Medical injector simulation device

• US 9,805,620 B2
• Filed: 01/09/2015
• Issued: 10/31/2017
• Est. Priority Date: 02/01/2005
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: Edwards, Eric S., Edwards, Evan T., Licata, Mark J., Meyers, Paul F., Williamson, T. Spencer, Worrell, Kai R., Weinzierl, David A.
• Primary Examiner(s): Thai, Xuan
• Assistant Examiner(s): Zaman, Sadaruz
• Application Number:
  US14/593,630
• Publication Number:
  US 20150302779A1
• Time in Patent Office: 1,026 Days
• Field of Search: 604 65- 67, 604503-505, 6048901-8921, 604137, 434262
• 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 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• 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 5/2053 Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• 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: G06Q 10/00 Administration; Management
• CPC Class Codes: G09B 23/285 for injections, endoscopy, bronchoscopy, sigmoidscopy, insertion of contraceptive devices or enemas

Abstract

An apparatus includes a simulated medicament delivery device and an electronic circuit system coupled to the simulated medicament delivery device. The electronic circuit system is configured to output an electronic output associated with a use of the simulated medicament delivery device.

Claims

1. A simulated auto-injector configured to simulate an operation of an actual auto-injector, the simulated auto-injector devoid of at least one of any medicament or any needle such that the simulated auto-injector is incapable of delivering the medicament, the simulated auto-injector comprising:

a housing, a distal end portion of the housing including a retention portion;

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 an audible output via the speaker when the switch is moved from a first state to a second state; and

an actuator coupled to the distal end portion of the housing, the actuator configured to move relative to the housing from a first actuator position to a second actuator position to simulate actuation of the actual auto-injector, the actuator including a protrusion configured to move the switch from the first state to the second state when the actuator is moved from the first actuator position to the second actuator position, the actuator including a retainer configured to engage the retention portion of the housing to maintain the actuator in the second actuator position, the actuator configured to be reset back to the first actuator position to repeatedly simulate the operation of the actual auto-injector.

2. The simulated auto-injector of claim 1, wherein the simulated auto-injector is devoid of a medicament delivery mechanism such that the simulated auto-injector is incapable of delivering the medicament.

3. The simulated auto-injector of claim 1, wherein the audible output is a first audible output, the simulated auto-injector further comprising:

a cover member movably coupled to the housing, a first portion of the cover member disposed within the housing and in contact with the electronic circuit system when the cover member is in a first cover position, a second portion of the cover member disposed about a portion of the actuator when the cover member is in the first cover position, the first portion spaced apart from the electronic circuit system and the second portion spaced apart from the actuator when the cover member is in a second cover position, the first portion configured to actuate the electronic circuit system when the cover member is moved from the first cover position to the second cover position,

the electronic circuit system configured to produce a second audible output when the electronic circuit system is actuated by the first portion of the cover member.

4. The simulated auto-injector of claim 3, wherein:

the electronic circuit system includes a processor, a power source, and an electrical contact configured to electrically couple the power source to the processor; and

the first portion of the cover member is disposed between a terminal of the power source and the electrical contact when the cover member is in the first cover position, the first portion being spaced apart from the terminal of the power source to electrically couple the processor to the power source when the cover member is in the second cover position.

5. The simulated auto-injector of claim 1, wherein:

the audible output is a recorded speech output; and

the electronic circuit system includes a visual output device, the electronic circuit system configured to produce a visual output via the visual output device when the switch is moved from the first state to the second state.

6. The simulated auto-injector of claim 1, wherein the switch is a first switch, the audible output is a first audible output, the simulated auto-injector further comprising:

a simulated needle guard removably coupled to the distal end portion of the housing, the simulated needle guard including a simulated needle sheath disposed through an opening defined by the actuator and within the housing when the simulated needle guard is coupled to the distal end portion of the housing, the simulated needle guard including a needle guard protrusion configured to actuate a second switch of the electronic circuit system when the simulated needle guard is removed from the distal end portion of the housing,

the electronic circuit system configured to produce a second audible output when the second switch is actuated.

