Abstract: An adapter is provided for use with an infusion set and inserter device used for placement of a subcutaneous infusion set or the like used for delivering a selected medication to a patient. The adapter comprises a first end adapted to be removably coupled to the infusion set and a second end adapted to be removably coupled to an insertion device, particularly the sled fixtured in a track of the insertion tool. The adapter is designed for receiving and supporting an infusion set in a position in the inserter which is used for placement of and insertion of the needle or cannula through the skin of a patient at a selected insertion site. The provided adapter connectors enable the use of a variety of insertion sets having differing configurations with a given inserter having a given configuration.

Abstract: An apparatus embodying the invention includes a probe head with an interrogation surface that is intended to be positioned adjacent or pushed into contact with a target material or tissue. The probe head is constructed to have a plurality of interrogation devices arranged across the face of the interrogation surface. The probe head is also constructed so that the interrogation device can conform to a non-uniform or non-planar surface of the target tissue. In some embodiments, the interrogation surface may have a particular shape that conforms to the shape of a target material. In other embodiments, one or more portions of the interrogation surface could be movable with respect to the remaining portions so that the interrogation surface could be movable with respect to remaining portions so that the interrogation surface can thereby conform to a non-uniform surface. In still other embodiments, a plurality of separately moveable interrogation devices can be arranged across the interrogation surface.

Abstract: A system and method for measurement and analysis of a sample by absorption spectrophotometry is taught by the present invention. According to various embodiments, the invention utilizes a novel receptacle comprising of at plurality of layers including a transparent layer, a channel layer, and a reflective layer coupled to one another and allowing for fluid communication within and among the layers to allow for illumination by a light source and interrogation and analysis by a light measuring device. Examples of the light source and light measuring devices that could be used with the present invention include reflectance and/or fluorescence spectroscopy and a spectrometer, respectively. Measurement and analysis of a sample is compared to known values of constituents for comparison.

Abstract: A system and method for detecting substances such as glucose in tissue. The system comprises an assay device and an optical apparatus. The assay device comprises a reactive region that is responsive to at least one substance in fluid to be collected from the tissue when the fluid is in contact with the reactive region, and which reactive region is also responsive to a first type of optical energy suitable to heat up and transfer heat by conduction to the tissue to ablate the tissue and form at least one opening in the tissue from which fluid is collected. The optical apparatus has an activation head to which the assay device is attached, and a first optical energy source that outputs a first type of optical energy. An optical detecting device is included in the optical apparatus that measures a characteristic of the at least one substance from the response of the reactive region when the reactive region is in contact with the at least one substance.

Abstract: An apparatus and method embodying the invention include utilizing a device with a limited number of interrogation devices to accomplish a large number of measurements on a target tissue (50). An instrument embodying the invention includes a plurality of detection devices (54) that are arranged in a predetermined pattern on a tissue contacting face of the instrument. The face of the instrument is located adjacent the target tissue (50), and a plurality of tissue characteristic measurement are simultaneously conducted. The detection devices (54) are moved to a new position, preferably without moving the tissue contacting face, and a second plurality of tissue characteristic measurements are simultaneously conducted. By conducting a series of measurements cycles in this manner, the ultimate resolution of the device is increased, while still obtaining a given resolution, which reduces potential cross-talk errors.

Abstract: A device to facilitate ablation of tissue, such as for forming one or more openings in the tissue for transdermal monitoring and/or delivery applications. The device comprises: (a) a support layer having at least one aperture therein, and (b) at least one energy absorbent film layer disposed over the at least one aperture in the support layer for making substantial contact with tissue through the aperture. The at least one energy absorbent film layer is under a tension force and absorbs energy focused thereon to thermally ablate the tissue. After ablation, the layer breaks apart allowing access to the ablated tissue beneath it.

Abstract: An apparatus and method according to the invention combine more than one optical modality (spectroscopic method), including but not limited to fluorescence, absorption, reflectance, polarization anisotropy, and phase modulation, to decouple morphological and biochemical changes associated with tissue changes due to disease, and thus to provide an accurate diagnosis of the tissue condition.

Abstract: An apparatus and method according to the invention combine more than one optical modality (spectroscopic method), including but not limited to fluorescence, absorption, reflectance, polarization anisotropy, and phase modulation, to decouple morphological and biochemical changes associated with tissue changes due to disease, and thus to provide an accurate diagnosis of the tissue condition.

Abstract: An apparatus and method embodying the invention include utilizing a device with a limited number of interrogation devices to accomplish a large number of measurements on a target tissue (50). An instrument embodying the invention includes a plurality of detection devices (54) that are arranged in a predetermined pattern on a tissue contacting face of the instrument. The face of the instrument is located adjacent the target tissue (50), and a plurality of tissue characteristic measurement are simultaneously conducted. The detection devices (54) are moved to a new position, preferably without moving the tissue contacting face, and a second plurality of tissue characteristic measurements are simultaneously conducted. By conducting a series of measurements cycles in this manner, the ultimate resolution of the device is increased, while still obtaining a given resolution, which reduces potential cross-talk errors.

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: An apparatus embodying the invention includes a probe head with an interrogation surface that is intended to be positioned adjacent or pushed into contact with a target material or tissue. The probe head is constructed to have a plurality of interrogation devices arranged across the face of the interrogation surface. The probe head is also constructed so that the interrogation device can conform to a non-uniform or non-planar surface of the target tissue. In some embodiments, the interrogation surface may have a particular shape that conforms to the shape of a target material. In other embodiments, one or more portions of the interrogation surface could be movable with respect to the remaining portions so that the interrogation surface could be movable with respect to remaining portions so that the interrogation surface can the thereby conform to a non-uniform surface. In still other embodiments, a plurality of separately moveable interrogation devices can be arranged across the interrogation surface.

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 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 fiber optic probe is provided that includes a housing, at least one optical fiber disposed within the housing, one end of each of the at least one optical fiber being disposed adjacent an opening in the housing forming a probe face, a binding agent that binds the at least one optical fiber within the housing, and a protective coating sealingly covering the probe face to prevent contaminants from contacting the at least optical fiber. A method for protecting a fiber optic probe having a housing, at least one optical fiber disposed within the housing, one end of each of the at least one optical fiber being disposed adjacent an opening in the housing forming a probe face, and a binding agent that binds the at least one optical fiber within the housing, includes polishing the probe face to create a substantially flat probe face, cleaning the probe face after polishing the probe face and sealing the probe face with a protective coating.

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 combined infection shield and calibration or reference target for use with a measuring instrument includes a removable calibration/reference layer. The removable calibration/reference layer has predetermined optical characteristics that can be utilized to calibrate or reference the instrument. When the calibration/reference layer is removed from the remaining portions of the device, the portion of the calibration/reference layer having the predetermined optical characteristics is irrevocably altered such that the calibration/reference layer cannot be reused. The combined infection shield and target may be attached to a shield holder, which in turn is attached to an instrument. Alternatively, the infection shield and target may be attached directly to an instrument. The target may include a calibration/reference layer having a reduced strength portion which causes the target to tear or separate in a predetermined manner.

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.