IMPLANTABLE OCULAR DRUG DELIVERY DEVICE AND METHODS

• US 20100189765A1
• Filed: 11/25/2009
• Published: 07/29/2010
• Est. Priority Date: 11/26/2008
• Status: Abandoned Application

• Current Assignee: Surmodics Incorporated
• Original Assignee: Surmodics Incorporated
• Inventors: Erickson, Signe R., Zhou, Jianbo, Punja, Krip, Beeley, Nathan R.F.
• Application Number:
  US12/625,705
• Publication Number:
  US 20100189765A1
• Time in Patent Office: Days
• US Class Current: 424/427
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61P 27/02 Ophthalmic agents

Abstract

The present invention provides implantable ocular drug delivery devices. Generally, the devices have a distal portion with a coil shaped body member and a proximal portion which contacts the sclera. In one aspect, the coil-shaped body member includes a unique configuration including two coiled portions with different pitches, which improves insertion of the device into the eye. In another aspect, the device has a proximal portion that includes a unique cap configuration having a concave distal face that improves stabilization of the device in the eye. In another aspect, the device includes a transitional portion between the cap and the coil-shaped body member that also improves stabilization of the device in the eye. The invention also provides methods for inserting the medical device into the eye, and methods for the treatment of an ocular condition.

Claims

1. An ocular drug delivery device comprising,

a proximal portion configured to contact the sclera of the eye, and

a distal portion comprising a coil-shaped body member,

wherein the coil-shaped body member comprises a first portion and a second portion, wherein first portion has a pitch that is greater than the second portion, and the second portion is proximal to the first portion, and

wherein the device comprises a bioactive agent.

2. The ocular drug delivery device of claim 1 wherein the second portion has a length that is greater than a length of the first portion.

3. The ocular drug delivery device of claim 1, wherein the second portion has a length in the range of 2.12 mm to 3.53 mm.

4. The ocular drug delivery device of claim 1, wherein the second portion comprises two to four full rotations.

5. The ocular drug delivery device of claim 1, wherein the first portion has a length in the range of 1.28 mm to 2.14 mm.

6. The ocular drug delivery device of claim 1, wherein the second portion has a pitch in the range of 0.74 mm to 1.23 mm.

7. The ocular drug delivery device of claim 1, wherein the first portion has a pitch in the range of 1.2 mm to 2 mm.

8. The ocular drug delivery device of claim 1 wherein the coil-shaped body member comprises three to five full rotations.

9. The ocular drug delivery device of claim 1 which has a length in the range of 4.9 mm to 6.5 mm.

10. The ocular drug delivery device of claim 1 which has an outer diameter in the range of 1.28 mm to 2.19 min.

11. The ocular drug delivery device of claim 1 wherein the coil-shaped body member has a surface area in the range of 18.9 mm² to 49.5 mm².

12. The ocular drug delivery device of claim 1 wherein the proximal portion comprises a cap having a distal face which contacts the outer surface of the eye when the coil-shaped body member is inserted into the vitreous.

13. The ocular drug delivery device of claim 12 comprising a transitional portion which is present between the distal face of the cap and a proximal end of the second portion of the coil-shaped body member, wherein the transitional portion is configured to wedge scleral tissue between the distal face of the cap and a surface of the coil-shaped portion of the body member that is proximal to and opposite the distal face of the cap.

14. The ocular drug delivery device of claim 13 wherein the length of the transitional portion is in the range of 0.15 mm to 0.3 mm.

15. The ocular drug delivery device of claim 13 wherein the distance between the distal face of the cap and an outermost surface of a first proximal rotation of the coil-shaped body member is in the range of about 0.5 mm to about 0.65 mm.

16. The ocular drug delivery device of claim 12 wherein the cap comprises a peripheral edge that is rounded.

17. The ocular drug delivery device of claim 12 wherein the cap has a circumference in the range of 4.52 mm to 7.54 mm.

18. The ocular drug delivery device of claim 12 wherein the cap has a thickness in the range of 0.25 mm to 0.64 mm.

19. The ocular drug delivery device of claim 1 wherein a surface of the coil shaped body member comprises a polymeric coating which controls release of the bioactive agent when the device is inserted in the eye.

20. An ocular drug delivery device comprising

a distal portion having a coil-shaped body member,

a proximal portion configured to contact the sclera of the eye, the proximal portion comprising a cap having a distal face which contacts the outer surface of the eye when the coil-shaped body member is inserted into the vitreous, wherein the distal face comprises a concave shape, and

a bioactive agent.

21. An ocular drug delivery device comprising a

a distal portion comprising a coil-shaped body member,

a proximal portion comprising a cap having a distal face which contacts the outer surface of the eye when the coil-shaped body member is inserted into the vitreous,

a transitional portion which is present between the distal face of the cap and a proximal end of the second portion of the coil-shaped body member, wherein the transitional portion is configured to wedge scleral tissue between the distal face of the cap and a surface of the coil-shaped portion of the body member that is proximal to and opposite the distal face of the cap, and a bioactive agent.