Method and apparatus for determination of chemical species in body fluid

Claim 2

A dermal concentration patch for determining the presence of an analyte inn 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, said concentration patch having sufficient permeability so as to permit water to escape through the support layer and outside of the concentration patch, wherein the reagent comprises a specific binding partner for the analyte to be determined.

Claim 3

A dermal concentration patch as in claim 1, wherein the support layer is hydrophobic.

Claim 4

A dermal concentration patch as in claim 1, further comprising an adhesive on the first side of the support layer and a hydrophilic permeable membrane on the second side of the support layer.

Claim 5

A dermal concentration patch as in claim 1, wherein the means for securing comprises adhesive tape.

Claim 6

A dermal concentration patch as in claim 1, wherein the reagent comprises an antibody having an affinity for the analyte to be determined.

Claim 7

A dermal concentration patch as in claim 1, wherein the reagent comprises antibody for at least one of creatine kinase MB and creatine kinase MM.

Claim 8

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; a discharge zone exposed too the atmosphere; a hydrophobic membrane, separating the concentration zone from the discharge zone; and means on the patch for removably securing the concentration zone in communication with the source of body fluid, wherein volatile components of the body fluid accumulated in the concentration zone are driven through the hydrophobic membrane in the vapor phase, but not in the liquid phase, thereby concentrating non-volatile desired components in the concentration zone.

Claim 9

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; a discharge zone exposed too the atmosphere; a hydrophobic membrane, separating the concentration zone from the discharge zone; and means on the patch for removably securing the concentration zone in communication with the source of body fluid, wherein volatile components of the body fluid accumulated in the concentration zone are driven through the hydrophobic membrane in the vapor phase, but not in the liquid phase, thereby concentrating non-volatile desired components in the concentration zone.

Claim 10

A concentration patch as in claim 7, wherein the means for removably securing the concentration zone comprises an adhesive surface, the source of body fluid comprises skin, and the concentration zone has a first side adapted to be placed in fluid communication with said skin, and further comprising: an inner porous layer on the first side of the concentration zone for spacing the concentration zone apart from the skin.

Claim 11

A concentration patch as in claim 8, further comprising an outer protective porous layer in the discharge zone.

Claim 12

A dermal concentration patch for concentrating components of perspiration expressed through the skin under the influence of body heat, comprising: a concentration zone adapted to be disposed in fluid communication with the skin, said zone being formed of a material which accumulates said perspiration; and a hydrophobic membrane adjacent the concentration zone, said membrane adapted to retain volatile and non-volatile components of said perspiration in the fluid phase within the concentration zone but permitting passage of volatile components of said perspiration in the vapor phase, wherein said concentration patch has sufficient permeability so as to permit water to escape through said concentration zone and hydrophobic membrane and outside of the concentration patch.

Claim 13

A dermal concentration patch for concentrating components of perspiration expressed through the skin under the influence of body heat, comprising: a concentration zone adapted to be disposed in fluid communication with the skin, said zone being formed of a material which accumulates said perspiration; and a hydrophobic membrane adjacent the concentration zone, said membrane adapted to retain volatile and non-volatile components of said perspiration in the fluid phase within the concentration zone but permitting passage of volatile components of said perspiration in the vapor phase, wherein said concentration patch has sufficient permeability so as to permit water to escape through said concentration zone and hydrophobic membrane and outside of the concentration patch.

Claim 14

The concentration patch of claim 10, additionally comprising means on the patch for removably securing the concentration zone in communication with the skin.

Claim 15

A dermal concentration patch for concentrating components of a body fluid under the influence of body heat, consisting essentially of: a hydrophilic concentration zone adapted for communication with a source of said body fluid; a hydrophobic membrane adjacent said concentration zone, said membrane adapted to concentrate non-volatile components of said body fluid in said concentration zone by permitting passage of volatile components therethrough in the vapor phase whilst retaining non-volatile and volatile components in the concentration zone in the fluid phase; and means on the patch for removably securing the concentration zone in communication with the source of body fluid.

Claim 16

A dermal concentration patch for concentrating components of a body fluid under the influence of body heat, consisting essentially of: a hydrophilic concentration zone adapted for communication with a source of said body fluid; a hydrophobic membrane adjacent said concentration zone, said membrane adapted to concentrate non-volatile components of said body fluid in said concentration zone by permitting passage of volatile components therethrough in the vapor phase whilst retaining non-volatile and volatile components in the concentration zone in the fluid phase; and means on the patch for removably securing the concentration zone in communication with the source of body fluid.

Claim 17

A concentration patch according to either claim 7 or 10, wherein said concentration zone comprises a hydrophilic material.

Claim 18

A concentration patch according too any one of claim 7, 10 or 12, wherein said concentration zone comprises a material selected from the group consisting of: knitting fabrics, nonwoven rayon, cellulose fibers and cotton gauze.

Claim 19

A concentration patch according to any one of claims 7, 10 or 12, wherein said hydrophobic membrane comprises teflon filter material.

Claim 20

A concentration patch according to either claim 7 or 10, wherein said hydrophobic membrane has a first side and a second side, said first said being adjacent said concentration zone, additionally comprising a flexible permeable outer layer adjacent said second side.

