APPARATUS AND METHOD FOR DELIVERING A THERAPEUTIC AGENT TO OCULAR TISSUE

• US 20100137780A1
• Filed: 09/25/2009
• Published: 06/03/2010
• Est. Priority Date: 10/18/2006
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Lvovich, Vadim F., Singh, Rishi P., Davis, Brian L.
• Granted Patent: US 8,311,624 B2
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61B 17/0231 for eye surgery
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61N 1/303 Constructional details electrodes for external use A61N1/0428
• 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

An apparatus for delivering at least one therapeutic agent to an ocular tissue of a subject includes at least one electrode, a medicament layer including the at least one therapeutic agent, an electrical signal source, and logic configured to control the electrical signal source. The at least one electrode has oppositely disposed, dome-shaped first and second major surfaces. The first major surface is curved such that the first major surface substantially conforms to the contour of the ocular tissue when placed in contact with the ocular tissue. The medicament layer is disposed on at least a portion of the second major surface. The electrical signal source provides a signal having certain characteristics and is electrically connected to the at least one electrode. The certain characteristics comprise at least one orienting frequency and at least one motivating frequency sufficient to motivate the at least one therapeutic agent into the ocular tissue.

Claims

1. An apparatus for delivering at least one therapeutic agent to an ocular tissue of a subject, said apparatus comprising:

at least one electrode having oppositely disposed, dome-shaped first and second electrically-conductive major surfaces, said first major surface being curved such that said first major surface substantially conforms to the contour of the ocular tissue when said first major surface is in contact with the ocular tissue;

a medicament layer including the at least one therapeutic agent, said medicament layer being disposed on at least a portion of said second major surface;

an electrical signal source for providing a signal having certain characteristics, said electrical signal source being electrically connected to said at least one electrode; and

logic configured to control said electrical signal source;

wherein said certain characteristics of said electrical signal source comprises at least one orienting frequency and at least one motivating frequency sufficient to motivate the at least one therapeutic agent into the ocular tissue.

2. The apparatus of claim 1, wherein each of said at least one orienting frequency and said at least one motivating frequency comprises an alternating current (AC) signal.

3. The apparatus of claim 1, wherein said at least one orienting frequency comprises an AC signal and said at least one motivating frequency comprises a direct current (DC) signal.

4. The apparatus of claim 1, wherein said at least one electrode is an interdigitated electrode.

5. The apparatus of claim 1, wherein said first major surface of said at least one electrode is curved such that said first major surface is substantially similar to the radius of curvature of a human eye.

6. The apparatus of claim 1 further including a positioning member for placing said at least a portion of said first major surface into contact with the ocular tissue.

7. The apparatus of claim 6, wherein said positioning member further comprises a clam-shaped housing, said housing comprising:

a first opposable member;

a second opposable member;

a hinge mechanism operably connecting said first opposable member with said second opposable member; and

a securing mechanism for mating said first opposable member with said second opposable member;

wherein said at least one electrode is securely seated within said housing.

8. The apparatus of claim 7, wherein each of said first and second opposable members is ring-shaped and includes a central opening, said at least one electrode being securely seated within said central opening of said first opposable member.

9. The apparatus of claim 8, wherein said second opposable member includes a dome-shaped member securely seated within said central opening thereof.

10. A system for delivering at least one therapeutic agent to an ocular tissue of a subject, said system comprising:

an apparatus including;

at least one electrode having oppositely disposed, dome-shaped first and second electrically-conductive major surfaces, said first major surface being curved such that said first major surface substantially conforms to the contour of the ocular tissue when said first major surface is in, direct contact with the ocular tissue;

a medicament layer including the at least one therapeutic agent, said medicament layer being disposed on at least a portion of said second major surface;

an electrical signal source for providing a signal having certain characteristics, said electrical signal source being electrically connected to said at least one electrode; and

logic configured to control said electrical signal source;

wherein said certain characteristics of said electrical signal source comprises at least one orienting frequency and at least one motivating frequency sufficient to motivate the at least one therapeutic agent into the ocular tissue;

an electrical lead having oppositely disposed proximal and distal ends, said proximal end being electrically connected to said electrical signal source and said distal end being electrically connected to said at least one electrode, said electrical lead for delivering said electrical signal to said at least one electrode; and

a displacement device for facilitating application of said first major surface of said at least one electrode to the ocular tissue, said displacement device being securely connected to said electrical lead.