7. The simulated auto-injector of claim 1, wherein the switch is a first switch, the audible output is a first recorded speech output, the simulated auto-injector further comprising:

a lock member removably coupled to the distal end portion of the housing, a first protrusion of the lock member configured to engage the actuator to limit movement of the actuator relative to the housing, a second protrusion of the lock member configured to actuate a second switch of the electronic circuit system when the lock member is removed from the distal end portion of the housing,

the electronic circuit system configured to produce a second audible output when the second switch is actuated.

8. The simulated auto-injector of claim 1, wherein the audible output is a characteristic sound produced during actuation of the actual auto-injector.

9. The simulated auto-injector of claim 1, wherein the electronic circuit system includes a network communication interface configured to transmit a wireless signal to a remote computing device, the wireless signal associated with a use of the simulated auto-injector.

10. An apparatus, comprising:

a housing of a simulated auto-injector, the simulated auto-injector configured to simulate an operation of an actual auto-injector, the simulated auto-injector devoid of at least one of any medicament or any needle such that the simulated auto-injector is incapable of delivering the medicament;

an electronic circuit system coupled to the housing, the electronic circuit system including a speaker, the electronic circuit system configured to produce an audible output via the speaker when the electronic circuit system is actuated;

an actuator coupled to a distal end portion of the housing, the actuator configured to move relative to the housing to simulate actuation of the actual auto-injector; and

a cover member movably coupled to the distal end portion of the housing, a first portion of the cover member disposed within the housing and in contact with the electronic circuit system when the cover member is in a first position, a second portion of the cover member disposed about a portion of the actuator when the cover member is in the first position, the first portion spaced apart from the electronic circuit system and the second portion spaced apart from the actuator when the cover member is in a second position, the first portion configured to actuate the electronic circuit system when the cover member is moved from the first position to the second position.

11. The apparatus of claim 10, wherein the simulated auto-injector is configured to repeatedly simulate the operation of the actual auto-injector.

12. The apparatus of claim 10, wherein the simulated auto-injector is devoid of a medicament delivery mechanism such that the simulated auto-injector is incapable of delivering the medicament, the simulated auto-injector configured to repeatedly simulate the operation of the actual auto-injector.

13. The apparatus of claim 10, wherein:

the electronic circuit system includes a processor, a power source, and an electrical contact configured to electrically couple the power source to the processor; and

the first portion of the cover member is disposed between a terminal of the power source and the electrical contact when the cover member is in the first position, the first portion being spaced apart from the terminal of the power source to electrically couple the processor to the power source when the cover member is in the second position.

14. The apparatus of claim 10, wherein:

the audible output is a first recorded speech output;

the electronic circuit system includes a switch, the electronic circuit system configured to produce a second recorded speech output when the switch is moved from a first state to a second state; and

the actuator includes a protrusion configured to move the switch from the first state to the second state when the actuator is moved relative to the housing to simulate actuation of the actual auto-injector.

15. The apparatus of claim 14, wherein the switch is configured to move repeatedly between the first state and the second state, the electronic circuit system configured to be reset when the switch moves from the second state to the first state.

16. The apparatus of claim 10, wherein:

the cover member is a simulated needle guard coupled to the distal end portion of the housing, the simulated needle guard including a simulated needle sheath disposed through an opening defined by the actuator and within the housing when the simulated needle guard is in the first position.

17. The apparatus of claim 10, wherein:

the distal end portion of the housing includes a retention portion; and

the actuator is configured to move relative to the housing from a first actuator position to a second actuator position to simulate actuation of the actual auto-injector, the actuator including a retainer configured to engage the retention portion of the housing to maintain the actuator in the second actuator position, the actuator configured to be reset back to the first actuator position to repeatedly simulate the operation of the actual auto-injector.

