Ophthalmic implant for delivering therapeutic substances

• US 10,398,593 B2
• Filed: 12/21/2016
• Issued: 09/03/2019
• 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 J
• Application Number:
  US15/386,586
• Publication Number:
  US 20170165110A1
• Time in Patent Office: 986 Days
• 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. A therapeutic device configured to be at least partially implanted in an eye, the device comprising:

a porous structure positioned in fluid communication with an outlet of the device;

a reservoir having a volume sized to contain one or more therapeutic agents and to be in fluid communication with the outlet through the porous structure;

a retention structure positioned near a proximal end region of the device, the retention structure comprising a narrowed portion and a flanged portion extending proximally from the narrowed portion;

an access portion opening extending through the retention structure leading into the reservoir; and

a pre-molded, penetrable barrier configured to be repeatedly penetrated positioned within and oversized relative to the access portion opening, wherein the penetrable barrier comprises;

a first region sized to reside within and mate with at least a portion of the flanged portion, and

a second region sized to reside within and mate with an inner surface of the narrowed portion of the retention structure,

wherein the first region has a first outer diameter, and the second region has a second outer diameter, wherein the first outer diameter is larger than the second outer diameter.

2. The device of claim 1, wherein the access portion opening is formed of a more rigid material than a material of the penetrable barrier such that radial compression of the penetrable barrier is provided.

3. The device of claim 2, wherein the radial compression encourages re-sealing after penetration and upon removal of a needle from the penetrable barrier.

4. The device of claim 1, further comprising an annular anchor positioned within the access portion opening 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.

5. The device of claim 4, wherein the at least a portion of the penetrable barrier in contact with the anchor applies radial compression to the anchor.

6. The device of claim 5, wherein the radial compression encourages re-sealing of the penetrable barrier upon removal of a needle from the penetrable barrier.

7. The device of claim 4, wherein the anchor is annular in shape and encircles the at least a portion of the penetrable barrier.

8. The device of claim 4, wherein the penetrable barrier is coupled to the device by mating features between an external surface of the penetrable barrier and corresponding surfaces of the access portion opening against which the penetrable barrier abuts and seals.

9. The device of claim 4, wherein the anchor is formed of a high durometer material that resists deformation.

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

11. The device of claim 4, wherein an outer surface of the anchor engages an undercut feature in the proximal end region of the device.

12. The device of claim 4, wherein the penetrable barrier further comprises one or more tabs, a flared skirt, flange, rib or other feature.

13. The device of claim 4, wherein an inner surface of the anchor is beveled to match an outer surface of the penetrable barrier around which the anchor encircles.

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

15. The device of claim 1, wherein the therapeutic device is capable of being implanted in the eye such that the flanged portion extends along the sclera, the narrowed portion extends trans-sclerally, and the reservoir is located within a vitreous humor of the eye.

16. The device of claim 15, wherein the narrowed portion has an outer dimension sized to seal a scleral incision having a length of 3.2 mm.

17. The device of claim 1, wherein the narrowed portion has a cross-sectional shape selected from the group consisting of lentoid, biconvex lens, oval, ovoid, and elliptical.

18. The device of claim 1, wherein the narrowed portion has a cross-sectional shape comprising a first curve along a first axis and a second curve along a second axis that is different from the first curve.

19. The device of claim 1, wherein the penetrable barrier further comprises a third region distal to the second region and sized to reside within and mate with a proximal end of the reservoir chamber.

20. The device of claim 19, wherein the third region has an outer diameter that is larger than the second region.

21. The device of claim 1, further comprising a cover covering the flanged portion of the retention structure.

22. The device of claim 21, wherein the cover encapsulates and bonds the flanged portion of the retention structure and an upper surface of the penetrable barrier positioned within the access portion opening.

23. The device of claim 21, wherein the cover encapsulates and bonds to at least an upper surface of the flanged portion.

24. The device of claim 23, wherein the cover encapsulates and bonds to a lower surface of the flanged portion.

25. The device of claim 24, wherein the cover bonds to the narrowed portion of the retention structure.

26. The device of claim 21, wherein the cover and the retention structure have the same shape profile.

27. The device of claim 21, wherein the cover and the penetrable barrier are penetrated during filling of the reservoir.

28. The device of claim 27, wherein the cover and the penetrable barrier are configured to reseal after penetration of the reservoir.

29. The device of claim 21, wherein the retention structure includes one or more through-holes.

30. The device of claim 21, wherein the cover is over-molded.

31. The device of claim 21, wherein the cover is a translucent material.

32. The device of claim 21, wherein the cover is silicone.

33. The device of claim 21, wherein the cover maintains a seal of the reservoir volume.