Expandable ocular devices

• US 8,545,430 B2
• Filed: 06/09/2011
• Issued: 10/01/2013
• Est. Priority Date: 06/09/2010
• Status: Active Grant

• Current Assignee: Alcon Incorporated
• Original Assignee: Transcend Medical Incorporated (Alcon Incorporated)
• Inventors: Silvestrini, Thomas A.
• Primary Examiner(s): Deak, Leslie
• Assistant Examiner(s): SASS, SARA A
• Application Number:
  US13/157,180
• Publication Number:
  US 20120035524A1
• Time in Patent Office: 845 Days
• Field of Search: None
• US Class Current: 604/8
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

Disclosed herein are systems, devices and methods for treating an ocular disorder in an eye. The ocular device includes a proximal end, a distal end, and an internal lumen forming a flow pathway extending from the proximal end to the distal end; at least one inflow region that communicates with the flow pathway; and an expandable portion having a plurality of interconnected struts forming multiple openings in the device communicating with the flow pathway. The expandable portion has a first cross-sectional shape suitable for insertion into the eye that is generally cylindrical and a second cross-sectional shape that is larger than the first cross-sectional shape. The system also includes a delivery device for inserting the ocular device into an eye including a sheath configured to surround at least a portion of the ocular device; an applier configured to insert into the internal lumen of the ocular device; and an actuator.

Claims

1. A system for treating an ocular disorder in an eye, comprising:

an ocular device comprising;

a proximal end, a distal end, and an internal lumen forming a flow pathway extending from the proximal end to the distal end wherein upon implantation in the eye the proximal end is configured to be in fluid communication with Schlemm'"'"'s canal of the eye and the distal end is configured to be in fluid communication with an anterior chamber of the eye;

at least one inflow region communicating with the flow pathway; and

an expandable portion comprising a plurality of interconnected struts forming multiple openings in the device that communicate with the flow pathway, wherein the expandable portion has a first diameter of a generally cylindrical first cross-sectional shape suitable for insertion into the eye through a self-sealing incision in the cornea and a second diameter of a second cross-sectional shape that is larger than the first diameter and sized to expand the general circumference of the surrounding tissue, the second cross-sectional shape being generally oval and configured to conform to the contour of the Schlemm'"'"'s canal and prevent rotation of the ocular device upon expansion; and

a delivery device for inserting the ocular device into an eye, the delivery device comprising;

a sheath configured to surround at least a portion of the ocular device;

an applier configured to insert into the internal lumen of the ocular device; and

an actuator.

2. The system of claim 1, wherein the expandable portion of the ocular device is located near the distal end and the second cross-sectional shape of the ocular device is funnel-shaped.

3. The system of claim 1, wherein the interconnected struts of the ocular device are braided or woven.

4. The system of claim 1, wherein the ocular device comprises a tube having cut-outs forming the interconnected struts.

5. The system of claim 1, wherein the second diameter of the ocular device is between about 75% and about 100% larger than the first diameter.

6. The system of claim 1, wherein at least a portion of the ocular device is coated with a flexible material.

7. The system of claim 1, wherein the expandable portion of the ocular device is self-expanding.

8. The system of claim 1, wherein the expandable portion of the ocular device is configured to be actively expanded.

9. The system of claim 8, wherein the expandable portion is configured to be actively expanded with a balloon coupled to the applier.

10. The system of claim 1, wherein the ocular device is positioned in the eye such that the inflow region communicates with the anterior chamber.

11. The system of claim 10, wherein one or more of the openings communicate with at least one tissue structure near an anterior angle of the eye, wherein the tissue structure is selected from the group consisting of trabecular meshwork, juxtacanalicular structure, aqueous vein, episcleral vein, Schlemm'"'"'s canal, a collecting channel, sclera, supraciliary space and suprachoroidal space.

12. The system of claim 11, wherein the ocular device is configured to conform to a contour of the tissue structure surrounding the ocular device.

13. The system of claim 1, wherein the ocular device is advanced around Schlemm'"'"'s canal up to about 340 degrees.

14. The system of claim 1, wherein the ocular device has a length that extends from the anterior chamber to a portion of Schlemm'"'"'s canal.

15. The system of claim 1, wherein the distal end of the ocular device is closed.

16. The system of claim 15, wherein the distal end of the ocular device is permanently coupled to the applier and the ocular device is not releaseably deployed within the eye.

17. The system of claim 16, wherein following expansion to the second diameter the expandable portion is returned to the first diameter and removed from the eye.

18. A method for the surgical treatment of an ocular disorder in an eye, comprising:

coupling an ocular stent device to a delivery device comprising an applier, a sheath, and an actuator;

forming a self-sealing incision in the cornea;

introducing the ocular stent device into the anterior chamber of the eye through the incision using the delivery device, the ocular stent device comprising;

a proximal end, a distal end, and an internal lumen forming a flow pathway extending from the proximal end to the distal end wherein upon implantation in the eye the proximal end is configured to be in fluid communication with Schlemm'"'"'s canal of the eye and the distal end is configured to be in fluid communication with an anterior chamber of the eye;

an inflow region near the proximal end communicating with the flow pathway; and

an expandable region comprising a plurality of interconnected struts forming multiple openings communicating with the flow pathway, wherein the expandable region has a first diameter of a generally cylindrical first cross-sectional shape suitable for insertion into the eye through the self-sealing incision in the cornea and a second diameter of a second cross-sectional shape that is larger than the first diameter and sized to expand the general circumference of the surrounding tissue, the second cross-sectional shape being generally oval and configured to conform to the contour of the Schlemm'"'"'s canal and prevent rotation of the ocular device upon expansion;

inserting the distal end of the ocular stent device into a tissue structure near an anterior angle of the eye such that the inflow region remains in communication with the anterior chamber and at least a portion of the expandable region is positioned within the tissue structure;

expanding the expandable region; and

conducting aqueous humor from the anterior chamber towards the tissue structure.

19. The method of claim 18, wherein expanding the expandable region comprises uncoupling the delivery device from the ocular stent device allowing the expandable region to passively expand.

20. The method of claim 18, wherein expanding the expandable region comprises actively expanding the expandable region with the delivery device.

21. The method of claim 18, wherein the second cross-sectional shape comprises a funnel shape.

22. The method of claim 18, wherein inserting the distal end of the ocular stent device into the tissue structure comprises inserting the distal end of the ocular stent device into at least one of a trabecular meshwork, juxtacanalicular structure, collecting channel, aqueous vein, episcleral vein, Schlemm'"'"'s canal, sclera, supraciliary space and suprachoroidal space.

23. The method of claim 22, further comprising returning the expandable region to the first cross-sectional shape.

24. The method of claim 23, further comprising removing the ocular stent device from the eye.

25. The method of claim 24, wherein the tissue structure is maintained in an expanded configuration after removal of the ocular stent device from the eye.

26. The method of claim 18, wherein inserting the distal end of the ocular stent device into the tissue structure comprises creating an opening in the tissue structure.