Plunger assembly for patient infusion device

• US 20080132842A1
• Filed: 06/06/2002
• Published: 06/05/2008
• Est. Priority Date: 06/06/2002
• Status: Abandoned Application

• Current Assignee: Insulet Corporation
• Original Assignee: Insulet Corporation
• Inventors: Flaherty, J. Christopher
• Application Number:
  US10/163,688
• Publication Number:
  US 20080132842A1
• Time in Patent Office: Days
• US Class Current: 604/151
• CPC Class Codes: A61M 2005/14506 mechanically driven, e.g. spring or clockwork
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 2205/106 reciprocating
• CPC Class Codes: A61M 2205/35 Communication
• CPC Class Codes: A61M 2205/6072 Bar codes
• CPC Class Codes: A61M 5/1454 spring-actuated, e.g. by a clockwork
• 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: F03G 7/065 using a shape memory element

Abstract

A device for delivering fluid, such as insulin, to a patient. The device includes an exit port assembly, a syringe-like reservoir including a side wall extending along a longitudinal axis towards an outlet connected to the exit port assembly, and a plunger assembly received in the reservoir. The plunger assembly includes a longitudinal segment connecting first and second lateral segments. The longitudinal segment includes a spring biasing the first and the second lateral segments longitudinally apart, and an actuator arranged to overcome the spring and bias the first and the second lateral segments longitudinally together upon actuation. Successively actuating the actuator causes longitudinal movement of the plunger assembly towards the outlet of the reservoir in order to cause fluid to be dispensed from the reservoir to the exit port assembly. According to one exemplary embodiment, the actuator comprises an elongated shape memory element.

Claims

1. A device for delivering fluid to a patient, comprising:

an exit port assembly;

a reservoir including an outlet connected to the exit port assembly, and a side wall extending along a longitudinal axis towards the outlet; and

a plunger assembly received in the reservoir and movable along the longitudinal axis of the reservoir towards the outlet of the reservoir, the plunger assembly including,

a first lateral segment extending laterally with respect to the longitudinal axis of the reservoir and contacting the side wall of the reservoir,

a second lateral segment positioned between the first lateral segment and the outlet of the reservoir, the second lateral segment extending laterally with respect to the longitudinal axis of the reservoir and contacting the side wall of the reservoir, and longitudinally spaced from the first lateral segment, and

a longitudinal segment extending substantially parallel with respect to the longitudinal axis of the reservoir and connecting the first and the second lateral segments and including,

a spring biasing the first and the second lateral segments longitudinally apart, and

an actuator arranged to overcome the spring and bias the first and the second lateral segments longitudinally together upon actuation.

2. A device according to claim 1, wherein the actuator of the longitudinal segment of the plunger assembly comprises an elongated shape memory element having a changeable length decreasing from an uncharged length to a charged length when at least one charge is applied to the shape memory element, the shape memory element connected between the first and the second lateral segments.

3. A device according to claim 2, wherein the shape memory element comprises one-way shape memory material.

4. A device according to claim 2, wherein the shape memory element comprises a wire.

5. A device according to claim 2, wherein the shape memory element is made of a nickel and titanium alloy.

6. A device according to claim 1, wherein the actuator of the longitudinal segment of the plunger assembly comprises a piezoelectric element.

7. A device according to claim 1, wherein the actuator of the longitudinal segment of the plunger assembly comprises a solenoid assembly.

8. A device according to claim 1, wherein the longitudinal segment of the plunger assembly further includes a rigid longitudinal projection of a predetermined length.

9. A device according to claim 1, wherein the plunger assembly is prevented from rotating with respect to the side wall of the reservoir.

10. A device according to claim 9, wherein the side wall of the reservoir and the first and the second lateral segments have oval cross-sections.

11. A device according to claim 1, wherein the plunger assembly further includes a case of resiliently flexible material enclosing the longitudinal segment and the first and the second lateral segments in a fluid-tight manner.

12. A device according to claim 1, wherein the case of the plunger assembly includes a first portion covering the first lateral segment, a second portion covering the second lateral segment, and a collapsible bellows covering the longitudinal segment and connecting the first and the second portions.

13. A device according to claim 1, wherein the first and the second lateral segments are substantially prevented from moving away from the outlet of the reservoir.

14. A device according to claim 13, wherein the first and the second lateral segments include outer circumferential ridges shaped and oriented to engage the side wall of the reservoir and substantially prevent movement of the first and the second lateral segments away from the outlet of the reservoir.

15. A device according to claim 1, wherein the actuator of the longitudinal segment of the plunger assembly is actuated when an electrical charge is applied to the actuator, and the device further comprises:

a local processor electrically connected to the actuator of the longitudinal segment of the plunger assembly and programmed to provide electrical charges to the actuator based upon flow instructions;

a wireless receiver connected to the local processor for receiving flow instructions from a separate, remote control device and delivering the flow instructions to the local processor; and

a housing containing the reservoir, the exit port assembly, the plunger assembly, the local processor and the wireless receiver, and wherein the housing is free of user input components for providing flow instructions to the local processor.

16. A system including a fluid delivery device according to claim 15, and further comprising a remote control device separate from the fluid delivery device and including:

a remote processor;

user interface components connected to the remote processor for allowing a user to provide flow instructions to the remote processor; and

a transmitter connected to the remote processor for transmitting the flow instructions to the receiver of the fluid delivery device.

17. A device according to claim 1, wherein the reservoir contains a therapeutic fluid.

18. A device according to claim 17, wherein the therapeutic fluid is insulin.

19. A device according to claim 1, wherein the exit port assembly includes a transcutaneous patient access tool.

20. A device according to claim 19, wherein the transcutaneous patient access tool comprises a needle.

21. A device according to claim 1, further comprising a fluid fill port connected to the reservoir.

22. A device according to claim 21, further comprising a resealable, needle-pierceable septum.

23. A device according to claim 2, further comprising a local processor connected to ends of the shape memory element and programmed to provide charges to the shape memory element based upon flow instructions.

