OCULAR IMPLANT WITH STIFFNESS QUALITIES, METHODS OF IMPLANTATION AND SYSTEM

• US 20120022429A1
• Filed: 09/26/2011
• Published: 01/26/2012
• Est. Priority Date: 01/28/2009
• Status: Active Grant

• Current Assignee: Alcon Incorporated
• Original Assignee: Transcend Medical Incorporated (Alcon Incorporated)
• Inventors: Silvestrini, Thomas A., de Juang, Eugene Jr.
• Granted Patent: US 8,172,899 B2
• Time in Patent Office: Days
• US Class Current: 604/8
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

Described herein are devices and methods for treating eye conditions. Described is an ocular implant including an elongate member having an internal lumen forming a flow pathway, at least one inflow port communicating with the flow pathway, and at least one outflow port communicating with the flow pathway. The elongate member is adapted to be positioned in the eye such that at least one inflow port communicates with the anterior chamber, at least one outflow port communicates with the suprachoroidal space to provide a fluid pathway between the anterior chamber and the suprachoroidal space when the elongate member is implanted in the eye. The elongate member has a wall material imparting a stiffness to the elongate member. The stiffness is selected such that after implantation the elongate member deforms eye tissue surrounding the suprachoroidal space forming a tented volume.

Claims

1. An ocular implant system for implantation into an eye, comprising:

an ocular implant having;

(a) an elongate member comprising a wall material having sufficient stiffness such that, when the elongate member is implanted in a deployed location in the eye, the elongate member is able to deform sub-scleral eye tissue adjacent the elongate member so as to form a tented volume beneath the sclera; and

(b) an internal lumen within the elongate member configured to form a flow pathway;

(c) at least one inflow port communicating with the internal lumen; and

(d) at least one outflow port communicating with the internal lumen;

wherein, when the elongate member is positioned in the deployed location, the at least one inflow port communicates with the anterior chamber and the at least one outflow port is positioned to drain aqueous humor from the anterior chamber toward the suprachoroidal space.

2. The implant system of claim 1, further comprising:

a delivery instrument comprising an elongated applier element formed of an elongated body that removably couples to the ocular implant, wherein the delivery instrument is configured to introduce the ocular implant into the anterior chamber through a corneal incision, advance the ocular implant through the anterior chamber, detach at least a portion of the ciliary body from the sclera to form an internal space between the ciliary body and the sclera, advance the ocular implant through the internal space, and detach the ocular implant from the elongated applier element and into the deployed location.

3. The implant system of claim 2, wherein the applier element is curved, wherein the ocular implant is sufficiently flexible so as to conform to a curvature of the applier element when removably coupled to the applier element, and wherein, upon detachment of the implant from the applier element, the ocular implant transitions to a shape that forms a substantially straight chord relative to a curvature of the sclera to form the tented volume.

4. The implant system of claim 2, wherein the applier element extends through the internal lumen of the ocular implant when the ocular implant is removably coupled to the applier element.

5. The implant system of claim 4, the delivery instrument further comprising a sheath positioned axially over a proximal portion of the applier element, wherein a distal end of the sheath abuts a proximal end of the ocular implant when the ocular implant is removably coupled to the applier element, and wherein the sheath acts as a stopper that impedes the implant from moving in a proximal direction relative to the delivery instrument as the applier element is detached from the ocular implant.

6. The implant system of claim 2, wherein the delivery instrument comprises:

(a) a handle component;

(b) a stopper element comprising a distal portion of a sheath fixedly positioned relative to the handle component, wherein the sheath is positioned proximally of the implant when the applier element is removably coupled to the implant;

(c) wherein the applier element is movably positioned relative to the sheath and extends longitudinally through the sheath, the elongated applier element sized to be longitudinally inserted through the internal lumen of the implant for removably coupling the delivery device to the implant, wherein the sheath is positioned proximally of the implant when the applier element is removably coupled to the implant.

7. The implant system of claim 1, wherein the stiffness of the elongate member is greater than a stiffness of eye tissue adjacent the elongate member when the elongate member is positioned in the deployed location and wherein at least a portion of the tented volume is within the supraciliary space.

8. The implant system of claim 1, wherein the elongate member is configured to form a chord relative to a curvature of the sclera when the implant is positioned in the deployed location.

9. The implant system of claim 1, wherein the eye tissue surrounding the tented volume comprises an outer tissue shell having a first boundary and a first curvature and an inner tissue shell having a second boundary and a second curvature, wherein the first curvature and the second curvature form a ratio, wherein the stiffness of the elongate member is configured to modify the ratio between the first curvature and the second curvature when the implant is positioned in the deployed location.

10. The implant system of claim 9, wherein the elongate member is shaped such that it intersects, but does not conform to the first or second curvatures when implanted in the deployed location in the eye.

