Abstract: A system and method embodying the invention can be used to detect a characteristic or condition of a patient. A method embodying the invention may include the steps of illuminating a portion of a skin of the patient with light, detecting a frequency spectrum of light scattered from the skin, determining, from first and second portions of the spectrum, a first parameter indicative of a blood content of the skin and a second parameter indicative of a melanin content of the skin, determining, from a third portion of the spectrum, a third parameter indicative of an uncorrected bilirubin concentration, and calculating a corrected bilirubin concentration based on the first, second and third parameters.

Abstract: A method of enhancing the permeability of a biological membrane, including the skin or mucosa of an animal or the outer layer of a plant to a permeant is described utilizing microporation of selected depth and optionally one or more of sonic, electromagnetic, mechanical and thermal energy and a chemical enhancer. Microporation is accomplished to form a micropore of selected depth in the biological membrane and the porated site is contacted with the permeant. Additional permeation enhancement measures may be applied to the site to enhance both the flux rate of the permeant into the organism through the micropores as well as into targeted tissues within the organism.

Abstract: A method of enhancing the permeability of a biological membrane, including the skin or mucosa of an animal or the outer layer of a plant to a permeant is described utilizing microporation of selected depth and optionally one or more of sonic, electromagnetic, mechanical and thermal energy and a chemical enhancer. Microporation is accomplished to form a micropore of selected depth in the biological membrane and the porated site is contacted with the permeant. Additional permeation enhancement measures may be applied to the site to enhance both the flux rate of the permeant into the organism through the micropores as well as into targeted tissues within the organism.

Abstract: A photothermal structure designed for the uniform application of a photothermal material, such as, for example, a dye or a pigment, to a tissue, e.g., the stratum corneum. In one embodiment, the photothermal structure comprises photothermal material combined with a carrier, such as, for example, an adhesive or an ink, and the resulting combination is applied to a substrate, such as, for example, an inert polymeric substrate to form a photothermal structure. In another embodiment, the photothermal structure comprises photothermal material incorporated into a film-forming polymeric material.

Abstract: A method of enhancing the permeability of a biological membrane, including the skin or mucosa of an animal or the outer layer of a 20 plant to a permeant is described utilizing microporation of selected depth and optionally one or more of sonic, electromagnetic, mechanical and thermal energy and a chemical enhancer. Microporation is accomplished to form a micropore of selected depth in the biological membrane and the porated site is contacted with the permeant. Additional permeation enhancement measures may be applied to the site to enhance both the flux rate of the permeant into the organism through the micropores as well as into targeted tissues within the organism.

Abstract: A method and apparatus for enhancing the flux rate of a fluid through a biological membrane. The method includes the steps of porating a section of the tissue to form one or more micropores in the tissue, and applying a flux enhancer to the tissue through the one or more micropores. The resulting enhancement of fluid flux in the tissue enables more effective harvesting from the body of fluids, as well as more effectively delivery of a drug.

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.

Abstract: An article capable of both collecting interstitial fluid and detecting an analyte in that fluid and a method for use of that article. Preferably, the article is also capable of measuring the amount of analyte in the interstitial fluid. The article can be used in conjunction with a meter that contains an appropriate detection element for determining the amount of analyte in the interstitial fluid.

Abstract: A method and device for forming artificial openings in a biological membrane with a pyrotechnic charge that is exploded in a controlled manner in proximity of the biological membrane to form the artificial opening(s) therein. The method and device are useful in connection with transdermal delivery and monitoring applications.

Abstract: A method and device for forming artificial openings in a biological membrane with a pyrotechnic charge that is exploded in a controlled manner in proximity of the biological membrane to form the artificial opening(s) therein. The method and device are useful in connection with transdermal delivery and monitoring applications.

Abstract: A device and methods of use for delivering a drug to the body, or monitoring an analyte found in the body, are described. The device includes a base, a plurality of puncturing members extending from the base, a plurality of holes extending through the base for the passage of the drug or the analyte, and a network of channels for distributing the drug or collecting the analyte. Methods of trans-dermal or trans-mucous delivery of a drug or monitoring of an analyte are also described.

Abstract: A disposable calibration device is used to calibrate a measurement system which transmits radiation or acoustic waves to a material or tissue in order to effect measurements. The disposable calibration device includes a structure with a window through which the radiation or acoustic waves can be transmitted, as well as a removable calibration target arranged on the window and capable of returning a portion of the radiation or acoustic waves for calibrating the measurement system. The removable calibration target can be peeled from a window to allow a measurement to be made on the material or tissue. Once a measurement is complete, the disposable calibration device can be discarded and a new calibration device can be inserted on the measuring system.

Abstract: A method of enhancing the permeability of a biological membrane, including the skin or mucosa of an animal or the outer layer of a plant to a permeant is described utilizing microporation of selected depth and optionally one or more of sonic, electromagnetic, mechanical and thermal energy and a chemical enhancer. Microporation is accomplished to form a micropore of selected depth in the biological membrane and the porated site is contacted with the permeant. Additional permeation enhancement measures may be applied to the site to enhance both the flux rate of the permeant into the organism through the micropores as well as into targeted tissues within the organism.

