Self administered injection pen apparatus and method

• US 5,514,097 A
• Filed: 02/14/1994
• Issued: 05/07/1996
• Est. Priority Date: 02/14/1994
• Status: Expired due to Term

• Current Assignee: Genentech, Inc. (Roche Holding AG)
• Original Assignee: Genentech, Inc. (Roche Holding AG)
• Inventors: Knauer, Peter M.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Van Over, Perry E.
• Application Number:
  US08/195,307
• Time in Patent Office: 813 Days
• Field of Search: 604/131, 604/135-139, 604/156, 604/187, 604/208, 604/211, 604/218, 604/220, 604/232
• US Class Current: 604/136
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/31516 reducing dead-space in the syringe barrel after delivery
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• 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 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/31536 Blocking means to immobilize a selected dose, e.g. to administer equal doses
• CPC Class Codes: A61M 5/31538 Permanent blocking, e.g. by medical personnel
• CPC Class Codes: A61M 5/31553 without axial movement of dose setting member
• CPC Class Codes: A61M 5/31561 using freely adjustable volume steps
• CPC Class Codes: A61M 5/31563 interacting with a displaceable stop member
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001

Abstract

A medicament injection apparatus for subcutaneous or intramuscular delivery of a medicament conceals the needle behind a needle shroud. On apparatus activation, the needle is trust forward, pushing the needle tip outside the needle shroud with enough force to puncture the skin. The needle is thus automatically introduced into the tissue at the proper needle\skin orientation. In the same action, the apparatus automatically dispenses an accurate pre-set dose. The dose can be set by a manual, variable dosing assembly or by an automatic dosing assembly. The automatic dosing assembly includes a safety mechanism preventing the pre-set dose from being changed except by a doctor or patient using a special wrench or tool.

Claims

1. A medicament injection apparatus comprising:

a housing having;

an exterior surface, and enclosing an interior volume;

a first end; and

a second end opposite said first end;

a needle shroud removably affixed to said first end of said housing and having an open end removed from said housing;

a medicament injection assembly, movably mounted in said interior volume of said housing, including;

an automatic dosing assembly including an automatic dose knob having a stop position,

wherein upon moving said automatic dose knob to said stop position said automatic dose assembly is set for a predetermined dose; and

upon engagement and activation of a motive force supplied by said automatic dosing assembly, a plurality of assemblies of said medicament injection assembly move from a first position to a second position in a first direction wherein said first direction is towards said open end of said needle shroud.

2. The medicament injection apparatus of claim 1, wherein one of said plurality of assemblies of said medicament injection assembly comprises:

a variable dosing assembly movably coupled to said automatic dosing assembly, and having a first end wherein;

said variable dosing assembly is selectively engaged by said user to dispense a predetermined and adjustable amount of a medicament from said medicament injection apparatus upon engagement and actuation of said medicament injection assembly.

3. The medicament injection apparatus of claim 2, wherein another one of said plurality of assemblies of said medicament injection assembly comprises:

a medicament cartridge assembly removably affixed to said first end of said variable dosing assembly, and including a first end and a second end opposite said first end wherein said second end is fashioned to accept a medicament cartridge having a first sealed end and a second end opposite said first sealed end which contains a movable plunger.

4. The medicament injection apparatus of claim 3, wherein said medicament cartridge assembly further comprises:

a needle subassembly removably affixed to said first end of said medicament cartridge assembly, and having a needle;

wherein when said needle subassembly is in said first position, said needle is contained within said needle shroud; and

when said needle subassembly is in said second position, said needle has an end extending through said open end of said needle shroud.

5. The medicament injection apparatus of claim 4, further comprising:

a needle safety cap removably affixed to said medicament cartridge assembly wherein said needle safety cap encloses said needle.

6. The medicament injection apparatus of claim 3, wherein said variable dosing assembly further comprises:

a pushrod subassembly including a pushrod wherein upon engagement and actuation of said automatic dosing assembly, said pushrod engages said plunger and moves said plunger in said first direction inside said medicament cartridge; and

a dosing sleeve subassembly movably mounted on said pushrod, wherein said dosing sleeve subassembly position on said pushrod determines a distance said pushrod moves in said first direction.

