Analyte monitoring device and methods of use

• US 8,346,336 B2
• Filed: 03/18/2009
• Issued: 01/01/2013
• Est. Priority Date: 04/30/1998
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Say, James, Tomasco, Michael F., Heller, Adam, Gal, Yoram, Aria, Behrad, Heller, Ephraim, Plante, Phillip John, Vreeke, Mark S., Friedman, Keith A., Colman, Fredric C.
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US12/406,800
• Publication Number:
  US 20090182215A1
• Time in Patent Office: 1,385 Days
• Field of Search: 600345-366, 600/309
• US Class Current: 600/345
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/72 Signal processing specially adapted for physiological signals or for diagnostic purposes character recognition, recognising digital ink, document-oriented image-based pattern recognition G06V30/00; recognition or understanding of postal images G06V30/424
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: C12Q 1/54 : involving glucose or galactose
• CPC Class Codes: G16H 10/40 : for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: H01L 23/3107 : the device being completely enclosed
• CPC Class Codes: H01L 23/49548 : Cross section geometry H01L23/49562 takes precedence
• CPC Class Codes: H01L 2924/00 : Indexing scheme for arrangements or methods for connecting or disconnecting semiconductor or solid-state bodies as covered by H01L24/00
• CPC Class Codes: H01L 2924/0002 : Not covered by any one of groups H01L24/00, H01L24/00 and H01L2224/00
• CPC Class Codes: H01L 2924/19041 : being a capacitor
• CPC Class Codes: H01L 2924/3011 : Impedance
• CPC Class Codes: Y10S 128/903 : Radio telemetry
• CPC Class Codes: Y10T 29/49 : Method of mechanical manufacture
• CPC Class Codes: Y10T 29/49124 : On flat or curved insulated base, e.g., printed circuit, etc.

Abstract

An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte. The analyte monitor may also be part of a drug delivery system to alter the level of the analyte based on the data obtained using the sensor.

Claims

1. A sensor control unit comprising:

an analyte sensor substrate having a narrow distal region for partial implantation through a skin surface and a wider proximal region, the substrate including at least a first surface and a second surface;

at least one working electrode disposed on the narrow distal region of the substrate and in fluid contact with interstitial fluid under the skin surface, the at least one working electrode formed on the first surface of the substrate;

at least one reference electrode disposed on the narrow distal region of the substrate, the at least one reference electrode formed on the first surface of the substrate;

at least one counter electrode disposed on the narrow distal region of the substrate, the at least one counter electrode formed on the second surface of the substrate;

a plurality of conductive contacts disposed on the wider proximal region of the substrate and on the first surface of the substrate, wherein a first one of the plurality of conductive contacts is in electrical communication with the working electrode, a second one of the plurality of conductive contacts is in electrical communication with the reference electrode, and a third one of the plurality of conductive contacts is in electrical communication with the counter electrode; and

at least one via formed through the substrate that electrically connects the counter electrode to the third one of the plurality of conductive contacts; and

a water resistant housing for placement on skin and configured to receive the analyte sensor substrate, wherein at least a portion of the wider proximal region the analyte sensor substrate is contained within the water resistant housing and wherein at least a portion of the narrow distal region of the analyte sensor substrate protrudes from a sensor port disposed on a base of the water resistant housing; and

a plurality of electronic components disposed in the water resistant housing, wherein at least one of the plurality of electronic components is in electrical contact with the plurality of conductive contacts disposed on the wider proximal region of the analyte sensor substrate, and wherein the at least one of the plurality of electronic components is configured to;

receive data from a display device;

receive a sensor signal from the sensor; and

transmit the sensor signal to the display device.

2. The analyte monitoring device of claim 1, wherein the water resistant housing comprises at least a first portion having an interlocking feature and at least a second portion having an interlocking feature, wherein when the first portion is interlocked with the second portion, a water resistant seal is formed between the first portion and the second portion.

3. The analyte monitoring device of claim 1, wherein the water resistant housing comprises at least a first portion having an interlocking feature and at least a second portion having an interlocking feature, wherein when the first portion is interlocked with the second portion, a waterproof seal is formed between the first portion and the second portion.

4. The analyte monitoring device of claim 1, wherein the water resistant housing comprises a planar skin-contacting surface, wherein the planar skin-contacting surface is water resistant or waterproof.

5. The analyte monitoring device of claim 4, further comprising a water resistant adhesive disposed on the planar skin-contacting surface of the water resistant housing.

6. The analyte monitoring device of claim 4, further comprising a waterproof adhesive disposed on the planar skin-contacting surface of the water resistant housing.

