Components and methods for patient infusion device

• US 20040064096A1
• Filed: 09/30/2002
• Published: 04/01/2004
• Est. Priority Date: 09/30/2002
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Insulet Corporation
• Inventors: Abelson, Matthew D., Flaherty, J. Christopher, Garibotto, John T., Chastain, David P., Gorman, William, Bussiere, John R.
• Granted Patent: US 7,128,727 B2
• Time in Patent Office: Days
• US Class Current: 604/131
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1583 Needle extractors
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1454 spring-actuated, e.g. by a clockwork
• 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: G16H 20/17 delivered via infusion or injection

Abstract

A transcutaneous access tool includes a first cannula moveable along an axis, a fixed member including an elongated prong extending parallel with the axis, and a deployment member secured to the first cannula and movable along the axis away from the fixed member. The deployment member includes spaced-apart, resiliently flexible fingers extending parallel with the axis and having distal ends that are laterally enlarged with respect to the axis. The resiliently flexible fingers are received on the prong of the fixed member. A second cannula is disposed within the lumen of the first cannula, and retraction member is secured to the second cannula and is movable along the axis. The retraction member includes at least one catch catching on the laterally enlarged distal ends of the fingers of the deployment element when the fingers are laterally held apart by the prong of the fixed member.

Claims

1. A transcutaneous access tool comprising:

a first cannula moveable along an axis of the transcutaneous access tool;

a fixed member including an elongated prong extending parallel with the axis;

a deployment member secured to the first cannula and movable along the axis away from the fixed member, the deployment member including spaced-apart, resiliently flexible fingers extending parallel with the axis and slidingly received on the prong of the fixed member, the fingers having distal ends that are laterally enlarged with respect to the axis;

a second cannula disposed within the lumen of the first cannula; and

a retraction member secured to the second cannula and movable along the axis between the fixed member and the deployment member, wherein the retraction member includes at least one catch extending laterally inwardly with respect to the axis and catching on the laterally enlarged distal ends of the fingers of the deployment element when the fingers are laterally held apart by the prong of the fixed member.

2. A transcutaneous access tool according to claim 1, further comprising:

a deployment spring biasing the deployment member away from the fixed member; and

a retraction spring biasing the retraction member away from the deployment member and towards the fixed member.

3. A transcutaneous access tool according to claim 2, further comprising a deployment latch mechanism maintaining the deployment member against the bias force of the deployment spring.

4. A transcutaneous access tool according to claim 3, wherein the deployment latch mechanism comprises:

a movable latch positioned in the path of the deployment member to maintain the deployment member against the bias force of the deployment spring; and

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 to the latch such that the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes the latch to be moved out of the path of the deployment member.

5. A transcutaneous access tool according to claim 1, further comprising a seal secured to the deployment member and coaxially positioned about the first cannula.

6. A transcutaneous access tool according to claim 1, wherein the first cannula is flexible and the second cannula is rigid.

7. A fluid delivery device including a transcutaneous access tool according to claim 1, and further comprising a housing containing the transcutaneous access tool and including an exit port, and wherein the fixed member is secured to the housing and the transcutaneous access tool is oriented with respect to the housing such that the axis extends through the exit port.

8. A fluid delivery device according to claim 7, further comprising an outlet port secured to a distal end of the first cannula, and wherein the outlet plug includes an air removal filter allowing air to exit the first cannula.

9. A fluid delivery device according to claim 8, wherein the port in the wall of the housing comprises an internal exit port and the housing further includes an external exit port for the first cannula and a sterilization access port adjacent the external exit port.

10. A fluid delivery device according to claim 7, further comprising:

an adhesive layer provided in at least one continuous band on an exterior surface of the housing surrounding the exit port of the housing and including resilient flaps normally sealing the exit port in a substantially air-tight manner; and

a protective layer removably covering the adhesive layer and including a sterilization access tube extending through the flaps of the adhesive layer and into the housing.

11. A fluid delivery device comprising:

a housing;

a reservoir positioned within the housing; and

a transcutaneous access tool positioned within the housing and including,

a cannula in fluid communication with the reservoir and linearly moveable along an axis of the transcutaneous access tool through a port in a wall of the housing,

a deployment member secured to the cannula and movable along the axis of the transcutaneous access tool against the wall of the housing defining the port, and

an annular seal coaxially positioned about the cannula and positioned between the deployment member and the wall of the housing defining the port, so that the seal provides a substantially fluid-tight seal between the deployment member and the wall of the housing when the deployment member is moved against the wall of the housing.

