Medical injector with compliance tracking and monitoring

• US 10,105,489 B2
• Filed: 04/27/2016
• Issued: 10/23/2018
• Est. Priority Date: 02/01/2005
• Status: Expired due to Fees

• 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, IV, T. Spencer
• Primary Examiner(s): Schmidt, Emily
• Application Number:
  US15/139,826
• Publication Number:
  US 20160235916A1
• Time in Patent Office: 909 Days
• 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. A method, comprising:

manipulating an actuator coupled to a medical injector such that a first portion of the actuator initiates delivery of a medicament from a medicament container that is at least partially disposed within a container housing of the medical injector via a needle configured to penetrate skin and a second portion of the actuator moves at least one of a switch or a sensor of an electronic circuit system coupled to the medical injector; and

outputting, from the electronic circuit system, an electronic signal in response to the moving one of the switch or the sensor, the electronic signal being a short-range radio frequency signal.

2. The method of claim 1, wherein the medical injector is any one of an autoinjector or a pen injector.

3. The method of claim 1, wherein:

the electronic signal is a first electronic signal; and

the electronic circuit system includes a processor and a pressure sensor configured to transmit a second electronic signal to the processor in response to a pressure exerted on the pressure sensor.

4. The method of claim 1, wherein the manipulating the actuator causes the first portion of the actuator and the second portion of the actuator to move together.

5. The method of claim 1, wherein the manipulating the actuator causes an energy storage member to produce a force that moves an elastomeric member within the medicament container to deliver the medicament.

6. The method of claim 1, wherein:

the switch is a reversible switch; and

the manipulating the actuator causes the second portion of the actuator to move the switch.

7. An apparatus, comprising:

a medical injector including a medicament container, a housing configured to receive the medicament container, a needle configured to be placed in fluid communication with the medicament container, and an actuator movably coupled to the housing, the medical injector configured to be actuated by moving a first portion of the actuator relative to the housing; and

an electronic circuit system coupled to the medical injector, the electronic circuit system including at least one of a switch or a sensor and a wireless communications module, the electronic circuit system configured to produce a first output when the at least one of the switch or the sensor is moved from a first state to a second state, the at least one of the switch or the sensor moved from the first state to the second state by movement of a second portion of the actuator, the second portion of the actuator configured to move when the first portion of the actuator is moved, the electronic circuit system configured to output, via the wireless communication module, a compliance signal associated with the actuation of the medical injector, the compliance signal being a short-range radio frequency signal.

8. The apparatus of claim 7, wherein the medical injector is any one of an autoinjector or a pen injector.

9. The apparatus of claim 7, wherein the wireless communications module is implemented at least in part in hardware, the wireless communications module configured to send one or more electronic signals to a plurality of communication devices via a wireless communications network.

10. The apparatus of claim 7, wherein the wireless communications module is implemented at least in part in hardware and includes at least one of a microprocessor, a transmitter, a receiver, a transceiver, a microchip, a radio chipset, a wireless interface card (WIC), a host controller interface (HCI), a universal asynchronous receiver or transmitter (UART), a power source, a sensor, a transponder, an antenna, a crystal, a circuit board, a liquid crystal display (LCD), a Small Computer System Interface (SCSI), a FireWire, a data uplink, a data downlink, a point-to-point link, a fiber optic link, a storage device, a personal computer card, a docking station, a parallel and/or bit-serial connection, a Universal Serial Bus (USB) port, a light emitting diode, a speaker, an amplifier, or a radiofrequency identification device (RFID).

11. The apparatus of claim 7, wherein the wireless communications module is implemented at least in part in hardware and includes a single chip containing components used for wireless communication.

12. The apparatus of claim 7, wherein the compliance signal includes a time stamp associated with the actuation of the medical injector.

13. The apparatus of claim 7, wherein:

the housing of the medical injector defines an internal volume within which the medicament container is received; and

the electronic circuit system is coupled to the medical injector such that the at least one of the switch or the sensor is outside of the internal volume.

14. The apparatus of claim 13, wherein the second portion of the actuator engages the at least one of the switch or the sensor to move the at least one of the switch or the sensor from the first state to the second state.

15. The apparatus of claim 7, wherein movement of the first portion of the actuator causes an injection force to be exerted on an elastomeric member within the medicament container;

the injection force produced non-electronically.

16. The apparatus of claim 15, wherein the injection force is produced by any one of a spring or a pressurized gas.

17. A method of delivering a medicament from a medical injector, comprising:

removing a safety member from an end portion of a housing of the medical injector, the medical injector including a medicament container, a needle configured to be placed in fluid communication with the medicament container, an actuator, and an electronic circuit system coupled to the housing, the needle configured to penetrate skin, the safety member covering the needle before the removing; and

manipulating the actuator to cause;

a first portion of the actuator to move to initiate delivery of the medicament from the medicament container via the needle; and

a second portion of the actuator to move one of a switch or a sensor of the electronic circuit system, the electronic circuit system producing a short-range radio frequency signal in response to the second portion of the actuator moving one of the switch or the sensor.

18. The method of claim 17, wherein the manipulating the actuator causes the first portion of the actuator and the second portion of the actuator to move together.

19. The method of claim 17, wherein movement of the first portion of the actuator causes an energy storage member to produce a force that moves an elastomeric member within the medicament container to deliver the medicament.

20. The method of claim 17, wherein:

the electronic circuit system includes at least one of a light output device or an audible output device; and

the electronic circuit system produces at least one of a light output via the light output device or an audible output via the audible output device in response to any one the removing a safety member or the second portion of the actuator engaging one of the switch or the sensor.

21. The method of claim 17, wherein the medical injector is an auto-injector containing a dose of epinephrine.