Devices, Systems and Methods for Ophthalmic Drug Delivery

• US 20080152694A1
• Filed: 07/20/2007
• Published: 06/26/2008
• Est. Priority Date: 07/20/2006
• Status: Abandoned Application

• Current Assignee: NeuroSystec Corporation
• Original Assignee: NeuroSystec Corporation
• Inventors: Pananen, Jacob E., Lobl, Thomas J., Nagy, Anna Imola, Schloss, John V.
• Application Number:
  US11/780,853
• Publication Number:
  US 20080152694A1
• Time in Patent Office: Days
• US Class Current: 424/427
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2205/7518 bacterial
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/385 using hydrophobic filters
• CPC Class Codes: A61N 1/36046 of the eye
• CPC Class Codes: A61P 27/02 Ophthalmic agents

Abstract

Devices, systems and techniques for delivering drugs to an ocular tissue are described. In at least some embodiments, a terminal component (e.g., a needle or open end of a catheter) is implanted in an ocular tissue and used to deliver one or more drugs. The delivered drugs may come from a source which is also implanted, or may be introduced from an external source (e.g., via a port). Both solid and liquid drug formulations can be used. Ocular implants can alternatively include a thin film coating that releases a drug into an ocular tissue.

Claims

1. A method of delivering one or more drugs to an ocular tissue, comprising:

implanting a drug source into a human or animal;

implanting a terminal component into an ocular tissue of the human or animal, the terminal component being in fluid communication with the drug source; and

delivering one or more drugs from the drug source to the ocular tissue through the terminal component.

2. The method of claim 1, wherein implanting a drug source includes implanting a reservoir containing a mass of a solid form of the one or more drugs, and further comprising

passing vehicle from a vehicle source past the solid drug mass in the implanted drug source so as to entrain the one or more drugs from said mass, and wherein the delivering step includes delivering the vehicle and entrained one or more drugs from the terminal component.

3. The method of claim 2, wherein the vehicle source is an implantable pump.

4. The method of claim 3, wherein the vehicle source is in fluid communication with the reservoir via a catheter.

5. The method of claim 4, wherein the implantable pump is implanted in the human or animal, and wherein the delivering step includes passing the vehicle and entrained one or more drugs through an antibacterial filter implanted in the human or animal.

6. The method of claim 4, wherein the implantable pump is a MEMS pump.

7. The method of claim 4, wherein the implantable pump is a piezo-electric pump.

8. The method of claim 4, wherein the implantable pump is a piston pump.

9. The method of claim 1, wherein the delivering step includes passing a fluid containing the one or more drugs through an antibacterial filter implanted in the human or animal.

10. The method of claim 1, wherein the step of implanting a drug source comprises implanting an osmotic pump.

11. The method of claim 1, wherein the one or more drugs delivered to the ocular tissue includes at least one of the following:

gacyclidine, one of its analogs, or one of its derivatives,

an NMDA receptor antagonist,

an anti-inflammatory drug,

a steroid,

an anti-fibrotic,

an integrin antagonist,

a molecule with the RDG (Arg-Gly-Asp) tripeptide cell adhesion motif,

fibronectin,

an antibiotic,

an antisecretory molecule,

a cholinergic agent,

a neuroprotective agent,

an anti-viral factor,

an anti-angiogenic factor,

an anti-neoplastic factor, and

a neurotrophic factor.

12. The method of claim 1, wherein the delivering step includes delivery of one or more drugs to the ocular tissue for at least one of the following:

treatment of neoplastic disease,

treatment of glaucoma,

treatment of an inflammatory disease of the ocular tissue,

treatment of the ocular tissue following trauma or surgery of the ocular tissue,

treatment of the ocular tissue to prevent fibrosis following surgery or injury by infections or trauma,

treatment of the ocular tissue to prevent detached retina or another disease where cell adhesion is needed,

treatment of the ocular tissue to inhibit further retinal detachment,

treating internal infections of ocular tissue,

reducing ocular pressure from glaucoma or other disease, and

treatment of neurodegeneration.

13. The method of claim 1, wherein the delivering step includes delivery of one or more drugs to the ocular tissue for treatment of macular degeneration.

14. The method of claim 1, wherein the implanted drug source is in fluid communication with the terminal component via at least one lumen of a multilumen catheter, wherein the one or more drugs are delivered to the ocular tissue through said at least one lumen, and further comprising

relieving intraocular pressure through another lumen of the multilumen catheter.

15. The method of claim 1, wherein the implanted drug source is in fluid communication with the terminal component via at least one lumen of a multilumen catheter, wherein the one or more drugs are delivered to the ocular tissue through said at least one lumen, and further comprising

receiving fluid from the human or animal through another lumen of the multilumen catheter.

16. The method of claim 1, wherein the terminal component includes an intraocular electrical stimulator, and further comprising

providing stimulation to the ocular tissue via the intraocular electrical stimulator.

17. The method of claim 16, wherein the intraocular electrical stimulator comprises a retinal implant having a plurality of electrodes and a plurality of apertures through which the one or more drugs are delivered.

18. The method of claim 1, wherein the delivering step includes delivery of one or more drugs to the ocular tissue for prevention of neurological damage resulting from surgical implantation or other physical trauma to at least one of a structure within the eyeball, an optic nerve or a visual cortex.

19. The method of claim 1, wherein the delivering step includes delivery of one or more drugs to the ocular tissue for treatment of hyperactivity of at least one of the peripheral or central visual nervous system.

20. The method of claim 1, wherein the one or more drugs are delivered from the terminal component in a fluid that includes a suspension of at least one of

small particles 100 nm to 0.1 mm in size having an affinity for the one or more drugs being delivered, and

nanoparticles 10 nm to 100 nm in size having an affinity for the one or more drugs being delivered.

21. The method of claim 20, wherein the fluid entrains drug from a solid drug mass in the implanted solid drug source.

22. The method of claim 1, wherein the one or more drugs includes gacyclidine.

23. The method of claim 1, wherein the one or more drugs includes an NMDA receptor antagonist.

24. The method of claim 1, wherein the step of implanting the terminal component includes implanting the terminal component in an ocular tissue outside of the sclera.

25. A method of fabricating solid pellets of gacyclidine base, comprising:

neutralizing a conjugate acid form of the gacyclidine base in solution with a pharmaceutically acceptable base, and

subjecting a suspension resulting from the neutralizing step to centrifugal force.

26. The method of claim 25, further comprising:

subjecting the suspension to sterile filtration prior to the step of subjecting the suspension to centrifugal force.

27. The method of claim 25, wherein the pharmaceutically acceptable base is sodium hydroxide.

28. A method, comprising:

applying gacyclidine to an ocular tissue to treat at least one of ocular tissue trauma, macular degeneration, vein occlusion, ischemia, diabetic retinopathy, neurodegeneration, and retinal damage resulting from exposure to intense light energy.

29. A method of delivering one or more drugs to an ocular tissue, comprising:

implanting a subcutaneous port in a human or animal;

implanting a terminal component into an ocular tissue of the human or animal, the terminal component being in fluid communication with the subcutaneous port;

placing the implanted subcutaneous port into fluid communication with a pump or other fluid source located external to the human or animal; and

delivering one or more drugs from the pump or other fluid source to the ocular tissue through the implanted terminal component.

30. A method of delivering one or more drugs to an ocular tissue, comprising:

implanting in an ocular tissue an implant having a thin film coating that includes a neuroprotective agent.

31. The method of claim 30, wherein the neuroprotective agent is an NMDA receptor antagonist.

32. The method of claim 31, wherein the NMDA receptor antagonist is gacyclidine.