Alza Corporation

Medtronic, Inc.

Larry A McNichols

John D Badzinski

Gary A Lattin

Paul D Sorenson

Joseph B Phipps

Ronald P Haak

Thomas A Riddle

Rama V Padmanabhan

Susan A Johnson

William N Reining

Dale A Dickson

Michael J Grace

Wiliam N Reining

Gary K Hayden

An electrotransport device () for delivering therapeutic agents includes an adjustable voltage boos multiple controller () for boosting the voltage from a power source () to a working voltage Vhaving a value just sufficient to provide the desired therapeutic current level Ithrough the electrodes (), at least of which contains the therapeutic agent to be delivered.

Electrotransport delivery device with voltage boosting circuit

An electrotransport device for delivering one or more therapeutic agents through the skin includes electrodes for contacting the skin, at least one electrode containing the agent, a power source for generating electrical current (I) for delivering the agent, a current generating and controlling means and a disabling means for permanently and irreversibly disabling the current. The disabling means may include a timer means, a counter means, or a body parameter sensor and limit comparator to effect permanent disabling. The disabling means may be a permanent transition to a disabled logic state, a permanent discharge of a power supply source, or a permanent diversion of electrotransport current from the electrodes, or a combination of the above. The permanent disabling means may include a circuit connection means having a frangible conducting member which permanently fractures and causes an irreversible open circuit in the connection to the electrodes upon removing a disposable/single use electrode assembly from a reusable portion of an electrotransport device.

Electrotransport delivery device having improved safety and reduced abuse potential

A reservoir and a family of reservoirs are provided which are designed to be used with a single controller to provide a wide range of therapeutic drug delivering regimens while maintaining many of the same reservoir configurations and drug formulations. A method of making a reservoir and a family of reservoirs and incorporating them into an electrotransport system is disclosed.

Methods of electrotransport drug delivery

An electrotransport device () for delivering one or more therapeutic agents through the skin includes electrodes () for contacting the skin (), at least one electrode containing the agent, a power source () for generating electrical current (I) for delivering the agent, a current generating and controlling means (), and a disabling means () for permanently and irreversibly disabling the current. The disabling means () may include a timer means (), a counter means (), or a body parameter sensor () and limit comparator () to effect permanent disabling. The disabling means may be a permanent transition to a disabled logic state, a permanent discharge of a power supply source (), or a permanent diversion of electrotransport current from the electrodes (), or a combination of the above. The permanent disabling means may include a circuit connection means () having a frangible conducting member () which permanently fractures and causes an irreversible open circuit in the connection to the electrodes () upon removing a disposable/single use electrode assembly () from a reusable portion of an electrotransport device.

Reservoir and a series of related reservoirs for use in an electrotransport drug delivery device and devices comprised thereof

An electrotransport device () for delivering therapeutic agents includes and adjustable voltage boost multiple controller () for boosting the voltage from a power source () to a working voltage Vhaving a value just sufficient to provide the desired therapeutic current level Ithrough the electrodes (), at least of which contains the therapeutic agent to be delivered.

An electrotransport system (,) for delivery of a drug through the skin (,) of a patient includes a tactile signal generator (,) for generating and transmitting a tactile signal to the skin of a patient upon the occurrence of an event associated with the operation of the system. The tactile signal may be an electric AC signaling current (Sr, Sp) applied through the skin, ie, an electric current different from the therapeutic electrotransport drive current. The electric signaling current is preferably a pulsed current of sufficient frequency and amplitude to allow the patient to feel it. The tactile signal may alternatively be generated by an electromechanical device in contact with the skin such as a piezoelectric vibrating element or magnetodynamic element such as a solenoid driven pin. The waveform of the tactile signaling current preferably has a zero average current component such that no net therapeutic drug is delivered by the tactile signal current. In certain cases, the tactile signaling current may contribute to electrotransport drug delivery.

Electrotransport drug delivery device having tactile signaling means

An electrotransport delivery device (410) includes control circuitry for discontinuously delivering a beneficial agent (eg, a drug) through a body surface (eg, skin 400). For example, the device may be the type which is manually activated by the patient or other medical personnel to activate electrotransport drug delivery. Once electrotransport delivery has been activated, a timer (221) counts a transition interval, typically about one minute, during which the device is allowed to operate and the impedance of the body surface (400) is allowed to stabilize. Thereafter, the electrotransport current and voltage are then monitored and compared to predetermined limits. Allowing for the transition interval permits tighter tolerances in monitoring the applied current.

Electrotransport delivery device

Electrotransport device and method of setting output

An electrotransport device (10) for delivering therapeutic agents includes an adjustable voltage boost multiple controller (100, 200) for boosting the voltage from a power source (102, 202) to a working voltage V.sub.w having a value just sufficient to provide the desired therapeutic current level I.sub.I through the electrodes (108, 112), at least one of which contains the therapeutic agent to be delivered.

A two-part electrotransport drug delivery device (20) is comprised of a controller (22) which has a plurality of different electronic outputs. The controller (22) is adapted to be mechanically and electrically coupled to a plurality of different drug-containing units (24). Each drug unit (24) includes a means (40, 42, Rx, Cx) for signaling the controller (22). The signal is read by the controller (22) and a predetermined electronic output is thereby selected and applied through the drug unit (24) in order to deliver the drug contained therein by electrotransport. The signal sent by the drug unit (24) to the controller (22) may be an optical signal (eg, reflected light), a signal sent by an electro-mechanical connector, an electrical signal (eg, resistance or capacitance), a magnetic signal or a metal detector sensing signal.

Electrotransport device with separable controller and drug unit and

An electrically powered iontophoretic delivery device is provided. The device includes a pair of electrode assemblies (41, 43) and a source of electrical power (30) connected thereto. Circuitry (60) is provided including an activation circuit (62) and a power generating circuit (70). Before use, neither the power generating circuit (70) nor the activation circuit (62) draw current from the power source (30). When the device is placed on the body (50) and electrical contact is established between the two electrode assemblies (41, 43), the activation circuit (62) is closed causing the power generating circuit (70) to be activated, thereby activating the device. The circuitry (60) improves the shelf-life of the device by minimizing current drain from the battery (30) before use.

Iontophoretic delivery device

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.

Activity controlled electrotransport drug delivery device

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.

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Coon Rapids, MN, United States of America

Larry A McNichols