7. The medicament injection apparatus of claim 1, wherein said automatic dosing assembly further comprises:

a thrusting assembly having a motive force subassembly that is selectively engaged and actuated by a user;

wherein upon engagement and actuation of said motive force subassembly, said thrusting assembly moves said plurality of assemblies of said medicament injection assembly from said first position to said second position.

8. The medicament injection apparatus of claim 7, wherein said thrusting assembly further comprises:

a tubular dose knob selectively engagable with a variable dosing assembly of said medicament injection assembly, and having a first open end and a second end opposite to said first open end;

wherein upon engagement of said tubular dose knob with said variable dosing assembly and movement of said tubular dose knob in a selected direction, said user adjusts an amount of a medicament to be dispensed from said medicament injection apparatus.

9. The medicament injection apparatus of claim 8 wherein said automatic dosing assembly further comprises:

a dose knob stop subassembly coupled to said tubular dose knob wherein said dose knob stop assembly limits movement of said tubular dose knob in said selected direction and so limits said amount of said medicament to be dispensed from said medicament injection apparatus to a predetermined and pre-set limit.

10. The medicament injection apparatus of claim 9, wherein said dose knob stop assembly further comprises:

two structures coupled to said tubular dose knob and each of said two structures having a surface wherein said two structures are mounted within said automatic dosing assembly so that said surfaces interact and interface with one another such that a combined length of the two structures is variable depending on a relative position of said two surfaces and further wherein said variable combined length determines said predetermined and pre-set limit.

11. The medicament injection apparatus of claim 10, wherein said dose knob stop subassembly further comprises:

a dose limiting sleeve coupled to at least one of said two structures and selectively engaged by said user to adjust said relative position of said surfaces of said two structures to set said predetermined and pre-set limit.

12. The medicament injection apparatus of claim 11, wherein said dose limiting sleeve comprises a tubular structure having a first end and a second end opposite said first open end wherein one of said two structures is positioned within said first open end of tubular structure.

13. The medicament injection apparatus of claim 12, wherein said one of said two structures includes a set of grooves and said dose limiting sleeve tubular structure includes a set of rails and further wherein said sets of grooves and rails rotationally couple said one of said two structures and said dose limiting sleeve tubular structure so that said one of said two structures and said dose limiting sleeve tubular structure rotate together.

14. The medicament injection apparatus of claim 10, wherein said two structures comprise angled cylinders.

15. The medicament injection apparatus of claim 10, wherein said two structures comprise stepped angled cylinders.

16. The medicament injection apparatus of claim 8 wherein said medicament injection assembly further comprises:

a runner having a first tubular portion and a second tubular portion wherein said first tubular portion has a first open end and a second open end opposite said first open end, and further wherein said second open end of said first tubular portion is coupled to a first open end of said second tubular portion and said second tubular portion has a second open end opposite said first end.

17. The medicament injection apparatus of claim 16, wherein said variable dosing assembly further comprises:

a dosing sleeve subassembly partially positioned within said first open end of said first tubular portion of said runner such that said dosing sleeve subassembly can move back and forth in both said first direction and said second direction within said first tubular portion of said runner;

wherein said second tubular portion of said runner has a smaller cross-section than a cross-section of said first open end of said tubular dose knob so that at least part of said second tubular portion of said runner is positioned inside said first open end of said tubular dose knob and said second tubular portion can move back and forth in both said first direction and said second direction within said tubular dose knob.

18. The medicament injection apparatus of claim 17 wherein said second tubular portion of said runner includes a set of grooves and said tubular dose knob includes a set of rails and further wherein said sets of grooves and rails rotationally couple said runner and said tubular dose knob so that said runner and said tubular dose knob rotate together to move said dosing sleeve subassembly back and forth in both said first direction and said second direction within said first tubular portion of said runner and adjust an amount of medicament dispensed from said medicament injection apparatus.

