Ultrasound-Mediated Transcleral Drug Delivery

• US 20080177220A1
• Filed: 01/08/2007
• Published: 07/24/2008
• Est. Priority Date: 01/06/2006
• Status: Abandoned Application

• Current Assignee: Curators of the University of Missouri (University of Missouri)
• Original Assignee: Curators of the University of Missouri (University of Missouri)
• Inventors: Lindgren, Daniel, Mitra, Ashim K.
• Application Number:
  US11/620,990
• Publication Number:
  US 20080177220A1
• Time in Patent Office: Days
• US Class Current: 604/22
• CPC Class Codes: A61F 9/0008 Introducing ophthalmic products into the ocular cavity or retaining products therein putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis

Abstract

The present invention relates to processes, systems, and apparatuses for transcieral delivery of pharmaceutical formulations to the eye using ultrasound. In one embodiment, a transducer is placed in contact with a coupling media contained in a coupling well in contact with the sclera. When the transducer is placed at a desired standoff distance, ultrasonic waves are emitted to increase tissue porosity and transport a pharmaceutical formulation through the scleral tissue and into the eye. In another embodiment, a function generator is coupled to an amplifier, a matching network, and a transducer configured to maximize the cavitation effect of ultrasonic waves for drug delivery across a sclera.

Claims

1. A method for delivering one or more pharmaceutical agents to an eye through its sclera, comprising:

filling a coupling well with a coupling media and a pharmaceutical formulation;

placing an ultrasonic-wave-generating device in contact with the coupling media and within a desired standoff distance from the sclera; and

using the ultrasonic wave-generating device to transport the pharmaceutical formulation into the eye through the sclera.

2. The method of claim 1, wherein the coupling well is a cartridge that positions the ultrasonic wave-generating device at a pre-determined standoff distance, wherein the pre-determined standoff distance is the desired standoff distance.

3. The method of claim 1, wherein the ultrasonic wave-generating device includes a transducer having a tip with a concave surface.

4. The method of claim 3, wherein the curvature of the tip of the transducer closely corresponds with the curvature of the eye.

5. The method of claim 1, wherein the ultrasonic wave-generating device is used to emit pulsed ultrasonic waves to transport the pharmaceutical formulation through the sclera.

6. The method of claim 1, wherein the ultrasonic wave-generating device is used to emit continuous ultrasonic waves to transport the pharmaceutical formulation through the sclera.

7. The method of claim 2, wherein the cartridge has a pre-determined standoff distance between about 0.5 and 1.5 centimeters.

8. The method of claim 1, wherein the eye is exposed to ultrasonic waves for an exposure time of about 10 minutes or less.

9. The method of claim 1, wherein the ultrasonic wave-generating device is operated at a frequency between about 100 kHz and 1.75 MHz.

10. An ultrasonic transcleral drug delivery system, comprising:

a function generator capable of generating electrical signals from algorithms;

an amplifier capable of increasing the intensity of the electrical signals;

a matching network capable of modifying the impedance of the electrical signals;

a transducer capable of emitting ultrasonic waves from the electrical signals, wherein the transducer has a tip shaped to enhance transport of a pharmaceutical formulation through scleral tissue;

and a coupling well capable of holding a coupling media containing the pharmaceutical formulation and adapted to allow the transducer to be positioned so as to provide a desired standoff distance from the scleral tissue.

11. The system of claim 10, wherein the coupling well is a cartridge that positions the transducer at a pre-determined standoff distance, wherein the pre-determined standoff distance is the desired standoff distance.

12. The system of claim 10, further comprising a visual display capable of graphically displaying the electrical signals.

13. The system of claim 10, wherein the transducer is capable of emitting ultrasonic waves in a continuous mode, in a pulsed mode, or in a combination of continuous and pulsed waves.

14. The system of claim 10, wherein the transducer tip shaped to enhance transport of the pharmaceutical formulation has a concave-curved tip that approximates the curvature of an eye at its sclera.

15. The system of claim 11, wherein the system further comprises a transducer-specific connector that connects the cartridge to the transducer.

16. An ultrasonic pharmaceutical-transport apparatus for delivering pharmaceutical formulations through a sclera, comprising:

an ultrasonic wave source capable of generating ultrasonic waves at a plurality of frequencies;

an ultrasonic transducer tip having a concave curvature approximating the curvature of a human eye;

a pre-configured cartridge adapted for containing a volume of a coupling media and a pharmaceutical formulation to be delivered through the sclera of the human eye, wherein the pre-configured cartridge positions the transducer tip at a pre-determined standoff distance from the sclera.

17. The apparatus of claim 16, wherein the ultrasonic wave-generating source comprises a function generator capable of generating electrical signals, an amplifier, and a matching network capable of modifying the electrical signals.

18. The apparatus of claim 16, wherein the transducer tip has a cross-sectional area with a diameter of between about 5 and 15 millimeters.

19. The apparatus of claim 16, wherein the plurality of frequencies comprises frequencies within the range between 100 kHz and 1.75 MHz.

20. The apparatus of claim 16, wherein the pre-configured cartridge is capable of being adjusted to provide for a plurality of pre-determined standoff distance settings.