System For Ambulatory Drug Infusion Comprising A Filling Apparatus For Flexible Containers, Container Assembly, And Use Of A Flexible Container

• US 20120150139A1
• Filed: 06/10/2011
• Published: 06/14/2012
• Est. Priority Date: 12/12/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics International AG (Roche Holding AG)
• Inventors: Studer, Gerald
• Granted Patent: US 8,827,976 B2
• Time in Patent Office: Days
• US Class Current: 604/408
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence

Abstract

An embodiment directed towards a system for ambulatory drug infusion over an extended time period from a flexible container is disclosed, and in which the system comprises a filling apparatus with a hollow support structure defining a container compartment, the container compartment being adapted to receive, fully or in part, the flexible container, and the support structure being adapted to limit the expansion of the flexible container by contacting the flexible container upon being filled, thus defining a maximum filling volume of the flexible container. In other embodiments, a container assembly is disclosed that comprises a flexible container and a support structure as well as use of a flexible container in or in combination with a system according to the invention or a container assembly according to the invention.

Claims

1. System for ambulatory drug infusion over an extended time period, the system comprising:

an ambulatory infusion apparatus, in which the infusion apparatus comprises;

a flexible container or a container coupler for fluidically coupling a flexible container,

a dosing unit in fluidic connection with the flexible container or a dosing unit coupler for fluidically coupling the flexible container and a dosing unit, and

an electronic controller unit configured to control operation of the dosing unit; and

a filling apparatus for the flexible container, in which the filling apparatus comprises a hollow support structure defining a container compartment, the container compartment being adapted to receive, fully or in part, the flexible container, and the support structure being adapted to limit the expansion of the flexible container by contacting the flexible container upon being filled, thus defining a maximum filling volume of the flexible container.

2. System according to claim 1, wherein the shape of the container compartment of the filling apparatus substantially corresponds to the shape of the flexible container after being filled.

3. System according to claim 1, wherein the filling apparatus comprises a positioning structure for fixing the flexible container with respect to the support structure.

4. System according to claim 1, wherein the support structure of the filling apparatus comprises a first support element and a second support element, the first support element and the second support element defining a first inner container compartment surface and a second inner container compartment surface, the container compartment surfaces facing each other.

5. System according to claim 4, wherein the filling apparatus comprises a volume setting assembly, wherein operating the volume setting assembly displaces at least one of the first support element and the second support element with respect to the other support element along a displacement axis.

6. System according to claim 5, wherein the volume setting assembly of the filling apparatus comprises an electrical actuator and a controller unit, the controller unit controlling operation of the electrical actuator.

7. System according to claim 1, wherein the filling apparatus comprises a filling pump.

8. System according to claim 7, wherein the filling apparatus comprises a filling timer operatively coupled to the filling pump, the filling timer being adapted to control the filling pump to operate for a given filling time.

9. System according to claim 7, wherein the filling pump of the filling apparatus is an pressure pump, the filling pump being adapted to fluidically couple to the flexible container and to a drug reservoir, the filling pump being adapted to force drug out of the drug reservoir and into the flexible container.

10. System according to claim 7, wherein the filling pump of the filling apparatus is a suction pump, the filling pump being fluidically coupled to the container compartment, the filling pump being adapted to suck air out of the container compartment, thus expanding the flexible container and sucking drug from a drug reservoir fluidically coupled to the flexible container into the flexible container.

11. System according to either of claim 7, wherein the filling apparatus comprises a pressure controller, the pressure controller being adapted to control or limit the operational pressure of the filling pump.

12. System according to claim 1, wherein the support structure of the filling apparatus is, at least in part, integral with a housing of the infusion apparatus.

13. System according to claim 1, wherein the support structure of the filling apparatus is, at least in part, integral with a removable packaging of the flexible container.

15. A method of preventing overfilling a flexible container with a defined drug amount comprising utilizing the flexible container in or in combination with a system according to claim 1.

17. System according to claim 8, wherein the filling pump of the filling apparatus is an pressure pump, the filling pump being adapted to fluidically couple to the flexible container and to a drug reservoir, the filling pump being adapted to force drug out of the drug reservoir and into the flexible container.

18. System according to claim 8, wherein the filling pump of the filling apparatus is a suction pump, the filling pump being fluidically coupled to the container compartment, the filling pump being adapted to suck air out of the container compartment, thus expanding the flexible container and sucking drug from a drug reservoir fluidically coupled to the flexible container into the flexible container.

19. System according to either of claim 10, wherein the filling apparatus comprises a pressure controller, the pressure controller being adapted to control or limit the operational pressure of the filling pump.

20. System according to claim 11, wherein the support structure of the filling apparatus is, at least in part, integral with a removable packaging of the flexible container.

14. Container assembly, comprising:

a flexible container, the flexible container comprising a container body at least one wall of which is made by a sheet of an elastic foil and a fluidic connector for fluidically connecting the container, the flexible container expanding upon being filled; and

a hollow support structure defining a container compartment, the flexible container being, at least in part, arranged in the container compartment, the support structure being adapted to limit the expansion of the flexible container by contacting the flexible container upon being filled, thus defining a maximum filling volume of the flexible container.

16. A method of preventing overfilling a flexible container with a defined drug amount comprising utilizing the flexible container in a container assembly according to claim 14.