Integrated medicament delivery device for use with continuous analyte sensor

• US 8,808,228 B2
• Filed: 06/05/2008
• Issued: 08/19/2014
• Est. Priority Date: 02/26/2004
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brister, Mark C., Quintana, Nelson, Llevares, Antonio C., Dobbles, John Michael, Yang, Richard C., Mensinger, Michael Robert
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US12/133,820
• Publication Number:
  US 20080262469A1
• Time in Patent Office: 2,266 Days
• Field of Search: 604/66, 604/65, 604/503, 604/504, 604/131, 604/50
• US Class Current: 604/66
• CPC Class Codes: A61B 2560/04 Constructional details of apparatus
• CPC Class Codes: A61B 2560/0406 specially shaped apparatus housings
• CPC Class Codes: A61B 2560/0431 Portable apparatus, e.g. comprising a handle or case
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• 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 2209/086 Docking stations
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/003 Kits for diabetics
• 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: A61M 5/31525 : Dosing burettes, pipettes B01L3/02
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/67 : for remote operation

Abstract

An integrated system for the monitoring and treating diabetes is provided, including an integrated receiver/hand-held medicament injection pen, including electronics, for use with a continuous glucose sensor. In some embodiments, the receiver is configured to receive continuous glucose sensor data, to calculate a medicament therapy (e.g., via the integrated system electronics) and to automatically set a bolus dose of the integrated hand-held medicament injection pen, whereby the user can manually inject the bolus dose of medicament into the host. In some embodiments, the integrated receiver and hand-held medicament injection pen are integrally formed, while in other embodiments they are detachably connected and communicated via mutually engaging electrical contacts and/or via wireless communication.

Claims

1. An integrated system for monitoring and treating diabetes, the system comprising:

a medicament injection pen configured for injecting an amount of a medicament into a host, wherein the medicament injection pen comprises a motor; and

an integrated receiver configured to receive sensor data from a continuous glucose sensor, wherein the sensor data is indicative of a glucose concentration of the host in vivo, wherein the integrated receiver comprises electronics configured to process the sensor data, and wherein the integrated receiver is configured to remotely control the motor.

2. The integrated system of claim 1, wherein the integrated receiver comprises a housing, and wherein the medicament injection pen is detachably connectable to the housing.

3. The integrated system of claim 2, wherein communication between the medicament injection pen and the integrated receiver is initiated based at least in part on detachable connection of the medicament injection pen and the housing.

4. The integrated system of claim 1, further comprising a user interface configured for at least one of input of host information, output of sensor data, or output of medicament therapy.

5. The integrated system of claim 4, wherein the user interface is further configured to display a graphical representation of at least one of sensor data or medicament delivery data, wherein the user interface is further configured to display a solid line representing at least one of a target glucose concentration or a range.

6. The integrated system of claim 1, wherein the electronics are configured to require validation prior to injecting an amount of medicament into the host.

7. The integrated system of claim 1, wherein the integrated receiver is configured to communicate with a single-point glucose monitor via a wired or wireless connection.

8. The integrated system of claim 1, wherein the motor is configured to set an amount of medicament.

9. The integrated system of claim 1, wherein the motor is configured to control a rate of medicament injection into the host.

10. The integrated system of claim 1, wherein the medicament injection pen and the integrated receiver each comprise mutually engaging electrical contacts, and wherein the mutually engaging electrical contacts are configured to allow communication between the medicament injection pen and the integrated receiver.

11. The integrated system of claim 10, wherein the system is configured to initiate communication between the medicament injection pen and the integrated receiver in response to engagement of the electrical contacts.

12. The integrated system of claim 10, wherein the system is configured to communicate medicament delivery data between the medicament injection pen and the integrated receiver in response to engagement of the electrical contacts.

13. The integrated system of claim 1, further comprising a receptacle configured to receive at least one of parts associated with the medicament injection pen or accessories associated with the medicament injection pen.

