Drug containment system

• US 20040001655A1
• Filed: 07/01/2002
• Published: 01/01/2004
• Est. Priority Date: 07/01/2002
• Status: Active Grant

• 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
• Granted Patent: US 7,025,754 B2
• Time in Patent Office: Days
• US Class Current: 383/202
• 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 packet comprising:

a needle guide and a septum retainer,

the needle guide being fixable to an outer face of a sealed packet and the septum retainer being fixable 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 disposed therein.

2. The container closure device of claim 1 wherein the septum retainer further comprises a cavity which receives the tip of an inserted needle and prevents the tip from contacting the adjacent face of the packet.

3. 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.

4. 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.

5. The container closure device of claim 2 wherein said septum retainer further comprises a plurality of channels which allow for continued liquid withdrawal as the packet collapses.

6. The container closure device of claim 5 wherein the septum retainer further comprises a raised portion which prevents collapse of the packet around the cavity of the septum retainer, said cavity providing a sump from which said liquid can be withdrawn without entraining residual air.

7. 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.

8. The container closure device of claim 7 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.

9. The container closure device of claim 8 wherein each of the septum retainer and the inner face of the packet comprises polyethylene terephthalate or acrylonitrile.

10. The container closure device of claim 1 wherein the needle guide and the outer face of the packet are adhesively sealed.

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

12. The container closure device of claim I wherein the needle guide further comprises a means for attaching the needle guide to a liquid delivery device.

13. The container closure device of claim 12 wherein the means for attaching the needle guide comprises a radially outwardly extending annular flange on the needle guide wherein the annular flange allows the packet to be securely held without applying pressure to the packet itself.

14. 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.

15. The liquid containment system of claim 14 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.

16. The liquid containment system of claim 15 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.

17. The liquid containment system of claim 16 wherein said inner layer comprises polyethylene terephthalate and said outer layer comprises polyethylene terephthalate.

18. The liquid containment system of claim 17 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.

19. The liquid containment system of claim 14 wherein said liquid comprises a pharmaceutically active material.

20. The liquid containment system of claim 14 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.

21. The liquid containment system of claim 14 wherein the septum retainer further comprises a plurality of channels which allow for continued liquid withdrawal as the packet collapses.

22. The liquid containment system of claim 21 wherein the septum retainer further comprises a raised portion having disposed therein a cavity wherein said cavity receives the tip of an inserted needle and prevents the tip from contacting the adjacent face of the packet;

and said raised portion of the septum retainer prevents collapse of the packet around the cavity;

said cavity providing a sump from which said liquid can be withdrawn without entraining residual air.

23. The liquid containment system of claim 14 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.

24. The liquid containment system of claim 14 wherein said annular flange engages a slot in a holder to secure the packet within the holder.