Infusion device and method with drive device in infusion device and method with drive device in separable durable housing portion

• US 7,569,050 B2
• Filed: 08/23/2005
• Issued: 08/04/2009
• Est. Priority Date: 05/06/2005
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Moberg, Sheldon B., Hanson, Ian B., Cheney, Paul S. II
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): BERDICHEVSKY, AARTI
• Application Number:
  US11/210,467
• Publication Number:
  US 20060264889A1
• Time in Patent Office: 1,442 Days
• Field of Search: 604/890.1, 604/131
• US Class Current: 604/890.1
• 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 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2207/10 Device therefor
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• 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 5/14248 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 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

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 and may be disposed of after it has been in use for a prescribed period. Components that normally come into contact with a patient or with infusion media are supported by the disposable housing portion for disposal after the prescribed use, while the durable housing portion supports electronics for controlling delivery of infusion media from the reservoir and a drive device and drive linkage.

Claims

1. A delivery device for delivering an infusion media 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;

a reservoir for containing infusion media supported on the first housing portion, the reservoir comprising a container having an interior space for containing an initial volume of infusion media and a moveable member disposed at least partially within the container and moveable for varying the interior space of the container to drive one or more discrete volumes of infusion medium from the initial volume of infusion medium in the interior space of the container, wherein each discrete volume is less than the initial volume;

electrical control circuitry and a drive device contained in the second housing portion, wherein the electrical control circuitry controls the delivery of infusion media from the reservoir to the user and the drive device is coupled to a drive linkage for selectively driving the drive linkage in a drive direction under control of the electrical control circuitry;

wherein the drive linkage operatively couples the drive device to the moveable member of the reservoir to selectively move the moveable member to change the interior space of the container of the reservoir and drive infusion media from the reservoir under control of the electrical control circuitry when the second housing portion is engaged with the first housing portion and the drive linkage is selectively driven in the drive direction by the drive device.

2. A delivery device according to claim 1, wherein the drive device comprises an electrical motor.

3. A delivery device according to claim 1, wherein the drive linkage operatively de-couples the drive device from the moveable member of the reservoir when the second housing portion is disengaged from the first housing portion.

4. A delivery device according to claim 1,

the drive linkage comprises a gear supported for rotation in a first direction;

the moveable member of the reservoir comprises a plunger disposed within the container of the reservoir and a threaded shaft extending from the plunger, the threaded shaft arranged in the first housing portion in a location for engagement with the gear of the drive linkage when the first and second housing portions are engaged together, and for disengagement with the gear of the drive linkage when the first and second housing portions are disengaged and separated from each other.

5. A delivery device according to claim 1, wherein the drive device comprises a threaded drive shaft screw and wherein the moveable member of the reservoir comprises a piston plunger moveable within the container, the piston plunger having a pair of pivotal arm members extending longitudinally out of the container in a V-configuration, wherein each arm member comprises a threaded foot portion extending toward the threaded drive shaft screw of the drive device, and wherein the delivery device further comprises cam surfaces arranged relative to the reservoir for pivoting the arm members toward the threaded screw to engage the threaded foot portions of the arm members with the threaded screw.

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

the reservoir container and the piston plunger are supported for rotation;

the arm members operatively couple with the drive shaft screw of the drive device when the reservoir container and the piston plunger are rotated in a direction allowing the cam surfaces to engage the arm members and the drive shaft screw and when the first housing portion and the second housing portion are engaged; and

the arm members and the drive shaft screw allow for separation of the reservoir and the drive device when the reservoir container and the piston plunger are rotated in a direction opposite to the direction that allows the cam surfaces to engage the arm members and the drive shaft screw and when the first housing portion and the second housing portion are disengaged.

7. A delivery device according to claim 1,

the drive linkage comprises a gear supported for rotation in a first direction;

the moveable member of the reservoir comprises a shaft for engaging the gear of the drive linkage when the second housing portion is engaged with the first housing portion, the shaft being supported for linear motion in a first direction and is linearly moveable in the first direction upon the gear of the drive linkage engaging the shaft and the drive linkage being selectively driven in the drive direction by the drive device.

8. A delivery device according to claim 7, wherein the gear of the drive linkage operatively de-couples from the shaft of the reservoir when the second housing portion is disengaged from the first housing portion.

9. A delivery device according to claim 1,

the drive linkage comprises a pinion gear supported for rotation in a first direction;

the moveable member of the reservoir comprises a threaded shaft for engaging the pinion gear of the drive linkage when the second housing portion is engaged with the first housing portion, the threaded shaft being supported for linear motion in a first direction and is linearly moveable in the first direction upon the pinion gear of the drive linkage engaging the threaded shaft and the drive linkage being selectively driven in the drive direction by the drive device.

10. A delivery device according to claim 9, wherein the pinion gear of the drive linkage operatively de-couples from the threaded shaft of the reservoir when the second housing portion is disengaged from the first housing portion.