Abstract: A method and apparatus for enhancing the flux rate of a fluid through a biological membrane. The method includes the steps of porating a section of the tissue to form one or more micropores in the tissue, and applying a flux enhancer to the tissue through the one or more micropores. The resulting enhancement of fluid flux in the tissue enables more effective harvesting from the body of fluids, as well as more effective delivery of a drug.

Abstract: A method of enhancing the permeability of the skin to an analyte for diagnostic purposes or to a drug for therapeutic purposes is described utilizing microporation and optionally sonic energy and a chemical enhancer. If selected, the sonic energy may be modulated by means of frequency modulation, amplitude modulation, phase modulation, and/or combinations thereof. Microporation is accomplished by (a) ablating the stratum corneum by localized rapid heating of water such that such water is vaporized, thus eroding the cells; (b) puncturing the stratum corneum with a micro-lancet calibrated to form a micropore of up to about 1000 .mu.m in diameter; (c) ablating the stratum corneum by focusing a tightly focused beam of sonic energy onto the stratum corneum; (d) hydraulically puncturing the stratum corneum with a high pressure jet of fluid to form a micropore of up to about 1000 .mu.m in diameter, or (e) puncturing the stratum corneum with short pulses of electricity to form a micropore of up to about 1000 .mu.

Abstract: A system and method for determining a duration that a patient has been experiencing a medical condition compares characteristics of fluorescent emissions from a target tissue to expected characteristics. In a system and method embodying the invention, a target tissue is illuminated with excitation light, and fluorescent emissions generated by the target tissue in response to the excitation light are detected. Different characteristics of the fluorescent emissions, including the fluorescent emission intensity or the fluorescent lifetime may be determined. The determined characteristics of the detected fluorescent emissions are then compared to expected characteristics of the fluorescent emissions. The amount that the detected fluorescent characteristics deviate from the expected fluorescent characteristics is used to determine a duration that a patient has been experiencing a medical condition. In some instances, the backscattered portions of the excitation light may also be used to make the determination.

Abstract: A system and method for calibrating a measurement instrument prior to making a measurement on a material or tissue includes utilizing a removable calibration device to calibrate the instrument, then removing a target portion of the calibration device so that a measurement may be performed. The calibration device may include an index matching agent, such as a gel, that is to be interposed between the patient's skin and an output end of the measuring instrument. A method embodying the invention may include making a bilirubin concentration measurement on a skin of a patient by measuring the amplitude of light reflected from the patient's skin at first and second wavelengths indicative of a blood content of the patient's skin, and measuring the amplitude of reflected light at a third wavelength indicative of an uncorrected bilirubin concentration, then calculating a corrected bilirubin concentration based on the three measurements.

Abstract: An apparatus and a method for electroporating tissue. At least one micropore is formed to a predetermined depth through a surface of the tissue, and electrical voltage is applied between an electrode electrically coupled to the micropore and another electrode spaced therefrom. By applying electroporation to tissue that has been breached by a micropore, the electroporation effects can be targeted at tissue structures beneath the surface, such as capillaries, to greatly enhance the withdrawal of biological fluid, and the delivery for uptake of compounds into the tissue. In a preferred embodiment, a device is provided having elements that are suitable for microporating the tissue and which serve as the electroporation electrodes.

Abstract: A method of enhancing the permeability of the skin to an analyte for diagnostic purposes or to a drug for therapeutic purposes is described utilizing microporation and optionally sonic energy and a chemical enhancer. If selected, the sonic energy may be modulated by means of frequency modulation, amplitude modulation, phase modulation, and/or combinations thereof. Microporation is accomplished by (a) ablating the stratum corneum by localized rapid heating of water such that such water is vaporized, thus eroding the cells; (b) puncturing the stratum corneum with a micro-lancet calibrated to form a micropore of up to about 1000 .mu.m in diameter; (c) ablating the stratum corneum by focusing a tightly focused beam of sonic energy onto the stratum corneum; (d) hydraulically puncturing the stratum corneum with a high pressure jet of fluid to form a micropore of up to about 1000 .mu.m in diameter, or (e) puncturing the stratum corneum with short pulses of electricity to form a micropore of up to about 1000 .mu.

Abstract: A disposable calibration device is used to calibrate a measurement system which transmits radiation or acoustic waves to a material or tissue in order to effect measurements. The disposable calibration device includes a structure with a window through which the radiation or acoustic waves can be transmitted, as well as a removable calibration target arranged on the window and capable of returning a portion of the radiation or acoustic waves for calibrating the measurement system. The removable calibration target can be peeled from window to allow a measurement to be made on the material or tissue. Once a measurement is complete, the disposable calibration device can be discarded and a new calibration device can be inserted on the measuring system.