19. The medicament injection apparatus of claim 18 wherein:

a pushrod of said variable dosing assembly has a first end and a second end opposite said first end wherein said second end of said pushrod is positioned within said first open end of said second tubular portion of said runner; and

said second end of said tubular dose knob is closed; and

further wherein

said second tubular portion of said runner with said pushrod positioned within said first open end of said second tubular portion and said tubular dose knob form an enclosed cavity with a variable length which is smaller when said plurality of assemblies of said medicament injection assembly are in said first position and larger when said plurality of assemblies are in said second position; and

said motive force subassembly is positioned inside said cavity such that said motive force subassembly exerts a force on said second end of pushrod in said first direction and said motive force subassembly exerts a force on said tubular dose knob in said second direction when said plurality of assemblies are in said first position.

20. The medicament injection apparatus of claim 19 wherein:

said pushrod and said runner are coupled so that;

when said plurality of assemblies are in said first position said pushrod and said runner are removably affixed; and

when said plurality of assemblies move from said first position to said second position said pushrod and said runner remain removably affixed for a predetermined distance; and

said pushrod is uncoupled from said runner once said pushrod and said runner have moved together said predetermined distance.

21. The medicament injection apparatus of claim 20 wherein said thrusting assembly further comprises:

a lock ring selectively engaging and holding said tubular dose knob against said force exerted in said second direction; and

a needle thrust locking mechanism selectively engaging and holding said runner and said pushrod against said force exerted in said first direction.

22. The medicament injection apparatus of claim 21, wherein said motive force subassembly comprises a spring and a thrust bearing.

23. The medicament injection apparatus of claim 1 wherein said medicament injection assembly further comprises:

a thrusting assembly having a motive force subassembly that is selectively engaged and actuated by a user;

wherein upon engagement and actuation of said motive force subassembly, said thrusting assembly moves said plurality of assemblies of said medicament injection assembly from said first position to said second position.

24. The medicament injection apparatus of claim 23, wherein one of said plurality of assemblies of said medicament injection assembly further comprises:

a variable dosing assembly movably coupled to said thrusting assembly, and having a first end wherein;

said variable dosing assembly is selectively engaged by said user to dispense a predetermined and adjustable amount of a medicament from said medicament injection apparatus upon engagement and actuation of said medicament injection assembly.

25. The medicament injection apparatus of claim 24, wherein another one of said plurality of assemblies of said medicament injection assembly further comprises:

a medicament cartridge assembly removably affixed to said first end of said variable dosing assembly, and including a first end and a second end opposite said first end wherein said second end is fashioned to accept a medicament cartridge having a first sealed end and a second end opposite said first sealed end which contains a movable plunger.

26. The medicament injection apparatus of claim 25, wherein said medicament cartridge assembly further comprises:

a needle subassembly removably affixed to said first end of said medicament cartridge assembly, and having a needle;

wherein when said needle subassembly is in said first position, said needle is contained within said needle shroud; and

when said needle subassembly is in said second position, said needle has an end extending through said open end of said needle shroud.

27. The medicament injection apparatus of claim 26, further comprising:

a needle safety cap removably affixed to said medicament cartridge assembly wherein said needle safety cap encloses said needle.

28. The medicament injection apparatus of claim 25, wherein said variable dosing assembly further comprises:

a pushrod subassembly including a pushrod wherein upon engagement and actuation of said thrusting assembly, said pushrod engages said plunger and moves said plunger in said first direction inside said medicament cartridge; and

a dosing sleeve subassembly movably mounted on said pushrod, wherein said dosing sleeve subassembly position on said pushrod determines a distance said pushrod moves in said first direction.

29. The medicament injection apparatus of claim 25, wherein said thrusting assembly further comprises:

a tubular dose knob selectively engagable with said variable dosing assembly of said medicament injection assembly, and having a first open end and a second end opposite to said first open end;

wherein upon engagement of said tubular dose knob with said variable dosing assembly and movement of said tubular dose knob in a selected direction, said user adjusts an amount of a medicament to be dispensed from said medicament injection apparatus.