11. The system of claim 10, wherein said displacement device further comprises:

oppositely disposed, flexible first and second arm members, each of said arm members including a distal end portion and a proximal end portion, said distal end portion of each of said first and second arm members including first and second channels for receiving at least a portion of an upper eyelid and a lower eyelid, respectively; and

a connection member operably joining said proximal end portion of each of said first and second arm members and said electrical lead.

12. A method for delivering at least one therapeutic agent to an ocular tissue of a subject, said method comprising the steps of:

providing an apparatus comprising at least one electrode, a medicament layer including the at least one therapeutic agent, an electrical signal source, and logic configured to control the electrical signal source, the at least one electrode having oppositely disposed first and second dome-shaped major surfaces, the medicament layer being disposed on at least a portion of the second major surface, the electrical signal source being electrically connected to the at least one electrode;

placing at least one portion of the first major surface into contact with the ocular tissue so that said at least one portion substantially conforms to the contour of the ocular tissue; and

causing the electrical signal source to provide a signal having certain characteristics to motivate the at least one therapeutic agent into the ocular tissue.

13. The method of claim 12, wherein said step of causing the electrical signal source to provide a signal further comprises the steps of:

selecting at least one orienting frequency; and

selecting at least one motivating frequency.

14. The method of claim 13, wherein each of said at least one orienting frequency and said at least one motivating frequency comprises an AC signal.

15. The method of claim 13, wherein said at least one orienting frequency comprises an AC signal and said at least one motivating frequency comprises a DC signal.

16. The method of claim 12, wherein said step of placing at least a portion of the first major surface into contact with the ocular tissue further comprises the steps of:

providing a displacement device that is operably joined with an electrical lead via a connection member, the displacement device comprising oppositely disposed, flexible first and second arm members, each of the arm members including a distal end portion and a proximal end portion, the distal end portion of each of the first and second arm members respectively including first and second channels;

positioning the displacement device about the eye of the subject so that at least a portion of the upper and lower eyelids is disposed within the first and second channels of the displacement device, respectively; and

operating the displacement device to sufficiently spread apart the upper and lower eyelids so that the first major surface of the at least one electrode contacts the ocular tissue.

17. The method of claim 12, wherein said step of placing at least a portion of the first major surface into contact with the ocular tissue further comprises the step of positioning the first major surface substantially adjacent an ocular tissue selected from the group consisting of the sclera, the eyelid, and the cornea.

18. The method of claim 12, wherein said step of placing at least a portion of the first major surface into contact with the ocular tissue further comprises the step of positioning the first major surface substantially adjacent or under the conjunctiva

19. A method for delivering at least one therapeutic agent to a select region of a subject'"'"'s eye, said method comprising the steps of:

providing an apparatus comprising at least one electrode, a medicament layer including the at least one therapeutic agent, an electrical signal source, and logic configured to control the electrical signal source, the at least one electrode having oppositely disposed, electrically-conductive first and second dome-shaped major surfaces, the medicament layer being disposed on at least a portion of the second major surface, the electrical signal source being electrically connected to the at least one electrode;

shaping at least one of the medicament layer and the at least one electrode so that delivery of the electrical signal to the at least one electrode motivates the at least one therapeutic agent into the select region of the subject'"'"'s eye; and

causing the electrical signal source to provide an electrical signal to the at least one electrode to motivate the at least one therapeutic agent into the selection region of the subject'"'"'s eye.

20. The method of claim 19, wherein the select region of the subject'"'"'s eye is the anterior segment of the subject'"'"'s eye.

21. The method of claim 20, wherein said step of shaping at least one of the medicament layer and the at least one electrode further comprises the step of centering the medicament layer on the second major surface of the at least one electrode so that the medicament layer is substantially adjacent at least a portion of the corneal surface.

22. The method of claim 19, wherein the select region of the subject'"'"'s eye is the posterior segment of the subject'"'"'s eye.

23. The method of claim 22, wherein said step of shaping at least one of the medicament layer and the at least one electrode further comprises the step of centering the medicament layer on the second major surface of the at least one electrode so that the medicament layer is substantially adjacent at least a portion of the pars plana.