12. A device according to claim 11, wherein the annular seal is secured to the deployment member.

13. A device according to claim 11, wherein the annular seal comprises at least one of an elastomer and rubber.

14. A device according to claim 11, wherein the cannula comprises a flexible cannula.

15. A device according to claim 11, wherein the transcutaneous access tool further comprises a deployment spring biasing the deployment member towards the port in the wall of the housing.

16. A device according to claim 15, wherein the transcutaneous access tool further includes a deployment latch mechanism maintaining the deployment member against the bias force of the deployment spring.

17. A device according to claim 16, wherein the deployment latch mechanism comprises:

a movable latch positioned in the path of the deployment member to maintain the deployment member against the bias force of the deployment spring; and

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 latch and a fixed portion of the device such that the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes the latch to be moved out of the path of the deployment member.

18. A device according to claim 11, wherein the cannula of the transcutaneous access tool comprises a first cannula and the transcutaneous access tool further includes:

a second cannula disposed within the lumen of the first cannula; and

a retraction member secured to the second cannula and movable along the axis of the transcutaneous access tool with respect to the deployment member.

19. A device according to claim 18, wherein the transcutaneous access tool further comprises a retraction spring biasing the retraction member away from the deployment member.

20. A device according to claim 18, wherein the first cannula is flexible and the second cannula is rigid.

21. A device according to claim 11, further comprising an outlet plug removably connected to a distal end of the cannula.

22. A device according to claim 21, wherein the outlet plug includes an air removal filter allowing air to exit the cannula.

23. A device according to claim 21, wherein the port in the wall of the housing comprises an internal exit port and the housing further includes an external exit port for the flexible cannula and a sterilization access port adjacent the external exit port.

24. A fluid delivery device comprising:

a housing having a port;

an adhesive layer provided on an exterior surface of the housing surrounding the port of the housing and including resilient flaps normally sealing the port in a substantially fluid-tight manner; and

a protective layer removably covering the adhesive layer and including a sterilization access tube extending through the flaps of the adhesive layer, through the port and into the housing.

25. A device according to claim 24, wherein the adhesive layer is provided in at least one continuous band around the port of the housing.

26. A device according to claim 25, wherein the adhesive layer is provided on a skin-contacting portion of the exterior surface of the housing, and the housing also includes a second port extending through the skin-contacting portion of the exterior surface.

27. A device according to claim 24, wherein the port in the housing comprises an exit port and the device further comprises a reservoir positioned within the housing, and a transcutaneous access tool positioned within the housing and including a cannula in fluid communication with the reservoir and moveable through the exit port in the housing.

28. A flow path assembly comprising:

a base layer having opposing first and second surfaces and defining,

a fill chamber outlet port extending through the base layer and between the opposing first and second surfaces,

an auxiliary chamber inlet port extending through the base layer and between the opposing first and second surfaces,

a first groove on the second surface of the base layer connecting the fill chamber outlet port to the auxiliary chamber inlet port,

an auxiliary chamber outlet port extending through the base layer and between the opposing first and second surfaces,

a reservoir inlet port extending through the base layer and between the opposing first and second surfaces,

a second groove on the second surface of the base layer connecting the auxiliary chamber outlet port to the reservoir inlet port,

a reservoir outlet port extending through the base layer and between the opposing first and second surfaces,

a cannula inlet port extending through the base layer and between the opposing first and second surfaces, and

a third groove on the second surface of the base layer connecting the reservoir outlet port to the cannula inlet port; and

a cover layer substantially covering the second surface of the base layer in a substantially fluid-tight manner.

29. An assembly according to claim 28, wherein the base layer is relatively rigid and the cover layer is relatively flexible.

30. An assembly according to claim 28, further comprising a cannula connector member secured to the first surface of the base layer in a substantially fluid-tight manner and defining a cannula connector chamber in fluid communication with the cannula inlet port of the base layer.

31. An assembly according to claim 30, wherein the cannula connector member is unitarily formed with the base layer.

32. An assembly according to claim 30, wherein the cannula connector member includes an open end for the cannula connector chamber and includes a needle septum fitted within the open end of the cannula connector chamber.

33. An assembly according to claim 28, further comprising a fill port member secured to the first surface of the base layer in a substantially fluid-tight manner and defining a fill port chamber in fluid communication with the fill chamber outlet port of the base layer.

34. An assembly according to claim 33, wherein the fill port member is unitarily formed with the base layer.

35. An assembly according to claim 33, wherein the fill port member includes an open end for the fill port chamber and a needle septum fitted within the open end of the fill port chamber.

36. An assembly according to claim 28, wherein the first surface of the base layer defines an auxiliary recess connecting the auxiliary chamber inlet port and the auxiliary chamber outlet port.

37. An assembly according to claim 36, further comprising a sensor assembly secured to the auxiliary recess of the first surface of the base layer in a substantially fluid-tight manner and including a sensor chamber in fluid communication with the auxiliary chamber inlet port and the auxiliary chamber outlet port of the base layer.

