Method and apparatus for determination of chemical species in body fluid

• US 4,957,108 A
• Filed: 09/08/1988
• Issued: 09/18/1990
• Est. Priority Date: 09/08/1988
• Status: Expired due to Term

• Current Assignee: Sudormed Incorporated
• Original Assignee: Sudor Partners
• Inventors: Miller, William R., Schoendorfer, Donald W.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US07/241,707
• Time in Patent Office: 740 Days
• Field of Search: 128/632, 128/636, 128/637, 128/760, 128/771, 604/312, 604/378, 422/58
• US Class Current: 600/362
• CPC Class Codes: A61B 10/0035 Vaccination diagnosis other than by injuring the skin, e.g. allergy test patches
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 10/0064 for taking sweat or sebum samples measuring sweat production A61B5/4266
• CPC Class Codes: A61B 2010/0009 Testing for drug or alcohol abuse
• CPC Class Codes: A61B 5/14517 for sweat
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: A61B 5/418 lymph vessels, ducts or nodes
• CPC Class Codes: A61B 5/4266 sweat secretion
• CPC Class Codes: A61F 2013/00608 with reinforcing layers
• CPC Class Codes: A61F 2013/00646 Medication patches, e.g. transcutaneous
• CPC Class Codes: B01L 3/505 flexible containers not provided for above
• CPC Class Codes: G01N 33/54386 Analytical elements

Abstract

Disclosed is a method and apparatus for the non-invasive determination of one or more preselected analytes in a body fluid expressed through the skin. The fluid is collected in a dermal concentration patch and concentrated by driving off a portion of the substantial water fraction under the influence of body heat. The analyte is optimally complexed with an immobilized specific binding partner and an indicium of the presence of the analyte is visually expressed.

Claims

1. A dermal concentration patch for determining the presence of an analyte in a subject mammal'"'"'s perspiration, comprising:

a water permeable support layer having a first and a second side;

at least one reagent immobilized to the support layer;

means for removably securing the first side of the support layer in fluid communication with the subject'"'"'s skin,

wherein water is permitted to escape through the support layer and outside of the concentration patch, and the reagent comprises a specific binding partner for the analyte to be determined; and

a permeable outer protective layer disposed adjacent the second side of the support layer.

2. A dermal concentration patch for determining the presence of an analyte in a subject mammal'"'"'s perspiration, comprising:

a water permeable support layer having a first and a second side, wherein the support layer comprises a plurality of microbeads;

at least one reagent immobilized to the support layer;

means for removably securing the first side of the support layer in fluid communication with the subject'"'"'s skin,

wherein water is permitted to escape through the support layer and outside of the concentration patch, and the reagent comprises a specific binding partner for the analyte to be determined.

3. A dermal concentration patch as in claim 2, further comprising a first fluid permeable layer disposed on the first side of the support layer and a second fluid permeable layer disposed on the second side of the support layer for encasing the microbeads.

4. A dermal concentration patch for determining the presence of an analyte in a subject mammal'"'"'s perspiration, comprising:

a water permeable support layer having a first and a second side;

at least one reagent immobilized to the support layer;

means for removably securing the first side of the support layer in fluid communication with the subject'"'"'s skin,

wherein water is permitted to escape through the support layer and outside of the concentration patch, and the reagent comprises a specific binding partner for the analyte to be determined; and

a hydrophobic layer on the second side of the support layer for retaining fluid while permitting vapor to escape therethrough.

5. A concentration patch for concentrating components of a body fluid under the influence of body heat, comprising:

a concentration zone adapted for communication with a source of body fluid, wherein the concentration zone comprises an immobilized specific binding partner for at least one analyte to be determined in the body fluid;

a discharge zone exposed to the atmosphere;

a microporous membrane separating the concentration zone from the discharge zone; and

means for removably securing the concentration zone in communication with the source of body fluid,

wherein undesired components of body fluid accumulated in the concentration zone are driven through the membrane, thereby concentrating desired components in the concentration zone.

6. A concentration patch as in claim 5, wherein the analyte is creatine kinase.

7. A method for determining the presence of an analyte in a body fluid, comprising the steps of:

accumulating a quantity of a body fluid from a subject mammal;

removing at least a portion of the water component from the fluid under the influence of body heat to form a concentrate;

binding at least one analyte in the concentrate to an immobilized specific binding partner of that analyte; and

exposing the immobilized specific binding partner of the analyte to an excess of a labeled binding partner for the analyte following the binding step so that analyte bound to the immobilized specific binding partner of the analyte will become bound to a labeled binding partner.

8. A method as in claim 7, wherein the labeled binding partner is a labeled purified analyte or analyte analog.