Iontophoretic drug delivery device having an improved controller

• US 5,688,232 A
• Filed: 09/28/1995
• Issued: 11/18/1997
• Est. Priority Date: 09/28/1995
• Status: Expired due to Fees

• Current Assignee: Vyteris, Inc.
• Original Assignee: Becton, Dickinson & Co
• Inventors: Flower, Ronald J.
• Primary Examiner(s): Bockelman, Mark
• Assistant Examiner(s): TAO, ELLEN
• Application Number:
  US08/535,447
• Time in Patent Office: 782 Days
• Field of Search: 604/19-20, 607/1-3, 607/59, 607/62-63
• US Class Current: 604/20
• CPC Class Codes: A61B 2090/0814 Preventing re-use
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis

Abstract

An iontophoretic system includes a medicament containing disposable patch removably attached to a patient'"'"'s skin in combination with a controller mechanism. The patch includes an anode and a cathode, and holds an electrolyte and a medicament. The controller includes a controller circuit which is coupled to the cathode and is adjustable to provide a desired current flow through the electrodes to drive the medicament to the skin of the patient. The controller preferably includes a variety of functions to ensure safe and proper delivery of the medicament. The controller circuit is preferably an application specific integrated circuit (ASIC) so as to provide a compact controller having increased reliability and reduced power consumption.

Claims

1. An iontophoretic drug delivery system comprising:

a medicament containing patch removably attachable to the skin of a user for transdermal delivery of a medicament, the patch having at least a first electrode and a second electrode, the medicament including a plurality of drug molecules;

a reusable controller removably electrically coupled to the patch, the controller providing sufficient energy to the patch to deliver the medicament from the patch into the skin of a patient; and

a current delivery safety circuit operatively coupled to the controller for assuring the substantially safe delivery of the medicament from the patch into the skin of the patient, the current delivery safety circuit including;

a coulombmeter electrically coupled to at least one of the first electrodes and second electrodes for monitoring a total number of electrons delivered through the patch, the coulombmeter providing an output signal if the total number of electrons is at most substantially equal to the plurality of drug molecules;

a current monitor circuit operatively coupled to at least one of the first electrode and second electrode for monitoring a rate of current flow through the patch, the current monitor circuit providing an output signal if the rate of current flow is at least equal to a first preselected value and at most equal to a second preselected value;

a patch identification detector electrically coupled to the patch, the patch identification detector providing an indication as to whether the patch and the controller are deemed incompatible, patch identification detector preventing a supply of energy to the patch sufficient to deliver the medicament from the patch into the skin of the patient if the patch and controller are deemed incompatible;

a patch marker circuit electrically coupled to at least one of the first electrode and second electrode of the patch, the patch marker circuit substantially permanently disabling the patch when substantially all of the medicament has been delivered from the patch to the skin of the patient; and

a voltage monitor circuit operatively coupled to the first electrode and the second electrode for monitoring a voltage therebetween, the voltage monitor providing an indication if the voltage potential between the first and second electrodes is at least greater than a first predetermined value and at most equal to a second predetermined value.

2. An iontophoretic drug delivery system comprising:

a medicament containing patch removably attachable to the skin of a user for transdermal delivery of a medicament, the patch having at least a first electrode and a second electrode;

a reusable controller removably electrically coupled to the patch, the controller including an energy source for providing sufficient energy to the patch to drive the medicament from the patch into the skin of the patient; and

a user interface circuit for at least one of providing and receiving information to the user, the user interface circuit including;

a battery monitor circuit electrically coupled to the energy source for monitoring an amount of energy stored in the energy source and providing a battery monitor signal in response thereto;

a treatment counter circuit for counting the number of times the controller is used and providing a treatment counter signal in response thereto;

a device life timer circuit for determining when a predetermined time period has elapsed, the predetermined time period corresponding to the useful life of the controller, the device life timer generating a device life timer signal in response thereto;

a data storage device being responsive to and storing at least one of the battery monitor signal, the treatment counter signal and the device life timer signal, the data storage device providing a data storage signal in response to the at least one of the battery monitor signal, treatment counter signal and device life timer signal, and

an LED driver circuit including an LED, the LED driver circuit being responsive to and providing a visual indication to a user of at least one of the battery monitor signal, the treatment counter signal, the device life timer signal and the data storage signal.

