Medicine administering system including injection pen and companion device

• US 9,959,391 B2
• Filed: 06/05/2017
• Issued: 05/01/2018
• Est. Priority Date: 07/10/2014
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Companion Medical, Inc. (Medtronic Plc)
• Inventors: Saint, Sean, Holmquist, Arnold, McCluskey, Cory, Pryor, Jack, Benke, Jasper
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US15/613,851
• Publication Number:
  US 20170270276A1
• Time in Patent Office: 330 Days
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/3126 Specific display means related to dosing
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 5/31525 Dosing burettes, pipettes B01L3/02
• CPC Class Codes: A61M 5/31528 by means of rotational movements, e.g. screw-thread mechanisms
• CPC Class Codes: A61M 5/31545 Setting modes for dosing
• CPC Class Codes: A61M 5/31565 Administration mechanisms, i.e. constructional features, modes of administering a dose dosing mechanisms for setting a dose A61M5/31533
• CPC Class Codes: A61M 5/31566 Means improving security or handling thereof
• CPC Class Codes: A61M 5/31568 Means keeping track of the total dose administered, e.g. since the cartridge was inserted
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: H04B 7/24 for communication between two or more posts wireless communication networks H04W
• CPC Class Codes: H04L 9/08 Key distribution or management, e.g. generation, sharing or updating, of cryptographic keys or passwords network architectures or network communication protocols for supporting key management in a packet data network H04L63/06
• CPC Class Codes: H04L 9/30 Public key, i.e. encryption algorithm being computationally infeasible to invert or user's encryption keys not requiring secrecy

Abstract

Methods, systems, and devices are disclosed for administering a medicament to a patient. In one aspect, a system includes an injection pen device in wireless communication with a mobile communication device. The injection pen device includes a housing including a chamber to encase a cartridge containing medicine, a dose setting and dispensing mechanism to set the mechanism to dispense a particular dose of the medicine from the loaded cartridge, a sensor unit to detect a dispensed dose based on positions and/or movements of the dose setting and dispensing mechanism, and an electronics unit in communication with the sensor unit to process the detected dispensed dose and time data associated with a dispensing event and to wirelessly transmit the dose data to a user'"'"'s device. The mobile communication device provides a software application to provide the user with health information using the processed dose data.

Claims

1. A system for administering a medicine to a patient, comprising:

an injection device, comprising;

a housing including a main body structured to include a chamber to encase a cartridge containing medicine upon loading of the cartridge in the chamber;

a dose setting and dispensing mechanism to set and dispense a particular dose of the medicine from the cartridge, the dose setting and dispensing mechanism including a dose knob, a shaft, and a plunger, wherein the dose knob is rotatable to cause the shaft to move to a position proportional to a set dose of the medicine, and wherein the dose knob is moveable to cause the shaft to drive the plunger to dispense the medicine from the cartridge;

a sensor to detect a dispensed dose, wherein the dispensed dose includes an amount of medicine dispensed from the cartridge, and

an electronics unit in communication with the sensor unit, the electronics unit including a processor and a non-transitory memory to process the detected dispensed dose and time data associated with a dispensing event to generate dose data, a transmitter to wirelessly transmit the dose data to a user device, and a power source to provide electrical power to the electronics unit; and

a mobile communication device in wireless communication with the injection device, wherein the mobile communication device includes a processor to process the dose data and a memory to store or buffer the dose data, a display, and a wireless communications unit to wirelessly receive the dose data from the injection device, wherein the processor includes a software application program product stored in the memory of the mobile communication device including instructions operable to cause the mobile communication device to perform operations comprising;

processing one or more dose data corresponding to one or more dispensing events to form a dose dispensing sequence, wherein

the dose dispensing sequence is formed such that the dispensing events of the dose disposing sequence all occur in temporal proximity of one another that span less than a predetermined temporal threshold, and

the last dispensing event in the dose dispensing sequence is always identified as the injection event and one or more of the dispensing events other than the last dispensing events in the dose dispensing sequence are identified as the priming events, wherein the injection device includes a software application program product stored in the memory of the processing unit of the injection device and includes instructions operable to cause the injection device to perform operations to communicatively unbond the injection device from the mobile communication device to which the injection device is communicatively bonded, comprising;

detecting a pattern sequence of operations of the dose setting and dispensing mechanism in a predetermined time frame; and

clearing encryption keys stored in the memory of the injection device associated with the mobile communication device when the pattern sequence is detected in the predetermined time frame.

2. The system of claim 1, wherein the predetermined temporal threshold is one of:

10 seconds or 30 seconds.

3. The system of claim 1, wherein the medicine includes insulin, or an infertility treatment drug.

4. The system of claim 1, wherein the time data includes a specific time of occurrence of the dispensing event, or a relative time associated with a beginning, a duration, or a conclusion of the dispensing event.

