Abstract: A device (10) for the electrically assisted delivery of a therapeutic agent is described. The device (10) has rigid zones or regions (12, 14) which are physically connected by a flexible means (16) such as a web. The flexible means (16) permits the rigid zones (12, 14) to move independently with respect to each other while remaining physically connected or coupled. In a preferred embodiment, the rigid zones are physically and electronically coupled by the flexible means. In another embodiment, the device (500) comprises one or more rigid zones, the skin side of the rigid zone having a radius of curvature (520) which approximates that of the body site to which the device (500) is to be attached. A method of increasing the body surface conformability of an electrotransport device (50, 150, 170) is described. The method involves the step of intentionally placing rigid subcomponents (58, 36, 37) of the device in physically separate zones (52, 54; 152, 154, 156, 158; 172, 174, 176, 178) within the device.

Abstract: A method for manufacturing a transdermal drug delivery device (10) is disclosed wherein a component (32) and/or a subassembly (20) are intentionally adapted to be separable from the rest of the device for disposal which is more medically or environmentally acceptable. In one embodiment, device 10 comprises upper and lower housings (16, 20), with lower housing (20) being separable from upper housing (16) and foldable upon itself to minimize medically unacceptable contact with, e.g., a drug reservoir (26 or 28) contained therein. A device (10) made in accordance with the invention is included.

Abstract: An electrotransport delivery device (10) with a display (14) having only on and off states, and a method of operating the display (14), are provided. Preferably, the display 14 is a light (e.g., a light emitting diode) with lit and unlit states or an audible alarm (e.g., a beeper) with sounding and silent states. The device (10) counts and stores the number of events (e.g., patient initiated drug delivery or sensed patient condition) which occur over a predetermined period of time (e.g., the period of time over which the device is worn by the patient). The event count is displayed by cycling the display (14) between on and off states according to a predetermined regimen which correlates the number of on/off cycles to the number of events. The device and method permit the use of a simple and inexpensive means (e.g., an LED) to display (e.g., to a medical technician) the number of e.g., patient initiated doses delivered over a previous period of therapy.

Abstract: Improved methods of ionophoretic drug delivery are described. By the intentional selection of drug(s) with specific characteristics, of ionotophoresis device, components or both permits the efficiency of drug delivery is increased.

Abstract: Improved methods of ionophoretic drug delivery are described. By the intentional selection of drug(s) with specific characteristics, of ionotophoresis device, components or both permits the efficiency of drug delivery is increased.

Abstract: An electrotransport system (20) for delivering a therapeutic agent (36) through a body surface (40) (eg, skin) of a patient includes a pair of electrodes (34, 38) for contacting the body surface, at least one of which contains the therapeutic agent (36). The system (20) is physically separated into a control unit (22) and a delivery unit (24) connected by a radiated energy signal-based telemetry link. The telemetry link may be radio frequency, ultrasonic, optical, infrared or inductively coupled. Signals from the control unit may be transmitted to the delivery unit by the telemetry link, or vice versa. The delivery unit may control electrotransport current on the signal transmitted. The radiated energy signal may be encoded to improve immunity to extrinsic interference. The delivery unit (24) may be configured with sensor means for detecting a condition such as a body or system parameter reaching some predetermined limit.

Abstract: A transdermal drug delivery device (20) is provided having both an active drug reservoir (24) and a passive drug reservoir (26). Drug is actively delivered by iontophoresis from the active drug reservoir (24) by an electric field generated by a power source (21). Simultaneously, drug is delivered from passive reservoir (26) by passive (i.e., non-electrically assisted) diffusion. In one embodiment, the passive drug reservoir (26) is electrically insulated from the active drug reservoir (24). In a second embodiment, both the active and the passive drug are contained in the same reservoir (34). In the second embodiment, the active drug is ionizable while the passive drug is non-ionizable. Most preferably, the active drug is an ionizable form (i.e., a salt form) of the passive drug.

