Glucose sensor assembly

• US 5,660,163 A
• Filed: 05/18/1995
• Issued: 08/26/1997
• Est. Priority Date: 11/19/1993
• Status: Expired due to Term

• Current Assignee: Alfred E. Mann Foundation For Scientific Research
• Original Assignee: Alfred E. Mann Foundation For Scientific Research
• Inventors: Lucisano, Joseph Y., Mann, Alfred E., Schulman, Joseph H., Lebel, Ronald J., Whitmoyer, David I., Rule, Orville Rey III
• Primary Examiner(s): NASSER, ROBERT L
• Application Number:
  US08/444,300
• Time in Patent Office: 831 Days
• Field of Search: 204/403, 204/408, 204/412, 204/415, 128/635, 128/632
• US Class Current: 600/345
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• 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: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence

Abstract

A glucose monitoring system continuously measures the glucose concentration in a patient'"'"'s blood, provides an indication of the rate of change of such concentration, and determines whether the measured concentration and rate of change are within certain preset limits. If not, an audible and/or visual alarm signal is generated. The glucose monitoring system includes a glucose sensor adapted to be inserted into the venous system of the patient, where it responds to blood glucose and produces sensor signals related to the glucose concentration. The sensor signals are delivered through a suitable interconnect cable to a glucose monitor. In one embodiment, the interconnect cable includes a contactless connector that electrically isolates the glucose sensor from the monitor, and reduces the number of conductors required to interface with a plurality of sensors. The glucose monitor interprets the sensor signals by applying a previously determined calibration to quantitatively determine the blood glucose value. The blood glucose value thus determined is then processed in order to determine the rate of change, is stored (to create a history or record), and may also be displayed in large, easy-to-read numerals. Rate of change information (trend) may also be numerically or graphically displayed.

Claims

1. A sensor assembly adapted for insertion into the venous system of a patient to measure the concentration of one or more substances in the patient'"'"'s blood, said sensor assembly comprising:

a substrate;

first and second working electrodes bonded to said substrate;

a reference electrode bonded to said substrate;

a collector electrode bonded to said substrate;

means for making electrical contact with said first and second working electrodes, reference electrode, and collector electrode;

a layer of insulation deposited on said substrate and means for making electrical contact so as to be interspersed between the electrodes bonded to said substrate, a prescribed surface area of each of said electrodes being exposed through said layer of insulation, whereby said first and second working electrodes, reference electrode and collector electrode are all electrically isolated from each other on said substrate;

first membrane means covering said substrate and electrodes;

a saline solution held within said first membrane, said saline solution being in contact with said electrodes bonded to said substrate;

second membrane means covering said first membrane means, said second membrane means having a window pocket therein above the exposed surface area of said first working electrode;

a prescribed enzyme placed within said window pocket;

means for applying a prescribed reference voltage between said collector electrode and said reference electrode, and between said first and second working electrodes and said reference electrode, and for measuring the electrical current that flows from said first and second working electrodes;

whereby when said sensor assembly is inserted in the patient'"'"'s venous system, oxygen and other substances in the blood of the patient may penetrate said first and second membrane means and electrochemically react in the presence of the prescribed enzyme held in said window pocket with the current flowing through said first working electrode, and electrochemically react in the absence of said enzyme with the current flowing through said second working electrode;

said currents flowing through said first and second working electrodes thereby providing a measure of oxygen and other substances in the blood of the patient as a function of the electrochemical reactions that occur at said first and second working electrodes.

2. The sensor assembly as set forth in claim 1 wherein said prescribed enzyme comprises glucose oxidase.

3. The sensor assembly as set forth in claim 2 wherein said sensor assembly includes first and second sets of the first and second electrodes, reference electrode, and collector electrode spaced-apart on said substrate, thereby forming separate spaced-apart sensors on said substrate.

4. The sensor assembly as set forth in claim 2 further including a temperature sensor mounted on said substrate.

5. The sensor assembly as set forth in claim 4 wherein said temperature sensor comprises a prescribed semiconductor having a resistivity that varies as a function of temperature, and means for applying a voltage across said semiconductor, whereby the current flowing through said semiconductor provides a measure of the resistivity, and hence the temperature.

6. The sensor assembly as set forth in claim 4 further including a cable carrying sufficient electrical conductors to make contact with said first and second electrodes, reference electrode, collector electrode and temperature sensor, said cable terminating in a first contactless connector, said first contactless connector having a battery and a control chip therein that receives and processes the electrical current that flows from the first and second working electrodes, said control chip including memory means for storing calibration data associated with said sensor assembly, processing means for processing the received electrical current with the calibration data to produce encoded sensor data signals, and transmitting means for transmitting the encoded sensor data signals to a receiver located in a second contactless connector, said second contactless connector being adapted to be coupled to said first contactless connector without making direct electrical contact therewith, whereby electrical isolation is provided between the first and second contactless connectors, said second contactless connector being coupled to a monitoring device whereat said encoded sensor data signals are decoded, displayed and stored.

