Flexible medicine reservoir with an internal reservoir port

• US 8,734,396 B2
• Filed: 10/23/2009
• Issued: 05/27/2014
• Est. Priority Date: 10/24/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics International AG (Roche Holding AG)
• Inventors: Wyss, Martin
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US12/604,519
• Publication Number:
  US 20100228196A1
• Time in Patent Office: 1,677 Days
• Field of Search: 604407-416, 604/905, 604/151, 604/246, 604/255, 604/256, 604/262, 128/DIG.24
• US Class Current: 604/151
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1475 Inlet or outlet ports
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence

Abstract

Devices for the automatic release of liquid medicaments are disclosed. In particular, a flexible container for storing a liquid medicament, a port for such a flexible container, and a device for the automated release of a liquid medicament are disclosed. A flexible container for storing a medicament comprises sealed top and bottom flexible sheets and at least one port mounted to a wall of the flexible container. The at least one port comprises a flange attached to the wall and an inner conduit connecting the inner storage volume and the exterior of the flexible container. The port comprises an adapter protruding through a hole in the top flexible sheet and a base plate having at least one drain channel connected to the inner conduit via an inner opening on the base plate. A device for the automated release of a medicament comprises at least one flexible container.

Claims

1. A flexible container for storing a medicament, the flexible container comprising:

a top flexible sheet having at least one port hole defined therethrough;

a bottom flexible sheet sealed to the top flexible sheet so as to form an inner storage volume between the top flexible sheet and the bottom flexible sheet; and

at least one port having;

a flange that is sealingly attached to an inner side of the top flexible sheet;

an adapter for connecting the port to a device and having an outer opening defined therein, the adapter extending from the flange and protruding through the at least one port hole in the top flexible sheet;

a base plate facing the inner storage volume and having an inner opening and at least one drain channel defined therein, the inner opening being disposed within the at least one drain channel;

an inner conduit defined therein extending from the inner opening to the outer opening so as to provide fluidic communication between the inner storage volume and the outer opening via the inner opening;

a septum disposed in a broad upper area of the inner conduit within the adapter and adjacent to the outer opening, the septum comprising a material able to reseal after being penetrated by an object; and

an outer conduit system that connects the port to the device, the outer conduit system defining an outer conduit system axis that is perpendicular to an inner opening axis extending through the inner opening,

wherein;

the flange, the adapter, and the base plate of the at least one port are integral to each other;

the at least one port is a unitary piece formed from a single continuous piece of material;

the at least one port is mounted within the flexible container only by the sealing attachment of the flange to the inner side of the top flexible sheet; and

the outer conduit system is directly connected to the inner conduit of the port and the septum separates the inner conduit from the outer opening, whereby the port can be simultaneously filled through the septum while connected to the device.

2. The flexible container of claim 1, wherein the at least one drain channel extends from the inner opening to an outer edge of the base plate.

3. The flexible container of claim 1, wherein the base plate comprises a network of interconnected drain channels.

4. The flexible container of claim 1, wherein the at least one drain channel is a plurality of drain channels arranged in a manner selected from a star-like manner and a grid-like network.

5. The flexible container of claim 1, wherein the at least one drain channel is a plurality of linear drain channels and circular drain channels.

6. The flexible container of claim 1, wherein the at least one drain channel is a plurality of drain channels formed by a number of protrusions arranged on the base plate.

7. The flexible container of claim 1, wherein the inner conduit is an integral part of the inner opening.

8. The flexible container of claim 1, wherein the flange of the at least one port is disposed within a depression on an inner side of the top flexible sheet.

9. The flexible container of claim 1, wherein the base plate comprises a shape that defines an essentially flat and smooth surface along the base plate and an adjacent area of an inner side of the top flexible sheet.

10. The flexible container of claim 1, wherein the at least one port further comprises a bubble filter, a pressure sensor, a pressure-transfer membrane, a pumping mechanism, a component of any of these, or combinations thereof.

11. The flexible container of claim 1, wherein the at least one port is a pair of ports sharing a common base plate and a common flange.

12. The flexible container of claim 1, wherein the adapter of the at least one port comprises an inwardly deformed upper edge that grips the septum.

13. The flexible container of claim 1, wherein the flange comprises circumferentially arranged energy directors that direct energy when the flange is sealingly attached to the inner side of the top flexible sheet by ultrasonic welding.

18. A device for the automated release of a medicament, the device comprising at least one flexible container according to claim 1.

19. The device of claim 18, wherein the device comprises an infusion pump.

14. A port for a flexible container that is used with a device and has walls for storing a medicament there between, the port comprising:

a flange which connects to an inner side of one of the walls;

an adapter for connecting the port to the device and having an outer opening defined therein, the adapter extending perpendicularly from the flange;

a septum disposed in a broad upper area of the inner conduit within the adapter and adjacent to the outer opening, the septum comprising a material able to reseal after being penetrated by an object;

a base plate extending from the flange and having an inner opening and at least one drain channel defined therein, the inner opening being disposed within the at least one drain channel; and

an outer conduit system that connects the port to the device, the outer conduit system defining an outer conduit system axis that is perpendicular to an inner opening axis extending through the inner opening,

wherein;

the port has an inner conduit defined therein, the inner conduit extending from the inner opening to the outer opening;

the adapter comprises an inwardly deformed upper edge that grips the septum;

the flange, the adapter, and the base plate are integral to each other;

the port is a unitary piece formed from a single continuous piece of material; and

the outer conduit system is directly connected to the inner conduit of the port and the septum separates the inner conduit from the outer opening, whereby the port can be simultaneously filled through the septum while connected to the device.

15. The port of claim 14, wherein the at least one drain channel extends from the inner opening to an outer edge of the base plate.

16. The port of claim 14, wherein the base plate comprises a network of interconnected drain channels.

17. The port of claim 14, wherein the port further comprises a bubble filter, a pressure sensor, a pressure-transfer membrane, a pumping mechanism, a component of any of these, or combinations thereof.