Abstract: An osmotic caplet is disclosed comprising an osmotic caplet exit for delivering a preselected dose of drug to a patient in need of therapy.

Abstract: An electro-osmotic cell capable of substantially reducing zero-current transport is disclosed, wherein the cell includes a cell housing having a first half cell and a second half cell, with an ion selective membrane therebetween, a first electrode positioned within the first half cell, a second electrode positioned within the second half cell, an electrolyte in electrical communication with the first electrode and the second electrode, and a wiring apparatus electrically connecting the first electrode and the second electrode, wherein the wiring apparatus has one or more structures used for counteracting salt concentration increases within the electro-osmotic cell. Such a cell may be used within an electro-osmotic fluid delivery device, along with a fluid inlet, a piston member adjacent the electro osmotic cell, and a drug reservoir adjacent the piston member, wherein the drug reservoir includes a sealed compartment having an exit port. A method for using such a device is similarly disclosed.

Abstract: The present invention is disclosed herein as an electrochemical cell having a cell housing with a first half cell and a second half cell, and an ion selective membrane between the cells. The electrochemical cell further has a first electrode positioned within the first half cell, a second electrode positioned within the second half cell, an electrolyte in electrical communication with both the first electrode and the second electrode. The electrodes of the cell are configured so that the electrochemical cell maintains a substantially constant salt concentration level throughout operation. The cell is preferably used in conjunction with an implantable fluid delivery apparatus. A method for using the device is additionally disclosed.

Abstract: The present invention features devices and methods for delivery of drug to an internal organ surface by delivery of drug directly to the surface of the organ such that the drug traverses the organ surface and enters the organ tissue. The device is in the form of an implantable drug delivery patch comprising a first layer, which is generally substantially drug-impermeable. When the first layer is placed on an outer surface of an organ, a drug reservoir is defined by the first layer and the organ surface.

Abstract: An electrotransport device and method of operating same provides a pulsed DC current of specified frequency and duration which transforms the skin into a higher electrotransport delivery efficiency state.

Abstract: The present invention features methods and devices for modulating the rate of delivery of a drug formulation from a drug delivery device by diverting drug away from a drug delivery pathway. In one embodiment, a flow regulator is positioned relative to a drug delivery pathway of a drug delivery system so that adjustment of the flow regulator can provide for diversion of drug away from the drug delivery pathway. Diverted drug can be either delivered into the systemic circulation of the subject, or can be captured in a waste reservoir.

Abstract: The invention features devices and methods for the systemic delivery of fentanyl or a fentanyl congener (e.g., sufentanil) to treat pain. In the present invention, a drug formulation comprising fentanyl or a fentanyl congener is stored within a drug delivery device (e.g., contained in a reservoir or impregnated within a matrix within the controlled drug delivery device). The drug formulation comprises an amount of drug sufficient for treatment and is stable at body temperatures (i.e., no unacceptable degradation) for the entire pre-selected treatment period. The drug delivery devices store the drug formulation safely (e.g., without dose dumping), provide sufficient protection from bodily processes to prevent unacceptable degradation of the formulation, and release the drug formulation in a controlled fashion at a therapeutically effective rate to treat pain.

Abstract: A fluid delivery device, comprising an electrochemical pump, wherein the pump is capable of transporting water; a pump product chamber, wherein the pump product chamber is capable of retaining water generated from the pump; a displaceable member positioned between the pump product chamber and a reservoir, wherein the displaceable member is controllably displaced upon generation of water from the electrochemical pump; a reservoir, wherein the reservoir is capable of containing a fluid which is delivered upon displacement of the displaceable member; and an housing for containing the pump, the pump product chamber, the displaceable member, and the reservoir.

Abstract: The present invention features methods and devices for modulating the rate of delivery of a drug formulation from a drug delivery device by diverting drug away from a drug delivery pathway. In one embodiment, a flow regulator is positioned relative to a drug delivery pathway of a drug delivery system so that adjustment of the flow regulator can provide for diversion of drug away from the drug delivery pathway. Diverted drug can be either delivered into the systemic circulation of the subject, or can be captured in a waste reservoir.

Abstract: The invention features devices and methods for the systemic delivery of fentanyl or a fentanyl congener (e.g., sufentanil) to treat pain. In the present invention, a drug formulation comprising fentanyl or a fentanyl congener is stored within a drug delivery device (e.g., contained in a reservoir or impregnated within a matrix within the controlled drug delivery device). The drug formulation comprises an amount of drug sufficient for treatment and is stable at body temperatures (i.e., no unacceptable degradation) for the entire pre-selected treatment period. The drug delivery devices store the drug formulation safely (e.g., without dose dumping), provide sufficient protection from bodily processes to prevent unacceptable degradation of the formulation, and release the drug formulation in a controlled fashion at a therapeutically effective rate to treat pain.

