Integrated system for biological fluid constituent analysis

• US 5,443,080 A
• Filed: 12/22/1993
• Issued: 08/22/1995
• Est. Priority Date: 12/22/1993
• Status: Expired due to Fees

• Current Assignee: Americare Diagnostics, Inc.
• Original Assignee: Americare Transtech, Inc.
• Inventors: Han, Kedu, Glenn, Daniel J., D'Angelo, Joseph P., Schur, Henry
• Primary Examiner(s): RIMELL, SAMUEL G
• Application Number:
  US08/173,635
• Time in Patent Office: 608 Days
• Field of Search: 128/637, 128/760, 128/766, 128/771, 128/632, 128/636, 424/449
• US Class Current: 600/573
• CPC Class Codes: A61B 10/0064 for taking sweat or sebum samples measuring sweat production A61B5/4266
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• 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 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: B01L 2300/0803 Disc shape
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 9/52 Supports specially adapted for flat sample carriers, e.g. for plates, slides, chips
• CPC Class Codes: G01N 21/251 Colorimeters; Construction thereof
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements

Abstract

A multi-part system to collect and analyze constituents of body fluid. The use of a multilayered gel matrix to facilitate the collection of analytes fluid and a chemistry detection methodology incorporated into the matrix to aid in the visual or electronic determination of the analyte is described.

Claims

1. An integrated system for biological fluid constituent analysis, comprising:

collector means for non-invasively collecting a body fluid analyte from a patient and indicator means responsive to the body fluid analyte for indicating a condition of the body fluid analyte;

electronic interpretation means receiving said indicator means and electro-optically interpreting said indicator means with regard to the condition of the body fluid analyte;

wherein said collector means are in the form of a multi-layer laminate including a chemical reactant layer coated with a test reagent and color developer specifically provided for a given test, an activation gel layer disposed below said chemical reactant layer, a collection gel layer disposed below said activation gel layer, and a skin interface membrane layer disposed below said collection gel layer for placement on the patient'"'"'s skin;

said indicator means being in the form of a color wheel, said color wheel being divided into a plurality of color segments each communicating with said multi-layer laminate for displaying a given color in response to a given amount of body fluid analyte processed through said layers.

2. The system according to claim 1, wherein said activation gel layer is a hygroscopic biopolymer gel with a biochemical intermediate incorporated therein for reacting with the collected body fluid analyte and producing a specific by-product in the reaction for detection in said chemical reactant layer.

3. The system according to claim 1, wherein said collection gel layer includes a hygroscopic biopolymer gel with an osmotic flow enhancer incorporated therein and specifically selected for the body fluid analyte to be tested.

4. The system according to claim 1, wherein said electronic interpretation means include a light source for illuminating the indicator means received therein, a photosensor sensing a reflection intensity from the indicator means, and means for interpreting the measured reflection intensity and providing information regarding a result of the interpretation.

5. The system according to claim 1, wherein said collector means for collecting a body fluid analyte are means for collecting a transdermally excreted body fluid analyte.

6. A collection and indication apparatus for biological fluid constituent analysis, comprising:

collector means for non-invasively collecting a body fluid analyte from a patient in the form of a multi-layer laminate including a chemical reactant layer, an activation gel layer disposed below said chemical reactant layer, and a collection gel layer disposed below said activation gel layer; and

indicator means contiguous with said collector means and responsive to the body fluid analyte for indicating a condition of the body fluid analyte, said indicator means being in the form of a color wheel, said color wheel being divided into a plurality of color segments each communicating with said multi-layer laminate for displaying a given color in response to a given amount of body fluid analyte processed through said layers.

7. The apparatus according to claim 6, including a skin interface membrane layer disposed below said collection gel layer for placement on a patient'"'"'s skin.

8. The apparatus according to claim 6, wherein said chemical reactant layer is coated with a test reagent and color developer specifically provided for a given test.

9. The apparatus according to claim 6, wherein said activation gel layer is a hygroscopic biopolymer gel with a biochemical intermediate incorporated therein for reacting with the collected body fluid analyte and producing a specific by-product in the reaction for detection in said chemical reactant layer.

10. The apparatus according to claim 8, wherein said biochemical intermediate incorporated in said hygroscopic biopolymer gel is an enzyme.

11. The apparatus according to claim 7, wherein said collection gel layer includes a hygroscopic biopolymer gel with an osmotic flow enhancer incorporated therein and specifically selected for the body fluid analyte to be tested.

12. The apparatus according to claim 6, further including storage means in the form of a booklet having pouches formed therein for receiving a plurality of said indicator means and for displaying indications of various test results.