Flexible multiple compartment drug container

• US 5,176,634 A
• Filed: 08/02/1990
• Issued: 01/05/1993
• Est. Priority Date: 08/02/1990
• Status: Expired due to Term

• Current Assignee: B Braun Medical Incorporated (B. Braun Holding GmbH & Co. KG)
• Original Assignee: McGaw, Inc. (B. Braun Holding GmbH & Co. KG)
• Inventors: Smith, Steven L., Young, H. T.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Polutta, Mark O.
• Application Number:
  US07/561,917
• Time in Patent Office: 887 Days
• Field of Search: 604/82, 604/87, 604/410, 604/56, 604/88-92, 604/408, 604/409, 604/416, 206/219, 206/221
• US Class Current: 604/87
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/2024 having peelable seals
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed

Abstract

A flexible container is provided for the storage and mixing together of diluents and medicaments. The container incorporates multiple compartments, separated by frangible seals, in which the diluents and medicaments are stored. The seals are ruptured by manipulation of the container to thereby mix the contents together for delivery through a standard IV arrangement to a patient.

Claims

1. A flexible container for combined storage and administration of medicament and diluent for IV solutions, the container comprising:

a flexible front sheet;

a flexible rear sheet sealed to the front sheet at a common peripheral edge;

a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheet to form a compartment containing a diluent;

a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheet to form an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment, the outlet compartment being empty when the diluent and medicament are in their separate compartments, wherein the first peelable seal is rupturable by hydraulic pressure generated by manipulation of the diluent compartment, and wherein the diluent and medicament are mixed together by further manipulation of the container after rupture of the first peelable seal to form a diluent/medicament solution and thereafter the second peelable seal is rupturable by hydraulic pressure generated by further manipulation of the now joined diluent and medicament compartments so that the diluent/medicament solution can flow into the outlet compartment; and

an outlet port in communication with the outlet compartment, the outlet port engaging the front sheet whereby the rear sheet can fully collapse against the front sheet as the diluent/medicament solution is emptied from the container.

2. A flexible container as defined in claim 1 wherein the medicament is a dry powder.

3. A flexible container as defined in claim 1 wherein the flexible rear sheet is vapor impermeable.

4. A flexible container as defined in claim 3 wherein the front sheet comprises a transparent thermoplastic polymer.

5. A flexible container as defined in claim 4 wherein the surface of the front sheet adjoining the rear sheet comprises a blend of thermoplastic elastomer and polymer;

and the surface of the rear sheet adjoining the front sheet comprises a polymer selected from the group consisting of polypropylene, polyethylene and a polypropylene - polyethylene copolymer.

6. A flexible container as defined in claim 5 wherein the rear sheet comprises:

a multi-layer laminate having

an inner layer of polypropylene interfacing with the front sheet;

an intermediate layer of aluminum foil; and

an outer layer of polyester.

7. A flexible container as defined in claim 6 wherein the front sheet comprises:

a bi-layer laminate having

an inner layer of a polypropylene - polyethylene co-polymer blended with styrene butadiene elastomer in about an 80%/20% ratio interfacing the rear sheet; and

an outer layer comprising polypropylene.

8. A container as defined in claim 7 wherein the polypropylene outer layer of the front sheet has a higher melting temperature than the inner layer of the front sheet.

9. A flexible container as defined in claim 4 wherein the interfacing layers of the front and rear sheets each comprise a thermoplastic elastomer.

10. A flexible container as defined in claim 4 wherein the interfacing layers of the front and rear sheets each comprise a polymer blended with styrene butadiene elastomer, the blend having a different percentage of styrene butadiene elastomer in the front and rear sheets.

11. A flexible container as defined in claim 5 further comprising:

a moisture impermeable cover sheet separably sealed to the front sheet, the cover sheet sized to extend over the medicament compartment.

12. A flexible container as defined in claim 11 wherein the cover sheet is a multi-layer laminate comprising:

a polypropylene copolymer layer adjacent the front sheet;

an intermediate layer of aluminum foil; and

an outer layer of polyester.

