# US 10,946,183 B2 · Aseptic connector

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- Number: US 10,946,183 B2
- Document ID: US10946183B2
- Status: Granted
- Kind: B2
- Application number: 15/625,401
- Filed: 2017-06-16
- Published: 2017-10-05
- Granted: 2021-03-16
- Earliest claimed: 2012-03-27
- Assignees: Cytiva Sweden AB
- Applicants: Cytiva Sweden AB
- Inventors: Eric Faldt; Klaus Gebauer
- Web page: https://patentgrep.com/patent/US10946183B2

## CPC

- A61M 39/105: {Multi-channel connectors or couplings, e.g. for connecting multi-lumen tubes (multi-channel connectors in general F16L37/56)}
- A61M 39/16: having provision for disinfection or sterilisation {(A61M39/143 takes precedence)}
- A61M 39/18: Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
- F16L 39/00: Joints or fittings for double-walled or multi-channel pipes or pipe assemblies {(quick-acting joints for double-walled or multi-channel pipes or pipe assemblies F16L37/56)}
- F16L 2201/44: sterile
- 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)}
- F16L: PIPES; JOINTS OR FITTINGS FOR PIPES; SUPPORTS FOR PIPES, CABLES OR PROTECTIVE TUBING; MEANS FOR THERMAL INSULATION IN GENERAL

## Abstract

The invention relates to a An aseptic connector comprising a first connection unit (102; 202; 302; 402; 502) provided with a first terminal end surface (104; 204; 304; 404; 504) and a second connection unit (106; 206; 306; 406; 506) provided with a second terminal end surface (108; 208; 308; 408; 508); said first and second terminal end surfaces are each provided with at least one first and second opening (110, 112; 210, 212; 310, 312; 410, 412; 510, 512), which openings are orientated to substantially coincide when said first and second connection units are connected to each other; said first and second openings are sealed by at least one film (114; 214; 314; 414; 514) arranged on said first and second connection units, so that the contact between the film and each connection unit is aseptic; said at least one film is adapted to be mated with a corresponding film on the other connection unit when said first and second connection units are connected to each other; and said mated films are adapted to be pulled out together two and two after mating such that corresponding first and second openings in said first and second terminal end surfaces are mated aseptically. At least two first ports (116; 216; 316; 416; 516) are arranged on the first connection unit, which first ports have fluid connection with the at least one first opening (110; 210; 310; 410; 510) in the first terminal end surface; and in that at least one second port (118; 218; 318; 418; 518) is arranged on the second connection unit, which the at least one second port has a fluid connection with the at least one second opening (112; 212; 312; 412; 512) in the second terminal end surface.

## Claims

### Claim 1

An aseptic manifold comprising,
a first connection unit having a first side and a second side that is opposite to the first side, wherein the first side of the first connection unit comprises at least two first ports and the second side of the first connection unit comprises a first terminal end surface, wherein the first terminal end surface is provided with at least two first openings sealed by a first film and each first opening is in fluid communication with a corresponding first port, and
a single piece second connection unit having a first side and a second side that is opposite to the first side, wherein the first side of the second connection unit comprises one second port and the second side of the second connection unit comprises a second terminal end surface, wherein the second terminal end surface is provided with at least two second openings sealed by a second film and the second openings each extend inside the second connection unit forming two conduits that merge into a single conduit inside the second connection unit to be in fluid communication with the one second port,
wherein each of the first two openings is positioned to coincide respectively with the two second openings when the units are connected, and
wherein the first film of the first connection unit is adapted to be mated with the second film of the second connection unit such that when the first and the second connection units are connected to each other the mated films are adapted to be pulled out together to allow the first and second terminal end surfaces to mate aseptically.

### Claim 2 (depends on 1)

The aseptic manifold of claim 1, wherein the aseptic manifold is a disposable unit.

### Claim 3 (depends on 1)

The aseptic manifold of claim 1, wherein a gasket is arranged around each opening and a gasket around a first opening of the at least two first openings is adapted to mate with a corresponding gasket around a second opening of the at least two first openings when the first and the second connection units mate with each other such that each first opening is sealingly connected with its corresponding second opening.

### Claim 4 (depends on 3)

The aseptic manifold of claim 3, wherein a first foam layer is arranged around each gasket of the first terminal surface and a second foam layer is arranged around each gasket of the second terminal surface such that the first foam layer is adapted to be compressed with the second foam layer when two connection units are mated.

