INTEGRATED MEDICAMENT DELIVERY DEVICE FOR USE WITH CONTINUOUS ANALYTE SENSOR

• US 20080262469A1
• Filed: 06/05/2008
• Published: 10/23/2008
• Est. Priority Date: 02/26/2004
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Dobbles, John Michael, Mensinger, Michael Robert, Yang, Richard C., Llevares, Antonio C., Brister, Mark C., Quintana, Nelson
• Granted Patent: US 8,808,228 B2
• Time in Patent Office: Days
• US Class Current: 604/504
• 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 and arranged for injecting an amount of a medicament into a host; and

an integrated receiver configured and arranged 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 and arranged to process the sensor data.

2. The integrated system of claim 1, wherein the electronics are further configured to calculate at least one of time of medicament therapy and amount of medicament therapy.

3. The integrated system of claim 1, wherein the integrated receiver comprises a housing, wherein the medicament injection pen is integrally formed with the housing.

4. 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.

5. The integrated system of claim 4, wherein communication between the medicament injection pen and the receiver is initiated based at least in part on detachable connection of the medicament injection pen and the housing.

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

7. The integrated system of claim 6, wherein the user interface is further configured to display a graphical representation of at least one of sensor data and medicament delivery data, wherein a solid line represents at least one of a target glucose concentration and a range.

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

9. The integrated system of claim 1, wherein the receiver is configured to communicate in at least one of wiredly with a single-point glucose monitor and wirelessly with a single-point glucose monitor.

10. The integrated system of claim 1, wherein the medicament injection pen comprises a motor.

11. The integrated system of claim 10, wherein the motor is configured to set the amount of medicament.

12. The integrated system of claim 10, wherein the motor is configured to control a rate of medicament injection into a host.

13. The integrated system of claim 10, wherein the receiver is configured to remotely control the motor.

14. The integrated system of claim 1, wherein the medicament injection pen and the 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 receiver.

15. The integrated system of claim 14, wherein the system is configured to initiate communication between the medicament injection pen and the receiver in response to engagement of the electrical contacts.

16. The integrated system of claim 14, wherein the system is configured to communicate medicament delivery data between the medicament injection pen and the receiver in response to engagement of the electrical contacts.

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

18. The integrated system of claim 1, wherein at least one of the parts associated with the medicament injection pen and accessories associated with the medicament injection pen comprise a medicament cartridge.

19. 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.

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

a receiver configured and arranged to receive sensor data from an operably connected continuous glucose sensor, wherein the continuous glucose sensor is configured and arranged 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 medicament injection pen configured to inject an amount of medicament into the host.

21. The integrated system of claim 20, wherein the medicament therapy comprises at least one of an amount of medicament therapy and a time of medicament therapy delivery.

22. The integrated system of claim 20, wherein the receiver and the medicament injection pen are integrally formed.

23. The integrated system of claim 22, further comprising a receptacle configured and arranged to receive at least one of parts associated with the medicament injection pen and accessories associated with the medicament injection pen.

24. The integrated system of claim 20, wherein the medicament injection pen is detachably connectable to the receiver.

25. The integrated system of claim 24, wherein the medicament injection pen and 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 receiver.

26. The integrated system of claim 25, wherein the system is configured to initiate communication between the medicament injection pen and the receiver in response to engagement of the mutually engaging electrical contacts.

27. The integrated system of claim 25, wherein the system is configured to communicate the medicament therapy between the receiver and the medicament injection pen in response to engagement of the mutually engaging electrical contacts.

28. The integrated system of claim 20, further comprising a housing integrally formed with the receiver, wherein the integrated electronics are located with the housing.

29. The integrated system of claim 27, wherein the medicament injection pen is detachably connectable with the housing.

30. The integrated system of claim 20, wherein the receiver further comprises a user interface, wherein the integrated electronics are configured to display at least one of sensor data and the medicament therapy thereon.

31. The integrated system of claim 30, wherein the receiver comprises a housing, and wherein the user interface is located on the receiver housing.

32. The integrated system of claim 20, further comprising a user interface configured to display at least one of the sensor data and the medicament therapy.

33. The integrated system of claim 32, wherein the integrated electronics are further configured to display a representation of medicament delivery on the user interface, and wherein the representation of medicament delivery is substantially adjacent to substantially time-corresponding sensor data.

34. The integrated system of claim 32, wherein the integrated electronics are further configured to display a representation of sensor data on the user interface, wherein the representation comprises at least one of a target glucose concentration and a range.

35. The integrated system of claim 32, wherein the user interface comprises a flexible LED screen operably connected to at least one of the receiver and the medicament injection pen, and wherein the integrated electronics are configured to display continuous glucose sensor data on the flexible LED screen.

36. The integrated system of claim 32, wherein the user interface comprises an image projection system configured to project continuous glucose sensor data onto a surface.

37. The integrated system of claim 20, wherein the medicament injection pen comprises a motor.

38. The integrated system of claim 37, wherein the motor is configured to automatically set the amount of medicament.

39. The integrated system of claim 37, wherein the motor is configured to control a rate of medicament injection into the host.

40. The integrated system of claim 37, wherein the receiver is configured to remotely control the motor.

41. The integrated system of claim 20, 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 injection pen.

42. The integrated system of claim 41, further comprising a user interface, wherein the integrated electronics are configured to display at least one of sensor data and the medicament therapy thereon.

43. The integrated system of claim 41, wherein the medicament injection pen kit further comprises a receptacle configured and arranged to receive at least one of a medicament cartridge and a medicament injection pen needle.

44. A method for monitoring and treating diabetes using an integrated diabetes monitoring and treatment device, the method comprising:

receiving sensor data from a continuous glucose sensor, wherein the sensor data is associated with a glucose concentration of a host;

processing the sensor data;

generating a medicament therapy; and

injecting an amount of medicament into the host based at least in part on the generated medicament therapy.

45. The method of claim 44, wherein the step of generating a medicament therapy comprises determining at least one of an amount of medicament to be delivered and a time of medicament delivery.

46. The method of claim 44, wherein the step of injecting comprises setting the amount of medicament.

47. The method of claim 46, wherein the step of setting the amount of medicament comprises setting a medicament injection rate.

48. The method of claim 46, wherein the step of setting the amount of medicament comprises remotely setting the amount of medicament.