A sterile connector and a sterile connection method

Abstract

This invention relates to a sterile connector, comprising: two connecting parts, a pre-compression snap-fit ​​device, and a locking device; each connecting part includes: a connecting body with a fluid channel, a sealing groove located at one end of the connecting body and coaxial with the fluid channel, and a sealing ring placed in the sealing groove, and a removable sterile membrane covering one end of the fluid channel and the sealing ring; when the two connecting parts are connected, one end of the two connecting parts are opposite each other and snap-fitted by the pre-compression snap-fit ​​device, and a pre-pressure is applied to the sealing ring for pre-compression; after the sterile membrane is removed and the two fluid channels are connected, the two connecting bodies are locked by the locking device, and a compression force is applied to the sealing ring to improve the sealing performance. The sterile connector described herein has two identical connecting bodies, making it easy to manufacture, and the covering membrane (i.e., the sterile membrane) is easy to remove and not easily broken during connection.

Description

Technical Field

[0001] This invention relates to the field of aseptic connection technology, and in particular to a sterile connector and a sterile connection method. Background Technology

[0002] Pharmaceutical industry delivery mainly includes traditional chemical pharmaceutical delivery and biopharmaceutical delivery. For the pharmaceutical industry, ensuring sterility during the delivery process is crucial. Sterile connectors are used for the dry connection of two independent fluid paths (pipelines). They can achieve sterile connection and establish a sterile liquid transport path in non-clean environments or production environments of various clean levels. The sterility of sterile connectors before connection is usually ensured by a releasable cover film, which can be removed when the two connectors are connected or close to each other. Chinese Patent 201710414828.5 discloses a sterile connecting device, including a second sterile connecting device and a first sterile device inserted into the second sterile connecting device. A locking ring of the first sterile device is in an initial index position. During connection, the locking ring rotates to a fixed position, generating a compressive force that allows the removal of a first membrane from the first sterile connecting device and a second membrane from the second sterile connecting device. This results in a seal between the first sealing member of the first sterile connecting device and the second sealing member of the second sterile connecting device, creating a sterile fluid channel. This sterile connecting device (i.e., a sterile connector) suffers from drawbacks: the two connecting bodies (the first sterile device and the second sterile connecting device) have different structures, making manufacturing difficult; and after connection and locking, removing the two covering membranes (the first membrane and the second membrane) is difficult and prone to breakage. Therefore, designing a sterile connector and sterile connection method with identical structures for both connecting bodies, ease of manufacturing, and easy removal of the covering membranes during connection without breakage, has become an urgent problem to be solved. Summary of the Invention

[0003] The purpose of this invention is to overcome the shortcomings of the prior art and provide a sterile connector and sterile connection method with two identical connecting main structures that are easy to manufacture and whose covering film is easy to remove and not easily broken during connection.

[0004] The specific technical solution of this invention is as follows:

[0005] A sterile connector includes: two connectors, a pre-compression snap-fit ​​device, and a locking device; each connector includes: a connecting body with a fluid channel, a sealing groove located at one end of the connecting body and coaxial with the fluid channel, and a sealing ring placed in the sealing groove, and a removable diaphragm covering one end of the fluid channel and the sealing ring; when the two connectors are connected, one end of the two connectors are opposite each other and snap-fitted by the pre-compression snap-fit ​​device, and a pre-pressure is applied to the sealing ring for pre-compression; after the diaphragm is removed and the two fluid channels are connected, the two connecting bodies are locked by the locking device, and a compression force is applied to the sealing ring to improve the sealing performance; the fluid channel is a connecting pipe; the sealing ring has a rectangular cross-sectional shape.

[0006] Preferably, the side of the connecting body is symmetrically provided with two notches that penetrate one end of the connecting body, and two locking through holes symmetrically provided on both sides of the fluid channel and penetrating the bottom surface of the two notches; each of the two notches is provided with a connecting ear; the connecting ear is integrally formed with the connecting body.

[0007] Preferably, the side of the connecting body is symmetrically provided with two planes; the planes are located between the two notches and are perpendicular to the bottom surface of the notches; one end of the diaphragm extends out of the plane; the planes are connected to both ends of the connecting body.

