Iontophoretic electrode

• US 9,180,286 B2
• Filed: 05/01/2013
• Issued: 11/10/2015
• Est. Priority Date: 02/27/2004
• Status: Active Grant

• Current Assignee: DJO LLC (Enovis Corp.)
• Original Assignee: Encore Medical Asset Corporation (Enovis Corp.)
• Inventors: Koschinsky, Ralph, Isaacson, James D., Hause, Robert F.
• Primary Examiner(s): Mendez, Manuel
• Application Number:
  US13/874,681
• Publication Number:
  US 20140039376A1
• Time in Patent Office: 923 Days
• Field of Search: 604 19- 22, 606/13, 606/14, 606/27, 606/31, 606/32, 606/41, 606/48, 606/129
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0428 Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0448 Drug reservoir

Abstract

An electrode for an iontophoretic drug delivery system includes a retainer having a malleable characteristic. The retainer and a conductor are connected to a platform. The conductor and a dose controller are electrically coupled to the iontophoretic drug delivery system. A drug delivery matrix is operably connected to the platform and proximate the conductor wherein the conductor, the drug delivery matrix, and the dose controller cooperate to deliver a drug to a user when the electrode is affixed to the user and operably connected to the iontophoretic drug delivery system.

Claims

1. A method for delivering a drug dose, the method comprising:

applying, to a treatment area of a patient, wherein the treatment area exhibits variations in skin and/or tissue resistance, a drug delivery electrode comprising a malleable retainer, a conductor, and a drug delivery matrix containing a drug, wherein the drug delivery matrix is segmented to cooperate with the conductor to deliver the drug from each segment of the drug delivery matrix at a predetermined dosage;

controlling, by a dose controller operably connected to the drug delivery electrode and a monitor, delivery of the drug from the drug delivery electrode by controlling at least one electrical characteristic of the drug delivery electrode, wherein the dose controller cooperates with the conductor to take into account the variations in skin and/or tissue electrical resistance within the treatment area, whereby an electro-chemical reaction between the conductor and the drug retained within the drug delivery device is adjusted;

monitoring, with a sensor placed near the treatment area, at least one characteristic associated with delivering the drug, wherein the sensor is in signal communication with the monitor and a current controller, and wherein the sensor, the monitor and the current controller cooperate to monitor an amount of electrical current flowing through the conductor proximate to the treatment area; and

automatically adjusting at least one electrical characteristic of the drug delivery electrode in response to the monitored characteristic,

whereby an accurate amount of a prescribed dosage of the drug is delivered to the treatment area despite the variations in skin and/or tissue electrical resistance within the treatment area.

2. The method of claim 1, further comprising conforming the drug delivery electrode to contours of the treatment area.

3. The method of claim 1, further comprising monitoring, with the sensor, at least one of voltage and resistance.

4. The method of claim 1, wherein the at least one electrical characteristic of the drug delivery electrode includes at least one of voltage, current, and resistance.

5. The method of claim 1, wherein automatically adjusting the at least one electrical characteristic of the drug delivery electrode further comprises adjusting according to a prescribed amount of medicament to be delivered.

6. The method of claim 1, further comprising:

setting an amount of electrical current supplied to the conductor.

7. The method of claim 1, further comprising adjusting the current amount supplied to the conductor in response to tissue resistance of the treatment area.

8. The method of claim 1, wherein the dose controller includes at least one of a variable resistor, a fixed resistor, a current regulator, a sensor, a monitor, or a voltage regulator.

9. The method of claim 1, further comprising providing a plurality of drug delivery electrodes.

10. The method of claim 9, wherein delivering the drug comprises delivering the drug from the plurality of drug delivery electrodes.

11. The method of claim 10, further comprising providing a return electrode.

12. The method of claim 1, wherein the at least one electrical characteristic of the drug delivery electrode is manually programmable or adjustable.

13. The method of claim 1, further comprising adjusting the at least one electrical characteristic of the drug delivery electrode based on empirical data relating to resistance values of a treatment area.

14. The method of claim 1, wherein the sensor is a current shunt.

15. The method of claim 1, wherein the sensor is a Hall Effect sensor.

16. The method of claim 1, wherein the drug delivery electrode is operably coupled to a plurality of conductors and a pair of dose controllers operably coupled to separate drug matrices, the pair of dose controllers comprising a fixed resistor and a variable resistor.

17. The method of claim 1, wherein a pair of drug delivery electrodes and return electrodes are operably connected to separate drug delivery matrices, and wherein each drug delivery electrode is operably connected to its respective drug delivery matrix directly via a dose controller resistor.

18. The method of claim 1, wherein the dose controller is not contained on the electrode but is instead remotely contained within a housing.

19. The method of claim 1, wherein the predetermined dose of the drug is delivered uniformly to the treatment area.

20. The method of claim 1, wherein the predetermined dose of the drug is delivered nonuniformly to the treatment area.