Multi-position infusion set device and process

• US 7,494,481 B2
• Filed: 12/03/2004
• Issued: 02/24/2009
• Est. Priority Date: 12/03/2004
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Collins, Sean M., Adams, Jason, Cushing, Tommy, Candioty, Albert D., Houghton, Frederick C., Kooiman, Kraig P., Shelter, Lance E., Taylor, Clint, Girgis, Milad T., Moberg, Sheldon B., Kavazov, Julian D., Highley, Brian, Hudak, Philip J., Holt, Mark D.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): KOHARSKI, CHRISTOPHER
• Application Number:
  US11/004,594
• Publication Number:
  US 20060129090A1
• Time in Patent Office: 1,544 Days
• Field of Search: 604/535, 604/93.01, 604/164.01, 604/29, 604/533, 604/539, 604/263, 604/174, 604/178, 604/180, 604/177
• US Class Current: 604/174
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 2025/0266 using pads, patches, tapes or the like
• CPC Class Codes: A61M 2025/028 having a mainly rigid support structure
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 39/02 Access sites
• CPC Class Codes: A61M 39/1011 Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence
• CPC Class Codes: A61M 39/1055 Rotating or swivel joints in general F16L27/00
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

An infusion set for subcutaneous delivery of an infusant. The infusion set may include a base removably attachable to an infusion site and a connector temporarily lockable to the base. The connector can engage the base in a plurality of orientations. The connector locks into the base after at least partial rotation of the connector about the base. The connector may include flexible arms which unlock the connector from the base. The base includes a cannula for insertion through the infusion site. The connector includes a tubing for passing the infusant. The infusant is subcutaneously passable from the tubing through the cannula when the connector is attached to the base. The infusion set may also include a hub removably attachable to the base that includes a needle that extends through the base and the cannula and a guard removably attachable to the base opposite the hub for surrounding the needle.

Claims

1. An infusion set system comprising:

a base removably attachable to an infusion site for providing a subcutaneous path in a first generally linear direction for an infusant; and

a connector removably lockable to the base;

the connector comprising a connector duct having a fluid flow path that extends in generally the first linear direction and aligns with the linear subcutaneous path upon the connector being locked to the base;

the connector further comprising a port to which a tubing may be connected in fluid flow communication with the connector duct;

at least one of the connector and the base further comprising a plurality of tabs;

at least one of the connector and the base further comprising a plurality of locking surfaces for engaging at least one of the plurality of tabs;

wherein the connector comprises a single, unitary body in which the connector duct is contiguous with the port for providing a fluid flow connection between the port and the connector duct;

wherein the base is configured to be engagable by the connector, in a plurality of removably lockable orientations;

wherein the connector is at least partially rotatable about an axis of the base;

wherein rotation of the connector about the base causes the at least one of the plurality of tabs to engage with at least one of the plurality of locking surfaces to lock the connector to the base by inhibiting separation of the connector from the base in an axial direction parallel to the axis of the base.

2. The infusion set system of claim 1,

wherein at least one of the connector and the base further comprises a plurality of apertures, and

wherein at least one of the plurality of tabs is insertable into the plurality of apertures.

3. The infusion set system of claim 2, wherein at least one tab of the plurality of tabs is flexible.

4. The infusion set system of claim 3, wherein at least one tab of the plurality of tabs is static relative to the connector.

5. The infusion set system of claim 4, wherein at least one flexible tab of the plurality of tabs and at least one static tab of the plurality of tabs are rotatable from an unlocked position within at least one aperture of the plurality of apertures to a locked position.

6. The infusion set system of claim 5, wherein the base comprises a plurality of abutments for locking at least one flexible tab of the plurality of tabs and at least one static tab of the plurality of tabs.

7. The infusion set system of claim 5, wherein the connector comprises a plurality of arms, and wherein each arm of the plurality of arms is fixedly attached to at least one flexible tab of the plurality of tabs.

8. The infusion set system of claim 5, wherein the at least one flexible tab of the plurality of tabs and the at least one static tab of the plurality of tabs are positioned to rotate about the center of the connector.

9. The infusion set system of claim 3, wherein the connector is at least partially rotatable about the base, and wherein at least one tab of the plurality of tabs is rotatable from an unlocked position within at least one aperture of the plurality of apertures to a locked position.

