Operating an infusion pump system

• US 7,794,427 B2
• Filed: 09/18/2006
• Issued: 09/14/2010
• Est. Priority Date: 09/26/2005
• Status: Active Grant

• Current Assignee: Insulet Corporation, M2 Medical Group Holdings, Inc.
• Original Assignee: Asante Solutions, Inc (Abbott Laboratories)
• Inventors: Wenger, Mitchell, Kirschen, Todd, Estes, Mark C., Mernoe, Morten, Causey, James
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Anderson; Michael J
• Application Number:
  US11/522,603
• Publication Number:
  US 20070073235A1
• Time in Patent Office: 1,457 Days
• Field of Search: 604/65, 604/151, 604/131, 604/93.01, 604/48, 604/19, 417/411
• US Class Current: 604/151
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/14506 mechanically driven, e.g. spring or clockwork
• CPC Class Codes: A61M 2005/14573 with a replaceable reservoir for quick connection/disconnection with a driving system
• 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 5/003 Kits for diabetics
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/1454 spring-actuated, e.g. by a clockwork
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump

Abstract

Some embodiments of a medical infusion pump system include a pump device and a removable controller device. When the pump device and the removable controller device are removably attached to one another, the components may provide a portable infusion pump unit to dispense medicine to a user. In particular embodiments, the removable controller device includes a user interface to readily provide information, for example, about the operation of the pump.

Claims

1. A medical infusion pump system, comprising:

a pump device including;

a pump housing including an interior wall that at least partially defines a space to slidably receive a prefilled medicine cartridge insertable through an opening defined by the pump housing;

a drive system to dispense medicine from the prefilled medicine cartridge when the prefilled medicine cartridge is slidably received in the pump housing, the drive system including a piston rod that is incrementally movable to apply a dispensing force to the prefilled medicine cartridge, the piston rod being irreversibly movable in a positive longitudinal direction into the space that receives the prefilled medicine cartridge;

one or more electrical contacts disposed on the pump housing, at least a portion of the drive system being in electrical communication with the one or more electrical contacts; and

a removable controller device including;

a controller housing that is removably attachable to the pump housing in a fixed relationship so that the space to slidably receive the prefilled medicine cartridge is positioned rearward of a rear face of the controller housing;

one or more electrical contacts disposed on the controller housing, the electrical contacts of the controller device being engageable with the electrical contacts of the pump device when removably attached;

a user interface arranged on the controller housing such that a display of the user interface is positioned along a front face of the controller housing that is opposite from the rear face, the user interface including the display and one or more user-selectable buttons;

wherein the pump device and the controller device, when removably attached, provide a hand-graspable portable unit.

2. The system of claim 1, wherein the controller device electrically communicates signals to at least a portion of the drive system of the pump device when the controller device and pump device are removably attached.

3. The system of claim 1, wherein the pump device comprises a first battery that transmits electrical energy to a second battery disposed in the controller device, and wherein the second battery provides energy to at least a portion of the drive system of the pump device.

4. The system of claim 3, wherein the first battery is switchable from a storage mode in which the first battery is sealed to an activation mode in which electrical energy drawable from the first battery to charge the second battery.

5. The system of claim 3, wherein the first battery has a greater energy density than the second battery and provides energy to charge the second battery over a period of time, and wherein the second battery has a greater initial current output than the first battery and provides energy to at least a portion of the drive system of the pump device.

6. The system of claim 1, wherein the medicine is insulin disposed in the medicine cartridge, and the pump housing is configured to enclose the medicine cartridge after the medicine cartridge is slidably received therein.

11. The system of claim 1, wherein the controller device electrically communicates signals to the pump device via a hard-wired electrical connection including the one or more electrical contacts of the pump device and the one or more electrical contacts of the controller device.

12. The system of claim 1, further comprising a cap attachable to the pump housing to enclose the medicine cartridge in the space when the pump housing slidably receives the medicine cartridge.

13. The system of claim 12, wherein when the medicine cartridge is received by the pump housing, the piston rod of the drive system is incrementally advanced toward the medicine cartridge, the piston rod comprising a flexible piston rod that adjusts from a curved shape to a noncurved shape.

14. The system of claim 1, wherein the drive system of the pump device comprises the piston rod that is incrementally advanced toward the medicine cartridge when the medicine cartridge is received by the pump housing, the piston rod comprising a flexible piston rod that adjusts from a curved shape to a noncurved shape.

20. The system of claim 1, wherein controller housing is configured to mate with a complementary portion of the pump housing so as to form a releasable mechanical connection.

21. The system of claim 20, wherein the controller housing mates the pump housing for a snap-fit engagement.

22. The system of claim 1, wherein the display of the user interface communicates menu options to a user when the user actuates the one or more of the buttons.

