MEDICINE ADMINISTERING SYSTEM INCLUDING INJECTION PEN AND COMPANION DEVICE

• US 20160012205A1
• Filed: 07/10/2015
• Published: 01/14/2016
• 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, McCluskey, Cory, Pryor, Jack, Benke, Jasper, Holmquist, Arnold
• Granted Patent: US 9,672,328 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 translationally moveable to cause the shaft to drive the plunger to push against the cartridge to dispense the medicine from the cartridge,

a sensor unit to detect a dispensed dose based on one or both of positions and 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 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'"'"'s 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 to the user, and a wireless communications unit to wirelessly receive the dose data from the injection pen device.

2. The system of claim 1, wherein the medicine includes insulin, an infertility treatment drug, or a pain 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, and/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 and 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 make contact against a moveable surface of the piston of the medicine cartridge.

8. The system of claim 7, wherein the bi-directional clutch shaft of the injection pen device includes a frictionous 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 of the injection pen device is operable to detect the set dose based on one or both of positions and movements of the dose setting and dispensing mechanism.

10. The system of claim 1, wherein the sensor unit and the data processing and communication unit 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.

11. The system of claim 10, 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.

12. 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 Bluetooth, a WiFi, or a ZigBee wireless transmission.

13. The system of claim 1, wherein the mobile communication device includes 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.

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

15. 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.

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

17. The system of claim 1, wherein the processing unit of the injection pen device or the mobile communication device includes a software application program product comprising a non-transitory computer-readable storage medium 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, wherein the determining includes assigning the last dispensing event in the dose dispensing sequence as the injection event and any previous dispensing events in the dose dispensing sequence as the priming events.

18. The system of claim 17, wherein the injection pen device further includes a sensor to detect external force signals applied to a needle assembly of the injection pen device that indicate contact of the injection pen device with the user, and wherein the software application program product further includes instructions to cause the mobile communication device to perform:

processing the detected external force signals to determine the presence of contact to the needle assembly with corresponding time information of the last dispensing event; and

determining the type of dispensing event of the last dispensing event is the injection dose if there was the presence of contact detected, or determining the type of dispensing event of the last dispensing event is the priming event if there was no presence of contact detected.

19. The system of claim 17, wherein the software application program product further includes instructions to cause the mobile communication device to perform:

if a single dispensing event occurs in the predetermined duration of time, identifying the single dispensing event as a priming event;

or

comparing the amount of the dispensed doses for each of the dispensing events in the dose dispensing sequence to a predetermined dose quantity threshold, and determining the type of dispensing event for a dispensed dose having its amount larger than the predetermined dose quantity threshold and the largest amongst the compared dispensing events as the injection event.

20. The system of claim 17, wherein the sensor unit is operable to detect a rate at which the medicine is dispensed from the cartridge, and wherein the software application program product further includes instructions to cause the mobile communication device to perform:

comparing the rate of the dispensed doses for each of the dispensing events in the dose dispensing sequence to a predetermined dispensing rate threshold, and determining the type of dispensing event for a dispensed dose having its detected rate slower than the predetermined dispensing rate threshold.

21. 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 the user'"'"'s health, and wherein one or both of the injection pen device and the mobile communication device include a visual, auditory, or haptic signaling unit to produce an alert based on the processed dose data.

22. The system of claim 1, wherein the injection pen device includes a software application program product comprising a non-transitory computer-readable storage medium stored in the memory of the processing unit of the injection pen device and having 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 the 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, wherein the pattern sequence includes setting the dose setting and dispensing mechanism to or greater than a first level and operating the dose setting and dispensing mechanism to dispense a dose;

initiating a count of the predetermined time frame when the dose setting and dispensing mechanism is set or greater than at a particular first level; 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.

23. A method to classify a dose of medicine dispensed from an injection pen, comprising:

detecting one or more doses of medicine dispensed from an injection pen device and time data associated with the one or more dispensed doses to generate dose data corresponding to dispensing events;

processing the 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 dose data in the dose dispensing sequence by assigning a last dispensing event in the dose dispensing sequence as the injection event and any previous dispensing events in the dose dispensing sequence as the priming events.

24. The method of claim 23, further comprising:

detecting force signal data applied at a dispensing portion of the injection pen device;

detecting force time data associated with the force data;

processing the detected force signal data and force time data to determine physical contact between the dispensing portion and a body based on a predetermined force threshold;

comparing the force time data associated with determined physical contact to the time data associated with the last dispensing event; and

determining that the type of dispensing event of the last dispensing event is the injection dose if the force time data associated with determined physical contact corresponds to the time data associated with the last dispensing event, or determining that the type of dispensing event of the last dispensing event is a priming event if the force time data associated with determined physical contact does not correspond to the time data associated with the last dispensing event.

25. The method of claim 23, further comprising:

comparing the amount of the dispensed doses for each of the dispensing events in the dose dispensing sequence to a predetermined dose quantity threshold; and

determining the type of dispensing event for a dispensed dose having its amount larger than the predetermined dose quantity threshold and the largest amongst the compared dispensing events as the injection event.

26. A method to classify a dose of medicine dispensed from an injection pen, comprising:

detecting one or more doses of medicine dispensed from an injection pen device and time data associated with the one or more dispensed doses to generate dose data corresponding to dispensing events, wherein the detecting includes sensing a rate at which the medicine is dispensed from the injection pen device;

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

comparing the rate of the one or more dispensed doses for each of the dispensing events in the dose dispensing sequence to a predetermined dispensing rate threshold; and

determining a type of dispensing event as a priming event for a dispensing event in the dose dispensing sequence when the corresponding sensed rate is slower than the predetermined dispensing rate threshold, and determining the type of dispensing event as an injection event for a dispensing event in the dose dispensing sequence when the corresponding sensed rate is faster than the predetermined dispensing rate threshold.

27. A method of unbonding an injection pen device from a mobile communication device, comprising:

providing instructions to a user of the injection pen device that has been communicatively bonded to a first mobile communication device to perform an operation sequence including two or more operations of the injection pen device in a predetermined time frame;

initiating, by a processing unit of the injection pen device, a count of the predetermined time frame once a dose setting mechanism of the injection pen device is set at or greater than a first level;

detecting, by the injection pen device, operations of the dose setting and a dose dispensing mechanism of the injection pen device; and

clearing encryption keys stored in the processing unit of the injection pen device associated with the first mobile communication device when the operation sequence is detected within the predetermined time.

28. The method of claim 27, wherein the instructions include operating a dose setting mechanism of the injection pen device to the first level or greater than the first level, operating the dose setting mechanism to a second level less than the first level, operating the dose setting mechanism to a third level greater than the second level, operating the dose setting mechanism to a fourth level less than the third level, and operating a dose dispensing mechanism of the injection pen.

29. The method of claim 27, wherein the providing instructions includes displaying the instructions to the user on a display screen of a second mobile communication device to perform the two or more operations of the injection pen device.

30. The method of claim 27, further comprising:

initiating, by a second mobile communication device, a bonding sequence to communicatively bond the second mobile communication device with the injection pen device;

prompting the user, at the display screen of the second mobile communication device, to enter a bond code into the second mobile communication device;

receiving, at the second mobile communication device, the user-entered bond code; and

providing, at the second mobile communication device, encryption keys to the injection pen device and the second mobile communication device.