14. The integrated system of claim 13, wherein at least one of parts associated with the medicament injection pen or accessories associated with the medicament injection pen comprise a medicament cartridge.

15. The integrated system of claim 1, further comprising a medicament injection pen kit, wherein the medicament injection pen kit is configured to receive the medicament injection pen, and wherein the medicament injection pen kit comprises a housing comprising a user interface, and wherein the integrated receiver is located within the housing and operably connected to the user interface.

16. An integrated system for monitoring and treating diabetes, the system comprising:

a receiver configured to receive sensor data from an operably connected continuous glucose sensor, wherein the continuous glucose sensor is configured to generate sensor data associated with a glucose concentration of a host;

a medicament delivery device configured to inject an amount of medicament into the host; and

integrated electronics configured to process the sensor data and to generate and display medicament dosage and effects data on a user interface.

17. The integrated system of claim 16, wherein the medicament dosage and effects data comprises at least one of an amount of medicament or a time of medicament delivery.

18. The integrated system of claim 16, wherein the receiver and the medicament delivery device are integrally formed.

19. The integrated system of claim 18, further comprising a receptacle configured to receive at least one of parts associated with the medicament delivery device or accessories associated with the medicament delivery device.

20. The integrated system of claim 16, wherein the medicament delivery device is detachably connectable to the receiver.

21. The integrated system of claim 20, wherein the medicament delivery device and receiver each comprise mutually engaging electrical contacts, and wherein the mutually engaging electrical contacts are configured to allow communication between the medicament delivery device and the receiver.

22. The integrated system of claim 21, wherein the system is configured to initiate communication between the medicament delivery device and the receiver in response to engagement of the mutually engaging electrical contacts.

23. The integrated system of claim 21, wherein the system is configured to communicate a medicament therapy between the receiver and the medicament delivery device in response to engagement of the mutually engaging electrical contacts.

24. The integrated system of claim 16, further comprising a housing integrally formed with the receiver, wherein the integrated electronics are located with the housing.

25. The integrated system of claim 24, wherein the medicament delivery device is detachably connectable with the housing.

26. The integrated system of claim 16, wherein the integrated electronics are configured to display sensor data on the user interface.

27. The integrated system of claim 26, wherein the receiver comprises a housing, and wherein the user interface is located on the receiver housing.

28. The integrated system of claim 16, further comprising a user interface configured to display the sensor data.

29. The integrated system of claim 16, further comprising a medicament injection pen kit comprising the receiver and the integrated electronics, wherein the medicament injection pen kit is configured to receive the medicament delivery device.

30. The integrated system of claim 29, wherein the integrated electronics are configured to display sensor data on the user interface.

31. The integrated system of claim 29, wherein the medicament injection pen kit further comprises a receptacle configured to receive at least one of a medicament cartridge or a medicament injection pen needle.

32. An integrated system for monitoring and treating diabetes, the system comprising:

a receiver configured to receive sensor data from an operably connected continuous glucose sensor, wherein the continuous glucose sensor is configured to generate sensor data associated with a glucose concentration of a host;

integrated electronics configured to process the sensor data and to generate a medicament therapy; and

a user interface configured to display at least one of the sensor data or the medicament therapy, wherein the user interface comprises a flexible LED screen operably connected to at least one of the receiver or the medicament injection pen, and wherein the integrated electronics are configured to display continuous glucose sensor data on the flexible LED screen.

33. An integrated system for monitoring and treating diabetes, the system comprising:

a receiver configured to receive sensor data from an operably connected continuous glucose sensor, wherein the continuous glucose sensor is configured to generate sensor data associated with a glucose concentration of a host;

integrated electronics configured to process the sensor data and to generate a medicament therapy; and

a user interface configured to display at least one of the sensor data or the medicament therapy, wherein the user interface comprises an image projection system configured to project continuous glucose sensor data onto a surface.