### Claim 5 (depends on 1)

The aseptic manifold of claim 1, wherein the first film has a first portion covering the first openings and another portion folded over the first portion forming a single sheet reaching outside the first terminal end surface as a first tab and the second film has a first portion covering the second openings and another portion folded over the first portion forming a single sheet reaching outside the second terminal end surface as a second tab and the first tab and the second tab are adapted to be pulled together to release the films from the connection units.

### Claim 6 (depends on 1)

The aseptic manifold of claim 1, wherein at least one of the first and second ports is provided with a valve, which is arranged to control fluid flow through the aseptic manifold.

### Claim 7 (depends on 1)

The aseptic manifold of claim 1, further comprising measuring means that comprises a sensor with RFID tag arranged at the aseptic manifold.

### Claim 8 (depends on 1)

The aseptic manifold of claim 1, wherein the connection units are provided with orientation specific locking means arranged to mechanically lock the connection units to each other.

### Claim 9 (depends on 1)

The aseptic manifold of claim 1, wherein the at least two first openings of the first terminal surface comprise two first openings, and the at least two first openings of the second terminal surface comprise two second openings that coincide with the two first openings when the units are connected.

### Claim 10 (depends on 1)

The aseptic manifold of claim 1, wherein the two conduit of the two second openings merge into the single conduit, forming a “Y” branching inside the single piece second connection unit.

### Claim 11 (depends on 1)

A sterile circuit comprising at least two lengths of tubing each fluidically connected to one of the at least two ports of the first connection unit of claim 1.

### Claim 12 (depends on 11)

The sterile circuit of claim 11, further comprising a container fluidically connected to the at least two lengths of tubing.

### Claim 13

An aseptic manifold comprising,
a first connection unit having a first side and a second side that is opposite to the first side, wherein the first side of the first connection unit comprises two first ports and the second side of the first connection unit comprises a first terminal end surface, wherein the first terminal end surface is provided with two first openings sealed by a first film and each first opening is in fluid communication with a corresponding first port, and
a single piece second connection unit having a first side and a second side that is opposite to the first side, wherein the first side of the second connection unit comprises one second port and the second side of the second connection unit comprises a second terminal end surface, wherein the second terminal end surface is provided with two second openings sealed by a second film and the second openings are in fluid communication with the one second port, wherein the two second openings each extend inside the second connection unit, forming two conduits that merge into a single conduit, forming a “Y” inside the second connection unit to be in fluid communication with the one second port,
wherein each of the first two openings is positioned to coincide respectively with the two second openings when the units are connected,
wherein the first film of the first connection unit is adapted to be mated with the second film of the second connection unit such that when the first and the second connection units are connected to each other the mated films are adapted to be pulled out together to allow the first and second terminal end surfaces to mate aseptically,
wherein a gasket is arranged around each opening and a gasket around a first opening of the two first openings is adapted to mate with a corresponding gasket around a second opening or the two first openings when the first and the second connection units mate with each other such that each first opening is sealingly connected with its corresponding second opening,
wherein a first foam layer is arranged around each gasket of the first terminal surface and a second foam layer is arranged around each gasket of the second terminal surface such that the first foam layer is adapted to be compressed with the second foam layer when two connection units are mated,
wherein the first film has a first portion covering the first openings and another portion folded over the first portion forming a single sheet reaching outside the first terminal end surface as a first tab and the second film has a first portion covering the second openings and another portion folded over the first portion forming a single sheet reaching outside the second terminal end surface as a second tab and the first tab and the second tab are adapted to be pulled together to release the films from the connection units.

### Claim 14 (depends on 13)

The aseptic manifold of claim 13, wherein at least one of the first and second ports is provided with a valve, which is arranged to control fluid flow through the aseptic manifold.

### Claim 15 (depends on 13)

The aseptic manifold of claim 13, further comprising measuring means that comprises a sensor with an RFID tag arranged at the aseptic manifold.

### Claim 16 (depends on 13)

The aseptic manifold of claim 13, wherein the connection units are provided with orientation specific locking means arranged to mechanically lock the connection units to each other.

### Claim 17 (depends on 13)

A sterile circuit comprising two lengths of tubing each connected to one of the two ports of the first connection unit of claim 13.

### Claim 18 (depends on 17)

The sterile circuit of claim 17, further comprising a container fluidically connected to the at least two lengths of tubing.
