Infusion medium delivery device and method with compressible or curved reservoir or conduit

• US 8,137,314 B2
• Filed: 10/27/2006
• Issued: 03/20/2012
• 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, Bente, Paul F. IV, Hanson, Ian B., Stutz, William H. Jr.
• Primary Examiner(s): Ho, Jackie
• Assistant Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US11/588,847
• Publication Number:
  US 20080051709A1
• Time in Patent Office: 1,971 Days
• Field of Search: 604/131, 604/133, 604/151, 604/153, 604/890.1, 604/891.1
• US Class Current: 604/151
• 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 2005/31518 designed to reduce the overall size of an injection device, e.g. using flexible or pivotally connected chain-like rod members
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14224 Diaphragm type
• CPC Class Codes: A61M 5/14232 Roller pumps
• 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 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: F04B 43/1223 the actuating elements, e.g. rollers, moving in a straight line during squeezing
• CPC Class Codes: F04B 43/1253 by using two or more rollers as squeezing elements, the rollers moving on an arc of a circle during squeezing
• CPC Class Codes: F04B 43/1269 the rotary axes of the rollers lying in a plane perpendicular to the rotary axis of the driving motor

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 media 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 infusion media from the reservoir and a drive device and drive linkage.

Claims

1. A delivery device comprising:

a first housing portion;

a second housing portion configured to selectively engage with and disengage from the first housing portion, the first housing portion provided with a conduit support surface that faces the second housing portion when the second housing portion is engaged with the first housing portion, the conduit support surface having a recessed groove;

a rotatable rotor carrying and supporting at least one pad or roller for movement in an annular path with the rotation of the rotor, the rotatable rotor and the at least one pad or roller being supported for rotation about an axis of rotation by the second housing portion when the first and second housing portions are engaged and when the first and second housing portions are disengaged;

a conduit supported by the first housing portion when the first and second housing portions are engaged and when the first and second housing portions are disengaged, the conduit having a flexible portion arranged within the recessed groove and within at least a portion of the annular path of the at least one pad or roller to be engaged at locations along the annular path by the at least one roller or pad and to receive a force from the at least one roller or pad in a direction parallel to the axis of rotation of the rotor when the second housing portion and the first housing portion are engaged, the flexible portion of the conduit being resiliently collapsible at the locations of engagement of the at least one roller or pad to provide a pumping action as the rotor rotates the at least one roller or pad along the annular path while the second housing portion and first housing portion are engaged, the conduit being connectable in fluid flow communication with an injection site;

a reservoir having an interior volume for containing a fluid, the interior volume of the reservoir being in fluid flow communication with the conduit; and

a drive device supported by the second housing portion and operatively coupled to the rotor for selectively rotating the rotor;

wherein the conduit support surface, reservoir and rotatable rotor are aligned along an axis parallel to the axis of rotation of the rotor when the second housing portion is engaged with the first housing portion, and wherein the recessed groove in the conduit support surface and the flexible portion of the conduit are located between the reservoir and the rotatable rotor when the second housing portion is engaged with the first housing portion; and

wherein the at least one pad or roller is connected to the rotatable rotor and engages the flexible portion of the conduit when the second housing portion is engaged with the first housing portion and disengages from the flexible portion of the conduit when the second housing portion is disengaged from the first housing portion.

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

the second housing portion has a housing structure with an internal volume;

the rotor is disposed outside of the internal volume; and

the delivery device further comprising a rotor shaft having a longitudinal axis, the rotor shaft coupled to the rotor and extending into the internal volume of the second housing portion and operatively coupled to the drive device.

3. A delivery device according to claim 2, wherein the rotor shaft extends through an aperture in a wall of the second housing portion.

4. A delivery device according to claim 3, further comprising a seal disposed around the aperture in the wall of the second housing portion, the seal providing at least one of an air tight, moisture tight or hermetically sealed environment within the second housing portion.

