Systems and methods allowing for reservoir filling and infusion medium delivery

• US 8,840,586 B2
• Filed: 10/27/2006
• Issued: 09/23/2014
• Est. Priority Date: 08/23/2006
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Bente, Paul F. IV, Hanson, Ian B., Moberg, Sheldon B., Mounce, R. Paul, Kovelman, Paul H., Kavazov, Julian D., Luan, Truong Gia
• Primary Examiner(s): Price, Nathan R
• Application Number:
  US11/588,875
• Publication Number:
  US 20080097327A1
• Time in Patent Office: 2,888 Days
• Field of Search: 604/122, 604150-152, 604/154, 604/155, 604233-235
• US Class Current: 604/156
• 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:

a reservoir for holding an infusion medium;

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

a plunger shaft connected to the piston, the plunger shaft having a mating portion for mating with a linkage portion of a drive device for driving the plunger shaft so as to move the piston to force the infusion medium out of the reservoir when the linkage portion of the drive device is mated with the mating portion of the plunger shaft; and

a handle, the handle having a handle mating portion for mating with the mating portion of the plunger shaft, the handle further having a gripping portion for gripping the plunger shaft, the handle capable of being used by a user to move the plunger shaft so as to move the piston to allow the infusion medium to fill into the reservoir when the handle mating portion of the handle is mated with the mating portion of the plunger shaft;

wherein the mating portion of the plunger shaft has a length such that at least some of the mating portion of the plunger shaft remains outside of the reservoir at all times while the plunger shaft is moved by the handle.

2. The system of claim 1, wherein the mating portion of the plunger shaft is threaded.

3. The system of claim 1, wherein the handle mating portion of the handle is threaded.

4. The system of claim 1,

wherein the mating portion of the plunger shaft comprises a partial nut;

and

wherein the handle mating portion of the handle comprises a threaded interface.

5. The system of claim 1, wherein the gripping portion of the handle comprises a gripping arm for gripping the plunger shaft when the handle mating portion of the handle is mated with the mating portion of the plunger shaft.

6. The system of claim 1,

wherein the reservoir has a port that is connectable to an infusion path to allow for delivering the infusion medium from the reservoir to a body of a particular user;

and

wherein the port is connectable to a transfer path to allow for the infusion medium to be filled into the reservoir from an infusion medium container.

7. The system of claim 1, further comprising:

a transfer guard connectable to the reservoir for providing a path to allow the infusion medium to be transferred from an infusion medium container to the reservoir.

8. The system of claim 1, further comprising:

a base adapted to be secured to a particular user;

wherein the reservoir is connected to the base or is integrated into the base.

9. The system of claim 8, wherein the reservoir is connectable to an infusion path to allow for delivering the infusion medium from the reservoir to a body of the particular user through an opening in the base.

10. The system of claim 1, further comprising:

the drive device having the linkage portion;

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

wherein the motor is able to move the linkage portion of the drive device so as to drive the plunger shaft when the linkage portion of the drive device is mated with the mating portion of the plunger shaft.

11. The system of claim 10, wherein the linkage portion of the drive device is threaded.

12. The system of claim 10, further comprising:

a disposable housing for housing the reservoir and for being secured to a particular user; 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 1, wherein the reservoir 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.

14. The system of claim 1, wherein the piston 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.

15. The system of claim 1, wherein the plunger shaft has a length such that a portion of the plunger shaft remains outside of the reservoir at all times while the plunger shaft is driven by the drive device.

16. The system of claim 1,

wherein the piston is moveable in an axial direction;

and

wherein the plunger shaft extends from the piston in the axial direction.

17. The system of claim 1, wherein at least some of the handle mating portion of the handle remains outside of the reservoir at all times while the plunger shaft is moved by the handle.

18. The system of claim 17, wherein at least some of the gripping portion of the handle remains outside of the reservoir at all times while the plunger shaft is moved by the handle.

19. The system of claim 1,

wherein the mating portion of the plunger shaft corresponds to a location at which the plunger shaft engages with and disengages from the linkage portion of the drive device when the plunger shaft is connected to and disconnected from, respectively, the drive device;

and

wherein the mating portion of the plunger shaft corresponds to the location at which the plunger shaft engages with and disengages from the mating portion of the handle when the plunger shaft is connected to and disconnected from, respectively, the handle.

20. The system of claim 1, wherein the mating portion of the plunger shaft is a threaded portion arranged external from the plunger head, the threaded portion for engaging a threaded portion of the linkage portion of the drive device and a threaded portion of the mating portion of the handle.

21. The system of claim 1,

the reservoir having an interior volume for holding the infusion medium;

the piston being moveable in a first direction to allow the infusion medium to fill into the interior volume of the reservoir and a second direction to force the infusion medium out of the interior volume of the reservoir;

the mating portion of the plunger shaft for mating with the linkage portion of the drive device for driving the plunger shaft so as to move the piston in the second direction to force the infusion medium out of the interior volume of the reservoir when the linkage portion of the drive device is mated with the mating portion of the plunger shaft;

the handle capable of being used by the user to move the plunger shaft so as to move the piston in the first direction to allow the infusion medium to fill into the interior volume of the reservoir when the handle mating portion of the handle is mated with the mating portion of the plunger shaft;

wherein the at least some of the mating portion of the plunger shaft remains outside of the reservoir at all times while the plunger shaft is moved by the handle.

22. The system of claim 21, wherein the at least some of the mating portion of the plunger shaft remains outside of the reservoir and outside the interior volume of the reservoir at all times while the plunger shaft is moved by the handle.

