Systems and methods allowing for reservoir filling and infusion medium delivery

• US 7,811,262 B2
• Filed: 11/20/2006
• Issued: 10/12/2010
• Est. Priority Date: 08/23/2006
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Moberg, Sheldon B., Hanson, Ian B., Bente, Paul F. IV
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US11/602,428
• Publication Number:
  US 20080051710A1
• Time in Patent Office: 1,422 Days
• Field of Search: 604/155, 604/86, 604/201
• US Class Current: 604/201
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/14573 with a replaceable reservoir for quick connection/disconnection with a driving system
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1456 with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
• CPC Class Codes: A61M 5/385 using hydrophobic filters

Abstract

A system includes a durable portion with a durable housing and a separable disposable portion with a disposable housing that selectively engage with and disengage from each other. The disposable housing secures to a patient and may be disposed of after it has been in use for a prescribed period. Components that normally come into contact with a patient or with an infusion medium may be part of the disposable portion to allow for disposal after a prescribed use. A reservoir for holding the infusion medium may be part of the disposable portion, and may be supported by the disposable housing. The durable portion may include other components such as electronics for controlling delivery of the infusion medium from the reservoir, and a drive device including a motor and drive linkage.

Claims

1. A system, comprising:

an infusion medium container for holding an infusion medium;

a plunger disposed at least partially within the infusion medium container, the plunger being moveable within the infusion medium container, the plunger comprising;

a plunger body for forcing the infusion medium out of the infusion medium container; and

a plunger septum; and

a transfer guard having a transfer element for piercing the plunger septum and for providing a path between the infusion medium container and a reservoir container to allow the infusion medium to be transferred from the infusion medium container to the reservoir container, the transfer guard configured to be attachable to and detachable from the reservoir container to allow removal of the reservoir container from the system.

2. The system of claim 1,

wherein the infusion medium container comprises a vial.

3. The system of claim 1,

wherein the transfer element comprises a needle.

4. The system of claim 3,

wherein the transfer guard has a first guard portion for at least partially surrounding a first end of the needle;

and

wherein the transfer guard has a second guard portion for of at least partially surrounding a second end of the needle.

5. The system of claim 1,

wherein the plunger septum is a self sealing septum that is able to seal after being pierced.

6. The system of claim 1, further comprising:

a reservoir container for holding fluidic media, of the reservoir container having a port connectable to an infusion path to allow for delivering the infusion medium contained in the reservoir container to a body of a user upon being detached from the system.

7. The system of claim 1, further comprising:

a reservoir container for holding fluidic media, wherein the reservoir container has a degassing portion that comprises a hydrophobic material for allowing gases to escape from the reservoir while keeping the infusion medium within the reservoir.

8. The system of claim 1, further comprising:

a reservoir container for holding fluidic media; and

a piston disposed at least partially within the reservoir container, the piston being moveable to allow the infusion medium to fill into the reservoir container from the infusion medium container and to force the infusion medium out of the reservoir container.

9. The system of claim 8,

wherein the piston has a degassing portion that comprises a hydrophobic material for allowing gases to escape from the reservoir container while keeping the infusion medium within the reservoir container.

10. The system of claim 8, further comprising:

a plunger shaft connected to the piston, the plunger shaft having a mating portion for mating with a linkage portion of a drive device, the drive device allowing for driving the plunger shaft so as to move the piston to force the infusion medium out of the reservoir container in a case where the linkage portion of the drive device is mated with the mating portion of the plunger shaft and the drive device drives the plunger shaft to move the piston.

11. The system of claim 10, further comprising:

the drive device having the linkage portion;

wherein the drive device further comprises a motor for moving the linkage portion.

12. The system of claim 11, further comprising:

a disposable housing for housing the reservoir container; and

a durable housing for housing the motor of the drive device, the durable housing configured to be selectively engaged with and disengaged from the disposable housing.

13. The system of claim 12,

wherein the disposable housing is securable to a user.

14. The system of claim 12,

wherein the durable housing is securable to a user.

15. The system of claim 12,

wherein the disposable housing is securable to a user;

and

wherein the durable housing is securable to the user.

20. The system of claim 1, the plunger body configured to have an opening for containing the plunger septum.

21. The system of claim 1, the plunger septum comprising a first material and the plunger body comprising a second material different from the first material.

22. The system of claim 1, the transfer guard having an end for engaging and disengaging a connector portion of the reservoir plunger in at least one of a friction-fit and snap-fit engagement and disengagement.

23. The system of claim 1, further comprising:

a reservoir container for holding fluidic media, the reservoir container having a wall defining an interior volume for receiving the infusion medium from the infusion medium container;

the transfer guard configured to be attachable to and detachable from the reservoir container to allow removal of the reservoir container including the wall from the system.

24. The system of claim 1, wherein the plunger is disposed within the infusion medium container in contact with the infusion medium contained in the infusion medium container.

16. A method for using a system, the system comprising an infusion medium container for holding an infusion medium, a plunger that is disposed at least partially within the infusion medium container, and a transfer guard, the plunger having a plunger body and a plunger septum, the plunger body for forcing the infusion medium out of the infusion medium container, the plunger septum capable of being pierced to allow the infusion medium to flow through the plunger body, the transfer guard having a transfer element the transfer guard configured to be attachable to and detachable from a reservoir container to allow removal of the reservoir container from the system, the method comprising:

piercing the plunger septum with the transfer element of the transfer guard to provide a path between the infusion medium container and the reservoir container; and

moving the infusion medium container relative to the reservoir container to cause the infusion medium to be transferred from the infusion medium container to the reservoir container through the plunger body.

17. The method of claim 16,

wherein

moving the infusion medium container relative to the reservoir container comprises:

moving the infusion medium container relative to the reservoir container to cause the plunger body to advance within the infusion medium container to force the infusion medium out of the infusion medium container through the plunger body.

18. The method of claim 16,

wherein piercing the plunger septum comprises:

piercing the plunger septum with the transfer element of the transfer guard to provide a path between the infusion medium container and the reservoir container; and

connecting the transfer guard to the reservoir container.

19. The method of claim 18,

wherein moving the infusion medium container relative to the reservoir container comprises:

moving the infusion medium container relative to the reservoir container to cause the infusion medium to be transferred from the infusion medium container to the reservoir container through the plunger body and through a port of the reservoir container; and

wherein the method further comprises;

disconnecting the transfer guard from the reservoir container to remove the reservoir from the system; and

connecting the port of the reservoir container to an infusion path that allows for a transfer of the infusion medium contained in the reservoir container to a body of a user.

25. A method of manufacturing a system, the method comprising:

providing an infusion medium container for holding an infusion medium;

disposing a plunger at least partially within the infusion medium container, the plunger being moveable within the infusion medium container, the plunger comprising;

a plunger body for forcing the infusion medium out of the infusion medium container; and

a plunger septum;

providing a transfer guard having a transfer element for piercing the plunger septum and for providing a path between the infusion medium container and a reservoir container to allow the infusion medium to be transferred from the infusion medium container to the reservoir container; and

configuring the transfer guard to be attachable to and detachable from the reservoir container to allow removal of the reservoir container from the system.