MEDICAL INJECTOR WITH COMPLIANCE TRACKING AND MONITORING

• US 20160235916A1
• Filed: 04/27/2016
• Published: 08/18/2016
• 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
• Granted Patent: US 10,105,489 B2
• Time in Patent Office: 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. A method, comprising:

manipulating an electronics housing coupled to a medicament delivery device such that a first portion of the electronics housing initiates delivery of a medicament from a medicament container that is at least partially disposed within a container housing of the medicament delivery device via a delivery member and a second portion of the electronics housing moves at least one of a switch or a sensor; and

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

2. The method of claim 1, wherein the medicament delivery device is any one of an autoinjector, a pen injector, a transdermal delivery system, or an inhaler.

3. The method of claim 1, wherein:

the electronic signal is a first electronic signal, the first electronic signal is transmitted to a 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.

4. An apparatus, comprising:

an electronics housing defining an opening within which a proximal end portion of a medicament delivery device is removably received, the electronics housing configured to be matingly coupled to the proximal end portion to remain coupled to the medicament delivery device such that the medicament delivery device is actuated by manipulating the electronics housing; and

an electronic circuit system coupled to the electronics housing, the electronic circuit system including at least one of a switch or a sensor coupled to the electronics housing, 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 switch or the sensor is changed from a first state to a second state, the electronic circuit system configured to receive an actuation signal associated with actuation of the medicament delivery device, the electronic circuit system configured to output, via the wireless communication module, 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.

5. The apparatus of claim 4, wherein the medicament delivery device is any one of an autoinjector, a pen injector, a transdermal delivery system, or an inhaler.

6. The apparatus of claim 4, 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 variety of communication devices via a wireless communications network.

7. The apparatus of claim 4, 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 (HCl), 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).

8. The apparatus of claim 4, wherein the wireless communications module is implemented at least in part in hardware and includes a single chip containing components used for wireless communication.

9. The apparatus of claim 4, wherein the wireless communications module includes a wireless access point.

10. The apparatus of claim 4, wherein the wireless communications module is implemented at least in part in hardware and is configured to employ a protocol for sending and receiving electronic signals.

11. The apparatus of claim 10, wherein the protocol is at least one of Wi-Fi, Bluetooth, Z₁gbee, Wi-Max, 802.XX, HomeRF, any protocol associated with Radio Frequency Identification (RFID) transmission.

12. An apparatus, comprising:

a medicament delivery device defining an internal volume within which a medicament container assembly can be disposed, the medicament container assembly including at least a medicament container and a delivery member, the medicament delivery device including a retainer configured to matingly receive the medicament container assembly within the internal volume, the medicament delivery device configured to actuate the medicament container assembly to initiate delivery of a medicament via the delivery member when the medicament delivery device is manipulated; and

an electronic circuit system coupled to the medicament delivery device, 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.

13. The apparatus of claim 12, wherein the medicament delivery device is any one of an autoinjector, a pen injector, a transdermal delivery system, or an inhaler.