Infusion medium delivery device and method with drive device for driving plunger in reservoir

• US 8,277,415 B2
• Filed: 11/22/2006
• Issued: 10/02/2012
• Est. Priority Date: 08/23/2006
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Mounce, R. Paul, Norton, Melissa D., Guezuraga, Robert M., Enegren, Bradley J., Bente, Paul F. IV, Hanson, Ian B., Kavazov, Julian D., Griffin, Christopher G., Moberg, Sheldon B., Holt, Mark D., Maule, Susie E., Kovelman, Paul H.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): GILBERT, ANDREW M
• Application Number:
  US11/604,172
• Publication Number:
  US 20080051711A1
• Time in Patent Office: 2,141 Days
• Field of Search: 604232-235, 604150-152, 604/154, 604/155, 604/69, 604/216, 604/218
• US Class Current: 604/150
• 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 delivery device includes a durable housing portion and a separable disposable portion that selectively engage and disengage from each other. The disposable housing portion secures to the patient-user and may be disposed of after it has been in use for a prescribed period. Components that normally come into contact with a patient-user or with infusion medium are supported by the disposable housing portion, while the durable housing portion supports other components such as electronics and a drive device. A reservoir is supported by the disposable housing portion and has a moveable plunger that operatively couples to the drive device, when the disposable and durable housing portions are engaged.

Claims

1. A delivery device for delivering a fluidic medium from first and second containers to a user, each container having a container wall defining an interior volume for containing the fluidic medium and a generally rigid plunger moveable within the interior volume of the container along an axial direction of the container for conveying the fluidic medium from the interior volume of the container, the device comprising:

a first housing portion adapted to be secured to a user, the first housing portion configured to be selectively engaged with and disengaged from the first container to allow disposal of the first container without disposing of the first housing portion and to allow selective engagement with and disengagement from the second container;

a second housing portion configured to be selectively engaged with and disengaged from the first housing portion;

an expandable structure supported by the first housing portion, the expandable structure having an interior volume and a surface for engaging the plunger and moving the plunger within the interior volume of the first container as the expandable structure is expanded;

a reservoir supported by the second housing portion, the reservoir for containing a fluidic medium for expanding the expandable structure;

a conduit for coupling the reservoir to the interior volume of the expandable structure; and

a drive device supported by the second housing portion, the drive device for selectively conveying the fluidic medium of the reservoir through the conduit from the reservoir to the interior volume of the expandable structure to selectively expand the expandable structure to engage and move the plunger within the interior volume of the first container to convey the fluidic medium from the interior volume of the first reservoir housing;

wherein, after the expandable structure has moved the plunger of the first container to convey at least some of the fluidic medium out of the interior volume of the first container, the first housing portion configured to be operatively disengaged from the first container and operatively engaged with the second container to allow the surface of the expandable structure to engage and move a plunger of the second container as the expandable structure is expanded to convey fluidic media from an interior volume of the second container.

2. A delivery device according to claim 1, wherein the drive device comprises a peristaltic drive device.

3. A delivery device according to claim 2,

wherein the peristaltic drive device comprises a rotatable rotor having a plurality of contact rollers or pads arranged to contact a first length of the conduit as the rotor is rotated;

and

wherein a support surface is provided on the second housing portion for supporting at least the first length of the conduit.

4. A delivery device according to claim 3, wherein the support surface comprises a curved surface.

5. A delivery device according to claim 1, wherein the drive device comprises a fluid pump.

6. A delivery device according to claim 3, wherein the drive device further comprises a motor operatively coupled to rotate the rotor.

7. A delivery device according to claim 6, further comprising linkage structure coupled to the motor and to the rotor, the linkage structure for transferring drive force from the motor to the rotor.

8. A delivery device according to claim 1, wherein the drive device comprises:

a rotatable rotor having a plurality of contact rollers or pads arranged to contact a first length of the conduit as the rotor is rotated; and

a motor operatively coupled to rotate the rotor;

wherein a support surface is provided on the second housing portion for supporting at least the first length of the conduit.