11. A delivery device according to claim 1, wherein the drive linkage is contained in the second housing portion.

12. A delivery device according to claim 11, wherein the drive linkage comprises a gear train and a threaded shaft attached to an outermost gear of the gear train away from the drive device, wherein the gear train provides a rotating action to the threaded shaft.

13. A delivery device according to claim 11, wherein:

the drive linkage comprises a threaded shaft coupled to the drive device for rotation;

the moveable member of the reservoir having one of the group consisting of a threaded seat, a keyed seat, and a slotted seat engageable with the threaded shaft of the drive linkage;

the seat on the moveable member of the reservoir operatively couples with the threaded shaft of the drive device when the first housing portion and the second housing portion are engaged, and wherein the threaded shaft is configured to separate from the seat of the moveable member when the first housing portion and the second housing portion are disengaged.

14. A delivery device according to claim 11, wherein:

the drive linkage comprises a shaft and pinion gear coupled to the drive device for rotation of the pinion gear; and

the moveable member of the reservoir comprises a moveable plunger operatively coupled with the pinion gear to move the plunger upon rotation of the pinion gear.

15. A delivery device according to claim 14, wherein the plunger comprises a single threaded rack that operatively couples to the pinion gear to be moveably driven with rotation of the pinion gear by the drive device when the first housing portion and the second housing portion are engaged.

16. A delivery device according to claim 11, wherein:

the drive linkage comprises two shafts and two pinion gears, each pinion gear coupled to a respective shaft, the shafts further coupled to the drive device for rotation of the shafts and pinion gears; and

the moveable member of the reservoir comprises a moveable plunger disposed at least partially within the container and moveable to drive infusion media out of the container, the plunger being operatively coupled with the two pinion gears to move the plunger upon rotation of the pinion gears.

17. A delivery device according to claim 16, wherein the plunger comprises two threaded racks that operatively couple to the pinion gears to be moveably driven with rotation of the pinion gears by the drive device when the first housing portion and the second housing portion are engaged.

18. A delivery device according to claim 11, wherein the drive linkage further comprises a shaft having first and second ends and a drive screw, and wherein the first end of the shaft is coupled to the drive device for rotation by the drive device, the second end of the shaft is coupled to the drive screw for rotation therewith and the drive screw is coupled to the reservoir for driving infusion media from the reservoir upon rotation of the drive screw.

19. A delivery device according to claim 18, wherein the moveable member of the reservoir comprises a piston plunger with a hollow, threaded interior along a longitudinal direction of the piston plunger, wherein the threaded interior is threaded to correspond to the drive screw of the drive device, and wherein the threaded interior operatively couples with the drive screw of the drive device when the first housing portion and the second housing portion are engaged.

20. A delivery device according to claim 18, wherein the moveable member of the reservoir comprises a piston plunger having a longitudinal dimension and a single rack having threads extending along the longitudinal dimension of the piston plunger, wherein the threads of the single rack operatively couple with the drive screw of the drive device for rotation therewith when the first housing portion and the second housing portion are engaged.

25. A method according to claim 14, wherein the drive linkage comprises a gear train and a threaded shaft attached to an outermost gear of the gear train away from the drive device, and wherein the method further comprises rotating the gear train with the drive device and rotating the threaded shaft with the gear train.

26. A method according to claim 14, wherein;

containing a drive linkage in the second housing comprises coupling a threaded shaft to the drive device for rotation by the drive device;

the moveable member of the reservoir having one of the group consisting of a threaded seat, a keyed seat, and a slotted seat engageable with the threaded shaft of the drive device;

operatively coupling the seat on the moveable member of the reservoir with the threaded shaft when the first housing portion and the second housing portion are engaged, and separating the threaded shaft from the seat of the moveable member when the first housing portion and the second housing portion are disengaged.

21. A delivery device for delivering an infusion media 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;

a reservoir for containing infusion media supported on the first housing portion, the reservoir comprising a container having an interior space for containing a volume of infusion media under atmospheric pressure and a moveable member disposed at least partially within the container and moveable for varying the interior space of the container to increase pressure of infusion media within the interior space of the container and drive infusion medium from the interior space of the container;

electrical control circuitry and a drive device contained in the second housing portion, wherein the electrical control circuitry controls the delivery of infusion media from the reservoir to the user and the drive device is coupled to a drive linkage for selectively driving the drive linkage in a drive direction under control of the electrical control circuitry;

wherein the drive linkage operatively couples the drive device to the moveable member of the reservoir to selectively move the moveable member to change the interior space of the container of the reservoir and drive infusion media from the reservoir under control of the electrical control circuitry when the second housing portion is engaged with the first housing portion and the drive linkage is selectively driven in a drive direction by the drive device.

