Subcutaneous glucose electrode
DCFirst Claim
1. A flexible analyte sensor comprising:
- a portion of the sensor that is adapted for positioning external to the animal and for connection to a device for measurement of the electrical signal generated by the sensor;
a portion of the sensor that is adapted for subcutaneous implantation in an animal, comprising;
at least one non-corroding, analyte-responsive working electrode; and
a sensing layer coupled to the working electrode;
wherein the sensor is flexible and is adapted to provide an electrical signal that is substantially insensitive to relative motion between the implanted portion of the sensor and tissue surrounding the implanted portion of the sensor.
3 Assignments
Litigations
0 Petitions
Reexaminations
Accused Products
Abstract
A small diameter flexible electrode designed for subcutaneous in vivo amperometric monitoring of glucoses is described. The electrode is designed to allow “one-point” in vivo calibration, i.e., to have zero output current at zero glucose concentration, even in the presence of other electroreactive species of serum or blood. The electrode is preferably three or four-layered, with the layers serially deposited within a recess upon the tip of a polyamide insulated gold wire. A first glucose concentration-to-current transducing layer is overcoated with an electrically insulating and glucose flux limiting layer (second layer) on which, optionally, an immobilized interference-eliminating horseradish peroxidase based film is deposited (third layer). An outer (fourth) layer is biocompatible.
1739 Citations
48 Claims
-
1. A flexible analyte sensor comprising:
-
a portion of the sensor that is adapted for positioning external to the animal and for connection to a device for measurement of the electrical signal generated by the sensor;
a portion of the sensor that is adapted for subcutaneous implantation in an animal, comprising;
at least one non-corroding, analyte-responsive working electrode; and
a sensing layer coupled to the working electrode;
wherein the sensor is flexible and is adapted to provide an electrical signal that is substantially insensitive to relative motion between the implanted portion of the sensor and tissue surrounding the implanted portion of the sensor. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
-
-
18. A glucose measurement system comprising:
-
a sensor configured to generate a signal indicative of the glucose concentration, the sensor comprising;
a non-corroding working electrode adapted for subcutaneous implantation in an animal; and
a sensing layer comprising a non-leachable glucose-responsive enzyme disposed on the working electrode; and
a signal measuring device operatively connected to the sensor for measuring the signal generated by the sensor, the signal measuring device being configured to allow the signal generated by the sensor to reach a basal signal level for a predetermined period of time before the signal is used as an indicator of the glucose concentration. - View Dependent Claims (19, 20, 21, 22, 23, 24)
-
-
25. An introduction system for a glucose sensor, comprising:
-
an introducer adapted for subcutaneous placement of a portion of a flexible glucose sensor in an animal; and
a portion of a flexible glucose sensor carried within the sensor introducer, the portion of a flexible glucose sensor comprising;
a non-corroding working electrode adapted for subcutaneous implantation in an animal; and
a sensing layer comprising a non-leachable, glucose-responsive enzyme disposed on the working electrode;
wherein the introducer can be withdrawn from the animal while leaving the portion of a flexible glucose sensor implanted within the subcutaneous tissue of the animal. - View Dependent Claims (26, 27, 28)
-
-
29. A method of measuring the concentration of glucose in an animal tissue, the method comprising the steps of:
-
(a) implanting into the animal a flexible sensor configured to generate a signal indicative of the concentration of glucose, the sensor comprising;
a non-corroding working electrode adapted for subcutaneous implantation in an animal; and
a sensing layer comprising a non-leachable glucose-responsive enzyme disposed on the working electrode;
(b) connecting a signal measuring device to the sensor;
(c) allowing the signal generated by the sensor to reach a basal signal level for a predetermined period of time; and
(d) measuring the glucose concentration using the signal generated by the sensor after step (c).
-
-
30. A method of measuring the concentration of glucose in an animal tissue, the method comprising the steps of:
-
(a) subcutaneously implanting into the animal a flexible sensor configured to generate a signal indicative of the glucose concentration, the sensor comprising;
a non-corroding working electrode adapted for subcutaneous implantation in an animal;
a sensing layer comprising a non-leachable glucose-responsive enzyme disposed on the working electrode; and
a glucose diffusion-limiting layer disposed on the sensing layer;
(b) allowing the glucose to reach the working electrode; and
(c) limiting the rate of glucose transport to the sensing layer to a level substantially lower than the rate of glucose transport to the tissue surrounding the sensor.
-
-
31. A method for inserting a flexible glucose sensor, comprising:
-
(a) providing an introducer having a width of not more than about 22 gauge adapted to subcutaneous placement of a portion of a flexible, glucose sensor in an animal;
(b) placing within the introducer a portion of a flexible, glucose sensor, the portion of a flexible, glucose sensor comprising;
a non-corroding working electrode adapted for subcutaneous implantation in an animal; and
a sensing layer comprising a non-leachable, glucose-responsive enzyme disposed on the working electrode;
(c) inserting the introducer into the animal so that the portion of the flexible, glucose sensor is carried into the subcutaneous tissue;
(d) withdrawing the introducer from the animal while leaving the portion of a flexible glucose sensor implanted within the subcutaneous tissue of the animal; and
(e) connecting a signal measuring device to a portion of the sensor exterior to the animal. - View Dependent Claims (32, 33)
-
-
34. A flexible glucose sensor comprising:
-
a portion of the sensor that is adapted for positioning external to the animal and for electrical contact with a device for measurement of the electrical signal generated by the sensor;
a portion of the sensor that is adapted for subcutaneous implantation in an animal;
comprising;
at least one non-corroding, glucose-responsive working electrode; and
a sensing layer coupled to the working electrode;
wherein the sensor is flexible and the width of the portion of the sensor that is adapted for subcutaneous implantation is less than about 0.29 mm. - View Dependent Claims (35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48)
-
Specification