Conjunctival inserts for topical delivery of medication or lubrication

• US 6,217,896 B1
• Filed: 04/01/1999
• Issued: 04/17/2001
• Est. Priority Date: 04/01/1999
• Status: Expired due to Fees

• Current Assignee: UAB Research Foundation (University of Alabama System)
• Original Assignee: UAB Research Foundation (University of Alabama System)
• Inventors: Benjamin, William J.
• Primary Examiner(s): Dudash, Diana
• Assistant Examiner(s): SHARAREH, SHAHNAM J
• Application Number:
  US09/283,957
• Time in Patent Office: 747 Days
• Field of Search: 424/422, 424/427, 424/428, 424/420, 424/426, 424/429
• 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

The present invention provides an improved conjunctival insert for topical delivery of medication or lubrication into the conjunctival spaces and upon the ocular surface of human eye. Specifically, three physical designs are provided, differing by size, named “Large”, “Medium” and “Small”. Also provided are methods of treating ocular maladies and of lubricating or moisturizing a dry eye using the disclosed conjunctival inserts. Such inserts can also be used for veterinary practices in the cases of primates and quadrupeds.

Claims

1. A conjunctival insert, wherein said insert is of a crescent shape in the horizontal plane, said insert comprising:

a central back curvature conforming to the bulbar surface;

a top with a sharp upper extreme;

a horizontal ridge situated approximately two-thirds of the way from said top, wherein the upper extreme of said top above said ridge becomes progressively thinner vertically; and

a rounded bottom with the most inferior portion at the horizontal middle.

2. The conjunctival insert of claim 1, wherein said back curvature has a radius of from about 12 mm to about 18 mm.

3. The conjunctival insert of claim 1, wherein said horizontal ridge having a crescent shape in the horizontal plane.

4. The conjunctival insert of claim 1, wherein said rounded bottom having a radius of curvature from left to right of from about 20 mm to about 25 mm, a radius of curvature from front to back of from about 0.5 mm to about 1.0 mm.

5. The conjunctival insert of claim 1, wherein said insert is sized to fit in large conjunctival sacs, having the features of:

a horizontal length of up to about 26.75 mm, wherein said length is measured along the back surface of said insert from left to right behind said horizontal ridge;

a thickness of said horizontal ridge of up to about 2.6 mm;

a vertical height of up to about 9.0 mm, wherein said height being maximum at the center of said insert and decreasing left and right of said insert; and

a volume capacity of up to about 160 μ

l.

6. The conjunctival insert of claim 1, wherein said insert is sized to fit in conjunctival sacs of medium capacity, having the features of:

a horizontal length of up to about 23.5 mm, wherein said length is measured along the back surface of said insert from left to right behind said horizontal ridge;

a thickness of said horizontal ridge of up to about 1.7 mm;

a vertical height of up to about 7.9 mm, wherein said height being maximum at the center of said insert and decreasing left and right of said insert; and

a volume capacity of up to about 110 μ

l.

7. The conjunctival insert of claim 1, wherein said insert is sized to fit in small conjunctival sacs, having the features of:

a horizontal length of up to about 20.25 mm, wherein said length is measured along the back surface of said insert from left to right behind said horizontal ridge;

a thickness of said horizontal ridge of up to about 0.8 mm;

a vertical height of up to about 6.8 mm, wherein said height being maximum at the center of said insert and decreasing left and right of said insert; and

a volume capacity of up to about 60 μ

l.

8. The conjunctival insert of claim 1, wherein said insert is made of materials selected from the group consisting of non-erodable and erodable materials.

9. The conjunctival insert of claim 8, wherein said non-erodable materials are selected from the group consisting of hydrogel and silicone rubber.

10. The conjunctival insert of claim 9, wherein said hydrogel is silicone hydrogel.

11. The conjunctival insert of claim 9, wherein said hydrogel contains polydimethyl siloxane units.

12. The conjunctival insert of claim 8, wherein said erodable materials are selected from the group consisting of cellulose derivatives, acrylates, natural products, starch derivatives and synthetic products.

13. The conjunctival insert of claim 12, wherein said cellulose derivatives are selected from the group consisting of methylcellulose, sodium carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose and hydroxypropylmethyl cellulose.

14. The conjunctival insert of claim 12, wherein said acrylates are selected from the group consisting of polyacrylic acid salts, ethylacrylates and polyacrylamides.

15. The conjunctival insert of claim 12, wherein said natural products are selected from the group consisting of gelatin, collagen, alginates, pectins, tragacanth, karaya, chrondrus, agar and acacia.

16. The conjunctival insert of claim 12, wherein said starch derivatives are selected from the group consisting of starch acetate, hydroxyethyl starch ethers and hydroxypropyl starch.

17. The conjunctival insert of claim 12, wherein said synthetic products are selected from the group consisting of polyvinylalcohol, poly vinylpyrrolidone, poly vinyl methyl ether, poly ethyleneoxide, neutralized carboxypolymethylene, xanthan gum, polyester, poly ortho ester, poly anhydride, poly phosphazine, poly phosphate ester, poly caprolactone, poly hydroxybutyric acid, poly glycolic acid, poly lactic acid and mixtures thereof.

18. The conjunctival insert of claim 1, wherein said insert is placed in either the inferior or superior cul-de-sac of an eye.

19. A method of delivering a drug to an individual'"'"'s eye, comprising the steps of:

placing said drug into the conjunctival insert of claim 1; and

contacting conjunctival tissues of said individual with said conjunctival insert containing said drug by placing said insert into inferior or superior cul-de-sac of the individual'"'"'s eye.

20. The method of claim 19, wherein said individual having a disease selected from the group consisting of glaucoma, eye infection, eye inflammation and allergy.

21. The method of claim 19, wherein said drug is selected from the group consisting of an anti-glaucoma drug, an antibacterial drug, an antifungal drug, an antiviral drug, a cycloplegic drug, a steroidal drug, a non-steroidal drug, an anti-inflammatory drug and an anti-allergy drug.

22. A method of lubricating and/or moisturizing a dry eye, comprising the steps of:

placing a lubricant or moisturizer into the conjunctival insert of claim 1; and

contacting conjunctival tissues of said dry eye with said conjunctival insert containing said lubricant or moisturizer by placing said conjunctival insert into inferior or superior cul-de-sac of said eye.