24. A device according to claim 23, further comprising a power supply connected to the local processor.

25. A device according to claim 1, wherein the first lateral segment includes:

two blocks laterally movable with respect to the longitudinal axis of the reservoir;

a spring biasing the two blocks apart and laterally outwardly to frictionally engage the side wall of the reservoir and prevent longitudinal movement of the first lateral segment towards the outlet of the reservoir; and

an actuator arranged to overcome the spring of the first lateral segment and bias the blocks together laterally upon actuation.

26. A device according to claim 25, wherein the actuator of the first lateral segment of the plunger assembly comprises an elongated shape memory element having a changeable length decreasing from an uncharged length to a charged length when at least one charge is applied to the shape memory element, the shape memory element connected between the two blocks of the first lateral segment.

27. A device according to claim 26, wherein the shape memory element of the first lateral segment comprises one-way shape memory material.

28. A device according to claim 26, wherein the shape memory element of the first lateral segment comprises a wire.

29. A device according to claim 26, wherein the shape memory element of the first lateral segment is made of a nickel and titanium alloy.

30. A device according to claim 25, wherein the actuator of the first lateral segment of the plunger assembly comprises a piezoelectric element.

31. A device according to claim 25, wherein the actuator of the first lateral segment of the plunger assembly comprises a solenoid assembly.

32. A device according to claim 25, wherein the second lateral segment includes:

two blocks laterally movable with respect to the longitudinal axis of the reservoir;

a spring biasing the two blocks of the second lateral segment apart and laterally outwardly to frictionally engage the side wall of the reservoir and prevent longitudinal movement of the second lateral segment towards the outlet of the reservoir; and

an actuator arranged to overcome the spring of the second lateral segment and bias the blocks of the second lateral segment together laterally upon actuation.

33. A device according to claim 32, wherein the actuator of the second lateral segment of the plunger assembly comprises an elongated shape memory element having a changeable length decreasing from an uncharged length to a charged length when at least one charge is applied to the shape memory element of the second lateral segment, the shape memory element of the second lateral segment connected between the two blocks of the second lateral segment.

34. A device according to claim 33, wherein the shape memory element of the second lateral segment comprises one-way shape memory material.

35. A device according to claim 33, wherein the shape memory element of the second lateral segment comprises a wire.

36. A device according to claim 33, wherein the shape memory element of the second lateral segment is made of a nickel and titanium alloy.

37. A device according to claim 32, wherein the actuator of the second lateral segment of the plunger assembly comprises a piezoelectric element.

38. A device according to claim 32, wherein the actuator of the second lateral segment of the plunger assembly comprises a solenoid assembly.

39. A device according to claim 32, wherein the actuators of the plunger assembly are electrically actuable, and the device further comprises:

a local processor electrically connected to the actuators of the plunger assembly and programmed to provide at least one of a pattern of electrical charges to the actuators based upon flow instructions, the pattern of electrical charges comprising,

providing a charge to the actuator of the first lateral segment,

providing a charge to the actuator of the longitudinal segment,

removing the charge from the actuator of the first lateral segment,

providing a charge to the actuator of the second lateral segment,

removing the charge from the actuator of the longitudinal segment, and

removing the charge from the actuator of the second lateral segment.

40. A device according to claim 39, further comprising;

a wireless receiver connected to the local processor for receiving flow instructions from a separate, remote control device and delivering the flow instructions to the local processor; and

a housing containing the reservoir, the exit port assembly, the plunger assembly, the local processor and the wireless receiver, and wherein the housing is free of user input components for providing flow instructions to the local processor.

41. A system including a fluid delivery device according to claim 40, and further comprising a remote control device separate from the fluid delivery device and including:

a remote processor;

user interface components connected to the remote processor for allowing a user to provide flow instructions to the remote processor; and

a transmitter connected to the remote processor for transmitting the flow instructions to the receiver of the fluid delivery device.

42. A device according to claim 1, further comprising a sensor for determining the longitudinal position of the plunger assembly within the reservoir.

43. A device according to claim 42, wherein the reservoir includes a longitudinally extending barcode and the sensor comprises an optical emitter/receiver mounted on the plunger assembly in alignment with the barcode.

44. A device according to claim 1, wherein the spring comprises a helical compression spring.

45. A device according to claim 25, wherein the spring of the first lateral segment comprises a helical compression spring.

46. A device according to claim 32, wherein the spring of the second lateral segment comprises a helical compression spring.

47. A device according to claim 1, wherein a fluid-tight seal exists between an outermost periphery of the second lateral segment and the side wall of the reservoir.

48. A device according to claim 1, wherein:

the side wall of the reservoir includes a first section extending from the outlet of the reservoir parallel with the longitudinal axis and a second section extending from the first section parallel with the longitudinal axis, and wherein the first section of the side wall has an internal cross-sectional dimension that is unequal to an internal cross-sectional dimension of the second section of the side wall; and

the first and the second lateral segments and the longitudinal segment of the plunger assembly are received in the second section of the side wall of the reservoir, and the plunger assembly further includes strut extending from the second lateral segment and slidingly received in the first section of the side wall of the reservoir, wherein the strut is sized and shaped to provided a substantially fluid-tight seal between the first section of the side wall and the strut.

49. A device according to claim 48, wherein the internal cross-sectional dimension of the first section of the side wall of the reservoir is smaller than the internal cross-sectional dimension of the second section of the side wall.