Devices, systems and methods for medicament delivery

• US 7,731,686 B2
• Filed: 01/09/2007
• Issued: 06/08/2010
• Est. Priority Date: 02/01/2005
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Intelliject Incorporated
• Inventors: Meyers, Paul F., Edwards, Eric Shawn, Licata, Mark J., Weinzierl, David A., Edwards, Evan Thomas
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US11/621,236
• Publication Number:
  US 20080033393A1
• Time in Patent Office: 1,246 Days
• Field of Search: 604/65, 604/67, 604/110, 604/131, 604/141, 604/189, 604/192, 128/200.14, 128/200.23, 340/539.12, 340/303, 340/568.1, 340/590, 340/652, 200/61.08, 206/459.1, 206/534, 368/10, 700/235
• US Class Current: 604/110
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• 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 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 2205/587 Lighting arrangements
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 35/00 Devices for applying media, e.g. remedies, on the human body devices for handling toiletry or cosmetic substances A45D; absorbent pads, e.g. swabs, A61F13/15
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• 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 5/2053 Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• 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
• 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 5/3234 Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
• 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: A61M 5/5086 : for indicating if defective, used, tampered with or unsterile

Abstract

An apparatus includes a label configured to be coupled to a medicament delivery device. The label includes a first surface and a second surface. The first surface is configured to be coupled to an outer surface of the medicament delivery device. The second surface includes a textual indicia. The label further includes an electronic circuit system configured to output an electronic signal.

Claims

1. An apparatus, comprising:

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

a housing defining an interior region configured to contain a medicament container;

a medicament delivery mechanism disposed within the interior region, the medicament delivery mechanism configured to produce a force acting on the medicament container when actuated;

an electronic circuit system including a switch disposed on a printed circuit board, the electronic circuit system configured to output an electronic signal associated with a use of the medicament delivery device when actuated, the electronic circuit system configured to be actuated when the switch is moved from a first state to a second state, the electronic circuit system coupled to an outer surface of the housing such that the electronic circuit system is exterior to the interior region defined by the housing;

an actuator configured to be moved between a first position and a second position, a first portion of the actuator disposed outside of the housing, the first portion of the actuator configured to tear a portion of the printed circuit board to irreversibly move the switch from the first state to the second state when the actuator is moved from the first position to the second position, a second portion of the actuator configured to engage a portion of the delivery mechanism to actuate the delivery mechanism when the actuator is moved between the first position and the second position; and

a locking member engaged with a portion of the actuator to limit movement of the actuator when the locking member is in a first locking member position.

2. The apparatus of claim 1, wherein the electronic signal is associated with recorded speech.

3. The apparatus of claim 1, wherein the medicament delivery device is any one of a pen injector, an auto-injector, an inhaler or a transdermal delivery device.

4. The apparatus of claim 1, wherein the electronic signal is a first electronic signal, the electronic circuit system is configured to output the first electronic signal when the actuator actuates the electronic circuit system, the apparatus further comprising:

a battery isolation member configured to electrically isolate a battery from the electronic circuit system when the battery isolation member is in a first battery isolation position, the electronic circuit system configured to output a second electronic signal when the battery isolation member is moved from the first battery isolation position to a second battery isolation position.

5. The apparatus of claim 1, wherein:

the electronic circuit system includes a light emitting diode; and

the electronic signal is conveyed to the light emitting diode thereby causing the light emitting diode to produce a visual output when the actuator actuates the electronic circuit system.

6. The apparatus of claim 1, wherein the medicament delivery mechanism is a non-electronic mechanism configured to convey the medicament into the body independently from the electronic signal.

7. The apparatus of claim 1, wherein the medicament container includes a piston, the medicament delivery mechanism configured to exert a force on the medicament within the medicament container via the piston to convey the medicament into the body independently from the electronic signal.

8. The apparatus of claim 1, wherein:

the printed circuit board defines an opening, the switch disposed on the printed circuit board adjacent the opening; and

the first portion of the actuator is disposed within the opening when the actuator is in the first position.

9. The apparatus of claim 1, wherein the locking member is a non-electronic mechanism configured to be manipulated manually.

10. The apparatus of claim 1, wherein:

the medicament delivery device is an auto-injector; and

the medicament delivery mechanism includes a non-electronic energy storage member configured to produce the force, the medicament delivery mechanism configured to be actuated independently from the electronic circuit system.

11. An apparatus, comprising:

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

an electronic circuit system including a switch disposed on a printed circuit board and a light output device disposed on the printed circuit board, the electronic circuit system configured to output a light output via the light output device when the switch is moved from a first state to a second state;

a system actuator configured to produce a force to deliver the medicament into the body; and

a locking member engaged with a portion of the system actuator to prevent the medicament from being delivered into the body when in a first position, the locking member spaced apart from the portion of the system actuator when in a second position, a portion of the locking member configured to tear a portion of the printed circuit board to irreversibly move the switch from the first state to the second state when the locking member is moved from the first position to the second position.

12. The apparatus of claim 11, wherein the locking member includes any one of a removable cap, a protective barrier, a safety tab or a needle guard.

