Devices, Systems, and Methods for Medicament Delivery

• US 20080306436A1
• Filed: 02/01/2006
• Published: 12/11/2008
• Est. Priority Date: 02/01/2005
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Intelliject Incorporated
• Inventors: Edwards, Eric S., Licata, Mark J., Edwards, Evan T.
• Granted Patent: US 7,749,194 B2
• Time in Patent Office: Days
• US Class Current: 604/67
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/2026 Semi-automatic, e.g. user activated piston is assisted by additional source of energy
• 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 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 2039/1083 having a plurality of female connectors, e.g. Luer connectors
• CPC Class Codes: A61M 2039/1088 having a plurality of male connectors, e.g. Luer connectors
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6036 characterised by physical shape, e.g. array of activating switches
• CPC Class Codes: A61M 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• 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 5/2046 : Media being expelled from injector by gas generation, e.g. explosive charge
• CPC Class Codes: A61M 5/2053 : Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• CPC Class Codes: A61M 5/2066 : comprising means for injection of two or more media, e.g. by mixing
• 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 5/2448 : comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/3129 : Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/3204 : Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
• 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
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/20 : for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms

Abstract

Certain exemplary embodiments comprise can comprise an auto-injector, which can comprise: a vial configured to store and/or contain an injectable medicament, the vial defining a vial longitudinal axis, and a housing comprising the vial. In various embodiments, the injectable medicament can be a medicine, medication, drug, pharmaceutical, prescriptive, agent, antidote, anti-venom, hormone, stimulant, vasodilator, anesthetic, and/or nutritional supplement that is substantially ready for injection.

Claims

1. An auto-injector, comprising:

a vial configured to store a dry substance separately from a liquid with which the dry substance is mixable to form an injectable medicament, said vial defining a vial longitudinal axis;

a mixing actuator configured to cause the dry substance to contact the liquid;

a piston configured to move within said vial, said piston configured to transfer the injectable medicament from said vial and through a single needle, said piston distinct from said mixing actuator; and

a force initiator configured to supply a driving force to the injectable medicament, said force initiator defining a force initiator longitudinal axis located non-co-axially with the vial longitudinal axis.

2. The auto-injector of claim 1, further comprising a frangible seal configured to resist mixing of the dry substance and the liquid.

4. The auto-injector of claim 1, wherein said mixing actuator is coupled to said piston.

5. The auto-injector of claim 1, wherein said mixing actuator is coupled to said vial.

6. The auto-injector of claim 1, further comprising a compressed gas container configured to provide an actuation pressure to said piston.

7. The auto-injector of claim 1, further comprising an actuator configured to discharge an actuating portion of a contents of a compressed gas container fluidly coupled to said piston.

8. The auto-injector of claim 1, wherein said vial is fluidly coupleable to an actuating portion of a contents of a compressed gas container.

9. The auto-injector of claim 1, further comprising a channel configured to convey at least a portion of the injectable medicament from said vial to said single needle.

12. The auto-injector of claim 1, further comprising a sheath configured to conceal said single needle following injection of the injectable medicament.

14. The auto-injector of claim 1, further comprising a safety tab configured to prevent accidental activation of said auto-injector.

3. (canceled)

10-11. -11. (canceled)

13. (canceled)

15-20. -20. (canceled)

21. An auto-injector, comprising:

a vial configured to store an injectable medicament, said vial defining a vial longitudinal axis;

a force initiator configured to supply a driving force to the injectable medicament, said force initiator defining a force initiator longitudinal axis located non-co-axially with the vial longitudinal axis;

a housing comprising said vial; and

an output device coupled to said housing and configured to render a use indication, said use indication one of a group of use indications automatically triggerable by a microprocessor, said group not regarding a quantity of the injectable medicament, said group regarding at least two of;

auto-injector replacement;

medicament mixing;

injection delay;

safety guard removal;

auto-injector positioning;

auto-injector orientation;

actuator location;

injection hazard avoidance;

injection duration;

injection status;

injection error;

auto-injector removal;

auto-injector reuse;

auto-injector recycling; and

auto-injector disposal.

23. The auto-injector of claim 21, wherein said use indication is triggered responsive to a value of a sensed variable.

24. The auto-injector of claim 21, wherein said use indication is triggered responsive to a user input.

25. The auto-injector of claim 21, wherein said use indication is triggered responsive to a determination of a hazardous condition.

26. The auto-injector of claim 21, wherein said use indication is rendered visually.

27. The auto-injector of claim 21, wherein said use indication is rendered audibly.

28. The auto-injector of claim 21, wherein said use indication is rendered haptically.

29. The auto-injector of claim 21, wherein said housing comprises said output device.

30. The auto-injector of claim 21, wherein said output device comprises at least one of a speaker, a display, a light emitting diode, a vibrator and a heater.

36. The auto-injector of claim 21, further comprising a sensor coupled to said microprocessor.

37. The auto-injector of claim 21, further comprising a switch coupled to said microprocessor.

39. The auto-injector of claim 21, further comprising a piston adapted to move within said vial.

40. The auto-injector of claim 21, further comprising said gas container.

41. The auto-injector of claim 21, further comprising a channel adapted to convey the at least a portion of the medicament from said vial to a needle.