30. The medicament injection apparatus of claim 25 wherein said medicament injection assembly further comprises:

a runner having a first tubular portion and a second tubular portion wherein said first tubular portion has a first open end and a second open end opposite said first open end, and further wherein said second open end of said first tubular portion is coupled to a first open end of said second tubular portion and said second tubular portion has a second open end opposite said first end.

31. The medicament injection apparatus of claim 30, wherein said variable dosing assembly further comprises:

a dosing sleeve subassembly partially positioned within said first open end of said first tubular portion of said runner such that said dosing sleeve subassembly can move back and forth in both said first direction and said second direction within said first tubular portion of said runner;

wherein said second tubular portion of said runner has a smaller cross-section than a cross-section of said first open end of said tubular dose knob so that at least part of said second tubular portion of said runner is positioned inside said first open end of said tubular dose knob and said second tubular portion can move back and forth in both said first direction and said second direction within said tubular dose knob.

32. The medicament injection apparatus of claim 31 wherein said second tubular portion of said runner includes a set of grooves and said tubular dose knob includes a set of rails and further wherein said sets of grooves and rails rotationally couple said runner and said tubular dose knob so that said runner and said tubular dose knob rotate together to move said dosing sleeve subassembly back and forth in both said first direction and said second direction within said first tubular portion of said runner and adjust an amount of medicament dispensed from said medicament injection apparatus.

33. The medicament injection apparatus of claim 32 wherein:

said pushrod has a first end and a second end opposite said first end wherein said second end of said pushrod is positioned within said first open end of said second tubular portion of said runner; and

said second end of said tubular dose knob is closed; and

further wherein

said second tubular portion of said runner with said pushrod positioned within said first open end of said second tubular portion and said tubular dose knob form an enclosed cavity with a variable length which is smaller when said plurality of assemblies of said medicament injection assembly are in said first position and larger when said plurality of assemblies are in said second position; and

said motive force subassembly is positioned inside said cavity such that said motive force subassembly exerts a force on said second end of pushrod in said first direction and said motive force subassembly exerts a force on said tubular dose knob in said second direction when said plurality of assemblies are in said first position.

34. The medicament injection apparatus of claim 33 wherein:

said pushrod and said runner are coupled so that;

when said plurality of assemblies are in said first position said pushrod and said runner are removably affixed; and

when said plurality of assemblies move from said first position to said second position said pushrod and said runner remain removably affixed for a predetermined distance; and

said pushrod is uncoupled from said runner once said pushrod and said runner have moved together said predetermined distance.

35. The medicament injection apparatus of claim 34 wherein said thrusting assembly further comprises:

a lock ring selectively engaging and holding said tubular dose knob against said force exerted in said second direction; and

a needle thrust locking mechanism selectively engaging and holding said runner and said pushrod against said force exerted in said first direction.

36. The medicament injection apparatus of claim 35 wherein said motive force subassembly comprises a spring and a thrust bearing.

37. The medicament injection apparatus as in claim 1 wherein,

said needle shroud is removably affixed to said first end of said housing by a friction fit.

38. A medicament injection apparatus as in claim 37 wherein,

said open end of said needle shroud is removed a first distance from said first end of said housing.

39. The medicament injection apparatus as in claim 38 further comprising:

another needle shroud, wherein upon removal of said needle shroud and removably affixing said another needle shroud to said first end of said housing, an open end of said another needle shroud is removed a second distance, different from said first distance, from said first end of said housing.

40. A medicament injection apparatus as in claim 37 further comprising:

at least two needle shrouds in addition to said needle shroud;

wherein each of said at least two needle shrouds can be individually removably affixed to said first end of said housing;

upon individually removably affixing said at least two needle shrouds to said first end of said housing, each of said at least two needle shrouds have an open end removed a predetermined distance from said first end of said housing; and

said predetermined distance is different for each of said at least two needle shrouds.

