WO2024008899A1

WO2024008899A1 - Aseptic connector

Info

Publication number: WO2024008899A1
Application number: PCT/EP2023/068796
Authority: WO
Inventors: Izzy BILLAU; Simon Woods; Nick WHITE
Original assignee: Watson-Marlow Limited
Priority date: 2022-07-08
Filing date: 2023-07-06
Publication date: 2024-01-11
Also published as: GB2620433A; GB202210044D0

Abstract

There is described an aseptic connector (2) for connection to an identical opposing aseptic connector, the aseptic connector (2) comprising: a body portion (4) defining a fluid passageway (8) having a first end (10) and a second end (12); a removable membrane (18) which covers and seals the second end (12) of the fluid passageway (8); a guide portion (26) extending from the body portion (4); and a slide member (30) which is slidably mounted on the guide portion (26), wherein the slide member (30) is connected to the removable membrane (18) and is slidable along the guide portion (26) thereby removing the membrane (18) from the second end (12) of the fluid passageway (8) so that it can engage the second end (12) of the fluid passageway (8) of the opposing aseptic connector (1) so as to form a continuous fluid pathway across the aseptic connectors (2).

Description

ASEPTIC CONNECTOR

The invention relates to an aseptic connector.

BACKGROUND

Sterile connectors for aseptic processing (commonly referred to as “aseptic connectors”) enable two lines of tubing to be joined while maintaining a sterile fluid pathway. This may be particularly important in medical, pharmaceutical and bioprocessing applications.

An end of each line of tubing may be provided with an aseptic connector which is configured to engage and mechanically connect with the opposing connector. Each aseptic connector is provided with a sealing arrangement which retains the sterility of the tubing (as well as any portions of the connector which form part of the fluid pathway) before, during and after their interconnection. For example, the end of each connector may be provided with a removable membrane which can be removed once the two connectors are interconnected, and the fluid pathway is sealed.

It is desirable to provide aseptic connectors which are simple and easy to operate in order to avoid user errors which could inadvertently compromise the sterility of the fluid pathway.

In accordance with an aspect of the invention, there is provided an aseptic connector for connection to an identical opposing aseptic connector, the aseptic connector comprising: a body portion defining a fluid passageway having a first end and a second end; a removable membrane which covers and seals the second end of the fluid passageway; a guide portion extending from the body portion; and a slide member which is slidably mounted on the guide portion, wherein the slide member is connected to the removable membrane and is slidable along the guide portion thereby removing the membrane from the second end of the fluid passageway so that it can engage the second end of the fluid passageway of the opposing aseptic connector so as to form a continuous fluid pathway across the aseptic connectors.

The removable membrane may be folded back on itself along a fold line to form a release tab which is connected to the slide member. The fold line may be located at an opposing side of the fluid passageway to the slide member.

In accordance with another aspect of the invention, there is provided an aseptic connector for connection to an identical opposing aseptic connector, the aseptic connector comprising: a body portion defining a fluid passageway having a first end and a second end; a guide portion extending from the body portion; and a slide member which is slidably mounted on the guide portion, wherein the slide member covers and seals the second end of the fluid passageway and is slidable along the guide portion thereby uncovering the second end of the fluid passageway so that it can engage the second end of the fluid passageway of the opposing aseptic connector so as to form a continuous fluid pathway across the aseptic connectors.

A seal may be provided at the second end of the fluid passageway; wherein the seal is axially compressed by the slide member.

The seal may have a structure which is configured to reduce compressive stiffness

An outer surface of the seal may be provided with an hourglass profile or a helical groove.

The slide member may comprise a male element and a female element which respectively engage with the female element and the male element of the slide member of the opposing aseptic connector.

The body portion of the aseptic connector may comprise a male element and a female element which respectively engage with the female element and the male element of the housing of the opposing aseptic connector.

The male and female elements of the housing may form snap fit connections with the female and male elements of the housing of the opposing aseptic connector.

One of the slide member and the guide portion may comprise a groove and the other of the slide member and the guide portion may comprise a rail which is received by the groove to slidably mount the slide member on the guide portion. The slide member may be slidably mounted on the guide portion such that it can be slid off a distal end of the guide portion.

