Automatic injector

• US 20030105430A1
• Filed: 11/08/2002
• Published: 06/05/2003
• Est. Priority Date: 11/30/2001
• Status: Abandoned Application

• Current Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Original Assignee: ELAN Pharma International Limited WIL House
• Inventors: Lavi, Gilad, Tsals, Izrail, Yigal, Gil
• Application Number:
  US10/290,664
• Publication Number:
  US 20030105430A1
• Time in Patent Office: Days
• US Class Current: 604/136
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2051 having tap means, e.g. tap means activated by sliding
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2005/208 Release is possible only when device is pushed against the skin, e.g. using a trigger which is blocked or inactive when the device is not pushed against the skin
• CPC Class Codes: A61M 2005/2414 from the side
• CPC Class Codes: A61M 2005/2418 comprising means for damping shocks on ampoule
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/2448 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/3146 Priming, e.g. purging, reducing backlash or clearance
• CPC Class Codes: A61M 5/31515 Connection of piston with piston rod
• CPC Class Codes: A61M 5/31535 Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
• CPC Class Codes: A61M 5/31555 by purely axial movement of dose setting member, e.g. during setting or filling of a syringe
• CPC Class Codes: A61M 5/326 Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user

Abstract

An injector is automatic in that the needle is injected automatically into the injection site (e.g., a patient'"'"'s skin), delivery is initiated upon activation of the injector, and the needle is retracted after the end of delivery. Preferably the needle is not seen by the user prior to, during or after injection. Prior and to and after injection, the needle is withdrawn into the device so as to avoid any potential injury or health risk to the user or health care provider. The injector includes a housing and a control unit arranged to slide within the housing to move a piston rod during drug delivery and to pivot within the housing for needle retraction. The injector may also include a back rod that moves the piston rod before activation of the injector for titration and reconstitution and automatically disengages from the piston rod upon activation of the injector. A needle-locking device can be used in any number of pen-like injectors or other types of injectors or syringes. The needle-locking device includes a clip that insures that a needle assembly within an injector is in a locked position before and after use.

Claims

1. An automatic injector for delivering a fluid, comprising:

a housing including an activator arranged to activate said injector, said housing having a proximate end and a distal end;

a syringe positioned within said housing, said syringe having a needle extending towards said distal end, a barrel, and a piston rod, said barrel arranged to contain the fluid therein, the fluid in communication with said needle, said piston rod slidingly located within said barrel for forcing the fluid through said needle upon activation of said injector;

a control unit adapted to engage said piston rod, said control unit further adapted to slide and pivot within said housing; and

a driving unit in communication with said housing and in communication with said control unit, said driving unit arranged to bias said control unit causing said control unit to slide towards said distal end and move said piston rod through said barrel to push the fluid through said needle for delivery into an injection site, said control unit arranged to pivot out of engagement with said piston rod at the end of delivery.

2. The automatic injector of claim 1, wherein said syringe has a first longitudinal axis, and said driving unit has a second longitudinal axis different than said first longitudinal axis.

3. The automatic injector of claim 2, wherein said second longitudinal axis is substantially parallel to said first longitudinal axis.

4. The automatic injector of claim 2, further comprising an automatic retracting mechanism that automatically retracts said needle into said housing after the rotation of the control unit.

5. The automatic injector of claim 4, said housing including a set of latches extending longitudinally rearward towards said proximate end and extending radially inward, said latches adapted to abut said syringe and prevent axial movement of said syringe toward said distal end of the housing after retraction of said needle.

6. The automatic injector of claim 4, wherein said retracting mechanism comprises a spring having a third longitudinal axis different from said first longitudinal axis.

7. The automatic injector of claim 4, said retracting mechanism comprising a spring adapted to provide a pushing force, said driving unit adapted to provide a pulling force greater than said pushing force.

8. The automatic injector of claim 3, said control unit further comprising a proximate end and a leaf spring extending towards said proximate end, said leaf spring arranged to abut said syringe after retraction of said needle and prevent potential re-exposure of said needle.

