Method of and device for improving a drainage of aqueous humor within the eye

• US 6,375,642 B1
• Filed: 02/15/2000
• Issued: 04/23/2002
• Est. Priority Date: 02/15/2000
• Status: Expired due to Term

• Current Assignee: Alcon Incorporated
• Original Assignee: Grieshaber & Company AG Schaffhausen
• Inventors: Stegmann, M. D. Robert, Grieshaber, Hans R.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/503,884
• Time in Patent Office: 798 Days
• Field of Search: 604/8, 604/9, 604/10, 604/265, 604/266, 604/294, 604/48, 604/51, 604/54, 623/4.1, 623/4, 623/5.11, 623/5.12
• US Class Current: 604/294
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

A method for improving a drainage of aqueous humor in an eye of a living being and a device for maintaining the drainage of aqueous humor are described, wherein a first incision is made in a lamellar section of the sclera to form a first scleral flap which is then folded upwards in the direction of the cornea, thereby creating a recess in the sclera. A second scleral flap is formed by incising a second lamellar section in the area of the recess and lifted upwardly in the direction of the first sclera flap, thereby creating a second recess and exposing a portion of the Schlemm'"'"'s canal for permitting injection of a highly viscous medium. At least one support element is implanted in the lumen of the Schlemm'"'"'s canal on each of both sides of the second recess and, optionally, in the exposed portion of the Schlemm'"'"'s canal, whereby each of the support elements is made of a material that is decomposable by the tissue of the Schlemm'"'"'s canal and/or aqueous humor. For formation of a gap-like opening, the second scleral flap or a portion thereof is detached from the partially aqueous humor-permeable Descemet'"'"'s membrane in the area of the Schwalbe'"'"'s line, and the detached portion is held open by several protrusions formed on the support element implanted in the exposed portion of the Schlemm'"'"'s canal.

Claims

1. A method for improving a drainage of aqueous humor in an eye of a living being by conducting the aqueous humor in the area of the irido-corneal angle of the anterior chamber via the trabecular meshwork to the Schlemm'"'"'s canal and ultimately to the natural channel system, said method comprising the steps of:

incising a first lamellar section of the sclera to form a first scleral flap;

lifting the first scleral flap upwards in the direction of the cornea, thereby creating a recess in the sclera;

incising a second lamellar section in the area of the recess to thereby form a second scleral flap and a support surface bounding the scleral flap;

lifting the second scleral flap upwards in the direction of the first sclera flap, thereby creating a second recess and exposing a portion of the Schlemm'"'"'s canal;

implanting in the lumen of the Schlemm'"'"'s canal on each of both sides of the second recess, and, optionally, in the exposed portion of the Schlemm'"'"'s canal, at least one support element, each said support element being made of a material that is decomposable by at least one of the components selected from the group consisting of tissue of the Schlemm'"'"'s canal and aqueous humor;

folding the first scleral flap back, after severance of the second scleral flap, for placement upon the support surface, thereby confining a subscleral space adjacent the first scleral flap;

injecting a viscous medium into the subscleral space; and

rejoining the first scleral flap to the sclera.

2. The method of claim 1 wherein said implanting step includes implanting on each of both sides of the exposed portion of the Schlemm'"'"'s canal, at least two substantially ring-shaped support elements in spaced-apart disposition to hold the lumen of the Schlemm'"'"'s canal in expanded position, with the support elements being made of biolytically decomposable material.

3. The method of claim 1 wherein said implanting step includes implanting on each of both sides of the exposed portion of the Schlemm'"'"'s canal, at least two substantially spherically-shaped support elements in spaced-apart disposition to hold the lumen of the Schlemm'"'"'s canal in expanded position, with the support elements being made of biolytically decomposable material.

4. The method of claim 1 wherein the support element has an elongate, tubular configuration to hold the lumen of the Schlemm'"'"'s canal in expanded position, with the support element being made of biolytically decomposable material.

5. The method of claim 1 wherein the support element is a braided mesh of elongate configuration to hold the lumen of the Schlemm'"'"'s canal in expanded position, with the braided mesh being made of a biolytically decomposable material.

6. The method of claim 1 wherein the support element being designed in the form of an elongate helical spring to hold the lumen of the Schlemm'"'"'s canal in expanded position, with the helical spring being made of a biolytically decomposable material.

7. The method of claim 1 wherein said implanting step includes implanting on each of both sides of the exposed portion of the Schlemm'"'"'s canal, at least two substantially ring-shaped and/or spherical support elements in spaced-apart disposition in the lumen of the Schlemm'"'"'s canal, and implanting in the exposed portion of the Schlemm'"'"'s canal an elongate support element, to hold the lumen and the exposed portion of the Schlemm'"'"'s canal in expanded position, with each of the support elements being made of biolytically decomposable material.

8. The method of claim 1, and further comprising the steps of detaching the second scleral flap along a portion thereof in the area of the Schwalbe'"'"'s line from the partially aqueous humor permeable Descemet'"'"'s membrane to form a gap-shaped opening;

and holding the detached portion of the second scleral flap in open disposition by protrusions projecting out from the support element arranged in the exposed portion of the Schlemm'"'"'s canal.

9. A device for improving a drainage of aqueous humor in an eye of a living being and maintaining a drainage of aqueous humor, comprising a support element for implantation into the lumen of the Schlemm'"'"'s canal, said support element having a configuration selected from the group consisting of ring shape, spherical shape, elongate shape and tubular shape, wherein the support element is made of a biolytically decomposable material.

10. The device of claim 9 wherein material is decomposable by at least one of the components selected from the group consisting of tissue of the Schlemm'"'"'s canal and aqueous humor.

11. The device of claim 9 wherein the support element has a throughbore defined by a cross section selected from the group consisting of circular ring shape and elliptical ring shape, with the material of the support element being deformable to conform to a cross section of the Schlemm'"'"'s canal.

12. The device of claim 9 wherein the support element has a width, which exceeds a height of the substantially elliptical Schlemm'"'"'s canal, for preventing a tilting of the implanted support element.

13. The device of claim 9 wherein the support element is a sphere having at least one throughbore.

14. The device of claim 9 wherein the support element is a sphere having a plurality of circumferentially spaced throughbores.

15. The device of claim 9 wherein the support element is a tube having a throughbore and defined by a cross section selected from the group consisting of circular ring shape and elliptical ring shape, said tube being formed with a plurality of spaced-apart apertures and being made of biolytically decomposable material which is flexible and freely movable in relation to a theoretical longitudinal axis to suit its disposition and orientation.

16. The device of claim 9 wherein the support element is an elliptic tube having a throughbore and defining a broad side and a narrow side, said broad side of the tube formed with a plurality of apertures which are spaced from one another in axial direction, and said narrow side of the tube being formed with at least two protrusions spaced from one another in axial direction and projecting radially outwards.

17. The device of claim 9 wherein the support element of elongate configuration is made as a braided mesh which is freely movable to suit its disposition and orientation.

18. The device of claim 9 wherein the support element is configured as a flexible helical spring of elongate configuration and is freely movable to suit its disposition and orientation.

19. The device of claim 9 wherein the biolytically decomposable material is biolytically decomposable by at least one of the components selected from the group consisting of tissue of the Schlemm'"'"'s canal and aqueous humor within a time period of 2 to 12 months after implantation.

20. The device of claim 19 wherein each support element is made of cross-linked sodium-hyaluronate.