The slide member may be slidable along a direction which is perpendicular to a longitudinal axis of the fluid passageway.

In accordance with an aspect of the invention, there is provided an aseptic connector assembly comprising a pair of aseptic connectors as described above.

BRIEF DESCRIPTION OF DRAWINGS

For a better understanding of the invention, and to show more clearly how it may be carried into effect, reference will now be made, by way of example, to the accompanying drawings, in which:

Figure 1 is a perspective view of an aseptic connector according to an embodiment of the invention;

Figures 2 and 3 are exploded views of the aseptic connector;

Figure 4 is a side view of a membrane of the aseptic connector;

Figures 5 and 6 are perspective and side views of a pair of aseptic connectors in a mechanically connected, but fluidically disconnected configuration;

Figures 7 and 8 are perspective and side views of the pair of aseptic connectors in a mechanically and fluidically connected configuration;

Figure 9 is a perspective view of an aseptic connector according to another embodiment of the invention;

Figure 10 is an exploded view of the aseptic connector of Figure 9;

Figure 11 is a perspective view of a pair of aseptic connectors according to the embodiment of Figure 9 before connection; Figures 12 and 13 are perspective and side views of the pair of aseptic connectors in a mechanically connected, but fluidically disconnected configuration;

Figures 14 and 15 are perspective and side views of the pair of aseptic connectors in a mechanically and fluidically connected configuration;

Figure 16 is a cross-sectional view of the pair of aseptic connectors in the mechanically and fluidically connected configuration;

Figure 17 shows a perspective and side views of a seal of the aseptic connection; and

Figure 18 shows a perspective and side views of an alternative seal of the aseptic connection.

DETAILED DESCRIPTION

Figures 1 to 3 show an aseptic connector 2 according to an embodiment of the invention.

The aseptic connector 2 generally comprises a body portion 4. The body portion 4 comprises a barb fitting 6 for insertion into a tube. A fluid passageway 8 extends through the body portion 4 from a first end 10 at the barb fitting 6 to a second end 12. The body portion 4 has a counterbore section 14 adjacent the second end 12 which receives a toroidal seal 16. The toroidal seal 16 has an outer diameter which corresponds to an inner diameter of the counterbore section 14 and an inner diameter which corresponds to the inner diameter of the fluid passageway 8. Accordingly, the toroidal seal 16 forms a continuation of the fluid passageway 8 with no significant deviation in the diameter.

A removable membrane 18 is affixed to the body portion 4 over the toroidal seal 16 at the second end 12 of the fluid passageway 8. The membrane 18 is welded or adhered to the body portion 4 in order to form a fluid tight seal which maintains the sterility of the fluid passageway 8. As shown in Figure 4, the membrane 18 is folded back on itself along a fold line 19 to form a release tab 32. As shown in Figure 1, the fold line 19 is located on one side (an upper side) of the fluid passageway 8 and the release tab extends to and beyond the opposite side of the fluid passageway 8. In other examples, the release tab 32 or a portion thereof may be formed separately to the membrane 18 and affixed thereto.

The toroidal seal 16 may have an axial dimension which is slightly greater than the depth of the counterbore section 14 such that it sits slightly proud of the end of the body portion 4. The application of the membrane 18 over the toroidal seal 16 may compress the seal 16 such that it lies flush with the end of the body portion 4 and thus the seal 16 may retain a preload force.

The aseptic connector 2 further comprises a genderless interconnection mechanism. Specifically, the aseptic connector 2 comprises a cantilevered beam 20 (male element) located on one lateral side of the body portion 4 and a complementary opening 22 (female element) located on the other lateral side of the body portion 4. The cantilevered beam 20 extends away from the body portion 4 and is provided with a retaining hook (i.e. , a barb) 24 at its distal end.

The aseptic connector 2 further comprises a guide portion 26. The guide portion 26 extends perpendicularly from the body portion 4 at a position which is adjacent to the second end 12. Each lateral side of the guide portion 26 comprises a linear groove 28 which extends along the length of the guide portion 26. The linear grooves 28 run parallel to one another and terminate adjacent a distal end of the guide portion 26. In other examples, the linear grooves 28 may be open at the distal end of the guide portion 26.

