Method of implanting intraocular and intraorbital implantable devices for the controlled release of pharmacological agents

• US 5,098,443 A
• Filed: 02/06/1991
• Issued: 03/24/1992
• Est. Priority Date: 03/23/1989
• Status: Expired due to Term

• Current Assignee: University of Miami
• Original Assignee: University of Miami
• Inventors: Olsen, Karl R., Parrish, Richard, Portugal, Lourdes, Parel, Jean-Marie
• Primary Examiner(s): SHAY, RANDY CITRIN
• Application Number:
  US07/651,543
• Time in Patent Office: 412 Days
• Field of Search: 623/4, 623/5, 623/6, 604/294, 604/890.1, 604/891.1, 604/892.1, 424/426, 424/427, 424/428, 424/429
• US Class Current: 128/898
• CPC Class Codes: A61F 2/14 Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
• CPC Class Codes: A61F 2/147 Implants to be inserted in the stroma for refractive correction, e.g. ring-like implants
• CPC Class Codes: A61F 2/1694 Capsular bag spreaders therefor
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• 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: Y10S 623/907 Method of manipulating parts of intraocular lens structure for implantation

Abstract

A series of implants for intraocular and/or intraorbital use are provided which permit the controlled release of pharmacological agents. The implants are substantial C-shaped rings and are insertable through incisions made in the eye wall or are sutured around the globe of the eye. The C-shaped rings may be formed from the biodegradable polymers so as to release a drug as the polymer biodegrades or the implant may be in the form of a hollow flexible polymeric cocoon with the drug disposed therewithin for slow release by osmosis.

Claims

1. A method of implanting a device into an eye for the controlled release of intraocular and intraorbital pharmacological agents comprising:

providing an implant having at least one pharmacological agent one of incorporated and encapsulated therewithin;

providing an inserter including a cannula having a first end and second end and a passage defined therethrough from said first end to said second end;

mounting a syringe to said first end of said cannula, said syringe including a plunger and a piston extending forwardly therefrom into said passage of said cannula;

mounting said implant within said passage forwardly of said piston whereby movement of said piston relative to said cannula ejects said implant from said cannula;

inserting said cannula into an incision in the eye; and

ejecting said implant from said cannula;

whereby said pharmacological agent is gradually released from said implant to the eye.

3. A method as in claim 1, wherein the implant is inserted so as to be disposed in an angle defined by the intersection of the eye'"'"'s iris and cornea.

4. A method as in claim 1, wherein the implant is inserted so as to be disposed at an equator of the eye'"'"'s lens capsular bag.

5. A method as in claim 4, wherein the implant is introduced during an extracapsular procedure after removal of the eye'"'"'s lens nucleus and cortex to release pharmacological agents for preventing lens epithelium proliferation.

6. A method as in claim 1, wherein the implant is positioned radially inwardly of the conjunctiva and releases antimitotic and/or other pharmacological agents.

7. A method as in claim 1, wherein said step of mounting the implant comprises mounting an implantable device formed from a biodegradable polymer having a drug incorporated therein so that the biodegradation of the polymer releases the drug.

8. A method as in claim 7, wherein said steps of providing an implant, mounting said implant and ejecting said implant comprise providing, mounting and ejecting an implantable device which is substantially C-shaped once implanted.

9. A method as in claim 1, wherein said step of mounting an implantable device comprises mounting a hollow flexible polymeric cocoon having a drug disposed interiorly of said polymeric cocoon, said drug being diffusible through the walls of said polymeric cocoon into tissue via osmosis.

2. A method of implanting a device into an eye for the controlled release of intraocular and intraorbital pharmacological agents comprising:

providing an inserter including a cannula having a first end and second end and a passage defined therethrough from said first end to said second end;

mounting a syringe to said first end of said cannula, said syringe including a plunger and a piston extending forwardly therefrom into said passage of said cannula;

mounting an implant within said passage forwardly of said piston whereby movement of said piston relative to said cannula ejects said implant from said cannula;

inserting said cannula into an incision in the eye; and

ejecting said implant from said cannula,

the implant being inserted so as to be positioned intravitreally at the eye'"'"'s equator so as to release said pharmacological agent into the eye'"'"'s vitreous cavity.

10. A method of implanting a device into an eye for the controlled release of intraocular and intraorbital pharmacological agents comprising:

providing an inserter including a cannula having a first end and second end and a passage defined therethrough from said first end to said second end;

mounting a syringe to said first end of said cannula, said syringe including a plunger and a piston extending forwardly therefrom into said passage of said cannula;

mounting an implant within said passage forwardly of said piston whereby movement of said piston relative to said cannula ejects said implant from said cannula;

inserting said cannula into an incision in the eye; and

ejecting said implant from said cannula,

the implant being disposed in surrounding relation to the exterior of the eye to provide therapeutic pharmacological agent release to orbital tissue, ocular muscles, sclera, and by diffusion into intraocular tissues.

11. A method as in claim 10, wherein the implant is sized so that first and second ends thereof overlap to serve as a buckle structure.

12. A method of controllably releasing intraocular and intraorbital pharmacological agents into an eye comprising:

making an implantable device for the controlled intraocular and intraorbital release of pharmacological agents, including providing a biodegradable polymer having a drug incorporated therein and forming said polymer into a C-shaped ring,

providing an inserter including a cannula having a first end and second end and a passage defined therethrough from said first end to said second end;

mounting a syringe to said first end of said cannula, said syringe including a plunger and a piston extending forwardly therefrom into said passage of said cannula;

mounting said C-shaped ring within said passage forwardly of said piston whereby movement of said piston relative to said cannula ejects said C-shaped ring from said cannula;

inserting said cannula into an incision in the eye; and

ejecting said implant from said cannula;

whereby said pharmacological agent is gradually released from said implant to the eye.

13. A method as in claim 12, wherein said step of making further includes the steps of:

providing a drug to be delivered by the implantable device in powder form;

providing a polymer for forming the device in one of powder form and liquid form;

mixing the powder drug and polymer; and

processing said mixture into a C-ring shaped implant by one of solvent casting and thermal forming through one of compression and injection molding techniques.

14. A method as in claim 12, further comprising the steps of covalently bonding the drug to a polymer backbone for the implant via water soluble or hydrolyzable organic links whereby release of the drug occurs by a biodegradation of said organic links.

15. A method as in claim 12, further comprising forming covalent bonds between the polymer and drug molecules so as to create a polymeric drug system such that polymeric degradation releases the drug.

16. A method of controllably releasing intraocular and intraorbital pharmacological agents into an eye comprising:

forming an implantable device including forming a hollow flexible polymeric cocoon shaped as a C-ring and filling said polymeric cocoon with a pharmacological agent which is diffusible through the wall of said polymeric cocoon by osmosis;

providing an inserter including a cannula having a first end and second end and a passage defined therethrough from said first end to said second end;

mounting a syringe to said first end of said cannula;

said syringe including a plunger and a piston extending forwardly therefrom into said passage of said cannula;

mounting said C-shaped ring within said passage forwardly of said piston whereby movement of said piston relative to said cannula ejects said C-shaped ring from said cannula;

inserting said cannula into an incision in the eye; and

ejecting said implant from said cannula;

whereby said pharmacological agent is gradually released from said implant to the eye.