Abstract: A method to detect a structure of interest includes shading a target from ambient light. A first plurality of images is acquired from the target. Background in the first plurality of images is reduced to minimize or eliminate brightness variation in the images and to generate a first plurality background-reduced images. A second plurality of images is acquired from the target. Background in the second plurality of images is reduced to generate a second plurality of background-reduced images. Noise in the second plurality of background-reduced images is reduced to generate a noise-reduced image, which is then multiplied to generate an amplified image. A structure of interest is detected in the amplified image. An imaging device that can be used to carry out the method is also included and includes an illuminator that shades the target from ambient light and scatters light.

Abstract: A transdermal agent sampling device is provided. The sampling device is comprised of a microblade array and a device for applying a partial vacuum. The microblade array comprises a sheet having a plurality of microblades for piercing the skin to a very shallow depth (i.e., 25 &mgr;m to 400 &mgr;m) to create microslits in the outermost stratum corneum layer of the skin. The partial vacuum applying device applies a partial vacuum in the range of about 0.1 to about 0.8 atm, and preferably about 0.3 to about 0.7 atm, for sampling a body analyte such as glucose in interstitial fluid. The partial vacuum is applied for a period of about 2 to about 30 seconds, and preferably about 5 to about 15 seconds. The interstial fluid is analyzed for body analyte (e.g., glucose) content or concentration.

Abstract: The invention provides an improved electrotransport drug delivery system for analgesic drugs, namely fentanyl and sufentanil. The fentanyl/sufentanil is provided as a water soluble salt (e.g., fentanyl hydrochloride), preferably in a hydrogel formulation, for use in an electrotransport device (10). In accordance with the present invention, a transdermal electrotransport delivered dose of fentanyl/sufentanil is provided which is sufficient to induce analgesia in (e.g., adult) human patients suffering from moderate-to-severe pain associated with major surgical procedures.

Abstract: An electrode assembly and a method of forming an anhydrous reservoir layer of an electrode assembly in an electrotransport transdermal agent delivery device are provided. The reservoir layer is adapted to be placed in agent-transmitting relation with a body surface and an electrode in electrical contact with a power source and the reservoir layer. The method includes the steps of dissolving a beneficial agent in a solvent, applying the solvent and dissolved beneficial agent to a surface of a hydrophilic polymer filtration membrane, removing the solvent from the surface of the filtration membrane, and disposing the beneficial agent/filtration membrane within the electrode assembly.

Abstract: The invention provides a method for adjusting, i.e., varying, the rate of delivery of a therapeutic agent through a body surface from an electrotransport assembly of the type which includes a predetermined, e.g., fixed, output electronic controller and a detachable therapeutic agent source. The method provides a plurality of therapeutic agent sources in which a single parameter or a series of parameters has been varied. The plurality of agent sources are supplied, one at a time, to the controller of the electrotransport assembly, so that together (i.e., source and controller) the agent delivery rate is varied.

Abstract: Method of making an electrotransport device containing an analog of a parent polypeptide having one or more amino acid residues substituted relative to the parent polypeptide with an amino acid residue selected from the group consisting of proline, glycine and asparagine.

Abstract: An electrotransport device (10) for the electrotransport delivery of agents having at least one hydrophobic site thereon, such as peptides and proteins, contains donor and counter electrodes (12, 16 and 14, 18), a power source and electrical control circuitry (24). The donor electrode (12, 16) contains, in addition to the agent, an electrotransport enhancer such as non-ionic surfactants or zwitterionic surfactants without a net charge. A method of increasing electrotransport flux of agent shaving at least one hydrophobic site thereon utilizes non-ionic or zwitterionic surfactants in the solution or suspension containing the agent. A method for the electrotransport delivery of an agent with at least one hydrophobic site through a body surface relies on the incorporation of a non-ionic surfactant or a zwitterionic surfactant without a net charge, into the solution or suspension containing the agent to decrease its hydrophobicity.

Abstract: A device (3) comprising a sheet member (6) having a plurality of microprotrusions (4) for penetrating the skin and a rigid support (15) contacting and extending across the sheet member (6) for transmitting an applied force evenly across the length and width of the sheet member (6) to reproducibly and reliably penetrate the skin with the microprotrusions (4).

