STERILE CONNECTOR

Abstract

A sterile connector includes a first section of tubing with a first end portion to be connected to a second end portion of a second section of tubing and/or another counterpart to establish fluid communication. An axial protrusion extends away from the first end portion of the first section of tubing in an axial direction, and a separation layer closes off an inside of the section of tubing. The separation layer has a predetermined breaking site, and the axial protrusion is connected pivotally to the first end portion of the first section of tubing to pivot from a first position to a second position when engaged with a second axial protrusion and/or with the other counterpart and is coupled to the separation layer to exert a breaking force on the separation layer in the second position.

Claims

1. A sterile connector for tubing comprising: a section of tubing with an end portion to be connected to a further end portion of a further section of tubing and/or another counterpart in order to establish fluid communication, at least one axial protrusion extending away from the end portion of the section of tubing in an axial direction of the section of tubing, and a separation layer which closes off an inside of the section of tubing, wherein the separation layer comprises a predetermined breaking site and that the at least one axial protrusion is connected pivotally to the end portion of the section of tubing to pivot from a first position to a second position when engaged with a further axial protrusion on the further end portion of the further section of tubing and/or with the other counterpart and is coupled to the separation layer so as to exert a breaking force on the separation layer in the second position which breaking force is big enough to break the separation layer at the predetermined breaking site.

2. The sterile connector according to claim 1, wherein an elastic hinge is provided for the pivotal connection of the axial protrusion to the end portion of the section of tubing.

3. The sterile connector according to claim 1, wherein the axial protrusion is tension-less in the first position and/or tensioned in the second position.

4. The sterile connector according to claim 1, wherein—viewed in a longitudinal cross section—the axial protrusion is connected to the end portion of the section of tubing through a U-shaped portion, wherein a first leg of the U-shaped portion is attached to the end portion of the section of tubing and a second leg of the U-shaped portion is attached to the axial protrusion.

5. The sterile connector according to claim 4, wherein—viewed in the longitudinal cross section—an open side of the U-shaped portion faces towards a central axis (X) of the section of tubing and/or a closed side of the U-shaped portion faces outwards with respect to the section of tubing.

6. The sterile connector according to claim 1, wherein the section of tubing, the axial protrusion, and the separation layer is made of the same material, wherein preferably the elastic hinge and/or the U-shaped portion is also made of the same material.

7. The sterile connector according to claim 1, wherein the axial protrusion is arranged circumferentially around the end portion of the section of tubing, preferably completely surrounding the end portion.

8. The sterile connector according to claim 1, wherein the axial protrusion extends radially away from the section of tubing.

9. The sterile connector according to claim 1, wherein—viewed in a longitudinal cross section—the axial protrusion is provided with a surface facing away from the section of tubing in the axial direction for engaging the further axial protrusion.

10. The sterile connector according to claim 1, wherein a connector element is provided which surrounds the section of tubing.

11. The sterile connector according to claim 10, wherein the connector element comprises a skirt configured to surround the end portion of the section of tubing and the axial protrusion when the section of tubing is connected to the further section of tubing and/or the other counterpart.

12. The sterile connector according to claim 11, wherein the skirt and the axial protrusion are sized such that the skirt is in contact with the axial protrusion when the axial protrusion is in the second position.

13. The sterile connector according to claim 10, wherein the connector element comprises a sheath portion which is in—preferably circumferential—contact with the section of tubing and which includes an edge portion configured to act as counter bearing against a base portion of the axial protrusion and/or the elastic hinge when the connector element is moved axially towards the end portion of the section of tubing.

14. A sterile connection between a section of tubing and a further section of tubing in fluid communication with each other, wherein the section of tubing and the further section of tubing each comprise the sterile connector according to claim 1 where the respective axial protrusions are in the respective second positions and the respective separation layers are broken, preferably such that the respective end portions of the sections of tubing are in direct contact with each other.

Description

BRIEF DESCRIPTION OF THE INVENTION

[0045] Further details and advantages are apparent from the figures and the accompanying description of the figures. The figures show:

[0046] FIG. 1 shows a sterile connector according to the invention,

[0047] FIGS. 2 to 4 illustrates establishing the sterile connection according to the invention in three stages, and

[0048] FIGS. 5 to 7 show three example configurations for predetermined breaking sites.

DETAILED DESCRIPTION OF THE INVENTION

[0049] FIG. 1 shows the sterile connector 1 according to the invention. It includes a section of tubing 2, at the end of which there are provided an axial protrusion 4 and separation layer 5, which closes of the inside 6 of the section of tubing 2. The inside 6 is the area through which later fluid is conveyed. It extends along the central axis X of the section of tubing 2.

