Drug containment system

• US 7,025,754 B2
• Filed: 07/01/2002
• Issued: 04/11/2006
• Est. Priority Date: 07/01/2002
• Status: Expired due to Fees

• Current Assignee: Battelle Memorial Institute
• Original Assignee: Ventaira Pharmaceuticals Inc. (Battelle Memorial Institute)
• Inventors: Proicou, George C., Peters, Richard D., Adams, Theodore Robert, Busick, David Rust
• Primary Examiner(s): Bianco, Patricia
• Application Number:
  US10/187,477
• Publication Number:
  US 20040001655A1
• Time in Patent Office: 1,380 Days
• Field of Search: 604/403, 604407-416, 604/262, 604/288.02, 604/905, 604/4.01, 604/6.154, 604/500, 604/518, 604/520, 604/522, 604/19, 604/82, 604/83, 604/906, 604 86- 90, 604200-206, 604/93.01, 604/257, 604261- 62, 604/288.01, 128/DIG.24, 383/9, 383/904, 383/906, 600/573, 600/580, 600576-579
• US Class Current: 604/408
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: Y10S 128/24 Medical-surgical bags
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

A container closure device for facilitating withdrawal of a liquid from a collapsible sealed packet is disclosed. The device includes a needle guide and a septum retainer wherein the needle guide is fixable to an outer face of the packet and the septum retainer is fixable to an inner face of the packet in alignment with the needle guide. The needle guide includes a tube for receiving a needle and insures proper alignment of the needle. The septum retainer includes a septum chamber having a septum disposed therein.

Claims

1. A container closure device for facilitating withdrawal a liquid from a collapsible sealed packed comprising:

a needle guide and a septum retainer,

the needle guide fixed to an outer face of a sealed packet and the septum retainer fixed to an inner face of the sealed packet in alignment with the needle guide,

the needle guide including a tube for receiving a needle and insuring proper alignment of the needle,

and the septum retainer having a septum and a plurality of channels disposed therein and a raised portion having a cavity formed therein for inhibiting collapse of the packet into the cavity, the cavity for receiving a tip of an inserted needle wherein the channels allow for contained liquid withdrawal as the packet collapses.

2. The container closure device of claim 1 wherein the septum retainer and inner face of the packet are constructed of materials capable of forming a heat seal to secure the septum retainer to the inner face of the packet.

3. The container closure device of claim 2 wherein each of the septum retainer and the inner face of the packet comprises at least one material selected from the group consisting of polyester, polyamide, polyethylene, polypropylene, polyvinylidine fluoride, ethylene acrylic acid, ethylene/methacrylic acid copolymer, acrylonitrile, polyacetal, and mixtures and copolymers thereof.

4. The container closure device of claim 3 wherein each of the septum retainer and inner face of the packet comprises polyethylene terephthalate or acrylonitrile.

5. The container closure device of claim 1 wherein the needle guide further comprises a radially outwardly extending annular flange on the needle guide.

6. The container disclosure device of claim 5 wherein the annular flange allows the packet to be securely held without applying pressure to the packet itself.

7. The container closure device of claim 1 wherein the septum retainer cavity further is adapted to prevent the tip from contacting the adjacent face of the packet.

8. The container closure device of claim 1 wherein the septum retainer further comprises a chamber wherein the septum is retained in isolation from the liquid contents of the packet.

9. The container closure device of claim 1 wherein the needle guide and the septum retainer include complementary contours thereby facilitating alignment of the septum retainer with the needle guide when the septum retainer is placed on the inner face of the packet and the needle guide is placed on the outer face of the packet.

10. The container closure device of claim 1 wherein the septum retainer cavity is adapted to provide a sump from which said liquid can be withdrawn without entraining residual air.

11. The container closure device of claim 1 wherein said packet contains a liquid comprising a pharmaceutically active material.

12. A liquid containment system comprising a collapsible sealed packet, a needle guide and a septum retainer,

the collapsible sealed packet comprising first and second flexible sheets superimposed and sealed together at their periphery to form a packet defining an interior for containing a liquid,

the needle guide secured to an outer face of the packet, and

the septum retainer secured to an inner face of the packet in alignment with the needle guide, the septum retainer including a raised portion having formed therein a cavity for inhibiting collapse of the packet into the cavity and for receiving a tip of an inserted needle, said septum retainer further comprising a plurality of channels which allow for contained liquid withdrawal as the packet collapses.

13. The liquid containment system of claim 12 wherein each of said first and second flexible sheets is a multilayer film comprising:

a barrier layer comprising a barrier material selected from the group consisting of foils and barrier polymers; and

an inner layer comprising a material selected from the group consisting of acrylonitrile and polyester;

wherein said inner layer is positioned between said interior of said packet and said barrier layer.

14. The liquid containment system of claim 13 wherein said multilayer film further comprises an outer layer comprising polyester;

wherein said barrier layer is positioned between said outer layer and said inner layer.

15. The liquid containment system of claim 14 wherein said inner layer comprises polyethylene terephthalate and said outer layer comprises polyethylene terephthalate.

16. The liquid containment system of claim 15 wherein the septum retainer comprises a polyethylene terephthalate and a heat-seal is formed between the inner layer and the septum retainer to secure the septum retainer to the inner face of the packet.

17. The liquid containment systems of claim 12 wherein said liquid comprises a pharmaceutically active material.

18. The liquid containment system of claim 12 wherein said needle guide includes a tube for receiving a needle and insuring proper alignment of the needle, and the septum retainer comprises a chamber wherein a septum is retained in isolation from the liquid contents of the packet.

19. The liquid containment system of claim 12 wherein the septum retainer cavity is adapted to prevent the tip from contacting the adjacent face of the packet;

and to provide a sump from which said liquid can be withdrawn without entraining residual air.

20. The liquid containment system of claim 12 wherein said needle guide comprises a radially outwardly extending annular flange wherein the annular flange enables the packet to be securely held without applying pressure to the packet itself.

21. A device comprising:

a collapsible sealed packet; and

a septum retainer fixed to an inner face of the sealed packet, said septum retainer having a raised portion having a cavity formed therein for inhibiting collapse of the packet into the cavity, the cavity for receiving a tip of a needle inserted into the sealed packet, said septum retainer further comprising a plurality of channels which allow for contained liquid withdrawal as the packet collapses.

22. The container closure device of claim 21 wherein the septum retainer cavity further is adapted to prevent the tip from contacting the adjacent face of the packet.

23. The container closure device of claim 21 wherein the septum retainer cavity provides a sump from which said liquid can be withdrawn without entraining residual air.

24. A liquid containment system comprising:

a collapsible sealed packet comprising first and second flexible sheets superimposed and sealed together to form a packet defining an interior for containing a liquid, and

a septum retainer secured to an inner face of the packet, the septum retainer including a raised portion having formed therein a cavity for inhibiting collapse of the packet into the cavity and a plurality of channels which allow for continued liquid withdrawal as the packet collapses, the cavity for receiving a tip of a needle inserted into said packet.

25. The liquid containment systems of claim 24 wherein said liquid comprises a pharmaceutically active material.

26. The liquid containment system of claim 24 wherein the septum retainer cavity is adapted to prevent the tip from contacting the adjacent face of the packet and to provide a sump from which said liquid can be withdrawn without entraining residual air.