5. The system of claim 1, wherein the software application program product stored in the memory of the mobile communication device further includes instructions operable to receive a user verification input indicative of whether a dispensed dose corresponds to a priming event.

6. The system of claim 1, wherein the housing of the injection device further includes a detachable cap to cover an end of the injection device including a needle assembly to dispense the medicine received from the cartridge.

7. The system of claim 1, wherein the shaft of the injection device includes a bi-directional clutch shaft.

8. The system of claim 7, wherein the plunger includes a screw component contained within the bi-directional clutch shaft, and the dose setting and dispensing mechanism includes a nut component fixed to the main body of the housing, wherein movement of the bi-directional clutch shaft causes the screw component to rotate a screw within the nut component and extend out of the main body to push against the medicine cartridge.

9. The system of claim 1, wherein the transmitter of the injection device is operable to wirelessly transmit the dose data to the mobile communication device using a Bluetooth or Bluetooth Low Energy transmission protocol.

10. The system of claim 1, wherein the mobile communication device includes one or more of the following devices:

a smartphone, a tablet, a wearable computing device including a smartwatch or smartglasses, a computer including a laptop or a desktop computer, or one or more computers networked in a communication network through the Internet.

11. The system of claim 1, wherein the injection device further includes a temperature sensor operable to detect temperature at or near the medicine cartridge, the temperature sensor in communication with the processor of the injection device to communicate the detected temperature.

12. The system of claim 1, wherein the injection device further includes an operation sensor to detect when the dose setting and dispensing mechanism is being operated.

13. The system of claim 1, wherein the dose dispensing mechanism is a motorized mechanism.

14. The system of claim 1, wherein the processor of the mobile communication device is operable to process the dose data to determine information about a user'"'"'s health or a value of insulin on board (IOB), and wherein one or both of the injection device or the mobile communication device include a visual, auditory, or haptic signaling unit to produce an alert based on the processed dose data or an indication of the IOB.

15. The system of claim 1, wherein the software application program product stored in the memory of the mobile communication device includes instructions stored thereon operable to cause the mobile communication device to generate a drug confusion alert indicative of (a) a potential drug interaction or (b) an incorrect delivery of the drug in response to a comparison of a particular injection event with one or both of an electronic medical record or a physician order.

16. The system of claim 1, wherein the mobile communication device further includes a camera communicatively connected to the data processing unit of the mobile communication device, the camera to capture an image of a bar code on the cartridge to enable processing of the barcode data by the processor of the mobile communication device and identification of the medicine in the cartridge.

17. The system of claim 1, wherein the software application program product stored in the memory of the mobile communication device includes instructions stored thereon operable to cause the mobile communication device to generate a maximum dose setting alarm indicative that a maximum dosage of a particular medicine for a particular user has been reached.

18. The system of claim 1, wherein the medicine includes glucagon.

19. The system of claim 18, wherein the software application program product stored in the memory of the mobile communication device includes instructions stored thereon operable to cause the mobile communication device to determine or set a glucagon dose.

20. The system of claim 18, wherein glucagon dose is set or determined in accordance with a glucagon factor and a particular rise in blood glucose level.

21. The system of claim 1, wherein the medicine includes a pain treatment drug.

22. The system of claim 1, wherein the dose setting and dispensing mechanism includes a screw component, and

the injection device includes a software application program product stored in the memory of the injection device and includes instructions operable to detect a replacement of the cartridge based on detection of a movement of the screw component in a particular direction for more than a predetermined number of units.

23. The system of claim 1, wherein the injection device is a medicament pen device.

24. A system for administering a medicine to a patient, comprising:

an injection device, comprising;

a housing including a main body structured to include a chamber to encase a cartridge containing medicine upon loading of the cartridge in the chamber;

a dose setting and dispensing mechanism to set and dispense a particular dose of the medicine from the cartridge, the dose setting and dispensing mechanism including a dose knob, a shaft, and a plunger, wherein the dose knob is rotatable to cause the shaft to move to a position proportional to a set dose of the medicine, and wherein the dose knob is moveable to cause the shaft to drive the plunger to dispense the medicine from the cartridge;

a sensor to detect a dispensed dose, wherein the dispensed dose includes an amount of medicine dispensed from the cartridge, and

an electronics unit in communication with the sensor unit, the electronics unit including a processor and a non-transitory memory to process the detected dispensed dose and time data associated with a dispensing event to generate dose data, a transmitter to wirelessly transmit the dose data to a user device, and a power source to provide electrical power to the electronics unit; and

a mobile communication device in wireless communication with the injection device, wherein the mobile communication device includes a processor to process the dose data and a memory to store or buffer the dose data, a display, and a wireless communications unit to wirelessly receive the dose data from the injection device, wherein the processor includes a software application program product stored in the memory of the mobile communication device including instructions operable to cause the mobile communication device to perform operations comprising;

