Ophthalmic implant for delivering therapeutic substances

Patent metadata

Field	Value
Publication number	US-12115102-B2
Application number	US-202217974228-A
Country	US
Kind code	B2
Filing date	Oct 26, 2022
Priority date	Mar 28, 2013
Publication date	Oct 15, 2024
Grant date	Oct 15, 2024

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.

First claim

What is claimed is:

1. A therapeutic device comprising:
a housing configured to be positioned at least partially within a vitreous of the eye upon implantation, the housing comprising a reservoir extending between a proximal end region of the housing and a distal end region of the housing, the distal end region defining an outlet from the reservoir having a rigid porous structure positioned within the outlet and, the reservoir having a volume sized to contain one or more therapeutic agents for delivery through the outlet into the eye for an extended period of time;
a proximal retention structure positioned near the proximal end region of the housing, the retention structure comprising a narrowed portion and a flanged portion extending proximally from the narrowed portion, wherein an access opening of the proximal retention structure extends through the retention structure into the reservoir;
a septum positioned within the access opening, the septum having a first region positioned within at least a portion of the flanged portion and a second region located distal to the first region positioned at least in part within the narrowed portion; and
a cover encapsulating at least the flanged portion of the proximal retention structure and bonded to an upper surface of the septum.

2. The device of claim 1 , wherein the cover additionally encapsulates at least the proximal end region of the housing.

3. The device of claim 1 , wherein the cover additionally encapsulates and bonds to an upper end portion of the access opening.

4. The device of claim 1 , further comprising one or more surface features extending within at least an upper surface of the flanged portion of the proximal retention structure.

5. The device of claim 4 , wherein the cover extends within and bonds to the one or more surface features.

6. The device of claim 5 , wherein the one or more surface features comprises at least a through-hole extending from the upper surface to a lower surface of the flanged portion.

7. The device of claim 1 , wherein the cover and the septum are configured to be penetrated with a needle during filling of the reservoir chamber and to re-seal upon removal of the needle.

8. The device of claim 1 , wherein the septum is pre-molded and the cover is over-molded.

9. The device of claim 8 , wherein the septum is a soft, high strength material and the cover is a high durometer material.

10. The device of claim 9 , wherein the material of the septum is a liquid injection molding silicone elastomer and the material of the cover is a translucent, liquid silicone rubber.

11. The device of claim 9 , wherein the access opening is formed of a material more rigid than the material of the septum.

12. The device of claim 11 , wherein the septum is under a radial compressive force due to being over-sized relative to the access opening and held by the access opening in an adhesion-free manner.

13. The device of claim 12 , wherein the radial compressive force encourages re-sealing of the septum after penetration and removal of a needle from the septum.

14. The device of claim 13 , wherein the cover prevents withdrawal of the penetrable barrier in a proximal direction upon removal of the needle from the septum.

15. The device of claim 1 , wherein the septum further comprises surface treatments on an external surface.

16. The device of claim 1 , wherein the cover has a thickness that is 0.007″-0.025″.

17. The device of claim 1 , wherein the cover extends beyond an outer diameter of the flanged portion and upward from an upper surface of the flanged portion providing a higher profile to the retention structure.

18. The device of claim 1 , wherein the septum further comprises a distal region that is flared and positioned within a proximal end region of the reservoir.

19. The device of claim 1 , wherein the septum further comprises one or more tabs, a flared skirt, flange, rib or other feature.

20. The device of claim 1 , wherein the upon being implanted in the eye, the flanged portion extends along the sclera, the narrowed portion extends trans-sclerally and at least a portion of the reservoir in the housing is located within a vitreous humor of the eye.

Assignees

• Forsight Vision4 Inc

Inventors

• Erickson Signe
• Campbell Randolph E
• Doud Darren

Classifications

• A61M39/0208

  Subcutaneous access sites for injecting or removing fluids (transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276) · CPC title

• A61F9/0017 Primary

  implantable in, or in contact with, the eye, e.g. ocular inserts · CPC title