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EP0245073B1 Expired / Lapsed EP ⏱️ 0.0 years remaining

A complete glucose monitoring system with an implantable, telemetered sensor module

Assignee: University of California Berkeley
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Filing: 1987-05-05
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Granted: 1993-12-22
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Expires: 2007-05-05
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Abstract

Abstract An electrochemical system includes a sensor module suitable for implantation in the body to monitor glucose and oxygen levels therein. The module has two oxygen sensors situated in an oxygen-permeable housing, arranged in a tandem relationship, and recessed in the housing, one sensor being unaltered and the other contacting glucose oxidase allowing for differential measurement of oxygen content in bodily fluids or tissues indicative of glucose levels. The module includes a communication capability for transmitting measurement information to an external recording device outside the body.

Inventors

  • 👤 David A. Gough
  • 👤 Joseph Y. Lucisano
  • 👤 Jon C. Armour
  • 👤 Brian D. Mckean

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-11-05 16:35
CPC Classifications
A; A61; A61B; A61B5/00; A61B5/145; A61B5/1468; A61B5/1486; A61B5/14865; A61B5/0002; A61B5/0031; Y; Y10; Y10S; Y10S128/00; Y10S128/903

Claims Analysis

Total Claims: 14
Claim 1
Independent Claim 250 words
An electrochemical system for detecting glucose and oxygen levels in fluids comprising: a housing (14;40); first and second sensor means (16,18;36,38) for measuring an oxygen content differential in bodily fluids, the first sensor means being unaltered and the second sensor means containing glucose oxidase (22) for oxidation of glucose; and, electronic circuit means (82) responsive to the first and second oxygen sensor means (16,18;36,38) for providing a signal indicative of an oxygen content differential in said fluids characterized in that: the electrochemical system is implantable into a body and capable of transmitting information about said glucose and oxygen levels in fluids or tissues therein outside said body; the housing (14;40) comprises a hollow catheter permitting facile implantation and is oxygen permeable but hinders the rate of entry of glucose and implantable in a body; the first and second sensor (16,18;36,38) are disposed in the housing (14;40) one behind the other and in fluid communication with fluids or in contact with tissues present in the body; the first and second sensor (16,18;36,38) each comprise a multi-electrode assembly including a working electrode (26), a counter electrode (28) and a reference electrode (30); the electronic circuit means is implantable, and the system further comprises: telemetry means (98) for communicating said signal from the interior to the exterior of the body; and, an external means (84) outside of the body and responsive to the telemetry means for connecting the oxygen content differential to glucose levels in the fluids or tissues, based upon said signal.
Claim 2
Dependent Claim 48 words
An electrochemical system according to claim 1, wherein the housing (14;40) is made of oxygen permeable material drawn from the group consisting of polydimethylsiloxane, polymers of tetrafluorethylene or its fluoro-chloro analogs alone or as copolymers with ethylene or propylene, polyethylene, polypropylene, cellulose acetate, and other oxygen-abiding polymeric materials.
Claim 3
Dependent Claim 46 words
An electrochemical system according to claim 1 or 2, wherein the catheter is a multilumen catheter and the first oxygen sensor means is disposed in a first lumen of the catheter and the second oxygen sensor means is disposed in a second lumen of the catheter.
Claim 4
Dependent Claim 44 words
An electrochemical system according to any of the preceding claims, wherein the first oxygen sensor means (16;36) comprises an electrically insulating support means (32) having its multi-electrode assembly mounted therein in a substantially parallel spaced relationship, the assembly having an active exposed working face.
Claim 5
Dependent Claim 73 words
An electrochemical system according to claim 4, wherein the second oxygen sensor (18;38) comprises an electrically insulating support means (32) having its multi-electrode assembly mounted therein in a substantially parallel spaced relationship, the assembly having an active exposed working face; and, a hydrophobic membrane about the active exposed working face and in communication with a second membrane, the second membrane containing glucose oxidase therein and being accessible to the bodily fluids or tissues.
Claim 6
Dependent Claim 44 words
An electrochemical system according to claim 5, wherein the second membrane is permeable to glucose and oxygen, and is fabricated from hydrophillic materials drawn from the group consisting of polyacrylamide, cross-linked proteins, polyhydroxyethylmethacrylate and its derivatives, and other hydrophillic proteins, polymers and copolymers, thereof.
Claim 7
Dependent Claim 48 words
An electrochemical system of claim 5, wherein the hydrophobic membrane is permeable to oxygen and relatively impermeable to glucose, and is fabricated from polydimethylsiloxyane, polymers of tetrafluoroethylene, or its fluoro chloro analogs or as copolymers with ethylene or propylene, polythylene, polypropylene, cellulose acetate, and other oxygen-abiding polymeric materials.
Claim 8
Dependent Claim 15 words
An electrochemical system according to claim 1, wherein the housing (40) includes a bilumen catheter.
Claim 9
Dependent Claim 26 words
An electrochemical system according to claim 8, wherein the first and second oxygen sensor means (36,38) are situated in different lumens of the bilumen catheter (40).
Claim 10
Dependent Claim 59 words
An electrochemical system according to any of the preceding claims, wherein the first and second oxygen sensor means (16,36;18,38) produce respective first and second sensor signals, each representative of an oxygen level in the fluids or tissues and the electronic circuit means (82) includes means for intermittently sampling the first and second sensor signals to produce said differential signal.
Claim 11
Dependent Claim 47 words
An electrochemical system according to claim 10, wherein the telemetry means (96,98) includes a voltage-controlled oscillator (96) having a frequency of oscillation determined by a sensor signal and a transmitter (98) which modulates a transmitter carrier in response to the frequency of oscillation of the voltage-controlled oscillator.
Claim 12
Dependent Claim 51 words
An electrochemical system according to claim 11, wherein the external means (84) includes demodulating means (122) for obtaining the first and second sensor signals from the transmitted carrier and programmable processing means (124) for combining the first and second sensor signals according to predetermined calibration characteristics to obtain the glucose levels.
Claim 13
Dependent Claim 18 words
An electrochemical system according to claim 4, wherein a hydrophobic membrane is disposed about the active working face.
Claim 14
Dependent Claim 49 words
An electrochemical system according to claim 13, wherein the hydrophobic membrane is permeable to oxygen and relatively impermeable to glucose, and is fabricated from polydimethylsiloxyane, polymers of tetrafluoroethylene, or its fluoro chloro analogs or as copolymers with ethylene or propylene, polythylene, polypropylene, cellulose acetate, and other oxygen-abiding polymeric materials.

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