Sensor controlled analysis and therapeutic delivery system

• US 20030023187A1
• Filed: 09/25/2002
• Published: 01/30/2003
• Est. Priority Date: 02/24/1998
• Status: Active Grant

• Current Assignee: Robert Tapper
• Original Assignee: Robert Tapper
• Inventors: Tapper, Robert
• Granted Patent: US 7,008,384 B2
• Time in Patent Office: Days
• US Class Current: 600/573
• CPC Class Codes: A61N 1/0436 Material of the electrode
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0444 Membrane
• CPC Class Codes: A61N 1/0448 Drug reservoir
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428

Abstract

A method and apparatus for non-invasively withdrawing and accurately evaluating analytes quickly, painlessly and reliably from a biological subject automatically and controlling subsequent administration of therapeutic agents in response to such analyte sample analysis. Improvements are provided in electro-osmotic sample withdrawal, dosimetry and iontophoretic delivery subsystems, biosensors electrode construction and arrangement, intervenors, mediators, bolus delivery, and related subsystems.

Claims

1. In the electronic dosimetry control system for iontophoretic delivery of therapeutic agents to a biological subject, the combination comprising:

means for delivering a slow A.C. electrical current to the skin of a biological subject to transport a therapeutic agent to the subject;

means for varying the time period over which said electrical current is supplied to the biological subject in accordance with the desired dosage to be delivered to the biological subject; and

means for terminating said electrical current delivered to the biological subject when said electrical current-time product equals the desired total dosage.

2. An electronic process for controlling iontophoretic delivery of therapeutic agents by electrical current applied over time to a biological subject, comprising the steps of:

establishing a total dosage to be delivered, in the form of a slow A.C. electrical current-time product, to the biological subject; and

automatically varying the time period over which said electrical current is applied by accumulating the electrical current-time product until termination at the selected dosage.

3. In an electronic control system for iontophoretic treatment of a biological subject, the combination comprising:

means for applying a slow A.C. electrical current to a biological subject over time;

means for establishing the magnitude of the desired total treatment dosage to be applied to the biological subject, in terms of electrical current-time product;

means for sensing the magnitude of said electrical current and for converting said magnitude to an electrical signal;

means for measuring said electrical signal over time as an indication of the actual electrical current-time product;

means for comparing said actual electrical current-time product with said desired total sample volume to be withdrawn; and

means for terminating said electrical current when said electrical current-time product equals said desired total treatment dosage as established by said determining means.

4. In an electronic control system for iontophoretic treatment of a biological subject, the combination comprising:

means for conveying a slow A.C. electrical current to the skin of a biological subject;

means for determining the magnitude of said electrical current;

means for controlling the time period over which said electrical current is supplied to the biological subject;

control means for automatically determining the therapeutic dosage to be applied to the biological subject;

means for electrically measuring the actual dosage applied to the biological subject as a function of said electrical current and time; and

means for terminating said electrical current applied to the biological subject when said electrical current-time product equals the desired total dosage as established by said control means.

5. In an electronic control system for iontophoretic delivery of a therapeutic agent to a biological subject, the combination comprising:

means for delivering an electrical current to the skin of a biological subject;

means for varying the time period over which said electrical current is supplied to the biological subject in accordance with the desired dosage to be delivered to the biological subject;

means for terminating said electrical current applied to the biological subject when said electrical current-time product equals the desired total dosage; and

means for intermittently reversing said electrical current, at a relatively low frequency which prevents skin damage, between approximately 20 times per second and approximately once every three minutes.

6. An electronic process for controlling iontophoretic delivery of a therapeutic agent by a slow A.C. electrical current applied over time to a biological subject, comprising the steps of:

selecting a total dosage to be delivered, in the form of an electrical current-time product, from the biological subject;

automatically varying the time period over which said electrical current is applied by accumulating the electrical current-time product until termination at the selected dosage;

conducting said electrical current through a surface of said subject in a first direction from a first electrode to a second electrode on said subject; and

intermittently reversing, at a relatively low frequency which prevents skin damage, between approximately 20 times per second and approximately once every three minutes, the polarity of said electrodes to cause said electrical current to flow in a second direction opposite to said first direction, whereby iontophoretic delivery is accomplished at the desired dosage.

7. A process as recited in claim 6, including the additional step of electrically connecting both of said electrodes in parallel for bolus delivery.

8. A process as recited in either of claims 6 or 7 wherein operation is conducted at plural frequencies.

9. In a patch adapted to be worn by a biological subject, the combination comprising;

means within said patch for electro-osmotic withdrawal of fluid sample;

biosensor means within said patch for evaluation of said samples; and

means within said patch for providing iontophoretic treatment to a biological subject in response to said biosensor means.

10. In a patch adapted to be worn by a biological subject, the combination comprising:

means within said patch for providing iontophoretic treatment to the biological subject; and

dosimetry control means within said patch for controlling the dosage of said iontophoretic treatment as a function of the product of time and electrical current applied to the subject.

11. A combination as recited in claim 10 wherein said electrical current is generated by a slow A.C. signal.