42. The auto-injector of claim 21, wherein said injectable medicament is a liquid.

43. The auto-injector of claim 21, wherein said injectable medicament is a mixture of a liquid and a solid.

44. The auto-injector of claim 21, further comprising a spring adapted to retract a needle fluidly coupled to said vial.

45. The auto-injector of claim 21, further comprising a releasable actuation lock adapted to prevent accidental activation of said auto-injector.

22. (canceled)

31-35. -35. (canceled)

38. (canceled)

46-49. -49. (canceled)

50. A processor readable medium storing code representing instructions to cause a processor to perform a process, the code comprising code to:

via an output device of an auto-injector, render a use indication, said use indication one of a group of use indications automatically triggerable by a microprocessor, said group not regarding a quantity of the injectable medicament, said group regarding at least two of;

auto-injector replacement;

medicament mixing;

injection delay;

safety guard removal;

auto-injector positioning;

auto-injector orientation;

actuator location;

injection hazard avoidance;

injection duration;

injection status;

injection error;

auto-injector removal;

auto-injector reuse;

auto-injector recycling; and

auto-injector disposal;

said auto-injector comprising;

a vial configured to store an injectable medicament, said vial defining a vial longitudinal axis;

a force initiator configured to supply a driving force to the injectable medicament, said force initiator defining a force initiator longitudinal axis located non-co-axially with the vial longitudinal axis; and

a housing comprising said vial, said output device coupled to said housing.

51. An apparatus, comprising:

a medicament delivery device configured to deliver only a single dose of a medicament into a body, the medicament delivery device including

a housing;

a medicament container disposed within the housing, the medicament container configured to contain the single dose of the medicament; and

an electronic circuit system configured to be coupled to the housing, the electronic circuit system configured to output an electronic output.

52. The apparatus of claim 51, wherein the electronic output includes a signal associated with at least one of a visual output, an audible output, a thermal output or a vibratory output.

53. The apparatus of claim 51, wherein the electronic output includes a verbal output.

54. The apparatus of claim 51, wherein the electronic output includes recorded speech.

55. The apparatus of claim 51, wherein the electronic output includes an instruction for using the medicament delivery device.

56. The apparatus of claim 51, wherein the electronic output includes a visual indicia associated with a placement of the medicament delivery device.

57. The apparatus of claim 51, wherein the electronic output is an indicia associated with any one of a status of the medicament delivery device, an expiration date associated with the medicament or a position of the medicament delivery device.

58. The apparatus of claim 51, wherein:

the medicament delivery device further includes a locking member movably coupled to the housing, the locking member configured to prevent the medicament delivery device from delivering the single dose of the medicament; and

the electronic circuit system is configured to output the electronic output when the locking member lock is moved relative to the housing.

59. The apparatus of claim 51, wherein:

the electronic circuit system includes a switch having a first state and a second state; and

the electronic circuit system is configured to output the electronic output when the switch is changed from the first state to the second state.

60. The apparatus of claim 51, wherein:

the electronic circuit system includes a sensor; and

the electronic circuit system is configured to output the electronic output in response to an input received from the sensor.

61. The apparatus of claim 51, wherein the electronic circuit system includes at least one of a processor, a memory component, a sensor, a switch or a battery.

62. The apparatus of claim 51, wherein the electronic circuit system includes at least one of a speaker, a light-emitting diode, a liquid crystal display, an organic polymer display, a fiber optic display, a vibrator, a heater, a cooler or a piezo-electric transducer.

63. The apparatus of claim 51, wherein the housing has a substantially rectangular shape.

64. The apparatus of claim 51, wherein:

the medicament delivery device further includes a label configured to be coupled to the housing; and

at least a portion of the electronic circuit system is incorporated into the label.

65. The apparatus of claim 51, wherein the medicament delivery device further includes a needle configured to be in fluid communication with the medicament container, the needle configured to be moved between first position and a second position, in the first position the needle is contained within the housing, in the second position a portion of the needle extends from the housing.

66. The apparatus of claim 51, wherein the medicament delivery device is configured to automatically inject the single dose of the medicament into the body.

67. An apparatus, comprising:

a housing;

a medicament injector configured to be disposed within the housing; and

an electronic circuit system configured to be coupled to the housing, the electronic circuit system configured to output a verbal output.

68. The apparatus of claim 67, wherein the verbal output includes an audible output.

69. The apparatus of claim 67, wherein the verbal output includes recorded speech.

70. The apparatus of claim 67, wherein the verbal output includes a visual output.

71. The apparatus of claim 67, wherein the verbal output includes a visual text message produced on a display screen.

72. The apparatus of claim 67, wherein the electronic system is further configured to output at least one of a visual output, an audible output or a haptic output.

73. The apparatus of claim 67, further comprising a locking member configured to prevent the medicament injector from being actuated, the electronic circuit system being configured to produce the verbal output when the locking member is moved relative to the housing.

