Ophthalmic implant for delivering therapeutic substances

Patent metadata

Field	Value
Publication number	US-11510810-B2
Application number	US-201916514128-A
Country	US
Kind code	B2
Filing date	Jul 17, 2019
Priority date	Mar 28, 2013
Publication date	Nov 29, 2022
Grant date	Nov 29, 2022

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 configured to be at least partially implanted in an eye, the device comprising:
a housing having a distal end region and a proximal end region;
a porous structure positioned in fluid communication with an outlet of the device near the distal end region of the housing;
a reservoir within the housing 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 rigid 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;
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 distal to the first region and proximate to a distal end of the penetrable barrier, the second region positioned within a proximal end region of the reservoir, the second region forming a sealing element in the proximal end region of the reservoir,
wherein the first region of the penetrable barrier has a first outer diameter and a third region proximate the sealing element 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 , 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.

5. The device of claim 4 , wherein the narrowed portion has an outer dimension sized to seal a scleral incision having a length of 3.2 mm.

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

7. The device of claim 1 , wherein the narrowed portion has a transverse cross-sectional shape perpendicular to a longitudinal axis of the device extending between the proximal end region and the distal end of the device, the transverse 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.

8. The device of claim 7 , wherein the flanged portion of the retention structure has a first distance across that is greater in diameter than a largest diameter of the housing and has a second distance across that is equal to or less than the largest diameter of the housing.

9. The device of claim 1 , wherein the second region prevents withdrawal of the penetrable barrier in a proximal direction.

10. The device of claim 1 , further comprising a cover that encapsulates at least an upper surface of the flanged portion of the retention structure.

11. The device of claim 10 , wherein the cover further encapsulates a lower surface of the flanged portion of the retention structure.

12. The device of claim 11 , wherein the cover comprises silicone.

13. 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;
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,
a second region proximate to a distal end of the penetrable barrier, the second region forming a sealing element positioned in the proximal end region of the reservoir; and

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, 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 13 , wherein the at least a portion of the penetrable barrier in contact with the anchor applies radial compression to the anchor.

15. The device of claim 14 , wherein the radial compression encourages re-sealing of the penetrable barrier upon removal of a needle from the penetrable barrier.

16. The device of claim 13 , wherein the anchor is annular in shape and encircles the at least a portion of the penetrable barrier.

17. The device of claim 13 , 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.

18. The device of claim 13 , wherein the anchor is formed of a high durometer material that resists deformation.

19. The device of claim 13 , wherein the penetrable barrier is bonded to the anchor creating a single septum structure.

20. The device of claim 13 , wherein an outer surface of the anchor engages an undercut feature in the proximal end region of the device.

21. The device of claim 13 , wherein the penetrable barrier further comprises one or more tabs, a flared skirt, flange, rib or other feature.

Assignees

• Forsight Vision4 Inc

Inventors

• Erickson Signe
• Campbell Randolph E
• Doud Darren

Classifications

• A61F9/0017 Primary

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

• A61M39/0208

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