Medicament delivery device configured to produce wireless and audible outputs

• US 10,192,464 B2
• Filed: 01/06/2014
• Issued: 01/29/2019
• Est. Priority Date: 07/28/2008
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: Edwards, Eric S., Edwards, Evan T., Licata, Mark J., Meyers, Paul F., Weinzierl, David A.
• Primary Examiner(s): Lee, Brandy S
• Application Number:
  US14/148,268
• Publication Number:
  US 20140309616A1
• Time in Patent Office: 1,849 Days
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• 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 2205/43 making noise when used correctly
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2209/06 Packaging for specific medical equipment
• 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 5/3157 Means providing feedback signals when administration is completed A61M5/20 takes 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 5/5086 for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: G09B 23/285 for injections, endoscopy, bronchoscopy, sigmoidscopy, insertion of contraceptive devices or enemas
• CPC Class Codes: H04R 1/028 associated with devices performing functions other than acoustics, e.g. electric candles

Abstract

An apparatus includes a simulated medicament delivery device and an electronic circuit system. The simulated medicament delivery device includes a housing, and is devoid of a medicament delivery mechanism that causes a medicament to be delivered. The electronic circuit system is coupled to the housing and includes an audible output device and a cover. The housing of the medicament delivery device and the cover of the electronic circuit system collectively define an acoustic enclosure. The audible output device is configured to be disposed within the acoustic enclosure.

Claims

1. A method, comprising:

removing a distal end portion of a medical injector from within an outer case, the medical injector including a housing, an actuator, a locking member, and an electronic circuit system, the locking member in contact with the actuator to limit movement of the actuator when the locking member is in a first position, the electronic circuit system including an output device and a network interface device, the outer case including a protrusion disposed within the housing and in contact with the electronic circuit system when the distal end portion of the medical injector is within the outer case, the protrusion disposed outside of the housing when the distal end portion of the medical injector is outside of the outer case, the electronic circuit system producing a first output via the output device in response to the protrusion being spaced apart from the electronic circuit system when the distal end portion of the medical injector is removed from within the outer case,

moving the locking member from the first position to a second position, the locking member spaced apart from the actuator when the locking member is in the second position; and

moving the actuator to initiate delivery of a medicament from the medical injector, the electronic circuit system producing a second output via the output device in response to the moving the actuator, the network interface device transmitting a wireless signal to a remote device, the wireless signal associated with at least one of the moving the locking member or the moving the actuator.

2. The method of claim 1, wherein:

the medical injector includes a medicament container within the housing;

the output device is a speaker disposed within the housing; and

the protrusion actuates the electronic circuit system when the distal end portion of the medical injector is removed from the outer case to cause the electronic circuit system to produce the first output via the speaker.

3. The method of claim 1, wherein:

the medical injector includes a medicament container within the housing, the housing defining a status aperture aligned with the medicament container; and

the outer case surrounds the housing of the medical injector such that the status aperture is obstructed when the distal end portion of the medical injector is within the outer case, the medicament within the medicament container being visible via the status aperture after the removing the distal end portion of the medical injector from within the outer case.

4. The method of claim 1, wherein the medical injector includes a medicament container within the housing, the housing defining a status aperture aligned with the medicament container, the outer case surrounding the housing of the medical injector such that the status aperture is obstructed when the distal end portion of the medical injector is within the outer case, the method further comprising:

viewing, after the removing, the medicament via the status aperture.

5. The method of claim 1, wherein:

the medical injector includes a medicament container within the housing, a needle, and a needle sheath, the medicament container placed in fluid communication with the needle in response to the moving the actuator to initiate delivery of the medicament from the medical injector, the needle sheath disposed about the needle before the moving the actuator; and

the removing the distal end portion of the medical injector from within the outer case is performed while maintaining the needle sheath about the needle.

6. The method of claim 1, further comprising:

replacing the distal end portion of the medical injector inside the outer case.

7. The method of claim 1, wherein the first output is a recorded speech output indicating an expiration date of the medicament.

8. The method of claim 1, wherein:

the wireless signal is a first wireless signal;

the remote device is a cell phone; and

the network interface device is configured to receive a second wireless signal from the cell phone, the second wireless signal including information associated with the medical injector.

9. The method of claim 1, wherein the second output is a recorded speech output including a countdown timer.

10. The method of claim 1, wherein the second output is a recorded speech output providing a post-injection disposal procedure.

