Infusion pumps and methods and delivery devices and methods with same

• US 20080051716A1
• Filed: 11/30/2006
• Published: 02/28/2008
• Est. Priority Date: 08/23/2006
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Stutz, William H.
• Granted Patent: US 8,202,250 B2
• Time in Patent Office: Days
• US Class Current: 604/151
• 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 second housing portion having an enclosed interior volume;

a drive shaft supported by the second housing portion, for movement in a generally linear dimension;

a drive device operatively connected to the drive shaft, 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, an inlet port in fluid flow communication with the channel and configured for connection to a reservoir, and an outlet port in fluid flow communication with the channel and configured for connection in fluid flow communication with an injection site;

a piston located in the piston channel and having a first piston section and a second piston section coupled together for limited movement, relative to each other, the second piston section having a surface for operable engagement with the drive shaft when the second housing portion and first hosing portion are engaged,

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

in the fill position, the first and second piston sections are separate to form a chamber having volume between the first and second piston sections, and the chamber is aligned in fluid flow communication with the inlet port;

in the pull position, the first and second piston sections are separated and the chamber formed between the first and second piston sections is located within the channel, between the inlet port and the outlet port, out of fluid flow communication with the inlet port and the outlet port;

in the dispense position, the chamber between the first and second piston sections is aligned in fluid flow communication with the outlet port.

2. 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.

3. A delivery device according to claim 2, wherein the reservoir is supported by the first housing portion.

4. A delivery device according to claim 1, wherein

each of the first and second piston sections have an end surface facing the end surface of the other of the first and second piston sections;

the second piston section has a hollow interior portion and an opening on one end, into the hollow interior portion, the hollow interior portion having a stop surface; and

the first piston section includes an extension portion extending into the hollow interior portion of the second piston section, the extension portion having a stop surface for engaging the stop surface of the hollow interior portion of the second piston section when the end surfaces of the first and second piston sections are fully separated and the piston is in the fill position.

5. A delivery device according to claim 1, wherein

each of the first and second piston sections have an end surface facing the end surface of the other of the first and second piston sections;

the first piston section has a hollow interior portion and an opening on one end, into the hollow interior portion, the hollow interior portion having a stop surface; and

the second piston section includes an extension portion extending into the hollow interior portion of the first piston section, the extension portion having a stop surface for engaging the stop surface of the hollow interior portion of the first piston section when the end surfaces of the first and second piston sections are fully separated and the piston is in the fill position.

6. A delivery device according to claim 1, wherein

each of the first and second piston sections have an end surface facing the end surface of the other of the first and second piston sections;

and

the end surfaces of the first and second piston sections are arranged to abut each other when the piston is in the dispense position.

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

the second piston section has an end surface facing away from the first piston section;

the first housing portion comprises a housing structure having an interior volume in which the pump device is located and a wall having an opening;

the surface of the second piston section that is for operable engagement with the drive shaft comprises the end surface of the second piston section that faces away from the first piston section, and is positioned to be acted upon by the drive shaft, through the opening in the wall of the housing structure of the first housing portion when the first housing portion and the second housing portion are engaged with each other.

8. A delivery device according to claim 7, 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.

9. A delivery device according to claim 7, wherein:

the drive shaft has an end that is positioned external to the second housing portion for operable connection with the end surface of the second piston section, when the first housing portion and the second housing portion are engaged with each other.

10. A delivery device according to claim 1, wherein one of the second housing portion and the first housing portion has at least one flexible pawl and the other of the second housing portion and the first 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.

11. A delivery device according to claim 10, 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.

12. 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 second housing portion and the first housing portion are engaged.

13. 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.

14. 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.

15. A delivery device according to claim 14, further comprising a one-way valve within the conduit.

16. 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.

17. 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, an inlet port in fluid flow communication with the channel and configured for connection to a source of fluidic medium, and an outlet port in fluid flow communication with the channel; and

a piston located in the piston channel and having a first piston section and a second piston section coupled together for limited movement, relative to each other, the second piston section having a surface for receiving a drive force from a drive shaft;

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

in the fill position, the first and second piston sections are separate to form a chamber having volume between the first and second piston sections, and the chamber is aligned in fluid flow communication with the inlet port;

in pull positions, the first and second piston sections are separated and the chamber formed between the first and second piston sections is located within the channel, between the inlet port and the outlet port, out of fluid flow communication with the inlet port and the outlet port; and

in the dispense position, the chamber between the first and second piston sections is aligned in fluid flow communication with the outlet port.

