Injection device and method for its operation

• US 6,599,272 B1
• Filed: 05/12/2000
• Issued: 07/29/2003
• Est. Priority Date: 05/12/1999
• Status: Expired due to Fees

• Current Assignee: Pharmacia AB (Pharmacia Corp.)
• Original Assignee: Pharmacia AB (Pharmacia Corp.)
• Inventors: Ramseyer, Markus, Arborgh, Jiro, Hjertman, Birger, Himbert, Hans, Fridholm, Jonas, Crafoord, Carl-Göran
• Primary Examiner(s): Mendez, Manuel
• Assistant Examiner(s): Han, Mark K
• Application Number:
  US09/570,296
• Time in Patent Office: 1,173 Days
• Field of Search: 604/110, 604/131, 604/138, 604/139, 604/156, 604/181, 604/186, 604/187, 604/194, 604/195, 604/196, 604/197, 604/199, 604/200, 604/205, 604/207, 604/209, 604/211, 604/224, 604/232, 604/246, 604/264, 604/272
• US Class Current: 604/209
• CPC Class Codes: A61M 2005/3152 including gearings to multiply or attenuate the piston displacing force
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• 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 5/284 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/315 Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
• CPC Class Codes: A61M 5/31536 Blocking means to immobilize a selected dose, e.g. to administer equal doses
• CPC Class Codes: A61M 5/31551 including axial movement of dose setting member
• CPC Class Codes: A61M 5/3156 using volume steps only adjustable in discrete intervals, i.e. individually distinct intervals
• CPC Class Codes: A61M 5/31563 interacting with a displaceable stop member
• CPC Class Codes: A61M 5/31575 using scaling up or down transmissions, e.g. gearbox
• CPC Class Codes: A61M 5/31581 performed by rotationally moving or pivoting actuator operated by user, e.g. an injection lever or handle
• 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
• CPC Class Codes: A61M 5/3287 Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence

Abstract

Injector devices and methods for their operation for containers having an opening with or for an injection needle. The container is optionally of syringe type with a barrel of substantially constant axial cross-section. In one embodiment, the devices include a penetration arrangement operable to move the needle from a rear position to a forward position, an injection arrangement operable at least to expel container content through the needle, and a transmission and a switch system allowing manual energy applied to the device to manually operate the penetration arrangement and then manually operate the injection arrangement.

Claims

1. Injector for containers having an opening with or for an injection needle, the container optionally being of syringe type with a barrel of substantially constant axial cross-section and including a barrel front, the opening for the needle being arranged at the barrel front, and at least one movable wall, optionally with a piston rod connected thereto, inserted in the barrel, the injector for the containers comprising a) a housing, b) a seat or carrier, arranged for reception of the needle or container and for allowing movement of the needle or container, respectively, in relation to the housing, in the axial direction between a rear, needle-covering, position and a forward, needle-exposing, position, c) a penetration arrangement operable to move the needle from the rear position to the forward position, d) optionally a return arrangement operable at least to move the needle in the rearward direction, e) an injection arrangement operable at least to expel container content through the needle, f) at least one control button arranged on the housing and operable to perform operation of the penetration arrangement and/or the injection arrangement, g) a separate or integral transmission, incorporating and connecting the penetration arrangement and the injection arrangement to the at least one control button, and adapted to allow manual energy applied on the at least one control button for movement thereof to be transmitted to the penetration arrangement and the injection arrangement, respectively, for operation thereof under movement of the control button, and h) a switch system adapted to permit phase shift of manual energy applied to the at least one control button first to operate the penetration arrangement and then to operate the injection arrangement.

2. The injector of claim 1, wherein the penetration arrangement is arranged to act directly on the needle, the container or the carrier.

3. The injector of claim 1, wherein the button is arranged for movement with at least a component perpendicular to the needle axis.

4. The injector of claim 3, wherein the button is arranged for guided translational movement.

5. The injector of claim 3, wherein that the button is arranged for at least partial rotational movement around a rotation axis.

6. The injector of claim 5, wherein the rotation axis is oriented substantially along the housing width direction.

7. The injector of claim 3, wherein the transmission comprises a redirect arrangement adapted to redirect the force applied to the button into an axial movement for the needle and/or movable wall.