9. The automatic injector of claim 1, wherein said driving unit is a spring arranged to bias said control unit to pull said piston rod into said barrel and then move said control unit into disengagement from said piston rod.

10. The automatic injector of claim 1, said piston rod including a holding latch, said holding latch arranged to engage said housing prior to an activation of said injector, said holding latch arranged to disengage said housing and engage said syringe to move said needle to the injection site upon activation of said injector, and said holding latch arranged to disengage said syringe upon movement of said needle to the injection site.

11. The automatic injector of claim 1, said control unit arranged to pivot to engage said control unit with said piston rod before delivery.

12. The automatic injector of claim 1, said piston rod including a holding latch that releasably engages both said housing and said syringe to bias said needle from said housing for injection of the fluid.

13. The automatic injector of claim 1, said housing including a cartridge, said cartridge releasably connected within said housing and adapted to hold said barrel.

14. The automatic injector of claim 1, said housing having an opening at said proximate end, said injector further comprising a back rod extending through said opening and arranged to push said piston rod into said barrel before activation of said injector.

15. The automatic injector of claim 14, said back rod having a threaded edge for rotational axial movement m relation to said opening.

16. The automatic injector of claim 14, said back rod having a serrated edge for incremental axial movement in relation to said opening.

17. The automatic injector of claim 16, further comprising a pawl for engagement with said serrated edge, said pawl arranged to allow incremental movement of said back rod towards said piston rod and prevent movement of said back rod away from said piston rod.

18. The automatic injector of claim 14, said back rod arranged to pull said piston to draw the fluid or a liquid into said barrel.

19. The automatic injector of claim 14, said back rod adapted to pivot about said opening to attach to said piston rod, said attachment allowing said back rod to push said piston rod into said barrel and to pull said piston rod from said barrel.

20. The automatic injector of claim 1, said piston rod having notches, and further comprising a pawl assembly attached to said housing and in communication with said notches to longitudinally move said piston rod into said barrel before activation of said injector.

21. The automatic injector of claim 1, further comprising a safety tab removably engaged with said activator, said tab arranged to prevent activation of said injector when said tab is engaged with said activator.

22. The automatic injector of claim 1, further comprising an adaptor arranged to provide fluid communication between an interior of a vial and said needle.

23. The automatic injector of claim 22, said adaptor including a spike having a conduit therethrough, said spike arranged to pierce into the vial for communication with the interior of the vial.

24. The automatic injector of claim 22, said adaptor including an elastomeric tube adapted to slide about said needle to seal a path between said adaptor and said needle.

25. The automatic injector of claim 1, further comprising a sleeve-like cartridge that receives and holds said syringe, said cartridge arranged to load within said housing.

26. The automatic injector of claim 25, further comprising a static latch that abuts and holds said cartridge in place after said cartridge is loaded.

27. The automatic injector of claim 25, said syringe including a needle hub attached to said needle and said barrel, said needle hub securing said needle to said barrel.

28. The automatic injector of claim 27, further comprising a clip in said cartridge, said clip including:

a hollow sleeve supporting the needle hub, said sleeve having a first rim towards a proximate end of the needle hub and a second rim towards a distal end of the needle hub, said sleeve adapted to slide longitudinally about the needle hub;

a first set of latches extending longitudinally from said first rim, said first set adapted to prevent axial movement of the needle hub after a delivery of a fluid from the needle;

a second set of latches extending longitudinally from said second rim, said second set adapted to prevent axial movement of said needle hub before and after delivery of the fluid.

29. The automatic injector of claim 28, said first set of latches are formed of a flexible elastic material and include proximate ends extending radially inward to abut the needle hub after the delivery.

30. The automatic injector of claim 29, said second set of latches are formed of a flexible elastic material and include distal ends extending radially outward.

31. The automatic injector of claim 30, at least one of said distal ends including a wide section arranged to prevent axial rotation of the clip, and a narrow section extending radially outward of said wide section.

32. The automatic injector of claim 31, said shell having an inner circumferential wall and an outer circumferential wall, said shell including grooves formed in said inner circumferential wall aligned with said second set of latches to accept said narrow section in a sliding relationship.

