Devices, systems, and methods for medicament delivery

• US 9,724,471 B2
• Filed: 04/03/2014
• Issued: 08/08/2017
• Est. Priority Date: 02/01/2005
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: Edwards, Evan T., Edwards, Eric S., Licata, Mark J.
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Snyder, Melissa A
• Application Number:
  US14/244,311
• Publication Number:
  US 20150011973A1
• Time in Patent Office: 1,223 Days
• 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 apparatus, comprising:

a housing associated with an automatic injection device, the housing defining a status window;

a contact member movably coupled to a distal end portion of the housing, the contact member including a surface configured to be placed against a target location;

a movable member disposed within the housing;

an energy storage member disposed within the housing, the energy storage member configured to exert a force on the movable member to move the movable member within the housing to transition the apparatus from an initial configuration to an activated configuration;

an electronic circuit system coupled to the housing, the electronic circuit system including a switch and a speaker, the electronic circuit system configured to produce a recorded speech output when the switch is manipulated; and

a use indicator configured to move within the housing along with the movable member between a first position and a second position, the use indicator configured to move from the first position to the second position when the contact member is in a fixed position relative to the housing, the use indicator providing a visual indication when the apparatus is in the activated configuration and the use indicator is in the second position.

2. The apparatus of claim 1, wherein:

the use indicator is in the first position when the apparatus is in the initial configuration, the use indicator being in the second position when the apparatus is in the activated configuration.

3. The apparatus of claim 1, wherein:

the use indicator exposes a colored portion indicating that the apparatus is in the activated configuration when the use indicator is in the second position.

4. The apparatus of claim 1, wherein the housing is the housing of an auto-injector, the apparatus further comprising:

a medicament container disposed within the housing, the medicament container including a medicament, the medicament being viewable through the status window when the apparatus is in the initial configuration,

the movable member configured to move within the medicament container to expel the medicament from the medicament container when the apparatus transitioned to the activated configuration.

5. The apparatus of claim 4, wherein:

the movable member is configured to expel the medicament via a needle in response to the force exerted by the energy storage member.

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

7. The apparatus of claim 1, wherein:

the movable member is piston; and

the use indicator is spaced apart from the piston.

8. The apparatus of claim 1, wherein

the recorded speech output identifies a location of the contact member and instructs a user to place the contact member against the target location.

9. The apparatus of claim 1, wherein the energy storage member is a non-electronic energy storage member and the contact member is configured to actuate the energy storage member when the contact member is moved relative to the housing, the apparatus further comprising:

a push button configured to actuate the electronic circuit system, the electronic circuit system configured to be actuated independently from the energy storage member.

10. The apparatus of claim 1, wherein:

the recorded speech output is a first recorded speech output;

the switch is a first switch; and

the electronic circuit system includes a second switch, the electronic circuit system configured to produce a second recorded speech output when the second switch is actuated, the first recorded speech output being different from the second recorded speech output.

11. An apparatus, comprising:

a housing associated with a medical injector, the housing defining a status window;

a container within the housing;

a movable member disposed within the housing, the movable member configured to receive a force to move a piston within the container from a first piston position to a second piston Position to transition the apparatus from an initial configuration to an activated configuration;

an electronic circuit system operably coupled to the housing, the electronic circuit system including a switch and an audible output device, the electronic circuit system configured to produce a plurality of recorded speech outputs associated with an injection event via the audible output device when the switch is actuated; and

a use indicator configured to move within the housing along with the movable member between a first indicator position and a second indicator position, the use indicator spaced apart from the piston, at least a portion of a contents of the container being viewable through the status window when the use indicator is in the first indicator position, the use indicator providing a visual indication when the piston is in the second piston position and the use indicator is in the second indicator position.

12. The apparatus of claim 11, wherein:

the use indicator is in the first indicator position when the apparatus is in the initial configuration, the use indicator is in the second indicator position when the apparatus is in the activated configuration.

13. The apparatus of claim 11, wherein:

the use indicator exposes a colored portion indicating that the apparatus is in the activated configuration when the use indicator is in the second indicator position.

14. The apparatus of claim 11, wherein:

the container is a medicament container including a medicament, at least a portion of the medicament being viewable through the status window when the apparatus is in the initial configuration.

15. The apparatus of claim 11, further comprising:

a contact member movably coupled to a distal end portion of the housing, the contact member including a surface configured to be placed against a target location,

the use indicator configured to move with the movable member between the first indicator position and the second indicator position independent from movement of the contact member relative to the housing.

16. The apparatus of claim 11, wherein:

the electronic circuit system is configured to produce a predetermined sequence of electronic outputs, the sequence including the plurality of recorded speech outputs.

17. The apparatus of claim 11, further comprising:

a contact member movably coupled to a distal end portion of the housing, the contact member including a surface configured to be placed against a target location,

the recorded speech output identifies a location of the contact member and instructs a user to place the contact member against the target location.

18. A method, comprising:

actuating an electronic circuit system to output a recorded speech output, the electronic circuit system coupled to a housing associated with a medical injector, the recorded speech output associated with an injection event;

placing a contact member against a target location, the contact member movably coupled to a distal end portion of the housing; and

actuating a non-electronic energy storage member within the housing to produce a force to move a movable member within the housing from a first position to a second position,

a use indicator moving along with the movable member, after the actuating the non-electronic energy storage member, from a first indicator position to a second indicator position within the housing, the use indicator moving from the first indicator position to the second indicator position when the contact member is in a fixed position relative to the housing, the use indicator providing a visual indication when the use indicator is in the second position.

19. The method of claim 18, wherein:

the actuating the non-electronic energy storage member includes actuating the non-electronic energy storage member to produce the force to move a needle from a first needle position to a second needle position, the needle fluidically coupled to a medicament container disposed within the housing.

20. The method of claim 18, wherein:

the actuating the electronic circuit system includes manipulating a button coupled to the housing; and

the actuating the non-electronic energy storage member includes manipulating an actuator coupled to an end portion of the housing, the manipulating the actuator being performed independently from the manipulating the button.

21. The method of claim 18, wherein the recorded speech output identifies a location of the contact member coupled to the housing and the target location.

22. The method of claim 18, wherein,

the movable member moves a piston when the movable member moves from the first position to the second position;

the placing includes moving the contact member relative to the housing; and

the use indicator is spaced apart from the piston.

23. The method of claim 18, wherein:

the movable member moves a piston within a container disposed within the housing when the movable member moves from the first position to the second position;

at least a portion of a contents of the container being viewable through a status window defined by the housing before the actuating the non-electronic energy storage member; and

the use indicator is spaced apart from the piston.

24. The method of claim 18, wherein the housing is associated with an auto-injector, the recorded speech output and the visual indication training a user in the operation of the auto-injector.