10. The infusion set system of claim 9, wherein the connector comprises a plurality of arms, and wherein each arm of the plurality of arms is fixedly attached to a tab of the plurality of tabs.

11. The infusion set system of claim 10, wherein the plurality of arms are flexible.

12. The infusion set system of claim 11, wherein each arm of the plurality of arms is flexed to remove a tab of the plurality of tabs from the locked position to the unlocked position.

13. The infusion set system of claim 12, wherein the connector is removable from the base by simultaneously flexing the plurality of arms.

14. The infusion set system of claim 9, wherein at least one of the connector and the base further comprises at least one abutment for locking at least one tab of the plurality of tabs into the locked position.

15. The infusion set system of claim 1,

wherein the base includes a cannula for insertion through the infusion site,

wherein the connector includes a tubing for passing the infusant, and

wherein the infusant is subcutaneously passable from the tubing through the cannula when the connector is attached to the base.

16. The infusion set of claim 15, further comprising:

a hub removably attachable to the base, the hub including a needle extending through the base and through the cannula; and

a guard removably attachable to the base opposite the hub for surrounding the needle,

wherein the needle is subcutaneously insertable into the infusion site for subcutaneously positioning the cannula.

17. The infusion set of claim 1, wherein the base includes an adhesive pad for attaching to the infusion site.

18. The infusion set of claim 1, wherein the infusion site is the skin of a patient.

19. An infusion set system as recited in claim 1, wherein the plurality of removably lockable orientations of said connector relative to said base includes at least:

a first orientation in which a port of said connector for passing fluid through the infusion set system faces in a first direction with respect to the base; and

a second orientation in which said port faces in a second direction with respect to the base different from said first direction.

20. The infusion set system of claim 1,

wherein the connector is rotatable at least between a first position and a second position;

wherein the connector is detachable from the base in the first position and the connector is locked in the axial direction to the base to inhibit separation of the connector from the base in the second position; and

wherein the plurality of tabs and the plurality of locking surfaces allow a constant radial motion between the first position and the second position.

21. The infusion set system of claim 1, wherein at least one of the connector and the base is configured to apply a force on at least one of the plurality of tabs when the connector is rotated about the base, the force being directed radially inward toward the axis of the base.

22. A method for assembling an infusant delivery system comprising:

positioning a base at an infusion site for providing a subcutaneous path in a first generally linear direction for the infusant;

engaging the base with a connector in one of a plurality of orientations corresponding to respective ones of a plurality of removably lockable orientations, the connector being removably lockable to the base;

rotating, at least partially, the connector on the base until the connector temporarily locks to the base in one of said removably lockable orientations;

providing the connector with a connector duct having a fluid flow path that extends in generally the first linear direction and aligning the linear subcutaneous path upon the connector being locked to the base;

providing the connector with a port to which a tubing may be connected in fluid flow communication with the connector duct;

providing a plurality of tabs on at least one of the connector and the base; and

providing a plurality of locking surfaces on at least one of the connector and the base for engaging at least one of the plurality of tabs;

wherein providing a the connector with a single, unitary body in which the connector duct is contiguous with the port for providing a fluid flow connection between the port and the connector duct;

wherein the connector is at least partially rotatable about an axis of the base;

wherein rotation of the connector about the base causes the at least one of the plurality of tabs to engage with at least one of the plurality of locking surfaces to lock the connector to the base by inhibiting separation of the connector from the base in an axial direction parallel to the axis of the base.

23. The method of claim 22, wherein at least one of the connector and the base further includes a plurality of apertures.

24. The method of claim 23, further comprising inserting at Least one of the plurality of tabs into the plurality of apertures.

25. The method of claim 24, wherein at least one tab of the plurality of tabs is rotatable from a position within at least one aperture of the plurality of apertures to a locked position.

26. The method of claim 25, further comprising providing at least one abutment on the base for locking at least one tab of the plurality of tabs into a position.

27. The method of claim 23, wherein at least one tab of the plurality of tabs is flexible.

28. The method of claim 27, wherein at least one tab of the plurality of tabs is static relative to the connector.

29. The method of claim 28, wherein at least one flexible tab of the plurality of tabs and at least one static tab of the plurality of tabs are rotatable from an unlocked position within at least one aperture of the plurality of apertures to a locked position.

30. The method of claim 29, further comprising providing a plurality of abutments for locking at least one flexible tab of the plurality of tabs and at least one static tab of the plurality of tabs.