8. The injector of claim 7, wherein the redirect system is mechanical.

9. The injector of claim 8, wherein the redirect system comprises a wire, a belt, a link system or a lever arrangement.

10. The injector of claim 8, wherein the redirect system includes a wheel.

11. The injector of claim 10, wherein the wheel is a toothed wheel.

12. The injector of claim 1, wherein the button is located lateral to the needle axis.

13. The injector of claim 12, wherein the button is located at least partially between axial ends of the container.

14. The injector of claim 1, wherein the transmission comprises force transforming parts.

15. The injector of claim 14, wherein the force transforming parts provide a higher gear ratio in the injection arrangement compared to a gear ratio in the penetration arrangement.

16. The injector of claim 1, wherein the switch system is adapted to enable phase shift once the needle is in a forward position exposed from the front of the housing.

17. The injector of claim 16, wherein the location is at or close to the needle forward position for the needle.

18. The injector of claim 16, wherein the switch system includes a lock for the needle in said location.

19. The injector of claim 16, further comprising a structure, with substantially fixed location with respect to the housing, arranged to redirect, unlock or enable the force applied to the button for operation of the injection arrangement.

20. The injector of claim 16, wherein at said location the phase shift is enabled within the movement range of the transmission.

21. The injector of claim 20, wherein the switch system includes a pawl and ratchet type mechanism.

22. The injector of claim 16, wherein when force is applied at a constant location in the housing, the penetration movement is adapted to bring an operative part of the injection arrangement into said constant location in the housing.

23. The injector of claim 22, wherein the operative part is a plunger arrangement for a syringe type container.

24. The injector of claim 23, wherein a change in gear ratio is adapted to take place at the phase shift.

25. The injector of claim 22, wherein at least one wheel is adapted to apply the force at the constant location.

26. The injector of claim 1, further comprising a lock arranged to hold, at least temporary, the needle in the forward position.

27. The injector of claim 1, further comprising a reconnect system adapted to allow repeated operation of the button.

28. The injector of claim 27, wherein the reconnect system is adapted to transmit force when the button is moved in one direction and is adapted to idle when the button is moved in the other direction.

29. The injector of claim 27, wherein the reconnect system is adapted to allow reversible phase action.

30. The injector of claim 27, wherein the reconnect system is adapted to allow reversible penetration movement.

31. The injector of claim 27, wherein the reconnect system is adapted to allow pumping action on the button for intermittent operation of the injection arrangement.

32. The injector of claim 31, further comprising a one-way arrangement for the movable wall of a syringe type container, adapted to prevent rearward movement of the movable wall.

33. The injector of claim 27, wherein the reconnect system includes at least one wheel with movable axis for engagement release.

34. The injector of claim 1, wherein the button is biased towards one end position.

35. The injector of claim 34, wherein the button is biased toward a distal position with respect to the housing.

36. The injector of claim 1, further comprising a return arrangement.

37. The injector of claim 36, wherein the needle is adapted to return by use of stored energy.

38. The injector of claim 37, wherein the needle return is adapted to be triggered by action on the button.

39. The injector of claim 37, wherein the needle is adapted to return by a counterspring adapted to be compressed during penetration movement.

40. The injector of claim 37, wherein the needle return is adapted to be triggered automatically at a predetermined point in the injection procedure.

41. The injector of claim 1, wherein the injector comprises a dose setting mechanism.

42. The injector of claim 1, wherein the seat or carrier is arranged to allow movement of a syringe type container rearwards towards the housing under forward displacement of the movable wall relative the container barrel.

43. The injector of claim 42, wherein the displacement of the movable wall is adapted to provide movable wall break-loose, deaeration, pre-ejection or preparation mixing.

44. The injector of claim 43, wherein the lever includes a hinged door.

45. The injector of claim 42, further comprising a lever for movement of the container.

46. The injector of claim 45, wherein the lever is force amplifying.

47. The injector of claim 1, wherein the housing maximum height, to maximum width, ratio is larger than 1.

48. The injector of claim 47, wherein the housing maximum height to maximum width ratio is larger than 1.5.

49. The injector of claim 1, wherein the housing maximum length to maximum height, ratio is less than 4.

50. The injector of claim 1, wherein the container is a dual or multiple chamber type container.

51. The injector of claim 50, wherein the container attachment to the housing comprises a screw thread, the length of which is adapted to the necessary movable wall displacement for unification of chamber contents.