13. A flexible container for separately storing and mixing a liquid diluent and a medicament, the container comprising:

a flexible rear sheet having a thermoplastic material layer;

a flexible front sheet having a thermoplastic material layer adjacent the thermoplastic material layer of the rear sheet, the front sheet sealed to the rear sheet around a common peripheral edge;

at least two peelable seals extending across a width of a container to define at least three compartments in the container including a first compartment containing a liquid diluent;

a second compartment containing a medicament, the second compartment adjacent the first compartment; and

a third outlet compartment adjacent either the diluent or the medicament compartment, wherein the outlet compartment is empty when the diluent and medicament are in the separable diluent and medicament compartments,

a first of said peelable seals being between the diluent and medicament compartments and rupturable by means of a hydraulic force provided by compressing the rear sheet and front sheet in the area of the diluent compartment resulting in a mixture of the diluent and medicament,

a second of said peelable seals adjacent the outlet compartment rupturable by means of a hydraulic force provided by compressing the front and rear sheets covering the diluent and medicament compartments to thereby admit the diluent/medicament mixture into the outlet compartment;

an outlet port in communication with the outlet compartment, the outlet port comprising means for enabling the front and rear sheets to fully collapse together as the diluent/medicament mixture is emptied from the container; and

a moisture impermeable foil covering the medicament compartment, wherein at least a portion of the foil is removable for visual inspection of the medicament in said medicament compartment.

14. A flexible container as defined in claim 13 wherein the flexible front sheet is transparent.

15. A flexible container as defined in claim 13 wherein the flexible rear sheet comprises a multi-layer laminate including a layer of aluminum foil.

16. A flexible container as defined in claim 13 wherein the medicament is a dry powder.

17. A method for forming a flexible container for combined storage and administration of medicament and diluent for IV solutions, the method comprising the steps of:

providing a flexible, transparent, front sheet;

providing a flexible, vapor impermeable, rear sheet;

sealing the front and rear sheets together at a common peripheral edge, wherein the surface of the front sheet adjoining the rear sheet comprises a blend of thermoplastic elastomer and polymer and the surface of the rear sheet adjoining the front sheet comprises a polymer selected from the group consisting of polypropylene, polyethylene and a polypropylene - polyethylene copolymer;

heating the front and rear sheets in a first localized area to fuse together the heated portions of the adjoining surfaces, thereby forming a first peelable seal extending between two sides of the common peripheral edge, said first peelable seal separably joining the front and rear sheets to thereby form a first compartment for containing a diluent;

heating the front and rear sheets in a second localized area to fuse together the heated portions of the adjoining surfaces, thereby forming a second peelable seal extending between the two sides of the common peripheral edge, said second peelable seal separably joining the front and rear sheets to thereby form an outlet compartment and a compartment for containing a medicament, the medicament compartment being between the outlet compartment and the diluent compartment;

filling the diluent compartment with a diluent solution and filling the medicament compartment with a medicament, while leaving the outlet compartment empty;

wherein the first peelable seal is rupturable by hydraulic pressure generated by manipulation of the diluent compartment, and wherein after rupture of the first peelable seal, the diluent and medicament are mixed together by further manipulation of the container to form a diluent/medicament solution and thereafter the second peelable seal is rupturable by hydraulic pressure generated by further manipulation of the now joined diluent and medicament compartments so that the diluent/medicament solution can flow into the outlet compartment; and

forming an outlet port in communication with the outlet compartment, the outlet port engaging the front sheet whereby the rear sheet is configured to fully collapse against the front sheet as the diluent/medicament solution empties from the container.

18. The method according to claim 17 comprising heating the front and rear sheets using a dual hot bar heat sealing apparatus having a front bar and a rear bar wherein the front bar temperature is higher than the rear bar temperature.

19. The method according to claim 17 wherein the medicament is a dry powder.