5. A delivery device according to claim 1, wherein the rotor comprises a rotary wheel and wherein the at least one pad or roller is supported by the rotary wheel.

6. A delivery device according to claim 1, wherein the rotor comprises a rotary wheel supported for rotation about a first axis of rotation and wherein the at least one pad or roller comprises at least one rotatable roller supported for rotation on the rotary wheel about a second axis of rotation that is orthogonal to the first axis of rotation.

7. A delivery device according to claim 1, wherein the flexible portion of the conduit is supported on a flat support surface.

8. A delivery device according to claim 1, wherein the flexible portion of the conduit that is arranged within at least a portion of the annular path of the at least one pad or roller comprises a portion of the conduit arranged in at least a partial coil around a generally annular path.

9. A delivery device according to claim 8, wherein the rotor is rotatable about a first axis of rotation and wherein the at least one pad or roller comprises a plurality of rollers, each supported for rotation on the rotor about a respective axis of rotation that is transverse to the first axis of rotation and along a path that aligns with the annular path of the conduit, when the first and second housing portions are engaged.

10. A delivery device according to claim 1, wherein the rotor is rotatable about a first axis of rotation and wherein the at least one pad or roller comprises at least one roller supported for rotation on the rotor about an axis of rotation that is transverse to the first axis of rotation.

11. A delivery device according to claim 1, wherein the rotor is rotatable about a first axis of rotation and wherein the at least one pad or roller comprises a plurality of rollers, each roller supported for rotation on the rotor about an axis of rotation that is transverse to the first axis of rotation.

12. A delivery device according to claim 1, wherein the second housing portion is configured to selectively engage with the first housing portion when the first and second housing portions are moved from mutually separated locations into contact with each other along a linear path of motion that is parallel to the axis of rotation of the rotor.

13. A delivery device according to claim 12, wherein the at least one roller or pad is arranged to move toward and contact the flexible portion of the conduit along a linear path of motion that is parallel to the axis of rotation of rotor, when the first and second housing portions are moved from mutually separated locations into contact with each other.

14. A delivery device according to claim 12, wherein when the first and second housing portions are moved from mutually separated locations into contact with each other, the force received by the flexible portion of the conduit from the at least one roller or pad is in a direction parallel to the linear path of motion.

15. A delivery device according to claim 1, wherein when the second housing portion and the first housing portion are engaged, the force received by the flexible portion of the conduit from the at least one roller or pad is in a direction parallel to the linear path of motion.

16. A delivery device according to claim 1, wherein the rotatable rotor carries and supports the at least one pad or roller for movement in an annular path when the second housing portion and the first housing portion are engaged and when the second housing portion and the first housing portion are disengaged.

17. A delivery device according to claim 1, wherein the conduit support surface is perpendicular to the axis of rotation of the rotatable rotor when the second housing portion and the first housing portion are engaged.

18. A delivery device according to claim 1, further comprising:

a power source carried by the first housing portion when the first and second housing portions are engaged and when the first and second housing portions are disengaged;

a first electrical connector carried by the first housing portion when the first and second housing portions are engaged and when the first and second housing portions are disengaged, the first electrical connector being in electrical communication with the power source;

a second electrical connector carried by the second housing portion when the first and second housing portions are engaged and when the first and second housing portions are disengaged, the second electrical connector being in electrical communication with the drive device;

the first and second electrical connectors being arranged to be in electrical communication with each other when the first and second housing portions are engaged and to be out of electrical communication with each other when the first and second housing portions are disengaged;

wherein, the first and second electrical connectors are electrically coupled to electrically couple the power source to the drive device when the first and second housing portions are engaged, and the first and second electrical connectors are electrically de-coupled to electrically decouple the power source and the drive device when the first and second housing portions are disengaged.

