DEVICE AND METHOD FOR DISPENSING FLUID FROM AN INFUSION PUMP

• US 20140035604A1
• Filed: 07/03/2013
• Published: 02/06/2014
• Est. Priority Date: 07/31/2012
• Status: Active Grant

• Current Assignee: Trividia Healthcare Systems, LLC
• Original Assignee: Nipro Healthcare Systems LLC (Sinocare, Inc.)
• Inventors: Paul, Patrick J., Baptista, Alexandre A.N., Arguello, Edward D.
• Granted Patent: US 9,839,745 B2
• Time in Patent Office: Days
• US Class Current: 324/713
• 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 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence
• CPC Class Codes: G01F 23/22 by measuring physical variables, other than linear dimensions, pressure or weight, dependent on the level to be measured, e.g. by difference of heat transfer of steam or water involving the use of floats G01F23/30

Abstract

The present disclosure is directed towards a compact, modular infusion pump and a delivery mechanism for accurate dispensing of very small amounts of medication. The infusion pump comprises a tubular, curved medication reservoir, and a flexible, one-piece drive train configured to push very small amounts of medication out of the medication reservoir. A method of measuring a level of medication inside the medication reservoir or cross-checking the accuracy of medication delivery is also described.

Claims

1. A modular infusion pump for dispensing a fluid, comprising:

a reservoir module, comprising;

a tubular, curved reservoir containing the fluid, the curved reservoir having a proximal end and a distal end; and

a flexible, one-piece drive train configured to slidably fit within the curved reservoir and to expel the fluid through the proximal end of the reservoir;

a control module comprising an electric motor, a drive shaft, and a lead screw, wherein the lead screw is configured to mechanically engage the drive train when the reservoir module is connected to the control module.

2. The modular infusion pump of claim 1, wherein the reservoir module comprises a medication output port fluidly coupled to the proximal end of the reservoir.

3. The modular infusion pump of claim 2, further comprising a cradle configured to mate with the medication output port of the reservoir module.

4. The modular infusion pump of claim 3, wherein the cradle is configured to adhere directly to the skin of the patient.

5. The modular infusion pump of claim 4, wherein the cradle comprises a short, flexible cannula configured to penetrate the skin of the patient.

6. The modular infusion pump of claim 2, further comprising an infusion set configured to mate with the medication output port.

7. The modular infusion pump of claim 6, wherein the infusion set comprises a tubing having an insertion needle at one end thereof, the insertion needle configured to deliver medication to the patient subcutaneously.

8. The modular infusion pump of claim 2, wherein the medication output port is configured to connect interchangeably with a cradle configured to adhere direct to a patient'"'"'s skin, or an infusion set comprising a medication delivery tubing.

9. The modular infusion pump of claim 2, wherein the reservoir module further comprises a self-sealing fill port configured to enable loading of medication into the reservoir.

10. The modular infusion pump of claim 2, wherein the medication output port is further configured to enable loading of medication into the reservoir.

11. The modular infusion pump of claim 1, wherein the reservoir module comprises a hydrophobic vent configured to equalize pressure inside and outside the reservoir module.

12. The modular infusion pump of claim 1, wherein the reservoir module further comprises a feeder track having a continuous, curved wall structure configured to guide the drive train.

13. The modular infusion pump of claim 1, further comprising a locking mechanism configured to mate the reservoir module with the control module.

14. The modular infusion pump of claim 13, wherein the locking mechanism comprises a locking pin on the control module and latching tabs on the reservoir module, and further wherein the locking pin and the latching tabs are configured to engage together when the reservoir module and the control module are brought in contact with each other.

15. The modular infusion pump of claim 1, wherein the control module further comprises at least one gear coupled to an output shaft of the electric motor.

16. The modular infusion pump of claim 15, wherein the at least one gear is mechanically coupled to the drive shaft.

17. A method of delivering very small amounts of medication from an infusion pump, comprising:

providing tubular medication reservoir having a medication delivery outlet at a proximal end thereof, wherein the medication reservoir is adapted to be mounted within the infusion pump in a curved configuration;

providing a flexible, continuous drive train connected to a plunger at a proximal end thereof;

mounting the medication reservoir in a curved configuration on the infusion pump; and

mounting the drive train in a curved configuration on the infusion pump.

18. The method of claim 17, further comprising driving the drive train through the medication reservoir mounted on the infusion pump and causing the plunger to push medication towards the medication delivery outlet.

19. The method of claim 18, further comprising pre-filling the medication reservoir prior to driving the drive train therethrough.

20. The method of claim 17, further comprising fluidly coupling the medication delivery outlet to a cannula for dispensing medication to a user.

21. The method of claim 17, further comprising fluidly coupling the medication delivery outlet to an infusion set, the infusion set comprising a tube for dispensing medication to a user.

