Interstitial fluid methods and devices for determination of an analyte in the body
First Claim
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1. A device for determining the presence or concentration of an analyte in the interstitial body fluid of a patient, the device comprising:
- (a) a plurality of test areas, each test area independently comprising (i) a porous matrix material having an absorption side and a test side and (ii) an indicating reagent system positioned on or impregnated in the test side of the porous matrix material, wherein each indicating reagent system is capable of indicating the presence or concentration of an analyte in interstitial body fluid by producing a spectrophotometric change upon contact with the interstitial body fluid;
(b) a substantially non-porous material separating each test area from adjacent test areas;
(c) an attachment means for attaching the device to the skin of a patient; and
(d) an extraction means for extracting interstitial body fluid through the skin of the patient;
wherein each test area is oriented so that the absorption side of the test area is positioned to contact the interstitial body fluid extracted through the skin of the patient.
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Abstract
Devices and methods for utilizing dry chemistry dye indicator systems for body fluid analysis, such as glucose level provided by incorporating a porous membrane in a disposable patch. The devices also provide for microtitration of fluid samples in fixed volumetric openings containing indicator reagent. The devices provided are low cost due to efficient manufacturing methods provided.
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Citations
61 Claims
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1. A device for determining the presence or concentration of an analyte in the interstitial body fluid of a patient, the device comprising:
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(a) a plurality of test areas, each test area independently comprising (i) a porous matrix material having an absorption side and a test side and (ii) an indicating reagent system positioned on or impregnated in the test side of the porous matrix material, wherein each indicating reagent system is capable of indicating the presence or concentration of an analyte in interstitial body fluid by producing a spectrophotometric change upon contact with the interstitial body fluid;
(b) a substantially non-porous material separating each test area from adjacent test areas;
(c) an attachment means for attaching the device to the skin of a patient; and
(d) an extraction means for extracting interstitial body fluid through the skin of the patient;
wherein each test area is oriented so that the absorption side of the test area is positioned to contact the interstitial body fluid extracted through the skin of the patient. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25)
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26. A method for testing the interstitial body fluid of a patient for the presence or concentration of an analyte comprising:
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providing a device comprising (a) a plurality of test areas, each test area independently comprising (i) a porous matrix material having an absorption side and a test side and (ii) an indicating reagent system positioned on or impregnated in the test side of the porous matrix material, wherein each indicating reagent system is capable of indicating the presence or concentration of an analyte in interstitial body fluid by producing a spectrophotometric change upon contact with the interstitial body fluid;
(b) a substantially non-porous material separating each test area from adjacent test areas;
(c) an attachment means for attaching the device to the skin of a patient; and
(d) an extraction means for extracting interstitial body fluid through the skin of the patient;
wherein each test area is oriented so that the absorption side of the test area is positioned to contact the interstitial body fluid extracted through the skin of the patient;
attaching the device to the skin of a patient;
extracting interstitial body fluid through the skin of the patient and onto the absorption side of the test areas;
detecting or measuring a spectrophotometric change or the absence thereof on the test side of the test areas. - View Dependent Claims (27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48)
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49. A process for preparing a device for determining the presence or concentration of an analyte in the interstitial body fluid of a patient, the device comprising:
- (a) a plurality of test areas, each test area independently comprising (i) a porous matrix material having an absorption side and a test side and (ii) an indicating reagent system positioned on or impregnated in the test side of the porous matrix material, wherein each indicating reagent system is capable of indicating the presence or concentration of an analyte in interstitial body fluid by producing a spectrophotometric change upon contact with the interstitial body fluid;
(b) a substantially non-porous material separating each test area from adjacent test areas;
(c) an attachment means for attaching the device to the skin of a patient; and
(d) an extraction means for extracting interstitial body fluid through the skin of the patient;
wherein each test area is oriented so that the absorption side of the test area is positioned to contact the interstitial body fluid extracted through the skin of the patient;the process comprising the steps of;
providing a porous matrix material having an absorption side and a test side;
applying an indicating reagent system to the test side of the porous matrix material, wherein the indicating reagent system is capable of indicating the presence or concentration of an analyte in interstitial body fluid by producing a spectrophotometric change upon contact with the interstitial body fluid;