22. A method for delivering an infusion media to a user, the method comprising:

securing a first housing portion to a user;

attaching a second housing portion to the first housing portion in a manner that allows a user to selectively detach the second housing portion from the first housing portion;

supporting a reservoir for containing infusion media on the first housing portion, the reservoir comprising a container having an interior space for containing an initial volume of infusion media and a moveable member disposed at least partially within the container and moveable for varying the interior space of the container to drive one or more discrete volumes of infusion medium from the initial volume of infusion medium in the interior space of the container, wherein each discrete volume is less than the initial volume;

containing electrical control circuitry and a drive device in the second housing portion;

coupling the drive device to a drive linkage for selectively driving the drive linkage in a drive direction under control of the electrical control circuitry; and

operatively coupling the drive device to the moveable member of the reservoir via the drive linkage, to selectively move the movaeable member to change the interior space of the container of the reservoir and drive infusion media from the reservoir to the user under control of the electrical control circuitry when the second housing portion and the first housing portion are engaged and the drive linkage is selectively driven in the drive direction by the drive device.

23. A method according to claim 22, wherein the drive device comprises an electrical motor.

24. A method according to claim 22, further comprising:

containing the drive linkage in the second housing portion; and

decoupling the drive device from the moveable member of the reservoir when the second housing portion is disengaged and separated from the first housing portion.

27. A method according to claim 24, wherein:

containing a drive linkage in the second housing portion comprises containing a shaft having a pinion gear on one end in the second housing portion and coupling the pinion gear to the drive device for rotation of the pinion gear by the drive device; and

the moveable member of the reservoir comprises a moveable plunger on the first housing portion, the moveable plunger located at least partially within the container and moveable to drive infusion media out of the container; and

operatively coupling the moveable plunger with the pinion gear to move the plunger upon rotation of the pinion gear.

28. A method according to claim 27, wherein the plunger comprises a single threaded rack and wherein operatively coupling the moveable plunger with the pinion gear comprises engaging the pinion gear and the single threaded rack and moving the single threaded rack of the plunger with rotation of the pinion gear by the drive device when the first housing portion and the second housing portion are engaged.

29. A method according to claim 24, wherein:

containing a drive linkage in the second housing portion comprises containing two shafts and two pinion gears in the second housing portion with each pinion gear coupled to a respective shaft, and coupling the shafts to the drive device for rotation of the shafts and pinion gears; and

the moveable member of the reservoir comprises a moveable plunger on the first housing portion, the moveable plunger being located at least partially within the container and moveable to drive infusion media out of the container; and

operatively coupling the moveable plunger to the two pinion gears to move the plunger upon rotation of the pinion gears.

30. A method according to claim 29, wherein the plunger comprises two threaded racks that operatively couple to the pinion gears to be moveably driven with rotation of the pinion gears by the drive device when the first housing portion and the second housing portion are engaged.

31. A method according to claim 24, wherein containing a drive device and drive linkage comprises containing a threaded drive shaft screw in the second housing portion and wherein the moveable member of the reservoir comprises a piston plunger on the first housing portion, the piston plunger being moveable within the container, the piston plunger having a pair of pivotal arm members extending longitudinally out of the container in a V-configuration, wherein each arm member comprises a threaded foot portion extending toward the threaded drive shaft screw of the drive device, and wherein the method further comprises supporting cam surfaces relative to the threaded screw for contacting and pivoting the arm members toward the threaded screw to selectively engage the threaded foot portions of the arm members with the threaded screw.

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

supporting the reservoir container and the piston plunger for rotation;

operatively coupling the arm members with the drive shaft screw of the drive device when the reservoir and the piston plunger are rotated in a direction allowing the cam surfaces to engage the arm members and the drive shaft screw and when the first housing portion and the second housing portion are engaged; and

separating the arm members and the drive shaft screw when the reservoir and the piston plunger are rotated in a direction opposite to the direction that allows the cam surfaces to engage the arm members and the drive shaft screw and when the first housing portion and the second housing portion are disengaged.

33. A method according to claim 24, wherein containing a drive linkage in the second housing portion comprises:

containing a shaft having and a drive screw in the second housing portion;

coupling the shaft to the drive device for rotation by the drive device;

coupling the shaft to the drive screw for rotation therewith; and

coupling the drive screw to the reservoir for driving infusion media from the reservoir upon rotation of the drive screw.

34. A method according to claim 33, wherein the moveable member of the reservoir comprises a piston plunger having a longitudinal dimension and a single rack having threads extending along the longitudinal dimension, wherein the method further comprises coupling the threads of the single rack operatively with the drive screw for rotation therewith when the first housing portion and the second housing portion are engaged.

35. A method according to claim 33, wherein the moveable member of the reservoir comprises a piston plunger with a hollow, threaded interior along a longitudinal direction of the piston plunger, wherein the threaded interior is threaded to correspond to the drive screw of the drive device, and wherein the method further comprises operatively coupling the threaded interior with the drive screw of the drive device when the first housing portion and the second housing portion are engaged.