Systems for forming sterile fluid connections and methods of use

• US 20030226857A1
• Filed: 03/28/2003
• Published: 12/11/2003
• Est. Priority Date: 04/12/2002
• Status: Abandoned Application

• Current Assignee: Hyclone Laboratories, Inc. (Danaher Corporation)
• Original Assignee: Hyclone Laboratories, Inc. (Danaher Corporation)
• Inventors: Buchanan, Bradley H., Goodwin, Michael, Elgan, Gregory P., Bibbo, Kenneth L., Wages, William
• Application Number:
  US10/402,359
• Publication Number:
  US 20030226857A1
• Time in Patent Office: Days
• US Class Current: 222/148
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1475 Inlet or outlet ports
• CPC Class Codes: A61J 3/002 Compounding apparatus specially for enteral or parenteral nutritive solutions bottling liquids B67C
• CPC Class Codes: A61L 2/02 using physical phenomena
• CPC Class Codes: A61L 2/07 Steam
• CPC Class Codes: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2/10 Ultraviolet radiation
• CPC Class Codes: A61L 2/18 Liquid substances or solutions comprising solids or dissolved gases
• CPC Class Codes: A61L 2/208 Hydrogen peroxide
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: B01F 23/53 using driven stirrers
• CPC Class Codes: B01F 27/911 forcing the material through orifices or slits, e.g. in a stationary part
• CPC Class Codes: B01F 31/441 performing a rectilinear reciprocating movement
• CPC Class Codes: B01F 31/449 Stirrers constructions
• CPC Class Codes: B01F 33/71 working at super-atmospheric pressure, e.g. in pressurised vessels
• CPC Class Codes: B01F 35/50 Mixing receptacles
• CPC Class Codes: B01F 35/513 Flexible receptacles, e.g. bags supported by rigid containers
• CPC Class Codes: B01F 35/71 Feed mechanisms with proportioning B01F35/80
• CPC Class Codes: B01F 35/712 for feeding fluids
• CPC Class Codes: B01F 35/7173 using gravity, e.g. from a hopper
• CPC Class Codes: B01F 35/7179 : using sprayers, nozzles or jets
• CPC Class Codes: B01F 35/71805 : using valves, gates, orifices or openings
• CPC Class Codes: B01F 35/71815 : using vibrations, e.g. standing waves or ultrasonic vibrations
• CPC Class Codes: C12M 23/14 : Bags
• CPC Class Codes: C12M 27/00 : Means for mixing, agitating or circulating fluids in the vessel by introduction of gas C12M29/06, C12M29/14, mixing in general or mixers per se B01F; mixing in apparatus for chemical or physical processes B01J

Abstract

A method for forming a sterile fluid connection includes inserting a dispensing end of a fill tube into a cavity of a sterilizer. A sterilizing field is generated within the cavity of the sterilizer. A cap mounted on the end of the fill tube is removed from the fill tube while in the cavity. A fill port is disposed within the cavity. The fill tube is fluid coupled with the fill port in the cavity of the sterilizer while the dispensing end of the fill tube and the fill port are exposed to the sterilizing field. A fluid is passed from the fill tube to the fill port.

Claims

1. A dispensing system comprising:

a sterilizing filter having an inlet port and an outlet port;

a substantially rigid fill tube having an interior surface bounding a sterile channel extending between a first end and an opposing second end;

an extension tube having an interior surface bounding a sterile fluid pathway extending between a first end and an opposing second end, the first end of the extension tube being fluid coupled with the outlet port of the sterilizing filter, the second end of the extension tube being fluid coupled with the first end of the fill tube; and

a cap removably disposed on the second end of the fill tube so as to seal the channel closed thereat.

2. A dispensing system as recited in claim 1, further comprising a puncture blade mounted to and projecting from the second end of the extension tube, the puncture blade being covered by the cap.

3. A dispensing system as recited in claim 1, wherein the cap comprises:

an annular sidewall having an exterior surface; and

a catch barb outwardly projecting from the exterior surface of the sidewall.

4. A dispensing system as recited in claim 3, wherein the catch barb encircles and radially outwardly projects from the sidewall.

