Minimally-invasive system and method for monitoring analyte levels

• US 7,426,408 B2
• Filed: 08/02/2004
• Issued: 09/16/2008
• Est. Priority Date: 12/21/2001
• Status: Active Grant

• 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:
  US10/903,640
• Publication Number:
  US 20050096519A1
• Time in Patent Office: 1,506 Days
• Field of Search: 600345- 50
• 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:

at least one active electrode passing through an opening in a substantially planar surface of an auxiliary electrode, said active electrode having a length such that said active electrode penetrates through the stratum corneum to a depth sufficient to access said analyte;

wherein

said planar surface of said auxiliary electrode is oriented such that a line normal to said planar surface is substantially parallel to a penetration direction of said active electrode, which substantially planar surface contacts an outside surface of patient'"'"'s skin when the active electrode has penetrated said stratum corneum; and

at least one reference electrode adapted to penetrate through the stratum corneum, said reference electrode disposed apart from said active electrode at a distance equal to or less than a distance between said active electrode and any portion of said auxiliary electrode;

wherein at least said active electrode and reference electrode are connected to a controller to enable the electrochemical detection of said analyte.

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

said device further includes a base portion integral with said auxiliary electrode; and

said active electrode is extendable beyond said base portion to a length sufficient to access said analyte.

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

said active electrode is retractable into said base portion.

4. A device as claimed in claim 3, wherein:

said active electrode is automatically extendable beyond said base portion and automatically retractable into said base portion.

5. A device as claimed in claim 3, wherein:

said active electrode is manually extendable beyond said base portion and automatically retractable into said base portion.

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

said auxiliary electrode is adapted to pass into the stratum corneum when contacting said patient'"'"'s skin.

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

said device is further adapted to detect at least one parameter of said patient, such that said length of said active electrode enables said active electrode to pass through the stratum corneum to said depth sufficient to access a component to enable the electrochemical detection of said parameter; and

said at least one analyte and said at least one parameter includes at least one of the following;

electrolytes, oxygen, nitric oxide, lactate, insulin, neurotransmitters, at least one drug, pH level in the patient'"'"'s blood, the patient'"'"'s temperature, and resistance of the patient'"'"'s skin.

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

a plurality of said active electrodes.

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

said auxiliary electrode is coupled to at least a portion of the surface of said base portion proximate to that from which said active electrode extends.

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

said active electrode is further adapted to have an electrical potential applied thereto to enable the electrochemical detection of said analyte.

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

said active electrode is selected from antimony, ruthenium, rhodium, platinum, palladium, graphite, gold, and oxides thereof.

12. A device as claimed in claim 1, wherein said substantially planar surface has a central opening through which said active electrode passes.

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

at least one active electrode passing through an opening in a substantially planar surface of an auxiliary electrode and having a length such that said active electrode penetrates through the stratum corneum of said patient to a depth sufficient to access said analyte;

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

at least one reference electrode adapted to pass through the stratum corneum, said reference electrode disposed apart from said active electrode at a distance equal to or less than a distance between said active electrode and any portion of said auxiliary electrode;

wherein

said planar surface of said auxiliary electrode is oriented such that a line normal to said surface is substantially parallel to a penetration direction of said active electrode, which substantially planar surface contacts an outside surface of said patient'"'"'s skin when the active electrode has penetrated said stratus corneum.

14. A device as claimed it in claim 13, wherein:

said auxiliary electrode is configured to substantially entirely surround said active electrode.

15. A device as claimed in claim 13, wherein:

said device further includes a base portion integral with said auxiliary electrode; and

said active electrode is extendable beyond said base portion for a length sufficient to access said analyte.

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

said active electrode is retractable into said base portion.

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

said active electrode is automatically extendable beyond said base portion and automatically retractable into said base portion.

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

said active electrode is manually extendable beyond said base portion and automatically retractable into said base portion.

19. A device as claimed in claim 13, wherein:

said auxiliary electrode is adapted to pass into the stratum corneum when contacting said patient'"'"'s skin.

20. A device as claimed in claim 13, wherein:

said device is further adapted to detect at least one parameter of said patient, such that said length of said active electrode enables said active electrode to pass through the stratum corneum to said depth sufficient to access a component to enable the electrochemical detection of said parameter; and

said at least one analyte and said at least one parameter includes at least one of the following;

electrolytes, oxygen, nitric oxide, lactate, insulin, neurotransmitters, at least one drug, pH level in the patient'"'"'s blood, the patient'"'"'s temperature, and resistance of the patient'"'"'s skin.

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

a plurality of said active electrodes.