processing one or more dose data corresponding to one or more dispensing events to form a dose dispensing sequence, wherein

the dose dispensing sequence is formed such that the dispensing events of the dose disposing sequence all occur in temporal proximity of one another that span less than a predetermined temporal threshold, and

the last dispensing event in the dose dispensing sequence is always identified as the injection event and one or more of the dispensing events other than the last dispensing events in the dose dispensing sequence are identified as the priming events, wherein the shaft of the injection device includes a bi-directional clutch shaft and the bi-directional clutch shaft of the injection device includes a surface in contact with the main body housing or the nut component and capable of preventing rotation of the bi-directional clutch shaft when the dose knob is being rotated to set the dose.

25. A system for administering a medicine to a patient, comprising:

an injection device, comprising;

a housing including a main body structured to include a chamber to encase a cartridge containing medicine upon loading of the cartridge in the chamber;

a dose setting and dispensing mechanism to set and dispense a particular dose of the medicine from the cartridge, the dose setting and dispensing mechanism including a dose knob, a shaft, and a plunger, wherein the dose knob is rotatable to cause the shaft to move to a position proportional to a set dose of the medicine, and wherein the dose knob is moveable to cause the shaft to drive the plunger to dispense the medicine from the cartridge;

a sensor to detect a dispensed dose, wherein the dispensed dose includes an amount of medicine dispensed from the cartridge, and

an electronics unit in communication with the sensor unit, the electronics unit including a processor and a non-transitory memory to process the detected dispensed dose and time data associated with a dispensing event to generate dose data, a transmitter to wirelessly transmit the dose data to a user device, and a power source to provide electrical power to the electronics unit; and

a mobile communication device in wireless communication with the injection device, wherein the mobile communication device includes a processor to process the dose data and a memory to store or buffer the dose data, a display, and a wireless communications unit to wirelessly receive the dose data from the injection device, wherein the processor includes a software application program product stored in the memory of the mobile communication device including instructions operable to cause the mobile communication device to perform operations comprising;

processing one or more dose data corresponding to one or more dispensing events to form a dose dispensing sequence, wherein

the dose dispensing sequence is formed such that the dispensing events of the dose disposing sequence all occur in temporal proximity of one another that span less than a predetermined temporal threshold, and

the last dispensing event in the dose dispensing sequence is always identified as the injection event and one or more of the dispensing events other than the last dispensing events in the dose dispensing sequence are identified as the priming events, wherein the sensor unit, the processor and the memory, and the transmitter of the injection device are housed in a housing compartment located in the dose knob, wherein the housing compartment does not move with the rotation of the dose knob when the dose is being set by the dose setting and dispensing mechanism, and the housing compartment does move with the dose knob when the dose is being dispensed by the dose setting and dispensing mechanism.

26. A system for administering a medicine to a patient, comprising:

an injection device, comprising;

a housing including a main body structured to include a chamber to encase a cartridge containing medicine upon loading of the cartridge in the chamber;

a dose setting and dispensing mechanism to set and dispense a particular dose of the medicine from the cartridge, the dose setting and dispensing mechanism including a dose knob and a shaft, wherein the dose knob is rotatable to cause the shaft to move to set the particular dose of the medicine;

a sensor to detect a dispensed dose, wherein the dispensed dose includes an amount of medicine dispensed from the cartridge, and

an electronics unit in communication with the sensor unit, the electronics unit including a processor and a non-transitory memory to process the detected dispensed dose and time data associated with a dispensing event to generate dose data, a transmitter to wirelessly transmit the dose data to a user device, and a power source to provide electrical power to the electronics unit; and

a mobile communication device in wireless communication with the injection device, wherein the mobile communication device includes a processor to process the dose data and a memory to store or buffer the dose data, a display, and a wireless communications unit to wirelessly receive the dose data from the injection device, wherein the processor includes a software application program product stored in the memory of the mobile communication device including instructions operable to cause the mobile communication device to perform operations comprising;

processing one or more dose data corresponding to one or more dispensing events to form a dose dispensing sequence and to identify one of the dispensing events the dose dispensing sequence as the injection event and one or more of the dispensing event in the dose dispensing sequence as the priming events, wherein the injection device includes a software application program product stored in the memory of the processing unit of the injection device and includes instructions operable to cause the injection device to perform operations to communicatively unbond the injection device from the mobile communication device to which the injection device is communicatively bonded, comprising;

detecting a pattern sequence of operations of the dose setting and dispensing mechanism in a predetermined time frame; and

clearing encryption keys stored in the memory of the injection device associated with the mobile communication device when the pattern sequence is detected in the predetermined time frame.