31. The method of claim 29, further comprising providing a plurality of arms, and wherein each arm of the plurality of arms is fixedly attached to at least one flexible tab of the plurality of tabs.

32. The method of claim 29, wherein the at least one flexible tab of the plurality of tabs and the at least one static tab of the plurality of tabs are positioned to rotate about the center of the connector.

33. The method of claim 22, further comprising providing a plurality of arms on the connector, wherein each arm of the plurality of arms is fixedly attached to a tab of the plurality of tabs.

34. The method of claim 33, wherein the plurality of arms are flexible.

35. The method of claim 34, further comprising flexing each arm of the plurality of arms to remove a tab of the plurality of tabs from a locked position to the unlocked position.

36. The method of claim 33, further comprising simultaneously flexing the plurality of arms to remove the connector from the base.

37. The method of claim of claim 22, further comprising inserting a cannula connected to the base through the infusion site, wherein the connector includes a tubing for passing the infusant, and wherein the infusant is subcutaneously passable from the tubing through the cannula when the connector is attached to the base.

38. The method of claim of claim 37, further comprising:

providing a hub removably attachable to the base, the hub including a needle extending through the base and through the cannula;

providing a guard removably attachable to the base opposite the hub for surrounding the needle; and

subcutaneously inserting the needle into the infusion site for subcutaneously positioning the cannula.

39. The method of claim 22, wherein the plurality of removably lockable orientations of said connector relative to said base includes at least:

a first orientation in which a port of said connector for passing fluid through the infusion set system faces in a first direction with respect to the base; and

a second orientation in which said port faces in a second direction with respect to the base different from said first direction.

40. The method of claim 22,

wherein the connector is rotatable at least between a first position and a second position;

wherein the connector is detachable from the base in the first position and the connector is locked in the axial direction to the base to inhibit separation of the connector from the base in the second position; and

wherein the plurality of tabs and the plurality of locking surfaces allow a constant radial motion between the first position and the second position.

41. The method of claim 22, wherein at least one of the connector and the base is configured to apply a force on at least one of the plurality of tabs when the connector is rotated about the base, the force being directed radially inward toward the axis of the base.

42. An infusion set comprising:

a base removably attachable to an infusion site for providing a subcutaneous path in a first generally linear direction for an infusant;

a connector removably attachable to the base;

the connector comprising a connector duct having a fluid flow path that extends in generally the first linear direction and aligns with the linear subcutaneous path upon the connector being locked to the base;

the connector further comprising a port to which a tubing may be connected in fluid flow communication with the connector duct;

wherein the connector comprises a single, unitary body in which the connector duct is contiguous with the port for providing a fluid flow connection between the port and the connector duct; and

at least one of the connector and the base further comprising a locking mechanism for temporarily locking the connector to the base,

wherein the base is engagable by the connector in a plurality of temporarily lockable orientations;

wherein the connector is at least partially rotatable about an axis of the base;

wherein rotation of the connector about the base causes the locking mechanism to temporarily lock the connector to the base by inhibiting separation of the connector from the base in an axial direction parallel to the axis of the base.

43. The infusion set system of claim 42, wherein at least one of the connector and the base further comprises a plurality apertures.

44. The infusion set of claim 43, wherein at least one Of the connector and the base further comprises a plurality of tabs insertable into the plurality of apertures.

45. The infusion set of claim 44, wherein the connector is at least partially rotatable about the base, and wherein at least one tab of the plurality of tabs is rotatable from a position within at least one aperture of the plurality of apertures to a locked position.

46. The infusion set of claim 45, wherein at least one Of the connector and the base comprises at least one abutment for locking at least one tab of the plurality of tabs into a position.

47. The infusion set of claim 45, wherein the connector comprises a plurality of arms, and

wherein each arm of the plurality of arms is fixedly attached to a tab of the plurality of tabs.

48. The infusion set of claim 47, wherein the plurality of arms are flexible.

49. The infusion set of claim 48, wherein each arm of the plurality of arms is flexed to remove a tab of the plurality of tabs from a locked position to the unlocked position.

50. The infusion set of claim 49, wherein the connector is removable from the base by simultaneously flexing the plurality of arms.

51. The infusion set system of claim 44, wherein at least one tab of the plurality of tabs is flexible.

52. The infusion set system of claim 51, wherein at least one tab of the plurality of tabs is static relative to the connector.

