Operating an infusion pump system

• US 8,409,142 B2
• Filed: 02/22/2007
• Issued: 04/02/2013
• Est. Priority Date: 09/26/2005
• Status: Active Grant

• Current Assignee: Insulet Corporation, M2 Medical Group Holdings, Inc.
• Original Assignee: Asante Solutions, Inc
• Inventors: Causey, James, Kirschen, Todd, Wenger, Mitchell, Friedman, Steven, Colton, Joshua, Christensen, Keld Sloth
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): LEE, BRANDY SCOTT
• Application Number:
  US11/677,743
• Publication Number:
  US 20070167912A1
• Time in Patent Office: 2,231 Days
• Field of Search: 604/154, 604/151, 604/131, 604/232, 604/93.01
• US Class Current: 604/151
• CPC Class Codes: A61M 2005/14506 mechanically driven, e.g. spring or clockwork
• 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 2205/273 preventing reuse, e.g. of disposables
• CPC Class Codes: A61M 2205/8212 with means or measures taken for minimising energy consumption
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1454 spring-actuated, e.g. by a clockwork
• 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 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: A61M 5/16804 Flow controllers
• CPC Class Codes: A61M 5/16886 for measuring fluid flow rate, i.e. flowmeters
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

Abstract

Some embodiments of a medical infusion pump system include a pump device having a cap device that mates with a pump housing to retain a medicine cartridge therein. In addition to retaining the medicine cartridge in the pump housing, the cap device may perform a number of preparatory functions or safety functions. In addition or in the alternative, some embodiments of the pump device may include a drive system that advances a piston rod to dispense medicine to the patient in a safe and energy efficient manner.

Claims

1. An infusion pump device, comprising:

a pump housing that defines an exterior opening to slidably receive a medicine cartridge inside a space of the pump housing;

a drive system to dispense a medicine from the medicine cartridge when the medicine cartridge is received by the pump housing; and

a cap device that directly engages the pump housing to cover the exterior opening of the pump housing and to retain the medicine cartridge inside the pump housing when the medicine cartridge is received by the pump housing,

wherein when the cap device engages the pump housing, the cap device acts upon the medicine cartridge to urge a plunger of the medicine cartridge to attach to a component of the drive system.

2. The infusion pump device of claim 1, wherein the cap device comprises one or more mating structures that mechanically secure to one or more complementary structures of the pump housing during engagement between the cap device and the pump housing, and wherein the cap device comprises a needle device that penetrates an output portion of the medicine cartridge positioned generally opposite from the plunger when the cap device engages the pump housing.

3. The infusion pump device of claim 1, wherein when the cap device engages the pump housing, the cap device acts upon the medicine cartridge to urge an initial breakaway movement of the plunger inside the medicine cartridge.

6. The infusion pump device of claim 1, further comprising a cap sensor that indicates when the cap device is engaged with the pump housing at a predetermined position.

7. The infusion pump device of claim 6, wherein the cap sensor communicates with a controller device that activates the drive system to dispense medicine when the cap device is engaged with the pump housing at the predetermined position.

8. A method of operating the infusion pump device of claim 1, comprising:

engaging the cap device with the pump housing to retain the medicine cartridge in the space defined by the pump housing; and

urging the cap device against the medicine cartridge so that the plunger of the medicine cartridge attaches to the component of the pump drive system.

9. The method of claim 8, further comprising penetrating a septum of the medicine cartridge with a needle device of the cap device member when the cap device engages the pump housing.

10. The method of claim 8, further comprising causing the cap device to act upon the medicine cartridge to thereby urge initial breakaway movement of the plunger inside the medicine cartridge.

11. The method of claim 8, further comprising receiving an indication of flow or nonflow of medicine through the cap device as detected by a flow sensor at least partially housed in the cap device.

12. The method of claim 8, further comprising locking at least a portion of the cap device into engagement with the pump housing to hinder replacement the medicine cartridge after the medicine cartridge is exhausted.

13. The method of claim 8, further comprising engaging the cap device with the pump housing in a predetermined position so that a cap sensor indicates when the cap device is at the predetermined position.

14. The method of claim 13, further comprising receiving an auto-shutoff indication when the cap device is arranged outside the predetermined position.

36. The infusion pump device of claim 1, wherein the cap device houses at least a portion of a flow sensor to detect flow or nonflow of medicine through the cap device.

4. The infusion pump device comprising

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

a drive system to dispense a medicine from the medicine cartridge when the medicine cartridge is received by the pumping housing; and

a cap device that directly engages the pump housing to retain the medicine cartridge therein when the medicine cartridge is received by the pumping housing, wherein the cap device houses at least a portion of a flow sensor to detect flow or nonflow of medicine through the cap device, and

wherein the cap device engages the pump housing, the cap device acts upon the medicine cartridge to urge a plunger of the medicine cartridge to attach to a component of the drive system.

