DEVICES, SYSTEMS AND METHODS FOR MEDICAMENT DELIVERY

• US 20080033393A1
• Filed: 01/09/2007
• Published: 02/07/2008
• Est. Priority Date: 02/01/2005
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Intelliject Incorporated
• Inventors: Edwards, Eric, Licata, Mark, Edwards, Evan, Weinzierl, David, Meyers, Paul
• Granted Patent: US 7,731,686 B2
• Time in Patent Office: Days
• US Class Current: 604/503
• 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 label configured to be coupled to a medicament delivery device, the label including

a first surface configured to be coupled to an outer surface of the medicament delivery device;

a second surface including a textual indicia; and

an electronic circuit system configured to output an electronic signal.

2. The apparatus of claim 1, wherein the first surface includes an adhesive configured to fixedly couple the label to the outer surface of the medicament delivery device.

3. The apparatus of claim 1, wherein the textual indicia includes any one of a description of the medicament delivery device, a source of the medicament delivery device or an instruction associated with the use of the medicament delivery device.

4. The apparatus of claim 1, wherein the electronic circuit system is coupled to the first surface of the first portion of the label.

5. The apparatus of claim 1, wherein the electronic circuit system is flexible.

6. The apparatus of claim 1, wherein the electronic circuit system includes a printed circuit board having a flexible substrate.

7. The apparatus of claim 1, wherein the electronic signal is associated with an initial use of the medicament delivery device.

8. The apparatus of claim 1, wherein the electronic signal includes an instruction associated with the use of the medicament delivery device.

9. The apparatus of claim 1, wherein:

the electronic circuit system includes a microprocessor; and

the electronic signal is associated with recorded speech.

10. 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.

11. An apparatus, comprising:

a printed circuit board configured to be coupled to a medicament delivery device, the printed circuit board including

a substrate; and

an electrical conductor disposed on the substrate, the substrate including an actuation portion configured to receive an actuator, the actuator being configured to deform the actuation portion of the substrate, thereby separating the electrical conductor.

12. The apparatus of claim 11 wherein the substrate is constructed from a flexible material.

13. The apparatus of claim 11, wherein the actuation portion of the substrate defines an opening adjacent the electrical conductor, the opening configured to receive the actuator.

14. The apparatus of claim 11, wherein the actuator is configured move substantially parallel to a surface of the actuation portion of the substrate to tear the actuation portion of the substrate, thereby severing the electrical conductor.

15. The apparatus of claim 11, wherein:

the actuation portion of the substrate defines an opening adjacent the electrical conductor, the opening configured to receive the actuator;

the actuator is configured move substantially parallel to a plane defined by a surface of the actuation portion of the substrate to produce a tear in the actuation portion of the substrate, thereby severing the electrical conductor; and

the opening is configured to propagate the tear in a predetermined direction.

16. The apparatus of claim 11, wherein:

the actuation portion of the substrate defines an opening adjacent the electrical conductor, the opening configured to receive the actuator; and

a boundary of the opening defined by the actuation portion has a discontinuous shape.

17. The apparatus of claim 11, wherein:

the actuation portion of the substrate defines an opening adjacent the electrical conductor, the opening configured to receive the actuator;

the actuator is configured to move substantially parallel to a surface of the portion of the substrate to produce a tear in the actuation portion of the substrate, thereby severing the electrical conductor; and

a boundary of the opening defined by the actuation portion has a stress concentration riser configured to propagate the tear in a predetermined direction.

18. The apparatus of claim 11, wherein the electronic conductor is a copper trace.

19. The apparatus of claim 11, wherein the printed circuit board further includes a processor coupled to the substrate, the processor configured to output an electronic signal when the electrical conductor is separated.

20. 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 the printed circuit board, the second surface including a textual indicia.

21. An apparatus, comprising:

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

an electronic circuit system configured to output an electronic signal associated with a use of the medicament delivery device;

a locking member configured to prevent the medicament from being delivered into the body, the locking member including an actuator configured to actuate the electronic circuit system.

22. The apparatus of claim 21, wherein:

the locking member has a first position and a second position, the locking member configured to prevent the medicament from being delivered into the body when in the first position, the locking member configured to allow the medicament to be delivered into the body when in the second position; and

the actuator is configured to actuate the electronic circuit system when the locking member is moved from the first position to the second position.