41. A medicament injection apparatus comprising:

a housing having;

an exterior surface and enclosing an interior volume;

a first end; and

a second end opposite said first end;

a needle shroud removably affixed to said first end of said housing and having an open end removed from said housing;

a medicament cartridge assembly movably mounted, in said interior volume of said housing so that upon application of a motive force, said medicament cartridge assembly moves from a first position to a second position in a first direction wherein said first direction is towards said open end of said needle shroud, and further wherein said medicant cartridge includes;

a first end;

a second end opposite said first end wherein said second end is fashioned to accept a medicament cartridge having a first sealed end and a second end opposite said first sealed end which contains a movable plunger and;

a variable dosing assembly having a first end removably affixed to said second end of said medicament cartridge assembly and a second end wherein;

said variable dosing assembly is selectively engaged by said user to control a predetermined and adjustable amount of medicament expelled from said medicament cartridge following application of said motive force; and

an automatic dosing assembly removably affixed to said second end of said variable dosing assembly and mounted in said interior volume of said housing, said automatic dosing assembly including an automatic dose knob having a stop position;

wherein upon moving said automatic dose knob to said stop position said automatic dose assembly is set for a predetermined dose; and

upon engagement and actuation of said automatic dosing assembly, said automatic dosing assembly supplies said motive force to said variable dosing assembly and said medicament cartridge assembly thereby moving said variable dosing assembly and said medicament cartridge assembly from said first position to said second position.

42. The medicament injection apparatus of claim 41, further comprising:

a needle subassembly removably affixed to said first end of said medicament cartridge assembly, and having a needle;

wherein when said medicament cartridge assembly is in said first position, said needle is contained within said needle shroud; and

when said medicament cartridge assembly is in said second position said needle has an end extending through said open end of said needle shroud.

43. The medicament injection apparatus of claim 42, further comprising:

a needle safety cap removably affixed to said medicament cartridge assembly wherein said needle safety cap encloses said needle.

44. The medicament injection apparatus of claim 41, wherein said variable dosing assembly further comprises:

a pushrod subassembly including a pushrod wherein upon engagement and actuation of said automatic dosing assembly, said pushrod engages said plunger and moves said plunger in said first direction inside said medicament cartridge; and

a dosing sleeve subassembly movably mounted on said pushrod, wherein said dosing sleeve subassembly position on said pushrod determines a distance said pushrod moves in said first direction.

45. The medicament injection apparatus of claim 41, wherein said automatic dosing assembly further comprises:

a thrusting assembly having a motive force subassembly that is selectively engaged and actuated by a user;

wherein upon engagement and actuation of said motive force subassembly, said thrusting assembly moves said variable dosing assembly and said medicament cartridge assembly from said first position to said second position.

46. The medicament injection apparatus of claim 45, wherein said thrusting assembly further comprises:

a tubular dose knob selectively engagable with said variable dosing assembly and having a first open end and a second end opposite to said first open end;

wherein upon engagement of said tubular dose knob with said variable dosing assembly and movement of said tubular dose knob in a selected direction, said user adjusts an amount of a medicament to be dispensed from said medicament injection apparatus.

47. The medicament injection apparatus of claim 46, wherein said automatic dosing assembly further comprises:

a dose knob stop subassembly coupled to said tubular dose knob wherein said dose knob stop assembly limits movement of said tubular dose knob in said selected direction and so limits said amount of said medicament to be dispensed from said medicament injection apparatus to a predetermined and pre-set limit.

48. The medicament injection apparatus of claim 47, wherein said dose knob stop assembly further comprises:

two structures coupled to said tubular dose knob and each of said two structures having a surface wherein said two structures are mounted within said automatic dosing assembly so that said surfaces interact and interface with one another such that a combined length of the two structures is variable depending on a relative position of said two surfaces and further wherein said variable combined length determines said predetermined and pre-set limit.

49. The medicament injection apparatus of claim 48, wherein said dose knob stop subassembly further comprises:

a dose limiting sleeve coupled to at least one of said two structures and selectively engaged by said user to adjust said relative position of said surfaces of said two structures to set said predetermined and pre-set limit.

50. The medicament injection apparatus of claim 49, wherein said dose limiting sleeve comprises a tubular structure having a first open end and a second end opposite said first open end wherein one of said two structures is positioned within said first open end of tubular structure.

