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

• US 8,444,607 B2
• Filed: 10/08/2008
• Issued: 05/21/2013
• 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:
  US12/247,945
• Publication Number:
  US 20090036870A1
• Time in Patent Office: 1,686 Days
• Field of Search: 604207-211, 604/218, 604/224
• US Class Current: 604/218
• 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 2205/103 rotating
• CPC Class Codes: A61M 2205/58 Means for facilitating use, e.g. by people with impaired vision
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14236 Screw, impeller or centrifugal type pumps
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/14526 the piston being actuated by fluid pressure
• 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 5/5086 for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A delivery device includes first and second housing portions that selectively engage and disengage. A reservoir on one housing portion operatively engages a drive device and/or a needle inserting device on the other housing portion. Upon proper engagement of the housing portions, the reservoir operatively couples to the drive device and/or the needle inserting device. A first magnet on the first housing portion and a second magnet (or a magnetically-attractive material) on the second housing portion are positioned to magnetically interact with each other, upon operative engagement of the housing portions. A third magnet on the second housing portion may be opposed to the first magnet to help align the housing portions for connection. A magnet-responsive device may be on one or both housing portions to detect alignment and/or connection of the housing portions.

Claims

1. A delivery device for delivering an infusion medium to a user, the device comprising:

first and second housing portions adapted to be carried by a user and configured to be selectively engaged together for operation and selectively separated from each other;

a reservoir supported by the first housing portion, the reservoir including a reservoir housing having an axis extending along an axial dimension of the reservoir and an interior defining a volume, a plunger head moveable relative to the reservoir housing along the axial dimension within the reservoir interior to selectively change the volume of the reservoir interior, and a plunger shaft extending from the plunger head to a position outside of the reservoir housing, the plunger shaft being fixed to the plunger head when the first and second housing portions are engaged together and when the first and second housing portions are separated from each other;

a rotatable lead shaft supported by the second housing portion for rotation about the axis of the reservoir when the first and second housing portions are engaged;

a nut member having an open side, the nut member being supported in a fixed relation with the plunger shaft of the reservoir for movement along the axis of the reservoir with movement of the plunger head along the axial dimension, the nut member being fixed to the plunger shaft when the first and second housing portions are engaged together and when the first and second housing portions are separated from each other, the nut member having a structure for engaging the rotatable lead shaft in any one of a plurality of positions along the axis of the reservoir;

the rotatable lead shaft being supported by the second housing portion in a position to be inserted in a direction transverse to the axis of the reservoir through the open side of the nut member to threadably engage with the nut member, as the first and second housing portions are brought together for operative engagement, the rotatable lead shaft being rotatable when threadably engaged with the nut member, to move the nut member relative to and along the length of the rotatable lead shaft with rotation of the lead shaft.

2. A delivery device according to claim 1, wherein the nut member includes a detectable feature and wherein the delivery device further includes a sensor arranged to detect the detectable feature to provide a signal corresponding to the position of the detectable feature, wherein the position of the detectable feature corresponds to a fill state of the reservoir.

3. A delivery device according to claim 2, wherein the detectable feature comprises a magnetic material.

4. A delivery device as recited in claim 1, wherein the axial dimension defines a linear central axis that extends through the nut member during movement of the nut member on the axial dimension.

5. A delivery device as recited in claim 1, wherein the nut member has a passage in which the rotatable lead shaft resides when the rotatable lead shaft is engaged with the nut member, and wherein the axial dimension extends through the passage.

6. A delivery device as recited in claim 1, wherein:

the nut member has a passage in which the rotatable lead shaft resides when the rotatable lead shaft is engaged with the nut member;

the axial dimension defines a linear central axis; and

the linear central axis extends through the passage of the nut member.

7. A delivery device as recited in claim 1, wherein the axial dimension defines a linear central axis that extends through the nut member during movement of the nut member on the axial dimension.

8. A delivery device as recited in claim 1, wherein the nut member has a passage in which the rotatable lead shaft resides when the rotatable lead shaft is engaged with the nut member, and wherein the axial dimension extends through the passage.

9. A delivery device according to claim 1, wherein the nut member is integral with the plunger shaft.

10. A delivery device, for delivering an infusion medium to a user, the device comprising:

first and second housing portions adapted to be carried by a user and configured to be selectively engaged together for operation and selectively separated from each other;

a reservoir supported by the first housing portion, the reservoir including a reservoir housing having an axis extending along an axial dimension of the reservoir and an interior defining a volume, a plunger head moveable relative to the reservoir housing along the axial dimension within the reservoir interior to selectively change the volume of the reservoir interior, and a plunger shaft extending from the plunger head to a position outside of the reservoir housing;

a rotatable lead shaft supported by the second housing portion for rotation about the axis of the reservoir when the first and second housing portions are engaged;

a nut member having an open side, the nut member being supported in a fixed relation with the plunger shaft of the reservoir for movement along the axis of the reservoir with movement of the plunger head along the axial dimension, the nut member being fixed to the plunger shaft when the first and second housing portions are engaged together and when the first and second housing portions are separated from each other, the nut member having a structure for engaging the rotatable lead shaft in any one of a plurality of positions along the axis of the reservoir;

the rotatable lead shaft being supported by the second housing portion in a position to be inserted through the open side of the nut member to threadably engage with the nut member, as the first and second housing portions are brought together for operative engagement, the rotatable lead shaft being rotatable when threadably engaged with the nut member, to move the nut member relative to and along the length of the rotatable lead shaft with rotation of the lead shaft;

wherein the nut member comprises a generally U-shaped member having a pair of arms that are separated by a gap between the arms.

