the docking surface 11, so that the docking surface 11 is in a completely sealed environment of the barrier membrane 3.

[0035] In the utility model, the barrier film 3 is a composite film, and when the protective cover 2 is removed, it can effectively isolate microorganisms in a daily environment, prevent contamination of the fluid channel in the connector 1, and achieve aseptic isolation.

[0036] like Figures 1 to 3As shown, the disposable sterile connector requires two sterile connectors to be docked for use. The protective cover 2 needs to be separated from the connector 1 first. The second buckle female component 241 and the second buckle male component 231 can be disengaged from the first buckle female component 12 and the first buckle male component 13 through the first handle 23 and the second handle 24 respectively, so as to separate the protective cover 2 from the connector 1, and the two groups of first buckle female components 12 and first buckle male components 13 of the sterile connectors with the two separated protective covers 2 are correspondingly engaged, and the fixed boss 423 forces the convex portion 151 to move up and down, and finally the convex portion 151 is separated from the first through hole 422. At this time, the parts of the two handles 411 exposed on the outside of the connector are on the same side. Two fingers hold the handle 411 with force, and pull the pull block 4 out of the lower groove 15 with force. When the pull block 4 drives the barrier film 3 away from the docking piece 1, the second bending surface 33 connected to the first barrier surface 31 is continuously pulled along the direction of being pulled out. The second barrier surface 34 is unfolded, so that the second barrier surface 34 is also disengaged from the docking surface, and finally the pull block 4 is guaranteed to completely pull out the barrier film 3. The through groove 152 is arc-shaped in the direction away from the lower groove 15. While increasing the downward pressure range of the convex portion 151, the stress at the connection between the elastic member and the through groove 152 can also be reduced. The convex portion 151 prevents the handle 411 from being directly pulled out in the pulling direction by mistake. The handle 411 can drive the entire pull block 4 to move along the clamping groove edge 424. When the pull block 4 is away from the clamping groove edge 424, the pull block 4 is separated from the connector 1, and the two partially raised sealing rings 14 abut against each other. The docking surfaces 11 of the two connectors 1 dock with each other, and a complete channel is formed on the fluid channel docking. Therefore, the utility model can be used to achieve aseptic connection in a non-sterile environment. After connecting a certain length of hose, the docking joint 16 is used to ensure the sterility of the hose after docking. Docking in a non-sterile environment ensures the sterility of the hose after connection.

[0037] In the description of this specification, the description with reference to the terms "one embodiment", "some embodiments", "examples", "specific examples", or "some examples" means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representation of the above terms does not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described may be combined in any one or more embodiments or examples in a suitable manner.

[0038] The above-mentioned embodiments only express the implementation methods of the utility model, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the patent of the utility model. It should be pointed out that, for ordinary technicians in this field, several modifications and improvements can be made without departing from the concept of the utility model, and these all belong to the protection scope of the utility model. Therefore, the protection scope of the utility model patent shall be based on the attached claims.

Claims

1. A disposable sterile connector for use in a non-sterile environment, characterized in that: It includes a connector, a protective cover, a pull block and a barrier film, the connector is snap-connected with the protective cover, the connector is provided with a fluid channel, one end of the fluid channel is provided with a docking joint, and the other end is a docking surface, a circular hole is provided in the middle of the docking surface for accommodating a sealing ring, the sealing ring partially protrudes from the docking surface, a lower groove is provided on one side of the docking surface, the pull block is snap-connected with the lower groove, part of the pull block is exposed on the outside of the connector, the barrier film is folded, the barrier film includes a first barrier surface and a second barrier surface, the first barrier surface is pressed by the lower surface of the protective cover, the second barrier surface is fitted with the docking surface, and one end of the first barrier surface is fixedly connected to the pull block.

2. The disposable sterile connector for use in a non-sterile environment according to claim 1, characterized in that: The connector also includes a first snap-on female component and a first snap-on male component, the first snap-on female component and the first snap-on male component are arranged on both sides of the docking surface, the lower groove is provided with a through groove, an elastic component is arranged in the through groove, one end of the elastic component is fixed to one side of the through groove, and a convex portion extends from the other end of the elastic component, the convex portion is suspended in the through groove so that the convex portion can move up and down in the through groove, the convex portion extends upward in the vertical direction into the pulling block, and a snap-on groove is provided on one side of the lower groove.

3. The disposable sterile connector for use in a non-sterile environment according to claim 2, characterized in that: The pull block includes a fixed end and a handle end, a strip hole adapted to the width of the barrier membrane is opened on one side of the fixed end, a fixed boss and a first through hole are arranged on the side of the strip hole away from the handle end, the opening size of the first through hole is sufficient to accommodate the fixed boss, the first through hole is adapted to the convex portion, a snap-in groove edge is arranged on the outer side of the fixed end, the snap-in groove edge is adapted to the snap-in groove, and a handle is arranged on one side of the handle end.

4. The disposable sterile connector for use in a non-sterile environment according to claim 3, characterized in that: The barrier film also includes a first bending surface and a second bending surface extending from both ends of the first barrier surface, and both ends of the second bending surface are respectively connected to the first barrier surface and the second barrier surface, the first bending surface passes through the strip hole and forms a first extension surface in a direction away from the first barrier surface, and a second through hole and a third through hole are respectively provided on one side of the first barrier surface, the second through hole is adapted to the convex portion, and the third through hole is adapted to the fixed boss, the fixed boss extends out of the barrier film in a vertical direction and extends to the protective cover and is partially exposed, and the first extension surface is hot-melt fixed to the bottom of the pull block.

5. The disposable sterile connector for use in a non-sterile environment according to claim 4, characterized in that: The protective cover includes a platform portion, and a first handle and a second handle are respectively provided on both sides of the platform portion. The lower ends of the first handle and the second handle are respectively provided with a second buckle female component and a second buckle male component. The first buckle female component is respectively adapted to the first buckle male component and the second buckle male component, and the first buckle male component is adapted to the second buckle female component.

6. The disposable sterile connector for use in a non-sterile environment according to claim 5, characterized in that: One end of the platform portion extends downward to form a second extension surface to fit and cover the second bending surface, and the other end of the platform portion extends downward to form a third extension surface to cover the first blocking surface and the first bending surface. A fourth through hole is provided on one side of the platform portion, and the fourth through hole is adapted to the fixing boss.

7. The disposable sterile connector for use in a non-sterile environment according to claim 1, characterized in that: The barrier film is a composite film.