Iontophoretic drug delivery system, including disposable patch

• US 5,830,175 A
• Filed: 07/24/1997
• Issued: 11/03/1998
• 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
• Application Number:
  US08/899,429
• Time in Patent Office: 467 Days
• Field of Search: 604/20-21, 604/890.1, 604/49, 607/115
• US Class Current: 604/20
• CPC Class Codes: A61B 2090/0814 Preventing re-use
• CPC Class Codes: A61N 1/0436 Material of the electrode
• CPC Class Codes: A61N 1/044 Shape of the electrode

Abstract

An iontophoretic drug delivery system of the present invention includes a disposable patch electrically interconnectible with a controller. The patch includes at least two electrode assemblies, with one of the electrode assemblies having a first electrode and a second electrode. In this way, during delivery of electrical current one of the electrodes is exhausted so that upon an attempt to reuse the patch, the controller does not detect the delivery of electrical current through said electrodes and fails to supply electrical current to the electrode assemblies for delivery of the drug. Electrical interconnection between the patch and the controller is established by inserting a tab extending from the patch into the controller.

Claims

1. A disposable patch for use in combination with a controller to form an operable iontophoretic drug delivery system, said disposable patch comprising:

a planar body portion including at least a first electrode assembly and a second electrode assembly, with each electrode assembly including at least one electrode; and

means contained in one of said electrode assemblies for preventing reuse of a patch when interconnected with a controller, said means including a counter electrode adjacent to said electrode and in electrical communication with said electrode, and said electrode and said counter electrode being in contact with and adjacent to a reservoir;

said counter electrode including a material which upon electrical current flowing through said electrode and said counter electrode is consumed in a limited period of time so that upon depletion of the consumable material, current will no longer flow through said electrode and said counter electrode, whereby after electrical current has initially flowed through said electrode between said electrode and said counter electrode for a preselected period of time sufficient to exceed the amount of time necessary to deplete the consumable material of said counter electrode, electrical current is supplied to said first electrode assembly and said second electrode assembly to deliver the drug to the patient.

2. A disposable patch for use in combination with a controller to form an operable iontophoretic drug delivery system, said disposable patch comprising:

a planar body portion including at least a first electrode assembly and a second electrode assembly, with each electrode assembly including at least one electrode so that when electrical current flows between said first electrode assembly and said second electrode assembly at least one drug may be delivered to a patient iontophoretically;

means contained in one of said electrode assemblies for preventing reuse of a patch when interconnected with a controller, said means being situated adjacent to one of the electrodes contained in either said first or second electrode assembly and in electrical communication therewith, and said electrode and means being in contact with and adjacent to a reservoir;

said means including a material which upon electrical current flowing along a pathway interconnecting said electrode and said means is consumed in a period of time less than the time necessary to consume said other electrodes so that upon depletion of the consumable material, current will no longer flow along the electrical pathway connecting said electrode and said means, whereby after electrical current has initially flowed through said electrode assembly between said electrode and said means for a period of time sufficient to exceed the amount of time necessary to deplete the consumable material of said means, electrical current can flow between said first electrode assembly and said second electrode to deliver the drug to the patient.

3. The disposable patch defined in claim 2 wherein said means includes an additional electrode.

4. The disposable patch defined in claim 3 wherein at least one of said electrical traces interconnecting said electrode and said additional electrode includes a resistor situated along at least one of the electrical traces so that a controller may monitor the electrical voltage drop at the resistor, and if none is present, the controller will not fully activate the patch for delivering the drug to the patient.

5. The disposable patch defined in claim 2 further comprising electrical interconnection means for interconnecting said body portion with a controller.

6. The disposable patch defined in claim 5 wherein said body portion includes a tab having a plurality of electrical traces thereon in electrical communication with said electrode assemblies and said electrical interconnection means.

7. An iontophoretic drug delivery system including a disposable patch electrically interconnectible with a controller, the system comprising:

a drug-filled patch removably attachable to the skin of a patient for iontophoretically delivering at least one drug to the patient;

said patch including at least a first electrode assembly and a second electrode assembly, with each electrode assembly including at least one electrode so that when electrical current flows between said first electrode assembly and said second electrode assembly said drug may be delivered to the patient;

an additional electrode contained in one of said electrode assemblies for preventing reuse of a patch when interconnected with the controller, said additional electrode being situated adjacent to one of the electrodes contained in either said first or second electrode assembly and in electrical communication therewith, with said additional electrode including a material which upon electrical current flowing along a pathway interconnecting said electrode and said additional electrode is consumed in a limited period of time so that upon depletion of the consumable material of the additional electrode, current will no longer flow along the electrical pathway;

a controller removably, electrically connectible to said patch, the controller providing sufficient energy to said patch to drive the drug into the skin of the patient and said controller including electronic means for monitoring and controlling electrical current supplied to said patch so that electrical current can initially flow between said electrode assembly between said electrode and said additional electrode and after a period of time sufficient to exceed the amount of time necessary to deplete the consumable material of said additional electrode, the flow of electrical current can be switched to flow between said first electrode assembly and said second electrode to deliver the drug to the patient and the flow of electrical current can be prevented in the event the controller fails to detect the initial flow of current between the electrode and the additional electrode.

8. The iontophoretic drug delivery system defined in claim 7, wherein the controller includes an open front end and the patch includes a tab so that the patch is electrically connected to the controller by inserting the tab of the patch into the open front end of the controller.

10. The method defined in claim 8, further comprising the step of preventing the flow of current if the initial flow of current between the electrode and the additional electrode is not detected.

11. The method defined in claim 8, wherein the controller is electrically connected to the patch by inserting a tab of the patch into an open front end of the controller.

9. A method for insuring that a patch is not reused, comprising the steps of:

electrically interconnecting a patch with a controller;

activating the controller so that electrical current can initially flow between an electrode and an additional electrode;

exhausting a consumable material of the additional electrode;

monitoring whether electrical current is flowing between the electrode and the additional electrode, and

switching the flow of current after a predetermined period of time in the event current initially flowed through the electrode and the additional electrode so that current flows through the electrode and another electrode whereby at least one drug is delivered to a patient.