A slide member 30 is slidably mounted to the guide portion 26 via the grooves 28. The slide member 30 comprises a pair of flanges 31 which project inwards towards one another from either side of a front surface 33. The slide member 30 thus has a substantially C-shaped profile. The flanges 31 run parallel to one another and are suitably spaced so as to allow them to be retained within the grooves 28 in order to hold the slide member 30 captive on the guide portion 26 but to allow the slide member 30 to freely slide along the length of the grooves 28.

The slide member 30 further comprises a genderless interconnection mechanism. Specifically, the slide member 30 comprises a protrusion 34 and a complementary opening 36 which are located side-by-side on the front surface 33 of the slide member 30.

The slide member 30 is attached to the membrane 18 via the release tab 32.

Figures 5 and 6 show an assembly comprising a pair of aseptic connectors 2 as described above. The connectors 2 are identical but are referred to as first and second connectors for clarity below, where necessary.

As shown, the first and second connectors are interconnected using the genderless interconnection mechanism provided on the body portion 4. Specifically, the beam 20 of the first connector is received in the opening 22 of the second connector and the beam 20 of the second connector is received in the opening 22 of the first connector to form a snap fit connection with the retaining hooks 24 preventing withdrawal.

In a similar manner, the slide members 30 of the first and second connectors 2 are interconnected by virtue of the genderless interconnection mechanism. Specifically, the protrusion 34 of the slide member 30 of the first connector is received in the complementary opening 36 of the slide member 30 of the second connector and the protrusion 34 of the slide member 30 of the second connector is received in the complementary opening 36 of the slide member 30 of the first connector. Accordingly, the slide members 30 are constrained to move simultaneously along the grooves 28.

The connectors 2 are assembled with the slide members 30 in a first configuration, as shown in Figures 3 and 4. In the first configuration, the slide members 30 are located at an upper end of the grooves 28 closest to the body portion 4 and particularly the toroidal seal 16 at the second end 12. In this position, the slide members 30 do not apply any tension to the release tab 32 and so the fluid passageway 8 of each connector continues to be sealed by the membrane 18. Accordingly, while the connectors 2 are mechanically connected, they remain fluidically disconnected with no fluid flow being possible between their respective fluid passageways 8.

In order to connect their fluid passageways 8, the slide members 30 are grasped and forced along the grooves 28, as denoted by the arrow in Figure 6, until they reach the opposite end of the grooves 28. This second configuration is shown in Figures 7 and 8. The slide members 30 pull the release tab 32 as they translate along the grooves 28 such that the membrane 18 is pealed away from the body portion 4 in an axial direction to reveal the seal 16. The length of the grooves 28 is sufficient to fully remove the membrane 18 from the body portion 4. The seals 16 of the first and second connectors 2 are therefore able to engage directly against one another to seal the fluid passageway 8 of the first connector 2 to the fluid passageway of the second connector 2. A continuous fluid pathway is therefore formed through the first and second connectors 2 such that fluid can pass across the interface between the second ends 12 of the connectors 2.

The translation of the slide members 30 along the guide portion 26 and its grooves 28 ensures that the membrane 18 is removed in a controlled and repeatable manner, and thus avoids operator error.

In other examples, the grooves may be open at the end of the guide portion such that the slide member can be removed entirely.

Figures 9 and 10 show an aseptic connector 102 according to another embodiment of the invention.

The aseptic connector 102 generally comprises a body portion 104. The body portion 104 comprises a barb fitting 106 for insertion into a tube. A fluid passageway 108 extends through the body portion 104 from a first end 110 at the barb fitting 106 to a second end 112. The body portion 104 has a counterbore section 114 adjacent the second end 112 which receives a seal 116.

As shown in Figure 17, the seal 116 has an hourglass-like profile which comprises a section that tapers (i.e., reduces in diameter) from either end towards the middle in an axial direction. This structure allows the seal 116 to be easily compressed in an axial direction and to return quickly to its relaxed state.

