Methods for placing a shunt into the intra-scleral space

• US 8,852,136 B2
• Filed: 12/08/2011
• Issued: 10/07/2014
• Est. Priority Date: 12/08/2011
• Status: Active Grant

• Current Assignee: AqueSys, Inc. (Abbvie Incorporated)
• Original Assignee: AqueSys, Inc. (Abbvie Incorporated)
• Inventors: Horvath, Christopher, Romoda, Laszlo O., Anderson, Cory
• Primary Examiner(s): MARCETICH, ADAM M
• Application Number:
  US13/314,939
• Publication Number:
  US 20130150770A1
• Time in Patent Office: 1,034 Days
• Field of Search: 604/8, 604/9, 604/10, 604/264, 604/265, 604/93.01, 604/158, 604/159, 604/160, 623/1.11, 623/4.1, 623/5.11, 606/108, 606/167, 606/166, 606/184, 606/185, 606/190
• US Class Current: 604/8
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2009/00861 adapted for treatment at a particular location
• CPC Class Codes: A61F 2009/00865 Sclera
• CPC Class Codes: A61F 2009/00872 Cornea
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/007 Methods or devices for eye surgery
• CPC Class Codes: A61F 9/00736 Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments A61F9/008 takes precedence
• CPC Class Codes: A61F 9/00763 with rotating or reciprocating cutting elements, e.g. concentric cutting needles atherectomy cutting instruments A61B17/3207; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202

Abstract

The present invention generally relates to intraocular shunts, and in particular, to intraocular shunts configured to form a drainage pathway between the anterior chamber and the intra-scleral space.

Claims

1. A method of deploying an intraocular shunt into an eye, the method comprising the steps of:

inserting, through a cornea and into an anterior chamber of the eye, a hollow shaft carrying an intraocular shunt;

from within the anterior chamber, piercing sclera of the eye with the shaft such that a distal tip of the shaft enters the sclera; and

while maintaining the shaft distal tip positioned in the sclera, advancing the shunt from the hollow shaft to position a first end of the shunt in the anterior chamber and a second end of the shunt between layers of sclera such that the shunt forms a passage from the anterior chamber to the sclera.

2. The method according to claim 1, wherein the shunt is a soft gel shunt.

3. The method of claim 1, wherein the insertion step comprises inserting the hollow shaft into the eye anteriorly of the corneal limbus.

4. The method of claim 1, wherein the insertion step comprises inserting the hollow shaft into the eye posteriorly of the corneal limbus.

5. The method of claim 1, wherein the method is performed without inducing subconjunctival blebbing.

6. The method according to claim 1, wherein the shunt is from about 2 mm to about 10 mm.

7. The method according to claim 1, wherein the shunt comprises a material that has an elasticity modulus that is between about 0.7×

10⁶ N/m² and 4.3×

10⁶ N/m².

8. The method according to claim 7, wherein the material has an elasticity modulus that is substantially identical to an elasticity modulus of an eye tissue.

9. The method according to claim 7, wherein the material has an elasticity modulus greater than an elasticity modulus of scleral tissue.

10. The method according to claim 7, wherein the shunt comprises a material that has an elasticity modulus that is between about 0.7×

10⁶ N/m² and about 2.9×

10⁶ N/m².

11. The method according to claim 7, wherein the shunt comprises a material that has an elasticity modulus that is between about 1.5×

10⁶ N/m² and about 4.3×

10⁶ N/m².

12. The method according to claim 1, wherein the shunt comprises a hollow body, and at least a portion of the body comprises a flexible material that allows for fluctuation of an inner diameter of the portion of the shunt based upon pressure exerted from surrounding tissue and/or fluid in the organ.

13. The method according to claim 12, wherein an end of the body comprises a flexible material.

14. The method according to claim 12, wherein a middle portion of the body comprises a flexible material.

15. The method according to claim 12, wherein the entire shunt comprises the flexible material.

16. The method according to claim 1, wherein the shunt comprises more than two ports.

17. The method according to claim 16, wherein a first end of the shunt comprises more than one port and a second end of the shunt comprises a single port.

18. The method according to claim 16, wherein a proximal portion of the shunt, proximal to a midpoint along a longitudinal axis of the shunt, comprises a single port and a distal portion of the shunt, distal to a midpoint along a longitudinal axis of the shunt, comprises more than one port.

19. The method according to claim 16, wherein a proximal portion of the shunt, proximal to a midpoint along a longitudinal axis of the shunt, comprises more than one port, and a distal portion of the shunt, distal to a midpoint along a longitudinal axis of the shunt, comprises more than one port.

20. The method according to claim 16, wherein at least one of the ports is oriented substantially perpendicular relative to the longitudinal axis.

21. The method according to claim 16, wherein at least one of the ports is oriented at an angle to a longitudinal axis of the body.

22. The method according to claim 1, wherein the shunt comprises a body having at least one slit.

23. The method according to claim 22, wherein the slit is located adjacent to the inlet.

24. The method according to claim 23, wherein the slit has a width that is substantially the same or less than an inner diameter of the inlet.

25. The method according to claim 22, wherein the slit is located adjacent to the outlet.

26. The method according to claim 25, wherein the slit has a width that is substantially the same or less than an inner diameter of the outlet.

27. The method according to claim 25, wherein the slit does not direct the fluid unless the outlet is obstructed.

28. The method according to claim 22, wherein the body comprises a slit adjacent to the inlet and a slit adjacent to the outlet.

29. The method according to claim 1, wherein the shunt comprises a body having a variable inner diameter that increases along a length of the body from the inlet to the outlet.

30. The method according to claim 29, wherein the inner diameter continuously increases along the length of the body.

31. The method according to claim 29, wherein the inner diameter remains constant along at least a portion of the length of the body.

32. The method according to claim 1, wherein the shunt comprises a proximal end, a distal end, and a central lumen extending therebetween such that after advancing the shunt from the hollow shaft, the lumen permits flow of aqueous humor through the shunt from the anterior chamber to the sclera.

33. A method of deploying an intraocular shunt into an eye, the method comprising the steps of:

inserting, through a cornea and into an anterior chamber of the eye, a hollow shaft carrying an intraocular shunt;

from within the anterior chamber, forming a slit in sclera of the eye with the shaft such that a distal tip of the shaft enters the sclera; and

releasing the shunt from the hollow shaft such that a distal end of the shunt is received within the slit between layers of sclera and forms a passage from the anterior chamber of the eye to the sclera.

34. The method of claim 33, wherein the releasing comprises positioning the shunt distal end in the sclera between deep and superficial layers of sclera.

35. The method of claim 33, wherein the releasing comprises advancing a pusher component within the shaft to distally advance the shunt within the shaft and through the slit.

36. The method of claim 35, wherein the advancing the pusher component comprises rotating a portion of a deployment mechanism.

37. The method according to claim 33, wherein the shunt comprises a proximal end and a central lumen extending between the proximal and distal ends such that after releasing the shunt from the hollow shaft, the lumen permits flow of aqueous humor through the shunt from the anterior chamber to the sclera.