Medicine administering system including injection pen and companion device

• US 10,483,000 B2
• Filed: 04/30/2018
• Issued: 11/19/2019
• 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:
  US15/966,845
• Publication Number:
  US 20190035500A1
• Time in Patent Office: 568 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 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 operable to move translationally to cause the shaft to drive the plunger to dispense the medicine from the cartridge;

a sensor to detect a dispensed dose, 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 power source to provide electrical power to the electronics unit, and a transmitter; and

a mobile communication device including a software application program product stored in a memory of the mobile communication device and including instructions operable to cause the mobile communication device to process one or more of the dose data corresponding to one or more dispensing events to form a dose dispensing sequence such that the dispensing events of the dose dispensing 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 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 regardless of relative sizes of the dispensing events,

wherein the transmitter of the injection pen device is operable to wirelessly transmit the dose data to the mobile communication device.

2. 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 processor of the injection pen device to communicate the detected temperature.

3. The system of claim 2, wherein the dispensed dose includes an amount of medicine dispensed from the cartridge, and wherein the processor of the mobile communication device is operable to process the dose data to determine information about a user'"'"'s health associated with the amount of medicine dispensed from the injection p device, and wherein the mobile communication device transfers the information about the user'"'"'s health to the one or more cloud computers for inclusion in a medical record of the user.

4. The system of claim 1, wherein the medicine includes insulin, wherein the software application program product further includes instructions operable to generate a user interface that displays the dose data associated with dispensed insulin on the display of the mobile communication device.

5. The system of claim 4, wherein the software application program product further includes instructions operable to calculate a recommended dose of the insulin in a dose calculator module, and wherein the user interface further displays a user input prompt associated with a meal size that corresponds to a predetermined amount of carbohydrates that a user of the system can enter into the dose calculator module to calculate the recommended dose of insulin.

6. The system of claim 1, wherein the medicine includes insulin, wherein the injection pen device includes an insulin data management software application program product stored in the non-transitory memory of the electronics unit and including instructions operable to cause the injection pen device to receive glucose data associated with an external glucose monitor device or with a health information repository application, and wherein the insulin data management software application program product includes instructions operable to calculate a recommended dose of the insulin based at least in part on the glucose data and insulin dose data.

7. The system of claim 6, wherein the glucose data is received at the software application of the mobile communication device from a data transfer provided by a second software application resident on the mobile communication device, wherein the second software application is associated with the external glucose monitor device or is associated with the health information repository application.

8. The system of claim 1, wherein the sensor of the injection pen device includes an encoder, wherein the plunger includes a screw component, and wherein the encoder is operable to detect a replacement of the cartridge based on detecting a retraction of the screw component in an opposing direction from a direction to dispense the dose.

9. The system of claim 1, wherein the mobile communication device includes a global positioning system (GPS) to produce location data corresponding to the mobile communication device, and wherein the software application program product further includes instructions operable to process the location data of the mobile communication device when the dose data is received from the injection pen device that indicates an estimated location of the injection pen device.

10. The system of claim 9, wherein the software application program product further includes instructions operable to display the estimated location of the injection pen device on a map for a user of the system to locate the injection pen device.

11. The system of claim 1, wherein the software application program product further includes instructions stored thereon operable to cause the mobile communication device to generate a notification to a caregiver via one or both of a text message and an email indicative of the dose data.

12. The system of claim 1, wherein the injection pen device further includes a force sensor operable to detect an external force applied to a needle assembly of the injection pen device that indicates contact of the injection pen device with a user.

13. The system of claim 12, wherein the software application program product further includes instructions operable to cause the mobile communication device to process the detected external force signals to verify that the last dispensing event was the injection dose.

14. The system of claim 1, wherein the mobile communication device includes a camera operable to capture images, and wherein the software application program product further includes instructions operable to process a captured image of a bar code on the cartridge and determine an identification of the medicine in the cartridge.

15. The system of claim 1, wherein the software application program product further includes instructions operable to generate a user interface that displays a history of dispensed doses.

16. The system of claim 15, wherein the software application program product further includes instructions operable to display a user selection on the user interface that allows a user of the system to indicate whether a dispensed dose in the history of dispensed doses was a prime dose or an injection dose.

