Ophthalmic implant for delivering therapeutic substances

• US 9,526,654 B2
• Filed: 03/27/2014
• Issued: 12/27/2016
• Est. Priority Date: 03/28/2013
• Status: Active Grant

• Current Assignee: Forsight Vision4, Inc. (Roche Holding AG)
• Original Assignee: Forsight Vision4, Inc. (Roche Holding AG)
• Inventors: Erickson, Signe, Campbell, Randolph E., Doud, Darren
• Primary Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US14/228,130
• Publication Number:
  US 20140296800A1
• Time in Patent Office: 1,006 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276

Abstract

Described are implantable therapeutic devices, systems and methods to treat a patient. The device includes a hollow refillable housing for implantation within the posterior segment of an eye through a penetration in the sclera including a proximal retention structure protruding outward from a proximal end region of the housing, an access portion opening, and a penetrable barrier positioned at least in part within the access portion opening, the penetrable barrier configured to be repeatedly penetrated. A rigid porous structure is positioned within a region of the housing away from the access portion opening into a reservoir chamber extends along an axis between the penetrable barrier and the porous structure includes a volume sized to deliver therapeutic amounts of a therapeutic agent to the eye for an extended period of time. A cover is coupled to at least an upper surface of the proximal retention structure.

Claims

1. An implantable therapeutic device to treat a patient, comprising:

a hollow refillable housing for implantation within the posterior segment of an eye through a penetration in the sclera of the eye, the housing having a proximal end region;

a proximal retention structure protruding outward from the proximal end region and comprising an access portion opening;

a penetrable barrier positioned at least in part within the access portion opening, the penetrable barrier configured to be repeatedly penetrated, wherein the penetrable barrier has an upper region having an outer diameter that is larger than an outer diameter of a lower end of the penetrable barrier;

a rigid porous structure positioned within a region of the housing away from the access portion opening;

a reservoir chamber extending along an axis between the penetrable barrier and the porous structure, the reservoir chamber comprising a volume sized to deliver therapeutic amounts of a therapeutic agent to the eye for an extended period of time, wherein the access portion opening opens into the reservoir chamber; and

an anchor positioned within the access portion opening that is annular in shape and in contact with at least a portion of the penetrable barrier such that the anchor encircles the at least a portion of the penetrable barrier.

2. The device of claim 1, wherein the penetrable barrier is pre-molded with soft, high strength material.

3. The device of claim 1, wherein the anchor is formed of a high durometer material that resists deformation.

4. The device of claim 1, wherein the penetrable barrier is bonded to the anchor creating a single septum structure.

5. The device of claim 1, wherein the anchor engages an undercut feature in the proximal end of housing.

6. The device of claim 1, wherein the penetrable barrier is oversized relative to the access portion opening such that the penetrable barrier applies radial compression to the anchor.

7. The device of claim 1, further comprising a cover covering an upper surface of the proximal retention structure.

8. The device of claim 7, wherein the access portion opening is over-molded by the cover.

9. The device of claim 8, wherein the cover encapsulates and bonds the proximal retention structure and an upper surface of the penetrable barrier positioned within the access portion opening.

10. The device of claim 8, wherein the cover encapsulates and bonds to at least the upper surface of the proximal retention structure.

11. The device of claim 10, wherein the cover encapsulates and bonds to a lower surface of the proximal retention structure.

12. The device of claim 7, wherein the cover maintains a seal of the reservoir chamber volume.

13. The device of claim 7, wherein the cover and the proximal retention structure have the same shape profile.

14. The device of claim 7, wherein the cover and the penetrable barrier are penetrated during filling of the reservoir chamber.

15. The device of claim 14, wherein the cover and the penetrable barrier are configured to reseal after penetration of the reservoir chamber.

16. The device of claim 7, wherein the proximal retention structure includes one or more through-holes.

17. The device of claim 7, wherein the penetrable barrier is pre-molded and the cover is over-molded.

18. The device of claim 7, wherein the penetrable barrier is a soft, high strength material and the cover is a high durometer material.

19. The device of claim 7, wherein the cover is a translucent material.

20. The device of claim 1, further comprising a sealing element positioned within a proximal end region of the reservoir chamber and coupled to the penetrable barrier.

21. The device of claim 1, wherein the penetrable barrier has a distal region that extends at least in part within a proximal end of the reservoir chamber.

22. The device of claim 21, wherein the distal region has a diameter that is greater than a narrowed portion of the retention structure.

23. The device of claim 21, wherein the distal region has a flared skirt sized to reside within and mate with at least a portion of the upper region of the reservoir chamber.

24. The device of claim 1, wherein an inner surface of the annular anchor is beveled to match the beveled penetrable barrier around which the anchor encircles.