18. A pump device according to claim 17, wherein

each of the first and second piston sections have an end surface facing the end surface of the other of the first and second piston sections;

the second piston section has a hollow interior portion and an opening on one end, into the hollow interior portion, the hollow interior portion having a stop surface; and

the first piston section includes an extension portion extending into the hollow interior portion of the second piston section, the extension portion having a stop surface for engaging the stop surface of the hollow interior portion of the second piston section when the end surfaces of the first and second piston sections are fully separated and the piston is in the fill position.

19. A pump device according to claim 17, wherein

each of the first and second piston sections have an end surface facing the end surface of the other of the first and second piston sections;

the first piston section has a hollow interior portion and an opening on one end, into the hollow interior portion, the hollow interior portion having a stop surface; and

the second piston section includes an extension portion extending into the hollow interior portion of the first piston section, the extension portion having a stop surface for engaging the stop surface of the hollow interior portion of the first piston section when the end surfaces of the first and second piston sections are fully separated and the piston is in the fill position.

20. A pump device according to claim 17, wherein

each of the first and second piston sections have an end surface facing the end surface of the other of the first and second piston sections;

and

the end surfaces of the first and second piston sections are arranged to abut each other when the piston is in the dispense position.

21. A pump device according to claim 17, 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 second piston section.

22. A pump device according to claim 21, wherein the housing structure of the infusion delivery device comprises:

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 second housing portion having an enclosed interior volume;

wherein the pump device is supported by the first housing portion and the drive device is supported by the second housing portion.

23. A pump device according to claim 22, wherein the drive shaft is supported by the second housing portion.

24. A method of making a pump device for conveying a fluidic medium, the method comprising:

providing a piston channel in a housing, where the piston channel has a generally linear, longitudinal axis;

providing an inlet port in fluid flow communication with the piston channel and configured for connection to a source of fluidic medium;

providing an outlet port in fluid flow communication with the piston channel;

providing a piston having a first piston section and a second piston section coupled together for limited movement, relative to each other, the second piston section having a surface for receiving a drive force from a drive shaft; and

supporting the piston within the piston channel for movement along the longitudinal axis of the piston channel between fill, pull and dispense positions, when a drive force is received from a drive shaft such that;

in the fill position, the first and second piston sections are separate to form a chamber having volume between the first and second piston sections, and the chamber is aligned in fluid flow communication with the inlet port;

in pull positions, the first and second piston sections are separated and the chamber formed between the first and second piston sections is located within the channel, between the inlet port and the outlet port, out of fluid flow communication with the inlet port and the outlet port; and

in the dispense position, the chamber between the first and second piston sections is aligned in fluid flow communication with the outlet port.

25. A method according to claim 24, wherein

supporting the piston within the piston channel comprises arranging each of the first and second piston sections end-to-end, with an end surface of each piston section facing an end surface of the other piston section;

providing a piston having first and second piston sections comprises providing the second piston section with a hollow interior portion and an opening on one end, into the hollow interior portion, the hollow interior portion having a stop surface and providing the first piston section with an extension portion extending into the hollow interior portion of the second piston section, the extension portion having a stop surface for engaging the stop surface of the hollow interior portion of the second piston section when the end surfaces of the first and second piston sections are fully separated and the piston is in the fill position.

26. A method according to claim 24, wherein:

supporting the piston within the piston channel comprises arranging each of the first and second piston sections end-to-end, with an end surface of each piston section facing an end surface of the other piston section;

providing a piston having first and second piston sections comprises providing the first piston section with a hollow interior portion and an opening on one end, into the hollow interior portion, the hollow interior portion having a stop surface and providing the second piston section with an extension portion extending into the hollow interior portion of the first piston section, the extension portion having a stop surface for engaging the stop surface of the hollow interior portion of the first piston section when the end surfaces of the first and second piston sections are fully separated and the piston is in the fill position.

27. A method according to claim 24, wherein

supporting the piston within the piston channel comprises arranging each of the first and second piston sections end-to-end, with an end surface of each piston section facing an end surface of the other piston section;

and

the end surfaces of the first and second piston sections are arranged to abut each other when the piston is in the dispense position.

28. A method according to claim 24, further comprising supporting the pump device 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 second piston section.

29. A method according to claim 28, wherein the housing structure of the infusion delivery device comprises a first housing portion and a second housing portion and wherein the method further comprises:

providing the first housing portion with a surface for securing the first housing portion to a user;

providing the first housing portion and the second housing portion with connection structure for selectively engaging the second housing portion with the first housing portion for operation and disengaging the second housing portion and first housing portion to allow disposal of the first housing portion without disposing of the second housing portion;

supporting the pump device with the first housing portion; and

supporting the drive device with the second housing portion.

30. A method according to claim 29, further comprising supporting the drive shaft with the second housing portion.