11. The method of claim 1, wherein the wireless signal is associated with the moving the actuator and includes information confirming that an injection operation is complete.

12. The method of claim 1, wherein the medical injector is an autoinjector and the medicament is epinephrine.

13. A method, comprising:

removing an end portion of a medical injector from within an outer case, the medical injector including a housing, a medicament container within the housing, a needle, a needle sheath, and an electronic circuit system, the needle sheath disposed about the needle to maintain the needle within a sterile field, the sterile field being maintained after the removing the end portion of the medical injector from within the outer case, the electronic circuit system including an output device and a network interface device, the electronic circuit system producing a first output via the output device in response to the removing the end portion of the medical injector from within the outer case;

removing a locking member from the medical injector to enable actuation of the medical injector, a first portion of the locking member coupled to the needle sheath such that the needle sheath is removed from about the needle when the locking member is removed, a second portion of the locking member engaging the electronic circuit system such that the electronic circuit system produces a second output via the output device in response to the removing the locking member; and

actuating the medical injector to initiate delivery of a medicament from the medicament container, the electronic circuit system producing a second output via the output device in response to the actuating, the network interface device transmitting a wireless signal to a remote device, the wireless signal associated with at least one of the removing the locking member or the actuating the medical injector.

14. The method of claim 13, wherein:

the output device is a speaker disposed within the housing of the medical injector; and

the outer case includes a protrusion disposed within the housing when the end portion of the medical injector is within the outer case, the protrusion actuating the electronic circuit system when the end portion of the medical injector is removed from within the outer case to cause the electronic circuit system to produce the first output via the output device.

15. The method of claim 13, wherein:

the housing of the medical injector defines a status aperture aligned with the medicament container; and

the outer case surrounds the housing of the medical injector such that the status aperture is obstructed when the end portion of the medical injector is within the outer case, the medicament within the medicament container being visible via the status aperture after the removing the end portion of the medical injector from within the outer case.

16. The method of claim 13, wherein:

the actuating includes moving an actuator coupled to the housing; and

the wireless signal is associated with the moving the actuator and includes information confirming that an injection operation is complete.

17. The method of claim 13, wherein the medical injector is an autoinjector and the medicament container contains epinephrine.

18. A method, comprising:

removing a distal end portion of a medical injector from within an outer case, the medical injector including an actuator, a locking member, and an electronic circuit system, the outer case covering the actuator when the distal end portion of the medical injector is within the outer case, a portion of the outer case engaging the electronic circuit system when the distal end portion of the medical injector is within the outer case, the portion of the outer case spaced apart from the electronic circuit system when the distal end portion of the medical injector is outside of the outer case, the locking member in contact with the actuator to limit movement of the actuator when the locking member is in a first position, the electronic circuit system including an output device and a network interface device, the electronic circuit system producing a first output via the output device in response to the portion of the outer case being spaced apart from the electronic circuit system by the removing the distal end portion of the medical injector from within the outer case;

moving the locking member from the first position to a second position, the locking member spaced apart from the actuator when the locking member is in the second position; and

moving the actuator to initiate delivery of a medicament from the medical injector, the electronic circuit system producing a second output via the output device in response to the moving the actuator, the network interface device transmitting a wireless signal to a remote device, the wireless signal associated with at least one of the moving the locking member or the moving the actuator.

19. The method of claim 18, wherein:

the medical injector includes a housing and a medicament container within the housing, the housing defining a status aperture aligned with the medicament container; and

the outer case surrounds the housing of the medical injector such that the status aperture is obstructed when the distal end portion of the medical injector is within the outer case, the medicament within the medicament container being visible via the status aperture after the removing the distal end portion of the medical injector from within the outer case.

20. The method of claim 18, wherein:

the wireless signal is a first wireless signal;

the remote device is a cell phone; and

the network interface device is configured to receive a second wireless signal from the cell phone, the second wireless signal including information associated with the medical injector.

21. The method of claim 18, wherein:

the medical injector includes a housing, a medicament container within the housing, a needle, and a needle sheath, the medicament container placed in fluid communication with the needle in response to the moving the actuator to deliver the medicament from the medical injector, the needle sheath disposed about the needle before the moving the actuator; and

the removing the distal end portion of the medical injector from within the outer case is performed while maintaining the needle sheath about the needle.

22. The method of claim 18, wherein the medical injector is an autoinjector and the medicament is epinephrine.

23. The method of claim 18, further comprising:

replacing the distal end portion of the medical injector inside the outer case.