52. The injector of claim 1, wherein the needle is arranged movable in relation to the container.

53. The injector of claim 52, wherein the container is non-movably arranged in the housing.

54. The injector of claim 1, wherein the container is of syringe type with attached needle for common axial movement.

55. The injector of claim 1, wherein the housing maximum length to maximum height ratio is less than 3.

56. Injector for containers having an opening with or for an injection needle, the container optionally being of syringe type with a barrel of substantially constant axial cross-section and including a barrel front, the opening for the needle being arranged at the barrel front and at least one movable wall, optionally with a piston rod connected thereto, inserted in the barrel, the injector for the containers comprising a) a housing, b) a seat or carrier, arranged for reception of the needle or container and for allowing movement thereof, in relation to the housing, in the axial direction between a rear, needle-covering, position and a forward, needle-exposing, position, c) a penetration arrangement operable to move the needle from the rear position to the forward position, d) optionally a return arrangement operable at least to move the needle in the rearward direction, e) an injection arrangement operable at least to expel container content through the needle, f) at least one control button arranged on the housing and operable to at least initiate operation of the penetration arrangement and/or the injection arrangement, wherein the at least one control button is arranged manually accessible on the housing and is arranged so as to allow a rotational or translational movement with respect to the housing, said movement having at least a movement component perpendicular to the needle axis, and g) a separate or integral transmission, incorporating and connecting at least the penetration arrangement to the at least one control button, and adapted to allow manual energy applied on the at least one control button during said movement to be transmitted to the penetration arrangement for operation thereof to move the needle at least partly from the rear, needle-covering, position towards the forward, needle-exposing, position.

57. Injector for containers of syringe type, comprising a barrel of substantially constant axial cross-section, a front opening and at least one movable wall, optionally with a piston rod connected thereto, inserted in the barrel for the displacement of a container content, the injector comprising a) a housing, b) a seat or carrier, arranged for reception of the needle or container and for allowing movement of the needle or container, respectively, in relation to the housing, in the axial direction, c) an injection arrangement operable at least to displace the container movable wall in the forward direction, wherein the seat or carrier is arranged to allow movement of the container rearwards towards the housing under forward displacement of the movable wall relative the container barrel, and d) a hinged lever arranged for directly or indirectly pressing the container rearwards.

58. The injector of claim 57, wherein displacement of the movable wall is adapted to provide movable wall break-loose, deaeration, pre-ejection or preparation mixing.

59. The injector of claim 57, wherein the lever includes a hinged door.

60. The injector of claim 57, wherein the lever is force amplifying.

61. A method for operating an injector for containers having an opening with or for an injection needle, the injector comprising a) a housing, b) a seat or carrier, arranged for reception of the needle or container and for allowing movement of the needle or container, respectively, in relation to the housing, in the axial direction between a rear, needle-covering, position and a forward, needle-exposing, position, c) a pump mechanism operable to expel container content through the needle, and d) at least one control button operable to move the needle in the axial direction and/or to activate the pump mechanism, the method including the steps of i) moving the needle from the rear position to the forward position, ii) ejecting container content through the needle by activation of the pump mechanism, and iii) optionally moving the needle from the forward position to the rear position, wherein manual force is applied to the at least one control button, and further wherein at least part of the force is transmitted to the needle to displace the needle under movement of the at least one control button in a first operation at least partly from the rear, needle-covering, position towards the forward, needle-exposing, position, and subsequent to the first operation, at least part of the force is transmitted to the pump mechanism to eject container content through the needle.

62. The method of claim 61, wherein, in the first operation, the force is transmitted by application of the force directly on the needle, the container or the carrier.

63. The method of claim 61, wherein the at least one control button is moved in a rotational or translational movement with respect to the housing, said movement having at least a movement component perpendicular to the container axis.

64. The method of claim 63, wherein the force applied to the button is translated into an axial force.

65. The method of claim 61, wherein the ratio between the movement applied to the button to the movement of the needle in the first operation is larger than 0.1 and less than 10.

66. The method of claim 61, wherein a single control button movement is used for the first operation and the second operation.

67. The method of claim 61, wherein, in the first operation, the at least one control button is at least partially released and the needle at least partially moved rearwards in a reversible manner.

68. The method of claim 61, wherein force amplification takes place between the first operation and the second operation.

69. The method of claim 61, wherein between the first operation and the second operation the at least one control button is at least partially released and moved in the opposite direction.

70. The method of claim 61, wherein the at least one control button is moved a second time to perform the second operation.

71. The method of claim 61, wherein the at least one control button is moved several times to perform the second operation.

72. The method of claim 61, wherein the needle is permanently or temporarily locked in the forward position between the first operation and the second operation.

73. The method of claim 61, wherein the needle is moved from the forward position to the rear position in a third operation after the second operation.

