Integrated delivery device for continuous glucose sensor

• US 8,460,231 B2
• Filed: 07/11/2011
• Issued: 06/11/2013
• Est. Priority Date: 02/26/2004
• Status: Expired due to Term

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brauker, James H., Tapsak, Mark A., Saint, Sean T., Kamath, Apurv U., Neale, Paul V., Simpson, Peter C., Mensinger, Michael Robert, Markovic, Dubravka
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US13/180,396
• Publication Number:
  US 20110270158A1
• Time in Patent Office: 701 Days
• Field of Search: 604/31, 604 65- 67
• US Class Current: 604/65
• 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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 11/00 Sprayers or atomisers specially adapted for therapeutic purposes in general B05B; aerosol containers B65D83/14
• CPC Class Codes: A61M 15/0001 Details of inhalators; Constructional features thereof
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• 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 2230/201 Glucose concentration
• 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 5/31525 Dosing burettes, pipettes B01L3/02
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Systems and methods for integrating a continuous glucose sensor, including a receiver, a medicament delivery device, and optionally a single point glucose monitor are provided. Manual integrations provide for a physical association between the devices wherein a user (for example, patient or doctor) manually selects the amount, type, and/or time of delivery. Semi-automated integration of the devices includes integrations wherein an operable connection between the integrated components aids the user (for example, patient or doctor) in selecting, inputting, calculating, or validating the amount, type, or time of medicament delivery of glucose values, for example, by transmitting data to another component and thereby reducing the amount of user input required. Automated integration between the devices includes integrations wherein an operable connection between the integrated components provides for full control of the system without required user interaction.

Claims

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

a continuous glucose sensor configured to continuously measure a signal indicative of a glucose concentration of a host;

a processor module configured to process the signal to generate a medicament therapy instruction, wherein the processor module is configured to trigger a validation of the medicament therapy instruction based on at least one of time of day, meals, sleep, calories, exercise, or sickness;

a communication module configured to communicate the validated medicament therapy instruction to a medicament delivery device; and

a medicament delivery device configured to deliver the validated medicament therapy to the host based at least in part on the communicated medicament therapy instruction.

2. The integrated system of claim 1, wherein the processor module is configured to predict glucose trends.

3. The integrated system of claim 2, wherein the therapy instruction is based on the predicted glucose trends.

4. The integrated system of claim 2, wherein the processor module is configured to consider at least one of an amount of medicament delivery, a type of medicament delivery, or a time of medicament delivery when predicting glucose trends.

5. The integrated system of claim 1, wherein the processor module is configured to process information about a metabolic response of the host to certain medicament deliveries.

6. The integrated system of claim 5, wherein the processor module is configured to determine at least one of an optimum time, an optimum amount, or an optimum type of medicament to deliver in a variety of conditions.

7. The integrated system of claim 1, wherein the processor module is configured to validate the medicament therapy instruction prior to outputting the medicament therapy instruction.

8. The integrated system of claim 1, wherein the medicament therapy comprises at least one of a medicament type, a medicament amount, or a medicament delivery time.

9. The integrated system of claim 1, further comprising a user interface configured to permit input of host information, to display sensor data and the medicament therapy instruction, and/or to provide an alert and/or an alarm.

10. The integrated system of claim 1, wherein the communication module is configured to communicate wirelessly with the medicament delivery device.

11. The integrated system of claim 1, wherein the medicament delivery device is a transdermal pump.

12. The integrated system of claim 1, wherein the continuous glucose sensor comprises an implantable continuous glucose sensor.

13. The integrated system of claim 1, wherein the wherein the information is associated with a fail-safe accuracy check.

14. The integrated system of claim 1, wherein the therapy instruction is based on the time of day.

15. The integrated system of claim 1, wherein the therapy instruction is based on the host'"'"'s meal.

16. The integrated system of claim 1, wherein the therapy instruction is based on the host'"'"'s sleep.

17. The integrated system of claim 1, wherein the therapy instruction is based on the host'"'"'s calories.

18. The integrated system of claim 1, wherein the therapy instruction is based on the host'"'"'s exercise.