Ocular insert with anchoring protrusions

• US 5,989,579 A
• Filed: 09/19/1997
• Issued: 11/23/1999
• Est. Priority Date: 10/02/1986
• Status: Expired due to Fees

• Current Assignee: Escalon Medical Corporation
• Original Assignee: Escalon Medical Corporation
• Inventors: Gantner, David Clayton, Bhatt, Padmanabh Pravinchandra, Raul, Victor Albert, Weiner, Alan L., Darougar, Sohrab
• Primary Examiner(s): Harrison, Robert H.
• Application Number:
  US08/934,382
• Time in Patent Office: 795 Days
• Field of Search: 424/422, 424/427, 424/428, 424/429, 604/890.1
• 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

Abstract

A flexible ocular insert device adapted for the controlled sustained release of an ophthalmic drug into the eye. In one embodiment, the device includes an elongated body of a polymeric material in the form of a rod or tube containing a pharmaceutically active ingredient and with at least two anchoring protrusions extending radially outwardly from the body. The device has a length of at least 8 mm and the diameter of its body portion including the protrusions does not exceed 1.9 mm. The sustained release mechanism may, for example, be by diffusion or by osmosis or bioerosion. The insert device is advantageously inserted into the upper or lower fornix of the eye so as to be independent of movement of the eye by virtue of the fornix anatomy. The protrusions may be of various shapes such as, for example, ribs, screw threads, dimples or bumps, truncated cone-shaped segments or winding braid segments. In a further embodiment, the polymeric material for the body is selected as one which swells in a liquid environment. Thus a device of smaller initial size may be employed. The present insert device is of a size and configuration such that, upon insertion into the upper or lower fornix, the device remains out of the field of vision so as to be well retained in place and imperceptible by a patient over a prolonged period of use. The device can be retained in the upper or lower fornix for 7 to 14 days or longer.

Claims

1. A method for the controlled sustained release of an ophthalmic drug into the eye over a period of time which comprises:

a. inserting an elongated device having a body of a polymeric material in the form of a rod or tube containing an ophthalmic drug into the upper or lower fornix so as to anchor said device into position therein, wherein said polymeric material is a material which is subject to swelling in a liquid environment, said device being sufficiently flexible to allow it to bend along the curvature of the eye within the upper or lower fornix upon being positioned so that the longitudinal axis of said device is generally parallel to the transverse diameter of the eyeball, said device being of a size and configuration such that, upon insertion into the upper or lower fornix, the device does not extend onto any visible portion of the eyeball, said device being independent of movement of the eye and remaining out of the field of vision so as to be well retained in place and imperceptible by a patient over a prolonged period of use;

b) allowing the device to swell so that it locks into place in the fornix as it grows in size such that the length of the device is at least 8 mm and the diameter does not exceed 1.9 mm; and

c) allowing said device to remain in the upper or lower fornix for drug release during said period of time, whereby the device when inserted into the upper or lower fornix can be retained therein for more than seven days.

2. The method of claim 1 wherein a device is employed having dimensions which initially are smaller than the desired final dimensions, so that the device is assisted in locking into place as the device increases in size after insertion into the fornix.

3. The method of claim 1 wherein a release modifier is employed during manufacture of said device and which includes the further step of adjusting the ratio of drug to release modifier during manufacture of said device to affect the rate of liquid diffusion into the device.

4. The method of claim 1 wherein said polymeric material is a silicone-containing material.

5. The method of claim 1 wherein said polymeric material is liquid silicone rubber.

6. The method of claim 1 wherein the length of the device is from 8 to 25 mm for use in the lower fornix to suit the eyes of different sizes such as infants, children and adults.

7. The method of claim 1 wherein the length of the device is from 8 to 35 mm for use in the upper fornix to suit the eyes of different sizes such as infants, children, and adults.

8. The method of claim 1 wherein the diameter of the device is from 0.5 to 1.9 mm to suit the eyes of different sizes such as infants, children, and adults.