Infusion pumps and methods and delivery devices and methods with same

• US 8,187,228 B2
• Filed: 11/30/2006
• Issued: 05/29/2012
• Est. Priority Date: 08/23/2006
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Bikovsky, Rafi
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US11/606,836
• Publication Number:
  US 20080097375A1
• Time in Patent Office: 2,007 Days
• Field of Search: 604/131, 604/151, 604/152, 604/890.1
• US Class Current: 604/152
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 2205/8206 battery-operated
• 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 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• CPC Class Codes: A61M 5/385 using hydrophobic filters
• CPC Class Codes: G01F 11/021 of the piston type G01F11/04 takes precedence
• CPC Class Codes: G01F 11/023 with provision for varying the stroke of the piston
• CPC Class Codes: G01F 11/029 provided with electric controlling means G01F11/022 and G01F11/024 take precedence
• CPC Class Codes: G01F 11/06 with provision for varying the stroke of the piston
• CPC Class Codes: Y10T 29/49826 Assembling or joining

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 an infusion medium, including a pump device, are supported by the disposable housing portion for disposal after the prescribed use, while the durable housing portion supports other components such as electronics for controlling delivery of the infusion medium from the reservoir and a drive device and drive linkage.

Claims

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

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

a second housing portion configured to be selectively engaged with and disengaged from the first housing portion to allow disposal of the first housing portion without disposing of the second housing portion, the first housing portion having an enclosed interior volume;

a drive shaft supported by the second housing portion when the second housing portion is selectively engaged with the first housing portion and when the second housing portion is disengaged from the first housing portion, for movement in a generally linear dimension;

a drive device operatively connected to the drive shaft when the second housing portion is selectively engaged with the first housing portion and when the second housing portion is disengaged from the first housing portion, to selectively move the drive shaft in the generally linear dimension; and

a pump device supported by the first housing portion, the pump device comprising;

a housing provided with a piston channel having a generally linear, longitudinal axis extending along an axial dimension, the piston channel having an inlet port for connection to a reservoir, and the piston channel having an outlet for connection in fluid flow communication with an injection site, the inlet port being separated from the outlet port by a distance along the axial dimension of the piston channel axis;

a piston located in the piston channel and having a first surface for receiving a drive force from the drive shaft when the first housing portion and the second housing portion are engaged, the piston having a second surface, and the piston having a generally linear, longitudinal axis extending along the longitudinal axis of the piston channel;

wherein the piston is moveable in the piston channel with movement of the drive shaft along the longitudinal axis of the piston channel between fill and dispense positions, such that;

in the fill position, the piston is moved to a position at which the second surface is laterally offset from the inlet port to allow fluid flow communication through the inlet port and into the piston channel;

in the dispense position, the piston is moved to a position at which the second surface covers the inlet port to obstruct fluid flow communication through the inlet port and to force fluid in the piston channel out of the outlet port; and

fluid that is allowed to flow through the inlet port into the piston channel is conveyed through the piston channel, in a direction of the longitudinal axis of the piston channel, to the outlet port by movement of the piston in the piston channel from the fill position to the dispense position.

2. A delivery device according to claim 1, wherein the pump device further comprises a one-way valve in fluid flow communication with the outlet port and arranged to allow fluid flow out from the piston channel through the outlet-port and inhibit fluid flow into the piston channel from the outlet port.

3. A delivery device according to claim 1, further comprising a reservoir having an interior volume for containing an infusion medium and a conduit connecting the interior volume of the reservoir in fluid flow communication with the inlet port of the housing of the pump device.

4. A delivery device according to claim 3, wherein the reservoir is supported by the first housing portion.

5. A delivery device according to claim 1, wherein:

the second housing portion comprises a housing structure having an interior volume in which the drive device is located,

the housing structure of the second housing portion includes a wall having an opening;

the drive shaft extends through the opening in the wall of the second housing portion.

6. A delivery device according to claim 5, wherein the drive shaft has an end that is positioned external to the second housing portion for operable connection with the surface of the piston, when the first housing portion and the durable second housing portion are engaged with each other.