The seal 116 has a maximum outer diameter which corresponds to an inner diameter of the counterbore section 114 and an inner diameter which corresponds to the inner diameter of the fluid passageway 108. Accordingly, the seal 116 forms a continuation of the fluid passageway 108 with no significant deviation in the diameter. The aseptic connector 102 further comprises a guide portion 126. The guide portion 126 extends perpendicularly from the body portion 104 at a position which is adjacent to the second end 112. Each lateral side of the guide portion 126 comprises a linear groove 128 which extends along the length of the guide portion 126. The linear grooves 128 run parallel to one another and are open at the distal end of the guide portion 126. In other examples, the linear grooves 128 may be closed and terminate adjacent a distal end of the guide portion 126.

A slide member 130 is slidably mounted to the guide portion 126 via the grooves 128. The slide member 130 comprises a pair of flanges 131 which project inwards towards one another from either side of a front surface 133. The slide member 130 thus has a substantially C-shaped profile. The flanges 131 run parallel to one another and are suitably spaced so as to allow them to be retained within the grooves 128 in order to hold the slide member 130 captive on the guide portion 126 but to allow the slide member 130 to freely slide along the length of the grooves 128.

The aseptic connector 102 further comprises a genderless interconnection mechanism. Specifically, the aseptic connector 102 comprises a right-angled arm 120 which extends from the guide portion 126 and which defines a slot that is sized to receive the guide portion 126 of an opposing connector. A retention mechanism may also be provided to prevent withdrawal of the guide portion 126 from the slot.

The slide member 130 further comprises a genderless interconnection mechanism. Specifically, the slide member 130 comprises a protrusion 134 and a complementary opening 136 which are located on either side of the slide member 130.

Figures 12 and 13 show an assembly comprising a pair of aseptic connectors 102 as described above. The connectors 102 are identical but are referred to as first and second connectors for clarity below, where necessary.

As shown, the first and second connectors are interconnected using the genderless interconnection mechanism provided on the body portion 104. Specifically, as shown in Figure 11, the aseptic connectors 102 are arranged such that longitudinal axes of the fluid passageways 108 are parallel but offset from one another. The aseptic connectors are translated relative to one another to bring the longitudinal axes into alignment such that the guide portion 126 of the first connector is received in the slot formed by the arm 120 of the second connector and the guide portion 126 of the second connector is received in the slot formed by the arm 120 of the first connector.

In a similar manner, the slide members 130 of the first and second connectors 102 are interconnected by virtue of the genderless interconnection mechanism. Specifically, the protrusion 134 of the slide member 130 of the first connector is received in the complementary opening 136 of the slide member 130 of the second connector and the protrusion 134 of the slide member 130 of the second connector is received in the complementary opening 136 of the slide member 130 of the first connector. Accordingly, the slide members 130 are constrained to move simultaneously along the grooves 128.

The connectors 102 are assembled with the slide members 130 in a first configuration, as shown in Figures 12 and 13. In the first configuration, the slide members 130 are located at an upper end of the grooves 128 closest to the body portion 104 and particularly the seal 116 at the second end 112. In this position, the slide members 130 cover the seal 116. Accordingly, while the connectors 102 are mechanically connected, they remain fluidically disconnected with no fluid flow being possible between their respective fluid passageways 108.

The seal 116 has an axial dimension which is greater than the depth of the counterbore section 114 such that it sits proud of the end of the body portion 104. The application of the slide member 130 over the seal 116 compresses the seal 116 such that it lies flush with the end of the body portion 104 and thus the seal 116 retains a preload force.

In order to connect their fluid passageways 108, the slide members 130 are grasped and forced along the grooves 128, as denoted by the arrow in Figure 13, until they reach the opposite end of the grooves 128. This second configuration is shown in Figures 14 and 15. As a result of this action, the slide members 130 are slid from between the opposing seals 116. The length of the grooves 128 is sufficient to fully remove the slide members 130 from between the seals 116. The seals 116 of the first and second connectors 102 are therefore able to expand axially and engage directly against one another to seal the fluid passageway 108 of the first connector 102 to the fluid passageway 108 of the second connector 102, as is shown in Figure 16. A continuous fluid pathway is therefore formed through the first and second connectors 102 such that fluid can pass across the interface between the second ends 112 of the connectors 102. The slide members 130 may be removed entirely from the grooves 128, if desired.