33. The automatic injector of claim 32, at least one of said grooves including an aperture extending radially outward through said outer circumferential wall, said aperture arranged to hold said narrow section of said distal end and prevent axial movement of said clip and of the needle hub prior to delivery.

34. The automatic injector of claim 33, at least one of said grooves including a locking slit distal of said aperture and extending radially outward toward said outer circumferential wall, said locking slit arranged to hold a respective one of the distal ends and prevent axial movement of said clip after delivery.

35. The automatic injector of claim 34, further comprising an automatic retracting mechanism arranged to bias the needle hub longitudinally from a first position where a proximate section of the needle hub is inside said clip to a second position where the proximate section is outside said clip, so that the proximate section of said needle hub passes through said first set of latches, said first set abutting the proximate section to prevent axial movement of the proximate section back into said clip and prevent axial movement of the needle hub.

36. The automatic injector of claim 1, said barrel comprising a cartridge having a closed distal end and a proximate end, said needle having a distal end for exposure to the injection site and a proximate end arranged to penetrate said closed distal end of the cartridge and provide fluid communication between the distal end of the needle and the interior of the cartridge, said proximate end of said cartridge arranged to accept said piston rod.

37. The automatic injector of claim 36, said cartridge including a front compartment and a rear compartment, each compartment including a substance from a group consisting of at least one of a liquid, a diluent, a lyophilized drug, a reconstituted drug, a powder, a solid element and a fluid element, wherein a combination of the substance from each compartment forms the fluid for delivery.

38. The automatic injector of claim 37, said cartridge further including a plug separating said front and rear compartments, and a bypass allowing the substances to mix prior to delivery.

39. The automatic injector of claim 36, said housing including a door between said distal and proximate ends for loading said cartridge into said housing.

40. The automatic injector of claim 1, said housing including a set of latches extending longitudinally rearward towards said proximate end and extending radially inward, said latches adapted to abut said syringe and prevent axial movement of said syringe toward said distal end of the housing until after activation of said injector.

41. The automatic injector of claim 1, further comprising a pressure sensitive sleeve slidingly holding said syringe and biased to extend beyond said distal end of said housing to a first position, said sleeve adapted to move axially rearward upon the application of rearward pressure applied to said sleeve to a second position.

42. The automatic injector of claim 41, said activation occurring only after application of the axial pressure and then depression of said activator during continued application of the pressure, said sleeve moving to separate said latches from said syringe to allow axial movement of said syringe toward said distal end of said housing.

43. The automatic injector of claim 41, said activator having a projection aligned with a notch in said sleeve when said sleeve is in the first position to prevent axial movement of said sleeve when said activator is depressed, said projection out of alignment with said notch when said sleeve is in the second position to allow axial movement of said sleeve when said activator is depressed.

44. The automatic injector of claim 1, further comprising a holding latch, said holding latch engaging said housing prior to an activation of said injector, and said holding latch disengaging said housing and communicating with said syringe to move said needle to the injection site upon activation of said injector.

45. The automatic injector of claim 1, the control unit including a projection for locking the syringe after delivery.

46. The automatic injector of claim 1, said housing further including a window arranged to allow viewing of the fluid.

47. The automatic injector of claim 1, said syringe further including a flange, said control unit arranged to pivot and engage said control unit with said flange for extending said needle out of said housing, said control unit further arranged to pivot and disengage said control unit from said flange and engage said control unit with said piston rod.

48. An automatic injector for delivering a fluid, comprising:

a housing including means for activating said injector, said housing having a proximate end and a distal end;

a syringe positioned within said housing, said syringe having a needle extending towards said distal end, a barrel, and a piston rod, said barrel arranged to contain fluid therein, the fluid in communication with said needle, said piston rod slidingly located within said barrel for forcing the fluid through said needle upon activation of said injector;

control means for engaging said piston rod and sliding within said housing during delivery and for pivoting out of engagement with said piston rod at the end of delivery; and

driving means for moving said piston rod through said barrel, via said control means, for moving the fluid through said needle for delivery into an injection site.

