Devices, systems and methods for medicament delivery

• US 8,926,594 B2
• Filed: 02/24/2012
• Issued: 01/06/2015
• Est. Priority Date: 02/01/2005
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: Edwards, Eric Shawn, Edwards, Evan Thomas, Licata, Mark J., Meyers, Paul F., Weinzierl, David A.
• Primary Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US13/404,699
• Publication Number:
  US 20120226226A1
• Time in Patent Office: 1,047 Days
• Field of Search: 604/131, 604134-137, 128/200.14, 128/200.23
• US Class Current: 604/890.1
• 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 5/2046 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 5/3129 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
• CPC Class Codes: G16H 20/13 : delivered from dispensers
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

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 housing associated with a medical device;

a container disposed within the housing;

a movable member having a first end portion and a second end portion, the second end portion disposed within the container;

a first actuator assembly configured to release an energy storage member disposed within the housing, the first end portion of the movable member configured to receive a force produced by the energy storage member to move the second end portion of the movable member within the container in response to the energy storage member being released;

an electronic circuit system including a first switch, a second switch, and an audible output device, the audible output device coupled to the housing, the electronic circuit system configured to output a first recorded speech output via the audible output device when the first switch is actuated, the electronic circuit system configured to output a second recorded speech output via the audible output device when the second switch is actuated; and

a second actuator assembly coupled to the housing, the second actuator assembly including an outer surface, a first protrusion, and a second protrusion, the outer surface accessible from outside of the housing, the first protrusion of the second actuator assembly being aligned with the first switch and configured to actuate the first switch when a first portion of the outer surface is manipulated, the second protrusion of the second actuator assembly being aligned with the second switch and configured to actuate the second switch when a second portion of the outer surface is manipulated.

2. The apparatus of claim 1, wherein:

the electronic circuit system includes a printed circuit board, the first switch coupled to a first portion of the printed circuit board, the second switch coupled to a second portion of the printed circuit board; and

the first protrusion is configured to contact the first switch to actuate the first switch, the second protrusion is configured to contact the second switch to actuate the second switch.

3. The apparatus of claim 1, wherein the first portion of the outer surface is accessible from outside of the housing and is configured to be manipulated separately from the second portion of the outer surface such that the first protrusion contacts the first switch to actuate the first switch when the first portion of the outer surface is moved relative to the housing.

4. The apparatus of claim 1, wherein the energy storage member is a non-electronic energy storage member.

5. The apparatus of claim 1, wherein the electronic circuit system is configured to produce a predetermined sequence of electronic outputs, the sequence including the first recorded speech output.

6. The apparatus of claim 1, wherein the electronic circuit system is configured to output the first recorded speech output for a predetermined time period, the electronic circuit system is configured to produce, in response to actuation of the first switch, a third recorded speech output after the predetermined time period has elapsed, the third recorded speech output different from the first recorded speech output.

7. The apparatus of claim 1, wherein:

the medical device is an autoinjector; and

at least one of the first recorded speech output or the second recorded speech output is associated with an injection event with the autoinjector.

8. The apparatus of claim 1, wherein:

the container is configured to move within the housing in response to the energy storage member being actuated.

9. The apparatus of claim 1, wherein the force is a first force, the second end portion of the movable member is configured to move in a first direction within the container in response to the energy storage member being actuated, the apparatus further comprising:

a retraction member configured to transmit a second force to move the movable member in a second direction within the container, the second direction opposite the first direction.

10. The apparatus of claim 1, wherein the container contains a medicament, the second end portion of the movable member configured to expel at least a portion of the medicament from the container when the second end portion of the movable member is moved within the container.

11. An apparatus comprising:

an outer housing associated with a medical injector;

an inner housing disposed within the outer housing;

an energy storage member disposed within the outer housing, the energy storage member configured to produce a force;

a movable member having a first end portion and a second end portion, the first end portion configured to receive the force produced by the energy storage member to move the second end portion of the movable member within the inner housing;

an electronic circuit system including a first switch, a second switch and an audible output device, the audible output device coupled to the outer housing, the electronic circuit system configured to produce a first recorded speech output via the audible output device when the first switch is actuated, the electronic circuit system configured to produce a second recorded speech output via the audible output device when the second switch is actuated, the second recorded speech output different from the first recorded speech output; and

an actuator assembly coupled to the outer housing, the actuator assembly including an outer surface and an inner surface, the inner surface including a first protrusion aligned with the first switch, the first protrusion configured to move relative to the outer housing when the outer surface is manipulated to actuate the first switch, the inner surface including a second protrusion aligned with the second switch, the second protrusion configured to move relative to the outer housing when the outer surface is manipulated to actuate the second switch.

12. The apparatus of claim 11, wherein the second end portion of the movable member is configured to move from a first position to a second position within inner housing, the movable member and the inner housing being collectively configured to limit a distance between the first position and the second position.

13. The apparatus of claim 11, wherein:

the inner housing is configured to move within the outer housing in response to the force being received by the first end portion of the movable member.