17. The system of claim 1, wherein the medicine includes insulin, and wherein the software application program product further includes instructions operable to calculate a total daily dose determined to be an average sum of all insulin delivered including long acting insulin and short acting insulin over the course of a day.

18. The system of claim 1, wherein the software application program product further 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 is a smartphone, a tablet, or a wearable computing device including a smartwatch or smartglasses, wherein the mobile communication device is in communication with one or more cloud computers networked in a communication network through the Internet.

20. The system of claim 1, wherein the injection pen device also includes a software application program product stored in the non-transitory memory of the injection pen device and including instructions operable to cause the injection pen device to process the one or more of the dose data to form the dose dispensing sequence such that the dispensing events of the dose dispensing sequence all occur in temporal proximity of one another that span less than the predetermined temporal threshold, and the last dispensing event in the dose dispensing sequence is identified as the injection event and the one or more of the dispensing events other than the last dispensing events in the dose dispensing sequence are identified as the priming events.

21. 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 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 plunger includes a screw component, 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 sensor includes an encoder,

a needle assembly to penetrate the skin of a user for dispensing the medicine,

an injection sensor operable to detect a signal indicative of proximity between the needle assembly and the user, 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 power source to provide electrical power to the electronics unit, and a transmitter; and

a mobile communication device including a software application program product stored in a memory of the mobile communication device and including instructions operable to cause the mobile communication device to process the dose data associated with the medicine dispensed from the injection pen device, and process the detected signal indicative of proximity to assign the detected dispensed dose as an injection dose,

wherein the transmitter of the injection pen device is operable to wirelessly transmit the dose data to the mobile communication device,

and wherein the encoder is operable to detect a replacement of the cartridge based on detecting a retraction of the screw component in an opposing direction from a direction to dispense the dose.

22. The system of claim 21, wherein the injection sensor includes a capacitive sensor.

23. The system of claim 21, wherein the mobile communication device includes a camera operable to capture images, and wherein the software application program product further includes instructions operable to process a captured image of a bar code on the cartridge and determine an identification of the medicine in the cartridge.

24. The system of claim 21, wherein the software application program product further includes instructions operable to generate a user interface that displays a history of dispensed doses.

25. The system of claim 24, wherein the software application program product further includes instructions operable to display a user selection on the user interface that allows a user of the system to indicate whether a dispensed dose in the history of dispensed doses was a prime dose or an injection dose.

26. The system of claim 21, wherein the medicine includes insulin, and wherein the software application program product further includes instructions operable to calculate a total daily dose determined to be an average sum of all insulin delivered including long acting insulin and short acting insulin over the course of a day.

27. The system of claim 21, wherein the mobile communication device includes a global positioning system (GPS) to produce location data corresponding to the mobile communication device, and wherein the software application program product further includes instructions operable to process the location data of the mobile communication device when the dose data is received from the injection pen device that indicates an estimated location of the injection pen device.

28. The system of claim 27, wherein the software application program product further includes instructions operable to display the estimated location of the injection pen device on a map for a user of the system to locate the injection pen device.

29. The system of claim 21, wherein the medicine includes insulin, wherein the software application program product further includes instructions operable to (i) generate a user interface that displays the dose data associated with dispensed insulin on the display of the mobile communication device, and (ii) to calculate a recommended dose of the insulin in a dose calculator module of the software application program product, and wherein the user interface further displays a user input prompt associated with a meal size that corresponds to a predetermined amount of carbohydrates that a user of the system can enter into the dose calculator module to calculate the recommended dose of insulin.

30. The system of claim 21, wherein the mobile communication device is operable to receive glucose data from an external glucose monitor device, wherein the glucose data is received at the software application from a data transfer provided by a second software application resident on the mobile communication device, wherein the second software application is associated with the external glucose monitor device or is associated with a health information repository application.

31. The system of claim 21, wherein the injection pen device also includes a software application program product stored in the non-transitory memory of the injection pen device and including instructions operable to cause the injection pen device to process the dose data associated with the medicine dispensed from the injection pen device, and process the detected signal indicative of proximity to assign the detected dispensed dose as the injection dose.