Integrated tissue poration, fluid harvesting and analysis device, and method therefor
First Claim
1. A method for obtaining interstitial fluid for diagnostic testing comprising:
- (a) porating a selected area of skin to form an opening for extracting a sample comprising interstitial fluid,which sample is suitable for quantitating an analyte;
(b) collecting the sample from the opening, wherein step (b) is enhanced by applying a vacuum to the selected area of the skin.
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Accused Products
Abstract
An integrated device (100, 200, 300, 400, 600, 1000) for harvesting a biological fluid from the tissue and analysis of the biological fluid. The device comprises a layer having a porating element disposed thereon to form at least one opening in the tissue. Biological fluid is harvested from the opening of the tissue and placed in contact with a sensor incorporated in the integrated device. The sensor is responsive to the biological fluid to provide an indication of a characteristic of the biological fluid, such as the concentration of an analyte in interstitial fluid. The porating element may comprise one or more heat conducting elements that are either optically or electrically heated, or one or more mechanical porating elements.
585 Citations
49 Claims
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1. A method for obtaining interstitial fluid for diagnostic testing comprising:
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(a) porating a selected area of skin to form an opening for extracting a sample comprising interstitial fluid,which sample is suitable for quantitating an analyte;
(b) collecting the sample from the opening, wherein step (b) is enhanced by applying a vacuum to the selected area of the skin.
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2. A method for obtaining biological fluid for diagnostic testing comprising:
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(a) forming an opening in an area of skin suitable for extracting a sample of biological fluid suitable for measuring a characteristic of the fluid;
(b) extracting the sample from the opening, wherein at least one of positive and negative pressure is employed in order to enhance the extraction of the sample. - View Dependent Claims (3, 4)
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5. A multi-layer integrated device comprising:
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(a) a receiving layer capable of receiving a sample of biological fluid including an analyte and facilitating the movement of the fluid;
(b) an analyte sensor capable of detecting the presence of analyte or measuring the concentration of analyte in the fluid; and
(c) a substrate layer that is capable of being in contact with a processing circuit, wherein the receiving layer (a) is located underneath at least a portion of the substrate layer (c) and facilitates the movement of the biological fluid to the sensor (b); and
further wherein said substrate layer (c) has at least one opening therein.
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6. A multi-layer integrated device comprising:
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(a) a receiving layer capable of receiving a sample of biological fluid including an analyte and facilitating the movement of the fluid;
(b) an analyte sensor capable of detecting the presence of analyte or measuring the concentration of analyte in the fluid;
(c) a substrate layer that is capable of being in contact with a processing circuit, and (d) a bottom layer;
wherein the receiving layer (a) is located underneath at least a portion of the substrate layer (c) and wherein said substrate layer (c) has at least one opening therein.
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7. An integrated device comprising:
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(a) a pad capable of receiving and transporting a biological sample containing an analyte;
(b) a detector for detecting the presence and/or quantitating the concentration of analyte in the sample, said mechanism capable of being in contact with a display for illustrating results of the detector; and
(c) a strap or adhesive tape for holding the pad to an area of skin surface, wherein the integrated device contains at least one opening suitable to allow the biological sample to contact the pad. - View Dependent Claims (8)
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9. An integrated device for removing and testing a biological sample from the skin comprising;
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(a) a lower section having at least one opening therein;
(b) a pad capable of collecting and transporting a biological sample containing an analyte; and
(c) a detector for determining the presense and/or quantity of the analyte, said detector capable of being in contact with a display for the results of the detector. - View Dependent Claims (10)
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11. An integrated fluid harvesting and analysis device, comprising:
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(a) a first layer having a porating element disposed thereon, the porating element forming at least one opening in the tissue;
(b) a sensor positioned in fluid communication with the at least one opening in the tissue, the sensor being responsive to a biological fluid collected from the tissue to provide an indication of a characteristic of the biological fluid. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 39)
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38. An integrated fluid harvesting and analysis device, comprising:
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(a) a first layer for positioning in contact with tissue and through which poration of tissue is achieved such that at least one opening is formed in the first layer and at least one opening is formed in the tissue;
(b) a sensor positioned in fluid communication with the at least one opening of the first layer, the sensor being responsive to a biological fluid collected from the tissue to provide an indication of a characteristic of the biological fluid.
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40. A method for harvesting biological fluid from tissue and analyzing the biological fluid, comprising steps of:
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(a) placing a layer in contact with a surface of tissue;
(b) forming at least one hole in the tissue;
(c) collecting biological fluid from the tissue through at least one opening in the layer; and
(d) wetting a sensor that is positioned in fluid communication with the at least one opening in the layer with biological fluid to measure a characteristic of the biological fluid. - View Dependent Claims (41, 42, 43, 44, 45, 46, 47, 48, 49)
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Specification