53. The infusion set system of claim 52, wherein at least one flexible tab of the plurality of tabs and at least one static tab of the plurality of tabs are rotatable from an unlocked position within at least one aperture of the plurality of apertures to a locked position.

54. The infusion set system of claim 53, wherein the base comprises a plurality of abutments for locking at least one flexible tab of the plurality of tabs and at least one static tab of the plurality of tabs.

55. The infusion set system of claim 53, wherein the connector comprises a plurality of arms, and wherein each arm of the plurality of arms is fixedly attached to at least one flexible tab of the plurality of tabs.

56. The infusion set system of claim 53, wherein the at least one flexible tab of the plurality of tabs and the at least one static tab of the plurality of tabs are positioned to rotate about the center of the connector.

57. The infusion set of claim 42, wherein the base includes a cannula for insertion through the infusion site,

wherein the connector includes a tubing for passing the infusant, and

wherein the infusant is subcutaneously passable from the tubing through the cannula when the connector is attached to the base.

58. The infusion set of claim 57, further comprising:

a hub removably attachable to the base, the hub including a needle extending through the base and through the cannula; and

a guard removably attachable to the base opposite the hub for surrounding the needle,

wherein the needle is subcutaneously insertable into the infusion site for subcutaneously positioning the cannula.

59. The infusion set of claim 42, wherein the base includes an adhesive pad for attaching to the infusion site.

60. The infusion set of claim 42, wherein the infusion site is the skin of a patient.

61. An infusion set system as recited in claim 42, wherein the plurality of temporarily lockable orientations of said connector relative to said base includes at least:

a first orientation in which a port of said connector for passing fluid through the infusion set system faces in a first direction with respect to the base; and

a second orientation in which said port faces in a second direction with respect to the base different from said first direction.

62. The infusion set system of claim 42,

wherein the connector is rotatable at least between a first position and a second position;

wherein the connector is detachable from the base in the first position and the connector is locked in the axial direction to the base to inhibit separation of the connector from the base in the second position; and

wherein the locking mechanism allows a constant radial motion between the first position and the second position.

63. The infusion set system of claim 42, wherein at least one of the connector and the base is configured to apply a force on the locking mechanism when the connector is rotated about the base, the force being directed radially inward toward the axis of the base.

64. An infusion set comprising:

base means for positioning at an infusion site to provide a subcutaneous path in a first generally linear direction for an infusant;

connector means for engaging the base, the connector means being temporarily lockable to the base by rotation of the connector means on the base means until the connector means temporarily locks to the base,

the connector means for providing a connector duct fluid flow path that extends in generally the first linear direction and aligns with the linear subcutaneous path upon the connector being locked to the base;

the connector means further comprising providing a port to which a tubing may be connected in fluid flow communication with the connector duct;

at least one of the connector means and the base means further comprising a plurality of tabs; and

at least one of the connector means and the base means further comprising a plurality of locking surfaces for engaging at least one of the plurality of tabs;

wherein the connector means a single, unitary body in which the connector duct is contiguous with the port for providing a fluid flow connection between the port and the connector duct;

wherein the base means is engagable by the connector means in a plurality of temporarily lockable orientations;

wherein the connector means is at least partially rotatable about an axis of the base means;

wherein rotation of the connector means about the base means causes the at least one of the plurality of tabs to engage with at least one of the plurality of locking surfaces to lock the connector means to the base means by inhibiting separation of the connector means from the base means in an axial direction parallel to the axis of the base means.

65. An infusion set system as recited in claim 64, wherein the plurality of temporarily lockable orientations of said connector means relative to said base means includes at least:

a first orientation in which a port of said connector means for passing fluid through the infusion delivery system faces in a first direction with respect to the base means; and

a second orientation in which said port faces in a second direction with respect to the base means different from said first direction.

66. The infusion set system of claim 64,

wherein the connector means is rotatable at least between a first position and a second position;

wherein the connector means is detachable from the base means in the first position and the connector means is locked in the axial direction to the base means to inhibit separation of the connector means from the base means in the second position; and

wherein the plurality of tabs and the plurality of locking surfaces allow a constant radial motion between the first position and the second position.

67. The infusion set system of claim 64, wherein at least one of the connector means and the base means is configured to apply a force on at least one of the plurality of tabs when the connector means is rotated about the base means, the force being directed radially inward toward the axis of the base means.