Abstract: An electrotransport drug delivery device (1) including a reusable component (2), a disposable component (4), and a removable liner (8) temporarily separating the mating surfaces of the components (2,4) during alignment and assembly of the components (2,4). At least one of the components (2,4) has an adhesive mating surface (11) facing the removable liner (8). Also disclosed are a disposable assembly (4) for an electrotransport device (1) and a method for assembling reusable and disposable components (2,4), the components (2,4) of the electrotranport device assembly (1) are adhesively mated.

Abstract: Improved methods of ionophoretic drug delivery are described. By the intentional selection of drug(s) with specific characteristics, of ionotophoresis device, components or both permits the efficiency of drug delivery is increased.

Abstract: The electrotransport drug delivery device includes a patient activity sensor which is used to selectively deliver drugs based upon a measured physical activity of the patient.

Abstract: A two-stage iontophoretic drug delivery system provides that iontophoretic current is delivered at a first level for a first predetermined interval to rapidly introduce a therapeutic agent into the bloodstream and thereafter reduced to a second lower level to maintain a desired steady-state therapeutic level of the agent. One embodiment provides that the initial interval is maintained sufficiently long to provide a peak dosage, thereafter which the current is shut off to allow concentration of the agent to subside in the bloodstream, whereupon a maintenance level of iontophoretic current is initiated. Another embodiment provides that the patient may selectively initiate a brief interval of increased iontophoretic current level to attain a brief interval of increased dosage.

Abstract: Improved methods of ionophoretic drug delivery are described. By the intentional selection of drug(s) with specific characteristics, of ionotophoresis device, components or both permits the efficiency of drug delivery is increased.

Abstract: A method and apparatus are disclose for transdermal iontophoretic delivery of ionic species, such as a drug in ionic form, in which therapeutic, electrical pulses having controlled, distinctive, dual-segment waveform characteristics are applied which facilitate more efficient drug administration throughout each pulse. The therapeutic pulses are generated at a predetermined frequency and have a predetermined pulse width. A first pulse segment and a second pulse segment comprise each dual-segment, therapeutic pulse. The electrical attributes of each pulse segment, including amplitude and duration, are controlled to produce the desired, pulsed output waveform.

Abstract: An ionic substance is mixed with a polar, non-ionic adhesive to form an electrode for use in the iontophoretic introduction of the ionic substance into a body. The electrode may be formed as a sheet of the mixture of a size and shape suitable for attachment to the electrode plate of an iontophoretic current generator. The mixture may be incorporated in an electrode as a means for holding the ionic substance, a means for attaching the electrode to the body, a means for attaching the iontophoretic current generator to the body, or a means for conducting the ionic current into the body. The electrode may also be employed in combination with an electrical stimulator to provide for simultaneous electrical stimulation and iontophoretic drug administration to the body.

Abstract: An iontophoresis device including a control module and a disposable electrode module. The control module includes a flexible printed circuit board carrying the battery and other electrical components. The control module is so configured that by trimming it along one of several labeled lines, various current levels may be selected. Trimming the control module provides a simple method for varying the dosage of the drug delivered by the iontophoresis device and simultaneously provides an easily readable visual indicator of the dosage level.

Abstract: An iontrophoretic medical device has a first light of controlled brightness. Iontophoretic contact with skin is measured by current flow and a second light is illuminated in proportion to current flow. Generally, equivalent brightness of the two lights indicates successful iontophoretic contact.

Abstract: An improved iontophoretic device for introducing an ionic substance into body tissue. A compact casing contains all the electronic circuitry necessary for generation and control of an iontrophoretic current. Stainless steel electrode plates are mounted directly on the casing and are electrically coupled to the electronics within. The device may be used in a simplified iontophoretic procedure: adhesive pads containing the ionic substance to be driven into the body tissue are applied to the stainless steel plates and the entire iontophoretic device is then affixed to the body by the adhesive pads and a safety strap, thus permitting normal patient movement during the iontophoretic process.