51. The medicament injection apparatus of claim 50, wherein said one of said two structures includes a set of grooves and said dose limiting sleeve tubular structure includes a set of rails and further wherein sets of grooves and rails rotationally couple said one of said two structures and said dose limiting sleeve tubular structure so that said one of said two structures and said dose limiting sleeve tubular structure rotate together.

52. The medicament injection apparatus of claim 51, wherein said two structures comprise angled cylinders.

53. The medicament injection apparatus of claim 51, wherein said two structures comprise stepped angled cylinders.

54. The medicament injection apparatus of claim 51, wherein said medicament injection apparatus further comprises:

a runner having a first tubular portion and a second tubular portion wherein said first tubular portion has a first open end and a second open end opposite said first open end, and further wherein said second open end of said first tubular portion is coupled to a first open end of said second tubular portion and said second tubular portion has a second open end opposite said first end.

55. The medicament injection apparatus of claim 54, wherein said variable dosing assembly further comprises:

a dosing sleeve subassembly partially positioned within said first open end of said first tubular portion of said runner such that said dosing sleeve subassembly can move back and forth in both said first direction and said second direction within said first tubular portion of said runner;

wherein said second tubular portion of said runner has a smaller cross-section than a cross-section of said first open end of said tubular dose knob so that at least part of said second tubular portion of said runner is positioned inside said first open end of said tubular dose knob and said second tubular portion can move back and forth in both said first direction and said second direction within said tubular dose knob.

56. The medicament injection apparatus of claim 55, wherein said second tubular portion of said runner includes a set of grooves and said tubular dose knob includes a set of rails and further wherein said sets of grooves and rails rotationally couple said runner and said tubular dose knob so that said runner and said tubular dose knob rotate together to move said dosing sleeve subassembly back and forth in both said first direction and said second direction within said first tubular portion of said runner and adjust an amount of medicament dispensed from said medicament injection apparatus.

57. The medicament injection apparatus of claim 56, wherein:

said pushrod has a first end and a second end opposite said first end wherein said second end of said pushrod is positioned within said first open end of said second tubular portion of said runner; and

said second end of said tubular dose knob is closed; and

further wherein

said second tubular portion of said runner with said pushrod positioned within said first open end of said second tubular portion and said tubular dose knob form an enclosed cavity with a variable length which is smaller when said variable dosing assembly and said medicament cartridge assembly are in said first position and larger when said variable dosing assembly and said medicament cartridge assembly are in said second position; and

said motive force subassembly is positioned inside said cavity such that said motive force subassembly exerts a force on said second end of pushrod in said first direction and said motive force subassembly exerts a force on said tubular dose knob in said second direction when said variable dosing assembly and said medicament cartridge assembly are in said first position.

58. The medicament injection apparatus of claim 57 wherein:

said pushrod and said runner are coupled so that;

when said variable dosing assembly and said medicament cartridge assembly are in said first position said pushrod and said runner are removably affixed; and

when said variable dosing assembly and said medicament cartridge assembly move from said first position to said second position said pushrod and said runner remain removably affixed for a predetermined distance; and

said pushrod is uncoupled from said runner once said pushrod and said runner have moved together said predetermined distance.

59. The medicament injection apparatus of claim 58, wherein said thrusting assembly further comprises:

a lock ring selectively engaging and holding said tubular dose knob against said force exerted in said second direction; and

a needle thrust locking mechanism selectively engaging and holding said runner and said pushrod against said force exerted in said first direction.

60. The medicament injection apparatus of claim 59, wherein said motive force subassembly comprises a spring and a thrust bearing.

61. A medicament injection apparatus as in claim 45 wherein,

said open end of said needle shroud is removed a first distance from said first end of housing.

62. The medicament injection apparatus as in claim 61 further comprising:

another needle shroud, wherein upon removal of said needle shroud and removably affixing said another needle shroud to said first end of said housing, said open end of said another needle shroud is removed a second distance, different from said first distance, from said first end of said housing.