14. The apparatus of claim 11, wherein the force is a first force, the second end portion of the movable member is configured to move in a first direction within the inner housing in response to the first force being received by the first end portion of the movable member, the apparatus further comprising:

a retraction member configured to transmit a second force to move the movable member in a second direction within the inner housing, the second direction opposite the first direction.

15. The apparatus of claim 11, wherein:

the electronic circuit system includes a printed circuit board, the first switch coupled to a first portion of the printed circuit board, the second switch coupled to a second portion of the printed circuit board; and

the first protrusion is configured to contact the first switch to actuate the first switch, the second protrusion is configured to contact the second switch to actuate the second switch.

16. The apparatus of claim 11, wherein the outer housing defines an opening within which the audible output device is disposed.

17. The apparatus of claim 11, wherein the energy storage member is a non-electronic energy storage member.

18. The apparatus of claim 11, wherein the electronic circuit system is configured to produce a third recorded speech output a predetermined time period after actuation of the first switch.

19. The apparatus of claim 11, wherein the a first portion of the outer surface is configured to be manipulated separately from a second portion of the outer surface, the first protrusion configured to contact the first switch when the first portion of the outer surface is manipulated, the second protrusion configured to contact the second switch when the second portion of the outer surface is manipulated.

20. The apparatus of claim 11, wherein:

the electronic circuit system is configured to produce the first recorded speech output for a predetermined time period; and

the electronic circuit system is configured to produce, in response to actuation of the first switch, a third recorded speech output after the predetermined time period has elapsed, the third recorded speech output different from the first recorded speech output.

21. The apparatus of claim 11, wherein the electronic circuit system is configured to produce at least one of the first recorded speech output or the second recorded speech output in a plurality of different languages.

22. The apparatus of claim 11, wherein the first protrusion is spaced apart from the second protrusion.

23. The apparatus of claim 11, wherein:

the electronic circuit system includes a printed circuit board, the first switch coupled to a first portion of the printed circuit board, the second switch coupled to a second portion of the printed circuit board, the second portion spaced apart from the first portion;

the first protrusion is configured to contact the first switch to actuate the first switch when the first protrusion is moved relative to the first housing, the second protrusion is configured to contact the second switch to actuate the second switch when the second protrusion is moved relative to the first housing; and

the audible output device is a speaker retained within an opening defined by the outer housing by a cover member, the cover member defining a plurality of sound openings.

24. An apparatus comprising:

a housing associated with an automatic injection device;

a movable member having a first end portion and a second end portion;

a non-electronic energy storage member disposed within the housing, the energy storage member configured to exert a force on the first end portion of the movable member to move the second end portion of the movable member within the housing;

an electronic circuit system including a printed circuit board, a first switch, a second switch, and an audible output device, the first switch coupled to a first portion of the printed circuit board, the second switch coupled to a second portion of the printed circuit board, the electronic circuit system coupled within the housing, the electronic circuit system configured to produce a first recorded speech output via the audible output device when the first switch is actuated, the electronic circuit system configured to produce a second recorded speech output via the audible output device when the second switch is actuated; and

an actuator assembly coupled to the housing, the actuator assembly including an outer surface and an inner surface, the inner surface including a first protrusion configured to move relative to the housing to actuate the first switch when a first portion of the outer surface is manipulated, the inner surface including a second protrusion configured to move relative to the housing to actuate the second switch when a second portion of the outer surface is manipulated.

25. The apparatus of claim 24, further comprising:

a cover configured to be coupled to the housing to retain the audible output device within an opening defined by the housing.

26. The apparatus of claim 24, wherein the housing iris an outer housing, the apparatus further comprising:

an inner housing disposed within the outer housing, the inner housing defining a passageway therein,

the second end portion of the movable member is configured to move from a first position to a second position within the passageway when the force is exerted on the first end portion of the movable member, the movable member and the inner housing being collectively configured to limit a distance between the first position and the second position.

27. The apparatus of claim 24, wherein the electronic circuit system is configured to produce a predetermined sequence of electronic outputs, the sequence including the first recorded speech output.

28. The apparatus of claim 24, wherein the electronic circuit system is configured to output the first recorded speech output for a predetermined time period, the electronic circuit system is configured to produce, in response to actuation of the first switch, a third recorded speech output after the predetermined time period has elapsed, the third recorded speech output different from the first recorded speech output.

29. The apparatus of claim 24, wherein first the recorded speech output is associated with an injection event associated with the automatic injection device.

30. The apparatus of claim 26, wherein the first portion of the outer surface is configured to be manipulated separately from the second portion of the outer surface, the first protrusion configured to contact the first switch when the first portion of the outer surface is manipulated, the second protrusion configured to contact the second switch when the second portion of the outer surface is manipulated.

31. The apparatus of claim 24, wherein:

the first protrusion is aligned with the first switch

the second protrusion is spaced apart from the first protrusion and is aligned with the second switch;

the audible output device is a speaker retained within an opening defined by the outer housing by a cover member, the cover member defining a plurality of sound openings.