18. The apparatus of claim 10, wherein:

the audible output is a recorded speech output; and

the electronic circuit system includes a visual output device, the electronic circuit system configured to produce a visual output via the visual output device when the electronic circuit system is actuated, the recorded speech output and the visual output collectively identifying the actuator.

19. The apparatus of claim 10, wherein the audible output is a first recorded speech output, the electronic circuit system includes a switch, the electronic circuit system configured to produce a second recorded speech output when the switch is moved from a first state to a second state, the apparatus further comprising:

a lock member removably coupled to the distal end portion of the housing, a first protrusion of the lock member configured to engage the actuator to limit movement of the actuator relative to the housing, a second protrusion of the lock member configured to move the switch from the first state to the second state when the lock member is removed from the distal end portion of the housing.

20. The apparatus of claim 19, wherein the switch is configured to move repeatedly between the first state and the second state, the electronic circuit system configured to be reset when the switch moves from the second state to the first state.

21. A method, comprising:

removing a cover member from a distal end portion of a housing of a simulated auto-injector configured to simulate an operation of an actual auto-injector, the simulated auto-injector devoid of at least one of any medicament or any needle such that the simulated auto-injector is incapable of delivering the medicament, a first portion of the cover member disposed within the housing and in contact with an electronic circuit system of the simulated auto-injector before the removing, a second portion of the cover member disposed about a portion of an actuator coupled to the distal end portion of the simulated auto-injector before the removing, the first portion actuating the electronic circuit system when the cover member is removed such that the electronic circuit system produces a first audible output;

moving the actuator from a first actuator position to a second actuator position to simulate actuation of the actual auto-injector, a protrusion of the actuator moving a switch of the electronic circuit system from a first state to a second state when the actuator is moved from the first actuator position to the second actuator position, the electronic circuit system producing a second audible output when the switch is moved from the first state to the second state; and

resetting, after the moving, the simulated auto-injector such that the simulated auto-injector can repeatedly simulate the operation of the actual auto-injector.

22. The method of claim 21, wherein the simulated auto-injector is devoid of a medicament delivery mechanism such that the simulated auto-injector is incapable of delivering the medicament.

23. The method of claim 21, wherein the resetting includes resetting the electronic circuit system.

24. The method of claim 21, wherein:

the electronic circuit system includes a processor, a power source, and an electrical contact configured to electrically couple the power source to the processor;

the first portion of the cover member is an isolation member disposed between a terminal of the power source and the electrical contact to electrically isolate the processor from the power source before the removing; and

the removing cover member includes removing the isolation member from between the terminal of the power source and the electrical contact to electrically couple the processor to the power source.

25. The method of claim 21, wherein the switch is a first switch, the method further comprising:

removing a lock member from the distal end portion of the housing, a first protrusion of the lock member in contact with the actuator to limit movement of the actuator relative to the housing when the lock member is coupled to the housing, a second protrusion of the lock member moving a second switch of the electronic circuit system from a first state to a second state when the lock member is removed, the electronic circuit system producing a third audible output when the second switch is moved from its first state to its second state.

26. The method of claim 21, wherein the cover member is a simulated needle guard, the simulated needle guard including a simulated needle sheath disposed through an opening defined by the actuator and within the housing when the simulated needle guard is coupled to the distal end portion of the housing.

27. The method of claim 21, wherein the second audible output is a characteristic sound produced during actuation of the actual auto-injector.

28. The method of claim 21, further comprising:

transmitting, from a network communication interface of the electronic circuit system, a wireless signal to a remote computing device, the wireless signal associated with a use of the simulated auto-injector.

29. The method of claim 21, wherein simulated auto-injector simulates the operation of an epinephrine auto-injector for delivery of a dose of epinephrine, the simulated auto-injector being devoid of a medicament delivery mechanism such that the simulated auto-injector is incapable of delivering the dose of epinephrine.