Minimally-invasive system and method for monitoring analyte levels

• US 6,952,604 B2
• Filed: 12/21/2001
• Issued: 10/04/2005
• Est. Priority Date: 12/21/2001
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: DeNuzzio, John D., Strohben, William E. Jr.
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US10/024,506
• Publication Number:
  US 20040015063A1
• Time in Patent Office: 1,383 Days
• Field of Search: 600345-350, 204/403
• US Class Current: 600/345
• 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 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

A minimally-invasive analyte detecting device and method for using the same. The system and method employ a device having an active electrode optionally coated with a substance, and a counter-electrode that is configured at least partially surround the active electrode. The configuration of the auxiliary electrode and active electrode improves the current flow through the device and increases the sensitivity of the device. When the device is placed against the patient'"'"'s skin, the active electrode is adapted to enter through the stratum corneum of a patient to a depth less than a depth in the dermis at which nerve endings reside. An electric potential is applied to the active electrode and the analyte level is determined based on the amount of current or charge flowing through the device.

Claims

1. A device for detecting at least one analyte in a patient, comprising:

a plurality of active electrodes, said active electrodes having a length such that said active electrodes are adapted to pass through the stratum corneum to a depth which is sufficient to access said analyte and less than a depth in the dermis at which nerve endings reside, to enable the electrochemical detection of said analyte; and

auxiliary electrodes configured to at least partially surround each of said active electrodes, and adapted to contact the surface of patient'"'"'s skin when the device is placed against said patient and operated to detect said at least one analyte;

wherein said plurality of active electrodes are adapted to be sequentially positioned at at least one active location of said device.

2. A device as claimed in claim 1, wherein:

said auxiliary electrode has an abraded surface which is adapted to contact said patient'"'"'s skin.

3. A device as claimed in claim 1, further comprising:

a data storage, adapted to store information pertaining to said at least one analye or said patient.

4. A device as claimed in claim 1, further comprising:

a communication device, adapted to communicate information between said device and an external device.

5. A device as claimed in claim 1, wherein:

said device is adapted for wearing by said patient for a duration of time.

6. A device as claimed in claim 1, wherein:

said analyte is electrochemically active.

7. A device as claimed in claim 1, wherein:

said analyte is selected from nitric oxide, neurotransmitters, insulin, and oxygen.

8. A device as claimed in claim 1, wherein:

said plurality of active electrodes are contained after use.

9. A device as claimed in claim 1, further comprising:

a delivery device integral therewith.

10. A device as claimed in claim 9, wherein:

said device and said delivery device are adapted to communicate with each other to control administration of a substance that said delivery device delivers to said patient.

11. A device for detecting at least one analyte in a patient, comprising:

a plurality of active electrodes having a length such that said active electrodes are adapted to pass through the stratum corneum of said patient to a depth which is sufficient to access said analyte and less than a depth in the dermis at which nerve endings reside; and

at least one substance adjacent to at least a portion of said active electrodes capable of reacting with at least one analyte to produce at least one electrochemically active product; and

auxiliary electrodes configured to at least partially surround each of said active electrodes, and adapted to contact the surface of said patient'"'"'s skin when the device is placed against said patient and operated to detect said at least one analyte;

wherein said plurality of active electrodes are adapted to be sequentially positioned at at least one active location of said device.

12. A device as claimed in claim 11, wherein:

said auxiliary electrode has an abraded surface which is adapted to contact said patient'"'"'s skin.

13. A device as claimed in claim 11, further comprising:

a data storage, adapted to store information pertaining to said at least one analye or said patient.

14. A device as claimed in claim 11, further comprising:

a communication device, adapted to communicate information between said device and an external device.

15. A device as claimed in claim 11, wherein:

said device is adapted for wearing by said patient for a duration of time.

16. A device as claimed in claim 11, wherein:

said substance is selected from glucose oxidases, glucose dehydrogenases, and electrochemically responsive receptors.

17. A device as claimed in claim 11, wherein:

said plurality of active electrodes are contained after use.

18. A device as claimed in claim 11, further comprising:

a delivery device integral therewith.

19. A device as claimed in claim 18, wherein:

said device and said delivery device are adapted to communicate with each other to control administration of a substance that said delivery device delivers to said patient.

20. A device for detecting at least one analyte in a patient, comprising:

a plurality of active electrodes adapted to be sequentially positioned at at least one active location of said device, each said active electrode having a length such that said active electrode is adapted to pass through the stratum corneum to a depth which is sufficient to access said analyte to enable the electrochemical detection of said analyte; and

auxiliary electrodes configured to at least partially surround each of said active electrodes, and adapted to contact patient'"'"'s skin when the device is placed against said patient.

21. A device as claimed in claim 20, wherein:

said plurality of active electrodes are contained after use.

22. A device for detecting at least one analyte in a patient, comprising:

a plurality of active electrodes adapted to be sequentially positioned at at least one active location of said device each said active electrode having a length such that said active electrode is adapted to pass through the stratum corneum of said patient to a depth sufficient to access said analyte; and

at least one substance adjacent to at least a portion of said active electrode capable of reacting with at least one analyte to produce at least one electrochemically active product; and

auxiliary electrodes configured to at least partially surround each of said active electrodes, and adapted to contact patient'"'"'skin when the device is placed against said patient.

23. A device as claimed in claim 22, wherein:

said plurality of active electrodes are contained after use.