Disposable, sterile fluid transfer device

• US 20070106264A1
• Filed: 10/20/2006
• Published: 05/10/2007
• Est. Priority Date: 04/26/2002
• Status: Active Grant

• Current Assignee: EMD Millipore Corporation (Merck & Co., Inc.)
• Original Assignee: Millipore Corporation
• Inventors: Morrissey, Martin, Tingley, Stephen, Renganath, Naren, Proulx, Stephen, Almasian, Joseph
• Granted Patent: US 8,579,871 B2
• Time in Patent Office: Days
• US Class Current: 604/533
• CPC Class Codes: A61M 2039/1027 Quick-acting type connectors
• CPC Class Codes: A61M 2039/222 frangible within tubing or bags
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 39/16 having provision for disinfection or sterilisation A61M39/143 takes precedence; methods or apparatus for disinfection or sterilisation A61L2/00
• 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: F16K 13/04 with a breakable closure member
• CPC Class Codes: F16K 15/18 with actuating mechanism; Combined check valves and actuated valves
• CPC Class Codes: F16K 3/265 with a sleeve sliding in the direction of the flow line
• CPC Class Codes: F16K 5/00 Plug valves; Taps or cocks comprising only cut-off apparatus having at least one of the sealing faces shaped as a more or less complete surface of a solid of revolution, the opening and closing movement being predominantly rotary taps of the lift-valve type F16K1/00
• CPC Class Codes: F16L 37/107 Bayonet-type couplings

Abstract

The present invention relates to a process for the sterile transfer of fluids, be they liquids or gases. It uses a presterilized device comprised of a body having a bore formed through at least a portion of its interior. Contained within the bore is a movable plunger. The body has a first and a second end. The first end contains a face designed to be attached to the upstream component. The second end is connected to a downstream component such as a filter, pipeline, sample bag and the like. The plunger has corresponding first and second ends. The first end of the plunger when it the closed position is in alignment with the face of the body which combined form a steamable surface and a sterile barrier against the environment to the rest of the interior of the body, the plunger and downstream components. The device is attached to an upstream component and the face and the first end of the plunger are steam sterilized in place.

Claims

1. ) A process for the sterile transfer of fluids comprising

a. providing a presterilized transfer device formed of a body having a bore formed through at least a portion of its interior, a movable plunger contained within the bore, the body having a first and a second end, the first end containing a face designed to be attached to the upstream component, the second end being connected to a downstream component, the plunger having a corresponding first and second end, the first end of the plunger when in a closed position being in alignment with the face of the body, which combined, form a steamable surface and a sterile barrier against the environment to the rest of the interior of the body, the plunger and downstream components;

b. attaching the first end of the transfer device to an upstream component to form a liquid tight seal;

c. steam sterilizing the upstream component and the face and first end of the plunger;

d. moving the plunger so as to allow for fluid communication between the upstream component and the bore and the downstream components; and

e. closing the plunger to seal the bore and downstream components from the upstream component.

2. ) The process of claim 1 wherein the bore of the transfer device is a central bore formed through the entire length of the body.

3. ) The process of claim 1 wherein the fluid is selected from the group consisting of liquids and gases.

4. ) The process of claim 1 wherein the device is formed of a plastic selected from the group consisting of polyetherimides(PEI), PEEK, PEK, polysulphones, polyarylsulphones, polyalkoxysulphones, polyethersulphones, polyphenyleneoxide, polyphenylenesulphide and blends thereof.

5. ) The process of claim 1 wherein the device is formed of polyetherimides(PEI).

6. ) The process of claim 1 wherein the device is capable of forming a sterile to sterile connection.

7. ) The process of claim 1 wherein the device is capable of forming a sterile to non-sterile connection.

8. ) The process of claim 1 wherein the transfer device and downstream components are presterilized by gamma radiation.

9. ) The process of claim 1 wherein the downstream components are formed of a tube having a first end connected to the second end of the body and a bag attached to the second end of the tube.

10. ) The process of claim 1 wherein the downstream components are formed of a tube having a first end connected to the second end of the body and a bag attached to the second end of the tube and further comprising the step of closing off the tube and removing the tube and bag for further use.

11. ) The process of claim 1 wherein the downstream components are formed of a tube having a first end connected to the second end of the body and a second transfer device attached to the second end of the tube.

12. ) The process of claim 1 wherein the downstream components are formed of a tube having a first end connected to the second end of the body and an encapsulated filter attached to the second end of the tube.

13. ) The process of claim 1 wherein the upstream component is a process pipe or fitting.

14. ) The process of claim 1 wherein the upstream component is a process pipe having a T fitting.

15. ) The process of claim 1 wherein the upstream component is a T fitting.