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Last Updated: April 26, 2024

Details for Patent: 9,327,077


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Title:Medical injector with compliance tracking and monitoring
Abstract: A system includes a medicament delivery device and a container configured to receive at least a portion of the medicament delivery device. The medicament delivery device includes an actuator and a first electronic circuit system. The actuator is configured to initiate delivery of a medicament into a body when the actuator is moved from a first position to a second position. The first electronic circuit system is configured to output a first electronic signal when the actuator is moved from the first position to the second position. The container includes a second electronic circuit system configured to receive the first electronic signal. The second electronic circuit system is configured to output a second electronic signal associated with the first electronic signal.
Inventor(s): Edwards; Eric S. (Midlothian, VA), Edwards; Evan T. (Fredericksburg, VA), Licata; Mark J. (Doswell, VA), Meyers; Paul F. (Fishers, IN), Weinzierl; David A. (Andover, MN), Williamson, IV; T. Spencer (Richmond, VA)
Assignee: kaleo, Inc. (Richmond, VA)
Filing Date:Jul 17, 2012
Application Number:13/550,999
Claims:1. An apparatus, comprising: an electronics housing having a distal end surface defining an opening within which a non-delivery end portion of a medicament delivery device is removably received, the medicament delivery device including a medicament container and a container housing, a distal end portion of the container housing having a contact portion configured to contact a target location of a body during a medicament delivering event the electronics housing configured to be matingly coupled to the non-delivery end portion and to remain coupled to the medicament delivery device such that the medicament delivery device is actuated by moving the electronics housing relative to the contact portion to initiate movement of the medicament container within a proximal end portion of the container housing, the electronics housing configured to surround a perimeter of the non-delivery end portion and extend along only a portion of a length of the medicament delivery device such that the contact portion remains outside of the electronics housing before and during actuation of the medicament delivery device; and an electronic circuit system coupled to the electronics housing, the electronic circuit system including a circuit board, a processor, a switch, a light output device, and a wireless communication antenna, the switch coupled to the circuit board such that the switch remains spaced apart from the contact portion during actuation of the medicament delivery device, the electronic circuit system configured to produce a light output via the light output device in response to an electronic signal produced by the switch, the electronic circuit system configured to receive an actuation signal associated with the actuation of the medicament delivery device, the electronic circuit system configured to output, via the wireless communication antenna, a compliance signal associated with the actuation signal, the compliance signal being a short-range radio frequency signal including a time stamp associated with the actuation of the medicament delivery device.

2. The apparatus of claim 1, further comprising: a cover configured to be removably coupled about the distal end portion of the container housing to cover the contact portion, a portion of the cover configured to engage the switch such that the switch is moved from the first state to the a second state when the cover is removed from about the distal end portion of the container housing.

3. The apparatus of claim 1, wherein the electronic circuit system includes a speaker, the electronic circuit system configured to produce a recorded speech output via the speaker when the switch is changed from a first state to a second state.

4. The apparatus of claim 1, wherein the compliance signal has a frequency between approximately 2400 MHz and approximately 2480 MHz.

5. The apparatus of claim 1, wherein the compliance signal includes any of a unique identification of the electronics housing, an indicator associated with a validity of a medicament delivery event, or a location associated with the medicament delivery device.

6. The apparatus of claim 1, wherein the electronics housing includes a communication port configured to couple the electronic circuit system to any one of a battery charger or a remote computing device via a hard-wired connection.

7. The apparatus of claim 1, wherein t actuation signal is produced by the switch.

8. The apparatus of claim 1, wherein the actuation signal is produced by a pressure sensor.

9. The apparatus of claim 1, wherein: the actuation signal is a wireless signal produced by the medicament delivery device; and the wireless communication antenna of the electronic circuit system is configured to receive the actuation signal.

10. The apparatus of claim 1, wherein the electronic circuit system includes a battery, the electronic circuit system configured to produce an indication associated with a life of the battery.

11. The apparatus of claim 1, wherein the medicament delivery device is any one of an autoinjector, a pen injector or an inhaler.

12. The apparatus of claim 1, wherein the electronics housing includes a retention portion configured to matingly receive the non-delivery end portion of the medicament delivery device to maintain the non-delivery end portion of the medicament delivery device within the electronics housing when the medicament delivery device is actuated by manipulating the electronics housing.

13. The apparatus of claim 1, wherein: the medicament delivery device is a first medicament delivery device; and the electronics housing is configured to be removed from the first medicament delivery device such that a non-delivery end portion of a second medicament delivery device can be received within the opening of the electronics housing.

14. The apparatus of claim 1, wherein the switch includes any one of an irreversible switch, a reversible switch, a two-state switch, a switch having more than two states, or a sensor configured to produce the electronic signal.

15. The apparatus of claim 1, wherein the container housing is distinct from the electronics housing.

16. The apparatus of claim 1, wherein: the electronic signal is a first electronic signal transmitted to the processor; and the electronic circuit system includes a pressure sensor configured to transmit a second electronic signal to the processor in response to a pressure exerted on the pressure sensor.