9. A delivery device according to claim 1,

wherein the drive device comprises a rotatable rotor having a plurality of contact rollers or pads arranged to contact a first length of the conduit as the rotor is rotated along a radius of curvature;

and

wherein a curved surface is provided on the second housing portion for supporting at least the first length of the conduit, the curved surface having a radius of curvature approximating the radius of curvature of the rotor rollers or pads.

10. A delivery device according to claim 9, wherein the drive device further comprises a motor operatively coupled to rotate the rotor.

11. A delivery device according to claim 1, wherein the expandable structure comprises a bellows structure.

12. A delivery device according to claim 1, wherein the plunger is arranged separate from the container wall and supported for movement relative to the container wall.

13. A delivery device according to claim 12, the plunger configured to seal against the container wall.

14. A delivery device according to claim 13, the plunger having a sealing member that seals against the container wall.

15. A delivery device according to claim 12,

wherein the container wall comprises a first material;

and

wherein the plunger comprises a second material different from the first material.

16. A delivery device according to claim 1,

the first housing portion comprising a disposable housing portion;

and

the second housing portion comprising a durable housing portion configured to be selectively engaged with and disengaged from the disposable housing portion to allow disposal of the disposable housing portion without disposing of the durable housing portion.

17. A delivery device according to claim 1, wherein the surface of the expandable structure for engaging the plunger is arranged in contact with the plunger when moving the plunger.

18. A delivery device according to claim 1, wherein the plunger is not moved during the period of time in which the plunger remains in a first position.

19. A delivery device according to claim 1, the expandable structure configured to allow the plunger to remain in a first position indefinitely.

20. A delivery device according to claim 1,

the drive device for selectively conveying a first discrete volume of the fluidic medium through the conduit from the reservoir to the interior volume of the expandable structure to selectively expand the expandable structure to engage and move the plunger within the interior volume of first container to a first position to convey the first discrete volume of the fluidic medium from the interior volume of the first container;

and

the drive device for selectively conveying a second discrete volume of the fluidic medium through the conduit from the reservoir to the interior volume of the expandable structure to selectively expand the expandable structure to engage and move the plunger within the interior volume of the first container to a second position to convey the second discrete volume of the fluidic medium from the interior volume of the first container following a period of time in which the plunger remains in the first position based on a reading from a sensor.

21. A delivery device according to claim 1, the expandable structure arranged at least partially within the interior volume of the first container when the first container is supported by the first housing portion.

22. A delivery device according to claim 1, wherein, when the second container is supported by the first housing portion, the drive device for selectively conveying the fluidic medium of the reservoir through the conduit from the reservoir to the interior volume of the expandable structure to selectively expand the expandable structure to engage and move the plunger within the interior volume of the second container to convey the fluidic medium from the interior volume of the second container.

23. A delivery device according to claim 16, wherein the disposable portion comprises the first container.

24. A delivery device according to claim 1,

the drive device for selectively conveying the fluidic medium of the reservoir through the conduit from the reservoir to the interior volume of the expandable structure to selectively expand the expandable structure to engage and move the plunger within the interior volume of the first container to a first position to convey a first discrete volume of the fluidic medium from the interior volume of the first container;

and

the drive device for selectively conveying the fluidic medium of the reservoir through the conduit from the reservoir to the interior volume of the expandable structure to selectively expand the expandable structure to engage and move the plunger within the interior volume of the first container to a second position to convey a second discrete volume of the fluidic medium from the interior volume of the first container following a period of time in which the plunger remains in the first position.

25. A delivery device according to claim 1, the surface of the expandable structure is configured to engage the plunger of the second container and move the plunger within the interior volume of the second container when the first reservoir housing has been replaced with the second container.

26. A delivery device according to claim 25,

the drive device for selectively conveying the fluidic medium of the reservoir through the conduit from the reservoir to the interior volume of the expandable structure to selectively expand the expandable structure to engage and move the plunger within the interior volume of the first container to a first position to convey the first discrete volume of the fluidic medium from the interior volume of the first container;

and

the drive device for selectively conveying the fluidic medium of the reservoir through the conduit from the reservoir to the interior volume of the expandable structure to selectively expand the expandable structure to engage and move the plunger within the interior volume of the first container to a second position to convey the second discrete volume of the fluidic medium from the interior volume of the first container following a period of time in which the plunger remains in the first position based on a reading from a sensor.