49. The automatic injector of claim 48, said control means pivoting into engagement with said piston rod before delivery, and sliding towards said distal end during delivery.

50. An automatic injector for titration and delivery of a fluid, comprising:

a housing including an activator arranged to activate said injector, said housing having a proximate end and a distal end;

a syringe positioned within said housing, said syringe having a needle extending towards said distal end, a barrel, and a piston rod, said barrel arranged to contain the fluid therein, the fluid in communication with said needle, said piston rod slidingly located within said barrel for forcing the fluid through said needle upon activation of said injector;

a displacer arranged to communicate with said piston rod before the activation, said displacer arranged to move said piston rod for titration before the activation and to automatically separate from said piston rod upon activation; and

a driving unit in communication with said housing and in communication with said piston rod, said driving unit arranged to move said piston rod through said barrel upon the activation to push the fluid through said needle for delivery into an injection site.

51. The automatic injector of claim 50, wherein said displacer is a back rod.

52. The automatic injector of claim 51, said piston rod having an aperture, said back rod arranged to extend into said aperture during communication with said piston rod and rotate said piston rod during titration.

53. The automatic injector of claim 51, said housing further comprising an opening at said proximate end, said back rod extending through said opening.

54. The automatic injector of claim 53, said back rod having a threaded edge for rotational axial movement in relation to said opening.

55. The automatic injector of claim 53, said back rod having a serrated edge for incremental axial movement in relation to said opening.

56. The automatic injector of claim 55, further comprising a pawl for engagement with said serrated edge, said pawl arranged to allow movement of said back rod towards said piston rod and prevent movement of said back rod away from said piston rod before the activation.

57. The automatic injector of claim 53, said back rod arranged to pivot about said opening to attach to said piston rod, said attachment allowing said back rod to push said piston rod into said barrel and to pull said piston rod from said barrel to draw the fluid into said barrel before the activation.

58. The automatic injector of claim 50, said housing further including a window arranged to allow viewing of the fluid.

59. The automatic injector of claim 50, wherein said syringe has a first longitudinal axis, and said driving unit has a second longitudinal axis different than said first longitudinal axis.

60. The automatic injector of claim 50, said syringe including a needle hub attached to said needle and said barrel, said needle hub securing said needle to said barrel.

61. The automatic injector of claim 60, further comprising a clip in said housing, said clip including:

a hollow sleeve supporting the needle hub, said sleeve having a first rim towards a proximate end of the needle hub and a second rim towards a distal end of the needle hub, said sleeve adapted to slide longitudinally about the needle hub;

a first set of latches extending longitudinally from said first rim, said first set adapted to prevent axial movement of the needle hub after a delivery of a fluid from the needle;

a second set of latches extending longitudinally from said second rim, said second set adapted to prevent axial movement of said needle hub before and after delivery of the fluid.

62. The automatic injector of claim 61, further comprising a bumper located within said housing at said distal end, said bumper arranged to absorb impact between said barrel and said housing.

63. An automatic injector for titration and delivery of a fluid, comprising:

a housing including an activator arranged to activate said injector, said housing having a proximate end and a distal end;

a syringe positioned within said housing, said syringe having a needle extending towards said distal end, a barrel, and a piston rod, said barrel arranged to contain the fluid therein, the fluid in communication with said needle, said piston rod slidingly located within said barrel for forcing the fluid through said needle upon activation of said injector;

titration means for moving said piston rod into said barrel before the activation to expel undesired air or fluid from the syringe and for automatically separating from said piston rod upon the activation; and

driving means for moving said piston rod through said barrel upon the activation to push the fluid through said needle for delivery into an injection site.

