Interstitial fluid collection and constituent measurement

• US 7,014,615 B2
• Filed: 01/29/2003
• Issued: 03/21/2006
• Est. Priority Date: 10/13/1993
• Status: Expired due to Term

• Current Assignee: Integ Incorporated (Johnson & Johnson)
• Original Assignee: Integ Incorporated (Johnson & Johnson)
• Inventors: Knudson, Mark B., Erickson, Brian J., Hilgers, Michael E., Shapland, J. Edward, Hendrickson, Tracy A., Solomon, Frank A.
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): Foreman, Jonathan
• Application Number:
  US10/354,503
• Publication Number:
  US 20040087873A1
• Time in Patent Office: 1,147 Days
• Field of Search: 600/573, 600/583, 600/584, 604/27, 604/117, 604/289, 604/290, 604/28, 606/181, 606/182
• US Class Current: 600/573
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters

Abstract

An apparatus and method is disclosed for obtaining and measuring constituents in a sample of body fluid. The apparatus includes a member which is sized to penetrate into at least the dermal layer of skin to collect a sample of body fluid located within the dermal layer.

Claims

1. A method for testing a sample of body fluid, comprising:

forming an artificial opening into a patient'"'"'s skin but not through a dermal layer of said skin with a penetration member, wherein said opening is sized to access a constituent-containing, substantially blood-free fluid in the skin;

drawing a sample of said blood-free fluid into a first portion of said penetration member that is outside of said dermal layer while a second portion of said penetration member is within said dermal layer; and

testing said sample for said constituent.

2. A method according to claim 1 wherein said constituent is glucose.

3. A method according to claim 1 wherein said sample is tested by passing light through said sample and measuring an absorption of predetermined wavelengths.

4. A method according to claim 1 wherein said sample is tested colorimetrically.

5. A method according to claim 1 wherein said sample is tested electro-chemically.

6. A method according to claim 1 wherein said sample is tested by attenuated total reflection.

7. A method according to claim 1 comprising compressing said skin in a region surrounding said opening.

8. A method for testing a sample of body fluid, comprising:

inserting a penetration member into a patient'"'"'s skin but not through a dermal layer of the skin wherein said penetration member is sized to access a constituent-containing, substantially blood-free fluid in the skin and wherein a first portion of said penetration member is outside of said dermal layer while a second portion of said penetration member is within said dermal layer; and

testing said accessed fluid for said constituent wherein said fluid is drawn into the first portion of said penetration member prior to said testing.

9. A method according to claim 8 wherein said constituent is glucose.

10. A method according to claim 8 wherein said sample is tested colorimetrically.

11. A method according to claim 8 wherein said sample is tested electrochemically.

12. A method according to claim 8 wherein said sample is tested by attenuated total reflection.

13. A method according to claim 8 wherein said penetration member is a needle.