Analyte sensor

• US 20070038044A1
• Filed: 06/03/2006
• Published: 02/15/2007
• Est. Priority Date: 07/13/2004
• Status: Active Grant

Abstract

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Claims

1. A system configured to control use of a medical device, the system comprising:

a reusable device and at least one single-use device, the single-use device being associated with the reusable device; and

a hardware key comprising a memory with information stored therein, wherein the hardware key is configured to operatively connect to the reusable device and to transmit at least a portion of the information to the reusable device.

2. The system of claim 1, wherein the hardware key is a dongle.

3. The system of claim 1, wherein the hardware key comprises a license comprising information selected from the group consisting of manufacturing information, calibration information, identification information, expiration information, duration information, insertion information, and combinations thereof.

4. The system of claim 3, wherein at least some of the information is encrypted in the memory of the hardware key.

5. The system of claim 1, wherein the reusable device is configured to authenticate the hardware key upon operative connection thereto.

6. The device of claim 1, wherein the reusable device is configured to read information from the hardware key.

7. The system of claim 1, wherein the reusable device is configured to mark or erase at least a portion of the information in the memory of the hardware key to ensure the hardware key is used only a predetermined number of times.

8. The system of claim 7, wherein the reusable device is configured to mark or erase at least a portion of the information in the memory of the hardware key to ensure the hardware key is used only once.

9. The system of claim 1, wherein the reusable device comprises a receiver, wherein the single-use device comprises at least one analyte sensor, and wherein the receiver is configured to receive, process, or display data from the analyte sensor.

10. The system of claim 9, wherein the receiver is configured to control an amount of time over which data is obtained from the analyte sensor responsive to receipt of information from the hardware key.

11. The system of claim 1, wherein the hardware key is configured to physically connect to a port on the reusable device.

12. The system of claim 1, wherein the medical device comprises an implantable glucose sensor system, wherein the reusable device comprises a receiver, and wherein the single-use device comprises a transcutaneous glucose sensor.

13. The system of claim 12, wherein the hardware key is packaged with the one or more transcutaneous glucose sensors, and wherein the hardware key is configured to limit the duration of or number of insertions of the one or more transcutaneous glucose sensors.

14. A method of limiting use of a medical device, the method comprising:

providing a hardware key associated with a single-use device, wherein the hardware key is configured to control an amount of time over which data is obtained from the single-use device; and

providing a reusable device comprising a port for connecting the hardware key thereto.

15. The method of claim 14, further comprising connecting the hardware key to the reusable device.

16. The method of claim 14, further comprising transmitting encrypted information from the hardware key to the reusable device.

17. The method of claim 16, wherein the transmitting step comprises transmitting at least one of manufacturing information, calibration information, identification information, expiration information, duration information, and insertion information.

18. The method of claim 14, further comprising authenticating the hardware key upon operative connection to the reusable device.

19. The method of claim 14, further comprising reading information from the hardware key upon operative connection to the reusable device.

20. The method of claim 14, further comprising marking or erasing at least a portion of the information from the hardware key after the step of reading information from the hardware key to ensure the hardware key is used only a predetermined number of times.

21. The method of claim 20, wherein the marking or erasing step comprises marking or erasing at least a portion of the information from the hardware key to ensure the hardware key is used only one time.

22. The method of claim 14, wherein the reusable device comprises a receiver, and wherein the receiver receives, processes, or displays data from the single-use device.

23. The method of claim 14, wherein the medical device comprises an implantable glucose sensor system, wherein the reusable device comprises a receiver, and wherein the single-use device comprise a transcutaneous glucose sensor.

24. The method of claim 23, wherein the hardware key is configured to limit a duration of insertion or a number of insertions of the transcutaneous glucose sensor.

25. A sensor system configured to measure an analyte concentration in a host, the system comprising:

at least one sensor configured to be implanted in a host and configured to measure an analyte concentration in a tissue of the host;

a receiver operatively connectable to the sensor and configured to provide analyte data representative of an analyte concentration in the host; and

a hardware key configured to connect to the receiver, wherein the hardware key comprises information selected from the group consisting of manufacturing information, calibration information, identification information, expiration information, duration information, insertion information, and combinations thereof.

26. The sensor system of claim 25, further comprising packaging configured to contain the sensor and the hardware key.

27. The sensor system of claim 25, wherein the hardware key is programmed with a license code.

28. The sensor system of claim 27, wherein the license code comprises information configured to control a duration of insertion or a number of insertions of the sensor.