23. The system of claim 22, wherein at least one of the menu options communicated by the user interface provides data indicative of a medicine dispensing rate.

24. The system of claim 22, wherein at least one of the menu options communicated by the user interface provides data indicative of a total amount of medicine dispensed in a given time period.

25. The system of claim 22, wherein at least one of the menu options communicated by the user interface provides data indicative of an amount of medicine remaining in the pump housing.

26. The system of claim 1, wherein the display of the user interface communicates time and date information to a user when no button has been actuated for a period of time.

29. The system of claim 1, wherein the user interface is mounted to the controller housing that is removably attachable to the pump housing so that the user interface is viewable to a user while looking toward the pump device.

30. The system of claim 1, further comprising a second removable controller device having a second user interface that is different from the user interface of the first removable controller device, the second removable controller device being removably attachable to the pump device in a fixed relationship and being electrically connected to the pump device when removably attached.

7. A medical infusion pump system, comprising:

a pump device including;

a pump housing that defines a space to receive a medicine;

a drive system to dispense the medicine when received by the pump housing, the drive system including a piston rod that is incrementally movable to apply a dispensing force;

one or more electrical contacts disposed on the pump housing, at least a portion of the drive system being in electrical communication with the one or more electrical contacts; and

a removable controller device including;

a controller housing that is removably attachable to the pump housing in a fixed relationship;

one or more electrical contacts disposed on the controller housing, the electrical contacts of the controller device being engageable with the electrical contacts of the pump device when removably attached;

a user interface arranged on the controller housing, the user interface including a display and one or more user-selectable buttons;

wherein the pump device comprises a first battery that transmits electrical energy to a second battery disposed in the controller device, the first battery providing energy to charge the second battery over a period of time, and

wherein the pump device and the controller device, when removably attached, provide a hand-graspable portable unit.

8. The system of claim 7, wherein the second battery intermittently discharges bursts of electrical current to power the drive system of the pump device.

9. The system of claim 7, wherein the first battery comprises a zinc-air cell battery and the second battery comprises a rechargeable battery having a greater initial current output than the zinc-air cell battery.

10. The system of claim 7, wherein the first battery comprises a zinc-air cell battery having a volumetric energy density greater than about 900 Wh/L.

15. A medical infusion pump system, comprising:

a pump device including;

a pump housing that defines a space to receive a medicine;

a drive system to dispense the medicine when received by the pump housing, the drive system including a piston rod that is incrementally movable to apply a dispensing force, wherein the drive system of the pump device comprises a rotational motor that acts upon a ratchet mechanism;

one or more electrical contacts disposed on the pump housing, at least a portion of the drive system being in electrical communication with the one or more electrical contacts; and

a removable controller device including;

a controller housing that is removably attachable to the pump housing in a fixed relationship;

one or more electrical contacts disposed on the controller housing, the electrical contacts of the controller device being engageable with the electrical contacts of the pump device when removably attached;

a user interface arranged on the controller housing, the user interface including a display and one or more user-selectable buttons;

wherein the pump device and the controller device, when removably attached, provide a hand-graspable portable unit.

16. The system of claim 15, wherein one or more full rotations of the rotational motor causes a pawl member of the ratchet mechanism to pivot.

17. The system of claim 15, wherein the rotational motor comprises a reversible motor that outputs rotation in a first direction and in a second opposite direction.

18. The system of claim 15, wherein the rotational motor receives electrical energy from a battery that is arranged in the controller device and outside of the pump housing.

19. The system of claim 15, wherein the rotational motor acts upon the ratchet mechanism to cause an incremental movement of the ratchet mechanism, the incremental movement of the ratchet mechanism driving the piston rod to advance only in a positive longitudinal direction such that the piston rod is a non-tractable piston rod that hinders reuse of the pump device after advancement of the piston rod in the positive longitudinal direction.

27. A medical infusion pump system, comprising:

a pump device including;

a pump housing that defines a space to receive a medicine;

a drive system to dispense the medicine when received by the pump housing, the drive system including a piston rod that is incrementally movable to apply a dispensing force;

one or more electrical contacts disposed on the pump housing, at least a portion of the drive system being in electrical communication with the one or more electrical contacts; and

a removable controller device including;

a controller housing that is removably attachable to the pump housing in a fixed relationship;

one or more electrical contacts disposed on the controller housing, the electrical contacts of the controller device being engageable with the electrical contacts of the pump device when removably attached;

a user interface arranged on the controller housing, the user interface including a display and one or more user-selectable buttons, wherein the display of the user interface enters a sleep mode in which an active display area is blank when no button has been actuated for a period of time;

wherein the pump device and the controller device, when removably attached, provide a hand-graspable portable unit.

28. The system of claim 27, wherein the display of the user interface dims after a first period of time in which no button has been actuated and the display enters the sleep mode after a second period of time in which no button has been actuated.