Interstitial fluid collection and constituent measurement

• US 6,080,116 A
• Filed: 10/09/1998
• Issued: 06/27/2000
• 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
• Application Number:
  US09/169,155
• Time in Patent Office: 627 Days
• Field of Search: 600/573, 600/583, 600/584, 604/51, 604/117, 604/289, 604/290, 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. An apparatus for simultaneously collecting a sample of a patient'"'"'s body fluid and preparing a collected sample for subsequent testing for an analyte contained within the collected sample, the apparatus comprising:

a housing sized to be manipulated by a patient with a housing end place against a skin surface of the patient;

a penetration member carried on the housing, the penetration member having a protruding end protruding from the housing, the protruding end for penetrating the skin surface, but not through a dermis, upon placement of the housing end against the skin surface;

a test site carried on the housing; and

a fluid flow pathway from the protruding end to the test site for fluid to flow from the protruding end to the test site when the protruding end is penetrated into the skin surface.

2. An apparatus according to claim 1 wherein the penetration member is a needle open at the protruding end and having a second open end at the Test site and the fluid flow pathway is a hollow interior of the needle.

3. An apparatus according to claim 2 further comprising a substrate at the test site for receiving the sample from the second end of the needle and dispersing the sample on the substrate.

4. An apparatus according to claim 3 wherein the substrate is an absorbent membrane.