74. The method of claim 73, wherein the third operation is triggered by operating a control.

75. The method of claim 74, wherein the at least one control button is used for triggering the third operation.

76. The method of claim 75, wherein the step of triggering is performed by release of the at least one control button after the second operation.

77. The method of claim 75, wherein the at least one control button is moved an additional time for triggering.

78. The method of claim 73, wherein the third operation is performed at a predetermined content of the container.

79. The method of claim 78, wherein the step of performing the third operation is by release of stored energy.

80. The method of claim 61, further comprising a step of setting a dose to be ejected.

81. The method of claim 61, further comprising a step of activating the pump mechanism by movement of a door on the device.

82. A method for operating an injector for containers having an opening with or for an injection needle, the injector comprising a) a housing, b) a seat or carrier, arranged for reception of the needle or container and for allowing movement of the needle or container, respectively, in relation to the housing, in the axial direction between a rear, needle-covering, position and a forward, needle-exposing, position, c) a pump mechanism operable to expel container content through the needle, and d) at least one manually accessible control button operable to move the needle in the axial direction and/or to activate the pump mechanism, the method including the steps of i) moving the needle from the rear position to the forward position, ii) ejecting container content through the needle by activation of the pump mechanism, and iii) optionally moving the needle from the forward position to the rear position, wherein manual force is applied to move the at least one manually accessible control button in a rotational or translational movement with respect to the housing, said movement having at least a movement component perpendicular to the container axis, and at least part of the force is transmitted to the needle to displace the needle in a first operation at least partly from the rear, needle-covering, position towards the forward, needle-exposing, position.

83. A method for operating an injector for containers of syringe type, comprising a barrel of substantially constant axial cross-section, a front opening and at least one movable wall, optionally with a piston rod connected thereto, inserted in the barrel for the displacement of a container content, the injector comprising a) a housing, b) a seat or carrier, arranged for reception of the needle or container and for allowing movement of the needle or container, respectively, in relation to the housing, in the axial direction, c) an injection arrangement operable at least to displace the container movable wall in the forward direction, and d) a hinged member attached to the housing, the method comprising moving the hinged member, and transmitting the hinged member movement into a pressing movement for the container rearwards towards the housing under forward displacement of the movable wall relative to the container barrel.

84. The method of claim 83, further comprising a step of performing movable wall break-loose, deaeration, pre-ejection and/or preparation mixing by displacement of the movable wall.

85. The method of claim 83, wherein the hinged member is a closeable door, the closure of which acts as the hinged member movement.

86. The method of claim 85, wherein at least a part of the container is enclosed by closure of the door.

87. The method of claim 83, wherein a control button is enabled for operation by the movement of the hinged member.

88. The method of claim 83, further comprising a step of amplifying the force applied to the hinged member when applied to the movable wall.

89. Injector for containers of syringe type, comprising a barrel of substantially constant axial cross-section, a front opening and at least one movable wall, optionally with a piston rod connected thereto, inserted in the barrel for the displacement of a container content, the injector comprising a) a housing, b) a seat or carrier, arranged for reception of the needle or container, c) an injection arrangement operable at least to displace the container movable wall in the forward direction, wherein the injection arrangement comprises at least one rail, at least partly coaxial or parallel with the barrel axis and constituting or being connected to a piston rod or plunger arrangement for displacement of the movable wall at least in the forward direction, and d) a driving wheel with a rotation axis, the axis being connected directly or indirectly to the housing, movably between two axis positions, the wheel in a first position being in engagement with the rail for movement thereof relative the housing and in a second position being out of engagement with the rail.

90. The injector of claim 89, wherein the rail and the wheel are correspondingly teethed.

91. The injector of claim 89, wherein an actuator is connected to the housing in a movable manner and is connected to the driving wheel, optionally via intermediate parts or wheels, for rotation thereof at actuator movement.

92. The injector of claim 91, wherein the actuator is arranged to allow movement under urging of the driving wheel toward the first position.

93. The injector of claim 92, wherein the actuator is connected to the driving wheel for movement of the rail in the forward direction when urging the driving wheel toward the first position.

94. The injector of claim 91, comprising a change of gear ratio between the actuator and rail.

95. The injector of claim 91, wherein the actuator is or includes a second wheel.

96. The injector of claim 91, wherein the actuator is a control button.

97. The injector of claim 96, wherein a connection between the control button and driving wheel includes a cam surface.

98. The injector of claim 97, wherein the control button is rotatable around a button axis on the housing, the cam surface has curvature, and the curvature is centered substantially at the button axis.