Method for measuring the cutaneous electrical resistance of a patient subjected to transdermal administration of medicine

• US 6,391,015 B1
• Filed: 05/17/1999
• Issued: 05/21/2002
• Est. Priority Date: 11/19/1996
• Status: Expired due to Fees

• Current Assignee: Encore Medical Asset Corporation (Enovis Corp.)
• Original Assignee: Iomed, Inc. (Enovis Corp.)
• Inventors: Millot, Philippe
• Primary Examiner(s): Nguyen, Anhtuan T.
• Assistant Examiner(s): Lam, Ann Y
• Application Number:
  US09/312,498
• Time in Patent Office: 1,100 Days
• Field of Search: 604/503, 604/500-501, 604/20, 604/48, 607/149, 607/153, 607/62, 607/59
• US Class Current: 604/503
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• 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

In accordance with the invention, an ionophoresis current (I) assisting administration is temporarily adjusted to a predetermined value (I_m) corresponding to a point on a rectilinear portion (0_A) adjoining the origin of the current/voltage characteristics of the skin of the patient, the voltage (V_skin) then present between the two electrodes applying the ionophoresis current to the skin of the patient is measured and the measured cutaneous resistance (R_cut) is obtained from the measured voltage (V_skin) and the predetermined value (I_m) of the ionophoresis current.

Claims

1. A method for measuring the cutaneous electrical resistance of a patient undergoing transdermal administration of medication assisted by an iontophoresis current, wherein the current is applied across a surface of a patient using an iontophoretic device, the iontophoretic device comprising a reservoir having a medicament, a first electrode and a second electrode, the method comprising the steps of:

temporarily adjusting the current from a treatment current density to a predetermined current density, wherein the predetermined current density is within a range of values for which the current density and the voltage have a direct relationship;

measuring the voltage drop across the surface of a patient between the first electrode and the second electrode; and

calculating the resistance of the surface of a patient at a region between the first and second electrodes from the measured voltage value and the predetermined current density.

2. The method according to claim 1, wherein the predetermined current density corresponds to a substantially zero current flux of the medicament to be delivered iontophoretically.

3. The method according to claim 1 further including the step of returning the predetermined current density back to substantially the same value as the treatment current density.

4. The method according to claim 3, wherein the steps are repeated at least once during the administration of medicament to a patient.

5. The method according to claim 3, wherein the step of returning the current density comprises the steps of:

changing the predetermined current density to at least one intermediate current density;

maintaining that intermediate current density for a period of time; and

changing the intermediate current density to the treatment current density.

6. The method according to claim 1, wherein the method further comprises the steps of:

comparing the calculated resistance with a predetermined minimum resistance;

determining if the calculated resistance is less than the minimum resistance; and

changing the treatment current density to zero if the calculated resistance is less than the minimum resistance.

7. The method according to claim 6, wherein the method further comprises the step of activating at least one of an audible and a visual alarm if the calculated resistance is less than the minimum resistance.

8. The method according to claim 6, wherein the method comprises the step of determining the minimum resistance so that a short-circuit of the surface of a patient may be detected.

9. The method according to claim 1, wherein the method further comprises the steps of:

comparing the calculated resistance with a predetermined maximum resistance;

determining if the calculated resistance is greater than the maximum resistance; and

changing the treatment current density to zero if the calculated resistance is greater than the maximum resistance.

10. The method according to claim 9, wherein the method further comprises the step of activating at least one of an audible and a visual alarm if the calculated resistance is greater than the maximum resistance.

11. The method according to claim 9, wherein the method comprises the step of determining the maximum resistance so that at least one of a lesion on the surface of a patient, the imminent appearance of a lesion on the surface of a patient, and insufficient hydration of the medicament may be detected.

12. The method of claim 1, wherein there is a predetermined minimum resistance and a predetermined maximum resistance associated with the surface of a patient, the method further comprising the steps of:

determining whether the calculated resistance is between the predetermined values of the minimum resistance and the maximum resistance; and

administering the treatment current density if the calculated resistance is between the predetermined values of the minimum resistance and the maximum resistance.

13. The method according to claim 1, wherein the measuring of the cutaneous electrical resistance is performed prior to administering a medicament to a patient.

14. The method according to claim 1, wherein the measuring of the cutaneous electrical resistance is performed after administering medicament to a patient.

15. The method according to claim 1, wherein the predetermined current density is in the range of about 0-50 μ

/cm2.

16. The method according to claim 15, wherein the predetermined current density is about 12.5 μ

A/cm2.

17. A method for measuring the cutaneous electrical resistance of a patient undergoing transdermal administration of medication assisted by an iontophoresis current, wherein the current is applied across a surface of a patient using an iontophoretic device, the iontophoretic device comprising a reservoir having a medicament, a first electrode and a second electrode, the method comprising the steps of:

temporarily adjusting the current from a treatment current density to a predetermined current density, wherein the predetermined current density corresponds to a substantially zero current flux of the medicament to be delivered iontophoretically;

measuring the voltage drop across the surface of a patient between the first electrode and the second electrode; and

calculating the resistance of the surface of a patient at a region between the first and second electrodes from the measured voltage value and the predetermined current density.

18. The method according to claim 17 further including the step of returning the predetermined current density back to substantially the same value as the treatment current density.

19. The method according to claim 18, wherein the steps are repeated at least once during the administration of medicament to a patient.

20. The method according to claim 18, wherein the step of returning the current density comprises the steps of:

changing the predetermined current density to at least one intermediate current density;

maintaining that intermediate current density for a period of time; and

changing the intermediate current density to the treatment current density.

21. The method according to claim 17, wherein the method further comprises the steps of:

comparing the calculated resistance with a predetermined minimum resistance;

determining if the calculated resistance is less than the minimum resistance; and

changing the treatment current density to zero if the calculated resistance is less than the minimum resistance.

22. The method according to claim 21, wherein the method further comprises the step of activating at least one of an audible and a visual alarm if the calculated resistance is less than the minimum resistance.

23. The method according to claim 21, wherein the method comprises the step of determining the minimum resistance so that a short-circuit of the surface of a patient may be detected.

24. The method according to claim 17, wherein the method further comprises the steps of:

comparing the calculated resistance with a predetermined maximum resistance;

determining if the calculated resistance is greater than the maximum resistance; and

changing the treatment current density to zero if the calculated resistance is greater than the maximum resistance.

25. The method according to claim 21, wherein the method further comprises the step of activating at least one of an audible and a visual alarm if the calculated resistance is greater than the maximum resistance.

26. The method according to claim 24, wherein the method comprises the step of determining the maximum resistance so that at least one of a lesion on the surface of a patient, the imminent appearance of a lesion on the surface of a patient, and insufficient hydration of the medicament may be detected.

27. The method of claim 17, wherein there is a predetermined minimum resistance and a predetermined maximum resistance associated with the surface of a patient, the method further comprising the steps of:

determining whether the calculated resistance is between the predetermined values of the minimum resistance and the maximum resistance; and

administering the treatment current density if the calculated resistance is between the predetermined values of the minimum resistance and the maximum resistance.

28. The method according to claim 17, wherein the measuring of the cutaneous electrical resistance is performed prior to administering a medicament to a patient.

29. The method according to claim 17, wherein the measuring of the cutaneous electrical resistance is performed after administering medicament to a patient.

30. The method according to claim 17, wherein the predetermined current density is in the range of about 0-50 μ

A/cm2.

31. The method according to claim 30, wherein the predetermined current density is about 12.5 μ

A/cm2.