Abstract: A fluid collection and sensor device for placement over at least one artificial opening made in a biological membrane for measuring a characteristic of a biological fluid collected from the tissue through the at least one artificial opening. The device comprises a sensor positioned in a flow path of the biological fluid for contacting a quantity of the biological fluid and generating an indication of a characteristic of the biological fluid. According to one aspect of the invention, a waste fluid storage element, such as a reservoir, is positioned in the device to collect the biological fluid after it has made contact with the sensor. According to another aspect of the invention, various surfaces of the fluid flow path of the fluid collection and sensor device are treated with an agent to limit or minimize clotting, aggregation or sepsis of the biological fluid, blockage or clogging of the flow path or degradation of the sensor.

Abstract: An improved light beam generation and focusing device (15, 50) has a light source (16, 51) constructed and arranged to emit at least one beam of light (20), and a lens assembly (17, 19, 56) constructed and arranged to focus the at least one beam of light on a surface plane. The device is constructed and arranged to sequentially direct the at least one beam of light to at least two spaced locations (21, 21?) on the surface plane. The lens assembly comprises a collimating lens (17), and a spaced focusing lens (19).

Abstract: A system and method for detecting a measuring an analyte in a biological fluid of an animal. A harvesting device (10) is provided suitable for positioning on the surface of tissue of an animal to harvest biological fluid therefrom. The harvesting device (10) comprises an analyte sensor (50) positioned to be contacted by the harvested biological fluid and which generates a measurement signal representative of the analyte. At least one attribute sensor (40) is provided to measure an attribute associated with the biological fluid harvesting operation of the harvesting device (10) or the assay of the biological fluid, and which generates an attribute signal representative of the attribute. Adjustments are made to operational parameters of the harvesting device (10) based on the one or more attributes.

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: 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: 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 method of enhancing the permeability of the skin or mucosa to an analyte for diagnostic purposed is described utilizing ultrasound or ultrasound plus a chemical enhancer. If desired the ultrasound may be modulated by means of frequency modulation, amplitude modulation, phase modulation and/or combinations thereof. A frequency modulation from low to high develops a local pressure gradient directed out of the body, thus permitting analytes in the body to traverse the skin and be collected and measured outside the body. The concentration of an analyte in the body is preferably determined by enhancing the permeability of the skin or other biological membrane optionally with a chemical enhancer, applying ultrasound optionally at a modulated frequency, amplitude, phase, or combinations thereof that further induces a local pressure gradient out of the body, collecting the analyte, and utilizing the analyte collection data calculating the concentration of the analyte in the body.