7. The sensor assembly as set forth in claim 6 wherein said second contactless connector is coupled to said monitoring device through a connection cable having two electrical conductors.

8. The sensor assembly as set forth in claim 6 wherein at least one of said first and second contactless connectors includes a permanent magnet that is attracted to a metallic member in the other contactless connector, and wherein said permanent magnet provides a holding force for maintaining said first and second contactless connectors in close proximity to each other.

9. A sensor assembly adapted for insertion into the venous system of a patient to measure the concentration of one or more substances in the patient'"'"'s blood, said sensor assembly comprising:

a substrate;

first and second sets of sensors spaced apart on said substrate, wherein each set of sensors comprises;

first and second working electrodes bonded to said substrate;

a reference electrode bonded to said substrate;

a collector electrode bonded to said substrate; and

means for making electrical contact with said first and second working electrodes, reference electrode, and collector electrode;

a layer of insulation deposited on said substrate and means for making electrical contact so as to be interspersed between the electrodes bonded to said substrate, a prescribed surface area of each of said electrodes being exposed through said layer of insulation, whereby said first and second working electrodes, reference electrode and collector electrode are all electrically isolated from each other on said substrate;

first membrane means covering said substrate and electrodes;

a saline solution held within said first membrane, said saline solution being in contact with said electrodes bonded to said substrate;

second membrane means covering said first membrane means, said second membrane means having a window pocket therein above the exposed surface area of said first working electrode;

a prescribed enzyme placed within said window pocket; and

means for applying a prescribed reference voltage within each set of sensors between said collector electrode and said reference electrode, and between said first and second working electrodes and said reference electrode, and for measuring the electrical current that flows from said first and second working electrodes within each set of sensors;

whereby when said sensor assembly is inserted in the patient'"'"'s venous system, oxygen and other substances in the blood of the patient may penetrate said first and second membrane means of each set of sensors and electrochemically react in the presence of the prescribed enzyme held in said window pocket of each set of sensors with the current flowing through each of said first working electrodes, and electrochemically react in the absence of said enzyme with the current flowing through each of said second working electrodes;

said currents flowing through said first and second working electrodes of each set of sensors thereby providing a measure of oxygen and other substances in the blood of the patient as a function of the electrochemical reactions that occur at said first and second working electrodes of each set of sensors.

10. The sensor assembly as set forth in claim 9 wherein said prescribed enzyme comprises glucose oxidase.

11. The sensor assembly as set forth in claim 9, wherein said first and second sets of sensors are separated on said substrate such that the window pockets are spaced apart about 0.4 to 1.0 inches along the length of the substrate.

12. The sensor assembly as set forth in claim 9 wherein said first and second sets of sensors further comprise a temperature sensor mounted on said substrate.

13. The sensor assembly as set forth in claim 11 wherein each of said temperature sensor comprises a prescribed semiconductor having a resistivity that varies as a function of temperature, and means for applying a voltage across said semiconductor, whereby the current flowing through said semiconductor provides a measure of the resistivity, and hence the temperature.

14. The sensor assembly as set forth in claim 12 further including a cable carrying sufficient electrical conductors to make contact with said first and second electrodes, reference electrode, collector electrode and temperature sensor of each of said sets of sensors, said cable terminating in a first contactless connector, said first contactless connector having a battery and a control chip therein that receives and processes the electrical current that flows from the first and second working electrodes of each set of sensors, said control chip including memory means for storing calibration data associated with said sensor assembly, processing means for processing the received electrical current with the calibration data to produce encoded sensor data signals, and transmitting means for transmitting the encoded sensor data signals to a receiver located in a second contactless connector, said second contactless connector being adapted to be coupled to said first contactless connector without making direct electrical contact therewith, whereby electrical isolation is provided between the first and second contactless connectors, said second contactless connector being coupled to a monitoring device whereat said encoded sensor data signals are decoded, displayed and stored.

15. The sensor assembly as set forth in claim 14 wherein said second contactless connector is coupled to said monitoring device through a connection cable having two electrical conductors.

16. The sensor assembly as set forth in claim 14 wherein at least one of said first and second contactless connectors includes a permanent magnet that is attracted to a metallic member in the other contactless connector, and wherein said permanent magnet provides a holding force for maintaining said first and second contactless connectors in close proximity to each other.