Sterile connector

• US 7,137,974 B2
• Filed: 07/24/2003
• Issued: 11/21/2006
• Est. Priority Date: 07/26/2002
• Status: Active Grant

• Current Assignee: EMD Millipore Corporation (Merck & Co., Inc.)
• Original Assignee: Millipore Corporation
• Inventors: Morrissey, Martin, Belongia, Brett M., Renganath, Naren, Proulx, Stephen, Nguyen, Chau, Nauseda, Curtis, Almasian, Joseph M., Lentine, Frank
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): Deak, Leslie R
• Application Number:
  US10/626,282
• Publication Number:
  US 20050090797A1
• Time in Patent Office: 1,216 Days
• Field of Search: 604/403, 604/411, 604/413, 604/905, 604/533, 604/507, 604537-539, 604/317, 604/513, 604/288.03, 604/33, 251/149.9, 251/148, 137/614, 137/614.04, 137/614.03, 137/614.06
• US Class Current: 604/411
• CPC Class Codes: A61M 39/14 for connecting tubes having sealed ends needle sets A61M5/162; having valves closing automatically on disconnection of line A61M39/26
• CPC Class Codes: A61M 39/18 Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: F16L 2201/44 sterile
• CPC Class Codes: F16L 29/007 Joints with cut-off devices controlled separately takes precedence; operating means for cut-off devices in general F16K31/00
• CPC Class Codes: G01N 1/2035 by deviating part of a fluid stream, e.g. by drawing-off or tapping
• CPC Class Codes: G01N 2001/205 using a valve
• CPC Class Codes: G01N 2001/2071 Removable sample bottle
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable
• CPC Class Codes: Y10T 137/87925 Separable flow path section, valve or closure in each

Abstract

A sterile to sterile connection device comprising a connector and one or more coupling devices. The connector has body portion which has two openings sealed from the environment so as to form a sterile environment within the connector. At least one of the openings being sealed from the environment by a sterile barrier plug. The connector also has a port capable movement within the body of the connector to at least an open and a closed position. The coupling device is formed of a body having two openings and a stem having a bore through at least a portion of the stem. The stem is contained within the body and capable of moving at least linearly through the body between a first and second stem position. One of the openings of the stem is sealed from the environment by a sterile barrier plug and the other is sealed to a presterilized component. The coupling device opening containing the sterile barrier plug is attached to either the inlet or outlet of the connector.

Claims

1. A sterile connection device comprising a connector having two openings, each opening being sealed from the environment so as to form a sterile environment within the connector, at least one opening being sealed from the environment by a first sterile barrier plug, the connector also comprising a port capable of three positions, a first closed position, a second partially opened position and a third open position, wherein the port of the connector in its closed position has a portion supporting the sterile plug and maintaining it in its position within the connector, the port has a first opening and a second opening wherein the first opening is capable of containing two or more sterile barrier plugs, at least one coupling device, the coupling device being comprised of a body having an inlet and an outlet, a stem contained within the body and capable of moving at least linearly through the body between a first and second stem position, the outlet being sealed from the environment by a sterile barrier plug and the inlet being sealed to a presterilized component, the outlet of the at least coupling device being attached to either the inlet or outlet of the connector.

2. The device of claim 1 wherein both openings of the connector is sealed by a sterile barrier plug and a coupling device is attached to each of the two openings of the connector.

3. The device of claim 1 wherein an area of the port surrounding each opening contains a liquid tight seal.

4. The device of claim 1 wherein an area of the port surrounding each opening contains a liquid tight seal in the form of an O-ring retained within a performed channel.

5. The device of claim 1 wherein an area of the port surrounding each opening contains a liquid tight seal in the form of a formed in place resilient gasket retained within a performed channel.

6. A process of forming a sterile to sterile connection comprising (a) taking a connector having two openings, each opening being sealed from the environment so as to form a sterile environment within the connector, at least one opening being sealed from the environment by a first sterile barrier plug, the connector also comprising a port capable of three positions, a first closed position, a second partially opened position and a third open position, wherein the port of the connector in its closed position has a portion supporting the sterile plug and maintaining it in its position within the connector, the port has a first opening and a second opening wherein the first opening is capable of containing two or more sterile barrier plugs, (b) attaching at least one coupling device to an opening of the connector containing the sterile barrier plug, the coupling device having a body having an inlet and an outlet, a stem contained within the body and capable of moving at least linearly through the body between a first and second stem position, the outlet being sealed from the environment by a sterile barrier plug and the inlet being sealed to a presterilized component, (c) moving the port to the second partially opened position to align the first opening with the sterile barrier plugs of the connector and the coupling device, (d) moving the plugs of the connector and the coupling into the first opening of the port and (e) moving the port to the third open position to align the second opening with the outlet of the coupling device so as to establish fluid communication between the coupling device and the connector.

7. The process of claim 6 further comprising (f) moving the stem of the coupling device through the second opening of the port of the connector to form a sterile pathway.

8. The process of claim 6 wherein the movement of the port in steps (c–

e) is linear.

9. A sterile connection device comprising a connector having two openings, an inlet and an outlet, each opening being sealed from the environment so as to form a sterile environment within the connector, the outlet being sealed to a sterile downstream component, the inlet being sealed from the environment by a first sterile barrier plug, the connector also comprising a port capable of three positions, a first closed position, a second partially opened position and a third open position, wherein the port of the connector in its closed position has a portion supporting the sterile plug and maintaining it in its position within the connector, the port has a first opening and a second opening wherein the first opening is capable of containing two or more sterile barrier plugs, at least one coupling device attached to the inlet of the connector, the coupling device being comprised of a body having an outlet for the device, a stem contained within the body and capable of moving at least linearly through the body between a first and second stem position, the stem containing an inlet to the device at a location distal from the outlet of the device, the outlet being sealed from the environment by a sterile barrier plug and the inlet being sealed to a presterilized component.

10. A process of forming a sterile to sterile connection comprising (a) taking a connector having two openings, each opening being sealed from the environment so as to form a sterile environment within the connector, at least one opening being sealed from the environment by a first sterile barrier plug, the connector also comprising a port capable of three positions, a first closed position, a second partially opened position and a third open position wherein the port of the connector in its closed position has a portion supporting the sterile plug and maintaining it in its position within the connector, the port has a first opening and a second opening wherein the first opening is capable of containing two or more sterile barrier plugs, (b) attaching at least one coupling device to the opening of the connector containing the sterile barrier plug, the coupling device having a body having an inlet and an outlet, a stem contained within the body and capable of moving at least linearly through the body between a first and second stem position, the outlet being sealed from the environment by a sterile barrier plug and the inlet being sealed to a presterilized component, (c) rotating the port to the second partially opened position so as to align the first opening of the port with the sterile plugs of the connector and coupling device, (d) moving the plugs of the connector and the coupling into the first opening of the port and (e) rotating the port to the third open position so as align the second opening of the port with the outlet of the coupling device so as to establish fluid communication between the coupling device and the connector.

11. The process of claim 10 further comprising (f) moving the stem of the coupling device linearly through the second opening of the port of the connector to form a sterile pathway.