7. An analyte monitoring system, comprising:

an analyte sensor, including;

an analyte sensor substrate having a narrow distal region for partial implantation through a skin surface and a wider proximal region, the substrate including at least a first surface and a second surface;

at least one working electrode disposed on the narrow distal region of the substrate and in fluid contact with interstitial fluid under the skin surface, the at least one working electrode formed on the first surface of the substrate;

at least one reference electrode disposed on the narrow distal region of the substrate, the at least one reference electrode formed on the first surface of the substrate;

at least one counter electrode disposed on the narrow distal region of the substrate, the at least one counter electrode formed on the second surface of the substrate;

a plurality of conductive contacts disposed on the wider proximal region of the substrate and on the first surface of the substrate, wherein a first one of the plurality of conductive contacts is in electrical communication with the working electrode, a second one of the plurality of conductive contacts is in electrical communication with the reference electrode, and a third one of the plurality of conductive contacts is in electrical communication with the counter electrode; and

at least one via formed through the substrate that electrically connects the counter electrode to the third one of the plurality of conductive contacts; and

a water resistant housing for placement on skin and configured to receive the analyte sensor substrate, wherein at least a portion of the wider proximal region the analyte sensor substrate is contained within the water resistant housing and wherein at least a portion of the narrow distal region of the analyte sensor substrate protrudes from a sensor port disposed on a base of the water resistant housing; and

a plurality of electronic components disposed in the water resistant on-skin housing, wherein at least one of the plurality of electronic components is in electrical contact with the plurality of conductive contacts disposed on the wider proximal region of the analyte sensor substrate, and wherein the at least one of the plurality of electronic components is configured to;

receive a signal from an external device; and

provide sensor data to the external device.

8. The system of claim 7, wherein the water resistant on-skin housing comprises at least two separate portions, wherein when the at least two separate portions are operatively coupled, a seal is formed between the at least two separate portions.

9. The system of claim 8, wherein the seal formed between the at least two portions of the water resistant on-skin housing is a hermetic seal.

10. The system of claim 8, wherein the seal formed between the at least two portions of the water resistant on-skin housing is a water resistant seal.

11. The system of claim 8, wherein the seal formed between the at least two portions of the water resistant on-skin housing is a waterproof seal.

12. The system of claim 8, wherein the at least two separate portions of the water resistant on-skin housing comprise a base portion and a cover portion.

13. The system of claim 8, wherein each of the at least two separate portions of the water resistant on-skin housing have interlocking structures disposed thereon.

14. A method for monitoring an analyte using, at least in part, a sensor control unit, the method comprising:

implanting a first portion of a sensor into subcutaneous tissue of a patient for fluid contact with interstitial fluid, the sensor including;

an analyte sensor substrate having a narrow distal region for partial implantation through a skin surface and a wider proximal region, the substrate including at least a first surface and a second surface;

at least one working electrode disposed on the narrow distal region of the substrate and in fluid contact with interstitial fluid under the skin surface, the at least one working electrode formed on the first surface of the substrate;

at least one reference electrode disposed on the narrow distal region of the substrate, the at least one reference electrode formed on the first surface of the substrate;

at least one counter electrode disposed on the narrow distal region of the substrate, the at least one counter electrode formed on the second surface of the substrate;

a plurality of conductive contacts disposed on the wider proximal region of the substrate and on the first surface of the substrate, wherein a first one of the plurality of conductive contacts is in electrical communication with the working electrode, a second one of the plurality of conductive contacts is in electrical communication with the reference electrode, and a third one of the plurality of conductive contacts is in electrical communication with the counter electrode; and

at least one via formed through the substrate that electrically connects the counter electrode to the third one of the plurality of conductive contacts; and

operatively coupling the plurality of conductive contacts disposed on the wider proximal region of the analyte sensor substrate to at least one electronic component disposed within a water resistant housing of the sensor control unit, wherein the water resistant housing is configured for placement on skin and configured to receive the analyte sensor substrate, wherein at least a portion of the wider proximal region the analyte sensor substrate is contained within the water resistant housing and wherein at least a portion of the narrow distal region of the analyte sensor substrate protrudes from a sensor port disposed on a base of the water resistant housing;

receiving a signal from an external device, wherein the signal is received by the at least one electronic component; and

providing sensor data from the at least one electronic component to the external device.

15. The method of claim 14, wherein the water resistant housing comprises at least two portions and wherein a first portion of the at least two portions comprises a sensor port.

16. The method of claim 15, further comprising coupling the first portion of the at least two portions of the water resistant housing to a second portion of the at least two portions of the water resistant housing to form a seal between the first portion and the second portion.

17. The method of claim 16, wherein the seal formed between the first portion and the second portion is a hermetic seal.

18. The method of claim 16, wherein the seal formed between the first portion and the second portion is a water resistant seal.

19. The method of claim 16, wherein the seal formed between the first portion and the second portion is a waterproof seal.

