Medicine administering system including injection pen and companion device

• US 9,672,328 B2
• Filed: 07/10/2015
• Issued: 06/06/2017
• Est. Priority Date: 07/10/2014
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Companion Medical, Inc. (Medtronic Plc)
• Inventors: Benke, Jasper, Saint, Sean, Pryor, Jack, Holmquist, Arnold, McCluskey, Cory
• Primary Examiner(s): Hayman, Imani
• Assistant Examiner(s): SHAH, NILAY J
• Application Number:
  US14/797,044
• Publication Number:
  US 20160012205A1
• Time in Patent Office: 697 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 pen device, comprising;

a housing including a main body structured to include a chamber to encase a cartridge containing medicine when the cartridge is loaded in the chamber,

a dose setting and dispensing mechanism to set and dispense a particular dose of the medicine from the loaded cartridge, the dose setting and dispensing mechanism including a dose knob, a shaft, and a piston assembly including 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 unit to detect a dispensed dose based on one or both of positions or movements of the dose setting and dispensing mechanism, 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 processing 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 pen, wherein the mobile communication device includes a data processing unit including a processor to process the dose data and a memory to store or buffer the dose data, a display to present a user interface, and a wireless communications unit to wirelessly receive the dose data from the injection pen device, wherein the data processing unit includes a software application program product stored in the memory of the data processing unit of the mobile communication device and having instructions stored thereon and operable to cause the mobile communication device to perform operations, comprising;

processing one or more dose data corresponding to one or more dispensing events over a predetermined duration of time to form a dose dispensing sequence; and

determining a type of dispensing event as a priming event or an injection event for the one or more dose data in the dose dispensing sequence that includes detecting a rate at which the medicine is dispensed for each dispensing event, and upon a determination that the rate at which the medicine is dispensed is slower than a predetermined dispensing rate threshold, identifying the dispensing event as the priming event, and upon a determination that the dispensed rate is faster than the predetermined dispensing rate threshold, identifying the dispensing event as the injection event.

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

3. 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.

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

5. The system of claim 1, wherein the plunger of the injection pen device is operable to be moved by the shaft such that the plunger pushes against a piston of the cartridge to cause the piston to move a certain distance that is proportional to the set dose of the medicine to dispense the medicine from the cartridge.

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

7. The system of claim 6, wherein the plunger of the piston assembly includes a screw component contained within the bi-directional clutch shaft, and the piston assembly 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.

8. The system of claim 7, wherein the bi-directional clutch shaft of the injection pen 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.

9. The system of claim 1, wherein the sensor unit, the processor and the memory, and the transmitter of the injection pen 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.

10. The system of claim 9, wherein the housing compartment of the injection pen device includes a catch component operable to only couple the housing compartment to the dose knob when the dose setting and dispensing mechanism is being operated to dispense the dose.

11. The system of claim 1, wherein the transmitter of the injection pen device is operable to wirelessly transmit the dose data to the mobile communication device using a wireless transmission protocol.

12. 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.

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

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

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

16. The system of claim 1, wherein the data processing unit 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 pen 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.

17. The system of claim 1, wherein the injection pen device includes a software application program product stored in the memory of the processing unit of the injection pen device and having includes instructions stored thereon and operable to cause the injection pen device to perform operations to communicatively unbond the injection pen device from a first mobile communication device of a user to which the injection pen 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 processing unit of the injection pen device associated with the first mobile communication device when the pattern sequence is detected in the predetermined time frame.

18. The system of claim 1, wherein the software application program product stored in the memory of the data processing unit 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.

19. 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 data processing unit and identification of the medicine in the cartridge.

20. The system of claim 1, wherein the software application program product stored in the memory of the data processing unit 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.

21. The system of claim 20, wherein the maximum dose setting is generated by determining a dispensed dosage of the particular medicine for the particular user over an interval of time.

22. The system of claim 21, wherein the maximum dose setting alarm is generated by computing one or more of:

an average value of multiple dosage values, a standard deviation of multiple dosage values, or maximum value of multiple dosage values.

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

24. The system of claim 23, wherein the software application program product stored in the memory of the data processing unit of the mobile communication device includes instructions stored thereon operable to cause the mobile communication device to determine or set a glucagon dose.

25. The system of claim 23, wherein glucagon dose is set or determined in accordance with a glucagon factor and a rise in blood glucose level.

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