22. The method of claim 17, further comprising providing an actuation mechanism for driving the drive train through the medication reservoir mounted on the infusion pump, the actuation mechanism comprising an electric motor, a drive shaft, and a lead screw, and wherein the lead screw is configured to mechanically engage the drive train.

23. An infusion pump for delivering small amounts of medication to a user, the pump comprising:

a long, tubular medication reservoir having a curved configuration, the medication reservoir comprising a medication delivery outlet at a proximal end;

a flexible, continuous drive train comprising a plunger at a proximal end and a cursor at a distal end; and

an actuation device configured to drive the drive train through the medication reservoir.

24. The infusion pump of claim 23, wherein the medication reservoir has a circular cross-section.

25. The infusion pump of claim 23, wherein the medication reservoir is made of a flexible polymeric material.

26. The infusion pump of claim 25, wherein the polymeric material is high density polyethylene.

27. The infusion pump of claim 23, wherein the medication reservoir is made of a rigid polymeric material.

28. The infusion pump of claim 23, wherein the medication reservoir has a long aspect ratio.

29. The infusion pump of claim 23, wherein the medication reservoir comprises alternating curved and straight sections.

30. The infusion pump of claim 23, wherein the medication reservoir has at least one straight section.

31. The infusion pump of claim 23, wherein the medication reservoir is curved throughout its length.

32. The infusion pump of claim 23, wherein the cursor is configured to indicate the position of the drive train within the medication reservoir.

33. The infusion pump of claim 23, wherein the plunger is configured to provide a hermetic seal between the plunger and the inner surface of the medication reservoir.

34. The infusion pump of claim 23, wherein the plunger is compressible.

35. The infusion pump of claim 23, wherein the plunger comprises an elastomeric ball.

36. The infusion pump of claim 23, wherein the plunger comprises a rigid sphere with an elastomeric outer shell.

37. The infusion pump of claim 23, wherein the drive train comprises an assembly of interconnected balls.

38. The infusion pump of claim 37, wherein the balls are interconnected using a tongue and groove mechanism.

39. The infusion pump of claim 23, wherein the drive train is a single-piece drive train.

40. The infusion pump of claim 39, wherein the single-piece drive train comprises a threaded spine.

41. The infusion pump of claim 40, wherein the threaded spine comprises an elongate center structure and a continuous thread on top of the center structure.

42. The infusion pump of claim 40, wherein the threaded spine further comprises at least one centering element on either side of the center structure.

43. The infusion pump of claim 23, wherein the actuation device comprises an electric motor.

44. The infusion pump of claim 43, wherein the electric motor is mechanically coupled to a motor shaft encoder configured to sense rotation of the electric motor.

45. The infusion pump of claim 43, wherein an output shaft of the electric motor is mechanically coupled to at least one gear.

46. The infusion pump of claim 45, wherein the at least one gear is mechanically coupled to a drive shaft.

47. The infusion pump of claim 46, wherein the drive shaft is further coupled to a force sensor configured to sense axial lateral forces generated by rotation of the drive shaft.

48. The infusion pump of claim 46, wherein the drive shaft is adapted to mount a lead screw configured to mechanically engage the drive train.

49. The infusion pump of claim 48, wherein the drive shaft is configured to enable the lead screw to slide on it axially and to rotate with it.

50. A method of measuring level of medication inside a medication reservoir of an insulin pump or cross-checking the accuracy of medication delivery, comprising:

providing a modular insulin pump, comprising;

a reservoir module comprising;

a tubular, curved medication reservoir;

a flexible, one-piece drive train configured to slidably fit within the medication reservoir; and

feeder track to guide the drive train within the reservoir module; and

a control module comprising actuating mechanism for driving the drive train through the medication reservoir and electronic circuitry for measuring the level of medication inside the medication reservoir;

providing parallel resistive traces on the underside of a lid covering the reservoir module;

providing a plunger at a proximal end and a cursor at a distal end of the drive train, wherein the cursor is configured to provide a moving electrical short between the parallel resistive traces; and

measuring a voltage signal across the parallel resistive traces.

51. The method of claim 50, wherein the parallel resistive traces comprise an electrically conductive polymeric material.

52. The method of claim 50, further comprising providing electrical terminations on at least one end of each of the parallel resistive traces to connect the parallel resistive traces to the electronic circuitry in the control module.

53. The method of claim 50, further comprising converting the voltage signal into a corresponding volume of medication present in the medication reservoir.

54. The method of claim 50, further comprising driving the drive train through the medication reservoir causing the plunger to push medication out of the medication reservoir via an outlet provided at the proximal end of the medication reservoir, and further causing the electric short created by the cursor to move along the parallel resistive traces.

55. The method of claim 50, further comprising using the voltage signal to detect occlusion within the medication reservoir or any downstream medication delivery tube or cannula.