Analyte sensor

• US 7,228,162 B2
• Filed: 01/13/2003
• Issued: 06/05/2007
• Est. Priority Date: 01/13/2003
• Status: Expired due to Fees

• Current Assignee: Konamite Limited
• Original Assignee: Isense Corporation
• Inventors: Sass, Richard G., Ward, W. Kenneth, Anderson, Ellen, Jansen, Lawrence B., Nynest, Mark
• Primary Examiner(s): Nasser; Robert L.
• Assistant Examiner(s): Mallari; Patricia
• Application Number:
  US10/342,144
• Publication Number:
  US 20040138541A1
• Time in Patent Office: 1,604 Days
• Field of Search: 600/583
• US Class Current: 600/345
• 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15163 Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6848 Needles

Abstract

A method of measuring an analyte concentration in body fluid in an animal body having skin and subcutaneous soft tissue that includes body fluid. The method comprises, introducing a portion of an analyte-measuring device into the subcutaneous soft tissue. The analyte-measuring device includes an analyte sensing element, having a sharpened distal end to facilitate introduction into the animal body. Additionally the sensing element has an indicating electrode that is adapted to be activated by electric power and to form a raw analyte measurement, when it is activated and in contact with the body fluid, in less than two minutes. The sensing device further has a reference electrode and an electric power and display device that is adapted to mate to the analyte-sensing element. The power and display device activates the analyte-sensing element by applying electric power to it. The analyte-sensing element is introduced into the animal body and is activated by the electric power and display device, thereby causing the analyte-sensing element to form a raw analyte measurement. The power and display device forms and displays a second analyte measurement that is related to the raw analyte measurement, within two minutes of the analyte sensing element being introduced into the body.

Claims

1. A method of measuring an analyte concentration in body fluid in an animal body having skin and subcutaneous soft tissue that includes body fluid, said method comprising:

(a) providing an analyte measuring device, including;

(i) an analyte sensing element having an indicating electrode, said indicating electrode being adapted to be activated by electric power, and to form a raw analyte measurement when so activated and in contact with said body fluid; and

(ii) an electric power, data processing and display device adapted to mate to said analyte sensing element and activate said analyte sensing element by applying electric power to it and adapted to receive said raw analyte measurement and to compute and display a refined analyte measurement, related to said raw analyte measurement;

(b) introducing said analyte sensing element into said animal body subcutaneous soft tissue, thereby placing said indicating electrode into contact with said animal body subcutaneous soft tissue and said body fluid;

(c) activating said analyte sensing element by applying electric power to it, thereby causing said analyte sensing element to form a raw analyte measurement;

(d) removing said analyte sensing element from said soft tissue after the raw analyte measurement is formed; and

(e) wherein said analyte sensing element retains body fluid in contact with said indicating electrode after said analyte sensing element is removed from said body, and wherein said analyte sensing element is removed from said body prior to a refined analyte measurement being formed.

2. The method of claim 1, wherein said analyte measuring device further includes a housing and wherein said analyte sensing element is adapted to be withdrawn into said housing and placed therein in a state wherein reuse is impractical.

3. The method of claim 1, wherein said analyte sensing element further includes a sharpened distal and said indicating electrode and said sharpened distal end are physically coincident.

4. The method of claim 1, wherein said analyte sensing element is in the form of a sharpened tube and said indicating electrode is inside said tube.

5. The method of claim 4, wherein at least a portion of said sharpened tube serves as a reference electrode.

6. The method of claim 1, wherein said analyte sensing element includes a reference electrode that is adapted to abut the skin during the formation of an analyte measurement.

7. The method of claim 1, wherein said analyte measuring device includes a housing and wherein said analyte sensing element and said electric power, data processing and display device are operatively connected to said housing.

8. The method of claim 1, wherein said analyte measuring device includes a housing having a housing aperture and at least a first analyte sensing element and a second analyte sensing element and wherein before said analyte measuring device is ever used, both said first analyte sensing element and said second analyte sensing element are stored in an inactive state, enclosed by said housing, but at the time of the first use of said device said first analyte sensing element is deployed into an active state, at least in part protruding through said housing aperture and after said first use said first analyte sensing element is withdrawn into said housing and placed in an inactive storage state and further wherein at the time of the second use of said device said second analyte sensing element is deployed into said active state and after said second use said second analyte sensing element is withdrawn into said housing and stored in said inactive storage state.

9. The method of claim 8, wherein said first analyte sensing element and said second analyte sensing element are held, during said inactive storage state, at a sub unit that is releasably attached to said housing.

10. The method of claim 9, wherein said sub unit is a magazine having at least two sensing element holders, and wherein said sensing elements are held by said magazine both before and after use.

11. The method of claim 1, wherein said electric power, data processing and display device applies electric power to said analyte sensing element by providing a known voltage between said indicating electrode and a reference electrode, and said raw analyte measurement is in the form of an electrical current that is related to glucose concentration and said electric power, data processing and display device receives said raw analyte measurement by measuring said electrical current.

12. The method of claim 1, wherein said electric power, data processing and display device measures said electric current at more than one instance in time and uses a resulting plurality of raw analyte measurements to form a single refined analyte measurement.

13. The method of claim 1, wherein said electric power, data processing and display device forms said refined analyte measurement, in part, by subtracting an initial transient current from said raw analyte measurement, said initial transient current being present when said raw analyte measurement begins in vivo.

14. The method of claim 1, wherein said refined analyte measurement includes an indication of a direction of change in analyte concentration.

15. A method, comprising:

introducing an analyte sensing element into an animal body;

applying electric power to said analyte sensing element to form a raw analyte measurement;

removing said analyte sensing element from said animal body, after the raw analyte measurement is formed, wherein said analyte sensing element retains body fluid from said animal body after said analyte sensing element is removed from said animal body; and

forming a refined analyte measurement based on said raw analyte measurement after said analyte sensing element is removed from said animal body.

16. The method of claim 15, wherein said analyte sensing element comprises an indicating electrode and wherein said body fluid is maintained in contact with said indicating electrode after said analyte sensing element is removed from said animal body.

17. A method, comprising:

providing an analyte sensing element adapted to be introduced into an animal body and adapted to retain body fluid from the animal body after said analyte sensing element is removed from the animal body; and

coupling to said analyte sensing element a device adapted to provide electric power to said analyte sensing element, said device adapted to form a raw analyte measurement based on analyte sensed by said analyte sensing element before removal of the analyte sensing element from the animal body and adapted to form a refined analyte measurement based on said raw analyte measurement after removal of said analyte sensing element from the animal body.