19. A delivery device according to claim 1, further comprising a rotor shaft mechanically coupled to the drive device to be selectively rotated by the drive device, wherein the second housing portion has an enclosed interior in which the drive device is located, the second housing portion has an outer wall provided with an opening through which the rotor shaft extends from the interior of the second housing portion to a location external to the second housing portion, and the second housing portion includes a seal that provides an hermetic seal in opening through which the rotor shaft extends, wherein the enclosed interior of the second housing portion is hermetically sealed.

20. A method of making a delivery device, the method comprising:

providing a first housing portion;

providing a second housing portion configured to selectively engage with and disengage from the first housing portion;

providing the first housing portion with a conduit support surface that faces the second housing portion when the second housing portion is engaged with the first housing portion, the conduit support surface having a recessed groove;

supporting a rotatable rotor for rotation on the second housing portion about an axis of rotation, the rotor carrying and supporting at least one pad or roller for movement in an annular path with the rotation of the rotor when the first and second housing portions are engaged and when the first and second housing portions are disengaged;

providing a conduit having a flexible portion;

coupling an interior volume of a reservoir in fluid flow communication with the conduit, the interior volume of the reservoir for containing a fluid;

supporting the flexible portion of the conduit on the first housing portion when the first and second housing portions are engaged and when the first and second housing portions are disengaged, and arranging the flexible portion of the conduit within the recessed groove and within at least a portion of the annular path of the at least one pad or roller to be engaged at locations along the annular path by the at least one pad or roller and to receive a force from the at least one pad or roller in a direction parallel to the axis of rotation of the rotor when the second housing portion and the first housing portion are engaged, the flexible portion of the conduit being resiliently collapsible at the locations of engagement of the at least one pad or roller to provide a pumping action as the rotor rotates while the first and second housing portions are engaged, the conduit being connectable in fluid flow communication with an injection site;

supporting a drive device on the second housing portion; and

operatively coupling the drive device to the rotor for selectively rotating the rotor to provide the pumping action while the first and second housing portions are engaged;

wherein providing the first housing portion with a conduit support surface and supporting the flexible portion of the conduit comprises, aligning the conduit support surface, reservoir and rotatable rotor along an axis parallel to the axis of rotation of the rotor when the second housing portion is engaged with the first housing portion, and providing the recessed groove of the conduit support surface and the flexible portion of the conduit at a location that is between the reservoir and the rotatable rotor when the second housing portion is engaged with the first housing portion; and

wherein supporting a rotatable rotor comprises connecting the at least one pad or roller to the rotatable rotor in a position to engage the flexible portion of the conduit when the second housing portion is engaged with the first housing portion and to disengage from the flexible portion of the conduit when the second housing portion is disengaged from the first housing portion.

21. A method according to claim 20, wherein:

providing a second housing portion comprising providing a housing structure with an internal volume;

supporting a rotatable rotor comprises supporting a rotor on the second housing portion, outside of the internal volume; and

operatively coupling the drive device to the rotor comprises extending a rotor shaft having a longitudinal axis into the interior volume of the second housing portion, operatively coupling the rotor shaft to the rotor and to the drive device to transfer drive force from the drive device to the rotor.

22. A method according to claim 21, wherein extending a rotor shaft comprises extending the rotor shaft through an aperture in a wall of the second housing portion.

23. A method according to claim 22, further comprising arranging a seal around the aperture in the wall of the second housing portion.

24. A method according to claim 20, wherein supporting a rotatable rotor comprises supporting a rotary wheel and wherein the at least one pad or roller is supported by the rotary wheel.

25. A method according to claim 20, wherein supporting a rotatable rotor comprises supporting a rotary wheel for rotation about a first axis of rotation and wherein the at least one pad or roller comprises at least one rotatable roller supported for rotation on the rotary wheel about a second axis of rotation that is orthogonal to the first axis of rotation.

26. A method according to claim 25, wherein supporting the flexible portion of the conduit comprises supporting the flexible portion of the conduit on a flat support surface.