[0050] There is a U-shaped element 9 which connects the end portion 3 of the section of tubing 2 to the base of the axial protrusion 4 wherein a first leg of the U-shaped portion 9 is attached to the end portion 3 of the section of tubing 2 and a second leg of the U-shaped portion 9 is attached to the axial protrusion 4.

[0051] There is also a connector element 12 comprising a skirt 13 which surrounds the end portion 3 of the section of tubing 2 and the axial protrusion 4 when the section of tubing 2 is connected to the further section of tubing and/or the other counterpart.

[0052] The connector element furthermore comprises a sheath portion 14 with an edge portion 15.

[0053] The protective cap 16 can be removed immediately before establishing the sterile connection 11 according to the invention.

[0054] In order to keep the figures easily viewable only FIG. 1 has been furnished with all the reference numerals.

[0055] The function of the elastic hinge 8, the U-shaped element 9, the axial protrusion 4, and the edge portion 15 becomes apparent from FIGS. 2 to 4. In FIG. 1 the axial protrusion 4 is in the first position.

[0056] FIG. 2 shows the sterile connector 1 according to the invention with an equally embodied further sterile connector 1 according to the invention where the respective axial protrusions have just made contact with each other.

[0057] As can be seen the radially and axially extending axial protrusions 4 make for a relatively large engagement surface 11 such that the requirements for personnel aligning the sterile connectors are not too great.

[0058] As can also be seen in FIG. 2 the respective axial protrusions 4 have started to pivot backwards out of the first position towards the second position. Because of the stiffness of the material at the base of the axial protrusion 4 this tension is transferred as tensile load into the separation layer 5.

[0059] Persons skilled in the art will appreciate that the edge portion 15 and the U-shaped portion 9 contribute to an effective tensioning of the separation layer 5. When a person pushes the connector elements 12 towards each other, the edge portions 15 push into the first leg of the U-shaped portion 9. Because of the flexibility of the material from which the section of tubing 2, the U-shaped portion 9, and the axial protrusion 4 is made, the first leg of the U-shaped portion 9 is pressed onto the second leg of the U-shaped portion 9. Both press into the base of the axial protrusion 4.

[0060] As a result the axial protrusion 4 is pivoted with the edge portion 15 as counter bearing towards the second position. Because of this pivoting action the base of the axial protrusion 4 rotates (as a flexible hinge together with part of the U-shaped portion 9) and due to the stiffness of the material exerts a tensioning force onto the separation layer 5.

[0061] It should be mentioned, that the material of the tubing even though it is flexible to a certain degree has a large enough stiffness in order to transmit the tension into the separation layer 5. A special aspect of the embodiments shown in FIG. 1 and FIGS. 2 to 4 is that the stiffness/flexibility of the material of the tubing, the axial protrusion 4 and the U-shaped portion 9 is chosen such that the stiffness is small enough to allow for the pivoting action described above and at the same time large enough to transmit a large enough tension into the separation layer for breaking the predetermined breaking site.

[0062] In FIG. 3 this process has progressed so far that the predetermined breaking site has broken and the insides 6 of the respective sections of tubing 2 are now in fluid communication.

[0063] The second position is defined as the position of the axial protrusion 4 in which the tension of the separation layer 5 overwhelms the breaking resistance of the predetermined breaking site 7 (here in a position somewhere between FIGS. 2 and 3).

[0064] The person operating the sterile connectors 1 according to the invention then finishes the sterile connection 11 by bringing the connector elements 12 together completely.

[0065] Persons skilled in the art will appreciate that the edge portions 15 of the connectors elements 12 support the seal between the sections of tubing 2 by pinching the respective U-shaped portions 9 and the bases of the respective axial protrusions 4 together.

[0066] In FIG. 4 the connection according the connection between the sterile connectors 1 is established.

[0067] A clip, hook, and/or brace or the like for keeping the sterile connector 1 according to the invention connected to the counterpart—in this case a further sterile connector 1—can preferably be arranged on the skirt 13. Such a clip, hook, and/or brace or the like can be embodied as in principle known in the prior art.

[0068] FIGS. 5, 6, and 7 show only the separations layer 5 in a view along the central axis X. Three different examples of predetermined breaking sites are shown, namely a point-like predetermined breaking 7 site in FIG. 5, a line-shaped predetermined breaking site 7 in FIG. 6, and a cross-shaped predetermined breaking site 7 in FIG. 7.

[0069] The invention does not only encompass embodiments with flexible hinges 8. For example mechanical hinges with a separation foil between the mechanical parts and the inside 6 are indeed conceivable.