# US 12,181,092 B2 · Sterile connector

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- Number: US 12,181,092 B2
- Document ID: US12181092B2
- Status: Granted
- Kind: B2
- Application number: 17/399,350
- Filed: 2021-08-11
- Published: 2022-02-24
- Granted: 2024-12-31
- Earliest claimed: 2020-08-18
- Assignees: Single Use Support GmbH
- Applicants: Single Use Support GmbH
- Inventors: Johannes Kirchmair
- Web page: https://patentgrep.com/patent/US12181092B2

## CPC

- F16L 37/26: in which the connection is made by transversely moving the parts together, with or without their subsequent rotation
- A61M 39/00: Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use (for respiratory devices, e.g. tracheal tubes, A61M16/00; artificial heart valves A61F2/24)
- A61M 39/14: for connecting tubes having sealed ends {(needle sets A61M5/162; having valves closing automatically on disconnection of line A61M39/26)}
- F16J 15/064: {the packing combining the sealing function with other functions}
- A61M 39/18: Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
- A61M 2039/0036: {characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer}
- A61M 2039/1061: {Break-apart tubing connectors or couplings}
- A61M 2039/1072: {with a septum present in the connector}
- F16L 2201/44: sterile
- F16L: PIPES; JOINTS OR FITTINGS FOR PIPES; SUPPORTS FOR PIPES, CABLES OR PROTECTIVE TUBING; MEANS FOR THERMAL INSULATION IN GENERAL
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- F16J: PISTONS {(specially adapted for dampers F16F9/32)}; CYLINDERS; SEALINGS

## 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

### Claim 1

A sterile connection between a first section of tubing and a second section of tubing in fluid communication with each other, wherein the first section of tubing and the second section of tubing each comprise a sterile connector including:
a section of tubing with an end portion to be connected to a second end portion of a second section of tubing and/or a counterpart element to establish fluid communication,
an 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 closing off an inside of the section of tubing,
wherein the separation layer comprises a predetermined breaking site, and the 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 second axial protrusion on the second end portion of the second section of tubing and/or with the counterpart element, 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; and
wherein the respective axial protrusions are in respective second positions and the respective separation layers are broken.

### Claim 2 (depends on 1)

The sterile connection according to claim 1, wherein the sterile connector of each of the first section of tubing and the second section of tubing further includes an elastic hinge for allowing the pivotal connection of the axial protrusion to the end portion of the section of tubing.

### Claim 3 (depends on 2)

The sterile connection according to claim 2, wherein the elastic hinge is made of the same material as the section of tubing, the axial protrusion, and the separation layer.

### Claim 4 (depends on 1)

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

### Claim 5 (depends on 1)

The sterile connection according to claim 1, wherein, when 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.

### Claim 6 (depends on 5)

The sterile connection according to claim 5, wherein, when viewed in the longitudinal cross section, an opening of the U-shaped portion faces towards a central longitudinal axis of the section of tubing and/or a closed side of the U-shaped portion faces outwards with respect to the section of tubing.

### Claim 7 (depends on 1)

The sterile connection according to claim 1, wherein the section of tubing, the axial protrusion, and the separation layer are made of the same material.

### Claim 8 (depends on 1)

The sterile connection according to claim 1, wherein the axial protrusion is arranged circumferentially around the end portion of the section of tubing.

### Claim 9 (depends on 8)

The sterile connection according to claim 8, wherein the axial protrusion completely surrounds the end portion of the section of tubing.

### Claim 10 (depends on 1)

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

### Claim 11 (depends on 1)

The sterile connection according to claim 1, wherein, when viewed in a longitudinal cross section, the axial protrusion has a surface facing away from the section of tubing in the axial direction for engaging the second axial protrusion.

### Claim 12 (depends on 1)

The sterile connection according to claim 1, wherein the sterile connector of each of the first section of tubing and the second section of tubing further includes a connector element surrounding the section of tubing.

### Claim 13 (depends on 12)

The sterile connection according to claim 12, 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 second section of tubing and/or the counterpart element.

### Claim 14 (depends on 13)

The sterile connection according to claim 13, wherein the skirt and the axial protrusion are configured such that the skirt is in contact with the axial protrusion when the axial protrusion is in the second position.

### Claim 15 (depends on 12)

The sterile connection according to claim 12, wherein the connector element comprises a sheath portion in contact with the section of tubing, the sheath portion including an edge portion configured to act as counter bearing against a base portion of the axial protrusion and/or an elastic hinge at a base of the axial protrusion when the connector element is moved axially towards the end portion of the section of tubing.

### Claim 16 (depends on 15)

The sterile connection according to claim 15, wherein the sheath portion is in circumferential contact with the section of tubing.

### Claim 17 (depends on 1)

The sterile connection according to claim 1, wherein the axial protrusion extends away from the section of tubing and away from the end portion of the section of tubing in the axial direction of the section of tubing.

### Claim 18 (depends on 17)

The sterile connection according to claim 17, wherein the axial protrusion extends away from the section of tubing and away from the end portion of the section of tubing in a radial direction of the section of tubing.

### Claim 19 (depends on 1)

The sterile connection according to claim 1, wherein the respective end portions of the sections of tubing are in direct contact with each other.
