Medical injector with compliance tracking and monitoring

• US 9,278,177 B2
• Filed: 03/23/2015
• Issued: 03/08/2016
• 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): SCHMIDT, EMILY LOUISE
• Application Number:
  US14/665,659
• Publication Number:
  US 20150196711A1
• Time in Patent Office: 351 Days
• 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:

a reusable injector housing defining an internal volume within which a medicament container assembly can be disposed, the medicament container assembly including at least a container housing, a medicament container and a needle, the medicament container and the needle being movably disposed within the container housing, the reusable injector housing including a retainer configured to matingly receive the medicament container assembly within the internal volume such that the container housing remains fixed within the reusable injector housing when the medicament container assembly is actuated, the reusable injector housing configured to actuate the medicament container assembly to initiate delivery of a medicament via the needle when the reusable injector housing is manipulated, the reusable injector housing configured such that the medicament container assembly can be removed from the internal volume of the reusable injector housing after delivery of the medicament; and

an electronic circuit system coupled to the reusable injector housing, the electronic circuit system configured to receive identification information from an identification mechanism of the medicament container assembly, the electronic circuit system configured to produce a first output associated with the identification information, the electronic circuit system configured to produce a second output in response to the actuation of the medicament container assembly.

2. The apparatus of claim 1, wherein:

the reusable injector housing includes an access member movably coupled to the reusable injector housing, the internal volume being accessible when the access member is in a first position, access to the internal volume being prevented when the access member is in a second position; and

the electronic circuit system is configured to produce a third output when the access member is moved from the first position to the second position.

3. The apparatus of claim 2, wherein:

the medicament container assembly is a first medicament container assembly;

the reusable injector housing is configured such that the first medicament container assembly can be removed from the internal volume of the reusable injector housing when the access member is in the first position; and

the retainer is configured to matingly receive a second medicament container assembly after the first medicament container assembly is removed from the internal volume of the reusable injector housing.

4. The apparatus of claim 1, wherein the reusable injector housing defines an opening through which a distal end portion of the medicament container assembly extends when the medicament container assembly is actuated, the distal end portion of the medicament container assembly including the needle, the needle configured to retract after delivery of the medicament from the medicament container assembly.

5. The apparatus of claim 1, wherein:

the needle is disposed within the container housing prior to actuation of the medicament container assembly; and

the reusable injector housing defines an opening, the needle being exposed outside of the opening in response to actuation of the medicament container assembly, the needle configured to retract after delivery of the medicament from the medicament container assembly.

6. The apparatus of claim 1, wherein the electronic circuit system includes a switch configured to detect when the medicament container assembly is within the internal volume, the identification information including a signal produced by the switch.

7. The apparatus of claim 1, wherein the electronic circuit system includes a light output device and a speaker, the first output being produced via at least one of the light output device or the speaker.

8. The apparatus of claim 1, wherein:

the identification mechanism of the medicament container assembly includes a radio frequency identification (RFID) tag; and

the electronic circuit system includes a switch and a receiver, the switch configured to detect when the medicament container assembly is within the internal volume, the receiver configured to receive a first signal from the RFID tag, the identification information including the first signal received from the RFID tag and a second signal produced by the switch.

9. The apparatus of claim 1, wherein the electronic circuit system includes a light output device, a speaker, and a temperature sensor, the electronic circuit system configured to produce a third output via at least one of the light output device or the speaker, the third output associated with a temperature of the medicament container assembly.

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

11. The apparatus of claim 1, wherein:

the medicament container assembly includes a needle sheath and a sheath remover, the needle sheath having an end portion disposed within the container housing such that the needle is disposed within a lumen defined by the needle sheath,

the sheath remover including a protrusion configured to exert a force against a shoulder of the needle sheath to remove the needle sheath from about the needle when the container housing is fixed within the reusable injector container.

12. The apparatus of claim 1, wherein:

the identification mechanism is coupled to an outer surface of the container housing;

the needle is disposed within the container housing prior to actuation of the medicament container assembly;

the reusable injector housing defines an opening, the needle being exposed outside of the opening in response to actuation of the medicament container assembly, the needle configured to retract after delivery of the medicament from the medicament container assembly; and

the electronic circuit system includes a light output device and a speaker coupled to the resusable injector housing, the first output being produced via at least one of the light output device or the speaker.

13. An apparatus, comprising:

an injector housing defining an internal volume within which a first medicament container assembly can be disposed, the first medicament container assembly including at least a container housing, a medicament container and a needle, the injector housing including an access member coupled to the injector housing, the internal volume being accessible when the access member is in a first position relative to the injector housing, access to the internal volume being prevented when the access member is in a second position relative to the injector housing, the injector housing configured to actuate the first medicament container assembly to initiate delivery of a medicament via the needle when the injector housing is manipulated, the needle being disposed within the container housing when the first medicament container assembly is disposed into the internal volume and prior to actuation of the medicament container assembly, the injector housing configured to receive a second medicament container assembly after the first medicament container assembly, including the container housing, is removed from the internal volume of the injector housing; and

an electronic circuit system coupled to the injector housing, the electronic circuit system configured to receive identification information from an identification mechanism of the first medicament container assembly, the electronic circuit system configured to produce a first output when the access member is moved from the first position to the second position, the electronic circuit system configured to produce a second output associated with the identification information.