11. A delivery device according to claim 10, wherein the plunger shaft comprises a pair of rods, each rod extending from the plunger head to one respective arm of the U-shaped member.

12. A delivery device according to claim 11, wherein at least one of the nut member and at least one of the rods includes a detectable feature and wherein the delivery device further includes a sensor arranged to detect the detectable feature to provide a signal corresponding to the position of the detectable feature, wherein the position of the detectable feature corresponds to a fill state of the reservoir.

13. A delivery device according to claim 12, wherein the detectable feature comprises a magnetic material.

14. A delivery device as recited in claim 10, wherein the axial dimension extends through the gap between the arms of the generally U-shaped member of the nut member.

15. A delivery device for delivering an infusion medium to a user, the device comprising:

a reservoir including a reservoir housing having an axis extending along an axial dimension of the reservoir and an interior defining a volume, a plunger head moveable relative to the reservoir housing along the axial dimension within the reservoir interior to selectively change the volume of the reservoir interior, and a plunger shaft fixed with the plunger head;

a rotatable lead shaft supported for rotation about the axis of the reservoir,

a nut member having an open side, the nut member being supported in a fixed relation with the plunger shaft of the reservoir for movement along the axis of the reservoir with movement of the plunger head along the axial dimension, the nut member being fixed to the plunger shaft, the nut member having a structure for engaging the rotatable lead shaft in any one of a plurality of positions along the axis of the reservoir;

the rotatable lead shaft and the nut member being movable relative to each other in at least an insertion direction in which the lead shaft is inserted through the open side of the nut member to an inserted position at which the lead shaft is threadably engaged with the nut member, the rotatable lead shaft being rotatable when threadably engaged with the nut member, to move the nut member relative to and along the length of the rotatable lead shaft with rotation of the lead shaft;

a first housing portion that holds the reservoir, including the plunger shaft to which the nut member is fixedly connected,

a second housing portion that holds the rotatable lead shaft and supports the rotatable lead shaft for rotation;

wherein the first and second housing portions are configured to be selectively brought together and engaged for operation and selectively separated from each other, and

wherein the nut member and the rotatable lead shaft are supported by the first and second housing portions, respectively, in an arrangement such that the rotatable lead shaft is inserted in a direction transverse to the axis of the reservoir through the open side of the nut member to the inserted position as the first and second housing portions are brought together and engaged.

16. A delivery device according to claim 15, wherein the nut member includes a detectable feature and wherein the delivery device further includes a sensor arranged to detect the detectable feature to provide a signal corresponding to the position of the detectable feature, wherein the position of the detectable feature corresponds to a fill state of the reservoir.

17. A delivery device according to claim 16, wherein the detectable feature comprises a magnetic material.

18. A delivery device according to claim 15, wherein the plunger shaft includes a detectable feature and wherein the delivery device further includes a sensor arranged to detect the detectable feature to provide a signal corresponding to the position of the detectable feature, wherein the position of the detectable feature corresponds to a fill state of the reservoir.

19. A delivery device according to claim 18, wherein the detectable feature comprises a magnetic material.

20. A delivery device according to claim 15, wherein the nut member is integral with the plunger shaft.

21. A delivery device, for delivering an infusion medium to a user, the device comprising:

a reservoir including a reservoir housing having an axis extending along an axial dimension of the reservoir and an interior defining a volume, a plunger head moveable relative to the reservoir housing along the axial dimension within the reservoir interior to selectively change the volume of the reservoir interior, and a plunger shaft fixed with the plunger head;

a rotatable lead shaft supported for rotation about the axis of the reservoir,

a nut member having an open side, the nut member being supported in a fixed relation with the plunger shaft of the reservoir for movement along the axis of the reservoir with movement of the plunger head along the axial dimension, the nut member being fixed to the plunger shaft, the nut member having a structure for engaging the rotatable lead shaft in any one of a plurality of positions along the axis of the reservoir;

the rotatable lead shaft and the nut member being movable relative to each other in at least an insertion direction in which the lead shaft is inserted in a direction transverse to the axis of the reservoir through the open side of the nut member to an inserted position at which the lead shaft is threadably engaged with the nut member, the rotatable lead shaft being rotatable when threadably engaged with the nut member, to move the nut member relative to and along the length of the rotatable lead shaft with rotation of the lead shaft;

the rotatable lead shaft and the nut member being further movable relative to each other from the inserted position in a direction in which the lead shaft is withdrawn from the nut member through the open side of the nut member to disengage the lead shaft from the nut member.