Claim 21

A concentration patch according too any one of claims 7, 11 or 12, wherein said means for removably securing the concentration zone comprises adhesive tape or a lower adhesive layer on said concentration zone.

Claim 24

A method as in claim 18, further comprising the step of expressing ann indicium of the concentration of the analyte.

Claim 25

A method as in claim 18, wherein the accumulating step is conducted in a porous layer.

Claim 26

A dermal concentration patch for the noninvasive determination of at least one preselected low-concentration analyte in a body fluid expressed through the skin as perspiration without the need for conventional instrumentation, comprising: a first layer adapted to be disposed in fluid communication with the skin, said layer being formed of a material which accumulates the body perspiration which vaporizes under the influence of body heat which is readily conducted from the surface of the skin through the accumulated perspiration fluids; a second layer adjacent the first layer, the second layer being formed of a material which will permit the passage of the vapor phase of fluids expressed from the skin but retain the fluid phase thereof within said first layer; and an immobilized reagent in contact with the first layer and with the accumulated perspiration for selectively binding with at least one preselected analyte, said concentration patch having sufficient permeability so as to permit water to escape through said first and second layers and outside of the concentration patch.

Claim 27

A dermal concentration patch for the noninvasive determination of at least one preselected low-concentration analyte in a body fluid expressed through the skin as perspiration without the need for conventional instrumentation, comprising: a first layer adapted to be disposed in fluid communication with the skin, said layer being formed of a material which accumulates the body perspiration which vaporizes under the influence of body heat which is readily conducted from the surface of the skin through the accumulated perspiration fluids; a second layer adjacent the first layer, the second layer being formed of a material which will permit the passage of the vapor phase of fluids expressed from the skin but retain the fluid phase thereof within said first layer; and an immobilized reagent in contact with the first layer and with the accumulated perspiration for selectively binding with at least one preselected analyte, said concentration patch having sufficient permeability so as to permit water to escape through said first and second layers and outside of the concentration patch.

Claim 28

A dermal concentration patch for the noninvasive determination of at least one preselected low-concentration analyte in a body fluid expressed through the skin as perspiration without the need for conventional instrumentation, comprising: a first layer adapted to be disposed in fluid communication with the skin, said layer being formed of a material which accumulates the body perspiration which is lost under the influence of body heat; a second layer adjacent the first layer, the second layer formed of a material which will permit passage of the liquid expressed from the skin; and an immobilized reagent in the second layer which selectively binds at least one preselected analyte, said concentration patch having sufficient permeability so as to permit water to escape through said first and second layers and outside of the concentration patch.

Claim 29

A dermal concentration patch for the noninvasive determination of at least one preselected low-concentration analyte in a body fluid expressed through the skin as perspiration without the need for conventional instrumentation, comprising: a first layer adapted to be disposed in fluid communication with the skin, said layer being formed of a material which accumulates the body perspiration which is lost under the influence of body heat; a second layer adjacent the first layer, the second layer formed of a material which will permit passage of the liquid expressed from the skin; and an immobilized reagent in the second layer which selectively binds at least one preselected analyte, said concentration patch having sufficient permeability so as to permit water to escape through said first and second layers and outside of the concentration patch.

Claim 30

A dermal concentration patch for determining the presence of an analyte in a subject mammal's perspiration, consisting essentially of: a water permeable support layer having a first and a second side; at least one specific binding partner for the analyte to be determined immobilized to the support layer; and means for removably securing the first side of the support layer in fluid communication with the subject's skin without preventing water from escaping through the support layer and outside of the concentration patch.

Claim 31

A dermal concentration patch for determining the presence of an analyte in a subject mammal's perspiration, consisting essentially of: a water permeable support layer having a first and a second side; at least one specific binding partner for the analyte to be determined immobilized to the support layer; and means for removably securing the first side of the support layer in fluid communication with the subject's skin without preventing water from escaping through the support layer and outside of the concentration patch.

Claim 34

The method of claim 24, additionally comprising analyzing the concentrated components of said body fluid in said concentration zone for the presence of said analyte.

Claim 35

The method of claim 25, wherein said analyte is selected from the group consisting of: diphtheria antitoxin, ascorbic acid, thiamine, riboflavin, nicotinic acid, amino acids, antipyrine, creatine, methylurea, acetamide, urea, thiourea, paraaminohippuric acid, mannitol, sucrose, lactate, sodium chloride, potassium, calcium, magnesium, phosphorus, manganese, sulfates, iodine, iron, fluirine, bromine, bismuth, lactic acid, pyruvate glucose, nitrogen, ammonia, uric acid, nicotine, morphine, sulfanilamide, atabrin, methadone, phencyclidine, aminopyrine, sulfaguanidine, sulfadiacine, amphetamines, creatine kinase, and high and low density lipoproteins.

Claim 36

The method of claim 24, wherein the securing step comprises application f adhesive tape.

Claim 37

The method of claim 24, wherein the securing step comprises securing the concentration zone in fluid communication with the skin of said mammal.

Claim 38

The method of claim 28, wherein the body fluid comprises perspiration.

Claim 39

The method of claim 24, wherein the concentrating step comprises hating said body fluid under the influence of body heat from said mammal.