14. The apparatus of claim 13, wherein:

the injector housing defines an opening through which a distal end portion of the first medicament container assembly extends when the first medicament container assembly is actuated, the distal end portion of the first medicament container assembly including the needle, the needle being covered prior to actuation of the medicament container assembly, the needle configured to retract after delivery of the medicament from the medicament container assembly.

15. The apparatus of claim 13, wherein the electronic circuit system includes a light output device and a speaker, at least one of the first output or the second output being produced via at least one of the light output device or the speaker.

16. The apparatus of claim 13, wherein:

the identification mechanism is coupled to an outer surface of the container housing; and

the electronic circuit system includes a switch configured to detect when the first medicament container assembly is within the internal volume, the identification information including a signal produced by the switch.

17. The apparatus of claim 13, wherein:

the medicament container assembly includes a needle sheath and a sheath remover, the needle sheath having an end portion disposed within the container housing such that the needle is disposed within a lumen defined by the needle sheath,

the sheath remover including a protrusion configured to exert a force against a shoulder of the needle sheath to remove the needle sheath from about the needle when the container housing is within the injector housing.

18. An apparatus, comprising:

an injector housing defining an internal volume;

a medicament container assembly matingly disposed within the internal volume, the medicament container assembly including a container housing, a needle sheath, a sheath remover a prefilled medicament container, and a needle, the needle sheath having an end portion disposed within the container housing such that the needle is disposed within the container housing and a lumen defined by the needle sheath when the medicament container assembly is disposed into the internal volume, the sheath remover including a protrusion configured to exert a force against a shoulder of the needle sheath to remove the needle sheath from about the needle when the container housing is within the internal volume of the injector housing, the container housing including an identification mechanism, the injector housing configured to actuate the medicament container assembly to initiate delivery of a medicament when the injector housing is manipulated; and

an electronic circuit system coupled to the injector housing, the electronic circuit system including a light output device and a speaker, the electronic circuit system configured to receive identification information from the identification mechanism, the electronic circuit system configured to produce a first output via at least one of the light output device or the speaker, the first output associated with the identification information, the electronic circuit system configured to produce a second output via at least one of the light output device or the speaker, the second output in response to the actuation of the medicament container assembly.

19. The apparatus of claim 18, wherein the electronic circuit system is configured to produce a recorded speech output by the speaker indicating that the temperature of the medicament container assembly is below a threshold temperature.

20. The apparatus of claim 18, wherein:

the electronic circuit system includes a switch configured to produce a signal when contacted by the medicament container assembly, the signal indicating the presence of the medicament container assembly within the injector housing, the electronic circuit system configured to produce a third output via at least one of the light output device or the speaker, the third output associated with the signal.

21. The apparatus of claim 18, wherein:

the medicament container assembly is a first medicament container assembly;

the injector housing including an access member coupled to the injector housing, the internal volume being accessible when the access member is in a first position relative to the injector housing to allow removal of the first medicament container assembly, access to the internal volume being prevented when the access member is in a second position relative to the injector housing, the injector housing configured to receive a second medicament container assembly after the first medicament container assembly is removed from the internal volume of the injector housing; and

the electronic circuit system is configured to produce a third output when the access member is moved from the first position to the second position.

22. The apparatus of claim 18, wherein:

the injector housing defines an opening through which a distal end portion of the medicament container assembly extends when the medicament container assembly is actuated, the distal end portion of the medicament container assembly including the needle, the needle being covered prior to actuation of the medicament container assembly, the needle configured to retract after delivery of the medicament from the medicament container assembly.

23. A method, comprising:

disposing a first medicament container assembly into an internal volume defined by an injector housing, the first medicament container assembly including a container housing, a medicament container and a needle coupled to a distal end portion of the medicament container, the needle being disposed within the container housing before and during the disposing, the injector housing including an electronic circuit system, the electronic circuit system including a switch and a light output device, the electronic circuit system configured to produce a first output via the light output device when the switch is actuated;

manipulating the injector housing at a first time to actuate the switch;

initiating delivery of a medicament from the first medicament container assembly after the disposing, the needle being exposed during delivery of the medicament, the needle configured to retract after delivery of the medicament, the electronic circuit system producing a second output via the light output device in response to delivery of the medicament;

removing the first medicament container assembly from the injector housing after delivery of the medicament and with the needle being disposed within the container housing; and

disposing a second medicament container assembly into the internal volume defined by the injector housing.

24. The method of claim 23, wherein the initiating includes manipulating an actuator coupled to the injector housing.

25. The method of claim 23, wherein the disposing the first medicament container assembly into the internal volume is performed such that electronic circuit system receives identification information from an identification mechanism of the first medicament container assembly, the electronic circuit system is configured to produce a third output associated with the identification information.

26. The method of claim 23, wherein the electronic circuit system includes a temperature sensor, the electronic circuit system configured to produce a third output associated with a temperature of the first medicament container assembly.

27. The method of claim 23, wherein:

the disposing the first medicament container assembly into the internal volume includes moving an access member coupled to the injector housing to expose the internal volume; and

the manipulating the injector housing at the first time includes moving the access member to prevent access to the internal volume.

28. The method of claim 23, wherein the electronic circuit system includes a battery, the method further comprising:

producing an indication associated with a life of the battery.

29. The method of claim 23, wherein the initiating delivery of the medicament includes placing a contact surface against a target location, the electronic circuit system producing a third output when the contact surface is placed against the target location.