38. An assembly according to claim 28, further comprising a sensor assembly secured to the first surface of the base layer in a substantially fluid-tight manner and including a sensor chamber in fluid communication with the auxiliary chamber inlet port and the auxiliary chamber outlet port of the base layer.

39. An assembly according to claim 28, wherein the first surface of the base layer defines a reservoir shelf connecting the reservoir inlet port and the reservoir outlet port.

40. An assembly according to claim 39, further comprising a reservoir secured to the reservoir shelf of the first surface of the base layer in a substantially fluid-tight manner and defining a reservoir chamber in fluid communication with the reservoir inlet port and the reservoir outlet port.

41. An assembly according to claim 40, wherein the reservoir includes a cylindrical side wall defining the reservoir chamber and having an open first end secured to the reservoir shelf of the first surface of the base layer in a substantially fluid-tight manner.

42. An assembly according to claim 40, wherein the cylindrical side wall of the reservoir comprises stainless steel.

43. An assembly according to claim 40, wherein the reservoir further includes an end cap closing the open first end of cylindrical side wall in a substantially fluid-tight manner and defining a reservoir port providing fluid communication between the reservoir chamber and the reservoir inlet port and the reservoir outlet port.

44. An assembly according to claim 43, wherein the end cap of the reservoir is made of a resiliently flexible material.

45. An assembly according to claim 43, wherein the end cap of the reservoir is made of stainless steel.

46. An assembly according to claim 41, wherein the cylindrical side wall of the reservoir is unitarily formed with the base layer.

47. A flow path assembly comprising:

a cylindrical side wall having opposing first and second open ends and defining a reservoir chamber;

an end cap closing the second open end of the side wall and defining a port providing fluid communication with the reservoir chamber;

a plunger received in the reservoir chamber and slidingly moveable along the side wall and between the opposing first and second open ends;

a lead screw extending into the first open end of the side wall and having a distal end secured to the plunger.

48. An assembly according to claim 47, wherein the distal end of the lead screw is rotatably secured in a recess of the plunger.

49. An assembly according to claim 47, wherein the distal end of the lead screw is rotatably secured in a snap-fit manner within the recess of the plunger.

50. An assembly according to claim 47, further comprising a relatively resiliently flexible o-ring positioned between the plunger and the side wall.

51. An assembly according to claim 47, wherein the cylindrical side wall comprises stainless steel.

52. An assembly according to claim 47, further comprising a base layer comprising:

opposing first and second surfaces;

a fill chamber outlet port extending through the base layer and between the opposing first and second surfaces;

a reservoir inlet port extending through the base layer and between the opposing first and second surfaces;

a reservoir outlet port extending through the base layer and between the opposing first and second surfaces; and

a cannula inlet port extending through the base layer and between the opposing first and second surfaces;

wherein the second surface of the base layer defines a first groove connecting the fill chamber outlet port to the reservoir inlet port, and a second groove connecting the reservoir outlet port to the cannula inlet port; and

wherein the first surface of the base layer defines a reservoir recess connecting the reservoir inlet port and the reservoir outlet port and receiving the end cap of the reservoir in a substantially fluid-tight manner; and

wherein the port of the end cap provides fluid communication between the reservoir chamber and the reservoir inlet port and the reservoir outlet port.

53. An assembly according to claim 52, further comprising a cover layer substantially covering the second surface of the base layer in a substantially fluid-tight manner.

54. An assembly according to claim 53, wherein the base layer is relatively rigid and the cover layer is relatively flexible.

55. A flow path assembly comprising:

a first portion of a housing of a fluid delivery device; and

a second portion of the housing of the fluid delivery device;

wherein the first and second portions of the housing assemble together to form an end wall of the housing, and the end wall defines,

a fill port;

a reservoir connection port;

a cannula connection port; and

at least one flow path connecting the fill port, the reservoir connection port and the cannula connection port.

56. An assembly according to claim 55, wherein the end wall further includes an interior surface defining a reservoir recess in fluid communication with the reservoir connection port.

57. An assembly according to claim 56, wherein the end wall includes a circumferential o-ring groove in the reservoir recess.

58. An assembly according to claim 55, wherein the first portion of the housing includes a first portion of the end wall and the second portion of the housing includes a second portion of the end wall, and the first and the second portions of the end wall have mating surfaces defining corresponding grooves which together define the flow path of the end wall when the first and the second portions of the housing are assembled together.

59. An assembly according to claim 58, wherein the fill port extends between the mating surface of the second portion of the end wall and an exterior surface of the second portion of the housing.

60. An assembly according to claim 59, wherein the fill port contains a needle septum.