Continuous glucose monitoring injection device

• US 10,252,002 B2
• Filed: 07/30/2015
• Issued: 04/09/2019
• Est. Priority Date: 08/01/2014
• Status: Active Grant

• Current Assignee: Embecta Corporation
• Original Assignee: Becton, Dickinson & Co
• Inventors: Haider, M. Ishaq, Harvey, Noel, Kankanala, Sundeep, Martin, Frank, Pettis, Ronald
• Primary Examiner(s): Mendez, Manuel A
• Application Number:
  US15/500,913
• Publication Number:
  US 20170216524A1
• Time in Patent Office: 1,349 Days
• Field of Search: 604 65- 67, 604131, 604151, 604504, 600365, 128DIG 12, 128DIG 13
• CPC Class Codes: A61M 2005/1402 Priming
• CPC Class Codes: A61M 2005/31588 electrically driven
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 2230/63 Motion, e.g. physical activity
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: G16H 15/00 : ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/10 : relating to drugs or medications, e.g. for ensuring correct administration to patients
• 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: G16H 40/67 : for remote operation
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

An electronic insulin delivery device receives glucose data from a glucose monitor and sets a bolus dose amount. The device may take the form of an insulin pen with automatic priming and accurate dosing provided by a motor in connection with an encoder. The device may communicate with and be controlled by a smart phone device. The smart phone device provides a user interface to receive user data including patient weight, insulin to carbohydrate ratio and exercise factor, and to send instructions to the device, including dose amount. The dose amount is determined taking into account glucose level and trend, and other factors. The delivery device may be in continuous communication with the glucose monitor and smart phone to provide for near real-time adjustments in glucose treatment. Glucose data, insulin injection data, and other relevant data may be stored and accessible to interested parties.

Claims

1. An electronic insulin delivery device for delivering a bolus of insulin to a patient, comprising:

an insulin cartridge;

a pen needle at a distal end of the insulin cartridge;

a receiver configured to receive patient glucose information from an electronic glucose monitor;

a processor configured to read the received patient glucose information and determine an appropriate insulin bolus dose for the patient;

a dose setting mechanism configured to set an insulin delivery amount corresponding to the determined insulin bolus dose; and

a housing having at least one user interface button corresponding to a dispense function for dispensing the determined insulin bolus dose.

2. The device of claim 1, wherein the receiver is configured to receive data from a physical activity monitor, a sleep monitor, or a scale.

3. The device of claim 1, wherein the dispense function comprises a motor connected to a displacement gear.

4. The device of claim 3, wherein the insulin delivery device further comprises an encoder in connection with the motor, and a sensor adapted to sense movement of the encoder and to provide signals indicative of encoder movement to a controller of the insulin delivery device, wherein said controller is adapted to control the insulin delivery amount based on the signals received from the encoder.

5. The device of claim 3, wherein the motor is adapted to prime the cartridge and pen needle prior to insulin delivery.

6. The device of claim 1, further comprising a memory for storing the received glucose information from the glucose monitor.

7. The device of claim 6, wherein the processor is programmed to read the glucose information from the memory to determine insulin delivery information comprising delivery success status, dose amount, and time of insulin delivery.

8. The device of claim 1, wherein the glucose information comprises most recent glucose levels and historical glucose trend information.

9. The device of claim 1, wherein the appropriate insulin bolus dose is determined based on at least a most recent glucose reading, patient weight, an insulin-to-carbohydrate ratio of the patient, and an exercise factor of the patient.

10. A method in an electronic insulin delivery device for delivering insulin to a patient, comprising:

receiving glucose information from a glucose monitor;

receiving additional patient information from an electronic device via a wireless communication interface;

setting an insulin bolus dosage amount based on the glucose information and the additional patient information;

activating a user interface on the electronic insulin delivery device to display the insulin bolus dosage amount;

delivering insulin from a cartridge of the insulin delivery device to the patient through a pen needle.

11. The method of claim 10, further comprising receiving an input on a user interface of the insulin delivery device.

12. The method of claim 10, wherein receiving additional patient information comprises receiving data from a physical activity monitor, a sleep monitor, or a scale.

13. The method of claim 10, wherein the insulin delivery device further comprises a motor connected to a displacement gear.

14. The method of claim 13, further comprising:

sensing movement of an encoder in connection with the motor;

providing signals indicative of encoder movement to a controller of the insulin delivery device; and

adjusting the insulin bolus dosage amount setting based on the signals received by the controller.

15. The method of claim 13, further comprising setting an insulin priming amount, wherein the motor is adapted to prime the insulin cartridge and pen needle prior to insulin delivery.

16. The method of claim 10, further comprising storing in a memory the received glucose information from the glucose monitor.

17. The method of claim 16, further comprising reading the glucose information from the memory and determining insulin delivery information comprising delivery success status, does amount, and time of insulin delivery.

18. The method of claim 10, wherein the glucose information comprises the most recent glucose level and historical glucose trend information.

19. The method of claim 10, wherein determining an insulin bolus dose amount is based on at least a most recent glucose reading, patient weight, an insulin-to-carbohydrate ratio of the patient, and an exercise factor of the patient.

20. An electronic insulin delivery device for delivering a bolus of insulin to a patient, comprising:

an insulin cartridge;

a pen needle at a distal end of the insulin cartridge;

a receiver wirelessly configured to wirelessly connect to an electronic glucose monitor and an electronic device, the receiver configured to receive patient glucose information from the electronic glucose monitor and additional patient information from the electronic device; and

a processor configured to;

read the received patient glucose information and the additional patient information;

determine a patient status based on the received patient glucose information and additional patient information;

determine if a notification should be actuated; and

actuate a notification.

21. The device of claim 20, further comprising a housing having a user interface configured to display a notification.

22. The device of claim 20, wherein the electronic device comprises a physical activity monitor, a sleep monitor, or a scale.

23. The device of claim 20, wherein the electronic insulin delivery device is further configured to indicate a notification through auditory, visual, or tactile feedback.

24. The device of claim 20, further comprising a memory for storing the received glucose information and received additional patient information, wherein the processor is configured to read the glucose information and additional patient information from the memory to determine the patient status.

25. The device of claim 20, further comprising a transmitter configured to transmit a notification to an external device.

26. The device of claim 20, wherein the processor is further configured to determine an appropriate insulin bolus dose for the patient, based on the received patient glucose information and the received additional patient information.

27. The device of claim 26, further comprising a dose setting mechanism configured to set an insulin delivery amount corresponding to the determined insulin bolus dose.

28. The device of claim 27, wherein the appropriate insulin bolus dose is determined based on at least a most recent glucose reading, patient weight, an insulin-to-carbohydrate ratio of the patient, and an exercise factor of the patient.