20. A sensor control system, comprising:

a sensor for monitoring an analyte, the sensor including;

an analyte sensor substrate having a narrow distal region for partial implantation through a skin surface and a wider proximal region, the substrate including at least a first surface and a second surface;

at least one working electrode disposed on the narrow distal region of the substrate and in fluid contact with interstitial fluid under the skin surface, the at least one working electrode formed on the first surface of the substrate;

at least one reference electrode disposed on the narrow distal region of the substrate, the at least one reference electrode formed on the first surface of the substrate;

at least one counter electrode disposed on the narrow distal region of the substrate, the at least one counter electrode formed on the second surface of the substrate;

a plurality of conductive contacts disposed on the wider proximal region of the substrate and on the first surface of the substrate, wherein a first one of the plurality of conductive contacts is in electrical communication with the working electrode, a second one of the plurality of conductive contacts is in electrical communication with the reference electrode, and a third one of the plurality of conductive contacts is in electrical communication with the counter electrode; and

at least one via formed through the substrate that electrically connects the counter electrode to the third one of the plurality of conductive contacts; and

an on skin housing unit configured to prevent water from penetrating therethrough when the on skin housing unit is in contact with water and further configured to receive the analyte sensor substrate, wherein at least a portion of the wider proximal region the analyte sensor substrate is contained within the on skin housing unit and wherein at least a portion of the narrow distal region of the analyte sensor substrate protrudes from a sensor port disposed on a base of the on skin housing unit; and

a plurality of electronic components disposed in the on skin housing unit, wherein at least one of the plurality of electronic components is in electrical contact with the plurality of conductive contacts disposed on the wider proximal region of the analyte sensor substrate, and wherein the at least one of the plurality of electronic components is configured to;

receive a signal from a display device; and

provide sensor data to the display device.

21. The system of claim 20, wherein the on-skin housing unit comprises at least a first portion and a second portion.

22. The system of claim 21, wherein when the first portion of the on-skin housing unit and the second portion of the on-skin housing unit are operatively coupled, a seal is formed between the first portion of the on-skin housing unit and the second portion of the on-skin housing unit.

23. The system of claim 22, wherein the seal formed between the first portion of the on-skin housing unit and the second portion of the on-skin housing unit is a water resistant seal.

24. The system of claim 22, wherein the seal formed between the first portion of the on-skin housing unit and the second portion of the on-skin housing unit is a waterproof seal.

25. The system of claim 21, wherein each of the first portion of the on-skin housing unit and the second portion of the on-skin housing unit comprise interlocking structures.

26. The system of claim 20, wherein the on-skin housing unit is configured to prevent water from penetrating therethrough when the on-skin housing unit is immersed in water up to a predetermined depth.

27. An analyte monitoring system, comprising:

a sensor configured for in vivo monitoring of analyte levels in a fluid, the sensor comprising;

an analyte sensor substrate having a narrow distal region for partial implantation through a skin surface and a wider proximal region, the substrate including at least a first surface and a second surface;

at least one working electrode disposed on the narrow distal region of the substrate and in fluid contact with interstitial fluid under the skin surface, the at least one working electrode formed on the first surface of the substrate;

at least one reference electrode disposed on the narrow distal region of the substrate, the at least one reference electrode formed on the first surface of the substrate;

at least one counter electrode disposed on the narrow distal region of the substrate, the at least one counter electrode formed on the second surface of the substrate;

a plurality of conductive contacts disposed on the wider proximal region of the substrate and on the first surface of the substrate, wherein a first one of the plurality of conductive contacts is in electrical communication with the working electrode, a second one of the plurality of conductive contacts is in electrical communication with the reference electrode, and a third one of the plurality of conductive contacts is in electrical communication with the counter electrode; and

at least one via formed through the substrate that electrically connects the counter electrode to the third one of the plurality of conductive contacts; and

a sensor control unit comprising;

an on skin housing unit configured to prevent water from penetrating therethrough when the on skin housing unit is in contact with water and further configured to receive the analyte sensor substrate, wherein at least a portion of the wider proximal region the analyte sensor substrate is contained within the on skin housing unit and wherein at least a portion of the narrow distal region of the analyte sensor substrate protrudes from a sensor port disposed on a base of the on skin housing unit; and

a plurality of electronic components disposed in the on skin housing unit, wherein at least one of the plurality of electronic components is in electrical contact with the plurality of conductive contacts disposed on the wider proximal region of the analyte sensor substrate, and wherein the at least one of the plurality of electronic components is configured to;

receive a signal from an external device; and

provide sensor data to the external device.

28. The analyte monitoring system of claim 27, wherein at least one of the plurality of electronic components is disposed in a hollow region of the housing.

29. The analyte monitoring system of claim 27, wherein the on-skin housing comprises a first portion and a second portion wherein when the first portion is operatively coupled to the second portion a water resistant seal is formed between the first portion and the second portion.

30. The analyte monitoring system of claim 27, wherein the on-skin housing is configured to prevent water penetration when the on-skin housing is immersed in water up to a predetermined depth.