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

• US 20050251024A1
• Filed: 05/05/2004
• Published: 11/10/2005
• Est. Priority Date: 05/05/2004
• Status: Active Grant

• Current Assignee: Mario Ammirati
• Original Assignee: Mario Ammirati
• Inventors: Ammirati, Mario
• Granted Patent: US 7,706,873 B2
• Time in Patent Office: Days
• US Class Current: 600/411
• 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;

providing a plurality of polarizable microcatheters surrounding the target location;

delivering the charged therapeutic agent to a delivery location 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.

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

3. The method of claim 2 wherein the microcatheters are implanted within the internal body tissue.

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

5. The method of claim 1 wherein the polarizable microcatheters comprise closed ends and are filled with an electrolytic solution.

6. The method of claim 1 wherein the polarizable microcatheters comprise an electrode.

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

8. 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.

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

10. 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.

11. The method of claim 10 wherein the number and position of the microcatheters is determined using the simulated target location on the computer based system.

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

13. The method of claim 12 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.

14. The method of claim 12 wherein the measuring of the concentration of the charged therapeutic agent is accomplished using a microdialysis technique.

15. 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.

16. The method of claim 1 further comprising:

determining a desired concentration of the charged therapeutic agent in the target location;

measuring concentration of the charged therapeutic agent within the target location;

comparing the measured concentration with the desired concentration; and

upon determining that the measured concentration is not approximately equal to the desired concentration, 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 step of adjusting delivery of the charged therapeutic agent to the target location is accomplished by adjusting strength of the electrical field, by switching polarity of one or more polarization means, and/or by adjusting rate of delivery of the charged therapeutic agent to the delivery location.

18. 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.

19. The method of claim 18 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.

20. 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.

21. A system for delivering a therapeutic agent to a target location within an internal body tissue, the system comprising:

a plurality of microcatheters implanted in the internal body tissue surrounding the target location, the microcatheters containing polarization means;

a reservoir of a charged therapeutic agent;

means to deliver the charged therapeutic agent from the reservoir to a delivery location between the microcatheters;

means to activate the polarization means; and

wherein the microcatheters are oriented so that when the polarization means are activated, an electrical field is generated between the microcatheters that drives the charged therapeutic agent throughout the target location.

22. The system of claim 21 further comprising means for measuring concentration of the charged therapeutic agent at a point between the microcatheters.

23. The system of claim 22 further comprising means to control flow rate of the charged therapeutic agent from the reservoir to the delivery location.

24. The system of claim 23 wherein the delivery means is a microcatheter.

25. The system of claim 23 wherein the measuring means is a microcatheter adapted to use a microdialysis technique.

26. The system of claim 25 wherein the activation means is a variable power source electrically coupled to the polarization means.

27. The system of claim 26 wherein the polarization means is selected from the group consisting of an electrolytic solution and an electrode.

28. The system of claim 21 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.

29. The system of claim 21 comprising means to switch polarity of one or more of the polarization means of the microcatheters to manipulate direction of movement of the charged therapeutic agent within the volume.

30. A method of treating a disease or condition comprising:

diagnosing a patient having the disease or condition;

identifying an affected location of internal tissue causing the disease or condition;

providing a plurality of polarizable microcatheters surrounding the affected location;

choosing a therapeutic agent to treat the diagnosed disease or condition;

determining a desired concentration level and desired time to which the affected location must be exposed to the therapeutic agent to treat the disease or condition;

delivering the charged therapeutic agent to the affected area in a quantity sufficient to achieve the desired concentration level; and

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

adjusting the electrical field to maintain the charged therapeutic agent within the affected location for the desired time.