INTEGRATED MEDICAMENT DELIVERY DEVICE FOR USE WITH CONTINUOUS ANALYTE SENSOR

• US 20080306444A1
• Filed: 06/05/2008
• Published: 12/11/2008
• Est. Priority Date: 06/08/2007
• Status: Abandoned Application

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Kamath, Apurv U., Yang, Richard C., Brister, Mark C., Leach, Jacob S., Quintana, Nelson
• Application Number:
  US12/133,761
• Publication Number:
  US 20080306444A1
• Time in Patent Office: Days
• US Class Current: 604/131
• 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 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2209/086 Docking stations
• CPC Class Codes: A61M 5/003 Kits for diabetics
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• 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 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/31525 Dosing burettes, pipettes B01L3/02
• CPC Class Codes: G06T 11/206 Drawing of charts or graphs

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. A medicament delivery device for monitoring and treating at least one of a plurality of hosts, the medicament delivery device comprising:

a communication module configured to interrogate a continuous glucose sensor and to receive sensor data therefrom, wherein the sensor data comprises a signal associated with an analyte concentration of a host;

a processor module configured to process the sensor data and calculate a medicament therapy, wherein the processor module comprises programming for calculating the medicament therapy based at least in part on the sensor data; and

a hand-held injector pen configured and arranged to deliver a medicament to the host, based at least in part on the medicament therapy.

2. The medicament delivery device of claim 1, further comprising a user interface configured and arranged for at least one of input of at least some medical information and display of at least some medical information, wherein medical information comprises at least one of host information, received sensor data, processed sensor data, the calculated medicament therapy, a delivered medicament therapy, an instruction, an alert, an alarm, and a failsafe.

3. The medicament delivery device of claim 2, wherein the user interface is detachably connected to the hand-held injector pen.

4. The medicament delivery device of claim 2, wherein host information comprises at least one of a host information, type of medicament to be delivered, a glucose target, predicted hypoglycemia, predicted hypoglycemia, a therapy protocol, an alert, and an alarm.

5. The medicament delivery device of claim 1, wherein the processor module is further configured for validation of the medicament therapy.

6. The medicament delivery device of claim 1, wherein the medicament therapy comprises at least one of a type of medicament to be delivered, an amount of medicament to be delivered and a time of delivery.

7. The medicament delivery device of claim 1, wherein the communication module is further configured to communicate treatment information to a central monitor, wherein the treatment information comprises at least one of host information, sensor data, the medicament therapy, and delivered medicament information.

8. The medicament delivery device of claim 1, wherein the communication module is configured for wireless communication.

9. The medicament delivery device of claim 8, wherein the wireless communication is selected from the group consisting of RF communication, IR communication, Bluetooth communication, and inductive coupling.

10. The medicament delivery device of claim 1, wherein the communication module and the medicament delivery device are integrally formed.

11. The medicament delivery device of claim 1, wherein the communication module and the medicament delivery device are detachably connected.

12. The medicament delivery device of claim 1, wherein the injector pen is configured for aseptic medicament delivery to a plurality of hosts.

13. The medicament delivery device of claim 12, wherein the injector pen is configured and arranged for pneumatic aseptic medicament delivery.

14. The medicament delivery device of claim 12, wherein the injector pen comprises a cartridge comprising a plurality of single-use needles.

15. The medicament delivery device of claim 14, wherein the cartridge is configured and arranged for automatic installation of a clean needle after a medicament delivery.

16. A method for monitoring and treating diabetes in one of a plurality of hosts, the method comprising:

interrogating a continuous glucose sensor;

receiving sensor data from the continuous glucose sensor, wherein the sensor data comprises a signal associated with an analyte concentration of a first host;

processing the sensor data;

calculating a medicament therapy based at least in part on the sensor data; and

delivering an amount of a medicament to the first host, based at least in part on the calculated medicament therapy.

17. The method of claim 16, wherein the steps of interrogating, receiving, processing, calculating and delivering are repeated with a second host.

18. The method of claim 17, further comprising a step of at least one of inputting at least some medical information and displaying at least some medical information, wherein medical information comprises at least one of host information, received sensor data, processed sensor data, the calculated medicament therapy, a delivered medicament therapy, an instruction, an alert, an alarm, and a failsafe.

19. The method of claim 17, further comprising detachably connecting a user interface.

20. The method of claim 17, further comprising validating the medicament therapy.

21. The method of claim 17, further comprising communicating treatment information to a central monitor, wherein the treatment information comprises at least one of host information, sensor data, the medicament therapy, and delivered medicament information.

22. The method of claim 21, wherein the step of communicating comprises communicating wirelessly.

23. The method of claim 17, wherein the steps of interrogating and receiving comprise communicating wirelessly.

24. The method of claim 17, wherein the step of delivering comprises aseptically delivering the medicament to a plurality of hosts.

25. The method of claim 17, wherein the step of delivering comprises pneumatically aseptically delivering the medicament.

26. The method of claim 17, wherein the step of delivering comprises automatically installing a clean needle after medicament delivery.