ASCEPTIC DISPENSER

• US 20130220484A1
• Filed: 11/01/2011
• Published: 08/29/2013
• Est. Priority Date: 11/01/2010
• Status: Active Grant

• Current Assignee: GE Healthcare Limited (General Electric Company)
• Original Assignee: GE Healthcare Limited (General Electric Company)
• Inventors: De Marco, Emiliano
• Granted Patent: US 9,533,777 B2
• Time in Patent Office: Days
• US Class Current: 141/183
• CPC Class Codes: A61J 1/06 Ampoules or carpules syringe ampoules or carpules A61M5/28
• CPC Class Codes: A61J 1/1412 Containers with closing means, e.g. caps
• CPC Class Codes: A61J 1/2037 having valve means
• CPC Class Codes: A61J 1/2075 for external venting
• CPC Class Codes: A61J 1/2082 for gas filtration
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like
• CPC Class Codes: B65B 55/02 Sterilising, e.g. of complete packages

Abstract

A sterile dispense system provides for transfer of a fluid from a disposable fluid-path to a vial without needles piercing the vial stopper, for disconnecting the vial from the disposable fluid-path while keeping integrity of the solution filled into the vial and to enable withdrawing of the solution from the vial. The pressure valve and luer valve are provided in serial connection to a fluid vial to enable clean filling and dispensing from the vial.

Claims

1. A vial assembly for a dispensing system, comprising:

a vial container having a container body defining a vial aperture and a vial cavity in fluid communication therewith;

a cap having a cap body affixed across said vial aperture so as to enclose said vial cavity, said cap body defining a gas filter aperture through said cap body, said filter aperture supporting a gas filter media therein, said cap body further defining a product passageway therethrough, said cap further comprising;

an elongate conduit including an elongate conduit body defining opposed first and second open ends and an elongate conduit passageway extending in fluid communication therebetween, said second open end of said conduit extending through said product passageway of said cap and in sealed engagement with said cap body,

a first valve member supported at said first end of said conduit; and

a second valve member supported by said first valve member, said first and second valve member are adjustable between a first orientation ensuring fluid isolation of said vial cavity and a second orientation placing said vial cavity in open fluid communication with an inlet port of said second valve member.

2. A vial assembly of claim 1, wherein said first valve member is one of a pressure valve and a luer valve.

3. A vial assembly of claim 2, wherein said second valve member is one of a pressure valve and a luer valve.

4. A vial assembly of claim 1, wherein said first valve member is one of a pressure valve and a luer valve, and wherein said second valve member is the other of a pressure valve and a luer valve.

5. A vial assembly of claim 1, wherein said first valve member is a pressure valve and said second valve member is a luer valve.

6. A vial assembly of claim 1, wherein said second end of said conduit supports an elongate rigid cannula extending through said vial cavity.

7. A vial assembly of claim 1, wherein said vial cavity and said conduit passageway are sterile environments.

8. A vial assembly of claim 7, wherein said sterile environment meets one of Class A and Class 100 levels.

9. A dispense cassette for dispensing a fluid, comprising:

a manifold comprising an elongate manifold body which defines an elongate fluid flowpath therethrough, wherein said flowpath further comprise axially-aligned flowpath segments and transverse segments, therethrough, said manifold body defining a plurality of valve sockets for receiving valve members, respectively, such that each valve socket is in fluid communication with pairs of adjacent co-axial flowpath segments as well as with a single transverse flowpath segment, said manifold further comprising a valve member rotatable seated within each valve socket, each said valve member defining a valve flowpath therethrough so as to selectably establish fluid communication between one co-axial flowpath segment and on of an opposed co-axial flowpath segment and a transverse flowpath segment;

an elongate hollow dispense conduit for each transverse segment, each dispense conduit having a dispense conduit body defining an open dispense passageway in fluid communication with its respective transverse segment,

wherein each dispense conduit is disconnectably connected to a respective vial assembly of claim 1.