[0008] Preferably, the pre-compression snap-fit ​​device includes: two snaps respectively disposed on both sides of the insulating membrane and consisting of snap hooks and snap holes; the snap hole of one snap is disposed on a connecting ear of one connecting body, and the snap hook is disposed on a connecting ear of the other connecting body; the snap hook of the other snap is disposed on another connecting ear of one connecting body, and the snap hole is disposed on another connecting ear of the other connecting body; the snap hooks and snap holes of the two snaps are snapped together one-to-one.

[0009] Preferably, the locking device includes: two locking blocks and four locking pins corresponding one-to-one with the four locking through holes of the two connecting bodies; each locking pin includes: a first locking pressure block and a second locking pressure block, a U-shaped locking block with its closed end connected to the inner end of the first locking pressure block, two locking protrusions symmetrically arranged on the inner side of the open end of the U-shaped locking block, and a locking rod with a locking head opposite to the open end of the U-shaped locking block and its outer end connected to the inner end of the second locking pressure block; the outer end of the first locking pressure block of the locking pin is connected to the inner end of one locking block, and the outer end of the second locking pressure block is connected to the inner end of another locking block, or the outer end of the second locking pressure block of the locking pin is connected to the inner end of one locking block, and the outer end of the first locking pressure block is connected to the inner end of another locking block. The inner ends of the locking blocks are connected; when locking, the locking blocks are pushed into the notches, the locking heads of the locking pins are inserted into the locking through holes and into the U-shaped locking blocks, the locking protrusions block the outer ends of the locking heads, and the first and second locking pressure blocks press against the locking through holes near the connecting body to achieve locking; when the locking device is locked, it is locked by two locking blocks and four locking pins perpendicular to the axis of the connecting body, and will not be unlocked due to the axial reset force of the sealing ring and the axial tension of the fluid channel causing the locking head to slip off from the U-shaped locking block, and the connection between the two connecting bodies is stable and reliable; the height of the locking blocks is the same as the distance between the other ends of the two connecting bodies; the cross-sectional shape of the locking blocks is the same as the cross-sectional shape of the notches.

[0010] Preferably, the sterile connector further includes: two protective covers with one open end, each corresponding to one of the two connectors; the inner side of the protective cover is provided with multiple vertical protrusions; the open end of the protective cover is provided with a disassembly ear; the protective cover covers the connector and one end of the protective cover opening is located at the other end of the connector, and the vertical protrusions press against the outer side of the connector; the protective cover is removed before the two connectors are connected; the protective cover is used to protect the connector, and the disassembly ear facilitates the removal of the protective cover.

[0011] Preferably, the insulating membrane is bonded to one end of the connecting body by heat pressing; the insulating membrane is easy to remove.

[0012] A method for aseptic connection of a sterile connector, wherein the sterile connector is the aforementioned sterile connector, comprising the following steps: Step 1, removing the protective cover and aligning one end of the two connectors together; Step 2, inserting the hooks of the two latches of the pre-compression latching device into the corresponding latch holes to clamp the connector and applying pre-pressure to the sealing ring for pre-tightening; Step 3, removing the insulating membrane and connecting the two fluid channels; Step 4, pushing the locking block of the locking pin of the locking device into the notch, inserting the locking head into the corresponding locking through hole and into the U-shaped locking block, with the locking protrusion blocking the rear end of the locking head, and the first locking pressure block and the second locking pressure block respectively pressing the locking through hole near the end of the connector body to achieve locking, and applying pressure to the sealing ring to improve sealing performance, thus completing the aseptic connection of the sterile connector.