11. The implant system of claim 1, wherein the wall material has a Young'"'"'s modulus that is less than 30,000 pounds per square inch.

12. The implant system of claim 1, wherein the wall material has a Young'"'"'s modulus that is between about 30,000 pounds per square inch and 70,000 pounds per square inch.

13. The implant system of claim 1, wherein the wall material has a Young'"'"'s modulus that is approximately 200,000 pounds per square inch.

14. The implant system of claim 1, wherein the wall material has a Young'"'"'s modulus that is less than or equal to 40,000,000 pounds per square inch.

15. The implant system of claim 1, wherein when the elongate member is positioned in the deployed location, the outflow port is positioned in at least one of the supraciliary space and suprachoroidal space.

16. The implant system of claim 1, wherein when the elongate member is positioned in the deployed location, the outflow port is positioned in the supraciliary space.

17. The implant system of claim 1, wherein when the elongate member is positioned in the deployed location, the outflow port is positioned between the sclera and the ciliary body.

18. The implant system of claim 1, wherein the implant includes multiple outflow ports positioned along a distal region of the implant and wherein when the elongate member is positioned in the deployed location, the outflow ports are positioned between the ciliary body and the sclera.

19. An ocular implant system for implantation into an eye, comprising:

an ocular implant having;

(a) an elongate member having sufficient stiffness such that, when the elongate member is implanted in a deployed location in the eye, the elongate member is able to deform sub-scleral eye tissue adjacent the elongate member so as to form a tented volume beneath the sclera; and

(b) an internal lumen within the elongate member configured to form a flow pathway;

(c) at least one inflow port communicating with the internal lumen; and

(d) at least one outflow port communicating with the internal lumen;

wherein, when the elongate member is positioned in the deployed location, the at least one inflow port communicates with the anterior chamber and the at least one outflow port is positioned to drain aqueous humor from the anterior chamber into the tented volume.

20. The implant system of claim 19, further comprising:

a delivery instrument comprising an elongated applier element formed of an elongated body that removably couples to the ocular implant, wherein the delivery instrument is configured to introduce the ocular implant into the anterior chamber through a corneal incision, advance the ocular implant through the anterior chamber, detach at least a portion of the ciliary body from the sclera to form an internal space between the ciliary body and the sclera, advance the ocular implant through the internal space, and detach the ocular implant from the elongated applier element and into the deployed location.

22. The implant system of claim 20, wherein the applier element extends through the internal lumen of the ocular implant when the ocular implant is removably coupled to the applier element.

23. The implant system of claim 22, the delivery instrument further comprising a sheath positioned axially over a proximal portion of the applier element, wherein a distal end of the sheath abuts a proximal end of the ocular implant when the ocular implant is removably coupled to the applier element, and wherein the sheath acts as a stopper that impedes the implant from moving in a proximal direction relative to the delivery instrument as the applier element is detached from the ocular implant.

24. The implant system of claim 20, wherein the delivery instrument comprises:

(a) a handle component;

(b) a stopper element comprising a distal portion of a sheath fixedly positioned relative to the handle component, wherein the sheath is positioned proximally of the implant when the applier element is removably coupled to the implant;

(c) wherein the applier element is movably positioned relative to the sheath and extends longitudinally through the sheath, the elongated applier element sized to be longitudinally inserted through the internal lumen of the implant for removably coupling the delivery device to the implant, wherein the sheath is positioned proximally of the implant when the applier element is removably coupled to the implant.

25. The implant system of claim 19, wherein the stiffness of the elongate member is greater than a stiffness of eye tissue adjacent the elongate member when the elongate member is positioned in the deployed location and wherein at least a portion of the tented volume is within the supraciliary space.

26. The implant system of claim 19, wherein the elongate member is configured to form a chord relative to a curvature of the sclera when the implant is positioned in the deployed location.

27. The implant system of claim 19, wherein the eye tissue surrounding the tented volume comprises an outer tissue shell having a first boundary and a first curvature and an inner tissue shell having a second boundary and a second curvature, wherein the first curvature and the second curvature form a ratio, wherein the stiffness of the elongate member is configured to modify the ratio between the first curvature and the second curvature when the implant is positioned in the deployed location.

28. The implant system of claim 27, wherein the elongate member is shaped such that it intersects, but does not conform to the first or second curvatures when implanted in the deployed location in the eye.

29. The implant system of claim 19, wherein when the elongate member is positioned in the deployed location, the outflow port is positioned in the supraciliary space.

21. The implant system of claim 21, wherein the applier element is curved, wherein the ocular implant is sufficiently flexible so as to conform to a curvature of the applier element when removably coupled to the applier element, and wherein, upon detachment of the implant from the applier element, the ocular implant transitions to a shape that forms a substantially straight chord relative to a curvature of the sclera to form the tented volume.