10. A dispense cassette of claim 9, wherein said manifold body supports a filter cartridge at an inlet port thereof so as to provide filtered fluid isolation of said fluid flowpath.

11. A dispense cassette of claim 9, further comprising a pump mechanism for directing fluid from a source through said filter cartridge into said flowpath.

12. A dispense cassette of claim 9, wherein said manifold flowpath is a sterile environment.

13. A dispense cassette of claim 12, wherein said manifold flowpath meets a sterility level of one of Class A and Class 100.

14. A dispense cassette of claim 13, wherein the sterility level of the manifold flowpath is at least that of the vial cavity when the vial assembly are in the first orientation.

15. A kit for dispensing a fluid, said kit comprising:

a sealed container having container wall defining a container cavity;

a dispense cassette of claim 9 positioned within said container cavity;

wherein said container and said dispense cassette are adapted to allow an operator to switch each vial assembly within the container cavity from said first orientation to said second orientation prior to opening said container.

16. A dispense cassette for dispensing a fluid, comprising:

A cassette manifold comprising;

a manifold body defining at least one valve socket;

a valve body positioned within said valve socket, said valve body defining a valve passage extending therethrough;

said manifold body defining an input port, and at least one output port, such that said valve body is positionable within said valve socket to place said input port in selectable fluid communication with said at least one output port;

a luer valve supported at the second end of said filtrate conduit body, said luer valve operable between an open and closed position, wherein said open position places valve in open fluid communication with said filtrate passageway and said closed position causes said valve to seal said filtrate passageway at said luer valve; and

A dispense vial comprising;

A dispense vial container body including a body wall defining a vial cavity and an annular neck defining a vial aperture, said vial aperture in fluid communication with said vial cavity;

A container cap including a cap body, said container cap affixed to the neck of said container body so as to span said vial aperture, said cap body including opposed top and bottom surfaces and defining a fluid aperture extending through cap body and opening on each of said first and second surfaces;

An elongate vial conduit comprising a vial conduit body having a first end defining a first aperture, a second end defining a second aperture, and an elongate tubular vial conduit body extending therebetween, said tubular vial conduit body defining an elongate fluid passageway extending in fluid communication between said first and second apertures of said vial conduit body, said second end of said fluid conduit body in fluid-tight connection with said fluid aperture of said cap body so that said fluid passageway is in fluid communication with said vial cavity;

A pressure-activated valve supported at the first end of said vial conduit body, said pressure-activated valve operable between an open and closed position, wherein said open position allows fluid to flow through said pressure-activated valve and either into or out of said fluid passageway of said vial conduit, and wherein said closed position seals said fluid passageway of said vial conduit at said pressure activated valve;

Wherein said luer valve releaseably connects to said pressure activated valve, such that said luer valve and said pressure-activated valve are rotatable with respect to each other between a first position and a second position which places said pressure-activated valve in said open position and said closed position, respectively.

17. A dispense cassette of claim 16, wherein said cap body further defines

a vent aperture and a flow aperture extending in open fluid communication between said top and bottom surfaces in registry with said vial aperture, and

wherein said cap body further comprises a gas vent affixed to said cap body, said gas vent including a porous filter media defining a filter pores extending through said filter media, said filter pores in fluid communication with said vent aperture of said cap body.

18. A dispense cassette of claim 17, further comprising:

An elongate vial needle having a first end defining a first opening, a second end defining a second opening, and an elongate tubular needle body extending therebetween, said needle body defining an elongate needle passageway extending in fluid communication between said first and second opening of said needle, said needle passageway in fluid communication with said fluid passageway of said vial conduit.

19. A dispense cassette of claim 16, further comprising:

an elongate filtrate conduit comprising a conduit body having a first end defining a first aperture, a second end defining a second aperture, and an elongate tubular body extending therebetween, said tubular body defining an elongate filtrate passageway extending in fluid communication between said first and second apertures, said first end connected to said manifold body such that said first aperture is in fluid communication with said at least one output port.