compressing a pre-determined portion of the porous matrix material to form a substantially non-porous compressed area and a plurality of uncompressed test areas, each test area comprising the porous matrix material having the indicating reagent system positioned on or impregnated in the test side of the porous matrix material, the substantially non-porous compressed area being located between each test area;
applying or attaching an extraction means for extracting interstitial body fluid through the skin of a patient to the absorption side of the matrix material;
applying or attaching an attachment means for attaching the device to the skin of the patient to form the device. - View Dependent Claims (50)
- (a) a plurality of test areas, each test area independently comprising (i) a porous matrix material having an absorption side and a test side and (ii) an indicating reagent system positioned on or impregnated in the test side of the porous matrix material, wherein each indicating reagent system is capable of indicating the presence or concentration of an analyte in interstitial body fluid by producing a spectrophotometric change upon contact with the interstitial body fluid;
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51. A process for preparing a device for determining the presence or concentration of an analyte in the interstitial body fluid of a patient, the device comprising:
- (a) a plurality of test areas, each test area independently comprising (i) a porous matrix material having an absorption side and a test side and (ii) an indicating reagent system positioned on or impregnated in the test side of the porous matrix material, wherein each indicating reagent system is capable of indicating the presence or concentration of an analyte in interstitial body fluid by producing a spectrophotometric change upon contact with the interstitial body fluid;
(b) a substantially non-porous material separating each test area from adjacent test areas;
(c) an attachment means for attaching the device to the skin of a patient; and
(d) an extraction means for extracting interstitial body fluid through the skin of the patient;
wherein each test area is oriented so that the absorption side of the test area is positioned to contact the interstitial body fluid extracted through the skin of the patient;the process comprising the steps of;
providing a porous matrix material having an absorption side and a test side;
compressing a pre-determined portion of the porous matrix material to form a substantially non-porous compressed area and a plurality of uncompressed test areas, the substantially non-porous compressed area being located between each test area;
applying an indicating reagent system to the test side of each test area, wherein each indicating reagent system is capable of indicating the presence or concentration of an analyte in interstitial body fluid by producing a spectrophotometric change upon contact with the interstitial body fluid;
applying or attaching an extraction means for extracting interstitial body fluid through the skin of a patient to the absorption side of the matrix material;
applying or attaching an attachment means for attaching the device to the skin of the patient to form the device. - View Dependent Claims (52)
- (a) a plurality of test areas, each test area independently comprising (i) a porous matrix material having an absorption side and a test side and (ii) an indicating reagent system positioned on or impregnated in the test side of the porous matrix material, wherein each indicating reagent system is capable of indicating the presence or concentration of an analyte in interstitial body fluid by producing a spectrophotometric change upon contact with the interstitial body fluid;
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53. A kit for use by a patient to determine the presence or concentration of an analyte in the interstitial body fluid of the patient, the kit comprising:
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(1) a device comprising;
(a) a plurality of test areas, each test area independently comprising (i) a porous matrix material having an absorption side and a test side and (ii) an indicating reagent system positioned on or impregnated in the test side of the porous matrix material, wherein each indicating reagent system is capable of indicating the presence or concentration of an analyte in interstitial body fluid by producing a spectrophotometric change upon contact with the interstitial body fluid;
(b) a substantially non-porous material separating each test area from adjacent test areas;
(c) an attachment means for attaching the device to the skin of a patient; and
(d) an extraction means for extracting interstitial body fluid through the skin of the patient;
wherein each test area is oriented so that the absorption side of the test area is positioned to contact the interstitial body fluid extracted through the skin of the patient;
(2) an applicator for positioning and placing the device on the skin of the patient. - View Dependent Claims (54, 55)
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56. A device for determining the presence or concentration of an analyte in the interstitial body fluid of a patient, the device comprising:
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a substantially impermeable backing;
a semipermeable membrane secured to the backing to form at least one pocket;
a gel including an indicator reagent capable of indicating the presence of an analyte in interstitial body fluid by producing a spectrophotometric change upon contact with the interstitial body fluid;
an absorption side matrix in communication with the semipermeable membrane; and
an adhesive located on the absorption side of the matrix, the adhesive capable of securing a device to a patient. - View Dependent Claims (57, 58, 59, 60, 61)
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Specification