27. A method according to claim 20, wherein supporting the flexible portion of the conduit comprises supporting the flexible portion of the conduit on a flat support surface.

28. A method according to claim 20, wherein arranging the flexible portion of the conduit that is arranged within at least a portion of the annular path of the at least one pad or roller comprises arranging a portion of the conduit in at least a partial coil around a generally annular path.

29. A method according to claim 28, wherein supporting a rotatable rotor comprises supporting a rotor for rotation about a first axis, wherein the at least one pad or roller comprises a plurality of rollers, each supported for rotation on the rotor about a respective axis of rotation that is transverse to the first axis of rotation and along a path that aligns with the annular path of the conduit, when the first and second housing portions are engaged.

30. A method according to claim 20, wherein supporting a rotatable rotor comprises supporting a rotor for rotation about a first axis and wherein the at least one pad or roller comprises at least one roller supported for rotation on the rotor about an axis of rotation that is transverse to the first axis of rotation.

31. A method according to claim 20, wherein supporting a rotatable rotor comprises supporting a rotor for rotation about a first axis of rotation and wherein the at least one pad or roller comprises a plurality of rollers, each roller supported for rotation on the rotor about an axis of rotation that is transverse to the first axis of rotation.

32. A method according to claim 20, wherein the conduit support surface is perpendicular to the axis of rotation of the rotatable rotor when the second housing portion and the first housing portion are engaged.

33. A method according to claim 20, further comprising:

supporting a power source on the first housing portion when the first and second housing portions are engaged and when the first and second housing portions are disengaged;

supporting a first electrical connector on the first housing portion when the first and second housing portions are engaged and when the first and second housing portions are disengaged, and coupling the first electrical connector in electrical communication with the power source;

supporting a second electrical connector on the second housing portion when the first and second housing portions are engaged and when the first and second housing portions are disengaged, and coupling the second electrical connector in electrical communication with the drive device;

arranging the first and second electrical connectors at locations to be in electrical communication with each other when the first and second housing portions are engaged and to be out of electrical communication with each other when the first and second housing portions are disengaged;

wherein, the first and second electrical connectors are electrically coupled to electrically couple the power source to the drive device when the first and second housing portions are engaged, and the first and second electrical connectors are electrically de-coupled to electrically decouple the power source and the drive device when the first and second housing portions are disengaged.

34. A delivery device comprising:

a first housing portion having a conduit support surface;

a second housing portion configured to selectively engage with and disengage from the first housing portion;

a rotatable rotor carrying at least one pad or roller for movement in a path with rotation of the rotor, the rotatable rotor and the at least one pad or roller being supported for rotation about an axis of rotation by the second housing portion when the first and second housing portions are engaged and when the first and second housing portions are disengaged;

a conduit supported by the first housing portion when the first and second housing portions are engaged and when the first and second housing portions are disengaged, the conduit having a flexible portion arranged within the path of the at least one pad or roller to be engaged at locations along the path by the at least one roller or pad and to receive a force from the at least one roller or pad when the second housing portion and the first housing portion are engaged, the flexible portion of the conduit being resiliently collapsible at the locations of engagement of the at least one roller or pad to allow fluid to flow through the conduit as the rotor rotates the at least one roller or pad along the annular path while the second housing portion and first housing portion are engaged; and

a reservoir having an interior volume for containing a fluid, the interior volume of the reservoir being in fluid flow communication with the conduit;

wherein the conduit support surface, reservoir and rotatable rotor are aligned along an axis parallel to the axis of rotation of the rotor when the second housing portion is engaged with the first housing portion, and wherein the conduit support surface and the flexible portion of the conduit are located between the reservoir and the rotatable rotor when the second housing portion is engaged with the first housing portion; and

wherein the at least one pad or roller is connected to the rotatable rotor and engages the flexible portion of the conduit when the second housing portion is engaged with the first housing portion and disengages from the flexible portion of the conduit when the second housing portion is disengaged from the first housing portion.