22. A device as claimed in claim 13, wherein:

said auxiliary electrode is coupled to at least a portion of the surface of said base portion proximate to that from which said active electrode extends.

23. A device as claimed in claim 13, wherein:

said active electrode is further adapted to have an electric potential applied thereto to enable reaction between said analyte in said patient and said substance to produce at least one electrochemically active product.

24. A device as claimed in claim 13, wherein said substantially planar surface has a central opening through which said active electrode passes.

25. A method for detecting an electrochemically active component in a patient, comprising:

placing a device against the skin of said patient, said device having at least one active electrode, said active electrode passing through an opening in a substantially planar surface of an auxiliary electrode and penetrating through the stratum corneum of said patient to a depth sufficient to access an electrochemically active component, said substantially planar surface of said auxiliary electrode oriented such that a line normal to said surface is substantially parallel to a penetration direction of said active electrode, which substantially planar surface contacts an outside surface of said patient'"'"'s skin when said active electrode has penetrated through said stratum corneum;

applying a potential to said active electrode, the amount of potential being adjusted with reference to a reference electrode of said device wherein said reference electrode is disposed away from said active electrode at a distance equal to or less than a distance between said active electrode and any portion of said auxiliary electrode; and

,

measuring current or charge from the electrochemical reaction of said electrochemically active component and said active electrode.

26. A method as claimed in claim 25, wherein:

said measuring is selected from integrated current, derivative of current, and derivative of charge.

27. A method as claimed in claim 25, wherein:

said applying an electric potential to said active electrode is selected from ramped, stepped, pulsed, programmed pulse and combinations thereof.

28. A method as claimed in claim 25, wherein:

said device further includes a base portion integral with said auxiliary electrode; and

said method further includes extending said active electrode beyond said base portion to a length sufficient to access said component.

29. A method as claimed in claim 28, further comprising:

retracting said active electrode into said base portion.

30. A method as claimed in claim 29, wherein:

said extending and retracting of active electrode are performed automatically.

31. A method as claimed in claim 29, wherein:

said extending and retracting of active electrode are performed manually.

32. A method as claimed in claim 25, wherein:

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

33. A method as claimed in claim 25, wherein:

said reference electrode is adapted to pass into the stratum corneum when the auxiliary electrode is contacting said patient'"'"'s skin.

34. A method as claimed in claim 25, further comprising:

storing information pertaining to said component.

35. A method as claimed in claim 25, further comprising:

communicating information between said device and an external device.

36. A method as claimed in claim 25, further comprising:

wearing said device on said patient for a duration of time.

37. A method as claimed in claim 25, wherein:

said device includes a plurality of said active electrodes; and

said method includes performing said placing, applying and measuring steps using said plurality of active electrodes.

38. A method as claimed in claim 25, further comprising:

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

39. A method as claimed in claim 25, wherein said component includes one of the following:

an electrolyte, oxygen, nitric oxide, lactate, insulin, neurotransmitters, a drug, pH level in the patient'"'"'s blood, a component indicative of the patient'"'"'s temperature, a component indicative of resistance of the patient'"'"'s skin, glucose oxidase, glucose dehydrogenase and lactate dehydrogenase.

40. A method as claimed in claim 25, wherein said substantially planar surface has a central opening through which said active electrode passes.

41. A method for detecting a component in a patient, comprising:

placing a device against the skin of said patient, said device having at least one active electrode, said active electrode passing through an opening in a substantially planar surface of an auxiliary electrode, and penetrating through the stratum corneum of said patient to a depth sufficient to access a component in the patient, said active electrode having at least one substance adjacent to at least a portion of said active electrode to enable said component to react with said substance to produce at least one electrochemically active product, said substantially planar surface of said auxiliary electrode oriented such that a line normal to said surface is substantially parallel to a penetration direction of said active electrode, which substantially planar surface contacts an outside surface of said patient'"'"'s skin when said active electrode has penetrated through said stratum corneum;

applying a potential to said active electrode, the amount of potential being adjusted with reference to a reference electrode of said device wherein said reference electrode is disposed away from said active electrode at a distance equal to or less than a distance between said active electrode and any portion of said auxiliary electrode; and

measuring current based on said reaction of said electrochemically active component in said patient and said substance.

42. A method as claimed in claim 41, wherein:

said measuring is selected from integrated current, derivative of current, and derivative of charge.

43. A method as claimed in claim 41, wherein:

said applying an electric potential to said active electrode is selected from ramped, stepped, pulsed, programmed pulse and combinations thereof.

44. A method as claimed in claim 41, wherein:

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

45. A method as claimed in claim 41, wherein said substantially planar surface has a central opening through which said active electrode passes.