3. An iontophoretic drug delivery system comprising:

a medicament containing patch removably attachable to the skin of a user for transdermal delivery of a medicament; and

a reusable controller removably electrically coupled to the patch, the controller providing sufficient current to the patch to drive the medicament from the patch into the skin of the patient, the controller further including a coulombmeter electrically coupled to the patch for detecting a total amount of current delivered from controller to the patch.

4. An iontophoretic drug delivery system as defined by claim 3, wherein the coulombmeter generates an output signal when the total amount of current substantially corresponds to the medicament in the patch being exhausted.

5. An iontophoretic drug delivery system as defined by claim 4, wherein the patch further includes a patch marker, the patch marker having a first condition indicative of medicament being present in the patch and a second condition indicative of medicament being substantially exhausted from the patch, and wherein the controller further includes a patch marker circuit operatively coupled to the patch marker, the patch marker circuit being responsive to the coulombmeter output signal and generating a signal which substantially permanently alters the patch marker from the first condition to the second condition.

6. An iontophoretic drug delivery system for delivering medication to an applied area of a user comprising:

an iontophoretic drug delivery patch for placement against the skin of the user, the iontophoretic drug delivery patch including at least first and second electrodes and a medicament; and

a reusable controller including an electronic control circuit for regulating the delivery of the medicament to the skin of the user, the electronic control circuit providing sufficient current to the patch to drive the medicament from the patch into the skin of the user, the electronic control circuit being an application specific integrated circuit (ASIC), the electronic control circuit including a current control circuit operatively coupled to at least one of the first and second electrodes for providing a desired current flow through the at least first and second electrodes to deliver the medicament to the skin of the user, the electronic control circuit further including a coulombmeter operatively coupled to the current control circuit for measuring a total quantity of current flow provided to the at least first and second electrodes.

7. An iontophoretic drug delivery system as defined by claim 6 wherein the electronic control circuit includes a current monitor circuit operatively coupled to the at least first and second electrodes the current monitor circuit monitoring the current flow through the at least first and second electrodes.

8. An iontophoretic drug delivery system as defined by claim 6 wherein the electronic control circuit includes a voltage monitor circuit electrically coupled to the iontophoretic drug delivery patch for monitoring a voltage potential between the at least first and second electrodes.

9. An iontophoretic drug delivery system as defined by claim 6 wherein the iontophoretic drug delivery system includes at least one light emitting device (LED) and wherein the electronic control circuit includes a light emitting diode (LED) driver mechanism coupled to the at least one LED, the LED driver providing an LED control signal that alternately activates and deactivates the at least one LED in accordance with an operating state of the iontophoretic drug delivery system.

10. An iontophoretic drug delivery system as defined by claim 6 wherein the electronic control circuit includes a switch closure detection circuit coupled to a switch for activating the iontophoretic drug delivery system, the switch closure detection circuit monitoring the on/off switch to provide an indication of the current state of the iontophoretic drug delivery system.

11. An iontophoretic drug delivery system as defined by claim 6 wherein the iontophoretic drug delivery system includes a data memory circuit coupled to the electronic control circuit, the data memory circuit recording characteristics of the delivery of medicament from the iontophoretic drug delivery patch to the skin of the patient.

12. An iontophoretic drug delivery system as defined by claim 6 wherein the electronic control circuit includes a treatment counter circuit, the treatment counter circuit recording the total number of medicament applications provided by the controller.

13. An iontophoretic drug delivery system as defined by claim 6 wherein the iontophoretic drug delivery patch includes a patch identification number indicative of the type of medicament being delivered, and wherein the electronic control circuit includes a patch identification circuit, the patch identification circuit storing a controller identification number, the patch identification circuit being responsive to the patch identification number, the patch identification circuit determining whether the patch identification number.

14. An iontophoretic drug delivery system for delivering medication to an applied area of a user comprising:

an iontophoretic drug delivery patch for placement against the skin of the user, the iontophoretic drug delivery patch including at least first and second electrodes and a medicament; and

a reusable controller including an electronic control circuit for regulating the delivery of the medicament to the skin of the user, the electronic control circuit providing sufficient current to the patch to drive the medicament from the patch into the skin of the user, the electronic control circuit being an application specific integrated circuit (ASIC), the electronic control circuit including a rate of current change limiter circuit electrically coupled to the iontophoretic drug delivery patch for monitoring a rate of change in the current flow from the at least first electrode to the at least second electrode, the rate of current change limiter circuit preventing a change of current rate greater than a predetermined rate of change thereby preventing patient discomfort.

