Alza Corporation

Medtronic, Inc.

Gary A Lattin

Larry A McNichols

Joseph B Phipps

Ronald P Haak

Felix T Theeuwes

John D Badzinski

Paul D Sorenson

J Bradley Phipps

Suneel K Gupta

Darrel F Untereker

J Richard Gyory

Tighe M Belden

Richard Spevak

Mark R Bilitz

Rama V Padmanabhan

Michael J Grace

Susan A Johnson

Andrew J Withell

John R Peery

Allan H Jevne

Scott Jay Gilbert

William N Reining

Keith J Bernstein

Dale A Dickson

Thomas A Riddle

Philip C Dretzka

Charles F Albert

Richard P Spevak

Wiliam N Reining

Gary A Messer

Larry A Mcnichols

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 method of increasing the delivery efficiency of an agent through a body surface by electrotransport is disclosed wherein the electrotransport current is applied for durations at a higher current density values followed by durations of lower current density values wherein the higher current density applications transform the body surface to an enhanced, non-transitory agent delivery efficiency state.

Electrotransport agent delivery method and apparatus

An electrotransport agent delivery device () for delivering a therapeutic agent through intact skin, and a method of operating same, is provided. The device applies a pulsing electrotransport current wherein current pulses have a magnitude above a critical level (I) at which the skin is transformed into a higher electrotransport delivery efficiency (E) state. Most preferably the length of the applied current pulses is at least 5 msec and preferably at least 10 msec.

An electrotransport agent delivery device () for delivering a therapeutic agent through intact skin, and a method of operating same, is provided. The device applies a pulsing electrotransport current wherein the length of the applied current pulses is at least 5 msec and preferably at least 10 msec. Most preferably, the current pulses have a magnitude above a critical level (I) at which the skin is transformed into a higher electrotransport delivery efficiency (E) state.

Electrotransport agent delivery apparatus

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

Electrotransport system having flexible means

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.

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.

Adjustable electrotransport drug delivery using a fixed output controller

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

Electrotransport device and method of setting output

An electrotransport agent delivery device for delivering a therapeutic agent through a body surface, and a method for increasing agent delivery efficiency, is provided. The device includes a current controller which delivers a pulsating electrotransport current and peak current density I.sub.max, I.sub.max being greater than a critical current density level I.sub.c above which the body exhibits a non-transitory higher agent delivery efficiency. Methods for increasing electrotransport delivery efficiency (E) of an agent through a body surface by creation of a higher agent delivery efficiency state are also provided.

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

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. The rigid zones (52, 54; 152, 154, 156, 158; 172, 174, 176, 178) are separate and are coupled by flexible connector means (56, 62; 160, 162). In this manner, a conformable mosaic of rigid zones which comprises the device is created.

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Forest Lake, MN, United States of America

Gary A Lattin