Sensor head for use with implantable devices

• US 9,328,371 B2
• Filed: 07/16/2013
• Issued: 05/03/2016
• Est. Priority Date: 07/27/2001
• Status: Expired due to Term

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Rhodes, Rathbun K., Tapsak, Mark A., Brauker, James H., Shults, Mark C.
• Primary Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US13/943,622
• Publication Number:
  US 20130299350A1
• Time in Patent Office: 1,022 Days
• Field of Search: 600/309, 600345-347, 600/365
• US Class Current: 1/1
• 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. An implantable continuous glucose sensor system configured for implantation in a host, the system comprising:

an electrode comprising an electroactive surface, wherein the electrode is configured for implantation and is configured to generate in vivo a signal indicative of glucose concentration in a host;

a membrane comprising;

a first domain configured to reduce a flux of glucose therethrough;

a second domain comprising an enzyme configured to react with glucose to produce a measured species, wherein the second domain is located less distant to the electroactive surface than the first domain; and

a third domain comprising an architecture that permits access to the electroactive surface only for species that have a molecular weight less than or about equal to a molecular weight of the measured species, wherein the third domain is located less distant to the electroactive surface than the second domain; and

sensor electronics operably connected to the electrode and configured to measure the signal from the electrode.

2. The implantable continuous glucose sensor of claim 1, wherein the molecular weight of the architecture limits diffusion of species that have a molecular weight more than 34 Daltons.

3. The glucose sensor of claim 1, wherein the first domain comprises a polyurethane.

4. The glucose sensor of claim 1, wherein the first domain is an outermost domain of the membrane.

5. The glucose sensor of claim 1, wherein the first domain is configured to interface with biological fluid.

6. The glucose sensor of claim 1, wherein the electrode is a working electrode, wherein the system further comprises a reference electrode and a counter electrode.

7. The glucose sensor of claim 1, wherein the counter electrode comprises an electroactive surface, wherein the counter electrode electroactive surface has a larger area than an area of the working electrode electroactive surface.