System and method for controlled delivery of a therapeutic agent to a target location within an internal body tissue

• US 7,706,873 B2
• Filed: 05/05/2004
• Issued: 04/27/2010
• Est. Priority Date: 05/05/2004
• Status: Active Grant

• Current Assignee: Mario Ammirati
• Original Assignee: Mario Ammirati
• Inventors: Ammirati, Mario
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): VU, QUYNH-NHU HOANG
• Application Number:
  US10/839,326
• Publication Number:
  US 20050251024A1
• Time in Patent Office: 2,183 Days
• Field of Search: 604/890, 604/891.1, 604 19- 20, 604/93.01, 604/288.01, 604501-503, 604/506, 604/272, 435/173.6, 600/411, 600/407, 600/423, 600/427, 600/433
• US Class Current: 604/20
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61K 9/0085 Brain, e.g. brain implants; Spinal cord
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• 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

A method and system for the localized delivery of therapeutic agents to internal body tissues, especially the brain. In one aspect the invention is a method of delivering a therapeutic agent to a target location within an internal body tissue, the method comprising: charging the therapeutic agent; providing a plurality of polarizable microcatheters surrounding the target location; delivering the charged therapeutic agent between the microcatheters; and polarizing the microcatheters thereby generating an electrical field between the microcatheters that moves the charged therapeutic agent throughout the target location. In another aspect the invention is a system for carrying out the method.

Claims

1. A method of delivering a therapeutic agent to a target location within an internal body tissue, the method comprising:

charging the therapeutic agent;

implanting at least a portion of a plurality of polarizable microcatheters within the internal body tissue to surround the target location, the polarizable microcatheters having closed ends and filled with a fluidic electrolytic solution;

delivering the charged therapeutic agent to a delivery location between the microcatheters; and

polarizing the electrolytic solution within the microcatheters thereby generating an electrical field between the microcatheters that moves the charged therapeutic agent throughout the target location.

2. The method of claim 1 wherein the delivery location is within or adjacent to the target location.

3. The method of claim 1 wherein the internal body tissue is the brain.

4. The method of claim 1 wherein the charged therapeutic agent is delivered to the delivery location using an open end microcatheter.

5. The method of claim 1 further comprising switching polarity of one or more of the polarizable microcatheters to manipulate direction of movement of the charged therapeutic agent.

6. The method of claim 1 further comprising varying strength of the electrical field generated by the polarizable microcatheters to control rate of movement of the charged therapeutic agent.

7. The method of claim 1 further comprising:

identifying the target location using magnetic resonance imaging; and

simulating the target location in three dimensional space using a computer based system.

8. The method of claim 7 wherein the number and position of the polarizable microcatheters is determined using the simulated target location on the computer based system.

9. The method of claim 1 further comprising measuring concentration of the charged therapeutic agent at a point in the internal body tissue between the polarizable microcatheters.

10. The method of claim 9 further comprising adjusting rate of movement or direction of movement of the charged therapeutic agent within the internal body tissue based on the concentration measurement.

11. The method of claim 9 wherein the measuring of the concentration of the charged therapeutic agent is accomplished using a microdialysis technique.

12. The method of claim 1 wherein the delivery of the charged therapeutic agent is accomplished in a rate controlled manner by a delivery system comprising a reservoir of the charged therapeutic agent and a valve.

13. The method of claim 1 further comprising:

diagnosing a patient having a brain disease or condition;

identifying an affected area of the brain causing the brain disease or condition, wherein the target location is the affected area;

choosing the therapeutic agent to treat the brain disease or condition; and

supplying the charged therapeutic agent to the target location in a quantity to treat the diagnosed brain disease or condition.

14. The method of claim 13 wherein the internal body tissue is the brain and the charged therapeutic agent is selected to treat viral infections, HIV-related neurological disease, stroke, head injuries, neuro-degenerative diseases, tumors, or psychotic disorders.

15. The method of claim 1 further comprising switching the polarity of the polarizable microcatheters to drive the charged therapeutic agent back and forth within the target location to maintain the charged therapeutic agent within the target location for a desired time.

16. An automated method of delivering and maintaining a therapeutic agent in a target location within an internal body tissue at a desired concentration, the method comprising:

a) providing a system comprising a controller, a memory device storing data corresponding to the desired concentration, a battery, a plurality of polarizable microcatheters, means for measuring concentration of the therapeutic agent, wherein the controller, the memory device, the battery, the plurality of polarizable microcatheters, and the concentration measuring means are operably connected to one another;

b) implanting the plurality of polarizable microcatheters within the internal body tissue so as to surround the target location;

c) implanting the concentration measuring means within the internal body tissue so that concentration of the therapeutic agent in the target location can be measured;

d) delivering the charged therapeutic agent to a delivery location between the polarizable microcatheters;

e) polarizing the polarizable microcatheters thereby generating an electrical field between the polarizable microcatheters that moves the charged therapeutic agent throughout the target location;

f) repetitively measuring concentration of the charged therapeutic agent within the target location with the concentration measuring means, the concentration measuring means transmitting signals indicative of the measured concentration to the controller;

g) the controller receiving the signals and comparing the measured concentration with the desired concentration stored in the memory device; and

h) upon determining that the measured concentration is not approximately equal to the desired concentration, the controller automatically adjusting delivery of the charged therapeutic agent to the target location until the measured concentration is approximately equal to the desired concentration.

17. The method of claim 16 wherein the adjusting delivery of the charged therapeutic agent to the target location in step h) is accomplished by the controller adjusting strength of the electrical field, switching polarity of one or more of the polarizable microcatheters, and/or adjusting rate of delivery of the charged therapeutic agent to the delivery location.

18. An automated method of treating a disease or condition comprising:

a) identifying an affected location of tissue causing a disease or condition;

b) selecting a charged therapeutic agent to treat the diagnosed disease or condition;

c) determining a desired concentration to which the affected location must be exposed to the charged therapeutic agent to treat the disease or condition;

d) implanting a plurality of polarizable microcatheters so as to surround the affected location;

e) delivering the charged therapeutic agent to the affected location from a reservoir in a quantity sufficient to achieve the desired concentration level in the affected location;

f) polarizing the polarizable microcatheters thereby generating an electrical field between the polarizable microcatheters that moves the charged therapeutic agent throughout the affected location;

g) repetitively measuring concentration of the charged therapeutic agent in-situ within the affected location; and

h) upon determining that the measured concentration is not approximately equal to the desired concentration, automatically adjusting delivery of the charged therapeutic agent to the target location until the measured concentration is approximately equal to the desired concentration.

19. The method of claim 18 wherein the tissue is brain tissue.