Medical injector with compliance tracking and monitoring

• US 9,327,077 B2
• Filed: 07/17/2012
• Issued: 05/03/2016
• 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., Weinzierl, David A., Williamson, T. Spencer IV
• Primary Examiner(s): Scmidt, Emily
• Application Number:
  US13/550,999
• Publication Number:
  US 20130184649A1
• Time in Patent Office: 1,386 Days
• Field of Search: 604/137, 604/890.1
• US Class Current: 1/1
• CPC Class Codes: A61M 15/0001 Details of inhalators; Constructional features thereof
• CPC Class Codes: A61M 15/008 Electronic counters
• 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 2005/2013 triggering of discharging means by contact of injector with patient body
• 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 2005/314 Flat shaped barrel forms, e.g. credit card shaped
• 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 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• 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 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• 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 2205/8206 : battery-operated
• 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 5/20 : Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• 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 5/2053 : 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: 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 5/315 : Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
• 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: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

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.

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.