Abstract: An osmotic delivery system having a space efficient piston. The enclosure has an interior holding the piston, a beneficial agent, and an osmotic agent including a tablet. The piston is movable with respect to an interior surface of the capsule, and defines a movable seal with the interior surface of the capsule. The moveable seal separates the osmotic agent from the beneficial agent. The piston has a recess that receives at least a portion of the osmotic agent. The osmotic agent imbibes liquid from a surrounding environment through a semipermeable body to cause the piston to move and in turn cause delivery of the beneficial agent from the capsule.

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 features devices and methods for treatment of pain. The drug delivery device is a drug delivery system adapted for whole implantation in a subject and to provide pain relief by delivery of fentanyl or a fentanyl congener (e.g., sufentanil) over a protracted period of time (e.g., at least 3 days or more than 3 days). The device comprises a housing defining a reservoir that contains a drug formulation, a pump operatively connected to the housing so as to facilitate movement of drug out of the reservoir and out of the device, and a thermal expansion element which defines a flow pathway comprising a thermal expansion channel to accommodate thermal expansion of formulation in the reservoir. The device can further comprise a valve positioned within the flow pathway so as to prevent movement of drug out of the reservoir prior to use.

Abstract: A membrane capable of inhibiting agent release from a delivery system when no electrical current is flowing and yet provide minimal impedance to electrically-assisted agent delivery, useful both for incorporating into electrotransport agent delivery systems and for use in measuring agent release rates in in vitro testing.

Abstract: The present invention is directed to an active agent dosage form which is adapted for retention in the stomach and useful for the prolonged delivery of an active agent formulation to a fluid environment of use. The active agent dosage form is a polymer matrix that swells upon contact with the fluids of the stomach. A portion of the polymer matrix is surrounded by a band of insoluble material that prevents the covered portion of the polymer matrix from swelling and provides a segment of the dosage form that is of sufficient rigidity to withstand the contractions of the stomach and delay expulsion of the dosage form from the stomach until substantially all of the active agent has been dispensed.

Abstract: The present invention provides an implantable guide for access to a treatment site. The implantable guide comprises a proximal end, a distal end, and a guide body defining a lumen, and can optionally comprise a stable positioning element for stably positioning a drug delivery device within the guide. The guide can be provided in connection with a drug delivery device. In use, the guide is implanted within a subject so as to provide a conduit through which a drug delivery device can be retrievably introduced to facilitate delivery of drug to a treatment site within a subject at a site distal to an accessible implantation site. The drug delivery device is then positioned within the guide lumen to provide for delivery of drug from the drug delivery to the desired treatment site.

Abstract: An osmotic delivery system having a space efficient piston. The capsule has an interior holding the piston, a beneficial agent, and an osmotic agent. The piston is movable with respect to an interior surface of the capsule, and defines a movable seal with the interior surface of the capsule. The moveable seal separates the osmotic agent from the beneficial agent. The piston has a recess that receives at least a portion of the osmotic agent. The osmotic agent imbibes liquid from a surrounding environment through a semipermeable body to cause the piston to move and in turn cause delivery of the beneficial agent from the capsule.

Abstract: The invention features devices and methods for the systemic delivery of fentanyl or a fentanyl congener (e.g., sufentanil) to treat pain. In the present invention, a drug formulation comprising fentanyl or a fentanyl congener is stored within a drug delivery device (e.g., contained in a reservoir or impregnated within a matrix within the controlled drug delivery device). The drug formulation comprises an amount of drug sufficient for treatment and is stable at body temperatures (i.e., no unacceptable degradation) for the entire pre-selected treatment period. The drug delivery devices store the drug formulation safely (e.g., without dose dumping), provide sufficient protection from bodily processes to prevent unacceptable degradation of the formulation, and release the drug formulation in a controlled fashion at a therapeutically effective rate to treat pain.

Abstract: A minimally invasive transdermal agent sampling device (2, 10) comprises a sheet (6) having a plurality of openings (8) and a plurality of microblades (4) for piercing the skin (20). A suction device (10) applies a negative pressure through the openings (8) to the microslits in the skin (20) for enhanced efflux of interstitial fluid. The device (2, 10) can be used for transdermal sampling of body analytes such as glucose for measuring/estimating blood glucose concentration.

Abstract: The invention provides a local concentration management system (LCMS) for delivery of highly concentrated therapeutic agent formulations. The LCMS comprises a device comprising an elongate body defining a lumen between its proximal and distal ends, and a diffuser element, a dilutor element, or both. The diffuser element, which is selectively permeable to the agent, is operatively associated with the elongate body so that agent flows through the elongate body, and into and through the diffuser element to exit the system. The dilutor element can be operatively associated with the system to be in fluid communication with the elongate body lumen, a diffusion space defined by a diffuser element inner wall, or both. The dilutor element is selectively water permeable, but substantially impermeable to agent, to provide for dilution of the agent during transit through the system. The LCMS system is designed to disperse and/or dilute the drug delivery stream.