5. A dispensing system as recited in claim 3, wherein the sidewall has a substantially frustaconical configuration.

6. A dispensing system as recited in claim 3, wherein the fill tube is comprised of metal.

7. A dispensing system as recited in claim 2, further comprising:

a transport tube having an interior surface bounding a sterile fluid pathway extending between a first end and an opposing second end;

a container having an inlet port and bounding a sterile chamber, the inlet port of the container being fluid coupled with the second end of the transport tube;

a tubular fill port bounding a passageway extending between a first end and an opposing second end, the second end of the fill port being fluid coupled with the first end of the transport tube, a membrane covering the first end of the passageway of the fill port, the first end of the fill port being configured to selectively mate against the second end of the fill tube so that the puncture blade ruptures the membrane, thereby producing fluid communication between the fill tube and the fill port.

8. A method for forming a sterile fluid connection, the method comprising:

inserting a dispensing end of a fill tube into a cavity of a sterilizer, the fill tube having an interior surface bounding a channel extending therethrough, a cap being removably mounted on the dispensing end of the fill tube so as to seal the channel closed thereat;

generating an sterilizing field within the cavity of the sterilizer;

removing the cap from the dispensing end of the fill tube while the dispensing end of the fill tube is exposed to the sterilizing field;

positioning a first fill port within the cavity of the sterilizer;

fluid coupling the dispensing end of the fill tube with the first fill port in the cavity of the sterilizer while the dispensing end of the fill tube and the first fill port are exposed to the sterilizing field; and

passing a fluid from the fill tube to the first fill port.

9. A method as recited in claim 8, wherein the act of inserting the dispensing end of the fill tube into the cavity of the sterilizer comprises the fill tube having an inlet end coupled to one end of an extension tube, and an opposing end of the extension tube being fluid coupled to an outlet port of a sterilizing filter, a fluid pathway of the extension tube and the channel of the fill tube being sterile.

10. A method as recited in claim 8, wherein the act of removing the cap from the dispensing end of the fill tube comprises:

inserting a cap remover into the cavity of the sterilizer;

engaging the cap on the dispensing end of the fill tube to the cap remover;

separating the cap remover from the fill tube so that the cap is retained on the cap remover; and

removing the cap remover with the cap retained thereon from the cavity of the sterilizer.

11. A method as recited in claim 8, wherein the cap is continually exposed to the sterilizing field during removal from the fill tube.

12. A method as recited in claim 8, wherein the act of generating a sterilizing field comprises generating an electron field within the cavity of the sterilizer.

13. A method as recited in claim 8, wherein the act of generating a sterilizing field comprises emitting a sterilizing vapor within the cavity of the sterilizer.

14. A method as recited in claim 8, wherein the act of fluid coupling the dispensing end of the fill tube with the first fill port comprises pushing a puncture blade projecting from the fill tube against a membrane formed on the first fill port so that the puncture blade ruptures the membrane.

15. A method as recited in claim 8, wherein the act of positioning the first fill port within the cavity of the sterilizer comprises:

securing the first fill port between two mated shuttles, and sliding the mated shuttles into the sterilizer.

16. A method as recited in claim 8, further comprising:

removing the first fill port from the cavity of the housing;

inserting a second fill port in the cavity of the housing;

fluid coupling the fill tube to the second fill port.

17. A sterilizer comprising:

a housing bounding a cavity;

means for generating a sterilizing field within the cavity;

a pair of shuttles which selectively move into and out of the housing, at least a portion of one of the shuttles being exposed to the cavity when within the housing, the shuttles also being selectively movable between separated and mated positions; and

a fill tube passageway extending through at least a portion of the housing so as to communicate with the cavity.

18. A sterilizer as recited in claim 17, wherein the means for generating a sterilizing field comprises an electron beam generator communicating with the cavity.

19. A sterilizer as recited in claim 17, wherein the shuttles bound a channel when the shuttles are mated, the channel communicating with the cavity when the mated shuttles are within the housing.

20. A sterilizer as recited in claim 19, wherein the channel is curved or bent.

21. A sterilizer as recited in claim 17, wherein the fill tube passageway extends through a portion of a plunger.