[0013] Compared with existing technologies, the beneficial effects of this invention are as follows: The sterile connector has two identical connecting bodies, making it easy to manufacture. The connection is performed in two steps: pre-compression and locking. One end of each connecting body is positioned opposite each other and engaged by a pre-compression locking device. Pre-compression is applied to the sealing ring, ensuring a tight seal. Under sealed conditions, the covering membrane (i.e., the antimicrobial membrane) is easy to remove with minimal force and is less prone to breakage, thus eliminating the risk of secondary contamination associated with traditional two-step connections. After removing the antimicrobial membrane and connecting the two fluid channels, the locking device locks the two connecting bodies until a "click" is heard, indicating that the sealing ring has been compressed to its optimal sealing position, improving the sealing effect. Covering one end of the fluid channel and the sealing ring with the antimicrobial membrane helps prevent bacteria and impurities from entering the pipeline and facilitates gas discharge. The antimicrobial membrane is heat-pressed to one end of the connecting body, making it easy to remove. The two fluid channels have the same inner diameter and are directly connected, avoiding the shear force caused by sudden changes in pipe diameter and preventing air bubbles from forming during flow. The pre-compression locking device and the locking device are easily assembled and disassembled via a locking connection. The locking directions of the pre-compression locking device and the locking device are perpendicular to each other and interlock, ensuring 100% prevention of accidental disassembly after connection, thus preventing misoperation. The protective cover is used to protect the connecting parts. The protective cover should be removed before the two connecting parts are connected, and the removal lugs facilitate the removal of the protective cover. Attached Figure Description

[0014] Figure 1 This is a schematic diagram of an exploded structure of the present invention;

[0015] Figure 2 This is a structural schematic diagram of the connector;

[0016] Figure 3 This is a schematic diagram of the structure where the protective cover is placed over the connector.

[0017] In the diagram: 1. Protective cover; 2. Vertical protrusion; 3. Fluid channel; 4. Connecting body; 5. Sealing groove; 6. Sealing ring; 7. Antibacterial membrane; 8. Disassembly ear; 9. Notch; 10. Flat surface; 11. Locking through hole; 12. Connecting ear; 13. Hook; 14. Locking hole; 15. Locking protrusion; 16. U-shaped locking block; 17. Locking head; 18. Locking rod; 19. First locking pressure block; 20. Second locking pressure block; 21. Detailed Implementation

[0018] The present invention will now be further described with reference to the accompanying drawings.

[0019] As attached Figure 1 Appendix Figure 2 Appendix Figure 3 As shown: A sterile connector includes: two connectors, a pre-compression snap-fit ​​device, a locking device, and two protective covers 1 with one end open and corresponding to the two connectors.

[0020] The protective cover 1 has four vertical protrusions 2 on its inner side; the opening end of the protective cover is provided with a disassembly ear 8; the protective cover 1 covers the connector and one end of the opening of the protective cover 1 is located at the other end of the connector, and the vertical protrusions 2 press against the outer side of the connector; the protective cover 1 is used to protect the connector, and the protective cover 1 is removed before the two connectors are connected, and the disassembly ear 8 facilitates the removal of the protective cover 1.

[0021] The connector includes: a connecting body 4 with a fluid channel 3, a sealing groove 5 located at one end of the connecting body 4 and coaxial with the fluid channel 3, a sealing ring 6 placed in the sealing groove 5, and a removable antimicrobial membrane 7 covering one end of the fluid channel 3 and the sealing ring 6; the sealing ring 6 has a rectangular cross-sectional shape; the fluid channel 3 is a connecting pipe with its other end extending out of the other end of the connecting body 4.

[0022] The connecting body 4 has a circular cross-sectional shape; the side of the connecting body 4 is symmetrically provided with two notches 9 that pass through one end of the connecting body 4 and two planes 10 that pass through both ends of the connecting body 4; the planes 10 are located between the two notches 9 and are perpendicular to the bottom surface of the notches 9; two locking holes 11 are symmetrically provided on both sides of the fluid channel 3 and pass through the bottom surface of the two notches 9; each of the bottom surfaces of the two notches 9 is provided with a connecting ear 12, and the connecting ear 12 is integrally formed with the connecting body 4; the antimicrobial membrane 7 is glued to one end of the connecting body 4 by heat pressing, and one end of the antimicrobial membrane 7 extends out of the plane 10.