17. An apparatus, comprising: an electronics housing including a retention portion configured to matingly receive a non-delivery end portion of a first medicament delivery device such that the non-delivery end portion remains fixed within the electronics housing during a medicament delivery event, the first medicament delivery device including a medicament container and a container housing, a delivery end portion of the first medicament delivery device including a contact member coupled to the container housing and configured to contact a target location of a body during the medicament delivery event, the electronics housing configured to extend along only a portion of the first medicament delivery device such that the contact member is outside of the electronics housing before and during the medicament delivery event, the electronics housing configured such that the first medicament delivery device is actuated by moving the electronics housing relative to the contact member to cause the medicament container to move within the container housing, the electronics housing configured to be removed from the first medicament delivery device such that the retention portion can matingly receive a non-delivery end portion of a second medicament delivery device; and an electronics circuit system coupled to the electronics housing, the electronic circuit system including at least one of a switch or a sensor, the electronic circuit system including a light output device and a wireless communications module, the at least one of the switch or the sensor positioned to remain physically separated from the contact member when the first medicament delivery device is actuated, the electronic circuit system configured to produce a light output via the light output device when the at least one of the switch or the sensor is changed from a first state to a second state, the electronic circuit system configured to output via the wireless communications module a compliance signal associated with the actuation of the first medicament delivery device, the compliance signal being a short-range radio frequency signal.

18. The apparatus of claim 17, wherein the electronics housing is configured to be disposed about the non-delivery end portion of the first medicament delivery device, the electronics housing configured to remain coupled to the first medicament delivery device when the first medicament delivery device is actuated.

19. The apparatus of claim 17, wherein the compliance signal has a frequency between approximately 2400 MHz and approximately 2480 MHz.

20. The apparatus of claim 17, wherein the first medicament delivery device is any one of an autoinjector, a pen injector or an inhaler.

21. The apparatus of claim 17, wherein the retention portion of the electronics housing defines an opening within which the non-delivery end portion of the first medicament delivery device is disposed.

22. The apparatus of claim 17, wherein the electronic circuit system includes a battery, the electronic circuit system configured to produce an indication associated with a life of the battery.

23. The apparatus of claim 17, wherein the electronics housing substantially surrounds the non-delivery end portion of the first medicament delivery device when the retention portion matingly receives the non-delivery end portion.

24. The apparatus of claim 17, wherein the electronics housing is distinct from the contact member.

25. The apparatus of claim 17, wherein the electronics housing is configured to surround a perimeter of the non-delivery end portion and extend along only the portion of the first medicament delivery device such that the contact member is spaced apart from the electronics housing.

26. The apparatus of claim 17, wherein the at least one of the switch or the sensor is configured to produce an electronic signal associated with at least one of a status of the first medicament delivery device within the electronics housing or the actuation of the first medicament delivery device.

27. The apparatus of claim 26, wherein: the at least one of the switch or the sensor is a pressure sensor configured to produce the electronic signal in response to a pressure exerted on the pressure sensor.

28. A method, comprising: disposing a non-delivery end portion of a first medicament delivery device into an opening defined by an electronics housing, the first medicament delivery device including a medicament container and a container housing, a delivery end portion of the first medicament delivery device including a contact member coupled to the container housing and configured to contact a target location of a body during a medicament delivery event, the disposing performed such that the contact member remains outside of the electronics housing before and during actuation of the first medicament delivery device, the electronics housing including an electronic circuit system, the electronic circuit system including at least one of a switch or a sensor coupled to the electronics housing such that the at least one of the switch or the sensor remains spaced apart from the contact member during actuation of the first medicament delivery device, the electronic circuit system including a light output device, and a wireless communications module, the electronic circuit system configured to produce a light output via the light output device when the at least one of the switch or the sensor produces an electronic signal; manipulating the electronics housing to cause the at least one of the switch or sensor to produce the electronic signal; actuating the first medicament delivery device by moving the electronics housing relative to the contact member causing the medicament container to move within the container housing, the electronic circuit system outputting, via the wireless communication module, a compliance signal, the compliance signal being a short-range radio frequency signal including a time stamp associated with the actuation of the first medicament delivery device; removing the end portion of the first medicament delivery device from the electronics housing; and disposing an end portion of a second medicament delivery device into the opening defined by the electronics housing.

29. The method of claim 28, wherein the compliance signal has a frequency between approximately 2400 MHz and approximately 2480 MHz.

30. The method of claim 28, wherein the first medicament delivery device is any one of an autoinjector, a pen injector or an inhaler.

31. The method of claim 28, further comprising: producing, from the electronic circuit system, a recorded speech output when the first medicament delivery device is actuated.

32. The method of claim 28, further comprising: producing, from the electronic circuit system, a light output when the first medicament delivery device is actuated.

33. The method of claim 28, wherein the compliance signal includes any of a unique identification of the electronics housing, an indicator associated with a validity of the medicament delivery event, or a location associated with the medicament delivery device.

34. The method of claim 28, further comprising: outputting via the electronic circuit system an indication associated with a life of a battery.

35. The method of claim 28, wherein the wireless communication module includes at least one of a microprocessor, a transmitter, a receiver, a transceiver, or a radio chipset.

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