23. The system of claim 1, wherein at least a portion of the mating portion of the plunger shaft remains within the reservoir while the plunger shaft is moved by the handle.

24. The system of claim 1,

the reservoir having an outer wall enclosing an interior volume having a first volume portion and a second volume portion, the first volume portion and the second volume portion separated by the piston;

the first volume portion for holding the infusion medium;

the first volume portion being variable in volume inversely with the second volume portion as the piston is moved within the reservoir;

wherein the at least some of the mating portion of the plunger shaft remains outside of the reservoir and outside the second volume portion at all times while the plunger shaft is moved by the handle.

25. The system of claim 1,

the reservoir having an axial dimension, the piston disposed in the reservoir for movement along the axial dimension;

wherein the plunger shaft and the mating portion of the plunger shaft extend out of the piston in a direction of the axial dimension of the reservoir.

26. The system of claim 1,

wherein the plunger shaft is arranged to be partially inside the reservoir and partially outside the reservoir while the plunger shaft is moved by the handle to move the plunger in the reservoir;

and

wherein the plunger shaft is arranged to be partially inside the reservoir and partially outside the reservoir while the plunger shaft is moved by the drive device to move the plunger in the reservoir.

27. A system, comprising:

a plunger shaft connected to a piston, the plunger shaft having a mating portion;

a handle having a handle mating portion for mating with the mating portion of the plunger shaft, the handle further having a gripping portion for gripping the plunger shaft, the handle capable of being pulled to move the plunger shaft so as to move the piston within a reservoir to allow an infusion medium to fill into the reservoir when the handle mating portion of the handle is mated with the mating portion of the plunger shaft; and

a drive device having a linkage portion for mating with the mating portion of the plunger shaft, the drive device configured to drive the plunger shaft so as to move the piston within the reservoir to force the infusion medium out of the reservoir when the linkage portion of the drive device is mated with the mating portion of the plunger shaft;

wherein the mating portion of the plunger shaft has a length such that at least some of the mating portion of the plunger shaft remains outside of the reservoir at all times while the plunger shaft is driven by the drive device.

28. The system of claim 27, wherein the gripping portion of the handle comprises a gripping arm for gripping the plunger shaft when the handle mating portion of the handle is mated with the mating portion of the plunger shaft.

29. The system of claim 27,

wherein the mating portion of the plunger shaft is threaded;

wherein the linkage portion of the drive device is threaded; and

wherein the linkage portion of the drive device is rotatable by the drive device to drive the plunger shaft so as to move the piston within the reservoir to force the infusion medium out of the reservoir when the linkage portion of the drive device is mated with the mating portion of the plunger shaft.

30. The system of claim 27, wherein the handle is shaped such that the handle mating portion of the handle is rotatable when mated with the mating portion of the plunger shaft to cause the gripping portion of the handle to grip the plunger shaft.

31. The system of claim 27, the gripping portion extending from the handle mating portion of the handle.

32. The system of claim 27, the gripping portion comprising a sleeve that surrounds the handle mating portion of the handle, the sleeve spaced apart from the handle mating portion by a distance that allows for the plunger shaft to be held between the sleeve and the handle mating portion.

33. The system of claim 27,

wherein the gripping portion comprises a first portion and a second portion;

wherein the first portion of the gripping portion extends from the handle mating portion of the handle; and

wherein the second portion of the gripping portion extends from the first portion in a different direction than a direction in which the first portion extends from the handle mating portion.

34. The system of claim 27, the gripping portion of the handle comprising a gripping arm for gripping the plunger shaft on an outside surface of the plunger shaft while remaining completely external to the plunger shaft.

35. The system of claim 27, wherein the mating portion of the plunger shaft is configured such that the plunger shaft is moveable relative to the linkage portion of the drive device upon being driven by the drive device.

36. The system of claim 27, wherein the linkage portion of the drive device remains outside of the reservoir regardless of how far the plunger shaft has been driven into the reservoir when the linkage portion of the drive device is mated with the mating portion of the plunger shaft.

37. The system of claim 27, wherein the gripping portion of the handle is biased in a direction toward the handle mating portion of the handle.

38. A method of manufacturing a system, comprising:

providing a reservoir;

disposing a piston at least partially within the reservoir such that the piston is moveable within the reservoir to allow an infusion medium to fill into the reservoir and to force the infusion medium out of the reservoir;

connecting a plunger shaft to the piston, the plunger shaft having a mating portion for mating with a linkage portion of a drive device and drivable by the drive device so as to move the piston to force the infusion medium out of the reservoir when the linkage portion of the drive device is mated with the mating portion of the plunger shaft; and

providing a handle that has a handle mating portion for mating with the mating portion of the plunger shaft and that further has a gripping portion for gripping the plunger shaft, the handle capable of being used to move the plunger shaft so as to move the piston to allow the infusion medium to fill into the reservoir when the handle mating portion of the handle is mated with the mating portion of the plunger shaft;

wherein the mating portion of the plunger shaft has a length such that at least some of the mating portion of the plunger shaft remains outside of the reservoir at all times while the plunger shaft is driven by the drive device.

39. The method of claim 38, further comprising:

providing a transfer guard that is connectable to the reservoir.

40. The method of claim 38, further comprising:

providing a base that is adapted to be secured to a user; and

connecting the reservoir to the base.

41. The method of claim 38, further comprising:

providing the drive device, the drive device including a motor for rotating the linkage portion at a location where the linkage portion mates with the mating portion of the plunger shaft.