[0023] The pre-compression snap-fit ​​device includes: two snap-fits respectively disposed on both sides of the insulating membrane 7 and consisting of snap-fit ​​hooks 13 and snap-fit ​​holes 14; the snap-fit ​​hole 14 of one snap-fit ​​is disposed on a connecting ear 12 of one connecting body 4, and the snap-fit ​​hook 13 is disposed on a connecting ear 12 of the other connecting body 4; the snap-fit ​​hook 13 of the other snap-fit ​​is disposed on another connecting ear 12 of one connecting body 4, and the snap-fit ​​hole 14 is disposed on another connecting ear 12 of the other connecting body 4; the snap-fit ​​hooks 13 and snap-fit ​​holes 14 of the two snap-fits are snapped together one-to-one.

[0024] The locking device includes: two locking blocks 15, and four locking pins corresponding one-to-one with the four locking through holes of the two connecting bodies; each locking pin includes: a first locking pressure block 20 and a second locking pressure block 21, a U-shaped locking block 17 whose closed end is connected to the inner end of the first locking pressure block 20, two locking protrusions 16 symmetrically arranged on the inner side of the open end of the U-shaped locking block 17, and a locking head 18 provided with a locking head 18 opposite to the open end of the U-shaped locking block 17 and whose outer end is connected to the inner end of the second locking pressure block 21; the outer end of the first locking pressure block 20 of the locking pin is connected to the inner end of one locking block 15, and the outer end of the second locking pressure block 21 is connected to the inner end of the other locking block 15, or the outer end of the second locking pressure block 21 of the locking pin is connected to the inner end of one locking block 15, and the outer end of the first locking pressure block 20 is connected to the inner end of the first locking pressure block 20. It is connected to the inner end of another locking block 15; when locking, the locking block 15 is pushed into the notch, the locking head 18 of the locking pin is inserted into the locking through hole and into the U-shaped locking block 17, the locking protrusion 16 blocks the outer end of the locking head 18, and the first locking pressure block 20 and the second locking pressure block 21 respectively press the locking through hole near the end of the connecting body to achieve locking; when the locking device is locked, it is locked by two locking blocks 15 and four locking pins perpendicular to the axis of the connecting body, and will not be unlocked due to the axial reset force of the sealing ring and the axial tension of the fluid channel causing the locking head 18 to slip off from the U-shaped locking block 17, and the connection between the two connecting bodies is stable and reliable; the height of the locking block 15 is the same as the distance between the other ends of the two connecting bodies; the cross-sectional shape of the locking block 15 is the same as the cross-sectional shape of the notch.

[0025] The aseptic connection method for the aseptic connector is as follows: Step 1, remove the protective cover 1 and place the two connectors with one end facing each other; Step 2, insert the hooks 13 of the two buckles of the pre-compression snap-fit ​​device into the corresponding buckle holes 14 to snap them in place, and apply pre-pressure to the sealing ring 6 for pre-compression; Step 3, pull out the two fluid channels 3 of the sterile membrane 7 to connect them; Step 4, push the locking block 15 of the locking pin of the locking device into the notch 9, insert the locking head 18 into the corresponding locking through hole 11 and into the U-shaped locking block 17, the locking protrusion 16 blocks the rear end of the locking head 18, the first locking pressure block 20 and the second locking pressure block 21 respectively press the locking through hole 11 near the end of the connecting body 4 to achieve locking, and apply pressure to the sealing ring 6 to improve the sealing performance, thus completing the aseptic connection of the aseptic connector.

[0026] In addition to the embodiments described above, within the scope disclosed in the claims and specification of this invention, the technical features or technical data of this invention can be reselected and combined to form new embodiments. These can be achieved by those skilled in the art without creative effort. Therefore, these embodiments not described in detail in this invention should also be regarded as specific embodiments of this invention and within the protection scope of this invention.