64. An automatic injector for titration and delivery of a fluid, comprising:

a housing including an activator arranged to activate said injector, said housing having a proximate end and a distal end;

a syringe positioned within said housing, said syringe having a needle extending towards said distal end, a barrel, and a piston rod, said barrel arranged to contain the fluid therein, the fluid in communication with said needle, said piston rod slidingly located within said barrel for forcing the fluid through said needle upon activation of said injector;

a displacer arranged to communicate with said piston rod before the activation, said displacer arranged to rotate to move said piston rod for titration before the activation, said displacer having an axial sliding relationship with said piston rod during titration; and

a driving unit in communication with said housing and in communication with said piston rod, said driving unit arranged to move said piston rod through said barrel upon the activation to push the fluid through said needle for delivery into an injection site.

65. A needle-locking device for preventing exposure of a needle held by a needle hub, comprising:

a hollow sleeve supporting the needle hub, said sleeve having a first rim towards a proximate end of the needle hub and a second rim towards a distal end of the needle hub, said sleeve adapted to slide longitudinally about the needle hub;

a first set of latches extending longitudinally from said first rim, said first set adapted to prevent axial movement of the needle hub after a delivery of a fluid from the needle; and

a second set of latches extending longitudinally from said second rim, said second set adapted to prevent axial movement of said needle hub before and after delivery of the fluid.

66. The needle-locking device of claim 65, said first set of latches are formed of a flexible elastic material and include proximate ends extending radially inward to abut the needle hub after the delivery.

67. The needle-locking device of claim 65, said second set of latches are formed of a flexible elastic material and include distal ends extending radially outward.

68. The needle-locking device of claim 67, at least one of said distal ends including a wide section arranged to prevent axial rotation of the clip, and a narrow section extending radially outward of said wide section.

69. The needle-locking device of claim 68, further comprising a cartridge shell housing said clip, said shell having an inner circumferential wall and an outer circumferential wall, said shell including grooves formed in said inner circumferential wall of said shell and aligned with said second set of latches to accept said narrow section in a sliding relationship.

70. The needle-locking device of claim 69, at least one of said grooves including an aperture extending radially outward through said outer circumferential wall, said aperture arranged to hold said narrow section of said distal end and prevent axial movement of said clip and of the needle hub prior to delivery.

71. The needle-locking device of claim 70, at least one of said grooves including a locking slit distal of said aperture and extending radially outward toward said outer circumferential wall, said locking slit arranged to hold a respective one of the distal ends and prevent axial movement of said clip after delivery.

72. The needle-locking device of claim 71, further comprising a retraction unit arranged to bias the needle hub longitudinally from a first position where a proximate section of the needle hub is inside said clip to a second position where the proximate section is outside said clip, so that the proximate section of said needle hub passes through said first set of latches, said first set abutting the proximate section to prevent axial movement of the proximate section back into said clip and prevent axial movement of the needle hub.

73. The needle-locking device of claim 65, further comprising a cartridge shell housing said clip, said shell having an inner circumferential wall and an outer circumferential wall, said shell including grooves formed in said inner circumferential wall of said shell and aligned with said second set of latches to accept said second set in a sliding relationship.

74. The needle-locking device of claim 73, at least one of said grooves including an aperture extending radially outward through said outer circumferential wall, said aperture arranged to hold a respective one of said second set of latches and prevent axial movement of said clip and of the needle hub prior to delivery.

75. The needle-locking device of claim 73, at least one of said grooves including a locking slit extending radially outward toward said outer circumferential wall, said locking slit arranged to hold a respective one of said second set of latches and prevent axial movement of said clip after delivery.

76. The needle-locking device of claim 75, further comprising a retraction unit arranged to bias the needle hub longitudinally from a first position where a proximate section of the needle hub is inside said clip to a second position where the proximate section is outside said clip, so that the proximate section of said needle hub passes through said first set of latches, said first set abutting the proximate section to prevent axial movement of the proximate section back into said clip and prevent axial movement of the needle hub.

77. The needle-locking device of claim 65, further comprising an adaptor arranged to provide fluid communication between an interior of a vial and said needle.

78. The needle-locking device of claim 77, said adaptor including a spike having a conduit therethrough, said spike arranged to pierce into the vial for communication with the interior of the vial.

79. The needle-locking device of claim 77, said adaptor including an elastomeric tube adapted to slide about said needle to seal a path between said adaptor and said needle.