DEVICES, SYSTEMS, AND METHODS FOR MEDICAMENT DELIVERY

• US 20170312433A1
• Filed: 07/17/2017
• Published: 11/02/2017
• 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.
• Granted Patent: US 10,835,673 B2
• Time in Patent Office: 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. A method of training a user in the operation of a medical injector, the method comprising:

activating an electronic circuit system to output a recorded speech output, the electronic circuit system coupled to a housing associated with the medical injector, the recorded speech output associated with a first instruction;

removing a safety lock from the housing, the safety lock configured to limit movement of a base when the safety lock is coupled to the housing, a first switch of the electronic circuit system being actuated when the safety lock is removed, the electronic circuit system producing a second instruction when the first switch is actuated;

placing, after the removing the safety lock, the base against a target location; and

moving, after the placing, the base from a first position to a second position relative to the housing, a portion of the base actuating a second switch of the electronic circuit system when the base is moved to the second position, the electronic circuit system producing a third instruction when the second switch is actuated.

2. The method of claim 1, wherein:

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

the moving the base is performed independently from the manipulating the button.

3. The method of claim 1, wherein:

the recorded speech output is a first recorded speech output; and

the second instruction includes a second recorded speech output that identifies the base coupled to the housing and the target location.

4. The method of training the user in the operation of the medical injector of claim 1, wherein:

the base includes a protrusion configured to retain the base in the second position; and

the safety lock includes a protrusion that separates the base from the housing to limit movement of the base when the safety lock is coupled to the housing.

5. The method of training the user in the operation of the medical injector of claim 1, wherein:

the medical injector is an epinephrine autoinjector.

6. An apparatus, comprising:

a housing associated with an automatic injection device;

an actuation member;

an energy storage member disposed within the housing, the energy storage member configured to exert a force on the actuation member to move the actuation member within the housing when the apparatus is transitioned from an initial configuration to an activated configuration;

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

a base configured to move relative to the housing between a first position and a second position, the base configured to manipulate the second switch when the base is transitioned from the first position and the second position; and

a safety lock removably coupled to the housing, a protrusion of the safety lock engaging the actuation member when the safety lock is coupled to the housing, the safety lock limiting movement of the base when the safety lock is coupled to the housing, the safety lock configured to manipulate the first switch of the electronic circuit system when the safety lock is removed from the housing.

7. The apparatus of claim 6, further comprising:

a status indicator configured to move between a first indicator position and a second indicator position, the status indicator being in the first indicator position when the apparatus is in the initial configuration, the status indicator being in the second indicator position when the apparatus is in the activated configuration, the status indicator including a visual indicia visible through a status window of the housing when in the second indicator position.

8. The apparatus of claim 6, 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; and

,

a plunger configured to move within the medicament container to expel the medicament from the medicament container when the apparatus transitioned to the activated configuration.

9. The apparatus of claim 6, wherein:

the base includes a surface configured to be placed against a target location, and the base includes a protrusion configured to engage the second switch when the base is transitioned from the first position to the second position.

10. The apparatus of claim 6, wherein:

the base is movably coupled to a distal end portion of the housing, the base including a surface configured to be pressed against a target location to move the base from the first position to the second position,

the first recorded speech output identifying the base and instructing a user to place the base against the target location.

11. The apparatus of claim 6, wherein:

the first recorded speech output is different from the second recorded speech output.

12. The apparatus of claim 6, wherein the base includes a protrusion configured to retain the base in the second position.

13. The apparatus of claim 6, wherein:

the apparatus is a training device; and

the electronic circuit system is configured to repeat at least one of the first recorded speech output or the second recorded speech output.

14. An apparatus, comprising:

a housing associated with a medical injector;

a movable member disposed within the housing, the movable member configured to move within the housing when the apparatus is transitioned from an initial configuration to an activated configuration;

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

a base configured to move relative to the housing between a first position and a second position, the base configured to actuate the second switch when the base is moved to the second position; and

a safety lock removably coupled to the housing, a protrusion of the safety lock engaging the movable member when the safety lock is coupled to the housing, the safety lock limiting movement of the base when the safety lock is coupled to the housing, the safety lock configured to actuate the first switch when the safety lock is removed from the housing.

15. The apparatus of claim 14, wherein:

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

16. The apparatus of claim 14, wherein:

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

a portion of the base contacts the movable member when the base moves from the first position to the second position.

17. The apparatus of claim 14, wherein:

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

18. The apparatus of claim 14, wherein:

the base is movably coupled to a distal end portion of the housing, the base including a surface configured to be pressed against a target location to move the base from the first position to the second position,

the recorded speech output identifying the base and instructing a user to place the base against the target location.

19. The apparatus of claim 14, wherein the base includes a protrusion configured to retain the base in the second position.

20. The apparatus of claim 14, wherein:

the apparatus is a training device; and

the electronic circuit system is configured to repeat at least one of the first instruction or the second instruction.