23. The apparatus of claim 21, wherein:

the electronic circuit system includes a microprocessor and a battery; and

the actuator is configured to actuate the electronic circuit system by selectively placing the battery in electrical communication with the microprocessor.

24. The apparatus of claim 21, wherein:

the electronic circuit system includes a switch, the electronic circuit system configured to output the electronic signal when the switch is moved from a first state to a second state;

the locking member has a first position and a second position, the locking member configured to prevent the medicament from being delivered into the body when in the first position, the locking member configured to allow the medicament to be delivered into the body when in the second position; and

the actuator is configured to 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.

25. The apparatus of claim 21, wherein the electronic signal is associated with recorded speech.

26. The apparatus of claim 21, wherein the medicament delivery device is any one of a pen injector, an auto-injector, an inhaler or a transdermal delivery device.

27. 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, the electronic circuit system configured to output a signal when the switch is moved from a first state to a second state;

a locking member configured to prevent the medicament from being delivered into the body when in a first position, the locking member configured to allow the medicament to be delivered into the body when in a second position, a portion of the locking member configured to 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.

28. The apparatus of claim 27, wherein the locking member includes any one of a removable cap, a protective barrier, a safety tab or a needle guard.

29. The apparatus of claim 27, wherein the portion of the locking member includes a protrusion configured to engage the switch.

30. The apparatus of claim 27, wherein the switch is configured to be irreversibly moved from the first state to the second state.

31. The apparatus of claim 27, wherein the electronic circuit system is coupled to an outer surface of the medicament delivery device.

32. The apparatus of claim 27, wherein the electronic circuit system further 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.

33. The apparatus of claim 27, 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.

34. An apparatus, comprising:

a housing configured to contain a medicament;

a flexible printed circuit board disposed on an outer surface of the housing, the printed circuit board including a first electrical contact portion and a second electrical contact portion;

an energy storage member; and

a label coupled to the flexible printed circuit board and the housing, the label configured to maintain a first surface of the energy storage member in electrical communication with the first electrical contact portion and maintain a second surface of the energy storage member in electrical communication with the second electrical contact portion.

35. The apparatus of claim 34, wherein the energy storage member is a battery

36. The apparatus of claim 34, wherein the label is disposed about the flexible printed circuit board.

37. The apparatus of claim 34, wherein the flexible printed circuit board is constructed from a flexible, monolithic substrate, the substrate defining the first electrical contact portion and the second electrical contact portion.

38. The apparatus of claim 34, wherein the first electrical contact portion and the second electrical contact portion are each devoid of a rigid member.

39. The apparatus of claim 34, wherein the housing is an outer portion of any one of a pen injector, an auto-injector, an inhaler or a transdermal delivery device.

40. A method, comprising:

assembling a medical device configured to contain a medicament;

placing an electronic circuit system against an outer surface of the medical device; and

coupling a label to the medicament delivery device such that the label is disposed about a portion of the electronic circuit system.

41. The method of claim 40, further comprising sterilizing a portion of the medicament delivery device before the placing the electronic circuit system.

42. The method of claim 40, wherein the label includes an opening configured to be aligned with a portion of the electronic circuit system.

43. The method of claim 40, wherein the medical device is any one of a pen injector, an auto-injector, an inhaler, a transdermal delivery device, a nasal medicament delivery device, a medicament container, an intravenous bag or a blister pack.

44. A method, comprising:

assembling a medical device configured to contain a medicament;

sterilizing a portion of the medical device;

coupling an electronic circuit system to a label; and

coupling the label to an outer surface of the medical device.

45. The method of claim 44, wherein the medical device is any one of a pen injector, an auto-injector, an inhaler, a transdermal delivery device, a nasal medicament delivery device, a medicament container, an intravenous bag or a blister pack.

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

output an electronic signal associated with a use of a medicament delivery device in response to a movement of a locking member, the locking member configured to prevent a medicament from being conveyed from the medicament delivery device into a body.

47. The processor-readable medium of claim 46, wherein the electronic signal is associated with at least one of a visual output, an audible output or a haptic output.

48. The processor-readable medium of claim 46, wherein the electronic signal is a first electronic signal, the code further comprising code to:

receive an input from any one of a switch or a sensor; and

output a second electronic signal in response to the received input.

49. The processor-readable medium of claim 46, wherein the electronic signal is a first electronic signal, the code further comprising code to:

output a second electronic signal in response to a movement of an actuator, the actuator configured to actuate the medicament delivery device.