Abstract: The invention is directed to a composition and product for use in an electrotransport device. The composition includes an ionized drug, an anti-inflammatory agent and a solvent. Preferably, the anti-inflammatory agent is hydrocortisone or esters thereof, and the solvent is water and a material such as an alcohol, a glycol, a glycerol, a cyclodextrin, a nonionic surfactant and/or mixtures thereof.

Abstract: An iontophoretic delivery device (10) is provided. Device (10) has an electronic circuit (32) having electronic components such as batteries (30) mounted thereon. Device (10) also includes a pair of electrode assemblies (18, 19). The electronic circuit (32) is electrically connected to the electrode assemblies (18, 19) using an electrically conductive adhesive (34). The adhesive can also be used to electrically connect two or more electronic components within circuit (32) or to connect an electronic component to the electronic circuit (32). In one practice of the invention, the electrically conductive adhesive (44) functions as an electrode and electrically connects the circuit (32) to an agent-containing reservoir (24, 25). In a further practice of the invention, the electrically conductive adhesive (93) functions as an agent reservoir and contains the agent to be iontophoretically delivered.

Abstract: Methods for modifying polypeptide agents to enhance their transdermal electrotransport flux are provided. The polypeptide is modified by reducing the potential of the polypeptide for forming &agr;-helical or &bgr;-sheet segments. In particular, amino acid residues known to stabilize &agr;-helical and &bgr;-sheet segments can be replaced with destabilizing residues and known helix breakers. Modified molecules and compositions including the molecules are also provided.

Abstract: An electrotransport apparatus using dispersed ion exchange material (19,83) is disclosed. The ion exchange material (19,83) may be dispersed in either the donor electrode assembly (10), the counter electrode assembly (10) or both electrode assemblies. The dispersed ion exchange material (83) comprises mobile ionic species (84-2) and substantially immobile ionic species (P). The dispersed ion exchange material (83, 84-2) interacts with competitive species (86) generated during electrotransport to render those species substantially immobile (87). Electrotransport devices exhibiting reduced polarization are also disclosed.

Abstract: The present invention relates to hydratable drug reservoir films for electrotransport drug delivery devices and to electrotransport drug delivery systems containing the hydratable drug reservoirs and to methods for manufacturing and using such systems. The hydratable reservoir films according to this invention are easily manufacturable and rapidly imbibe water and/or drug solution with good water retention and stability.

Abstract: The present invention comprises a composition comprising a matrix (12) adapted to be placed in drug- and permeation-enhancing mixture-transmitting relation to a selected skin (18) or other body site. The matrix (12) contains sufficient amounts of drug, permeation enhancer(s) and poly-N-vinyl amide to continuously administer to the site, the drug, in a therapeutically effective amount, and the permeation-enhancing mixture, in an amount effective to enhance the permeation of the skin (18) to the drug, the device (10) shows increased transdermal flux as compared to the transdermal flux of the drug from a device (10) containing no poly-N-vinyl amide. Incorporating poly-N-vinyl amide into the transdermal system also improves the adhesion and stability of the system.

Abstract: A novel electrotransport drug delivery system (10) and therapeutic agent-containing reservoir (26, 28) for use therein are provided. An inert filler material effective to reduce the quantity of therapeutic agent otherwise present is incorporated in the reservoir (26, 28) along with the therapeutic agent to be delivered via electrotransport. Methods for making the reservoir (26, 28) and drug delivery system (10) are provided as well.

Abstract: An improved method for the manufacture of transdermal drug delivery devices comprising liquid dispersions of a liquid in an aqueous or nonaqueous matrix is disclosed. More particularly, the invention relates to preventing the formation of a crystalline structure in such liquid dispersions by annealing films and laminates in-line immediately following film formation and/or lamination during the manufacture of these devices.

Abstract: A percutaneous agent delivery or sampling device comprising a sheet having a plurality of microblades for piercing the skin for increasing transdermal flux of an agent. The microblades having a relatively sharp angled leading edge which transitions to a relatively gradually angled blade edge.