IP Library Granted Patent US 10,105,489
Granted Patent B2
US 10,105,489 · App. 15/139,826 · Granted Oct 23, 2018

Medical injector with compliance tracking and monitoring

Inventors: Eric S. Edwards (Moseley, VA); Evan T. Edwards (Charlottesville, VA); Mark J. Licata (Doswell, VA); Paul F. Meyers (Fishers, IN); David A. Weinzierl (Andover, MN); T. Spencer Williamson, IV (Richmond, VA)
Assignee: kaleo, Inc.
A61M5/20A61M5/19A61M5/2033A61M5/2053A61M5/2448A61M5/315A61M5/326A61M15/0001A61M15/008A61M15/009G06F19/00G06F19/3468A61M5/24A61M5/3129A61M5/3204A61M2005/206A61M2005/2013A61M2005/2073A61M2005/314A61M2205/14A61M2205/3331A61M2205/3368A61M2205/3553A61M2205/3561A61M2205/3569A61M2205/3576A61M2205/3584A61M2205/3592A61M2205/43A61M2205/50A61M2205/502A61M2205/52A61M2205/581A61M2205/582A61M2205/583A61M2205/6018A61M2205/6036A61M2205/8206
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Quick Facts
Patent No.
US 10,105,489
App. No.
15/139,826
Granted
Oct 23, 2018
Kind
B2
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 (37)

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.

Assignments (8)
SECURITY INTEREST Recorded Aug 4, 2021
From: KALEO, INC.
To: U.S. BANK NATIONAL ASSOCIATION
Reel/Frame 057076/0316 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 27, 2016
From: MEYERS, PAUL F.
To: WORRELL, INC.
Reel/Frame 038398/0843 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 27, 2016
From: EDWARDS, ERIC S.; EDWARDS, EVAN T.; LICATA, MARK J.; WILLIAMSON, T. SPENCER, IV
To: INTELLIJECT, LLC
Reel/Frame 038398/0847 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 27, 2016
From: WORRELL, INC.
To: INTELLIJECT, LLC
Reel/Frame 038398/0855 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 27, 2016
From: WEINZIERL, DAVID A.
To: NORTH POLE ENGINEERING, INC.
Reel/Frame 038398/0859 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 27, 2016
From: NORTH POLE ENGINEERING, INC.
To: INTELLIJECT LLC
Reel/Frame 038398/0863 →
MERGER Recorded Apr 27, 2016
From: INTELLIJECT, LLC
To: INTELLIJECT, INC.
Reel/Frame 038398/0867 →
CHANGE OF NAME Recorded Apr 27, 2016
From: INTELLIJECT, INC.
To: KALEO, INC.
Reel/Frame 038543/0757 →
Continuity (10)
Continuation 13550999 · Jul 17, 2012
Continuation 12017405 · Jan 22, 2008
Continuation In Part 11671025 · Feb 5, 2007
Continuation In Part 11621236 · Jan 9, 2007
Continuation In Part 10572148
Provisional Application 60648822 · Feb 1, 2005
Provisional Application 60731886 · Oct 31, 2005
Provisional Application 60885969 · Jan 22, 2007
Provisional Application 60787046 · Mar 29, 2006
Related Publication 20160235916A1 · Aug 18, 2016
Cited By (11)
US 1,122,440 US 12,214,169 US 12,226,613 US 12,226,614 US 12,274,867 US 12,283,373 US 12,322,504 US 12,397,118 US 12,533,298 US 12,629,478 US 12,691,213