38. The infusion pump device of claim 4, wherein the cap device comprises a needle device that penetrates an output portion of the medicine cartridge positioned generally opposite from the plunger when the cap device engages the pump housing.

39. The infusion pump device of claim 4, wherein when the cap device engages the pump housing, the cap device acts upon the medicine cartridge to urge an initial breakaway movement of the plunger inside the medicine cartridge.

5. An infusion pump device comprising:

a pump housing that defines an exterior opening to slidably receive a medicine cartridge inside a space of the pump housing;

a drive system to dispense a medicine from the medicine cartridge when the medicine cartridge is received by the pump housing; and

a cap device that engages the pump housing to cover the exterior opening of the pump housing and to retain the medicine cartridge inside the pump housing when the medicine cartridge is received by the pump housing,

wherein when the cap device engages the pump housing, the cap device acts upon the medicine cartridge to urge a plunger of the medicine cartridge to attach to a component of the drive system, wherein at least a portion of the cap device locks with the pump housing to hinder replacement of the medicine cartridge after the medicine cartridge is exhausted.

41. The infusion pump device of claim 5, wherein the cap device comprises one or more mating structures that mechanically secure to one or more complementary structures of the pump housing during engagement between the cap device and the pump housing, and wherein the cap device comprises a needle device that penetrates a septum of the medicine cartridge positioned generally opposite from the plunger when the cap device engages the pump housing.

42. The infusion pump device of claim 5, wherein when the cap device engages the pump housing, the cap device acts upon the medicine cartridge to urge an initial breakaway movement of the plunger inside the medicine cartridge.

15. An infusion pump device, comprising:

a pump housing that defines an exterior opening to slidably receive a medicine cartridge inside a space of the pump housing;

a drive system to dispense a medicine from the medicine cartridge when the medicine cartridge is received by the pump housing;

the drive system comprising a battery-powered actuator housed inside the pump housing and a piston rod that is advanced toward the medicine cartridge to dispense the medicine from the medicine cartridge when the medicine cartridge is received by the pump housing, the piston rod having a plunger engagement device that adjusts from a disengaged condition in which the plunger engagement device is spaced away from the plunger to an engaged condition in which the plunger engagement device attaches to the plunger when the medicine cartridge is received by the pump housing.

16. The infusion pump device of claim 15, further comprising a cap device that engages the pump housing to retain the medicine cartridge therein when the medicine cartridge is received by the pump housing, wherein when the cap device engages the pump housing, the cap device acts upon the medicine cartridge to urge the plunger into attachment with the plunger engagement device of the piston rod, and wherein when the cap device engages the pump housing, the cap device acts upon the medicine cartridge to urge an initial breakaway movement of the plunger inside the medicine cartridge.

17. The infusion device of claim 15, wherein the plunger engagement device comprises one or more penetration members that pierce into a first side of the plunger during attachment of the plunger and the plunger engagement device.

19. The infusion device of claim 17, wherein the penetration members comprise substantially rigid pins that penetrate longitudinally into the plunger.

21. The infusion device of claim 15, wherein the drive system comprises a reversible motor that decouples from a ratchet mechanism during at least a portion of a drive step.

37. The infusion device of claim 17, wherein the penetration members comprise substantially rigid blades that penetrate longitudinally into the plunger.

43. The infusion pump device of claim 15, wherein the plunger engagement device further comprises adhesive so as to secure the piston rod to the plunger when the medicine cartridge is received by the pump housing.

18. An infusion pump device, comprising:

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

a drive system to dispense a medicine from the medicine cartridge when the medicine cartridge is received by the pump housing;

the drive system comprising a piston rod having a plunger engagement device that attaches to the plunger of the medicine cartridge when the medicine cartridge is received by the pump housing, wherein the plunger engagement device comprises one or more penetration members that pierce into a first side of the plunger during attachment of the plunger and the plunger engagement device, wherein the penetration members comprise substantially rigid blades that penetrate longitudinally into the plunger.

40. The infusion pump device of claim 18, wherein at least a portion of the cap device locks with the pump housing to hinder replacement of the medicine cartridge after the medicine cartridge is exhausted.