15. An iontophoretic drug delivery system for delivering medication to an applied area of a user comprising:

an iontophoretic drug delivery patch for placement against the skin of the user, the iontophoretic drug delivery patch including at least first and second electrodes and a medicament; and

a reusable controller including an electronic control circuit for regulating the delivery of the medicament to the skin of the user, the electronic control circuit providing sufficient current to the patch to drive the medicament from the patch into the skin of the user, the electronic control circuit being an application specific integrated circuit (ASIC), the electronic control circuit including a life timer circuit having a clock mechanism, the life timer circuit providing an indication of a remaining amount of useful life of the controller, the life timer circuit preventing activation of the iontophoretic drug delivery system if at least a predetermined time period has elapsed.

16. An iontophoretic drug delivery system for delivering medication to an applied area of a user comprising:

an iontophoretic drug delivery patch for placement against the skin of the user, the iontophoretic drug delivery patch including at least first and second electrodes and medicament;

a reusable controller including an electronic circuit for regulating the delivery of the medicament to the skin of the user, the electronic control circuit providing sufficient current to the patch to drive the medicament from the patch to the skin of the user, the electronic control circuit including;

a data memory circuit for recording characteristics of the delivery of medicaments from the iontophoretic drug delivery patch to the skin of the patient; and

a light emitting diode (LED) driver circuit, the LED driver circuit providing a data signal indicative of the contents of the data memory circuit; and

an LED, the LED being operatively coupled to the LED driver circuit for optically transmitting the contents of the data memory circuit a remote data recieving station for receiving optical transmissions from the LED.

17. An iontophoretic drug delivery system for delivering medication to an applied area of a user comprising:

an iontophoretic drug delivery patch, the patch including at least first and second electrodes, a medicament, and a patch marker, the patch marker having a first condition indicative of the medicament being present in the patch and a second condition indicative of the medicament in the patch being at least partially delivered; and

a reusable controller including an electronic control circuit for regulating the delivery of the medicament to the skin of the user, the electronic control circuit providing sufficient current to the patch to drive the medicament from the patch into the skin of the user, the electronic control circuit including a patch marker circuit operatively coupled to the patch marker, the patch marker circuit generating a signal which substantially permanently alters the patch marker from the first condition to the second condition when the medicament in the patch is at least partially delivered.

18. An iontophoretic drug delivery system for delivering medication to an applied area of a user comprising:

an iontophoretic drug delivery patch for placement against the skin of the user, the iontophoretic drug delivery patch including at least first and second electrodes and a medicament; and

a reusable controller including an electronic control circuit for regulating the delivery of the medicament to the skin of the user, the electronic control circuit providing sufficient current to the patch to drive the medicament from the patch into the skin of the user, the electronic control circuit including a rate of current change limiter circuit electrically coupled to the iontophoretic drug delivery patch, the rate of current change limiter circuit monitoring a rate of change in the current flow from the at least first electrode to the at least second electrode and preventing a change of current rate greater than a predetermined rate of change.

19. An iontophoretic drug delivery system for delivering medication to an applied area of a user comprising:

an iontophoretic drug delivery patch for placement against the skin of the user, the iontophoretic drug delivery patch including at least first and second electrodes and a medicament; and

a reusable controller including an electronic control circuit for regulating the delivery of the medicament to the skin of the user, the electronic control circuit providing sufficient current to the patch to drive the medicament from the patch into the skin of the user, the electronic control circuit including a life timer circuit, the life timer circuit providing an indication of a remaining amount of useful life of the controller, the life timer circuit preventing activation of the iontophoretic drug delivery system if at least a predetermined time period has elapsed.

20. A disposable iontophoretic drug delivery patch for delivering medicament to an applied area of a user when the patch is mated to a reusable iontophoretic controller, the patch comprising:

at least one medicament for delivery to a user;

at least first and second electrodes, at least one of the first and second electrodes being in electrical communication with the at least one medicament;

means for electrically connecting the at least first and second electrodes to the iontophoretic controller;

a patch marker, the patch marker having a first condition indicative of full medicament being present in the patch and a second condition indicative of the medicament in the patch being at least partially delivered to a user, the patch marker permanently changing from the first condition to the second condition in response to a signal received from the iontophoretic controller wherein the first and second conditions are electrically detectable by the controller;

means for electrically interfacing the patch marker to the iontophoretic controller.

21. An iontophoretic patch, as defined by claim 20, wherein the patch marker includes an electrical fuse having a first terminal and a second terminal, the first condition being defined as electrical continuity between the first and second terminals, the second condition being defined as a substantially open circuit between the first and second terminals.