Sensor head for use with implantable devices

• US 8,509,871 B2
• Filed: 10/28/2008
• Issued: 08/13/2013
• Est. Priority Date: 07/27/2001
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Rhodes, Rathbun K., Tapsak, Mark A., Brauker, James H., Shults, Mark C.
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): D'ANGELO, MICHAEL J
• Application Number:
  US12/260,017
• Publication Number:
  US 20090045055A1
• Time in Patent Office: 1,750 Days
• Field of Search: 600345-347, 600/365
• US Class Current: 600/345
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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: C12Q 1/002 Electrode membranes
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 33/48707 by electrical means G01N33/49, G01N33/493 take precedence
• CPC Class Codes: G01N 33/48785 Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply

Abstract

The present invention provides a sensor head for use in an implantable device that measures the concentration of an analyte in a biological fluid which includes: a non-conductive body; a working electrode, a reference electrode and a counter electrode, wherein the electrodes pass through the non-conductive body forming an electrochemically reactive surface at one location on the body and forming an electronic connection at another location on the body, further wherein the electrochemically reactive surface of the counter electrode is greater than the surface area of the working electrode; and a multi-region membrane affixed to the nonconductive body and covering the working electrode, reference electrode and counter electrode. In addition, the present invention provides an implantable device including at least one of the sensor heads of the invention and methods of monitoring glucose levels in a host utilizing the implantable device of the invention.

Claims

1. A continuous glucose sensor system comprising:

an implantable body comprising an electrode configured to measure a glucose concentration in a host, wherein the electrode is configured to generate a current output;

a membrane disposed over the electrode, the membrane comprising silicone and an enzyme configured to catalyze a reaction of glucose and oxygen from a biological fluid surrounding the membrane; and

sensor electronics operably connected to the electrode and configured to measure a current from the electrode;

wherein the continuous glucose sensor system is configured to maintain a 100% current output from the electrode in a fluid with an oxygen concentration of about 0.5 mg/L and a glucose concentration of 400 mg/dL, wherein the 100% current output corresponds to a current output of the system in a fluid with a glucose concentration of 400 mg/dL and an ambient oxygen concentration.

2. The continuous glucose sensor system of claim 1, wherein the membrane comprises a glucose blocking domain.

3. The continuous glucose sensor system of claim 1, wherein the electrode is a working electrode, and wherein the implantable body further comprises a reference electrode.

4. The continuous glucose sensor system of claim 1, wherein the membrane comprises polyurethane.

5. The continuous glucose sensor system of claim 1, wherein the membrane is configured to control a flux of oxygen and glucose therethrough.

6. The continuous glucose sensor system of claim 1, wherein the membrane is configured to reduce passage therethrough of interfering species.

7. The continuous glucose sensor system of claim 1, wherein a portion of the membrane is configured to limit diffusion of species that have a molecular weight greater than 34 kD.

8. The continuous glucose sensor system of claim 1, wherein the continuous glucose sensor system is configured to maintain a 100% current output in a fluid with an oxygen concentration of 0.5 mg/L and a glucose concentration of 400 mg/dL.

9. A continuous glucose sensor system comprising:

an implantable body comprising an electrode configured to measure a glucose concentration in a host, wherein the electrode is configured to generate a current output;

a membrane disposed over the electrode, the membrane comprising silicone and an enzyme configured to catalyze a reaction of glucose and oxygen from a biological fluid surrounding the membrane; and

sensor electronics operably connected to the electrode and configured to measure a current from the electrode;

wherein the continuous glucose sensor system is configured to maintain a 100% current output from the electrode in a fluid with a glucose concentration of 400 mg/dL when an oxygen concentration in the fluid is decreased from about 7 mg/L to an oxygen concentration of about 0.5 mg/L.

10. The continuous glucose sensor system of claim 9, wherein the 100% current output corresponds to the current output of the system in a fluid with a glucose concentration of 400 mg/dL and an ambient oxygen concentration.

11. A continuous glucose sensor system comprising:

an implantable body comprising an electrode configured to measure a glucose concentration in a host, wherein the electrode is configured to generate a current output;

a membrane disposed over the electrode, the membrane comprising a first domain that comprises silicone and a second domain that comprises an enzyme configured to catalyze a reaction of glucose and oxygen from a biological fluid surrounding the membrane, wherein the first domain has a thickness of about 0.032 inches or less; and

sensor electronics operably connected to the electrode and configured to measure a current from the electrode;

wherein the continuous glucose sensor system is configured to maintain a 100% signal current output from the electrode in a fluid with an oxygen concentration of about 0.5 mg/L and a glucose concentration of 400 mg/dL, wherein the 100% current output corresponds to a current output of the system in a fluid with a glucose concentration of 400 mg/dL and an ambient oxygen concentration.

12. The system of claim 11, wherein the first domain is configured to allow passage of glucose therethrough.

13. A continuous glucose sensor system comprising:

an implantable body comprising an electrode configured to measure a glucose concentration in a host, wherein the electrode is configured to generate a current output;

a membrane disposed over the electrode, the membrane comprising a first domain that comprises silicone and a second domain that comprises an enzyme configured to catalyze a reaction of glucose and oxygen from a biological fluid surrounding the membrane, wherein the first domain has a thickness of about 0.032 inches or less; and

sensor electronics operably connected to the electrode and configured to measure a current from the electrode;

wherein the continuous glucose sensor system is configured to maintain a 100% current output from the electrode in a fluid with a glucose concentration of 400 mg/dL when an oxygen concentration in the fluid is decreased from an oxygen concentration of about 7 mg/L to an oxygen concentration of about 0.5 mg/L.

14. The continuous glucose sensor system of claim 13, wherein the 100% current output corresponds to a current output of the system in a fluid with a glucose concentration of 400 mg/dL and an ambient oxygen concentration.

15. The system of claim 13, wherein the first domain is configured to allow passage of glucose therethrough.