27. A delivery device according to claim 1, wherein, after the interior volume of the first container has been substantially emptied of the fluidic medium, the first housing portion configured to be operatively disengaged from the first reservoir housing and operatively engaged with the second container to allow the surface of the expandable structure to engage and move the plunger of the second container as the expandable structure is expanded to convey the fluidic media from the interior volume of the second container.

28. A delivery device according to claim 1, wherein the surface of the expandable structure for engaging the plunger is integral with the expandable structure.

29. A delivery device according to claim 1,

the expandable structure having an axial direction parallel with the axial direction of the first container, the expandable structure configured to expand along the axial direction of the expandable structure;

the expandable structure having a wall defining the interior volume of the expandable structure;

the wall extending along the entire length of the axial direction of the expandable structure; and

the wall comprising the surface of the expandable structure for engaging the plunger of one of the first and second containers.

30. A delivery device according to claim 1, the first housing portion having a recess for selective insertion of the first container into and removal of the first container from the recess.

31. A method for making a delivery device for delivering a fluidic medium from first and second containers, each container having a wall defining an interior volume for containing the fluidic medium and a generally rigid plunger moveable within the interior volume of the container along an axial direction of the container for conveying the fluidic medium from the interior volume of the container to a user, the method comprising:

providing a first housing portion adapted to be secured to a user;

configuring the first housing portion to be selectively engaged with and disengaged from the first container to allow disposal of the first container without disposing of the first housing portion and to allow selective engagement with and disengagement from second container;

providing a second housing portion configured to be selectively engaged with and disengaged from the first housing portion;

supporting an expandable structure on the first housing portion, the expandable structure having an interior volume;

arranging a surface of the expandable structure for engaging the plunger and moving the plunger within the interior volume of the first container as the expandable structure is expanded;

supporting a reservoir on the second housing portion, the reservoir for containing a fluidic medium for expanding the expandable structure;

coupling a conduit in fluid flow communication with the reservoir and the interior volume of the expandable structure; and

supporting a drive device on the second housing portion, the drive device for selectively conveying the fluidic medium of the reservoir through the conduit from the reservoir to the interior volume of the expandable structure to selectively expand the expandable structure to engage and move the plunger within the interior volume of the first container to convey the fluidic medium from the interior volume of the first container;

wherein, after the expandable structure has moved the plunger of the first container to convey at least some of the fluidic medium out of the interior volume of the first container, the first housing portion configured to be operatively disengaged from the first container and operatively engaged with the second container to allow the surface of the expandable structure to engage and move a plunger of the second container as the expandable structure is expanded to convey fluidic media from an interior volume of the second container.

32. A method according to claim 31, wherein supporting a drive device comprises supporting a peristaltic drive device to the conduit.

33. A method according to claim 31, wherein supporting a drive device comprises supporting a rotatable rotor for rotation and arranging the rotor having a plurality of contact rollers or pads to contact a first length of the conduit as the rotor is rotated.

34. A method according to claim 33, further comprising providing a support surface for supporting the first length of the conduit.

35. A method according to claim 34, wherein the support surface is curved.

36. A method according to claim 33, wherein supporting a drive device further comprises operatively coupling a motor to rotate the rotor.

37. A method according to claim 36, wherein supporting a motor comprises coupling a linkage structure to the motor and to the rotor for transferring drive force from the motor to the rotor.

38. A method according to claim 37, further comprising providing a support surface for supporting the first length of the conduit, wherein the support surface is curved.

39. A method according to claim 31, wherein supporting a drive device comprises:

supporting a rotatable rotor for rotation, the rotor having a plurality of contact rollers or pads arranged to contact a first length of the conduit as the rotor is rotated along a radius of curvature; and

supporting at least the first length of the conduit on a surface in the second housing portion.

40. A method according to claim 39, wherein supporting at least the first length of the conduit comprises arranging a curved surface to support the first length of the conduit, the curved surface having a radius of curvature approximating the radius of curvature of the rotor rollers or pads.

41. A method according to claim 40, wherein the expandable structure comprises a bellows structure.

42. A method according to claim 31, wherein the expandable structure comprises a bellows structure.