7. A delivery device according to claim 1, wherein one of the first housing portion and the second housing portion has at least one flexible pawl and the other of the first housing portion and the second housing portion has at least one receptacle having a shape for receiving the at least one flexible pawl, when the first housing portion and the second housing portion are engaged with each other.

8. A delivery device according to claim 7, wherein each flexible pawl includes a first stop surface and each receptacle includes a second stop surface and wherein the first stop surface engages the second stop surface, upon the pawl being received within the receptacle.

9. A delivery device according to claim 1, further comprising electrical control circuitry contained in the second housing portion, wherein the electrical control circuitry controls the drive device for delivery of the infusion medium from the reservoir to the user when the first housing portion and the second housing portion are engaged.

10. A delivery device according to claim 1, wherein the first housing portion comprises a base portion having a bottom surface and an adhesive material on the bottom surface for securing the first housing portion to the skin of the user.

11. A delivery device according to claim 1, wherein the first housing portion comprises a base portion having a bottom surface securable to the skin of the user, the delivery device further comprising an injection site at which a hollow needle or cannula may be inserted into a user'"'"'s skin when the bottom surface of the base portion is secured to the user'"'"'s skin, and a conduit coupling the injection site in fluid flow communication with the outlet port of the pump device.

12. A delivery device according to claim 11, further comprising a one-way valve within the conduit.

13. A delivery device according to claim 1, further comprising a conduit coupled to the inlet port of the pump device, and a one-way valve within the conduit.

14. A delivery device according to claim 1,

the drive shaft having a first end for operatively communicating with the surface of the piston when the first housing portion and the second housing portion are engaged;

the first end of the drive shaft arranged to be out of operative communication with the surface of the piston when the first housing portion and the second housing portion are disengaged.

15. A delivery device according to claim 14, the drive shaft having a second end located within the second housing portion and operatively coupled to the drive device within the second housing portion.

16. A delivery device according to claim 1,

the drive shaft having a first end for engaging the surface of the piston when the first housing portion and the second housing portion are engaged;

the first end of the drive shaft arranged to be disengaged from the surface of the piston when the first housing portion and the second housing portion are disengaged.

17. A delivery device according to claim 1,

the drive shaft comprising a shaft having a constant linear dimension along a longitudinal axis and supported for movement along the longitudinal axis of the shaft.

18. A delivery device according to claim 1,

the drive shaft extending through an opening of the second housing portion and having one end within an interior of the second housing portion and a second end outside of the second housing portion.

19. A delivery device according to claim 1,

the drive shaft coupled to a rotational motion producing device.

20. A delivery device according to claim 1, wherein the housing is made of a generally rigid material that maintains a constant shape as the piston is moved from the fill position to the dispense position.

21. A pump device for conveying a fluidic medium, the pump device comprising:

a housing provided with a piston channel having a generally linear, longitudinal axis extending along an axial dimension, the piston channel having an inlet port for connection to a reservoir, and the piston channel having an outlet port for connection in fluid flow communication with an injection site, the inlet port being separated from the outlet port by a distance along the axial dimension of the piston channel axis; and

a piston located in the piston channel and having a first surface for receiving a drive force from a drive shaft, the piston having a second surface, and the piston having a generally linear, longitudinal axis extending along the longitudinal axis of the piston channel;

wherein the piston is moveable in the piston channel and along the longitudinal axis of the piston channel between fill and dispense positions upon receiving a force from a drive shaft, such that;

in the fill position, the piston is moved to a position at which the second surface is laterally offset from the inlet port to allow fluid flow communication through the inlet port and into the piston channel;

in the dispense position, the piston is moved to a position at which the second surface covers the inlet port to obstruct fluid flow communication through the inlet port and to force fluid in the piston channel out of the outlet port;

and fluid that is allowed to flow through the inlet port into the piston channel is conveyed through the piston channel, in a direction of the longitudinal axis of the piston channel, to the outlet port by movement of the piston in the piston channel from the fill position to the dispense position.

22. A pump device according to claim 21, wherein the pump device further comprises a one-way valve in fluid flow communication with the outlet port and arranged to allow fluid flow out from the piston channel through the outlet port and inhibit fluid flow into the piston channel from the outlet port.