20. An infusion pump device, comprising:

a pump housing that defines an exterior opening to slidably receive a medicine cartridge inside a space of the pump housing; and

a drive system comprising a battery-powered actuator and configured to dispense a medicine from the medicine cartridge when the medicine cartridge is received by the pump housing;

the drive system comprising a piston rod that is advanced toward the medicine cartridge dispense the medicine from the medicine cartridge when the medicine cartridge is received by the pump housing, the piston rod having a plunger engagement device that adjusts from a disengaged condition in which the plunger engagement device is spaced away from the plunger to an engaged condition in which the plunger engagement device attaches to the plunger when the medicine cartridge is received by the pump housing,

wherein the plunger engagement device comprises one or more penetration members that pierce into a first side of the plunger during attachment of the plunger and the plunger engagement device, and wherein the penetration members penetrate longitudinally into the plunger through a majority of the longitudinal length of the plunger, the penetration members reducing the compliance of the plunger when being forced toward the medicine in the cartridge.

44. The infusion pump device of claim 20, wherein the penetration members comprise substantially rigid blades that penetrate longitudinally into the plunger.

45. The infusion pump device of claim 20, wherein the penetration members comprise substantially rigid pins that penetrate longitudinally into the plunger.

46. The infusion pump device of claim 20, wherein the drive system comprises a battery-powered actuator housed inside the pump housing.

22. An infusion pump device, comprising:

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

a drive system to dispense a medicine from the medicine cartridge when the medicine cartridge is received by the pump housing; and

a cap device that directly engages the pump housing by mechanically securing the cap device to one or more mating structures of the pump housing so as to retain the medicine cartridge therein when the medicine cartridge is received by the pump housing,

wherein when the cap device engages the pump housing, the cap device contacts a wall of the medicine cartridge at a location spaced away from a plunger of the medicine cartridge to urge an initial breakaway movement of the plunger inside the medicine cartridge.

23. The infusion pump device of claim 22, wherein the cap device comprises a needle device that penetrates an output portion of the medicine cartridge when the cap device engages the pump housing.

24. The infusion pump device of claim 23, wherein when the cap device engages the pump housing, the cap device acts upon the medicine cartridge to urge the plunger of the medicine cartridge to attach to a component of the drive system.

25. The infusion pump device of claim 22, wherein the cap device houses at least a portion of a flow sensor to detect flow or nonflow of medicine through the cap device.

27. The infusion pump device of claim 22, further comprising a cap sensor that indicates when the cap device is engaged with the pump housing at a predetermined position.

28. The infusion pump device of claim 27, wherein the cap sensor communicates with a controller device that activates the drive system to dispense medicine when the cap device is engaged with the pump housing at the predetermined position.

29. A method of operating the infusion pump device of claim 22, comprising:

engaging the cap device with the pump housing to retain the medicine cartridge in the space defined by the pump housing; and

urging the cap device to act upon the medicine cartridge to thereby urge the initial breakaway movement of the plunger inside the medicine cartridge against the medicine cartridge so that a plunger of the medicine cartridge attaches a component of a pump drive system.

30. The method of claim 29, further comprising penetrating the medicine cartridge with a needle device of the cap member when the cap device engages the pump housing.

31. The method of claim 30, further comprising urging the cap device against the medicine cartridge so that the plunger which is positioned inside the medicine cartridge attaches a component of a pump drive system.

32. The method of claim 29, further comprising receiving an indication of flow or nonflow of medicine through the cap device as detected by a flow sensor at least partially housed in the cap device.

33. The method of claim 29, further comprising locking at least a portion of the cap device into engagement with the pump housing to hinder replacement the medicine cartridge after the medicine cartridge is exhausted.

34. The method of claim 29, further comprising engaging the cap device with the pump housing in a predetermined position so that a cap sensor indicates when the cap device is at the predetermined position.

35. The method of claim 34, further comprising receiving an auto-shutoff indication when the cap device is arranged outside the predetermined position.

26. An infusion pump device, comprising:

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

a drive system to dispense a medicine from the medicine cartridge when the medicine cartridge is received by the pump housing; and

a cap device that engages the pump housing by mechanically securing the cap device to one or more mating structures of the pump housing so as to retain the medicine cartridge therein when the medicine cartridge is received by the pump housing,

wherein when the cap device engages the pump housing, the cap device contacts a wall of the medicine cartridge at a location spaced away from a plunger of the medicine cartridge to urge an initial breakaway movement of the plunger inside the medicine cartridge, and wherein at least a portion of the cap device locks with the pump housing to hinder replacement of the medicine cartridge after the medicine cartridge is exhausted.

47. The infusion pump device of claim 26, wherein the cap device comprises one or more mating structures that mechanically secure to one or more complementary structures of the pump housing during engagement between the cap device and the pump housing, and wherein the cap device comprises a needle device that penetrates a septum of the medicine cartridge positioned generally opposite from the plunger when the cap device engages the pump housing.

48. The infusion pump device of claim 26, wherein when the cap device engages the pump housing, the cap device acts upon the medicine cartridge to urge an initial breakaway movement of the plunger inside the medicine cartridge.