13. The apparatus of claim 11, wherein the portion of the locking member includes a protrusion configured to tear the portion of the printed circuit board.

14. The apparatus of claim 11, wherein:

the medicament delivery device includes a housing defining an interior region configured to contain a medicament container and the system actuator, a portion of the system actuator operably coupled to the medicament container; and

the electronic circuit system is coupled to an outer surface of the housing such that the electronic circuit system is exterior to the interior region defined by the housing.

15. The apparatus of claim 11, wherein the printed circuit board includes a substrate constructed from a flexible material,

the switch including an electrical conductor disposed on a portion of the substrate,

the substrate defining an opening adjacent the electrical conductor, the opening configured to receive the portion of the locking member such that when the locking member is moved from the first position to the second position, the portion of the locking member separates the electrical conductor thereby moving the switch from its first state to its second state.

16. The apparatus of claim 11, further comprising:

a label configured to be coupled to an outer surface of the medicament delivery device, the label including a first surface and a second surface, the first surface coupled to a portion of the electronic circuit system, the second surface including a textual indicia.

17. The apparatus of claim 11, wherein the electronic circuit system is configured to output a recorded speech output including an instruction associated with an operation of the medicament delivery device when the switch is moved from the first state to the second state.

18. The apparatus of claim 11, wherein the electronic circuit system is configured to output a first recorded speech output including a first instruction for using the medicament delivery device when the switch is moved from the first state to the second state, the apparatus further comprising:

an initiator configured to engage a portion of the system actuator to initiate delivery of the medicament from the medicament delivery device into the body, the electronic circuit system configured to output a second recorded speech output including a second instruction for using the medicament delivery device when the initiator initiates delivery of the medicament.

19. The apparatus of claim 11, wherein the electronic circuit system is configured to output a first recorded speech output including a first instruction for using the medicament delivery device when the switch is moved from the first state to the second state, the apparatus further comprising:

a battery isolation member configured to electrically isolate a battery from the electronic circuit system when the battery isolation member is in a first position, the electronic circuit system configured to output a second recorded speech output including a second instruction for using the medicament delivery device when the battery isolation member is moved from its first position to a second position.

20. The apparatus of claim 11, wherein the medicament delivery device is configured to deliver a single dose of the medicament into the body.

21. The apparatus of claim 11, wherein the system actuator includes a non-electronic medicament delivery mechanism configured to produce the force independently from the operation of electronic circuit system.

22. An apparatus, comprising:

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

an electronic circuit system having a first switch including a first electrical conductor and a second switch including a second electrical conductor, the electronic circuit system configured to produce a first recorded speech output when the first switch is moved from a first state to a second state, the electronic circuit system configured to produce a second recorded speech output when the second switch is moved from a first state to a second state;

an actuator configured to initiate delivery of the medicament from the medicament delivery device into the body when moved from a first configuration to a second configuration, a portion of the actuator configured to irreversibly tear through the second electrical conductor when the actuator is moved from the first configuration to the second configuration; and

a safety member configured to be moved between a first position and a second position, the safety member engaged with a portion of the actuator to prevent movement of the actuator from the first configuration to the second configuration when the safety member is in its first position, a portion of the safety member configured to irreversibly tear through the first electrical conductor when the safety member is moved between the first position and the second position.

23. The apparatus of claim 22, wherein the medicament delivery device is any one of a pen injector, an auto-injector, an inhaler or a transdermal delivery device.

24. The apparatus of claim 22, wherein the safety member includes any one of a removable cap, a protective barrier, a locking member or a needle guard.

25. The apparatus of claim 22, wherein the medicament delivery device further includes:

a battery isolation member configured to electrically isolate a battery from the electronic circuit system when the battery isolation member is in a first battery isolation member position, the electronic circuit system configured to produce a third recorded speech output when the battery isolation member is moved from its first position to a second position.

26. The apparatus of claim 22, wherein at least one of the first recorded speech output and the second recorded speech output is associated with an instruction associated with an operation of the medicament delivery device.

27. The apparatus of claim 22, wherein

the electronic circuit system includes a light emitting diode;

and

the electronic circuit system is configured to produce a visual output via the light emitting diode when the first switch is moved from the first state to the second state.

28. The apparatus of claim 22, wherein the medicament delivery device includes a non-electronic medicament delivery mechanism configured to cause a flow of medicament when the actuator is moved from its first configuration to its second configuration, the medicament delivery mechanism configured to cause the flow independently from the operation of electronic circuit system.

29. The apparatus of claim 22, further comprising:

a housing defining an interior region configured to contain a medicament container and a medicament delivery mechanism operably coupled to the medicament container,

the electronic circuit system being coupled to an outer surface of the medicament delivery device such that the electronic circuit system is exterior to the interior region defined by the housing.

30. The apparatus of claim 22, wherein:

the electronic circuit system includes a printed circuit board defining a first opening adjacent the first electrical conductor and a second opening adjacent the second electrical conductor;

the portion of the actuator is disposed within the second opening when the actuator is in the first configuration; and

the portion of the safety member is disposed within the first opening when the safety member is in its first position.