Minimising calibration problems of in vivo glucose sensors

• US 20040063167A1
• Filed: 07/11/2003
• Published: 04/01/2004
• Est. Priority Date: 07/12/2002
• Status: Abandoned Application

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Sabra, Mads Christian, Kaastrup, Peter
• Application Number:
  US10/617,617
• Publication Number:
  US 20040063167A1
• Time in Patent Office: Days
• US Class Current: 435/27
• CPC Class Codes: C12Q 1/006 for glucose

Abstract

The present invention pertains to the minimisation of calibration problems of glucose sensors. Accordingly, the invention provides a method of improving the performance of a ROS producing glucose sensor, said method comprising providing the glucose sensor with a ROS removing compartment capable of reducing the diffusion of ROS out of the glucose sensor to a level at which biointerference is abolished or substantially reduced. The invention further relates to use of a ROS removing compartment in a ROS producing glucose, a ROS producing glucose sensor comprising a ROS removing compartment, and to the use of such a sensor in a human.

Claims

1. A method of improving the performance of a glucose oxidase based glucose sensor, said method comprising providing the glucose sensor with a ROS removing compartment capable of reducing the diffusion of ROS out of the glucose sensor to a level at which biointerference is abolished or substantially reduced.

2. A method according to claim 1, wherein the ROS removing compartment comprises catalase and/or one or more reactive oxygen species scavenger.

3. A method according to claims 1 or 2, wherein the reactive oxygen species is selected from the group consisting of H₂O₂, O.²⁻

, and OH⁻

.

4. A method according to any of the preceding claims, wherein the ROS removing compartment is able to ensure that the concentration of H₂O₂ in the tissue surrounding the glucose sensor remains below 10 μ

M.

5. A method according to claim 1 or 2, wherein substantially no activation of TGFO and substantially no monocyte chemotaxis occur in the tissue surrounding the glucose sensor.

6. A method according to any of the preceding claims, wherein the abolished or reduced biointerference leads to a decreased requirement for calibration of the glucose sensor when compared to the operation of a similar glucose sensor without a ROS removing compartment.

7. A method according to any of the preceding claims, wherein the sensor will require calibration no more than once a day, such as once every second day, once every third day, or once a week during functioning for a period of several days, one week, several weeks, several months, such as 3 months, preferably 6 months, most preferably one year.

8. A method according to any of the preceding claims, wherein the implanted sensor functions adequately several months, such as 3 months, preferably 6 months, most preferably one year.

9. A method according to any of the preceding claims, wherein the encapsulation process is substantially decreased as evidenced by the thickness of the collagen capsule around the glucose measuring part of the sensor being less than 1 mm, such as less than 0.5 mm, preferably less than 0.1 mm, even more preferably less than 0.05 mm, most preferably less than 0.01 mm after a functional period of time which is several days, one week, several weeks, several months, such as 3 months, preferably 6 months, most preferably one year.

10. A method according to any of the preceding claims wherein the glucose oxidase based glucose sensor is an implanted or semi-implanted glucose sensor.

12. Use according to claim 9, wherein the ROS removing compartment comprises catalase and/or one or more reactive oxygen species scavengers.

11. Use of a ROS removing compartment in a glucose oxidase based glucose sensor so that biointerference is substantially decreased or avoided.

13. Use according to any of claims 11 and 12, wherein the ROS removing compartment able to ensure that the concentration of H₂O₂ in the tissue surrounding the glucose sensor remains below 10 μ

M

14. Use according to any of claims 11 to 13, wherein the glucose sensor is implanted or semi-implanted in a human.

15. A glucose oxidase based glucose sensor comprising a ROS removing compartment capable of reducing the diffusion of ROS out of the glucose sensor to a level at which biointerference is abolished or substantially reduced

16. A glucose oxidase based glucose sensor according to claim 15, wherein the ROS removing compartment comprises catalase and/or one or more reactive oxygen species scavengers.

17. A glucose oxidase based glucose sensor according to claim 15 or 16 wherein the ROS removing compartment is able to ensure that the concentration of H₂O₂ in the tissue surrounding the glucose sensor remains below 10 μ

M

18. A glucose oxidase based glucose sensor according to any of claims 15 to 17, which is to be implanted or semi-implanted in a human.

19. A glucose oxidase based glucose sensor according to any of claims 15 to 18, wherein the ROS removing compartment is separated from the surrounding tissue by a biocompatible membrane.