The translation of the slide members 130 along the guide portion 126 and its grooves 128 ensures that the slide members 130 are removed in a controlled and repeatable manner, and thus avoids operator error.

In an alternative example, a seal 216 as shown in Figure 18 may be used. As shown, the seal 216 comprises a helical groove 217 which runs around the outer surface of the seal 216. Again, this structure allows the seal 216 to be easily compressed in an axial direction and to return quickly to its relaxed state.

It will be appreciated that other examples may use different forms of seal which have a structure that is configured in order to reduce the compressive stiffness in an axial direction (i.e., beyond the mechanical properties of the material itself).

It will be appreciated that in other examples, the guide portions 26, 126 may comprise a rail instead of a groove 28, 128. Alternatively, the which is received in a groove formed in the slide/slide member 30, 130.

To avoid unnecessary duplication of effort and repetition of text in the specification, certain features are described in relation to only one or several aspects or embodiments of the invention. However, it is to be understood that, where it is technically possible, features described in relation to any aspect or embodiment of the invention may also be used with any other aspect or embodiment of the invention.

The invention is not limited to the embodiments described herein, and may be modified or adapted without departing from the scope of the present invention.

Claims

1. An aseptic connector for connection to an identical opposing aseptic connector, the aseptic connector comprising: a body portion defining a fluid passageway having a first end and a second end; a removable membrane which covers and seals the second end of the fluid passageway; a guide portion extending from the body portion; and a slide member which is slidably mounted on the guide portion, wherein the slide member is connected to the removable membrane and is slidable along the guide portion thereby removing the membrane from the second end of the fluid passageway so that it can engage the second end of the fluid passageway of the opposing aseptic connector so as to form a continuous fluid pathway across the aseptic connectors.

2. An aseptic connector as claimed in claim 1 , wherein the removable membrane is folded back on itself along a fold line to form a release tab which is connected to the slide member.

3. An aseptic connector as claimed in claim 2, wherein the fold line is located at an opposing side of the fluid passageway to the slide member.

4. An aseptic connector for connection to an identical opposing aseptic connector, the aseptic connector comprising: a body portion defining a fluid passageway having a first end and a second end; a guide portion extending from the body portion; and a slide member which is slidably mounted on the guide portion, wherein the slide member covers and seals the second end of the fluid passageway and is slidable along the guide portion thereby uncovering the second end of the fluid passageway so that it can engage the second end of the fluid passageway of the opposing aseptic connector so as to form a continuous fluid pathway across the aseptic connectors.

5. An aseptic connector as claimed in claim 4, wherein a seal is provided at the second end of the fluid passageway; wherein the seal is axially compressed by the slide member.

6. An aseptic connector as claimed in claim 5, wherein the seal has a structure which is configured to reduce compressive stiffness.

7. An aseptic connector as claimed in claim 5 or 6, wherein an outer surface of the seal is provided with an hourglass profile or a helical groove.

8. An aseptic connector as claimed in any one of the preceding claims, wherein the slide member comprises a male element and a female element which respectively engage with the female element and the male element of the slide member of the opposing aseptic connector.

9. An aseptic connector as claimed in any one of the preceding claims, wherein the body portion of the aseptic connector comprises a male element and a female element which respectively engage with the female element and the male element of the housing of the opposing aseptic connector.

10. An aseptic connector as claimed in claim 9, wherein the male and female elements of the housing form snap fit connections with the female and male elements of the housing of the opposing aseptic connector.

11. An aseptic connector as claimed in any one of the preceding claims, wherein one of the slide member and the guide portion comprises a groove and the other of the slide member and the guide portion comprises a rail which is received by the groove to slidably mount the slide member on the guide portion.

12. An aseptic connector as claimed in any one of the preceding claims, wherein the slide member is slidably mounted on the guide portion such that it can be slid off a distal end of the guide portion.

13. An aseptic connector as claimed in any one of the preceding claims, wherein the slide member is slidable along a direction which is perpendicular to a longitudinal axis of the fluid passageway.

14. An aseptic connector assembly comprising a pair of aseptic connectors as claimed in any one of the preceding claims.