23. A pump device according to claim 21, wherein the pump device is supported in a housing structure of an infusion delivery device having a drive device operatively coupled to the drive shaft for driving the drive shaft to apply the drive force to the surface of the piston.

24. A pump device according to claim 23, wherein the housing structure of the infusion delivery device comprises:

a disposable housing portion adapted to be secured to a user;

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, the durable housing portion having an enclosed interior volume;

wherein the pump device is supported by the disposable housing portion and the drive device is supported by the durable housing portion.

25. A pump device according to claim 24, wherein the drive shaft is supported by the durable housing portion.

26. A pump device according to claim 21, where the second surface of the piston has a generally cylindrical shape.

27. A pump device according to claim 21, where the second surface of the piston extends along the direction of the longitudinal axis of the piston channel.

28. A pump device according to claim 27, where the first surface of the piston extends along the direction transverse to the longitudinal axis of the piston channel.

29. A pump device according to claim 21, wherein the housing is made of a generally rigid material that maintains a constant shape as the piston is moved from the fill position to the dispense position.

30. A pump device according to claim 21, wherein the inlet port is configured for receiving fluid into the piston channel, the outlet port configured for conveying fluid out of the piston channel, the piston channel and piston configured to convey fluid in the axial dimension of the piston channel axis from the inlet port to the outlet port.

31. A method for delivering an infusion medium to a user, the method comprising:

providing a first housing portion and a second housing portion;

providing the first housing portion and the second housing portion with connection structure to allow the first housing portion and the second housing portion to be selectively engaged with each other for operation and disengaged from each other to allow disposal of the first housing portion without disposing of the second housing portion;

supporting a drive shaft with the second housing portion when the second housing portion is selectively engaged with the first housing portion and when the second housing portion is disengaged from the first housing portion, for movement in a generally linear dimension;

operatively connecting a drive device to the drive shaft when the second housing portion is selectively engaged with the first housing portion and when the second housing portion is disengaged from the first housing portion, to selectively move the drive shaft in the generally linear dimension;

supporting a pump housing with the first housing portion, the pump housing having a piston channel having a generally linear, longitudinal axis extending along an axial dimension;

providing the piston channel with an inlet port for connection to a source of fluidic medium;

providing the piston channel with an outlet port, the outlet port being separated from the inlet port by a distance along the axial dimension of the piston channel axis;

providing a piston having a first surface for receiving a drive force from the drive shaft when the first housing portion and the second housing portion are engaged for operation, the piston having a second surface, and the piston having a generally linear, longitudinal axis extending along the longitudinal axis of the piston channel; and

supporting the piston in the piston channel for movement in the piston channel along the longitudinal axis of the piston channel between fill and dispense positions upon receiving a force from a drive shaft, such that;

in the fill position, the piston is moved to a position at which the second surface is laterally offset from the inlet port to allow fluid flow communication through the inlet port and into the piston channel; and

in the dispense position, the piston is moved to a position at which the second surface covers the inlet port to obstruct fluid flow communication through the inlet port and to force fluid in the piston channel out of the outlet port; and

fluid that is allowed to flow through the inlet port into the piston channel is conveyed through the piston channel, in a direction of the longitudinal axis of the piston channel, to the outlet port by movement of the piston in the piston channel from the fill position to the dispense position.

32. A method according to claim 31, further comprising:

arranging a one-way valve in fluid flow communication with the outlet port to allow fluid flow out from the piston channel through the outlet-port and inhibit fluid flow into the piston channel from the outlet port.

33. A method according to claim 31, further comprising connecting a reservoir having an interior volume for containing an infusion medium in fluid flow communication with inlet port of the housing of the pump device through a fluid conduit.

34. A method according to claim 33, further comprising supporting the reservoir with the first housing portion.

35. A method according to claim 31, further comprising:

providing the second housing portion with an interior volume and a wall having an opening;

supporting the drive device in the interior volume of the second housing portion, and

extending the drive shaft through the opening in the wall of the second housing portion.

36. A method according to claim 35, further comprising positioning an end of the drive shaft external to the second housing portion for operable connection with the surface of the piston, when the first housing portion and the second housing portion are engaged with each other.