74. The apparatus of claim 67, wherein:

the electronic circuit system includes a switch having a first state and a second state; and

the electronic circuit system is configured to produce the verbal output when the switch is changed from the first state to the second state.

75. The apparatus of claim 67, wherein:

the electronic circuit system includes a sensor; and

the electronic circuit system is configured to produce the verbal output in response to an input received from the sensor.

76. The apparatus of claim 67, wherein the verbal output includes any one of an instruction for using the apparatus, an indication of a status of the apparatus, an indication of an expiration date associated with a medicament contained in the medicament injector or an indication of a position of the apparatus.

77. The apparatus of claim 67, wherein the medicament injector includes

a medicament container disposed within the housing, the medicament container configured to contain only a single dose of a medicament;

and

a needle configured to be placed in fluid communication with the medicament container such that the single dose of the medicament can be injected into a body through the needle.

78. An apparatus, comprising:

a medicament delivery device configured to deliver a medicament into a body, the medicament delivery device including;

a housing;

medicament container disposed within the housing, the medicament container configured to contain the medicament;

a delivery member coupled to the medicament container, the delivery member configured to convey the medicament into the body; and

an electronic circuit system configured to be coupled to the housing, the electronic circuit system configured to output a plurality of electronic instructions, each of the plurality of electronic instructions being associated with an initial use of the medicament delivery device.

79. The apparatus of claim 78, wherein the plurality of electronic instructions is output in a predetermined sequence.

80. The apparatus of claim 78, wherein the plurality of electronic instructions is output in a sequence determined based on input received from any one of a switch, a sensor or a timer.

81. The apparatus of claim 78, wherein the plurality of electronic instructions includes any one of a visual output, an audible output or a haptic output.

82. The apparatus of claim 78, wherein the plurality of electronic instructions includes an instruction in verbal form.

83. The apparatus of claim 78, wherein the plurality of electronic instructions includes an instruction in the form of recorded speech.

84. The apparatus of claim 78, wherein the plurality of electronic instructions includes an instruction associated with removal of a locking member from the medicament delivery device.

85. The apparatus of claim 78, wherein the plurality of electronic instructions includes an instruction associated with activation of a mixing mechanism configured to mix the medicament contained in the medicament container.

86. The apparatus of claim 78, wherein the plurality of electronic instructions includes an instruction associated with positioning the medicament delivery device adjacent the body.

87. The apparatus of claim 78, wherein the plurality of electronic instructions includes an instruction associated with actuation of the medicament delivery device.

88. The apparatus of claim 78, wherein the electronic circuit system includes at least one of a processor, a memory component, a sensor, a switch or a battery.

89. The apparatus of claim 78, wherein the electronic circuit system includes at least one of a speaker, a light-emitting diode, a liquid crystal display, an organic polymer display, a fiber optic display, a vibrator, a heater, a cooler or a piezo-electric transducer.

90. The apparatus of claim 78, wherein:

the medicament delivery device further includes a label configured to be coupled to the housing; and

at least a portion of the electronic circuit system is incorporated into the label.

91. The apparatus of claim 78, wherein

the plurality of electronic instructions is a first plurality of electronic instructions;

and

the electronic circuit system is further configured to output a second plurality of electronic instructions associated with an event subsequent to the use of the medicament delivery device.

92. The apparatus of claim 78, wherein the delivery member is a needle.

93. The apparatus of claim 78, wherein the medicament delivery device is configured to automatically inject the medicament into the body.

94. An apparatus, comprising:

a medicament delivery device configured to deliver a medicament into a body, the medicament delivery device including;

a housing;

medicament container disposed within the housing, the medicament container configured to contain the medicament;

delivery member coupled to the medicament container, the delivery member configured to convey the medicament into the body; and

a label disposed on an exterior surface of the housing, the label including an electronic circuit system configured to produce an electronic output.

95. The apparatus of claim 94, wherein the medicament delivery device is configured to deliver only a single dose of the medicament.

96. The apparatus of claim 94, wherein the electronic output includes a signal associated with recorded speech.

97. The apparatus of claim 94, wherein the electronic output includes an instruction associated with the use of the medicament delivery device.

98. The apparatus of claim 94, wherein the electronic circuit system includes a processor, a memory component, a light-emitting diode and a switch.

99. The apparatus of claim 94, wherein the delivery member includes a needle configured to be in fluid communication with the medicament container, the needle configured to be moved between first position and a second position, in the first position the needle is contained within the housing, in the second position a portion of the needle extends from the housing.

100. The apparatus of claim 94, wherein the medicament delivery device is configured to automatically inject the medicament into the body.

101. An apparatus, comprising:

a medicament delivery device configured to deliver a medicament into a body, the medicament delivery device including

a sensor configured to produce a signal when disposed adjacent to the body; and

an electronic circuit system operatively coupled to the sensor, the electronic circuit system configured to produce an output in response the signal produced by the sensor.

102. The apparatus of claim 101, wherein the electronic output includes a signal associated with recorded speech.

103. The apparatus of claim 101, wherein the electronic output includes an instruction associated with the use of the medicament delivery device.

104. The apparatus of claim 101, wherein the medicament delivery device is configured to automatically inject the medicament into the body.