22. A delivery device, for delivering an infusion medium to a user, the device comprising:

a reservoir including a reservoir housing having an axis extending along an axial dimension of the reservoir and an interior defining a volume, a plunger head moveable relative to the reservoir housing along the axial dimension within the reservoir interior to selectively change the volume of the reservoir interior, and a plunger shaft fixed with the plunger head;

a rotatable lead shaft supported for rotation about the axis of the reservoir,

a nut member having an open side, the nut member being supported in a fixed relation with the plunger shaft of the reservoir for movement along the axis of the reservoir with movement of the plunger head along the axial dimension, the nut member being fixed to the plunger shaft, the nut member having a structure for engaging the rotatable lead shaft in any one of a plurality of positions along the axis of the reservoir;

the rotatable lead shaft and the nut member being movable relative to each other in at least an insertion direction in which the lead shaft is inserted through the open side of the nut member to an inserted position at which the lead shaft is threadably engaged with the nut member, the rotatable lead shaft being rotatable when threadably engaged with the nut member, to move the nut member relative to and along the length of the rotatable lead shaft with rotation of the lead shaft;

wherein the nut member comprises a generally U-shaped member having a pair of arms that are separated by a gap between the arms.

23. A delivery device according to claim 22, wherein the plunger shaft comprises a pair of rods, each rod extending from the plunger head to one respective arm of the U-shaped member.

24. A delivery device according to claim 23, wherein at least one of the nut member and at least one of the rods includes a detectable feature and wherein the delivery device further includes a sensor arranged to detect the detectable feature to provide a signal corresponding to the position of the detectable feature, wherein the position of the detectable feature corresponds to a fill state of the reservoir.

25. A delivery device according to claim 24, wherein the detectable feature comprises a magnetic material.

26. A method of delivering an infusion medium to a user, the method comprising:

supporting a reservoir on a first housing structure, the reservoir including a reservoir housing having an axis extending along an axial dimension of the reservoir and an interior defining a volume, a plunger head moveable relative to the reservoir housing along the axial dimension within the reservoir interior to selectively change the volume of the reservoir interior, and a plunger shaft;

supporting a rotatable lead shaft for rotation about the axis of the reservoir;

supporting a nut member having an open side in a fixed relation with the plunger shaft of the reservoir for movement along the axis of the reservoir with movement of the plunger head along the axial dimension, the nut member being fixedly connected to the plunger shaft, the nut member having a structure for engaging the rotatable lead shaft in any one of a plurality of positions along the axis of the reservoir; and

supporting the rotatable lead shaft for relative movement between the rotatable lead shaft and the nut member in at least an insertion direction in which the lead shaft is inserted through the open side of the nut member to an inserted position at which the lead shaft is threadably engage with the nut member, the rotatable lead shaft being rotatable when threadably engaged with the nut member, to move the nut member relative to and along the length of the rotatable lead shaft with rotation of the lead shaft;

supporting the rotatable lead shaft by a second housing portion;

configuring the first and second housing portions to be selectively brought together and engaged for operation and selectively separated from each other, and

wherein the nut member and the rotatable lead shaft are supported by the first and second housing portions, respectively, in an arrangement such that the rotatable lead shaft is inserted in a direction transverse to the axis of the reservoir through the open side of the nut member to the inserted position as the first and second housing portions are brought together and engaged.

27. A method according to claim 26, wherein at least one of the plunger shaft and the nut member includes a detectable feature and wherein the delivery device further includes a sensor arranged to detect the detectable feature to provide a signal corresponding to the position of the detectable feature, wherein the position of the detectable feature corresponds to a fill state of the reservoir.

28. A method according to claim 26, wherein the nut member is integral with the plunger shaft.

29. A method, of delivering an infusion medium to a user, the method comprising:

supporting a reservoir on a first housing structure, the reservoir including a reservoir housing having an axis extending along an axial dimension of the reservoir and an interior defining a volume, a plunger head moveable relative to the reservoir housing along the axial dimension within the reservoir interior to selectively change the volume of the reservoir interior, and a plunger shaft;

supporting a rotatable lead shaft for rotation about the axis of the reservoir;

supporting a nut member having an open side in a fixed relation with the plunger shaft of the reservoir for movement along the axis of the reservoir with movement of the plunger head alone the axial dimension the nut member being fixedly connected to the plunger shaft the nut member having a structure for engaging the rotatable lead shaft in any one of a plurality of positions along the axis of the reservoir; and

supporting the rotatable lead shaft for relative movement between the rotatable lead shaft and the nut member in at least an insertion direction in which the lead shaft in a direction transverse to the axis of the reservoir is inserted through the open side of the nut member to an inserted position at which the lead shaft is threadably engage with the nut member, the rotatable lead shaft being rotatable when threadably engaged with the nut member, to move the nut member relative to and along the length of the rotatable lead shaft with rotation of the lead shaft;

further comprising supporting the rotatable lead shaft and the nut member for further movement relative to each other from the inserted position, in a direction in which the lead shaft is withdrawn from the nut member through the open side of the nut member to disengage the lead shaft from the nut member.