Electrotransport delivery device

• US 5,697,896 A
• Filed: 12/08/1994
• Issued: 12/16/1997
• Est. Priority Date: 12/08/1994
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Badzinski, John D., Haak, Ronald P., McNichols, Larry A.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/353,036
• Time in Patent Office: 1,104 Days
• Field of Search: 604/20-21
• US Class Current: 604/20
• CPC Class Codes: A61N 1/0412 Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
• CPC Class Codes: A61N 1/0428 Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
• CPC Class Codes: A61N 1/303 Constructional details electrodes for external use A61N1/0428

Abstract

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.

Claims

1. An electrically powered device for delivering an agent by electrotransport through a body surface of a patient, including:

a pair of electrodes for contacting the body surface, at least one of the electrodes containing the agent to be delivered;

an electrotransport drive circuit, including a source of electrical power, for delivering electrotransport current through said electrodes and the patient to thereby deliver said agent to the patient;

an activator, operatively connected to the drive circuit, for activating said drive circuit to initiate the delivery of said agent;

a monitoring circuit connected for monitoring the operation of said drive circuit and for deactivating said drive circuit from delivering the electrotransport current if the operation is outside of a predetermined limit established therefor; and

a controller operative in response to the initiation of the delivery of electrotransport current to inhibit said monitoring circuit from deactivating said drive circuit until after a transition time period from said initiation.

2. The device of claim 1, wherein the monitoring circuit includes apparatus for measuring electrotransport current and for deactivating said current delivery if the current is below a predetermined value after said transition time period.

3. The device of claim 1, wherein the monitoring circuit includes apparatus for measuring voltage and for deactivating said current delivery if the voltage is below a predetermined value after said transition time period.

4. The device of claim 1, wherein the monitoring circuit includes apparatus for measuring electrotransport current and for deactivating said current delivery if the current is greater than a predetermined value after said transition time period.

5. The device of claim 1, wherein the monitoring circuit includes apparatus for measuring voltage and for deactivating said current delivery if the voltage is aboved a predetermined value after said transition time period.

6. The device of claim 1, wherein the drive circuit delivers electrotransport current to the electrodes in a discontinuous manner.

7. The device of claim 1, wherein the drive circuit, when activated, applies electrotransport current to the electrodes for a predetermined delivery interval.

8. The device of claim 7, including a lockout controller operative to inhibit delivery of electrotransport current during a lockout interval after completion of the delivery interval.

9. The device of claim 1, wherein the activator is manually operated.

10. The device of claim 1, wherein the body surface is human skin and the transition time period is at least about 40 to 60 seconds.