Claims

1. A sterile connector, comprising: The two connectors are characterized in that the aseptic connector further includes: a pre-compression snap-fit ​​device and a locking device; the connector includes: a connecting body with a fluid channel, a sealing groove at one end of the connecting body and a sealing ring placed in the sealing groove, and a removable diaphragm covering one end of the fluid channel and the sealing ring; when the two connectors are connected, one end of the two connectors are opposite each other and snap-fitted by the pre-compression snap-fit ​​device, and a pre-pressure is applied to the sealing ring for pre-compression; after the diaphragm is removed and the two fluid channels are connected, the two connecting bodies are locked by the locking device, and a pressure is applied to the sealing ring for compression to improve the sealing performance; The locking device includes a locking block and a locking pin; the locking pin includes: a first locking pressure block and a second locking pressure block, a U-shaped locking block whose closed end is connected to the inner end of the first locking pressure block, two locking protrusions symmetrically arranged on the inner side of the open end of the U-shaped locking block, and a locking rod with a locking head opposite to the open end of the U-shaped locking block and whose outer end is connected to the inner end of the second locking pressure block.

2. The sterile connector according to claim 1, characterized in that, The connecting body has two symmetrical notches that are connected to one end of the connecting body on its side, and two locking through holes that are symmetrically located on both sides of the fluid channel and are connected to the bottom surface of the two notches; each of the two notches has a connecting lug on its bottom surface.

3. The sterile connector according to claim 2, characterized in that, The connecting body has two symmetrical planes on its side; the planes are located between the two notches and are perpendicular to the bottom surface of the notches; one end of the diaphragm extends out of the plane.

4. The sterile connector according to claim 2 or 3, characterized in that, The pre-compression snap-fit ​​device includes: two snaps respectively disposed on both sides of the insulating membrane and consisting of snap hooks and snap holes; the snap hole of one snap is disposed on a connecting ear of one connecting body, and the snap hook is disposed on a connecting ear of the other connecting body; the snap hook of the other snap is disposed on another connecting ear of one connecting body, and the snap hole is disposed on another connecting ear of the other connecting body.

5. The sterile connector according to claim 2 or 3, characterized in that, The locking device includes: two locking blocks and four locking pins corresponding one-to-one with the four locking through holes of the two connecting bodies; the outer end of the first locking pressure block of the locking pin is connected to the inner end of one locking block, and the outer end of the second locking pressure block is connected to the inner end of another locking block, or the outer end of the second locking pressure block of the locking pin is connected to the inner end of one locking block, and the outer end of the first locking pressure block is connected to the inner end of another locking block; when locking, the locking blocks are pushed into the notches, the locking heads of the locking pins are inserted into the locking through holes and into the U-shaped locking blocks, the locking protrusion blocks the outer end of the locking heads, and the first and second locking pressure blocks press against the locking through holes near the connecting bodies to achieve locking; when the locking device is locked, it is locked by the two locking blocks and the four locking pins perpendicular to the axis of the connecting bodies, and the locking heads will not slip off from the U-shaped locking blocks due to the axial reset force of the sealing ring and the axial tension of the fluid channel, thus ensuring a stable and reliable connection between the two connecting bodies.

6. The sterile connector according to claim 1, 2, or 3, characterized in that it further... include: Two protective covers with one open end, each corresponding to a connector; multiple vertical protrusions are provided on the inside of the protective covers; and detachment ears are provided at the open ends of the protective covers. The protective cover covers the connector with one end of the protective cover opening at the other end of the connector, and the vertical protrusion presses against the outside of the connector's side panel; the protective cover is removed before the two connectors are connected.

7. The sterile connector according to claim 1, 2, or 3, characterized in that, The bacterial barrier membrane is bonded to one end of the connecting body by heat pressing.

8. A method for aseptic connection of a sterile connector, wherein the sterile connector is the sterile connector according to any one of claims 1 to 7, characterized in that, Step 1: Remove the protective cover and align one end of the two connectors with the other end. Step 2: Insert the hooks of the two pre-compression locking devices into the corresponding locking holes to apply pre-pressure to the sealing ring for pre-tightening. Step 3: Pull out the insulating membrane to connect the two fluid channels. Step 4: Push the locking block of the locking pin of the locking device into the notch, insert the locking head into the corresponding locking through hole and into the U-shaped locking block, with the locking protrusion blocking the rear end of the locking head. The first and second locking blocks press against the locking through hole near the connecting body to achieve locking, and apply pressure to the sealing ring to improve sealing, completing the aseptic connection of the aseptic connector.

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